Instructions for use
PulmoVista 500
Electrical impedance tomographSoftware 1.2n
WARNINGTo properly use this medical device, read and comply with these instructions for use.
2 Instructions for use PulmoVista 500 SW 1.2n
Typographical conventions
Any text shown on the screen and any labeling on the device are printed in bold and italics, e.g., ROI 1 or Ref.
The "greater than" symbol > indicates the navigation path in a dialog window, for example System setup > System > Country. In this example, System setup represents the dialog window title, System represents a horizontally aligned tab, and Country a vertically aligned tab.
Screen reproduction
The reproductions of screen content in the instructions for use can differ from the content actually shown on the screen.
Trademarks
1 Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each new sequence of actions.
Bullet points indicate individual actions or differ-ent options for action.
– Dashes indicate the listing of data, options, or objects.
(A) Letters in parentheses refer to elements in the related illustration.
A Letters in illustrations denote elements referred to in the text.
Trademark Trademark owner
Medical Cockpit™ Dräger
Infinity® Dräger
PulmoVista™ Dräger
MEDIBUS™ Dräger
MEDIBUS.X® Dräger
Buraton® Schülke+
Mikrobac® BODE Chemie
Instructions for use PulmoVista 500 SW 1.2n 3
Safety information definitions
Definition of target groups
For this product, users, service personnel, and experts are defined as target groups.
These target groups must have received instruction in the use of the product and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product.
The product must be used, installed, reprocessed, maintained, or repaired exclusively by defined target groups.
User
Users are persons who use the product in accordance with its intended use.
Service personnel
Service personnel are persons who are responsible for the maintenance of the product.
Service personnel must be trained in the maintenance of medical devices and install, reprocess, and maintain the product.
Experts
Experts are persons who perform repair or complex maintenance work on the product.
Experts must have the necessary knowledge and experience with complex maintenance work on the product.
Abbreviations and symbols
For explanations refer to sections "Abbreviations" and "Symbols" in chapter "Overview".
WARNING
A WARNING statement provides important in-formation about a potentially hazardous situa-tion which, if not avoided, could result in death or serious injury.
CAUTION
A CAUTION statement provides important infor-mation about a potentially hazardous situation which, if not avoided, may result in minor or mod-erate injury to the user or patient or in damage to the medical device or other property.
NOTE
A NOTE provides additional information intended to avoid inconvenience during operation.
4 Instructions for use PulmoVista 500 SW 1.2n
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Instructions for use PulmoVista 500 SW 1.2n 5
Contents
Contents
For your safety and that of your patients. . . 7
General safety information . . . . . . . . . . . . . . . . 8Product-specific safety information. . . . . . . . . . 11
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 16Indications/contraindications . . . . . . . . . . . . . . 16Environment of use. . . . . . . . . . . . . . . . . . . . . . 18Option ADAP . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
PulmoVista 500 . . . . . . . . . . . . . . . . . . . . . . . . 20Medical Cockpit (Infinity C500). . . . . . . . . . . . . 21EIT module . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Power supply module (Infinity P2500) . . . . . . . 24Patient interface . . . . . . . . . . . . . . . . . . . . . . . . 25Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 27Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Operating concept . . . . . . . . . . . . . . . . . . . . . 31
Hardware elements . . . . . . . . . . . . . . . . . . . . . 32Screen elements. . . . . . . . . . . . . . . . . . . . . . . . 34
Assembly and preparation . . . . . . . . . . . . . . 37
Safety information for assembly and preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Preparing the Cockpit . . . . . . . . . . . . . . . . . . . . 38Connecting the mains power supply. . . . . . . . . 39Using the trolley . . . . . . . . . . . . . . . . . . . . . . . . 40Intrahospital transport . . . . . . . . . . . . . . . . . . . 41Preparation for using the MEDIBUS or MEDIBUS.X protocol . . . . . . . . . . . . . . . . . . . . 42Position of the user. . . . . . . . . . . . . . . . . . . . . . 43
Getting started . . . . . . . . . . . . . . . . . . . . . . . . 45
Switching on PulmoVista 500 . . . . . . . . . . . . . . 46Device check . . . . . . . . . . . . . . . . . . . . . . . . . . 47Attaching the patient interface . . . . . . . . . . . . . 49Connecting the trunk cable. . . . . . . . . . . . . . . . 52Monitoring sessions . . . . . . . . . . . . . . . . . . . . . 52
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Safety information for operation . . . . . . . . . . . 56Starting a new measurement . . . . . . . . . . . . . 57Main view . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Other views . . . . . . . . . . . . . . . . . . . . . . . . . . . 63Freeze display . . . . . . . . . . . . . . . . . . . . . . . . 71Export screenshot . . . . . . . . . . . . . . . . . . . . . . 71Marking events . . . . . . . . . . . . . . . . . . . . . . . . 72Signal quality . . . . . . . . . . . . . . . . . . . . . . . . . . 72Standby mode . . . . . . . . . . . . . . . . . . . . . . . . . 75Additional functions provided by the option ADAP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76Ending operation . . . . . . . . . . . . . . . . . . . . . . . 80
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 81
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82Configuring the screen layout . . . . . . . . . . . . . 82Configuring EIT settings . . . . . . . . . . . . . . . . . 88Configuring the system . . . . . . . . . . . . . . . . . . 90Configuring data recording . . . . . . . . . . . . . . . 94
Problem solving . . . . . . . . . . . . . . . . . . . . . . 97
Message – Cause – Remedy . . . . . . . . . . . . . 98
Cleaning and disinfection. . . . . . . . . . . . . . . 105
Safety information for reprocessing. . . . . . . . . 106Reprocessing procedure . . . . . . . . . . . . . . . . . 108Before reusing on patient . . . . . . . . . . . . . . . . 109
Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113Preventive maintenance . . . . . . . . . . . . . . . . . 114Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Disposing of the medical device . . . . . . . . . . . 116Disposing of batteries . . . . . . . . . . . . . . . . . . . 116
Contents
6 Instructions for use PulmoVista 500 SW 1.2n
Technical data. . . . . . . . . . . . . . . . . . . . . . . . . 117
Ambient conditions . . . . . . . . . . . . . . . . . . . . . . 118Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118Performance characteristics. . . . . . . . . . . . . . . 118Operating data . . . . . . . . . . . . . . . . . . . . . . . . . 119Classification . . . . . . . . . . . . . . . . . . . . . . . . . . 120Communication interfaces on Medical Cockpit Infinity C500 . . . . . . . . . . . . . . . . . . . . 121Device combinations . . . . . . . . . . . . . . . . . . . . 121EMC declaration. . . . . . . . . . . . . . . . . . . . . . . . 121Connections to IT networks . . . . . . . . . . . . . . . 124
Principles of operation . . . . . . . . . . . . . . . . . 125
Image generation . . . . . . . . . . . . . . . . . . . . . . . 126Information displayed by PulmoVista 500 . . . . 136Definition of baseline frames . . . . . . . . . . . . . . 142Definitions for color scales and scales of impedance waveforms . . . . . . . . . . . . . . . . . . . 145Principles of breath detection and determination of the tidal rate. . . . . . . . . . . . . . 147Literature references . . . . . . . . . . . . . . . . . . . . 148
List of accessories . . . . . . . . . . . . . . . . . . . . . 151
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Instructions for use PulmoVista 500 SW 1.2n 7
For your safety and that of your patients
For your safety and that of your patients
General safety information . . . . . . . . . . . . . . 8
Strictly follow these instructions for use . . . . . . 8Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Connected devices. . . . . . . . . . . . . . . . . . . . . . 9Safe connection with other electrical equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 9Electromagnetic compatibility (EMC) . . . . . . . . 10Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Storing the instructions for use . . . . . . . . . . . . . 10
Product-specific safety information . . . . . . . 11
Essential performance . . . . . . . . . . . . . . . . . . . 13
For your safety and that of your patients
8 Instructions for use PulmoVista 500 SW 1.2n
General safety information
The following WARNING and CAUTION statements apply to general operation of the medical device.
WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these instructions for use or in the instructions for use of another product being used with this medical device.
Strictly follow these instructions for use
Service
Accessories
WARNING
Risk of incorrect operation and of incorrect use
Any use of the medical device requires full un-derstanding and strict observation of all sec-tions of these instructions for use. The medi-cal device must only be used for the purpose specified under "Intended use" on page 16.
Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device la-bels. Failure to observe these safety informa-tion statements constitutes a use of the medi-cal device that is inconsistent with its intend-ed use.
WARNING
Risk of medical device failure and of patient injury
The medical device must be inspected and serviced regularly by service personnel and experts. Repair and complex maintenance car-ried out on the medical device must be per-formed by experts.
If the above is not complied with, medical de-vice failure and patient injury may occur. Ob-serve chapter "Service".
Dräger recommends that a service contract is obtained with DrägerService and that all re-pairs are performed by DrägerService. For maintenance Dräger recommends the use of authentic Dräger repair parts.
WARNING
Risk due to incompatible accessories
Dräger has tested only the compatibility of ac-cessories listed in the current list of accesso-ries. If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure.
Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories.
Instructions for use PulmoVista 500 SW 1.2n 9
For your safety and that of your patients
Connected devices
Safe connection with other electrical equipment
Patient safety
The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to persons familiar with the most important inherent characteristics of the medical device.
Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device.
These instructions for use do not contain any information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the medical device
– Potentially negative effects on patients with different underlying diseases
Medical device modification or misuse can be dangerous.
WARNING
Risk of electric shock and of device malfunc-tion
Any connected devices or device combina-tions not complying with the requirements mentioned in these instructions for use can compromise the correct functioning of the medical device and lead to an electric shock. Before operating the medical device, strictly comply with the instructions for use of all con-nected devices or device combinations.
CAUTION
Risk of patient injury
Electrical connections to equipment not listed in these instructions for use or these assembly in-structions must only be made when approved by each respective manufacturer.
For your safety and that of your patients
10 Instructions for use PulmoVista 500 SW 1.2n
Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility. During installation and before initial operation, follow the information in section: "EMC declaration" (page 121).
This device can be affected by other electrical devices.
Training
Training for users is available from the Dräger organization responsible (see www.draeger.com).
Storing the instructions for use
WARNING
Risk due to electrostatic discharge
Malfunctions that endanger the patient may occur if no protective measures against elec-trostatic discharge are employed in the follow-ing situations:– When touching the pins of connectors that
carry the ESD warning symbol.– When establishing connections with these
connectors.
To prevent malfunctions, observe the follow-ing measures and train the relevant person-nel:– Observe the ESD protective measures.
Such measures may include wearing anti-static clothing and shoes, touching a po-tential equalization pin before and while making the connection, or using electrical-ly insulating and antistatic gloves.
– Observe the requirements for the electro-magnetic environment. Observe the fol-lowing section: "Electromagnetic environ-ment" (page 122).
WARNING
Risk due to electromagnetic disturbance
Wireless communication devices (e.g., cellu-lar phones) and medical electrical equipment (e.g., defibrillators, electrosurgical devices) emit electromagnetic radiation. When such devices are operated too close to this device or its cables, the functional integrity of this de-vice may be compromised by electromagnetic disturbances. As a result, the patient could be put at risk.
Maintain a distance of at least 0.3 m (1.0 ft) be-tween this device and wireless communica-tion devices, to ensure that the essential per-formance of this device is fulfilled.
Maintain an adequate distance between this device and other medical electrical equip-ment.
WARNING
Risk of image distortion which may lead to wrong therapeutic decisions
If images or waveforms are distorted, check if electromagnetic interference is compromis-ing the function of the medical device and, if possible, avoid the interference.Other equipment may interfere with the func-tion of the medical device, even if the other equipment complies with CISPR emission re-quirements.
CAUTION
Risk of incorrect use
Instructions for use must be kept accessible to the user.
Instructions for use PulmoVista 500 SW 1.2n 11
For your safety and that of your patients
Product-specific safety information
WARNING
To properly use this medical device, the user must obtain a full understanding of the perfor-mance characteristics of this medical device prior to use by carefully reading these Instruc-tions for Use.
WARNING
Risk of incorrect use
This medical device must only be used by physicians, respiratory therapists, and nurs-es, who have received training on the use of this medical device.
WARNING
Risk of device malfunction
Only devices listed in these instructions for use may be connected to the medical device. Otherwise, the correct functioning of this medical device may be compromised.
WARNING
Risk of wrong therapeutic decisions
Do not use this medical device as the sole ba-sis for diagnosis or therapeutic decisions.
WARNING
Danger of personal injury
Modifications to the medical device may cause malfunctioning.
Do not modify this medical device without au-thorization by Dräger.
WARNING
Risk of ineffective defibrillation
Remove all parts of the patient interface from the patient before cardiac defibrillation.
WARNING
Risk of device malfunction
If the patient interface was connected during defibrillation despite the warning, all parts of the patient interface, including the patient ca-ble and the trunk cable, must be replaced.
WARNING
Risk of electric shock and of device malfunc-tion
Do not use the medical device in environ-ments that are subject to conductive pollu-tion, e.g., metal or graphite particles or dust, or continuous conductivity, e.g., wet condi-tions.
WARNING
Risk of fire and of explosion
Do not use the medical device in areas where combustible or explosive gas mixtures are likely to occur.
WARNING
Risk of fire
Do not use the medical device in an oxygen-enriched environment.
WARNING
Risk of fire
Do not position the medical device close to an oxygen outlet which opens to the ambient at-mosphere. Keep the medical device at least 1 m (3.3 ft) in front of the O2 outlet and 20 cm (7.9 in) to the side of the O2 outlet.
WARNING
Risk of device malfunction
Do not use the medical device outside the specified ambient conditions.
For your safety and that of your patients
12 Instructions for use PulmoVista 500 SW 1.2n
WARNING
Risk of electric shock and of device malfunc-tion
Avoid the ingress of liquids.
WARNING
Risk of damage to the device
If liquid is accidentally spilled on the medical device, disconnect the medical device from the mains power supply. Contact service per-sonnel.
WARNING
Risk of device malfunction
Do not expose the medical device to direct ra-dioactive radiation.
WARNING
Risk of device malfunction
Do not directly expose any part of the medical device, except the patient interface, to X-rays.
WARNING
Risk of device malfunction
If the ventilation slots or heat exchange sur-faces of the medical device are covered, the air flow is blocked and the medical device may overheat.
Do not cover the ventilation slots and heat ex-change surfaces of the medical device.
WARNING
Risk of electric shock
Do not open the housing of the medical de-vice.
WARNING
Risk of electric shock and of device malfunc-tion
Only connect passive storage media without their own power supply to the USB port.
WARNING
Risk of electric shock and of device malfunc-tion
Do not use the medical device in areas outside the specification for electrical supply as stat-ed in the section "Operating data" on page 119.
WARNING
Risk of image distortion and impaired func-tional integrity of other bioimpedance measur-ing devices and risk of cardiac arrhythmia
Do not use the medical device in conjunction with other bioimpedance measuring devices.
WARNING
Risk of device malfunction
Do not use the medical device in the presence of strong magnetic fields, e.g., MRT.
WARNING
Risk of skin burns
Disconnect the electrode belt from the device or from the patient during electricity-based therapies such as electrosurgery or electro-cautery.
WARNING
Risk of patient contamination
Do not attach the electrode belt to the sterile part of the patient’s body where surgery is be-ing performed.
CAUTION
X-rays can impair the quality of EIT images.
Only operate the medical device at a distance of at least 1.5 m (4.9 ft) from X-ray devices.
Instructions for use PulmoVista 500 SW 1.2n 13
For your safety and that of your patients
The Medical Cockpit (Infinity C500) is only designed for use with the software supplied with PulmoVista 500. A software update must be performed by experts.
Essential performance
PulmoVista 500 displays EIT dynamic images and changes of end-expiratory lung impedance in a way which allows the informed user to interpret the displayed information correctly.
PulmoVista 500 ensures that the currents passed to the patient are within acceptable limits.
PulmoVista 500 is not a life-supporting device in the sense of IEC 60601-1-2.
CAUTION
Risk of damage to the touchscreen
Do not allow sharp instruments to touch the touch-screen of the Medical Cockpit (Infinity C500).
CAUTION
Risk of overheating
Keep the medical device away from sources of heat such as direct sunlight or radiators. Do not cover the device with bedclothes.
CAUTION
Risk of wrong therapeutic decisions
Check if EKG, EMG, EOG or EEG are influenced by EIT measurements.
CAUTION
Risk due to missing anti-virus software
PulmoVista 500 does not include any anti-virus software and thus relies on the anti-virus mea-sures of the hospital.
14 Instructions for use PulmoVista 500 SW 1.2n
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Instructions for use PulmoVista 500SW 1.2n 15
Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Indications/contraindications . . . . . . . . . . . . 16
Medical indications . . . . . . . . . . . . . . . . . . . . . . 16Medical contraindications . . . . . . . . . . . . . . . . . 16
Environment of use . . . . . . . . . . . . . . . . . . . . 18
Option ADAP. . . . . . . . . . . . . . . . . . . . . . . . . . 18
Application
16 Instructions for use PulmoVista 500SW 1.2n
Intended use
PulmoVista 500 is a non-invasive monitoring device used as a tool for assessing the patient's distribution of ventilation and changes of lung volume.
PulmoVista 500 is intended to perform thoracic bioimpedance measurements by applying the technique of electrical impedance tomography (EIT).
PulmoVista 500 displays regional information on ventilation-related changes of air content within the electrode plane.
PulmoVista 500 displays regional information on changes of end-expiratory lung volume within the electrode plane.
PulmoVista 500 displays this information in the following form:– Real-time cross-sectional EIT dynamic images– Cross-sectional EIT status images– Real-time impedance waveforms– Derived numeric parameters– Trend data
PulmoVista 500 is intended for use on patients with a chest circumference ranging from 70 cm (27.6 in) to 150 cm (59 in).
PulmoVista 500 must only be used by qualified and trained medical personnel.
The displayed information is only intended to serve as a supplementary source for the assessment of lung function.
Indications/contraindications
Medical indications
PulmoVista 500 is intended for use on patients whose regional distribution of ventilation and of lung volume are of clinical interest. To ensure proper contact between the electrodes and the skin during the measurements, patients must be in a supine, prone, or lateral position. In a seated position, the patient must lean against a backrest.
Medical contraindications
WARNING
Risk of pacemaker impairment
Do not use PulmoVista 500 on patients with pacemaker.
WARNING
Risk of defibrillator impairment
Do not use PulmoVista 500 on patients with an implantable cardioverter-defibrillator.
WARNING
Risk of incorrect measurements and image distortions
Do not use PulmoVista 500 on patients with other electrically active implants which are likely to interfere with PulmoVista 500.
Instructions for use PulmoVista 500SW 1.2n 17
Application
WARNING
Risk of excessive skin damage
Do not use PulmoVista 500 on patients whose skin is damaged in the region where the pa-tient interface needs to be placed.
WARNING
Risk of image distortion
Do not use PulmoVista 500 on patients where the electrodes cannot provide sufficient elec-trical contact to the skin of the patient, e.g., due to wound dressings.
WARNING
Do not use PulmoVista 500 on patients where the attachment of the patient interface could pose a risk to the patient, e.g., patients with spinal lesions or fractures.
WARNING
Risk of image distortion
Do not use PulmoVista 500 on patients with uncontrolled body movements.
WARNING
Safety and effectiveness have not been estab-lished for pregnant women or for children un-der 5 years of age.
Do not use PulmoVista 500 on these patients.
NOTE
The measurement accuracy in patients with a tidal volume of less than 200 mL has not been validat-ed.
NOTE
There is a risk of image distortion in patients with a body mass index higher than 50.
Application
18 Instructions for use PulmoVista 500SW 1.2n
Environment of use
PulmoVista 500 is intended for use in hospital environments only.
When switched off and disconnected from the patient, PulmoVista 500 may accompany a patient during transport within the hospital.
The use in computed tomography examination labs is possible, but this may result in impaired EIT data.
The use in operating rooms is possible, but requires special safety measures regarding sterile surgery areas and electrosurgical treatment. For further information, see the following section: "Product-specific safety information" on page 11.
PulmoVista 500 must not be used:– During transport– In areas of explosion hazard– In oxygen-rich environments– In areas where radioactive substances are used
Option ADAP
The option ADAP (Advanced Data Analysis Package) extends the functionality of the basic EIT software with the following functions:– Patient data entry– Data recording– Data review– File handling– Higher frame rate– Filter setting Band pass– Manual adjustment of the operating frequency
For a detailed description, refer to "Additional functions provided by the option ADAP" on page 76.
WARNING
Risk of fire and of explosion
PulmoVista 500 is not intended to be used in areas with explosion hazards and in the pres-ence of flammable anesthetic agents or other flammable agents.
Instructions for use PulmoVista 500 SW 1.2n 19
Overview
Overview
PulmoVista 500 . . . . . . . . . . . . . . . . . . . . . . . . 20
Medical Cockpit (Infinity C500) . . . . . . . . . . . 21
Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
EIT module . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Right side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Underside . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Power supply module (Infinity P2500) . . . . . 24
Underside . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Patient interface . . . . . . . . . . . . . . . . . . . . . . . 25
Electrode belt . . . . . . . . . . . . . . . . . . . . . . . . . . 25Patient cable. . . . . . . . . . . . . . . . . . . . . . . . . . . 26Trunk cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 27
Abbreviations in the PulmoVista 500 software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Abbreviations in the instructions for use. . . . . . 28Abbreviations for labeling . . . . . . . . . . . . . . . . . 28
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Overview
20 Instructions for use PulmoVista 500 SW 1.2n
PulmoVista 500
The electrical impedance tomograph PulmoVista 500 consists of the following components:
A Medical Cockpit (Infinity C500)
B Handle
C EIT module
D Trolley with 4 double castors with locking brakes
E Power supply module (Infinity P2500)
F Electrode belt
G Patient cable
H Trunk cable
01
0a
FA
B
C
G
HD
E
Instructions for use PulmoVista 500 SW 1.2n 21
Overview
Medical Cockpit (Infinity C500)
The Medical Cockpit, hereafter referred to as the Cockpit, is the user interface for PulmoVista 500. The Cockpit displays images, waveforms, and parameters originating from the EIT module or from a Dräger device connected via MEDIBUS or MEDIBUS.X.
Front
Infinity C500 (MS18746):
Infinity C500 (MK31500):
A Alert bar, lights up red during system start, not otherwise used
B Audio pause button (only active during screen calibration)
C Rotary knob
D Battery LED, indicates battery status
E On/Off key
F Mains power LED, lights up when the device is connected to AC power
00
21
34
A
B
CF DE
B
CE DF
A
Overview
22 Instructions for use PulmoVista 500 SW 1.2n
Back
Infinity C500 (MS18746):
Infinity C500 (MK31500):
A Cockpit holder
B Cover with opening for system cable
C USB ports (right and left)
D Serial communication ports (RS 232)
01
21
35
A
C
D
C
B
C C
A
B
D
Instructions for use PulmoVista 500 SW 1.2n 23
Overview
EIT module
Right side
A Trunk cable port
B Label for trunk cable port
C Test connector
D Label for test connector
Underside
E System cable port, for connection to power supply
Front
F Securing bracket for system cable plug
Back
G Ventilation slots
01
50
19
B A
CD
E
02
01
37
D
F
G
G
Overview
24 Instructions for use PulmoVista 500 SW 1.2n
Power supply module (Infinity P2500)
Underside
A System cable port, for connection to EIT module
B System cable port, for connection to Cockpit
C Potential equalization connector
D Power cord connection
Front
The front of the power supply module has two LEDs.
If the power supply module has been disconnected from the mains power supply for several minutes, the yellow LED will briefly light up when the power supply module is again connected to the mains power supply.
The battery is being charged if the green LED is lit and the yellow LED is not lit.
01
4b
A B C D
LED Color Symbol Meaning Status Principles of operation
Green AC power Unlit Mains power supply not available
Lit Mains power supply avail-able, battery charging in progress
Yellow ! Battery failure indicator
Unlit Battery working correctly
Lit Battery failure
Instructions for use PulmoVista 500 SW 1.2n 25
Overview
Patient interface
The patient interface is made up of the following components:– Electrode belt– Reference electrode– Patient cable– Trunk cable
Electrode belt
The electrode belt has 16 equally spaced electrodes and a closure stud. Electrode studs 1 and 16 are numbered.
The electrode belt is available in 5 sizes readily identifiable by different colors and a size label. See Page 49.
Exterior surface
A Closure with 6 different positionsPosition 3 from the right provides optimal reconstruction of the EIT images.
B Electrode studs, 1 to 16
C Size label
D Closure stud
Interior surface
E Electrodes, 1 to 16
F Midposition marker
02
1
L
1
L
16
B C B DA
02
2
E F E
Overview
26 Instructions for use PulmoVista 500 SW 1.2n
Patient cable
The patient cable has 16 equally spaced serially numbered snaps to connect to the electrode studs on the electrode belt. One end of the patient cable has a reference electrode snap. The other end of the patient cable terminates in a snap for the closure stud of the electrode belt.
The patient cable is available in 5 sizes, corresponding to each electrode belt size. The snaps on the patient cable are color-coded to match the corresponding electrode belt.
A 16 electrode snaps
B Reference electrode snap, labeled Ref
C Right patient cable port, green colored, labeled R
D Left patient cable port, red colored, labeled L
E Closure snap, labeled C
Trunk cable
A Trunk cable plug
B Right patient cable plug, green colored, labeled R
C Left patient cable plug, red colored, labeled L
NOTE
The patient cable is specifically designed for the detection of very low voltages. Due to its sophisti-cated nature, the patient cable is very delicate and must be handled with care. Avoid kinking, stretch-ing, or twisting the cable.
Size ColorS Medium blueM Dark blueL Dark redXL GrayXXL Violet
02
8
L
4321
R
125 13 14 15 166 7 8 9 10 11 RС
E
A
C BD0
16
RL
A
B
C
Instructions for use PulmoVista 500 SW 1.2n 27
Overview
Abbreviations
Abbreviations in the PulmoVista 500 software
MEDIBUS abbreviations can be found in the document "MEDIBUS for V and VN ventilators" (9039527).
MEDIBUS.X abbreviations can be found in the document "Profile Definition MEDIBUS.X" (9052608).
Additional MEDIBUS data abbreviations:
Abbreviation Explanation
/min Per minute
ADAP Advanced Data Analysis Pack-age
C Cursor C
CL Compliance loss (decrease in compliance)
CL HP Compliance loss towards higher PEEP levels (decrease in com-pliance with increasing PEEP levels)
CL LP Compliance loss towards lower PEEP levels (decrease in com-pliance with decreasing PEEP levels)
cmH2O Centimeters of water1 cmH2O = approx. 1 mbar
CW Compliance win (increase in compliance)
dB Decibel
EIP End-inspiratory pressure
EELI global Global change of end-expiratory lung impedance
EELI ROI Regional change of end-expira-tory lung impedance
IP address Internet protocol address
kHz Kilohertz
mbar Millibar
min Minute
mL Milliliter
mmHg Millimeters of mercury
MTV global Global minute tidal variation
MTV ROI Regional minute tidal variation
Paw Airway pressure
PEEP Positive end-expiratory pressure
PIP Peak inspiratory pressure
Ref Cursor Ref
Ref Reference
ROI Region of interest
RVD Regional ventilation delay (regional delay during ventila-tion)
RVD Ratio Ratio of the RVD pixels to the to-tal number of ventilated pixels
RVD SD RVD standard deviation (standard deviation of the RVD)
s Second
Ti Inspiratory time
Tidal rate Tidal rate per minute
TV global Global tidal variation
TV ROI Regional tidal variation
Vol. Volume
VT Tidal volume
I:E Ratio of inspiratory time to expi-ratory time
V Volume
Abbreviation Explanation
Overview
28 Instructions for use PulmoVista 500 SW 1.2n
Abbreviations in the instructions for use
Abbreviations for labeling
Abbreviation Explanation
A Ampere
AC Alternating current
BF Body floating
CISPR Comité international spécial des perturbations radioélectriques (Special International Commit-tee on Radio Interference)
cm Centimeter
COM1 Communication port 1
CT Computer tomography
DC Direct voltage
EEG Electroencephalogram
EELI End-expiratory lung impedance
EIT Electrical impedance tomogra-phy
ECG Electrocardiogram
EMG Electromyography
EMC Electromagnetic compatibility
EOG Electrooculogram
ESD Electrostatic discharge
FEM Finite element method
GHz Gigahertz
RF Radio frequency
Hz Hertz
in Inch
LED Light-emitting diode
MB Megabyte
MEDIBUS Dräger communication protocol for medical devices
MRT Magnetic resonance imaging
Rel. Relative
SIM Subscriber Identity Module
USB Universal serial bus
V Voltage
SELV Safety extra low voltage
Abbreviation Explanation
C Closure snap
IPX Degree of protection against in-gress of water
L Left
R Right
Ref Reference electrode snap
Abbreviation Explanation
Instructions for use PulmoVista 500 SW 1.2n 29
Overview
Symbols
Symbol Explanation
On/Off key
Mains power supply(AC power)
Battery indicator
Caution! Observe important safety-rel-evant information and precautionary measures in the instructions for use.
Follow instructions for use.
ESD (Electrostatic discharge) warning symbol
Observe disposal instructions
Applied part type BF
Manufacturer
20xx Year of manufacture
Risk of medical device tipping over when the medical device is pushed
Non-ionizing electromagnetic radiation
Protective earth
Potential equalization connector
USBport
Serial connection
Serial number
Part number, sometimes including revi-sion index
Small
Medium
Large
Extra large
SN
REF
S
M
L
XL
Extra extra large
Temperature during storage
Relative humidity during storage
Ambient pressure during storage
System cable port for connection of the EIT module to the power supply mod-ule
Trunk cable port for connection of the trunk cable to the EIT module
Test connectors
China RoHS mark
Connection for potential equalization bonding at the bottom of the power supply unit
Keep away from rain
Identification of packaging material
This end up
Non-stackable
Fragile
Use by
~ Waveform (symbol on the screen)
Maximum weight
System connector at the Cockpit
Audio paused key (not used)
Symbol Explanation
XXL
EIT
TEST
02
max. 44 kg (97 lbs)
SysCon
30 Instructions for use PulmoVista 500 SW 1.2n
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Instructions for use PulmoVista 500 SW 1.2n 31
Operating concept
Operating concept
Hardware elements. . . . . . . . . . . . . . . . . . . . . 32
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Rotary knob . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Fixed keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32LEDs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Screen elements . . . . . . . . . . . . . . . . . . . . . . . 34
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Header bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Monitoring area. . . . . . . . . . . . . . . . . . . . . . . . . 34Main menu bar . . . . . . . . . . . . . . . . . . . . . . . . . 35Dialog windows. . . . . . . . . . . . . . . . . . . . . . . . . 35Button and tab colors . . . . . . . . . . . . . . . . . . . . 36Calibrating the touchscreen . . . . . . . . . . . . . . . 36
Operating concept
32 Instructions for use PulmoVista 500 SW 1.2n
Hardware elements
Overview
The Cockpit is the user interface for PulmoVista 500. This section describes its most important hardware elements.
Rotary knob
The rotary knob (A) is the main navigational tool of the Cockpit.
Using the rotary knob
1 To select a setting, press a button on the screen.
2 Turn the rotary knob clockwise to increase a numeric value, scroll down a list or navigate to the right during horizontal navigation.
Turn the rotary knob counterclockwise to decrease a numerical value, scroll up a list or navigate to the left during horizontal navigation.
3 Press the rotary knob to confirm a setting or to activate a function when it appears yellow.
Rotary knob backlight
The backlight of the rotary knob lights up yellow when an action is required to be confirmed by pressing the knob.
Fixed keys
Two fixed keys are located at the Cockpit. The On/Off key (A) is located in the left corner. The Audio Paused key (B) has no functionality.
02
7
A
011
BA
Instructions for use PulmoVista 500 SW 1.2n 33
Operating concept
LEDs
The Cockpit is equipped with several LEDs that report the device status.
Infinity C500 (MS18746):
Infinity C500 (MK31500):
A Mains power LED
B On/Off key and LED. The LED in the key lights up when the system is switched on
C Battery LED – indicates the battery status
D Ambient light sensor
LED indications
00
31
34
A B C
B CAD
LED Symbol LED Color/State Principles of operation
AC power Unlit No mains power supply available
Solid green Mains power supply available
Power Unlit System is switched off
Solid green System is switched on
Battery Unlit No battery power available
Solid green Batteriy >80 % capacity
Solid yellow Battery 80 % capacity
Flashes yellow Fault
Operating concept
34 Instructions for use PulmoVista 500 SW 1.2n
Screen elements
Overview
The following diagram describes the major screen elements of the Cockpit as the user interface of PulmoVista 500. Each element is described in more detail in the following sections.
A Header bar
B Monitoring area
C Main menu bar
Header bar
The blue header bar is always visible and always appears along the top of the Cockpit. The header bar is divided into several fields which are reserved for specific types of information. The fields that are displayed are limited during Standby and may change according to the installation of optional software.
By touching different fields in the header, specific dialog windows can be opened.
A Patient name (requires the option ADAP)
B System time
C Filter settings
D Signal quality indicator
E Technical messages
F Help text messages
Monitoring area
The monitoring area consists of the area for images and waveforms and the parameter boxes. The appearance and the content of the monitoring area can be adapted to the clinical situation with the use of the Views... button, see page 58.
A Dynamic image
B Status image
C Impedance waveforms
D Parameter boxes for displaying the following:– Tidal rate– Tidal variation or minute tidal variation
50
2
A
B
C
50
35
04
A B C D EF
AD
BC
Instructions for use PulmoVista 500 SW 1.2n 35
Operating concept
Main menu bar
The main menu bar is located along the right edge of the screen and is always visible. It consists of the following buttons:
A Views..., for accessing the predefined views– Main– Full-screen image– End-insp. trend– EELI trend– Diagnostics
For details, see "Main view" on page 58.
B Freeze display, see "Freeze display" on page 71
C Export screenshot, see "Export screenshot" on page 71
D Mark event..., see "Event marking" on page 72
E Data review... (requires the ADAP option), see "Data review" on page 76
F Record (requires the ADAP option), see "Data recording" on page 76
G Signal check... for checking the electrode resistance, see "Signal quality" on page 72
H System setup... for configuring the system functions, see "Configuration" on page 81
I Start/ Standby... for selecting standby mode or starting the measurement, see "Standby mode" on page 75
Touching a button opens the corresponding dialog window or activates the corresponding function.
Dialog windows
Dialog windows consist of one or more pages, which may in turn have subpages. Pages and subpages are accessed by touching the corresponding horizontal or vertical tab. Dialog windows contain elements for operating the system and inform the user of current settings. Dialog windows can be opened by touching a button in the main menu bar.
A Dialog window title
B Button for closing the dialog window
C Horizontal tabs
D Vertical tabs
50
2
A
CD
F
GHI
E
B
50
5
A
C
D
B
CC C
D
D
Operating concept
36 Instructions for use PulmoVista 500 SW 1.2n
Button and tab colors
Colors identify the availability of functions or settings.
The colors listed in the following table indicate if a button or a tab is available or selectable and if a user action is required.
If a selection is not confirmed within 15 seconds, it will revert to the previous setting.
Calibrating the touchscreen
If the touchscreen can no longer be operated, it might be maladjusted. In this case, calibrate the touchscreen.
1 Press and hold the rotary knob and the key simultaneously for at least 10 seconds.
The calibration screen is displayed.
2 Touch the markings displayed consecutively on the touchscreen.
Only for Infinity C500 (MS18746):
3 To confirm the calibration, touch the green tick.
Color Status
Light green The button is active, ready for selection.
Dark green The button has been selected and displays the current selec-tion.
Yellow The button is selected. However, user input or confirmation by pressing the rotary knob is re-quired.
Gray The button is not available for selection due to a certain mode or required connection.
NOTE
No screen content is displayed during touchscreen calibration. Therefore, only calibrate the touch-screen if no screen content needs to be displayed.
Instructions for use PulmoVista 500 SW 1.2n 37
Assembly and preparation
Assembly and preparation
Safety information for assembly and preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Preparing the Cockpit . . . . . . . . . . . . . . . . . . 38
Tilting the Cockpit . . . . . . . . . . . . . . . . . . . . . . . 38Turning the Cockpit . . . . . . . . . . . . . . . . . . . . . 38
Connecting the mains power supply . . . . . . 39
Using the trolley . . . . . . . . . . . . . . . . . . . . . . . 40
Parking the trolley. . . . . . . . . . . . . . . . . . . . . . . 40
Intrahospital transport . . . . . . . . . . . . . . . . . . 41
Before transportation . . . . . . . . . . . . . . . . . . . . 41Moving the trolley . . . . . . . . . . . . . . . . . . . . . . . 41
Preparation for using the MEDIBUS or MEDIBUS.X protocol . . . . . . . . . . . . . . . . . . . 42
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Connecting PulmoVista 500 to a Dräger device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Position of the user . . . . . . . . . . . . . . . . . . . . 43
Assembly and preparation
38 Instructions for use PulmoVista 500 SW 1.2n
Safety information for assembly and preparation
Preparing the Cockpit
Tilting the Cockpit
The Cockpit can be tilted up and down.
1 Press and hold the tilt release button (A).
2 Tilt the Cockpit to the desired working position.
3 Release the button and make sure that it engages securely.
Make sure that the Cockpit mount (B) is secure.
Turning the Cockpit
The Cockpit can be turned 30° to the left or to the right.
Turn to the desired working position.
WARNING
Risk of device malfunction, of electric shock, and of mechanical instability
Do not install or modify PulmoVista 500. Only assemblies that are described in these in-structions for use may be modified by the us-er.
Only service personnel may assemble PulmoVista 500. For relevant information, contact the local DrägerService support.
WARNING
Risk of device malfunction, of electric shock, and of mechanical instability
If there are any signs of damage, do not use PulmoVista 500.
Contact DrägerService.
CAUTION
Risk of damage to the Cockpit
Check that the Cockpit is fitted securely.
04
3
A
B
Instructions for use PulmoVista 500 SW 1.2n 39
Assembly and preparation
Connecting the mains power supply
Make sure that the mains power supply is in accordance with the specifications in the "Operating data" section.
Insert the mains plug into the mains power outlet.
The LED on the Cockpit and the LED on the power supply module light up green.
Power supply from the internal battery
The power supply module incorporates an internal battery to ensure that operation of the device can continue for at least 5 minutes without mains power (if the battery is fully charged).
When mains power is connected, the internal battery is being charged. The internal battery will only reach its full capacity after charging for 24 hours.
Power supply for the Cockpit and the EIT module
The Cockpit and the EIT module are supplied with power from the power supply module using two system cables. The system cables have already been permanently installed.
WARNING
Risk of electric shock and of device malfunc-tion
Do not use the medical device outside of a hospital.
WARNING
Risk of electric shock
Only connect PulmoVista 500 to a mains pow-er supply with protective grounding.
WARNING
Risk of high leakage current
Wrong connections may jeopardize the elec-trical safety of this device.
Only connect the mains plug to a fixed mains power socket.
WARNING
Risk of electric shock
Wrong connections, e.g., to other equipment, may violate the insulation concept.
Do not disconnect the system cables. Contact DrägerService if necessary.
WARNING
Risk of explosion
The device must be located in a well-ventilat-ed area when connected to the mains power supply. Electrolytic gas can occur when the batteries are charging. In a sufficient concen-tration, this can cause an explosion.
NOTE
Keep PulmoVista 500 connected to the mains power supply during storage to prevent battery de-pletion.
NOTE
Only use the power supply cord supplied by Dräger.
NOTE
Position PulmoVista 500 so that its mains plug can be pulled out for disconnection without difficulty.
Assembly and preparation
40 Instructions for use PulmoVista 500 SW 1.2n
Potential equalization
The power supply module contains a potential equalization connector, which can be used in specific cases for connections with other electrical devices to ensure an equal ground potential. For further details, refer to IEC 60601-1, or applicable national or international standards.
Using the trolley
Check the correct condition of the trolley before each use.
Make sure that all device parts, e.g.,Cockpit, are securely attached.
Parking the trolleyWARNING
Risk of tipping over
Do not attach additional items to the trolley.
CAUTION
Risk of tipping over
Do not tilt the device more than 10°.
03
3
10°
CAUTION
When parking the trolley, lock all double castors and make sure that the brakes are working cor-rectly.
Instructions for use PulmoVista 500 SW 1.2n 41
Assembly and preparation
Intrahospital transport
Do not switch on PulmoVista 500 during intrahospital transport.
Before transportation
1 Switch off PulmoVista 500 and remove the mains plug from the mains power outlet.
2 Remove the patient cable plugs from the patient cable ports.
3 Do not attach any additional parts to the handle.
4 Rotate the Cockpit to the central position.
Moving the trolley
1 Before moving the trolley, release all four locking brakes.
2 To move the trolley, securely hold the trolley handle and move the device in the longitudinal direction.
3 During transportation across inclinations, around corners or across thresholds, (e.g., in doors or elevators) the medical device must not collide with any object.
WARNING
Risk of patient injury and risk of device dam-age
During intrahospital transport a pulling force may be exerted on the patient, the patient ca-ble, and the electrode belt, e.g., if the patient cable becomes caught on other objects.
Disconnect the patient from the device. To do this, switch off the device and remove the pa-tient cable from the trunk cable.
During inter-clinical transport securely posi-tion the parts remaining with the patient.
WARNING
Danger of personal injury and device damage
A toppling risk exists near thresholds, on un-even ground and on ramps.
Move the trolley at a walking pace. Securely hold the device using the handle when pass-ing thresholds and obstacles.
Assembly and preparation
42 Instructions for use PulmoVista 500 SW 1.2n
Preparation for using the MEDIBUS or MEDIBUS.X protocol
Overview
PulmoVista 500 can display data from Dräger devices using the MEDIBUS- or MEDIBUS.X protocol.
Only connect the following Dräger devices1) to the COM 1 port of PulmoVista 500:– Evita 2 dura– Evita 4, Evita 4 edition– Evita XL– Evita V300– Evita Infinity V500– Babylog VN500– Savina 300
The devices listed for connection to the serial port meet the requirements of IEC 60950-1 for ungrounded SELV circuits or the requirements of IEC 60601-1 (2nd edition and higher) for touchable secondary circuits with max. 24 V DC nominal voltage.
The MEDIBUS or MEDIBUS.X interface must only be connected to the devices specified by Dräger by service personnel.
The following data can be displayed:
– Volume waveform (Main view)
– Tidal volume parameter (Main view)
– 3 configurable parameters, as defined in the system setup (view End-insp. trend, EELI trend)
– The parameters PEEP and EIP (or PIP if EIP is not available) in the Diagnostics view
– All MEDIBUS parameters on the Data review page
The following MEDIBUS or MEDIBUS.X data is recorded as part of data recording (requires the option ADAP):– All measured values– 3 real-time waveforms
Connecting PulmoVista 500 to a Dräger device
Prerequisite: PulmoVista 500 is in standby mode.
Use the appropriate MEDIBUS cable (see "List of accessories" on page 151) to connect PulmoVista 500 to the Dräger device in use.
Infinity C500 (MS18746):
Infinity C500 (MK31500):
1 Not all products are commercially available worldwide.
03
01
36
B
A
B A
Instructions for use PulmoVista 500 SW 1.2n 43
Assembly and preparation
1 Insert the connector (A) into the COM 1 port (B) at the back of the Cockpit.
2 Attach the other connector to the Dräger device.
3 Tighten the knurled screw to secure the connector.
4 Prepare the Dräger device to be connected as described in the relevant instructions for use.
Configuring the data import
See "Configuring the data import" on page 86.
Position of the user
To be able to read the screen contents properly, it is recommended that the user stands at the following distances from the display:
– Less than 70 cm (27.6 in) during operation
– Less than 3 m (9.8 in) when reading displayed data
44 Instructions for use PulmoVista 500 SW 1.2n
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Instructions for use PulmoVista 500 SW 1.2n 45
Getting started
Getting started
Switching on PulmoVista 500 . . . . . . . . . . . . 46
Device check. . . . . . . . . . . . . . . . . . . . . . . . . . 47
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Preparing the device check . . . . . . . . . . . . . . . 47Performing the device check . . . . . . . . . . . . . . 48
Attaching the patient interface . . . . . . . . . . . 49
Preparing the patient . . . . . . . . . . . . . . . . . . . . 49Attaching the electrode belt . . . . . . . . . . . . . . . 49
Connecting the trunk cable . . . . . . . . . . . . . . 52
Monitoring sessions. . . . . . . . . . . . . . . . . . . . 52
Continuing the monitoring session . . . . . . . . . . 53Starting a new monitoring session . . . . . . . . . . 53
Getting started
46 Instructions for use PulmoVista 500 SW 1.2n
Switching on PulmoVista 500
Press the On/Off key (A) on the Cockpit.
All LEDs are tested. After initialization the startup screen is displayed.
The progress bar indicates the progress of the startup.
At the end of the startup, PulmoVista 500 displays the Start/Standby dialog window. The Start/Standby (B) page is selected. PulmoVista 500 is in standby mode..
The Start/Standby page provides the following buttons and tabs:
– Start (C), to start measurement, see page 53
– Standby (D), to switch to standby mode, see page 75
– New patient (E), to start a new monitoring session, see page 53
– Device check (F), to open the device check page, see page 47
WARNING
Risk of electric shock and of device malfunc-tion
Do not use the medical device if condensation is present.
CAUTION
After extended exposure to a cold environment, acclimatize the device carefully so that condensa-tion cannot form on the electronic parts and does not damage the device.
01
85
06
A
A
Infinity C500 (MS18746)
Infinity C500 (MK31500)
50
0
Start/Standby
B
D
E
C
F
Instructions for use PulmoVista 500 SW 1.2n 47
Getting started
Device check
Overview
The device check must be performed prior to each use of PulmoVista 500. The device check must be performed at least every 24 hours if the device is in use.
It is recommended to perform the device check in case of persisting obvious distorted results or technical messages not related to known adverse measurement conditions.
Do not start the device check while the patient is connected to PulmoVista 500.
Preparing the device check
All plugs of the trunk cable must be connected to the EIT module.
1 Insert trunk cable plug (A) into the trunk cable port (B).
2 Insert green patient cable plug (C) into the test connector (D).
3 Insert red patient cable plug (E) into the test connector (F).
WARNING
Risk of electric shock and of device malfunc-tion
Do not use PulmoVista 500 if the device check has failed.
03
1
RL
TEST
R
L
E
B
F
DC
A
Getting started
48 Instructions for use PulmoVista 500 SW 1.2n
Performing the device check
The device check is only possible in standby mode. If PulmoVista 500 is not already in standby mode, switch to standby mode.
Switching to standby mode
1 Touch the Start/ Standby... button in the main menu bar.
2 Touch the Standby button on the Start/Standby page.
Performing the device check
3 Touch the Device check (A) tab.
The status of the last device check is displayed (B).
4 Touch the Start button (C) and confirm with the rotary knob.
PulmoVista 500 starts the device check. The device check is completed automatically. The progress of the device check is indicated by a help text message (D) in the header bar.
While the device check is running, the Device check page cannot be closed.
The test results obtained from the device check are stored until the next test, even if the device is switched off.
If the device check was successful, measurements may be started.
If the device check fails, do not operate the device. Contact DrägerService.
On completion of the device check
Disconnect the patient cable plugs from the test connector on the EIT module.
50
1
A
C
Start/Standby
B
D
Instructions for use PulmoVista 500 SW 1.2n 49
Getting started
Attaching the patient interface
Preparing the patient
1 Clean the respective skin areas properly. Ensure that the respective skin surface is free of body fluids or material which may impede electrode contact.
2 Remove chest hair as necessary to ensure proper electrode contact.
Attaching the electrode beltWARNING
Risk of infection
Before each use, reprocess the medical de-vice and all accessories in accordance with these instructions for use, see chapter "Cleaning and disinfection" on page 105. Ob-serve the hospital hygiene regulations!
WARNING
Risk of excessive leakage current
If more than four additional applied parts from other devices are used together with PulmoVista 500, make sure that the overall pa-tient leakage current is below the safety limit specified in the standard IEC 60601-1.
CAUTION
Avoid damage to the cables by gripping the plugs when disconnecting parts of the patient cable as-sembly instead of pulling on the cables.
WARNING
Risk of skin injury
The electrode belt may cause skin injury.
Examine the skin of the patient regularly for ir-ritations, lesions, or other signs that may indi-cate skin injury. If necessary, remove the elec-trode belt.
CAUTION
Risk of skin injury
Do not use the electrode belt for more than 24 hours consecutively on the same patient.
CAUTION
Danger of unstable circulation
Positioning the electrode belt may lead to hemo-dynamic instability in patients with unstable circu-lation.
Do not attach the electrode belt to patients where this may pose a risk of hemodynamic instability.
CAUTION
Ensure that perspiration or gel does not establish a conductive connection between the closure stud of the electrode and the skin of the patient. This could impair the measurement quality.
Getting started
50 Instructions for use PulmoVista 500 SW 1.2n
Selecting the belt size
The size labels and color coding of the electrode belt and the patient cable match. The following table shows size and color according to chest circumference.
1 Estimate the chest circumference at the height of the 4th to 6th intercostal space at the medioclavicular line.
2 Select a suitable electrode belt. The attached electrode belt must be just tight enough to provide sufficient contact between the skin and the electrodes. If possible, select a belt size that allows the use of position 3 of the belt closure (see page 25). Other positions can affect the accuracy of EIT data.
3 Select the patient cable of the same size.
Connecting the patient cable to the electrode belt
Connect the patient cable before attaching the electrode belt to the patient.
1 Connect snap 1 (A) of the patient cable to stud 1 (B) of the electrode belt. Ensure the orientation of the cable over the stud is maintained as illustrated and as marked on the electrode belt.
2 Connect all other snaps in numerical order to the studs of the electrode belt. Make sure that the patient cable changes direction above each stud.
Moisture from the skin usually results in sufficient conductivity between the skin and the electrodes a few minutes after the belt has been applied. If sufficient conductivity is not achieved, electrode gel or spray may be applied to the black electrode surface areas (C) on the electrode belt.
3 If the skin is obviously dry, it is recommended to apply electrode gel or spray to the electrodes before the electrode belt is applied.
Chest circumference Color Size70 to 85 cm (28 to 33 in)
Medium blue
80 to 96 cm (31 to 38 in)
Dark blue
92 to 110 cm (36 to 43 in)
Dark red
106 to 127 cm (42 to 50 in)
Gray
124 to 150 cm (49 to 59 in)
Violet
00
6
S
M
L
XL
XXL
1 16
1 16
B
A
00
5C
Instructions for use PulmoVista 500 SW 1.2n 51
Getting started
Attaching the electrode belt on the patient
1 Place the electrode belt with the patient cable connected at the height of the 4th to 6th intercostal space (medioclavicular line) around the chest of the patient. For female patients place the electrode belt so upon the chest in such a way that its position matches approximately the 5th intercostal space.
Ensure that the left-right orientation of the electrode belt is correctly maintained. The red patient cable port must be to the patient's left and the green patient cable port to the patient's right.
2 Ensure that the midposition marker (D) in the center of the electrode belt is located over the spine of the patient.
3 Ensure that the electrode belt is positioned so that electrodes 1 and 16 are equidistant from the sternal edge.
Wherever possible attach the electrodes with an equal distance to each other. Irregular electrode distances affect the quality of the EIT data.
4 Close the electrode belt so that all electrodes have close contact with the skin.
Depending on the position of the belt closure, the EIT image may change slightly. With increasing distance between electrodes 1 and 16 the left and right ventral parts of the EIT image close up. Where wound dressings or other material prevent skin contact with all 16 electrodes, EIT measurements can be performed with only 15 electrodes. However, at least 15 electrodes must have effective contact with the skin.
5 Connect the closure snap (E) to the closure stud (F).
Connecting the reference electrode
6 Apply an ECG electrode (G) anywhere on the abdomen.
7 Attach the reference electrode snap (H) to the ECG electrode.
14
00
08
Male Female
D
00
70
09
С
1 2
E
F
1 2С
Ref
HG
Getting started
52 Instructions for use PulmoVista 500 SW 1.2n
Connecting the trunk cable
1 Position PulmoVista 500 next to the bed of the patient.
2 Connect the patient cable plugs (A) of the trunk cable to the patient cable ports (B). Ensure that the color and the label on the patient cable plugs match the corresponding color and label on the patient cable ports.
3 Make sure there is no tension on the trunk cable or the patient cable. Ensure that the cables are not tangled or looped around the extremities of the patient.
Monitoring sessions
Before starting a monitoring session, open the Signal check page. Make sure that the skin-electrode contact of all electrodes is sufficient and stable. See "Signal check" on page 73.
While PulmoVista 500 is in standby mode, the Start/Standby page (A) enables the user to choose between:
– Continuing the monitoring session
– Starting a new monitoring session
Prerequisite: The Start/Standby (A) page is open. PulmoVista 500 is in standby mode.
00
4
LR
LR
BA
50
0
Start/Standby
A
B
C
Instructions for use PulmoVista 500 SW 1.2n 53
Getting started
Continuing the monitoring session
Touch the Start button (B).
Trend data and reference data from the last session are saved. Trend data is not collected while PulmoVista 500 is switched off or in standby mode. Collection of trend data is resumed when the monitoring session is continued. The measurement starts.
Starting a new monitoring session
When a new monitoring session is started, the trend data and reference data of the previous patient is deleted.
1 Touch the New patient button (C). Press the rotary knob to confirm.
2 Touch the Start button (B).
The new measurement starts.
54 Instructions for use PulmoVista 500 SW 1.2n
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Instructions for use PulmoVista 500 SW 1.2n 55
Operation
Operation
Safety information for operation. . . . . . . . . . 56
Starting a new measurement. . . . . . . . . . . . . 57
15-electrode mode . . . . . . . . . . . . . . . . . . . . . . 57
Main view. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Setting ROIs . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Displaying reference data. . . . . . . . . . . . . . . . . 61Deleting reference data . . . . . . . . . . . . . . . . . . 62
Other views . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Selecting a view . . . . . . . . . . . . . . . . . . . . . . . . 63Full-screen image. . . . . . . . . . . . . . . . . . . . . . . 63End-inspiratory trend . . . . . . . . . . . . . . . . . . . . 64EELI trend . . . . . . . . . . . . . . . . . . . . . . . . . . . 65Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Freeze display. . . . . . . . . . . . . . . . . . . . . . . . . 71
Export screenshot . . . . . . . . . . . . . . . . . . . . . 71
Marking events . . . . . . . . . . . . . . . . . . . . . . . . 72
Signal quality . . . . . . . . . . . . . . . . . . . . . . . . . 72
Signal quality indicator . . . . . . . . . . . . . . . . . . . 72Signal check . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Standby mode . . . . . . . . . . . . . . . . . . . . . . . . . 75
Activating standby mode . . . . . . . . . . . . . . . . . 75
Additional functions provided by the option ADAP . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . 76Data recording . . . . . . . . . . . . . . . . . . . . . . . . . 76Data review. . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Ending operation . . . . . . . . . . . . . . . . . . . . . . 80
Switching off the system. . . . . . . . . . . . . . . . . . 80Removing the patient interface. . . . . . . . . . . . . 80Disconnecting PulmoVista 500 from a Dräger device . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Operation
56 Instructions for use PulmoVista 500 SW 1.2n
Safety information for operation
WARNING
Risk of excessive leakage current to the pa-tient
Do not simultaneously touch the contacts of any connector and the patient.
WARNING
Risk of image distortion which may lead to wrong therapeutic decisions
The following sources may distort the clinical information content of EIT data:– Patient movement, muscle contractions– Changes of skin-electrode contact– Changes of fluid accumulation in the tho-
rax or under the skin– Movement of fluids or tissue, e.g., dia-
phragm, into or within the electrode plane– Very low impedance of the thorax, e.g., due
to thickened skin or lung edema– Adiposity– Temperature changes
For more information refer to "Signal quality" on page 72 and "General considerations" on page 131.
CAUTION
Screenshots contain compressed information. The image quality of screenshots might be affect-ed by artifacts or loss of information.
NOTE
PulmoVista 500 does not provide a warning when the battery is depleted.
Instructions for use PulmoVista 500 SW 1.2n 57
Operation
Starting a new measurement
Touch the Start button on the Start/Standby page.
PulmoVista 500 automatically starts a calibration cycle.
During calibration PulmoVista 500 performs the following actions:– Determination of the skin-electrode transfer
impedances of all electrodes– Determination if the 15-electrode mode must be
activated, see "15-electrode mode" on page 57– Optimization of the measurement frequency
(when operating frequency is set to Auto, see "Adjustment of operating frequency" on page 89)
– Automatic adjustment of the scales of EIT waveforms and images
During calibration a message is displayed in the header bar. A countdown timer shows the seconds until calibration is finished.
The following functions are not available during calibration:– Record– Mark event– Reference
During calibration preliminary EIT data is displayed which is subject to change.
When calibration is finished, PulmoVista 500 shows calibrated EIT data on the standard monitoring screen (Main view).
15-electrode mode
If during calibration within a started or restarted measurement contact between the skin and an electrode cannot be adequately established (e.g., resistance between the skin and the electrode too great, wound dressing, disconnected electrodes), the device starts in the 15-electrode mode. Whereas the image resolution may be reduced, measurements can be continued without limitations. The message 15-electrode mode is displayed in the header bar. The area around the inactive electrode is highlighed in color in the margin of the EIT images.
To restore the 16-electrode mode see page 98.
Operation
58 Instructions for use PulmoVista 500 SW 1.2n
Main view
The Main view is the standard monitoring page.
Images represent the regional distribution of ventilation, i.e., the change of lung volume within the electrode plane. Waveforms represent the volume changes within the electrode plane or parts of it over time. Parameters represent regional volume changes as a percentage of the whole.
Regions of interest (ROIs) are defined for all views from this page.
The Main view displays the following:
A Dynamic image – shows impedance changes in a caudo-cranial image referenced to a dynamic baseline.
B Status Image, as selected in System setup, see page 85– Tidal image: Differential image of the end of
inspiration compared to the beginning of inspiration, which represents regional distribution of impedance changes of the last detected breath.
– Minute image: Tidal images averaged over the last minute
Electrode positions are represented in the dynamic images and status images. If the skin-electrode impedance is too great, the corresponding electrode is displayed in red. If the skin-electrode impedance is too unstable, the corresponding electrode is displayed in white.
C Global impedance waveform – shows the relative impedance changes of the entire electrode plane and, if available and configured, the volume waveform imported by MEDIBUS or MEDIBUS.X
D Regional impedance waveforms – represent relative impedance changes of the defined ROI
E Blue markers – represent beginning and end of inspiration
F Parameter field – displays the tidal rate
G Parameter field – displays the following: – Global tidal variation TV global or global
minute tidal variation MTV global depending on the selected status image, always defined as 100 %
– Tidal volume VT, if available and selected in System setup, see page 87
H Parameter fields – display the regional tidal variation or regional minute tidal variation as a percentage of TV global or MTV global depending on the selected status image and the defined ROI
Numeric values, see page 137.
I Reference button Ref
J Button Set ROI... for setting the ROI
K Button Enhance contrast – While this button is pressed, the colors in all images are displayed more vividly in particular to support the recognition of regions with oppositely phased impedance changes.
50
9
A
F
G
H
H
H
H
C
D
D
D
I
JB
D
E
K
NOTE
The tidal rate determined by PulmoVista 500 de-pends on user-selected filter settings and thus may not reflect the respiratory rate of the patient. For this reason, the determination of the Tidal rate is not defined as a measuring function in the sense of the Directive 93/42/EEC concerning Medical Devices.
Instructions for use PulmoVista 500 SW 1.2n 59
Operation
Displaying reference data
See "Displaying reference data" on page 61.
Setting ROIs
This function is used to define ROIs of 4 equal sizes within the status image. A region of interest (ROI) is a user-defined area within a status image. The image can be divided horizontally or into quadrants. The area covered by each ROI is represented by the corresponding regional impedance waveform.
ROIs may overlap or be set so that the ROIs do not cover the entire thoracic contour. It is not possible to move the ROIs beyond the border of the image. It is possible that the ROIs do not represent all the ventilation in the measured plane.
Prerequisite: The Main or End-insp. trend view is open.
Touch the Set ROI... button.
The Set ROI... page provides the following buttons and tabs:
A Vertical slider – moves the ROI vertically within the image (inactive when the set ROIs cover the entire height of the image)
B Horizontal slider – moves the ROI horizontally within the image (inactive when the set ROIs cover the entire width of the image)
C Width – changes the width of ROIs
D Height – changes the height of ROIs
E Layers – ROIs are adjacent and vertically aligned
F Quadrants – ROIs are adjacent and positioned in an upper left/right and lower left/right arrangement
G Free – single ROIs can be moved independently of each other
Setting ROIs as layers
1 Touch the Layers button (E).
2 Touch the button in the Width row (C). Set the value by turning the rotary knob and press to confirm.
3 Touch the button in the Height row (D). Set the value by turning the rotary knob and press to confirm.
4 Touch the horizontal (B) or vertical (A) slider. Move the ROIs by using the touchscreen or by turning the rotary knob. Alternatively, the ROIs can also be moved by touching and dragging them within the image.
53
0
Set ROI
C D
F
B
A
GE5
36
Operation
60 Instructions for use PulmoVista 500 SW 1.2n
Setting ROIs as quadrants
1 Touch the Quadrants button (F).
2 Touch the button in the Width row (C). Set the value by turning the rotary knob and press to confirm.
3 Touch the button in the Height row (D). Set the value by turning the rotary knob and press to confirm.
4 Touch the horizontal (B) or vertical (A) slider. Move the ROIs by using the touchscreen or by turning the rotary knob. Alternatively, the ROIs can also be moved by touching and dragging them within the image.
Setting ROIs independently of each other
1 Touch the Free button (G).
The ROI 1 (A), ROI 2 (B), ROI 3 (C) and ROI 4 (D) buttons are displayed.
2 Touch the relevant button for the ROI.
3 Touch the button in the Width row (E). Set the value by turning the rotary knob and press to confirm.
4 Touch the button in the Height row (F). Set the value by turning the rotary knob and press to confirm.
5 Touch the horizontal (G) or vertical (H) slider. Move the ROIs by using the touchscreen or by turning the rotary knob. Alternatively, the ROIs can also be moved by touching and dragging them within the image.
53
7
51
9
Set ROI
A B C D
E F
G
H
Instructions for use PulmoVista 500 SW 1.2n 61
Operation
Displaying reference data
Prerequisite: The Main view is open.
Touch the Ref button (A).
Reference data are displayed in the following form:
– Reference time (B) is displayed as hh:mm
– Status image reference (C)
– Unfilled blue impedance waveform overlaid on pale blue solid impedance waveform (D)
– Reference parameter in the corresponding parameter box (E), in addition to the current value
Status image
When the status image is set to Tidal, the reference image is the tidal image at the time the Ref button was pressed.
When the status image is set to Minute, the reference image is the minute image at the time the Ref button was pressed.
For setting the status image, see page 85.
Reference waveforms
When the status image is set to Tidal, the reference waveform is made up of repeated sequences of the impedance waveform of the reference breath. The reference breath is the last detected breath before the Ref button was pressed.
When the status image is set to Minute, the reference waveform is made up of the impedance waveform of the breaths within the last minute before the Ref button was pressed. In this case, the duration of the reference waveform displayed depends on the selected time scale. When the time scale is set to less than one minute, only the first part of the reference waveform is displayed. When the time scale is set to longer than one minute, then the reference waveform is made up of repeated sequences of one minute, or part thereof.
For setting the status image, see page 85.
Reference parameters
Reference parameters represent the distribution of regional (minute) tidal variations in the reference status image. If Display change is selected, deviation bars in the parameter fields represent the change of distribution of regional (minute) tidal variations between the reference status image and the current status image. The current and reference values of the global tidal variation (TV global) are always defined as 100 %, regardless of the possibly different tidal variations at the different times. Hence, the difference between current and regional reference tidal variations represents the redistribution of regional tidal variation. In contrast, the status images and waveforms display increases and decreases in the absolute values of the tidal variation. (Only when the reference function is activated, otherwise the autoscaling of the images and waveforms will "hide" these effects.)
Changing filter settings
If reference data are displayed and filter settings are changed, the changed filter settings will not affect the displayed reference data.
52
0
A
C
D
D
D
D
D
E
E
E
E
E
B
Operation
62 Instructions for use PulmoVista 500 SW 1.2n
Displaying changes
To display the changes between the reference data and the current data.
Touch the Display change button (F).
The status image is replaced by the image Change: Current minus Ref (G). This image (G) represents the differences between the current status image and the reference image. Changes are displayed on a different color scale, see page 145.
The deviation from the reference parameter is graphically displayed:– No changes (H)– Increased (I)– Decreased (J)
In contrast to the image (G), the displayed deviations in the parameter fields only reflect changes of regional distribution. Changes of tidal variations which do not affect the regional distribution are not displayed as deviations.
Deleting reference data
Prerequisite: Reference data are displayed.
Touch the Ref button (A).
The following actions will lead to the loss of reference data:
– PulmoVista 500 is switched off.
– Standby mode is activated and the frame rate is changed.
– Standby mode is activated and New patient is selected.
– The simulation mode is activated.5
21
FG
I
H
J
A
Instructions for use PulmoVista 500 SW 1.2n 63
Operation
Other views
The display of the measured EIT data can be changed by the user in the Views dialog window. The following views can be selected:
A Main
B Full-screen image
C End-insp. trend
D EELI trend
E Diagnostics
Selecting a view
1 Touch the Views... button in the main menu bar.
2 Touch the button to select the desired view.
3 Touch the X button to close the dialog window or wait for the Views dialog window to close automatically after a few seconds.
Full-screen image
The Full-screen image view provides a large format view of the status image or dynamic image, as selected in System setup, see page 82. The image not selected for large format viewing is shown in small format.
The Full-screen image view displays the following:
A Small format image, according to selection in System setup
B Global impedance waveform
C Large format image, as selected in System setup
D Button Ref
E Parameter fields as in the Main
Displaying reference data
See "Displaying reference data" on page 61.
511
A
B
C
D
Views
E
51
8
AB DA E
E
E
E
E
E
C
Operation
64 Instructions for use PulmoVista 500 SW 1.2n
End-inspiratory trend
The End-insp. trend view provides a comparative evaluation of two status images, each representing the regional distribution of impedance changes at two different cursor positions. In the End-insp. trend view the differences between these two status images are displayed. These can be interpreted as changes of the regional distribution of the tidal volume in the electrode plane.
The changes in the status images at Ref and C are expressed as follows:
The End-insp. trend view displays the following:
A Differential image Change: C minus Ref, displays an image based on the differences between the status images at cursor positions Ref and C
B Status image Ref– refers to cursor position Ref
C Status image C– refers to cursor position C
D Cursor button Ref
E Cursor button C
F Cursor position Ref
G Cursor position C
H Table displaying the following data at the selected cursor positions:– Tidal variation values, expressed as
percentages– MEDIBUSor MEDIBUS.X data, if MEDIBUS
or MEDIBUS.X is available as selected in System setup, see page 86
– Date and time
I Global impedance waveform – up to 2 hours of data is displayed as a compressed waveform.
J MEDIBUS or MEDIBUS.X trend parameters, if MEDIBUS or MEDIBUS.X is available as selected in System setup, see page 86
K Button for the time scale (inactive when the zoom area has been zoomed into)
L Button Refresh (inactive when the zoom area has been zoomed into)
If signal quality is low, this is indicated at the cursor label and then the waveform is a darker gray color.
M Button Event list... - all events since the start of measurement are displayed in a table.
N Button Set ROI... – to define ROIs.
O Button for opening the Zoom page – enables the selection of a zoom area within the trend data.
P Button for zooming in/zooming out – allows the zooming in and zooming out of the zoom area (inactive when no zoom area has been defined).
Setting the cursor position
1 Touch the relevant cursor button Ref (D) or C (E).
2 Select the desired point in time by turning the rotary knob. Alternatively, touch the relevant cursor and move it by swiping in the waveform field.
If the cursor position is changed in the End-insp. trend view, the cursor is set to the same position in the EELI trend view.
Zero change No difference between values at Ref and C
Positive changes Value at C is greater than the value at Ref
Negative chang-es
Value at C is less than the val-ue at Ref
53
2
A B C
I
JH
DE
KL
F G
M
N
OP
Instructions for use PulmoVista 500 SW 1.2n 65
Operation
Setting the time scale
The time scale determines the duration of the trend waveforms. The time scale can be set from 1 to 120 minutes. The default setting is 10 minutes.
1 Touch the Time scale button (K).
2 Select the time by turning the rotary knob and press to confirm.
If the time scale is changed in the EELI trend view and the Diagnostics view, the time scale also changes in the End-insp. trend view.
EIT data
Touch the Refresh (L) button (inactive when the zoom area has been zoomed into).
EELI trend
In the EELI trend view the changes of the end-expiratory lung impedance are displayed. These can be interpreted as changes of the end-expiratory lung volume in the electrode plane. The change in end-expiratory lung impedance EELI at Ref and C is expressed as follows:
The EELI trend view displays the following:
A Differential image EELI: C minus Ref – displays an image based on the differences between the end-expiratory values at cursor positions Ref (H) and C (I).
B Global impedance waveform – up to 120 minutes of data is displayed as a compressed waveform. The end-expiratory level at each cursor position is displayed as a horizontal dashed line.
C Regional impedance waveforms – up to 120 minutes of data is displayed as a compressed waveform. The end-expiratory level at each cursor position is displayed as a horizontal dashed line.
D Parameter field EELI global – the change in global end-expiratory lung impedance, expressed as a factor of the global tidal variation at the cursor position Ref.
E Parameter fields EELI ROI – the change in end-expiratory lung impedance for the corresponding ROI, expressed as a factor of the global tidal variation at the cursor position Ref.
F Cursor button Ref
G Cursor button C
H Cursor position Ref
I Cursor position C
CAUTION
Risk of wrong therapeutic decisions
The trend views are affected by various factors. For information on the influencing factors, see page 131.
Zero change No difference between values at Ref and C
Positive changes Value at C is greater than the value at Ref
Negative chang-es
Value at C is less than the val-ue at Ref
53
1
A
J
ML
E
E
E
E
D
F G
B H I
K
C
C
C
C
N
OP
Operation
66 Instructions for use PulmoVista 500 SW 1.2n
J Table displaying the following data at the selected cursor positions Ref and C:– Tidal variation values, expressed as
percentages– MEDIBUSor MEDIBUS.X data, if MEDIBUS
or MEDIBUS.X is available as selected in System setup, see page 86
– Date and time
K MEDIBUSor MEDIBUS.X trend parameters, if MEDIBUS or MEDIBUS.X is available as selected in System setup, see page 86
L Button Time scale (inactive when the zoom area has been zoomed into)
M Button Refresh (inactive when the zoom area has been zoomed into)
N Button Event list... - all events since the start of measurement are displayed in a table.
O Button for opening the Zoom page – enables the selection of a zoom area within the trend data.
P Button for zooming in/zooming out – the zooming in and zooming out of the zoom area (inactive when no zoom area has been defined).
If signal quality is low, this is indicated at the cursor label and then the waveform is a darker gray color.
Setting the cursor position
1 Touch the relevant cursor button Ref (F) or C (G).
2 Select the desired point in time by turning the rotary knob. Alternatively, touch the relevant cursor and move it by swiping in the waveform field.
If the cursor position is changed in the EELI trend view, the cursor is set to the same position in the End-insp. trend view.
Setting the time scale
The time scale determines the duration of the trend waveforms. The time scale can be set from 1 to 120 minutes. The default setting is 10 minutes.
1 Touch the Time scale button (L).
2 Select the time by turning the rotary knob and press to confirm.
If the time scale is changed in the EELI trend view and the Diagnostics view, the time scale also changes in the End-insp. trend view.
Refreshing EIT data
Touch the Refresh button (M) (inactive when the zoom area has been zoomed into).
CAUTION
Risk of wrong therapeutic decisions
The trend views are affected by various factors. For information on the influencing factors, see page 131.
Instructions for use PulmoVista 500 SW 1.2n 67
Operation
Diagnostics
The Diagnostics view enables the systematic analysis of regional compliance changes and delays in regional ventilation in a maximum of 15 time periods in addition to the evaluation of ventilation distribution. The analysis section of every time period is called a “section”.
In the Diagnostics view, the Conduct analysis dialog window is displayed first. The PEEP trial analysis function enables the automatic analysis of incremental or decremental PEEP maneuvers, in which the PEEP is increased or decreased in steps. In contrast, the Customized analysis function enables the evaluation of any other ventilation-therapeutic interventions. Both functions facilitate the evaluation of maneuvers and interventions.
If the trend data contain a PEEP maneuver, the changes to the end-expiratory lung impedance (EELI) caused by the PEEP adjustment are detected automatically and a section is defined for every detected EELI level. The PEEP trial analysis function can be started immediately.
If no PEEP maneuver is detected in the trend data, the user can define own sections at any point in the displayed trend area and analyze these sections with the Customized analysis function.
The Conduct analysis dialog window displays the following elements:
A Global impedance waveform – up to 2 hours of data is displayed as a compressed waveform in relation to time. If available, the trend parameters PEEP and EIP which are imported via MEDIBUS or MEDIBUS.X are also displayed. On older ventilators which do not transmit EIP values, PIP values are displayed instead. PIP equals EIP during pressure-controlled ventilation and volume-controlled ventilation with AutoFlow.
B Sections with alphabetically sorted labels – the respective PEEP value is also displayed in the label if PEEP measured values are available.
C Zoom button – only available if the horizontal slider (D) is not at the start or end of the scale.
D Horizontal slider for adjusting the zoom area – sections can only be automatically defined and manually added in the area between the sliders.
E PEEP trial analysis – only active if a PEEP maneuver was automatically detected in the trend data or if at least 3 sections were placed on incremental or decremental levels of the end-expiratory lung impedance.
F Customized analysis – only active if at least one section was defined in the trend data.
G Button for the time scale – only active if the zoom button is not selected.
H Refresh – for activating the time scale (only active if the zoom button is not selected).
The Conduct analysis dialog window also contains the Sections and RVD configuration pages.
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A B
D D
E F GH
C
NOTE
The previous analysis is deleted every time the section settings are changed.
Operation
68 Instructions for use PulmoVista 500 SW 1.2n
Configuring the section settings
On the Sections (A) page, the user can make the following settings:
– Automatically define sections (B) – The sections are automatically defined and can be shifted as needed by tapping on a section on the global waveform and dragging it across the screen to the desired position or moving it there by turning the rotary knob. To confirm the position, press the rotary knob or tap outside of the waveform field.
– Manually add a section (C) – The new, light gray section is added in the middle of the two sliders and can be moved to the desired position by tapping the waveform field, dragging the section across the screen, or by turning the rotary knob. To confirm the position, press the rotary knob or tap outside of the waveform field.
– Manually delete a section (D) – Tap the desired section. The section is highlighted in light gray. Touch the Remove section button (D). Another section can be selected by turning the rotary knob. Press the rotary knob to delete the section.
– Define spontaneous breaths per second (E).
– Define the reference section for the individual analysis (F).
Section can only be moved within the area defined by the sliders.
Configuring the RVD settings
On the RVD (A) page, the user can make the following settings:
– Switch the calculation and display of the RVD parameter on (B) or off (C).
– Set the cut-off frequency of the low-pass filter for RVD (D).
– Set the RVD cut-off value (E). All pixels with an RVD value greater than the set RVD cut-off value are displayed in yellow.
– Select the RVD parameter. Tap the RVD Ratio (F) or RVD SD (G) button. RVD Ratio, indicated as % of the total number of pixels of the ventilated area, describes the ratio of the number of pixels with an RVD above the RVD cut-off value to the total number of pixels. RVD SD, indicated as % of Ti, describes the standard deviation of all RVD values of the ventilated area.
If the calculation and display of the RVD parameter is switched off, only the buttons (B) and (C) are active.
The following relevant notes on using and interpreting the RVD parameter must be observed:
The Regional Ventilation Delay (RVD) is a parameter which displays regional inspiration delays in comparison with global inspiration and may indicate the cyclical collapse and re-opening of lung regions as well as display regionally varying time constants. Varying time constants have a particularly heavy impact on the display of the RVD parameter during long inspiratory times, short expiratory times and a quick rise in ventilation pressure. A “long” ventilation phase can be recognized based on the patient flow of 0 at its end.
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Instructions for use PulmoVista 500 SW 1.2n 69
Operation
The influence of varying time constants can be largely suppressed through a slow pressure rise up to the end of the inspiration and a long expiratory time.
Results of the analysis
If the PEEP trial analysis or Customized analysis button is pressed, the Conduct analysis dialog window closes. The results of the analysis are displayed as follows:
A Global impedance waveform – up to 2 hours of data are displayed as a compressed waveform in relation to time. If available, the trend parameters PEEP and EIP which are imported via MEDIBUS or MEDIBUS.X are also displayed. Sections whose tidal images are displayed in the analysis are highlighted in light gray. Sections which are not displayed are displayed in dark gray.
B Zoom button – only available if the horizontal slider is not at the start or end of the scale.
C Tidal images (max. 5 images are displayed simultaneously)
– With an active RVD analysis: Areas in which a regional delay was detected, depending on the configuration, are displayed in yellow. Tapping a tidal image opens the RVD analysis dialog window which displays an RVD image. The RVD image displays an early inspiration compared to the global progression in cyan and a delayed inspiration in yellow. Furthermore, the progression of the impedance waveform of a selected pixel is compared to the progression of the global impedance waveform. By tapping the displayed image, any pixel can be selected.
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70 Instructions for use PulmoVista 500 SW 1.2n
– With an inactive RVD analysis: Areas in which a regional delay was detected are not marked. Tapping a tidal image opens the Details dialog window in which the tidal image is displayed in a larger format and the progression of the impedance waveform of a pixel is compared to the progression of the global impedance waveform.
D Display of the RVD parameter – Depending on the configuration, as the standard deviation of the RVD (RVD SD) for every section or as the RVD Ratio. RVD SD, indicated as % of Ti, describes how inhomogeneous the regional inspiration within the contour of the ventilated area is. RVD Ratio, indicated as % of the total number of pixels, describes the ratio of the pixels with RVD to the total number of pixels within the contour of the ventilated area.
E PEEP trial analysis: Images of the Compliance loss for every displayed section. The pixel compliance loss is calculated in relation to the maximum compliance which is ascertained within all sections.If there is a compliance loss towards higher PEEP levels (CL HP [%]), the loss is displayed in orange. If there is a compliance loss towards lower PEEP levels (CL LP [%]), the loss is displayed in white. The regions without a compliance loss are displayed in dark gray.Customized analysis: Images of the compliance changes in comparison to the selected reference section for every displayed section, referred to as a compliance win (CW [%]) and Compliance loss (CL [%]). The regions with compliance win are displayed in cyan and the areas with compliance loss in orange.
F In addition to the images, the sum of the values for CL HP [%] or CW [%] is displayed as follows:
– PEEP trial analysis: Compliance loss towards higher PEEP levels (CL HP [%]) in orange
– Customized analysis: Compliance win (CW [%], Compliance win towards lower PEEP levels) in cyan
G In addition to the images, the sum of the values for CL LP [%] or CL [%] is displayed as:
– PEEP trial analysis: Compliance loss towards lower PEEP levels (CL LP [%]) in white
– Customized analysis: Compliance loss (CL [%]) in orange
H Diagram with the numeric values of all sections depending on the settings and analysis type.
I Scroll buttons for shifting the displayed images – only active if more than 5 sections are defined.
J Event list...
K Help...
L Conduct analysis...
M Capture analysis – The currently displayed analysis is saved as a screenshot.
N Review analysis... – only active if at least one analysis is saved. Saved analyses can be opened and viewed in a separate dialog window.
O Create report – only active if a USB mass storage device with sufficient storage space is connected to the cockpit. An image file is created containing the entered parameters, the event list, all available analysis parameters and MEDIBUS values, and a screenshot of the analysis. Furthermore, an editable text file with the same information but without the screenshot is created. Reports can also be created based on previously saved analyses. To do this, the saved analysis must be selected with the Review analysis... button, followed by tapping the Create report button.
Instructions for use PulmoVista 500 SW 1.2n 71
Operation
Freeze display
The Main and Full-screen image views provide a Freeze display function.
To activate the freeze display function:
Touch the Freeze display button in the main menu bar.
The following is immediately frozen:– Dynamic image– Status image– All waveforms– Numerical values in the Main and Full-screen
image
While the freeze display function is active, all buttons in the main menu bar except Freeze display and Record are inactive.
To deactivate the freeze display function:
Touch the Freeze display button in the main menu bar once again.
Export screenshot
This function is only available if a USB storage medium with sufficient storage space is connected to the Cockpit.
1 Connect a USB storage medium to the left or right USB port on the Cockpit. When the USB storage medium is correctly connected, the Export screenshot button turns light green.
2 Touch the Export screenshot button in the main menu bar. When the button is touched, it turns dark green.
The screen image is written to the USB storage medium as a bitmap file.
The USB storage medium may be removed when the button turns light green.
Operation
72 Instructions for use PulmoVista 500 SW 1.2n
Marking events
The user can mark events during measurement. An event is marked with the time when the button was pressed. Events are flagged with a number which is automatically incremented. The events can be annotated. All events which are entered during the entire measuring time frame, can be viewed on the Event list page.
Touch the Mark event... button in the main menu bar.
The Mark event page displays the following:
A Event number
B Event time
C Input line or comment of last event, where applicable
D Clear button
E Enter button
Adding comments to an event
1 Enter the required comments using the on-screen keyboard. A maximum of 30 characters can be entered. The inserted text is displayed in the input line (C).
2 Confirm with the Enter button (F) or by pressing the rotary knob.
Clearing comments
Touch the Clear button (D).
Signal quality
Signal quality indicator
PulmoVista 500 continuously determines the global signal quality of the measured data. The signal quality is displayed in the header bar as a bar graph.
When the signal quality is classified as Low, impedance waveforms in the End-insp. trend view, EELI trend view, and the Diagnostics view are displayed in darker gray color.
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Instructions for use PulmoVista 500 SW 1.2n 73
Operation
When one of the following messages is displayed, the signal quality is Low:– Safety function activated - Technical– Safety function activated - Temperature– Restart calibration– Electromagnetic disturbance– Check patient cable connection– Check electrode contact
See "Problem solving" on page 97.
The signal quality is an indicator for the reliability of the EIT data. In principle, always try to achieve a high signal quality. A medium quality or, in rare cases, also a low quality may be tolerated to obtain useful information from PulmoVista 500. This depends on:– the experience of the user– additionally available clinical information– the possible contribution of EIT data to
therapeutic decisions
Even when the signal quality is high, artifacts cannot be completely excluded, see "General considerations" on page 131.
Touching one of the following messages in the header bar will cause the Signal check dialog to open:– Restart calibration– Check electrode contact– Check reference electrode– Unstable electrode contact– 15-electrode mode– Low signal quality
Signal check
The Signal check page is a graphical representation of electrode location and resistance at each of the 16 electrodes, as well as at the reference electrode. Electrode resistance is continuously monitored. The bargraph is updated dynamically.
Touch the Signal check... button in the main menu bar.
The Signal check page displays the following:
A Electrode position
B Resistance of each electrode
C Resistance of reference electrode
D Defined limit of resistance
E Start button to restart calibration
NOTE
The electrode resistance depends on various con-ditions which may not be related to the information displayed by PulmoVista 500. For this reason, the determination of such resistances is not defined as a measuring function in the sense of the Directive 93/42/EEC concerning Medical Devices.
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74 Instructions for use PulmoVista 500 SW 1.2n
The status of the electrodes (A) is indicated as follows:
If the resistance exceeds the defined limit of 300 for the EIT electrodes and 400 for the reference electrode, the bargraph representing the affected electrode is displayed in red. The message Check electrode contact or Check reference electrode is concurrently displayed.
PulmoVista 500 has been optimized for electrode resistances of 30 to 200 Ohm and a reference electrode resistance of 30 to 400 Ohm. Outside of this range the signal quality may be reduced.
Restarting calibration
Prerequisite: PulmoVista 500 is not in standby mode.
When the message Restart calibration is displayed, calibration is recommended.
Touch the Start button (E).
The following functions are not available during calibration:– Record– Mark event– Reference
Status Explanation
Gray Skin-electrode contact is sufficient for measurement to proceed
White Skin-electrode contact is unstable, measurement will proceed but sig-nal quality may be impaired
Red Skin-electrode contact is insufficient for measurement to proceed
Instructions for use PulmoVista 500 SW 1.2n 75
Operation
Standby mode
Switch to standby mode for the following actions:– Starting a new monitoring session– Performing a device check– Changing the following settings in System
Setup:– Imported MEDIBUS or MEDIBUS.X
waveforms– EITsettings– Language– Access to service settings– Dräger default settings– File handling for data recording (requires
the option ADAP)– Simulation of patient data– Switching off PulmoVista 500
Activating standby mode
1 Touch the Start/ Standby... button in the main menu bar.
2 Touch the Standby (B) button on the Start/Standby (A) page.
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76 Instructions for use PulmoVista 500 SW 1.2n
Additional functions provided by the option ADAP
The ADAP option extends the functionality of the basic EIT software.
Patient data
The patient name is displayed in the header bar and on the Patient data page. When data is recorded, the patient ID forms part of the file name.
Entering patient data, see "Patient data" on page 94.
Data recording
Recording can be done in a single mode or in a continuous mode. To select the Record mode, see "Configuring data recording" on page 94.
When the device is not connected to mains power supply, the recording of data is limited by the level of available battery charge.
Lack of available disk memory can limit recording of data, see "Free disk space (J)" on page 96.
Starting a recording
Touch the Record button in the main menu bar.
The progress of the recording is displayed in the header bar (A).
Stopping a recording
Prerequisite: The recording process is running.
Touch the Record button in the main menu bar once again.
Switching to standby mode or restarting the measurement also stops the recording process.
Data review
The Data review page enables the review of previously recorded EIT data files.
Touch the Data review... button in the main menu bar.
The Data review page displays the following:
A Dynamic image – shows impedance changes in a caudo-cranial image referenced to a fixed baseline
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Continuous mode Duration of the recording is dis-played in minutes
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Instructions for use PulmoVista 500 SW 1.2n 77
Operation
B Status image – as selected in the display settings on the Data review page– Tidal image: Differential image of the end of
inspiration compared to the beginning of inspiration, which represents regional distribution of impedance changes of the last detected breath.
– Minute image: Tidal images averaged over the last minute or less, when the cursor is located within the first minute of the EIT data file.
C Set ROI... – to set the ROI, see "Setting ROIs" on page 79
D File... – to select a file, see page 78
E Patient data... – displays patient data associated with the opened file, see page 78
F Display... – to change the display settings, see page 79
G MEDIBUS data... – displays the MEDIBUS or MEDIBUS.X parameters at the cursor position if the selected file contains MEDIBUS or MEDIBUS.X data. One MEDIBUS or MEDIBUS.X parameter can be selected that is superimposed on the global impedance waveform, see page 79.
H File name of the selected EIT data file and name from associated patient data, or additional help text
I Global impedance waveform – displays the relative impedance changes
J Regional impedance waveforms – represent relative impedance changes of the defined ROI
K Cursor
L 5 navigation buttons:– Previous page , opens the previous
page of the EIT data file– Play – moves the cursor through the
current page of the EIT data file. In Standby mode the cursor speed is increased with repeated pressing.Depending on the selected cursor speed the recorded EIT data files may replay faster or slower than real-time data
– Pause – pauses the cursor at its current location. Play can be resumed by pressing the Pause button a second time.
– Stop – stops the play function and returns the cursor to the beginning of the current page
– Next page , opens the next page of the EIT data file
M Global tidal variation TV global or global minute tidal variation MTV global – depending on the selected status image, expressed as the sum of all regional relative impedance changes of the entire status image (dimensionless)
N Regional tidal variation or minute tidal variation – depending on the selected status image, expressed as the sum of regional relative impedance changes within the defined ROI (dimensionless)
O Global tidal variation TV global or global minute tidal variation MTV global – depending on the selected status image, always expressed as 100 %
P Regional tidal variation or minute tidal variation – depending on the selected status image of the defined ROI, expressed as percentage
Q Global relative impedance change (compared to the baseline level) at the cursor position, expressed as the sum of all regional relative impedance changes within the entire displayed dynamic image (dimensionless)
Operation
78 Instructions for use PulmoVista 500 SW 1.2n
R Regional relative impedance change at the cursor position, expressed as the sum of regional relative impedance changes within the part of the displayed dynamic image (dimensionless) that corresponds to the defined ROI within the status image
S MEDIBUS or MEDIBUS.X parameter (displayed in green), if selected on the MEDIBUS data page
T Event marker
U Indicator for the signal quality of the selected EIT data file
V Event comment
W Button Auto rescale
Selecting the file
All recorded EIT data are stored on the hard disk of the Cockpit in the following file structure:– Folder– Subfolder– File
Prerequisite: The Data review page is open.
1 Touch the File... button.
2 Touch the button (A) to open the list of all available folders. Select the folder using the touchscreen or the rotary knob.
3 Touch the button (B) to open the list of all available subfolders. Select the subfolder using the touchscreen or the rotary knob.
4 Touch the button (C) to open the list of all available files. Select the file using the touchscreen or the rotary knob.
Displaying patient data
Patient data is displayed on the Patient data page.
Prerequisite: The Data review page is open.
Touch the Patient data... button.
The following patient data are displayed:– Name (D)– Age/Date of birth (E)– Patient ID (F)– Short comment (G)– Notes (H)
Patient data are entered and edited from System setup > Data recording > Patient data. Once patient data has been recorded as part of an EIT data file, it cannot be edited.
If no patient data are entered, see page 95.
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Instructions for use PulmoVista 500 SW 1.2n 79
Operation
Changing display settings
Initial display settings on the Data review page are the same as display settings in the Main view. Once display settings on the Data review page are changed, they persist until the device is switched off.
Display settings made on the Data review page do not affect Main view settings.
Prerequisite: The Data review page is open.
1 Touch the Display... button.
The following display settings can be set:– Filter (A)– Cut-off freq. [/min] (B)– Artifact filter (C)– Status image (D)– Display thoracic contour (E)– Time scale (F)
2 Set the display settings in the same manner as in System Setup, see "Configuring the screen layout" on page 82.
Displaying MEDIBUS or MEDIBUS.X data
MEDIBUS or MEDIBUS.X data are displayed on the MEDIBUS data page.
Prerequisite: The Data review page is open.
1 Touch the MEDIBUS data... button.
All MEDIBUS or MEDIBUS.X parameters at the cursor position are displayed in the list (A) on the MEDIBUS data page if the selected file contains MEDIBUS or MEDIBUS.X data.
2 Touch the button (B) to open the list of all available MEDIBUS or MEDIBUS.X parameters. Select the parameter to be superimposed on the global impedance waveform using the touchscreen or the rotary knob.
Setting ROIs
The initial ROI settings are the same on the Data review page and in the Main view. Once ROI settings on the Data review page are changed, they persist until the device is switched off.
ROI settings on the Data review page do not affect Main view settings.
Set the ROIs in the same manner as in the Main view, see page 59.
When ROIs are set to Layers or Quadrants, the central positon of all the ROIs is indicated by "x" "y" value. When the ROIs are set to Free, the central position of each ROI is indicated.
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Operation
80 Instructions for use PulmoVista 500 SW 1.2n
Ending operation
Switching off the system
1 PulmoVista 500 to standby mode: Touch the Start/ Standby... button in the main menu bar. Touch the Standby button on the Start/Standby page.
2 Press the On/Off key (A) on the Cockpit.
PulmoVista 500 opens the Shut down device dialog window.
The OK button (B) is preselected.
3 Confirm with the rotary knob.
Canceling the Shut down
Touch the Cancel button (C).
Removing the patient interface
Prerequisite: PulmoVista 500 is switched off.
1 Remove the patient cable plugs from the patient cable ports on the trunk cable.
2 Remove the reference electrode snap from the reference electrode.
3 Remove the closure snap from the closure stud.
4 Open the electrode belt.
5 Lift the patient and remove the electrode belt from under the patient. Make sure that the electrode belt does not snap back towards the patient. Ensure that the patient is lifted clear of the electrode belt so that no skin damage can occur when removing the electrode belt.
6 Remove the patient cable from the electrode belt.
If no further EIT measurements are intended for the patient, remove the reference electrode. If electrode gel or electrode spray has been used, clean residue off the skin of the patient.
Disconnecting PulmoVista 500 from a Dräger device
When the transfer of MEDIBUS or MEDIBUS.X data is no longer required, the MEDIBUS cable must be removed from PulmoVista 500 and the Dräger device in use.
To remove the MEDIBUS cable, see page 42.
NOTE
In the case of voltage peaks in the mains power supply, it may not be possible to switch off the de-vice. Contact DrägerService .
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A device shut-down can be forced by pressing the On/Off switch (A) for 4 seconds. This may result in data loss. This type of shut-down should therefore only be used if a normal shut-down is not possible.
Instructions for use PulmoVista 500 SW 1.2n 81
Configuration
Configuration
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Configuring the screen layout. . . . . . . . . . . . 82
Configuring the display. . . . . . . . . . . . . . . . . . . 82Configuring the data import . . . . . . . . . . . . . . . 86
Configuring EIT settings . . . . . . . . . . . . . . . . 88
Frame rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88Operating frequency. . . . . . . . . . . . . . . . . . . . . 89
Configuring the system . . . . . . . . . . . . . . . . . 90
Selecting country-specific settings . . . . . . . . . . 90Service pages. . . . . . . . . . . . . . . . . . . . . . . . . . 91Simulating patient data . . . . . . . . . . . . . . . . . . . 93
Configuring data recording . . . . . . . . . . . . . . 94
Patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . 94File handling . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Configuration
82 Instructions for use PulmoVista 500 SW 1.2n
Overview
This chapter describes the system setup functions. The System setup dialog window provides the user with the following setup pages:– Screen layout– EIT settings– System– Data recording (Requires the option ADAP)
Changes to system setup settings become effective immediately. Changes to settings are retained after switching off PulmoVista 500. All settings can be set to factory defaults on the Service page.
The Product specific page in the Service dialog window is password-protected.
Configuring the screen layout
The Screen layout page consists of the Display and Data import subpages.
Configuring the display
1 Touch the System setup... button in the main menu bar to open the Screen layout page (A).
2 Select the Display (B) tab.
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Instructions for use PulmoVista 500 SW 1.2n 83
Configuration
On the Display page, the user can change the following settings:
Filter and cut-off frequency settings
These settings can be used to display impedance changes below a particular frequency (low pass) or within a particular frequency range (band pass). Filter settings determine the nature of impedance changes reflected in the displayed data as changes due to ventilation, cardiac and high frequency noise artifacts can be separated.
Filter and cut-off frequency settings only affect the display of data, not data recording. Band pass filtering only affects the display of data in the Main and Full-screen image views. The following table illustrates the effect of combinations of filter and cut-off frequency settings.
Item Parameters Settings
(C) Filter Off (L), Low pass (M), Band pass (N)
(D) Cut-off freq. [/min] Cut-off frequency for low-pass filter (O), upper cut-off frequency for band-pass filter (P), lower cut-off frequency for band-pass filter (Q)
(E) Artifact filter On, Off
(F) Status image Tidal (R), Minute (S)
(G) Full-screen image Dynamic image (T), Status image (U)
(H) Display thoracic contour On, Off
(I) Display contour of ventilated area
On, Off
(J) Time scale Displayed duration of the impedance waveform (V)
(K) Baseline update Breath (W), Time scale (X)
Filter setting Cut-off frequency setting (/min)
Principles of operation
Off (I) – Impedance changes of all frequen-cies are displayed.
Signals from high-frequency noise may be included.
Configuration
84 Instructions for use PulmoVista 500 SW 1.2n
Low pass (J) Below the heart rate but above the respiratory rate, e.g., heart rate less 10
Ventilation-related impedance changes are displayed.
High-frequency noise signals and cardiac-related impedance changes are attenuated.
Above the heart rate, e.g., heart rate plus 20
Ventilation- and cardiac-related im-pedance changes are displayed.
High-frequency noise signals are at-tenuated.
Band pass (K)
(Requires ADAP)
Numeric values are not dis-played when band pass filtering is activated.
The low cut-off frequency must be less than the heart rate, the upper cut-off frequency must be above the heart rate, e.g., low frequency: heart rate less 10, upper frequency: Heart rate plus 10
Cardiac-related impedance changes are displayed.
High-frequency noise signals and ventilation-related impedance changes are attenuated.
Filter setting Cut-off frequency setting (/min)
Principles of operation
Instructions for use PulmoVista 500 SW 1.2n 85
Configuration
Setting the filter
Touch the relevant button for the filter.
Setting the cut-off frequency
1 Touch the relevant button for the frequency.
2 Set the value by turning the rotary knob and press to confirm.
Frequency settings may be changed regardless of the selected filter mode. This enables the frequency settings to be customized before changing the filter modes.
Configuring the artifact filter
This configuration defines whether interferences are dampened in the displayed impedance waveforms. However, it does not affect the data recording.
In the row Artifact filter (E) touch the On or Off button.
Configuring the status image
The status image is either a tidal image or a minute image. The tidal image represents the regional distribution of the impedance changes due to tidal ventilation of the last detected breath. The minute image represents the regional distribution of the impedance changes due to tidal ventilation of the spontaneous or mechanical breaths of the last minute.
Touch the Tidal button (R) to display a tidal image or the Minute button (S) to display a minute image.
Configuring the full-screen image
If Full-screen image has been selected, the selected image is shown full screen. The other image is shown smaller.
Touch the Dynamic image (T) or Status image button (U).
Displaying the thoracic contour
This function determines if the thoracic contour is displayed. The thoracic contour is a schematic representation of the thorax of the patient with a reference to the spine.
Touch the On or Off button.
Displaying the contour of the ventilated area
This configuration defines whether a contour is displayed that separates the ventilated area (blue or white) from the non-ventilated area (black).
The contour surrounds the area of the smallest still detectable and displayed impedance change (blue) and thus the ventilated area. Areas with small impedance changes which were previously displayed as non-ventilated (black) may now be displayed as ventilated (blue to white). This may now also cause a significant change of the contour.
Clinical and therapy-related influences must be taken into account when interpreting the contour. A change of the contour alone should not lead to the conclusion that clinically relevant changes have occurred in the distribution of ventilation.
In the Main and Full-screen image views, the contour surrounds in the dynamic image the area ventilated during the last breath.
In the End-insp. trend and EELI trend views, on the other hand, the contour surrounds in the two status images and in the differential images the area that was at least temporarily ventilated during the selected time scale.
In the row Display contour of ventilated area (I) touch the On or Off button.
In the Diagnostics view, the contour surrounds in all displayed images the area that was at least temporarily ventilated during the selected sections.
Configuration
86 Instructions for use PulmoVista 500 SW 1.2n
Setting the time scale
The time scale setting determines the duration of the impedance waveforms in the Main view and the Full-screen image view.
1 Touch the button (V) in the rowTime scale (J).
2 Select the value by turning the rotary knob and press to confirm.
The available time scale settings vary with the selected frame rate.
Baseline update
The baseline update setting defines at which interval the baseline of the impedance waveforms is updated.
Touch the Breath button (W) to update the baseline after each detected breath.
Touch the Time scale (X) button to update the baseline each time the cursor passes the zero position of the time scale.
For more details, see "Definition of baseline frames" on page 142.
Configuring the data import
MEDIBUS or MEDIBUS.X settings for COM 1 are fixed on PulmoVista 500 and must be adjusted on the connected Dräger device. To connect the Dräger device, see "Preparation for using the MEDIBUS or MEDIBUS.X protocol" on page 42. Use the values below to configure the COM settings on the Dräger device according to its instructions for use.
1 Touch the System setup... button in the main menu bar to open the Screen layout page (A).
2 Select the Data import (B) tab.
PulmoVista 500 displays the MEDIBUS or MEDIBUS.X settings (C) of PulmoVista 500 and the model of the connected Dräger device (D).
On the Data import page, the user can change the following settings:– Imported waveforms (E)– Volume waveform (G)– Trend display (J)
Imported waveforms
To select which MEDIBUS or MEDIBUS.X waveforms are stored with EIT data, proceed as follows:
1 Touch the button (F) to open the parameter selection list.
2 Select a parameter.Baud rate 19200
Parity none
Stop bit 1
50
8
System setup
A
B
CD
E F
IHG
J K
FF
KK
Instructions for use PulmoVista 500 SW 1.2n 87
Configuration
Volume waveform
Used to determine if the imported volume waveform is superimposed on the global impedance waveform.
Prerequisite: "Volume waveform" is selected in the Imported waveforms (E) field.
Touch the On (H) or Off button (I).
A transmission delay of MEDIBUS or MEDIBUS.X data may cause a phase shift between the volume and the impedance waveforms. Filtering causes a delay of the impedance waveforms, which may affect the phase shift.
Trend display
This setting defines which three MEDIBUS or MEDIBUS.X parameters are displayed as part of trend data. If available, all MEDIBUS- or MEDIBUS.X parameters are stored during recording, regardless of the displayed parameter. This setting applies to the End-insp. trend and EELI trend views.
1 Touch the button (K) to open the parameter selection list.
2 Select a parameter.
Configuration
88 Instructions for use PulmoVista 500 SW 1.2n
Configuring EIT settings
1 Touch the System setup... button in the main menu bar.
2 Touch the EIT settings tab (A).
On the EIT settings page, the user can change the following settings:– Frame rate [Hz] (B)– Operating frequency [kHz] (F)– Adjustment of operating frequency (G), (H)
Frame rate
The frame rate is the frequency at which dynamic images are generated.
Available settings: 10, 15, 20, 30 and additionally 40, 50 for the option ADAP.
Changing frame rate
Prerequisite: PulmoVista 500 is in standby mode.
1 Touch the Frame rate [Hz] button (B).
2 Select the value by turning the rotary knob and press to confirm.
Increasing the frame rate increases the temporal resolution but may also cause a reduction in the signal quality. Recording EIT data at high frame rates may result in large files (up to 15 MB per minute at a frame rate of 50 Hz). Frame rates >30 Hz are only recommended for analysis of cardiac-related impedance changes.
If the reference function is activated, changing the frame rate deletes the reference data.
Noise spectrum
A noise spectrum analysis is conducted during the calibration phase. The noise spectrum is displayed in the diagram (C).
51
3
System setup
B
EF
G H
A
CD
Instructions for use PulmoVista 500 SW 1.2n 89
Configuration
Operating frequency
The operating frequency is displayed in the field (F) and as a dashed vertical line in the diagram (D).
Adjustment of operating frequency
Automatic:PulmoVista 500 determines the optimal operating frequency based on automatic spectrum analysis during the calibration phase.
Touch the Auto button (G).
Manual:This function requires the ADAP option.If adjustment of frequency is set to Manual, the horizontal slider (E) can be used to adjust the operating frequency between 80 and 130 kHz.
1 Touch the Manual button (H).
2 Set the horizontal slider (E) by turning the rotary knob or by touching the slider. Press the rotary knob to confirm.
Set the operating frequency to a value within a frequency range where there is a low level of background noise.
Configuration
90 Instructions for use PulmoVista 500 SW 1.2n
Configuring the system
The System page consists of the following subpages:– Country– Service– Simulation
Selecting country-specific settings
1 Touch the System setup... button in the main menu bar.
2 Touch the System tab (A).
3 Touch the Country tab (B).
On the Country page, the user can change the following settings:– Language (C)– Date and time (D)– Airway pressure (E)
Language
Prerequisite: PulmoVista 500 is in standby mode.
1 Touch the button (F) to open the language selection.
2 Select the country-specific language.
Date and time
Prerequisite: PulmoVista 500 is in standby mode.
PulmoVista 500 displays the current date and time in the Date and time (D) lines.
1 Touch the relevant buttons for year, month, day, hour, and minute.
2 Select the value by turning the rotary knob and press to confirm.
3 Touch the Apply button (G) to activate the settings.
Airway pressure unit
The airway pressure unit of displayed MEDIBUS data can be selected.
Touch the mbar (H) or cmH2O (I) button.
51
4
System setup
A
BC
D
E
F
G
H I
Instructions for use PulmoVista 500 SW 1.2n 91
Configuration
Service pages
1 Touch the System setup... button in the main menu bar.
2 Touch the System tab (A).
3 Touch the Service tab (B).
PulmoVista 500 displays the following product identification data in the (C) field:– Product name– Part number – SW version– Serial number
On this page, the user has the following options:– Open the Service dialog window (D)– Change to Dräger default settings (E)
Dräger default settings
Prerequisite: PulmoVista 500 is in standby mode.
1 Touch the Dräger default button (E).
2 Press the rotary knob to confirm.
The following system settings are reset to factory settings:
51
5
System setup
A
BC
D
E
Parameters Setting
Filter Off
Status image Tidal image
Full-screen image Status image
Display of thoracic contour On
Time scale 30 s
Frame rate 20 Hz
Adjustment of operating frequency
Automatic
Record mode Continuous
File length for recording 30 s
Saved MEDIBUS or MEDIBUS.X waveforms
Paw, Flow, Vol.
MEDIBUS or MEDIBUS.X volume waveform super-imposed on the global im-pedance waveform
Off
MEDIBUS or MEDIBUS.X data in the trend view
PEEP
PIP
VT
Display contour of ventilat-ed area
Off
Artifact filter Off
Configuration
92 Instructions for use PulmoVista 500 SW 1.2n
Accessing the Service dialog window
Prerequisite: PulmoVista 500 is in standby mode and the System setup > System > Service page is open.
1 Touch the Enter menu button (D).
The Service dialog window consists of the following pages:– System information (F)– Product specific (G)– Applications (H)
Page System information
The System information page is preselected and contains information about the software versions of the installed system components (I).
Page Product specific
This page is password-protected.
Prerequisite: The Service page is open.
1 Touch the Product specific tab (G).
2 Enter the password.
Page Applications
Prerequisite: The Service dialog window is open.
1 Touch the Applications tab (H).
The list of installed applications is displayed (L).
Installing applications
Only use SIM cards and USB-SIM card readers supplied by Dräger.
1 Insert the SIM card into the USB SIM card reader.
2 Insert the USB SIM card reader into the USB port on the Cockpit.
3 Touch the Install button (K).
4 Select the application from the list (J) using the rotary knob and press to confirm. If only one application is available, there is no need to select the application.
54
5
Service
F G H
I
54
6
Service
H
J LK
Instructions for use PulmoVista 500 SW 1.2n 93
Configuration
5 To assure correct installation of the application, wait at least 20 seconds before removing the USB SIM card reader.
6 If applicable, install further applications (repeat steps 3, 4, and 5).
7 When all applications are installed, restart the device.
The installed application is displayed in the list (L).
Simulating patient data
In the simulation mode, previously recorded patient data can be displayed in all views. The simulation mode can be used for demonstration purposes. If patient data are changed in the simulation mode, e.g., for demonstration purposes, these changes will not affect recorded data.
Prerequisite: PulmoVista 500 is in standby mode.
1 Touch the System setup... button in the main menu bar.
2 Touch the System tab (A).
3 Touch the Simulation tab (B).
55
3
System setup
A
C D
BE
F
G
H
Configuration
94 Instructions for use PulmoVista 500 SW 1.2n
To activate simulation mode, proceed as follows:
1 Touch the relevant buttons (E), (F), (G), or (H) to open the list of available folders, subfolders, and files. Select a folder, a subfolder, and the EIT data files that are intended to be used for the simulation.
Selecting folders and subfolders requires the option ADAP.
Without the ADAP option, a folder and a subfolder are preselected. The relevant (E) and (F) buttons are inactive. A preinstalled example EIT data file for demonstration purposes can be selected using the button (G).
2 Touch the On button (C) and press the rotary knob to confirm.In the header, Simulation is displayed.
To stop the simulation mode, proceed as follows:
1 Touch the Start/ Standby... button in the main menu bar. Touch the Standby button on the Start/Standby page.
2 Touch the System setup... button in the main menu bar.
3 Touch the System tab (A).
4 Touch the Simulation tab (B).
5 Touch the Off button (D).
Configuring data recording
Data recording requires the option ADAP.
The Data recording page consists of the Patient data and File handling subpages.
Patient data
1 Touch the System setup... button in the main menu bar.
2 Touch the Data recording tab (A).
3 Touch the Patient data tab (B).5
16
A
B
System setup
CDE
FG
I
J
K
L
M N
HHH
HH
Instructions for use PulmoVista 500 SW 1.2n 95
Configuration
On the Patient data page, the user can change the following data and settings:– Name (C)– Age/Date of birth (D)– Patient ID (E)– Short comment (F)– Notes (G)– Record mode (K)– File length (L)
Entering or editing patient data
Touch the Edit button (H) next to the field to be edited to display the on-screen keyboard. Enter the patient data (up to 20 characters for each field, up to 50 characters for the Notes field).
When data is recorded, file names are automatically created using the following format:– Folder: current date– Subfolder: Patient ID_Short comment– File: Patient ID_Short comment_Incremental
counter
The directory and the file name are displayed in the (I) field. If either the patient ID or short comment is changed, a new subfolder and a new file name is created after the first recording.
If no Patient ID or no Short comment is entered, the subfolder and the file name are both automatically labeled ID_SC.
The incremental counter depends on the record mode.
Clearing data
Touch the Clear data button (J) to clear the text fields.
Data recording settings
The record mode and the file length can be adjusted.
The record mode can be set as follows:– Single – Single file mode to record a single file
of a selected file length when the Record button in the main menu bar is touched.
– Cont. – Continuous mode to record multiple continuous files of a selected file length as long as the Record button in the main menu bar is active.
Touch the Single (M) or Cont. button (N).
File length
1 Touch the File length button (L).
2 Select the value by turning the rotary knob and press to confirm.
Be aware that the time taken to open files increases with the size of the file.
Record mode File name Principles of operation
Cont. ID_SC_XX_YYY XX increments each time the recording function is started
YYY increments with each new file
Single ID_SC_XX XX increments each time the recording function is started
NOTE
A continuous recording is automatically ended after 24 hours.
Configuration
96 Instructions for use PulmoVista 500 SW 1.2n
File handling
All recorded EIT data are stored on the hard disk of the Cockpit in the following file structure:– Folder– Subfolder – File
Folders, subfolders, and files can be deleted or copied to a connected USB storage medium.
Prerequisite: PulmoVista 500 is in standby mode.
Accessing the File handling page
1 Touch the System setup... button in the main menu bar.
2 Touch the Data recording (A) tab.
3 Touch the File handling (B) tab.
The File handling page contains the following:– Folder (C)– Subfolder (D)– File (E)
– Properties of the folder, subfolder, or file (F)– Size of the file– Number of the contained subfolders or files– Date of the file record
– Button to open the list of all folders, subfolders, or files (G)
– Button Copy to USB (H)– Button Delete (I)
Deleting a folder, subfolder, or file
1 Touch the relevant button (G) to open the list of all available folders, subfolders, or files. Select a folder or subfolder or a single file.
2 Touch the relevant Delete button (I) and confirm by pressing the rotary knob.
Copying a folder, subfolder, or file
1 Connect a USB storage medium to the left or right USB port on the Cockpit.
2 Touch the relevant button (G) to open the list of all available folders, subfolders, or files. Select a folder or subfolder or a single file.
3 Touch the relevant Copy to USB button (H) and confirm by pressing the rotary knob.
Free disk space (J)
A portion of the hard disk drive is reserved for EIT data. This parameter indicates the available space in this reserved section.
Free USB space (K)
This parameter indicates the available space on the connected USB storage medium.
After data export to USB storage medium
Wait until message "Copied files: X" is shown before removing the USB storage medium.
51
7
System setup
A
B
C
D
E
HIF
G
JK
F
F
HI
G
H
I
G
Instructions for use PulmoVista 500 SW 1.2n 97
Problem solving
Problem solving
Message – Cause – Remedy . . . . . . . . . . . . . 98
Problem solving
98 Instructions for use PulmoVista 500 SW 1.2n
Message – Cause – Remedy
Messages are displayed in the message field of the header bar in hierarchical order.
If several messages occur simultaneously, the message field displays the highest-priority message.
In the following table, the messages are listed in alphabetical order. If a message occurs, the table helps to identify causes and remedies. The different causes and remedies must be worked through in the order listed until the condition has been resolved.
Priority Message Cause Remedy
090 15-electrode mode During the start of measure-ment, there was insufficient contact between one elec-trode and the skin. Images are generated using the 15-electrode mode.
In the 15-electrode mode, mon-itoring can be continued when it is not possible to locate all 16 electrodes against the skin, e.g., due to wound dressings.
Spatial resolution may be de-creased in the region of the in-active electrode. Interpretation of EIT data is still possible.
To reestablish the 16-electrode mode, touch the "Signal check..." button to identify the electrode with unstable contact. After improving electrode con-tact, touch the "Start" button.
Restore electrode contact or decrease electrode resistance as described in these instruc-tions for use.
Instructions for use PulmoVista 500 SW 1.2n 99
Problem solving
160 Check electrode contact The resistance of at least one electrode is too high.
Touch the "Signal check..." but-ton to check the resistance of the electrodes. Use the "Signal check" dialog window to evalu-ate the effectiveness of adjust-ments.
Check if the electrode has good contact with the skin. Consider applying electrode gel to all electrodes with insufficient or unstable contact.
Press the electrode gently against the skin. Make sure that the patient cable is securely at-tached to all electrodes.
The patient cable was not connected correctly to the electrode belt.
Connect the patient cable cor-rectly to the electrode belt as described in these instructions for use.
The patient cable was not connected correctly to the trunk cable.
Connect the patient cable cor-rectly to the trunk cable as de-scribed in these instructions for use.
The trunk cable was not connected correctly to the EIT module.
Connect the trunk cable cor-rectly to the EIT module as de-scribed in these instructions for use.
Restart the measurement. If the condition persists, replace the electrode belt. If the condition persists, perform the device check. If the device check pass-es, replace the patient cable. If the device check fails, replace the trunk cable. If the condition persists, call DrägerService.
120 Check patient cable con-nection
The patient cable was not connected correctly to the electrode belt.
Connect the patient cable cor-rectly to the electrode belt as described in these instructions for use.
Priority Message Cause Remedy
Problem solving
100 Instructions for use PulmoVista 500 SW 1.2n
150 Check reference elec-trode
The resistance of the refer-ence electrode is too high.
Touch the "Signal check..." but-ton to check the resistance of the reference electrode. Use the "Signal check" dialog win-dow to evaluate the effective-ness of adjustments.
If the maximum resistance is displayed, check first if the pa-tient cable was connected to the reference electrode and if the reference electrode was ap-plied to the patient.
Check if the reference electrode has good contact with the skin. Press the reference electrode gently against the skin.
Restart the measurement. If the condition persists, replace the reference electrode. If the con-dition persists, call DrägerSer-vice.
200 Device failure Internal communication fail-ure. Cockpit or EIT module is faulty. Electrocautery or electrosurgery also may cause this message.
Restart the device. If the mes-sage appears again, call DrägerService.
040 Electrode belt not detect-ed
The closure snap on the pa-tient cable was not connect-ed correctly after the elec-trode belt was closed.
Connect the closure snap of the patient cable to the closure stud on the electrode belt after the electrode belt is closed.
105 Electromagnetic distur-bance
Electromagnetic distur-bances have been detected during the measurement.
Investigate which devices in the patient vicinity cause distur-bances. If possible, deactivate the source of the disturbance while performing measure-ments or increase the distance between the source of the dis-turbance and the patient.
Activate the artifact filter.
If no disturbances are visible in the waveforms and images, the measurement can be contin-ued.
Priority Message Cause Remedy
Instructions for use PulmoVista 500 SW 1.2n 101
Problem solving
100 Low signal quality The signal quality is low. Touch the "Signal check..." but-ton to check the resistance of the electrodes. Use the "Signal check" dialog window to evalu-ate the effectiveness of adjust-ments.
If necessary, decrease the re-sistance as described in these instructions for use. Restart the measurement.
If the condition persists, set the frame rate to 10 Hz. Restart the measurement. If the signal quality improves, the frame rate can be increased again gradu-ally.
Restart the measurement. Ob-serve the signal quality.
If the signal quality does not im-prove at a frame rate of 10 Hz, perform a device check.
If the device check passes, re-place the electrode belt and re-start the measurement. If the condition persists, replace the patient cable and restart the measurement.
If the device check fails, call DrägerService.
050 Patient cable not detect-ed
The patient cable is not con-nected to the trunk cable.
The patient cable is faulty.
Connect the patient cable to the trunk cable before starting the measurement. If the condition persists, replace the patient ca-ble.
130 Patient cable or trunk ca-ble faulty
The patient cable or the trunk cable is faulty.
Perform the device check. If the device check passes, replace the patient cable. If the device check fails, replace the trunk cable.
Priority Message Cause Remedy
Problem solving
102 Instructions for use PulmoVista 500 SW 1.2n
080 Period of use of elec-trode belt elapsed
The recommended period of use of the electrode belt has elapsed.
If signal quality during EIT mea-surement is adequate, monitor-ing can be continued. If signal quality during EIT measure-ment is low, consider replacing the electrode belt.
038 Ready for device check The patient cable plugs are plugged into the test con-nectors. The device is ready to start the device check.
Perform the device check. Af-terwards remove the patient ca-ble plugs from the test connec-tors.
110 Restart calibration A significant change in one of the following conditions has occurred: Electrode re-sistance, signal quality, body position.
Pacemaker signals, electro-cautery, or electrosurgery also may cause this mes-sage.
Open the "Signal check" dialog window and restart the calibra-tion. If this message has likely been caused by pacemaker sig-nals, electrocautery, or electro-surgery, no remedy is required.
190 Safety function activated - Technical
The safety function was ac-tivated for technical rea-sons.
Restart the device. If the mes-sage appears again, call DrägerService.
180 Safety function activated - Temperature
The safety function was ac-tivated because the tem-perature in the EIT module is too high.
Make sure that the ventilation slots of the EIT module are not covered or occluded. Let the device cool down. Restart the device. If the message appears again, call DrägerService.
170 Temperature high The temperature in the EIT module is too high.
Make sure that the ventilation slots of the EIT module are not covered or occluded. If the mes-sage does not disappear, switch off the device and let it cool down.
Restart the device. If the mes-sage appears again, call DrägerService.
060 Trunk cable not detected The trunk cable is not con-nected to the EIT module.
The trunk cable is faulty.
Connect the trunk cable to the EIT module before starting the measurement. If the condition persists, replace the trunk ca-ble.
Priority Message Cause Remedy
Instructions for use PulmoVista 500 SW 1.2n 103
Problem solving
If technical messages continue to display which are not related to known adverse conditions or to the measurement set-up, perform a device check.
140 Unstable electrode con-tact
The variation in the resis-tance of at least one elec-trode is too high.
Touch the "Signal check..." but-ton to identify all electrodes with poor contact. Use the "Signal check" dialog window to evalu-ate the effectiveness of adjust-ments.
Restart the measurement. If the condition persists, replace the electrode belt and restart the measurement. If the condition persists, replace the patient ca-ble and restart the measure-ment.
Restart the measurement. If the condition persists, replace the electrode belt. If the condition persists, replace the patient ca-ble. If the condition persists, call DrägerService.
070 Wrong patient cable The size of the patient cable and of the electrode belt in use do not match.
Use the correct patient cable size for the electrode belt in use.
Priority Message Cause Remedy
104 Instructions for use PulmoVista 500 SW 1.2n
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Instructions for use PulmoVista 500 SW 1.2n 105
Cleaning and disinfection
Cleaning and disinfection
Safety information for reprocessing. . . . . . . 106
Classification of medical devices . . . . . . . . . . . 107Classification of device-specific components . . 107
Reprocessing procedure . . . . . . . . . . . . . . . . 108
Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . 108Manual cleaning . . . . . . . . . . . . . . . . . . . . . . . . 108Disinfecting the patient interface . . . . . . . . . . . 109Disinfecting surfaces . . . . . . . . . . . . . . . . . . . . 109Visual inspection. . . . . . . . . . . . . . . . . . . . . . . . 109
Before reusing on patient . . . . . . . . . . . . . . . 109
Cleaning and disinfection
106 Instructions for use PulmoVista 500 SW 1.2n
Safety information for reprocessing
WARNING
Risk of infection
Reusable products must be reprocessed to prevent increased risk of infection and impair-ment of their operation.– Observe the hygiene regulations of the
hospital.– Perform the reprocessing using a validat-
ed method.– Reprocess reusable products after every
use.– Observe the manufacturer specification
for cleaning agents and disinfectants.
WARNING
Risk of electric shock
Do not sterilize PulmoVista 500 and its acces-sories as this may damage the insulation of cables. Instead, perform the cleaning proce-dures described in the instructions for use.
WARNING
Risk of electric shock
Do not disconnect the system cables. If nec-essary, contact service personnel.
WARNING
Risk of electric shock and of device malfunc-tion
Penetrating liquid may cause malfunction of or damage to the device, which may endanger the patient.
Do not immerse or rinse the EIT system or its components (e.g., patient interface, Cockpit, cables, USB storage media) in liquids. During surface disinfection make sure that no liquids enter the device.
If a liquid is accidentally spilled on the device, disconnect the device from the power source. Contact service personnel regarding the con-tinued safety of the device before putting it back into operation.
WARNING
Do not use sharp tools or abrasives. Do not immerse electrical connectors in water or oth-er liquids. Avoid the accumulation of liquid at the edge of the screen as this may damage the device.
CAUTION
Do not clean the Cockpit using an alcoholic solu-tion. Such solutions may damage the Cockpit.
CAUTION
Risk of damage to the touchscreen
Do not spray the cleaning liquid directly on the touch screen. The cleaning liquid must be applied to a cloth or tissue before cleaning the surface.
Instructions for use PulmoVista 500 SW 1.2n 107
Cleaning and disinfection
Dräger cannot provide any assurances as to the effectiveness of non-validated cleaning agents, disinfectants, and methods. Dräger on principle does not provide any assurances regarding the following points:– Capability of substances to prevent infection– Environmental compatibility of substances
– Safe handling of substances– Precautionary measures when using
substances
More information on these aspects can be found in the manufacturer specifications for the respective cleaning agent or disinfectant.
When using flammable substances for disinfection, make sure that the room is sufficiently ventilated.
When used in the intended manner there is no limit to the number of times the electrode belt, the patient cable and the trunk cable may be reprocessed within the recommended lifetime.
Classification of medical devices
Medical devices and their components are classified according to the way they are used and the resulting risk.
Classification of device-specific components
This medical device and all its components have been classified as non-critical.
CAUTION
Risk due to faulty products
Signs of wear can occur in reusable products, e.g., cracks, deformation, discoloring, or peeling.
Check the products for signs of wear and replace them if necessary.
NOTE
Do not clean the touch screen of the Cockpit while monitoring a patient. Before cleaning, take the de-vice out of operation.
Classification Definition
Non-critical Components that come into contact with intact skin only
Semi-critical Components that carry breathing gas or come into contact with mucous mem-branes or pathologically altered skin
Semi-critical A No special requirements for reprocessing
Semi-critical B Increased requirements for reprocessing
Critical Components that penetrate the skin or mucous membranes or come into con-tact with blood
Cleaning and disinfection
108 Instructions for use PulmoVista 500 SW 1.2n
Reprocessing procedure
Prerequisite: The patient interface is disassembled, see "Removing the patient interface" on page 80.
Disinfectants
Information on disinfectants
Use disinfectants that have been approved for the relevant country and are suitable for the respective reprocessing methods.
Compounds using the following agents may cause material damage and must not be used, unless specifically recommended by Dräger, on any part of the device or accessories:– Halogen-releasing compounds– Strong organic acids– Oxygen-releasing compounds
It is the responsibility of the user to observe national and hospital-specific guidelines as well as all guidelines issued by relevant regulatory authorities. Always observe the instructions provided by the manufacturer of the disinfectant.
The effectiveness of the selected disinfectant must be proven by the manufacturer of the disinfectant. The following disinfectants have been tested by Dräger and shown to have good effectiveness and material compatibility at the time of the test:
Surface disinfectant for device surfaces– Buraton 10F (Schülke+)
Surface disinfectant for patient interface– Mikrobac Tissues (BODE Chemie)
The composition of the disinfectants is the responsibility of the manufacturer and can change over time.
Manual cleaning
1 Wipe all foreign material off the surface of the patient interface, using a disinfectant soaked cloth:– Patient cable– Electrode belt– Trunk cable
2 Wipe all foreign material off the surface of the following parts, using a damp cloth:– Cockpit– EIT module– Power supply module– Trolley
3 Do not scrape off foreign material which is stuck to the surface, but soften with a damp cloth and then wipe off.
4 Wipe until all foreign material is visibly removed and allow to dry completely. Carefully dry the Cockpit surfaces with a lint-free cloth.
5 Check that all visible soiling has been removed. If necessary, repeat manual cleaning until visible soiling is removed.
In cases of major contamination of the trunk cable, electrode belt or patient cable with potentially infectious material, e.g., after soaking in body fluids such as blood, vomit or urine, it is the responsibility of the user to select the appropriate method of cleaning and disinfecting. Dräger recommends the disposal of the infected part.
Instructions for use PulmoVista 500 SW 1.2n 109
Cleaning and disinfection
Disinfecting the patient interface
The following components of the patient interface can be disinfected:– Trunk cable– Electrode belt– Patient cable
1 After manual cleaning disinfect the patient interface by wiping with a cloth soaked in disinfectant.
Observe the instructions provided by the manufacturer of the disinfectant.
2 Re-wipe with a cloth soaked in water which has at least drinking-water quality.
3 Remove disinfectant residues with a clean dry cloth.
4 Inspect parts for visible damage.
Disinfecting surfaces
The following device surfaces can be disinfected:– Cockpit– EIT module– Power supply module– Trolley
1 After manual cleaning, disinfect surfaces by wiping with a cloth soaked in disinfectant.
2 Remove disinfectant residues with a clean dry cloth.
Visual inspection
Inspect all parts for damage and wear, e.g., formation of cracks, embrittlement or major hardening, and residual soiling.
Before reusing on patient
1 Make sure that the device is connected to the mains power supply, see "Connecting the mains power supply" on page 39.
2 Confirm readiness for operation, see "Device check" on page 47.
3 Attach patient interface, see "Attaching the patient interface" on page 49.
110 Instructions for use PulmoVista 500 SW 1.2n
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Instructions for use PulmoVista 500 SW 1.2n 111
Service
Service
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Definition of maintenance concepts . . . . . . . . . 113
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Preventive maintenance . . . . . . . . . . . . . . . . 114
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Service
112 Instructions for use PulmoVista 500 SW 1.2n
Overview
This chapter describes the maintenance measures required to maintain the proper functioning of the medical device. Maintenance measures must be performed by the personnel responsible.
It is not advisable to use the electrode belt or the patient cable for longer than 1 year, or the trunk cable for longer than 2 years as components may deteriorate over time and with usage.
WARNING
Risk of infection
Users, service personnel and experts can be-come infected with pathogenic germs.
Disinfect and clean device or device parts be-fore any maintenance measures and also be-fore returning the medical device for repair.
WARNING
Risk of electric shock
Current-carrying components are located un-der the housing covers.– Do not remove the housing covers.– Maintenance measures must be performed
by the personnel responsible. Dräger rec-ommends DrägerService to perform these measures.
WARNING
Risk of fire, explosion, or excessive tempera-ture
Replacement of the batteries must only be performed by experts.
WARNING
If the device is mechanically damaged or if it is not working correctly, do not use it. Contact service personnel.
WARNING
When servicing the device, always use re-placement parts that are qualified to Dräger standards. Dräger cannot warrant or endorse the safe performance of third-party replace-ment parts for use with the device.
WARNING
Limited availability
The battery of the power supply module must be replaced at periodic intervals.
NOTE
If PulmoVista 500 is to be isolated from the mains power supply, e.g., for maintenance, it is neces-sary to pull out the mains plug from the mains socket outlet.
NOTE
Prior to any maintenance and repair work the pa-tient must be fully disconnected from the device.
Instructions for use PulmoVista 500 SW 1.2n 113
Service
Definition of maintenance concepts
Inspection
Perform inspections at regular intervals and observe the following specifications.
Concept Definition
Maintenance All measures (inspection, preventive maintenance, repair) intended to main-tain and restore the functional condition of a medical device
Inspection Measures intended to determine and assess the actual state of a medical de-vice
Preventive maintenance Recurrent specified measures intended to maintain the functional condition of a medical device
Repair Measures intended to restore the functional condition of a medical device af-ter a device malfunction
Checks Interval Personnel responsible
Inspection Every 2 years Experts
Check the electrical safety in accor-dance with IEC 62353
Every 2 years Experts
Check that the multiplexer test is oper-ating correctly
Every 2 years Experts
Check that the trolley and castors are in sound condition and are operating correctly
Every 2 years Experts
Check that the device, its components, and accessories are in sound condition (no visible damage, labels complete and legible, instructions for use at hand)
Every 2 years Experts
Check that the mains power LEDs at the Cockpit and at the power supply module are operating correctly
Every 2 years Experts
Check that the touchscreen is operat-ing correctly
Every 2 years Experts
Service
114 Instructions for use PulmoVista 500 SW 1.2n
Preventive maintenance
The following table shows the preventive maintenance intervals:
Repair
Dräger recommends that all repairs are performed by DrägerService and that only authentic Dräger repair parts are used.
WARNING
Risk of faulty components
Device failure is possible due to wear or mate-rial fatigue of the components.
To maintain the proper operation of all compo-nents, this device must undergo inspection and preventive maintenance at specified inter-vals.
WARNING
Risk of electric shock
Before performing preventive maintenance, disconnect the device from the power supply.
Component Interval Measure Personnel responsible
Internal battery (Infinity P2500)
Every 2 years Replace Experts
Instructions for use PulmoVista 500 SW 1.2n 115
Disposal
Disposal
Disposing of the medical device. . . . . . . . . . 116
Disposing of batteries . . . . . . . . . . . . . . . . . . 116
Disposal
116 Instructions for use PulmoVista 500 SW 1.2n
Disposing of the medical device
At the end of its service life:
Have the medical device appropriately disposed of in accordance with applicable laws and regulations.
For countries subject to the EU Directive 2002/96/EC
This device is subject to EU Directive 2002/96/EC (WEEE). In order to comply with its registration according to this directive, it must not be disposed
of at municipal collection points for waste electrical and electronic equipment. Dräger has authorized a company to collect and dispose of this device. To initiate collection or for further information, visit Dräger on the Internet at www.draeger.com. Use the Search function with the keyword "WEEE" to find the relevant information. If access to Dräger's website is not possible, contact your local Dräger organization.
Disposing of batteries
The medical device battery contains pollutant substances.
The following applies to the Federal Republic of Germany: In accordance with legislation for batteries, the end user must return batteries containing harmful substances to the distributor or the collection center operated by public waste disposal corporations. The battery contained in the device must therefore be removed by experts prior to disposing of the device. For countries outside of the Federal Republic of Germany, observe the applicable national laws and regulations for battery disposal.
WARNING
Risk of explosion and of chemical burns
Improper handling of batteries can result in explosions and chemical burns.
Do not throw batteries into fire. Do not force batteries open.
Instructions for use PulmoVista 500 SW 1.2n 117
Technical data
Technical data
Ambient conditions . . . . . . . . . . . . . . . . . . . . 118
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Performance characteristics . . . . . . . . . . . . . 118
Operating data . . . . . . . . . . . . . . . . . . . . . . . . 119
Classification . . . . . . . . . . . . . . . . . . . . . . . . . 120
Communication interfaces on Medical Cockpit Infinity C500 . . . . . . . . . . . . . . . . . . . 121
Device combinations . . . . . . . . . . . . . . . . . . . 121
EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 121
General information . . . . . . . . . . . . . . . . . . . . . 121Electromagnetic environment . . . . . . . . . . . . . . 122Recommended separation distances from wireless communication devices . . . . . . . . . . . 123
Connections to IT networks . . . . . . . . . . . . . 124
Technical data
118 Instructions for use PulmoVista 500 SW 1.2n
Ambient conditions
During operation
Temperature (device) 5 to 40 °C (41 to 104 °F)
Temperature (electrode belt and cables) 5 to 45 °C (41 to 113 °F)
Ambient pressure 700 to 1060 hPa (10.15 to 15.37 psi)
Relative humidity 20 to 95 %, without condensation
Height Up to 3000 m (9842 ft)
During storage and transportation
Temperature –20 to 40 °C (–4 to 104 °F)
Ambient pressure 500 to 1060 hPa (7.25 to 15.37 psi)
Relative humidity 20 to 90 %, without condensation
Settings
Frame rate 10, 15, 20 or 30 frames per second
Frame rate with the option ADAP 10, 15, 20, 30, 40 or 50 frames per second
Cut-off frequency for low pass filter 10 to 300/min
Upper and lower cut-off frequencies for the band-pass filter
30 to 300/min
Performance characteristics
EIT measurement
Number of electrodes 16 electrodes plus 1 reference electrode
Feed current amplitude 80 to 100 % of maximum patient auxiliary current conforming to IEC 60601-1 (3rd edition)
Feed current frequency 80 to 130 kHz
Display unit (Medical Cockpit Infinity C500)
Resolution 1440 x 900 pixels
Contrast ratio Min. 500 : 1
Horizontal viewing angle 130° (typical)
Vertical viewing angle 100° (typical)
Instructions for use PulmoVista 500 SW 1.2n 119
Technical data
Operating data
Mains power supply
Mains supply nominal voltage and frequency range
100 V to 240 V, 50/60 Hz
Mains power supply characteristics Mains supply must comply with clause 4.10.2 of IEC 60601-1 (3rd edition) and, in particular, comply with overvoltage category II or lower in accordance with IEC 60664-1.
Inrush current 1.1 A (typical)
Current consumption
at 230 V Max. 0.6 A
at 100 V Max. 1.3 A
Power consumption
maximum during operation 125 W
typically during operation Approx. 80 W
maximum when device is switched off, but charging batteries
40 W
Internal battery
Type VRLA lead batteries, maintenance-free (2 pcs)(VRLA: Valve Regulated Lead Acid)
Rated voltage 12 V
Rated capacity 5.5 Ah, 10 hours discharge (550 mA up to 10.5 V DC)
Fuse F15AL 32 VDC, interrupting capacity 1000 A, UL 248-1, plug-in fuse 19.05 mm x 18.54 mm x 5.08 mm (0.75 in x 0.73 in x 0.2 in)
Time bridged following mains power failure
With new and fully charged internal battery Min. 5 minutes (typically 10 minutes)
Charging
Charging time (fully discharged batteries) Min. 12 hours
Sound pressure level (for free-field measurement over a reflecting surface)
Max. 45 dB(A)
Dimensions (W x H x D)
PulmoVista 500 incl. trolley 600 mm x 1400 mm x 750 mm(23.62 in x 55.12 in x 29.53 in)
Weight
PulmoVista 500 including trolley at maximum 44 kg (97 lbs)
Technical data
120 Instructions for use PulmoVista 500 SW 1.2n
Materials used
Electrode belt Silicone rubber, conductive silicone rubber, stain-less steel, gold-plated brass
Patient cable Plastics (thermoplastic polyurethane (TPU), poly-amide (PA), polyurethane (PUR), polypropylene (PP), thermoplastic elastomer (TPE), polybutylene terephthalate (PBT))
Trunk cable Plastics (polyamide (PA), thermoplastic polyure-thane (TPU), polyurethane (PUR))
Classification
Applied parts Applied parts are: electrode belt, reference elec-trode, patient cable, trunk cable
Mode of operation Continuous
Protection against electric shock regarding
External power supply Degree of protection I according to IEC 60601-1
Applied parts Type BF conforming to IEC 60601-1
Protection against harmful ingress of water IPX1 (dripping water: Vertically falling drops) con-forming to IEC 60529
Microenvironments of pollution Level 2 conforming to IEC 60601-1
Electromagnetic compatibility (EMC) (conforming to European Directive 89/336/EEC)
Tested in accordance with IEC 60601-1-2
Biocompatibility of the applied parts Tested in accordance with ISO 10993 for intact skin and an application duration of <24 hours
Classification as per EC Directive 93/42/EEC An-nex IX
II a
Operating data (Continued)
Instructions for use PulmoVista 500 SW 1.2n 121
Technical data
Device combinations
This device can be operated in combination with other Dräger devices or with devices from third-party manufacturers. Follow the accompanying documents of the individual devices.
If a device combination is not approved by Dräger, the safety and the functional integrity of the individual devices may be compromised. The
operating organization must ensure that the device combination complies with the applicable editions of the relevant standards for medical devices.
Device combinations approved by Dräger meet the requirements of the following standards:– IEC 60601-1 (electrical safety, mechanical
safety, software)– IEC 60601-1-2 (EMC)
EMC declaration
General information
This device was tested for electromagnetic compatibility using accessories from the list of accessories. Other accessories may only be used if they do not compromise the electromagnetic compatibility. The use of non-compliant accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device.
This device may be used in the direct vicinity of other devices only if Dräger has approved this device arrangement. If no approval has been given by Dräger, it must be ensured that this device
functions correctly in the desired arrangement before use. The instructions for use for the other devices must be followed.
Communication interfaces on Medical Cockpit Infinity C500
Digital outputs Communication interfaces
USB interfaces at the Cockpit sides Passive USB storage media only
Digital inputs
RS 232-connector 1 (9-pin) (on the rear panel) MEDIBUS connection for Dräger device
RS 232 connector 3 (9-pin) (on the rear panel) Reserved for future use
The RS 232 ports are electrically isolated from the equipment electronics.
NOTE
In the case of transient high voltage in the mains power supply, it may not be possible to switch off the device. Contact DrägerService.
Technical data
122 Instructions for use PulmoVista 500 SW 1.2n
Electromagnetic environment
This device may only be used in environments specified in section "Environment of use" on page 18.
Emissions Compliance
Radiated emissions Class A, group 2 (30 MHz to 1 GHz)
Conducted emissions Class A, group 2 (150 kHz to 30 MHz)
NOTE
The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a res-idential environment (for which CISPR 11 class B is normally required), this equipment might not of-fer adequate protection to radio-frequency com-munication services. The user might need to take mitigation measures, such as relocating or re-ori-enting the equipment.
Immunity against Test level and required electromagnetic environ-ment
Electrostatic discharge (ESD) (IEC 61000-4-2) Contact discharge: ±8 kV
Air discharge: ±15 kV
Fast transient electrical disturbances (bursts) (IEC 61000-4-4)
Power cable: ±2 kV
Longer signal input lines/output lines: ±1 kV
Impulse voltages (surges) (IEC 61000-4-5) Voltage, external conductor – external conductor: ±1 kV
Voltage, external conductor – protective ground con-ductor: ±2 kV
Magnetic fields at mains frequency (IEC 61000-4-8)
50 Hz: 30 A/m
Voltage dips and short interruptions in the supply voltage (IEC 61000-4-11)
Voltage dips of 30 % to 100 %, 8.3 ms to 5 s, differ-ent phase angles
Radiated high-frequency disturbances (IEC 61000-4-3)
80 MHz to 2.7 GHz: 3 V/m
Conducted high-frequency disturbances (IEC 61000-4-6)
150 kHz to 80 MHz: 3 V, ISM bands: 6 V
Electromagnetic fields in the vicinity of wireless communication devices
Various frequencies from 385 MHz to 5785 MHz: 9 V/m to 28 V/m
Instructions for use PulmoVista 500 SW 1.2n 123
Technical data
Recommended separation distances from wireless communication devices
To ensure that the functional integrity of this device is maintained, there must be a separation distance of at least 1.0 m (3.3 ft) between this device and wireless communication devices.
Technical data
124 Instructions for use PulmoVista 500 SW 1.2n
Connections to IT networks
In an IT network, data can be exchanged by means of wired or wireless technologies. An IT network can be any data interface (e.g., RS232, LAN, USB, printer interface) that is described in standards and conventions.
The following IT networks can be established using the RS232 interface and the USB port of PulmoVista 500:
– RS232 interface according to EIA RS-232 (CCITT V.24/V.28) for MEDIBUS and MEDIBUS.X in a point-to-point connection (exclusively for the Dräger devices specified in these instructions for use with a data connection validated by Dräger)
– Interfaces based on USB 1.1 or USB 2.0 to connect a passive USB storage medium without its own voltage supply or to connect a USB card reader supplied by Dräger
PulmoVista 500 can receive data from the specified Dräger devices via the MEDIBUS or MEDIBUS.X interface and supports the following functions:– Display of waveforms and parameter data– Recording and saving of data
PulmoVista 500 can save EIT files with the following data on a USB storage medium via the USB interface:– EIT data– Patient data– Data from a Dräger device received via
MEDIBUS or MEDIBUS.X
Software options can be enabled via the USB port. Only use SIM cards and USB-SIM card readers supplied by Dräger.
Only service personnel are allowed to connect PulmoVista 500 via the MEDIBUS or MEDIBUS.X interface to the specified Dräger devices. The accompanying documents of the Dräger device to be connected must be observed.
Subsequent changes to the passive USB storage medium, e.g., formating using different operating systems or loading different data using an IT device may impair the correct operation of the data transmission from or to the USB storage medium.
The USB port of PulmoVista 500 does not include an integrated virus scanner and has no firewall installed. This does not pose a risk to the correct medical operation of the device, but transmitted data can be distorted, damaged or deleted.
Removal of the USB storage medium or the data cable to the Dräger device during data transmission may damage the transmitted data.
Any other use of PulmoVista 500 interfaces is prohibited and may lead to new risks for patients, users and third parties.
Instructions for use PulmoVista 500 SW 1.2n 125
Principles of operation
Principles of operation
Image generation . . . . . . . . . . . . . . . . . . . . . . 126
Determination of regional bioelectric properties within the thorax . . . . . . . . . . . . . . . 126Image reconstruction . . . . . . . . . . . . . . . . . . . . 127Bioelectric properties of lung tissue . . . . . . . . . 128Functional EIT . . . . . . . . . . . . . . . . . . . . . . . . . 129Some examples of EIT images from PulmoVista 500 . . . . . . . . . . . . . . . . . . . . . . . . 129Special considerations when using the Diagnostics view. . . . . . . . . . . . . . . . . . . . . . . . 133Electrode plane. . . . . . . . . . . . . . . . . . . . . . . . . 135
Information displayed by PulmoVista 500 . . 136
Dynamic image. . . . . . . . . . . . . . . . . . . . . . . . . 136Status images. . . . . . . . . . . . . . . . . . . . . . . . . . 136Impedance waveforms . . . . . . . . . . . . . . . . . . . 137Numeric values. . . . . . . . . . . . . . . . . . . . . . . . . 137
Definition of baseline frames . . . . . . . . . . . . 142
Main and Full-screen image views . . . . . . . . . . 142End-insp. trend and Diagnostics views. . . . . . . 143EELI trend view . . . . . . . . . . . . . . . . . . . . . . . 144Data review page (optional with the option ADAP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Definitions for color scales and scales of impedance waveforms . . . . . . . . . . . . . . . . . . 145
Main and Full-screen image views . . . . . . . . . . 145End-insp. trend, EELI trend, and Diagnostics views. . . . . . . . . . . . . . . . . . . . . . . 146Data review page (optional with the option ADAP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Principles of breath detection and determination of the tidal rate . . . . . . . . . . . . 147
Literature references . . . . . . . . . . . . . . . . . . . 148
Principles of operation
126 Instructions for use PulmoVista 500 SW 1.2n
Image generation
Determination of regional bioelectric properties within the thorax
PulmoVista 500 is a functional lung monitor that performs thoracic bioimpedance measurements by applying the technique of electrical impedance tomography (EIT). PulmoVista 500 determines the regional bioelectric properties within a cross-sectional plane (the "electrode plane") of the thorax.
To perform the measurements, an electrode belt containing 16 electrodes is placed around the chest wall. Additionally, one reference electrode is attached to a central part of the body, preferably on the abdomen. The reference electrode ensures that all bioimpedance measurements at different electrode pairs are referenced to the same electric potential.
Principle of measurement
PulmoVista 500 applies a known alternating current "I1" to a pair of electrodes and measures the resulting surface potentials "Vn" at the remaining 13 electrode pairs. Applying the law of Ohm, the bioelectric impedance between the injecting and the measuring electrode pairs can be determined from the known current and the measured voltages.
Subsequently, the adjacent electrode pair is used for the next current injection and another 13 voltage measurements are performed. The location of the injecting and measuring electrode pairs successively rotates around the entire thorax. One complete rotation results in 16 voltage profiles, each consisting of 13 voltage measurements. The resulting 208 values, called a frame, are used to reconstruct one cross-sectional image.
03
4
Instructions for use PulmoVista 500 SW 1.2n 127
Principles of operation
Image reconstruction
A current injection (A) at the surface of a subject with homogenous bioelectric properties causes a reproducible distribution of potentials inside the subject. The regions in the thorax with the same electrical potential, as a result of current injection, are called isopotential lines (B). The distribution of isopotential lines contributes to a predictable voltage profile on the surface of the body. The voltages (C) next to the current injection are the highest, as indicated by the darker gray color. The voltages decrease with increasing distance from the current injection. The voltage (D) on the side opposite the current injection is the lowest.
Voltage profiles of an inhomogeneous medium
A regional increase of impedance (E) of the subject results in a change in each of the 16 voltage profiles which make up one frame.
No matter where the current is injected, the regional increase of impedance always causes an increase of the voltages "behind" this region.
PulmoVista 500 uses a FEM-based, linearized Newton-Raphson reconstruction algorithm to convert the 208 voltage changes of a frame into an EIT image. For better illustration, a schematic approach for image reconstruction is described below, which generates the images in a comparable way.
03
5
C
B
D
A
03
6
E
Principles of operation
128 Instructions for use PulmoVista 500 SW 1.2n
Superposition of voltage profiles
The reconstruction algorithm superposes the 16 voltage profiles on each other. Reconstruction artifacts are eliminated by applying selective boundary filtering.
Resulting image
The resulting image (F) displays the region of increased impedance (E) at the correct location.
Each EIT image consists of a matrix of 32 x 32 pixels. In order to create larger images for better graphical representation, and particularly for better interpretability, linear interpolation is applied. However, the underlying resolution of the images remains unchanged.
Like CT scans, the projection of the displayed EIT images is from caudal to cranial. That means that the left side of the image displays the right side of the patient. The upper part of the image displays the ventral aspect of the patient.
Bioelectric properties of lung tissue
The measured voltages depend on the bioimpedance of the body tissue between the injecting and the measuring electrode pairs. The impedance of lung tissue changes with the air content. Thus ventilation and changes of end-expiratory lung volume result in changes of the voltages measured at the body surface.
Resistivity of different tissues [1]*:
In humans, an inspiration maneuver from residual volume to total lung capacity amplifies regional bioimpedance by around 300 % [2, 3]*.
Cardiac activity and perfusion cause a change in thoracic bioimpedance from diastole to systole in a range of 3 % [4]*.
Extravascular lung water, body movement, and the skin-electrode resistance can also affect thoracic bioimpedance in different ways.
03
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38
E
F
* "Literature references" on page 148
Tissue Resistivity (, m)
Blood 1.5
Heart 1.6 to 4.3
Lung (end of expiration) 7.2
Lung (end of inspiration) 23.6
Fat 27.2
Instructions for use PulmoVista 500 SW 1.2n 129
Principles of operation
Functional EIT
PulmoVista 500 performs functional EIT, meaning that it mainly displays relative impedance changes as a result of lung function, i.e., ventilation and changing end-expiratory lung volume.
If the signals are not filtered, cardiac-related impedance changes are also displayed. All other factors which might affect the absolute impedance are eliminated by only displaying relative impedance changes, rather than absolute impedance values.
Thus the dynamic images provided by PulmoVista 500 contain information on the functional condition of the different lung regions within the electrode plane.
Various validation studies [5, 6, 7, 8, 9, 10, 11, 12]* have demonstrated a significant correlation between ventilation-related impedance changes and air content, for example as determined by CT scans.
Some examples of EIT images from PulmoVista 500
Status image of lungs of a normal-weight healthy adult
Subjects of normal body weight show ventilation which is fairly evenly distributed, as shown in the above image. Corresponding to findings in the literature [1]*, the right lung (represented by ROI 1
and ROI 3 in this example) accounts for 52 to 55 % of global ventilation (defined as 100 %) in a seated or supine individual.
Status image of lungs of an obese, otherwise healthy, adult
In healthy lungs there is little difference in the distribution of ventilation between normal-weight and obese individuals. However, the ventilated lung regions of obese individuals are displayed much smaller in the image as the lungs are surrounded by a large amount of adipose tissue.
Pathological conditions which may lead to non-ventilated lung regions
Various factors are associated with non- or under-ventilated lung regions. These may include:
– overinflation (more common in the ventral regions)
– pneumothorax (more common in the ventral and lateral lung regions)
– atelectasis (more common in the dorsal regions)
– pleural effusion (more common in the dorsal regions)
– pneumonia54
7
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8
Principles of operation
130 Instructions for use PulmoVista 500 SW 1.2n
EIT and CT images from a patient with dorsal pleural effusion
A fluid accumulation such as a pleural effusion represents a non-ventilated area and is displayed by PulmoVista 500 in black or purple color. In the CT scan the same region is displayed in bright color.
Interpretation of negative impedance changes
The definition of baseline frames typically leads to a display of solely positive impedance changes. Nevertheless, in some circumstances negative impedance changes may occur which need to be interpreted correctly.
The following known effects may lead to negative impedance changes:
– A deeper expiration than inspiration. Since the baseline is taken at a particular end-expiratory level, a deeper expiration in the subsequent breath reduces the end-expiratory lung volume and thus leads to values below the defined baseline level.
– Pendelluft: The baseline frame taken at the end of expiration defines, for every pixel, the zero level. If all parts of the lung increase and decrease their impedance simultaneously, then negative values do not occur. However, when a lung region has different filling characteristics to other lung regions, the minimum of this particular region may differ from the defined zero level. This may then result in negative values in this region.
– Artifacts: During EIT measurements, various conditions may cause artifacts, which need to be considered during interpretation of images.
54
95
50
Instructions for use PulmoVista 500 SW 1.2n 131
Principles of operation
General considerations
PulmoVista 500 is not a life-supporting device according to IEC 60601-1-2.
The EIT measurements performed by PulmoVista 500 and the derived parameters are not defined as a measuring function according to the Directive 93/42/EEC concerning Medical Devices.
When interpreting EIT data, the following considerations must be taken into account:
– PulmoVista 500 provides a mean spatial resolution of approximately 20 % of the thoracic diameter. The spatial resolution decreases towards the center of the body.
– The displayed shape of the electrode plane does not exactly match the geometry of the patient.
– The displayed position of impedance changes does not always exactly match where the impedance change occurred.
– The impedance changes determined by PulmoVista 500 reflect an interaction of different physiological processes rather than the effects of one isolated source.
– Changes of PEEP, extravascular lung water, body position, position of the electrode belt, and skin-electrode resistance (e.g., after applying electrode gel) can affect the thoracic impedance and in particular the end-expiratory lung impedance in different ways. These changes have especially to be taken into account when interpreting the trend data provided by PulmoVista 500.
– The relationship between volume changes and impedance changes may be affected by the level of end-expiratory lung volume. For example, the same tidal volume of two spontaneous breaths or mechanical breaths applied at very different PEEP levels may result in different impedance changes. Typically, the higher the PEEP levels, the lower are the related impedance changes. For interpretation of tidal impedance changes make sure to also consider the volume information provided by the ventilator.
– Body movements can cause artifacts.
– Strong electromagnetic fields of sensitive frequency bands may create artifacts when the measurement circuit of the EIT system is exposed to these fields. Possible pathways of this energy are, for example, the patient, the mains power supply, the trunk cable, and the patient cable.
– Low pass filtering and band pass filtering may cause a phase shift and thus a delayed display of impedance waveforms.
– The use of pulsating air suspension mattresses induces a slow, steady modulation of the impedance waveforms, which may compromise the interpretation of EIT data. This slow modulation has especially to be taken into account when interpreting the EELI trend view provided by PulmoVista 500.
In the presence of certain physiological conditions, the reconstruction algorithm may introduce overshoot effects leading to areas of large negative impedance changes. These areas are displayed in purple. This effect may occur when regions of high conductivity (e.g., the heart, pleural effusion) and low conductivity (e.g., well-ventilated lung tissue) are located next to each other.
Principles of operation
132 Instructions for use PulmoVista 500 SW 1.2n
Examples
Example of an artifact induced by electromagnetic fields:
Status images with artifacts often contain alternating patterns of positive and negative impedance changes.
Example of an overshoot:
The overshoot phenomenon may cause inverted regional impedance changes relative to the global impedance waveform. This results in negative values of the corresponding parameters for the regional tidal or minute tidal variations.
The minimum value in the global impedance waveform is always defined as end of expiration (A) which usually concurs with the minimum value in the regional impedance waveforms. In this example, the minimum value concurs with ROI 1 (B), but in ROI 2 the overshoot leads to a maximum value (C).
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1
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9
ROI 1
Global
ROI 2
dZTidal image
ROI 2
ROI 1
A
B
C
Instructions for use PulmoVista 500 SW 1.2n 133
Principles of operation
Special considerations when using the Diagnostics view
As with any recent clinical information, experience with the numeric values described in this case is also limited. For this reason, users should interpret these numeric values carefully and under consideration of other, well-established clinical data.
For PEEP maneuvers, the PEEP trial analysis function enables the systematic analysis of regional changes to compliance and delays in regional ventilation RVD in addition to the evaluation of ventilation distribution. A compliance loss towards higher PEEP levels (CL HP) may indicate overdistented regions, and a compliance loss towards lower PEEP levels (CL LP) may indicate collapsed regions [13].
In contrast, the Customized analysis function enables the evaluation of any other therapeutic measures. Here, the compliance win (CW) and compliance loss (CL) in comparison with the selected reference section is displayed and indicated as a change percentage.
RVD is a parameter which displays regional inspiration delays in comparison with global inspiration and may indicate the cyclical collapse and re-opening of lung regions [14, 15].
The following aspects must be carefully considered when defining the compliance changes CL LP and CL HP and CL and CW:– Before the start of the PEEP trial analysis
function, make sure that every PEEP level has been correctly assigned to a section. A section averages the selected number of spontaneous breaths. For this reason, sections which contain several breaths must be set to areas with an end-expiratory lung impedance which is as constant as possible.
– The change to the regional ventilation can only be interpreted as a change to the regional compliance if the ventilator displays a flow of 0 at the end of the inspiration and expiration. This is because, if regional inspiratory times or expiratory times are shorter than the corresponding regional time constants, a CL LP and CL HP and CL and CW may also be triggered by varying regional time constants.
– If the ventilator transfers no EIP value, the PIP parameter can be used as a substitute for the calculation of the compliance during volume-controlled ventilation. For this, the AutoFlow function must be activated.
– If no ventilation pressures are available from the ventilator, the ventilation change can only be interpreted as a change to the compliance during pressure-controlled ventilation. This is because if no ventilation pressures are detected during volume-controlled ventilation, the falling pressure differences may cause the regional tidal variation to decrease, which, in turn, would cause the CL LP, CL HP, and CL to rise, without any change to the regional compliance of the lung. The pressure difference may have fallen due to rising compliances in other lung areas at the respective PEEP level.
The following aspects must be carefully considered when defining the RVD parameter (Regional Ventilation Delay):– The ventilation may also be delayed in lung
regions with large time constants. This is particularly apparent with a short expiratory time or with a quick rise in the ventilation pressure together with a long inspiratory time.
– The longer the pressure rise time, the lower the impact of varying regional time constants on the RVD analysis.
– If the ventilator displays a flow of 0 at the end of the expiration, this indicates a sufficiently long expiratory time.
– With the RVD analysis of low-flow maneuvers, the section length must be set to a value of 1 to prevent the low-flow maneuver from being averaged together with regular spontaneous breaths.
Principles of operation
134 Instructions for use PulmoVista 500 SW 1.2n
All information provided by PulmoVista 500 refers to the EIT sensitivity region, i.e. to the lens-shaped intrathoracic volume which is surrounded by the electrode belt and whose impedance changes contribute to the generation of EIT images.
Only when the electrode belt is in a suitable position, can it be assumed that the information provided by PulmoVista 500 represents volume changes in the entire lung.
This fact must be taken into consideration in particular when interpreting the CL LP and CL HP and CL and CW parameters during PEEP maneuvers:
If the electrode belt is attached too close to the basal part of the lungs, a PEEP-induced shift of the diaphragm may cause the ventilation to be overestimated, meaning that values for CL LP and CL HP and CL and CW may not only be caused by overdistension or collapse.
In contrast, if the belt is attached to close to the apical part of the lungs, an early overdistension of the apical lung may suggest that basal areas are also already overdistented.
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Electrode plane
In the context of these instructions for use, the term "electrode plane" describes the lens-shaped intra-thoracic volume whose impedance changes contribute to the generation of EIT images.
The actual thickness and shape of the electrode plane depends on the dimension, the bioelectric properties, and the shape of the thorax, and particularly on the morphological structures within the thorax. Further, the extent of the homogeneity of transthoracic bioelectric properties also affects the dimension of this electrode plane.
The electrodes of the electrode belt used with PulmoVista 500 have a width of 40 mm (1.6 in). This means that the electrode plane in regions close to the body surface is at least 40 mm (1.6 in) thick The thickness of the plane increases towards the central region of the body.
The contribution of impedance changes is reduced the further away they are from the electrode plane. Distance from the electrode plane moves the position of impedance changes located close to the body surface towards the central region along the depicted projection lines.
However, as the contribution of impedance changes outside the electrode plane is relatively small, the effect on the image is limited.
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136 Instructions for use PulmoVista 500 SW 1.2n
Information displayed by PulmoVista 500
Dynamic image
The dynamic image continuously displays relative impedance changes within the electrode plane as a series of tomograms. The temporal resolution is high, enabling the assessment of regional ventilation even at high respiratory rates. For example, when the frame rate is set to 20 images per second for a patient with a respiratory rate of 20 breaths per minute, PulmoVista 500 generates 60 images per breath.
Relative impedance changes are determined by referencing the current frame (i.e., the 208 measured voltages gn, see "Principle of measurement" on page 126) to a baseline frame gnref. This results in a frame of relative voltage deviations dgn.
To generate the dynamic image, the reconstructed frame from the end of expiration of the last detected breath is always defined as the baseline frame (A). This means, regardless of the actual values of the baseline frame (which also reflects a certain distribution of absolute impedance), only regional differences between the reconstructed frames (B, C) of the current breath and the baseline frame (A) are displayed. If the end-expiratory impedance distribution of the current breath is identical to that of the last breath, the resulting dynamic image is a black image (B).
As the baseline frame is continuously updated after each detected breath, mainly impedance changes due to tidal ventilation are displayed. Due to this baseline definition, end-expiratory impedance variations are suppressed to a great extent in the dynamic image.
Status images
Further analysis of the lung regions is achieved using a status image. The status image can be configured as a tidal image or a minute image.
The tidal image represents regional distribution of impedance changes of the last detected breath. The tidal image is a differential image of the end of inspiration compared to the beginning of inspiration. The tidal image is automatically updated after each breath. The beginning of inspiration and the end of inspiration are indicated as vertical blue lines on the impedance waveforms.
The minute image represents regional distribution of impedance changes over the last minute. The minute image displays tidal images averaged over
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Principles of operation
the last minute. The minute image is ideal for the assessment of regional distribution during ventilation with varying tidal volumes.
Regional quantification can be customized in the status image by adjusting the position and size of the Regions Of Interest (ROIs).
Impedance waveforms
The impedance waveforms represent the impedance changes within the electrode plane over time. All impedance waveforms are plotted simultaneously over the same time base.
The global impedance waveform represents the sum dZglobal of relative impedance changes dZp in all pixels of each dynamic image plotted over time. It is normalized to the display height by a suitable scale factor.
The global impedance waveform mainly displays impedance changes related to ventilation. Thus, there is usually a strong correlation between this waveform and the volume waveform displayed on ventilators.
In contrast to the global impedance waveform, the four regional impedance waveforms display the sum of impedance changes within the specified ROIs. The regional impedance waveforms allow comparison of impedance changes in different lung regions.
To make them comparable, all regional impedance waveforms are normalized using the same scaling factor. This is usually smaller than the global scaling factor.
Numeric values
Numeric values are continuously calculated and displayed. This allows the quantification and comparison of impedance changes.
The Tidal rate parameter, determined from the global impedance waveform, typically represents the number of breaths detected per minute. When the band-pass filter is activated, numeric values are not displayed.
The TV global (global tidal variation) parameter represents the difference between the minimum value and the maximum value in the global impedance waveform for each breath. The MTV global (global minute tidal variation) parameter represents the average of the global tidal variations over the last minute. The TV global and MTV global parameters are always defined as 100 %, independently of the tidal volume. They serve solely as a reference for the display of the regional tidal variations or regional minute tidal variations.
Regional tidal variations TV ROI represent the difference between the corresponding values of the regional impedance waveforms for each breath. Regional minute tidal variations MTV ROI represent the average of the regional tidal variations over the last minute. End of expiration and end of inspiration are detected on the global impedance waveform and indicated by markers. Regional tidal variations and regional minute tidal variations show the percentage of impedance change which takes place in the corresponding ROI.
Further numeric values are displayed in the EELI trend view.
The numeric value EELI global displays the deviation of the global end-expiratory status at the cursor positions Ref and C in relation to the global tidal variation at Ref.
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138 Instructions for use PulmoVista 500 SW 1.2n
The numeric value EELI ROI displays the deviation of the regional end-expiratory status at the cursor positions Ref and C in relation to the global tidal variation at Ref.
In the Diagnostics view, the CL (= Compliance Loss) and RVD (= Regional Ventilation Delay) parameters are also calculated and displayed for every defined section. The algorithms used for the calculations are partially based on publications which point out the following:– The method for determining the CL HP [%] and
CL LP [%] parameters enables an estimation of lung region overdistension and collapse [13]
– The RVD index enables the detection of cyclical opening and closing of lung regions [14, 15]
Compliance loss (CL) and compliance win (CW)
Trend data without a PEEP maneuver can be analyzed using the Customized analysis function. This analysis ascertains changes to the regional compliance in comparison with a selectable reference section for every displayed section. These changes are printed as Compliance loss CL and compliance win CW.– The CL [%] parameter describes a regional
compliance loss in comparison with the reference and is displayed in orange.
– The CW [%] parameter describes a regional compliance win in comparison with the reference and is displayed in cyan.
Pixels with the same compliance as in the reference section are displayed in dark gray.
CL and CW are calculated as follows:
1 The EIT data is low-pass filtered with a cut-off frequency of 80 min–1. The artifact filter is activated.
2 If a section contains several spontaneous breaths, these are averaged to ascertain the tidal variation TV.
3 The tidal variation TVi is calculated for every pixel within the ventilated area.
4 The compliance is calculated for every section and every pixel:
If no pressure values are available from the ventilator, the EIP – PEEP pressure difference is set to 1.
5 Every pixel in the selected reference section is defined as RefCompliance.
6 In every section and for every pixel, CL is calculated as the compliance loss of the section in comparison with the reference compliance. CLI is set to 0 if the difference results in a positive value.
7 The global parameter CL is also calculated for every section by summing up the compliance loss percentage of all pixels (NV) of the ventilated area:
8 In every section and for every pixel, CW is calculated as the compliance win of the section in comparison with the reference compliance. CWi is set to 0 if the difference results in a negative value.
9 The global parameter CW is also calculated for every section by summing up the compliance win percentage of all pixels:
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Compliance loss (CL LP and CL HP)
CL images represent the PEEP-induced regional compliance loss for various levels of a PEEP maneuver.
With this method, both of the following conditions are differentiated for every pixel:– The CL LP parameter describes the regional
compliance loss in comparison with the ascertained maximum regional compliance towards lower PEEP levels and is displayed in white.
– The CL HP parameter describes the regional compliance loss in comparison with the ascertained maximum regional compliance towards higher PEEP levels and is displayed in orange.
Pixels which experience no compliance loss are displayed in dark gray.
CL LP and CL HP are calculated as follows:
1 The EIT data is low-pass filtered with a cut-off frequency of 80 min–1. The artifact filter is activated.
2 If a section contains several spontaneous breaths, these are averaged to ascertain the tidal variation TV.
3 The tidal variation TVi is calculated for every pixel within the ventilated area.
4 The compliance is calculated for every section and every pixel:
If no pressure values are available from the ventilator, the EIP – PEEP pressure difference is set to 1.
5 The maximum compliance is defined for every pixel of all sections.
6 In every section and for every pixel, CL LPi is calculated as the compliance loss percentage of the section in comparison with the maximum compliance. CL LPi is set to 0 if the observed section is at a higher PEEP level than the section with the maximum compliance.
7 The global parameter CL LP is also calculated as the weighted average of all pixels of the ventilated area:
8 In every section and for every pixel, CL HPi is calculated as the compliance loss percentage of the section in comparison with the maximum compliance. CL HPi is set to 0 if the observed section is at a lower PEEP level than the section with the maximum compliance.
9 The global parameter CL HP is also calculated as the weighted average of all pixels of the ventilated area:
Regional ventilation delay (RVD)
During a low-flow maneuver, the algorithm for quantifying the RVD defines regional inspiratory delays which can be linked to cyclical opening and closing [14, 15].
The RVD parameter defines the extent of the temporal delay of the regional inspiration (derived from the regional impedance waveform) in comparison with the global inspiration (derived from the global impedance waveform) for every pixel within the contour of the ventilated area.
Principles of operation
140 Instructions for use PulmoVista 500 SW 1.2n
The RVD is calculated using the following steps:
1 The EIT data is low-pass filtered with a cut-off frequency of 80 min–1. The artifact filter is activated.
2 If a section contains several spontaneous breaths, these are averaged to ascertain the RVD parameter.
3 A second, adjustable low-pass filter, which only has an effect on the impedance values used for the RVD parameter, is also activated.
4 Only pixels within the ventilated area are analyzed.
5 The Ti start and Ti end moments are defined for every section based on the global impedance waveform by ascertaining the start and end of the inflation during a low-flow maneuver. If the section does not contain a low-flow maneuver, the start and end of the inspiration of the regular spontaneous breaths are ascertained.
6 The time Ti is calculated, i.e. the time period between Ti start and Ti end.
7 For the global impedance waveform: T40glob, the moment at which the global impedance waveform reaches 40 % of its tidal variation, is ascertained.
8 For every pixel within the ventilated area: T40i, the moment at which the regional impedance waveform reaches 40 % of its tidal variation, is ascertained.
9 Calculation of the RVD parameter:
The numeric RVD value represents the inspriatory delay of the observed pixel. The value is based on the global inspiratory time Ti and therefore represented as a percentage.
If the value of the RVD parameter exceeds the RVD cut-off value set by the user, the affected pixels are marked in yellow in the corresponding tidal image.
Global RVD parameters
Depending on the configuration, PulmoVista 500 calculates one of two global RVD parameters which represent either the inhomogeneity of the regional inspiration progressions or the ratio of the area affected by the RVD to the entire ventilated area.
– Standard deviation of the RVD (RVD SD) deviation [14, 15]. To calculate the RVD SD parameter, indicated as % of Ti, the standard deviation of all RVD pixel values is defined within the ventilated area. Therefore, the RVD SD parameter describes the inhomogeneity of the regional inspiration progressions. RVD SD is calculated as follows:
– Ratio of the RVD (RVD Ratio)The RVD Ratio (indicated in %), which indicates the ratio of the number of pixels affected by the RVD (NRVD) to the total number of pixels (NV) within the ventilated area, is calculated as the second RVD parameter. The RVD Ratio parameter is calculated as follows:
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Improvement of the algorithms used to calculate CL LP, CL HP, and RVD
Several limitations were identified in the algorithms described in the referenced publications for the definition of CL [13] and RVD [14, 15]. These limitations were removed as follows with the implementation in PulmoVista 500:
– During PEEP maneuvers, the end-expiratory lung volume (EELI) is generally high at high PEEP levels and low at low PEEP levels. In contrast, the tidal variation (TV) remains constant during volume-controlled ventilation. Because of the calculation of relative impedance changes in comparison with a baseline, this leads to a loss in the tidal variations towards higher PEEP levels, which are not, however, linked to changes in the tidal volume.
Improvement: The tidal variations are adjusted using a correction factor.
– The CL LP and CL HP values require knowledge of the pressure values (EIP, PEEP) in order to calculate the regional compliance. This requires the availability of the pressure values from the ventilator which are, however, often not available.
Improvement: The CL LP and CL HP are still calculated, even if no pressure values are available. This makes it possible to evaluate all maneuvers which are performed during constant pressure-controlled ventilation.
– RVD times are always indicated as positive values which are ascertained from the earliest to latest pixel. This makes it difficult to differentiate regions with quick and slow inspiration.
Improvement: The global point in time T40glob is subtracted from the respective T40i point in time to allow the respective RVD to be indicated as a positive (= late) and negative (= early) value.
– RVD is only used during low-flow maneuvers. Up to now, there was no research analyzing how slowly a ventilation pressure needs to rise for the RVD to continue returning usable data.
Improvement: The RVD can be calculated for every spontaneous breath. However, the inspiratory rise must be considered during RVD interpretation.
– The respective PEEP values need to be known to automatically assign sections to the respective PEEP levels.
Improvement: The various PEEP levels are indirectly ascertained based on the identified EELI levels. This enables automatic detection of the sections, even if no PEEP values are available.
– The calculation of CL LP, CL HP, and RVD in regions with very small tidal variations is very susceptible to errors.
Improvement: Regions with tidal variations below 10 % of the maximum tidal variation are excluded from the calculation.
– Filter settings are not described in every published analysis, meaning that they could vary from case to case, especially for suppressing cardiac impedance changes.
Improvement: Uniform filter settings are used to calculate CL LP, CL HP, and RVD. A low-pass filter with a cut-off frequency of 80 min–1 is used to suppress cardiac impedance changes. If the definition of the RVD is still disturbed by cardiac impedance changes despite the filter, the user can configure an additional low-pass filter which only affects the RVD definition.
NOTE
The global RVD parameters are not affected by these changes.
Principles of operation
142 Instructions for use PulmoVista 500 SW 1.2n
Definition of baseline frames
Main and Full-screen image views
The Main and Full-screen image views focus on providing information related to functional impedance changes due to ventilation.
All information displayed in Main and Full-screen image views (status images, impedance waveforms, and parameters) is based on the dynamic image which continuously displays relative impedance changes referenced to a baseline as a series of cross-sectional images.
Each single image represents the reconstructed deviations between the current frame and a baseline frame (BF).
The frame at the end of expiration from the last detected breath is defined as the baseline frame. This baseline frame is the frame with the smallest value of summarized voltages between the last two detected maxima of the global impedance waveform.
As all frames are referred to the smallest frame of the last breath, usually only positive changes are displayed in the dynamic image.
Baseline update (Breath)
Typically, the baseline frame is updated continuously after each detected end of inspiration. The update of the baseline frame can be compared to the way a volume waveform of a ventilator returns to zero value at the end of each breath. Consequently, all effects that may impair absolute impedance values and thus lead to end-expiratory offsets in the impedance waveform are typically eliminated. Only changes which occur within a respiratory cycle are displayed. Changes are mainly caused by ventilation-related impedance changes. If not suppressed by filter settings, impedance changes related to cardiac activity, which also occur within the respiratory cycle, are displayed as well.
A Referred to BFA
B Referred to BFB
C Referred to BFC
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Baseline update (Time scale)
During therapeutic procedures, e.g., recruitment maneuvers, it might be desirable to observe end-expiratory offsets in the impedance waveforms that are caused by changes of end-expiratory lung impedance. The baseline update after each detected breath eliminates those offsets. For this reason, PulmoVista 500 provides the alternative baseline update option Time scale, which only affects the display of the impedance waveforms. The dynamic image, status images, and parameters are not affected by the setting of the baseline update.
When the baseline update is set to Time scale, the baseline is updated each time the cursor passes the zero position of the time scale. Consequently, the time period between two baseline updates depends on the setting of the time scale.
End-insp. trend and Diagnostics views
The End-insp. trend and Diagnostics views enable the comparison of the distribution of ventilation within the electrode plane of breaths over a longer period.
The End-insp. trend and Diagnostics views allow a comparative evaluation of two or more status images, each representing the regional distribution of ventilation-related impedance changes at two different cursor positions. The End-insp. trend view displays the differential image Change: C minus Ref, which represents the changes between these two status images. Thus the End-insp. trend view enables the comparison of the distribution of ventilation within the electrode plane of two different breaths. The Diagnostics view displays a tidal image and images of the compliance loss or compliance change for each selected section.
For image generation, the breath at cursor position Ref is referenced to a first baseline frame at the end of expiration before this first breath. The breath at cursor position C is referenced to a second baseline frame at the end of expiration before the second breath. Similarly, the spontaneous breaths are referenced to an averaged baseline frame in every section in the Diagnostics view.
By referencing the breaths to individual baseline frames, all other factors contributing to impedance changes and possibly compromising comparison of distribution of ventilation are eliminated.
NOTE
Occasionally the down-slope of the impedance waveforms is irregular. This irregularity is due to variations that may occur during the continuous update of the baseline frames. If the baseline up-date is set to Time scale, irregularities may occur when the cursor passes the zero position.
NOTE
Frequent changes of end-expiratory lung imped-ance, which can occur during spontaneous breath-ing on the upper pressure level in APRV, for exam-ple, may cause significant baseline changes in the Main and Full-screen image views. Under those rare conditions, the breath-by-breath baseline up-date leads to large offsets in the impedance wave-forms which may compromise their interpretability. In such cases, it is recommended that the baseline update option is set to Time scale.
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Principles of operation
144 Instructions for use PulmoVista 500 SW 1.2n
EELI trend view
The EELI trend view provides information on changes in end-expiratory lung impedance which are mainly due to changes of end-expiratory lung volume within the electrode plane. These changes are displayed as positive or negative offsets in the global and regional impedance waveforms.
In order to display and quantify those changes, all frames displayed in this view are referred to one single baseline frame at a fixed position. This is in contrast to the baseline definition of the Main and Full-screen image views.
The frame containing the smallest value of summarized voltages is defined as the baseline frame, corresponding to the lowest point in the Global impedance waveform.
If the view is refreshed or the time scale is changed, then the baseline frame is redefined.
If the bioelectric conditions of the skin or within the thorax have significantly changed during the measurements, these changes may affect the end-expiratory levels. Thus, comparability of the end-expiratory levels at Ref and C may be impaired.
The following conditions may affect bioelectric properties and thus end-expiratory lung impedance:– repositioning of the electrode belt– opening and closing of the electrode belt– applying electrode gel to the skin of the patient– change in patient position– large changes of intra-thoracic fluid content
The Change: C minus Ref image of the EELI trend view displays the changes of end-expiratory lung volume within the electrode plane. In contrast,
the Change: C minus Ref image of the End-insp. trend view displays the changes of tidal volume within the electrode plane.
Data review page (optional with the option ADAP)
As in the EELI trend view, all frames displayed in the data review page are referenced to one single baseline frame at a fixed position.
The frame containing the smallest value of summarized voltages is defined as the baseline frame. The baseline frame corresponds to the lowest point in the global impedance waveform within the entire recorded EIT file.
If the time scale is set to smaller values, the baseline frame might not be present within the displayed part of the EIT file.
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Definitions for color scales and scales of impedance waveforms
Main and Full-screen image views
After image reconstruction, the relative impedance changes that have been determined for each of the pixels are translated into a color scale. Regions with impedance changes of less than 10 % of the determined maximum regional impedance change are represented in black. Impedance changes above 10 % of the maximum regional impedance change are displayed in dark blue. As values increase, the dark blue turns into a lighter blue. A white color indicates the regions of maximum regional impedance change (i.e., 100 %) within the image.
The color scale is adjusted continuously ("auto-scaled") to permanently display the dynamics of regional ventilation independently of actual tidal volumes and other bioelectric conditions. Thus all end-inspiratory images typically contain some white regions.
After each detected breath, the minima and maxima of the impedance waveform are determined. The color scale and scales of the impedance waveforms are adjusted based on the determined minimum and maximum values.
Waveforms are auto-scaled so that even small impedance changes are amplified. This means that some conditions (e.g., apnea, very low tidal volumes, or damping of waveforms due to filtering) may not be recognized. In order to make the user aware of this situation, waveforms that only show very small impedance changes are displayed in a darker gray color.
The color scales of the dynamic and status images are always the same, thus allowing more effective comparison. Similarly, the scales of the four regional impedance waveforms are always set to the same value.
As the baseline is "zeroed" after each breath, the images usually only contain positive values.
The zero position of the color scale is always located in a position which provides 85 % for the display of positive changes (A). The scalar endpoints of positive and negative impedance changes are of the same magnitude. However, positive impedance changes (A) are represented over 85 % of the color scale while negative impedance changes (B) are compressed to 15 % of the color scale.
While auto-scaling provides an optimized continuous display of the distribution of ventilation, it prevents these images being used for the quantitative analysis of ventilation.
When the Reference function has been activated in the Main view, two status images can be displayed. The scaling of these two images is based on the status image with the smaller maximum impedance change. This scaling may result in white saturated areas – either in the reference status image or in the current status image and its corresponding dynamic image. Alternatively, the Change: Current minus Ref image can be selected. The color scale of this differential image is designed to display major changes between two images at different points in time.
As these changes can be positive (C) or negative (D), the zero value (representing no change) is always displayed in the midposition of this differential color scale. Negative values are not compressed.
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146 Instructions for use PulmoVista 500 SW 1.2n
Minimum and maximum values of this color scale are the same that are taken for the dynamic image. Thus, all color scales displayed in the Main and Full-screen image views always contain identical end points.
End-insp. trend, EELI trend, and Diagnostics views
The scales for images and impedance waveforms in the End-insp. trend, EELI trend, and Diagnostics views are automatically scaled each time these views are either opened, updated, or the time scale is changed. If the cursor position is changed or an analysis is started, the images are also rescaled automatically.
End-insp. trend view
The auto-scaling of the two status images in the End-insp. trend view is based on the maximum impedance changes in these images. The two status images and the resulting differential image have the same scalar endpoints.
The scaling is based on the status image with the smaller maximum impedance change. This scaling may result in white saturated areas in the other status image.
EELI trend view
Auto-scaling of the differential image in the EELI trend view is based on the values of the maximum regional tidal variation as determined at cursor position Ref. This auto-scaling results in an almost black image if the compared EELI patterns are very similar. In contrast, changes of EELI in the range of the maximum tidal variation at cursor position Ref result in a differential image with regions which correspond to the minimum or maximum values of the color scale.
Diagnostics view
The automatic scaling of the tidal images is based on the maximum impedance changes of the selected section. All tidal images and the images of compliance changes have the same scalar endpoints. The scaling is based on the tidal image of the section with the smallest maximum impedance change. This scaling may result in white saturated areas in the tidal images of other sections.
In contrast, the compliance loss images are always scaled to 100 %. The color scale of the images of compliance changes is identical to that of the differential images in the End-insp. trend view. The color scale of the compliance loss images shows CL HP in orange and CL LP in white. Regions with no compliance loss are displayed in dark gray.
Data review page (optional with the option ADAP)
The auto-scaling on the Data review page is based on the minimum and maximum values contained in the EIT data file which has been selected.
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Principles of operation
Principles of breath detection and determination of the tidal rate
Breath detection is based on the global impedance waveform. PulmoVista 500 determines the maximum and minimum values of the last 15 seconds and defines the difference in these values as the "tidal range". If a positive slope following a minimum exceeds 25 % of the tidal range, PulmoVista 500 defines this minimum as the end of expiration. If a negative slope following a maximum exceeds 25 % of the tidal range, PulmoVista 500 defines this maximum as the end of inspiration.
After the end of expiration has been defined, PulmoVista 500 only checks for the end of inspiration, and vice versa. This assures that even during irregular breathing, the detected end of inspiration and end of expiration will alternate.
The tidal rate is calculated using the formula "Tidal rate = 180 / t", where t is the time period of the last 3 detected breaths in seconds.
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148 Instructions for use PulmoVista 500 SW 1.2n
Literature references
1 Heyward VH. 1998. Practical body composition assessment for children, adults, and older adults. Int J Sport Nutr (8): 285-307
2 Faes, T. J. C., H. A. van der Meij, J. C. de Munck und R. M. Heethaar. 1999. The electric resis-tivity of human tissues (100 Hz-10 MHz): A meta-analysis of review studies. Physiol Meas 20 (4): R1-R10.
3 Barber, D.C. 1989. A review of image reconstruction techniques for electrical impedance tomog-raphy. Med Phys 16 (2): 162-169.
4 Visser, K. R. 1989. Electric properties of flowing blood and impedance cardiography. Ann Biomed Eng 17:463-473.
5 Luepschen, H., T. Meier, M. Grossherr, T. Leibecke, H. Gehring and S. Leonhardt. 2005. Clinical applications of thoracic electrical impedance tomography. Paper presented at the 6th Confer-ence on Biomedical Applications of Electrical Impedance Tomography, London.
6 Victorino, J. A., J. B. Borges, V. N. Okamoto, G. F. J. Matos, M. R. Tucci, M. P. R. Caramez, H. Tanaka, et al. 2004. Imbalances in regional lung ventilation: A validation study on electrical im-pedance tomography. Am J Respir Crit Care Med 169 (7): 791-800.
7 Hinz, J., P. Neumann, T. Dudykevych, L. G. Andersson, H. Wrigge, H. Burchardi and G. Heden-stierna. 2003. Regional ventilation by electrical impedance tomography: A comparison with ven-tilation scintigraphy in pigs. Chest 124 (1): 314-322.
8 Frerichs, I., J. Hinz, P. Herrmann, G. Weisser, G. Hahn, T. Dudykevych, M. Quintel and G. Hellige. 2002. Detection of local lung air content by electrical impedance tomography compared with electron beam CT. J Appl Physiol 93 (2): 660-666.
9 Riedel, T., T. Richards and A. Schibler. 2005. The value of electrical impedance tomography in assessing the effect of body position and positive airway pressures on regional lung ventilation in spontaneously breathing subjects. Intensive Care Med 31 (11): 1522-1528.
10 Odenstedt, H., S. Lindgren, C. Olegård, K. Erlandsson, S. Lethvall, A. Aneman, O. Stenqvist and S. Lundin. 2005. Slow moderate pressure recruitment maneuver minimizes negative circulatory and lung mechanic side effects: Evaluation of recruitment maneuvers using electric impedance tomography. Intensive Care Med 31 (12): 1706-1714.
11 van Gendringen H. R., A. J. van Vught and J. R. Jansen. 2004. Regional lung volume during high-frequency oscillatory ventilation by electrical impedance tomography. Crit Care Med 32 (3): 787-794.
12 Meier, T., H. Luepschen, J. Karsten, T. Leibecke, M. Großherr, H. Gehring and S. Leonhardt. 2008. Assessment of regional lung recruitment and derecruitment during a PEEP trial based on electrical impedance tomography. Intensive Care Med 34 (3): 543-550.
13 Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomog-raphy. Intensive Care Med 2009; 35:1132-1137.
14 Muders T, Luepschen H, Zinserling J, Geschus S, Fimmers R, Guenther U, et al. Tidal recruit-ment assessed by electrical impedance tomography and computed tomography in a porcine model of lung injury*. Crit Care Med. 2012; 40 (3): 903-11.
Instructions for use PulmoVista 500 SW 1.2n 149
Principles of operation
15 Wrigge H, Zinserling J, Muders T, Varelmann D, Gunther U, von der Groeben C, et al. Electrical impedance tomography compared with thoracic computed tomography during a slow inflation maneuver in experimental models of lung injury. Crit Care Med. 2008; 36 (3): 903-9.
150 Instructions for use PulmoVista 500 SW 1.2n
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Instructions for use PulmoVista 500 SW 1.2n 151
List of accessories
List of accessories
PulmoVista 500 part number: 8420000
WARNING
Risk due to incompatible accessories
Dräger has tested only the compatibility of ac-cessories listed in the current list of accesso-ries. If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure.
Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories.
Name/Description Order-No.
Trunk cable 8420048
Patient cable, size S 8420029
Patient cable, size M 8420047
Patient cable, size L 8420035
Patient cable, size XL 8420271
Patient cable, size XXL 8420273
Electrode belt, size S 8420059
Electrode belt, size M 8420058
Electrode belt, size L 8420057
Electrode belt, size XL 8420056
Electrode belt, size XXL 8420055
ECG electrode (pack of 50) 4527750
MEDIBUS cable (male/female) 8306488
MEDIBUS cable (female/female) 8416326
Retrofit kit ADAP 8420006
152 Instructions for use PulmoVista 500 SW 1.2n
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Instructions for use PulmoVista 500 SW 1.2n 153
Index
Index
Numeric
15-electrode mode . . . . . . . . . . . . . . . . . . . . . . . 57
A
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . 27ADAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
additional functions . . . . . . . . . . . . . . . . . . . 76Airway pressure unit . . . . . . . . . . . . . . . . . . . . . 90Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Applications page . . . . . . . . . . . . . . . . . . . . . . . 92Artifact filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
B
Baseline frames . . . . . . . . . . . . . . . . . . . . . . . . 142
C
Cable connectors . . . . . . . . . . . . . . . . . . . . . . . . 27Calibrating the touchscreen . . . . . . . . . . . . . . . . 36Calibration
restarting . . . . . . . . . . . . . . . . . . . . . . . . . . . 74CL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138CL HP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139CL LP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139Cleaning
reprocessing procedures . . . . . . . . . . . . . . 108Clear data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95Cockpit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
hardware elements . . . . . . . . . . . . . . . . . . . 32preparing . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Color concept . . . . . . . . . . . . . . . . . . . . . . . . . . 36Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Connections to IT networks . . . . . . . . . . . . . . . 124Contour of the ventilated area . . . . . . . . . . . . . . 85Copying to USB . . . . . . . . . . . . . . . . . . . . . . . . . 96Cursor position . . . . . . . . . . . . . . . . . . . . . . . . . 64Cut-off frequency . . . . . . . . . . . . . . . . . . . . . . . . 83CW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
D
Data importconfiguring . . . . . . . . . . . . . . . . . . . . . . . . . 86
Data recordingconfiguring . . . . . . . . . . . . . . . . . . . . . . . . . 94settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Data review . . . . . . . . . . . . . . . . . . . . . . . . . . . 76Date and time settings . . . . . . . . . . . . . . . . . . . 90EELI trend . . . . . . . . . . . . . . . . . . . . . . . . 64, 65Default settings . . . . . . . . . . . . . . . . . . . . . . . . . 91Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Device check . . . . . . . . . . . . . . . . . . . . . . . . . . 47Device combinations . . . . . . . . . . . . . . . . . . . 121Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67Dialog windows . . . . . . . . . . . . . . . . . . . . . . . . 35Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . 108Disinfecting
patient interface . . . . . . . . . . . . . . . . . . . . 109surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Disk space . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96Display
configuring . . . . . . . . . . . . . . . . . . . . . . . . . 82Displaying changes . . . . . . . . . . . . . . . . . . 62, 71Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116Dräger default settings . . . . . . . . . . . . . . . . . . . 91Dynamic image . . . . . . . . . . . . . . . . . . . . . . . . 136
E
EIT datarefreshing . . . . . . . . . . . . . . . . . . . . . . . . . . 65
EIT settingsconfiguring . . . . . . . . . . . . . . . . . . . . . . . . . 88
Electrode belt . . . . . . . . . . . . . . . . . . . . . . . . . . 25attaching . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Electrode plane . . . . . . . . . . . . . . . . . . . . . . . 135Electromagnetic compatibility . . . . . . . . . . . . . . 10EMC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 121End-inspiratory trend . . . . . . . . . . . . . . . . . . . . 64Ending operation . . . . . . . . . . . . . . . . . . . . . . . 80Environment of use . . . . . . . . . . . . . . . . . . . . . 18Export screenshot . . . . . . . . . . . . . . . . . . . . . . 71
Index
154 Instructions for use PulmoVista 500 SW 1.2n
F
File handling . . . . . . . . . . . . . . . . . . . . . . . . . . . 96deleting . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
File length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95Filter settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Fixed keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Frame rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88Freeze display . . . . . . . . . . . . . . . . . . . . . . . . . . 71Full-screen image . . . . . . . . . . . . . . . . . . . . . . . 63
G
General WARNINGS and CAUTIONS . . . . . . . 11Getting started . . . . . . . . . . . . . . . . . . . . . . . . . . 45
H
Header bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
I
Image generation . . . . . . . . . . . . . . . . . . . . . . 126Impedance waveforms . . . . . . . . . . . . . . . . . . 137Indications/contraindications . . . . . . . . . . . . . . . 16Install applications . . . . . . . . . . . . . . . . . . . . . . . 92Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Internal battery . . . . . . . . . . . . . . . . . . . . . . . . . 39
L
Language settings . . . . . . . . . . . . . . . . . . . . . . . 90LEDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Literature references . . . . . . . . . . . . . . . . . . . . 148
M
Main menu bar . . . . . . . . . . . . . . . . . . . . . . . . . 35Main view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Mains power supply . . . . . . . . . . . . . . . . . . . . . . 39Manual disinfection . . . . . . . . . . . . . . . . . . . . . 108Measurement
starting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57MEDIBUS, MEDIBUS.X
configuring . . . . . . . . . . . . . . . . . . . . . . . . . . 86connecting to a Dräger device . . . . . . . . . . . 42trend display . . . . . . . . . . . . . . . . . . . . . . . . 87
Medical contraindications . . . . . . . . . . . . . . . . . 16Medical indications . . . . . . . . . . . . . . . . . . . . . . 16Message-Cause-Remedy . . . . . . . . . . . . . . . . . 98Monitoring area . . . . . . . . . . . . . . . . . . . . . . . . . 34Monitoring sessions . . . . . . . . . . . . . . . . . . . . . . 52
N
New measurement . . . . . . . . . . . . . . . . . . . . . . 57Numeric values . . . . . . . . . . . . . . . . . . . . . . . . 137
O
Operating concept . . . . . . . . . . . . . . . . . . . . . . 31Operating frequency . . . . . . . . . . . . . . . . . . . . . 89
adjusting . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Option
ADAP . . . . . . . . . . . . . . . . . . . . . . . . . . 18, 76
P
Patient cable . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . 94Patient interface . . . . . . . . . . . . . . . . . . . . . . . . 25
attaching . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Position of the user . . . . . . . . . . . . . . . . . . . . . . 43Potential equalization . . . . . . . . . . . . . . . . . . . . 40Power supply module . . . . . . . . . . . . . . . . . . . . 24Principles of operation . . . . . . . . . . . . . . . . . . 125Product specific page . . . . . . . . . . . . . . . . . . . . 92PulmoVista 500
components . . . . . . . . . . . . . . . . . . . . . . . . 20
R
Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76Reference function
displaying data . . . . . . . . . . . . . . . . . . . . . . 61parameters . . . . . . . . . . . . . . . . . . . . . . . . . 61waveform . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Reprocessing procedure . . . . . . . . . . . . . . . . 108ROI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
defining as layers . . . . . . . . . . . . . . . . . . . . 59defining as quadrants . . . . . . . . . . . . . . . . . 60setting as free . . . . . . . . . . . . . . . . . . . . . . . 60
Rotary knob . . . . . . . . . . . . . . . . . . . . . . . . . . . 32RVD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68RVD ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70RVD SD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
S
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Safety instructions . . . . . . . . . . . . . . . . . . . . . 106Screen layout . . . . . . . . . . . . . . . . . . . . . . . . . . 82
configuring . . . . . . . . . . . . . . . . . . . . . . . . . 82Service . . . . . . . . . . . . . . . . . . . . . . . . . . . .91, 111Service menu . . . . . . . . . . . . . . . . . . . . . . . . . . 92Signal check . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Instructions for use PulmoVista 500 SW 1.2n 155
Index
Signal quality . . . . . . . . . . . . . . . . . . . . . . . . . . . 72indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Simulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75Status images . . . . . . . . . . . . . . . . . . . . . . . . . 136SW versions page . . . . . . . . . . . . . . . . . . . . . . . 92Switching off . . . . . . . . . . . . . . . . . . . . . . . . . . . 80Switching on . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29System settings . . . . . . . . . . . . . . . . . . . . . . . . . 90
country-specific . . . . . . . . . . . . . . . . . . . . . . 90System setup . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
T
Technical data . . . . . . . . . . . . . . . . . . . . . . . . . 117Thoracic contour . . . . . . . . . . . . . . . . . . . . . . . . 85Time scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Transporting patients within the hospital . . . . . . 41Trolley
moving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41parking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40preparing . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Trunk cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26connecting . . . . . . . . . . . . . . . . . . . . . . . . . . 52
U
USB space . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96User interface . . . . . . . . . . . . . . . . . . . . . . . . . . 34
V
Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63Visual inspection . . . . . . . . . . . . . . . . . . . . . . . 109Volume waveform . . . . . . . . . . . . . . . . . . . . . . . 87
Z
Zoom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67, 69Zoom in/zoom out . . . . . . . . . . . . . . . . . . . . 64, 66
These instructions for use only apply to the following device with the serial number filled in:PulmoVista 500 SW 1.2nWithout the serial number filled in by Dräger, these instructions for use are provided for general information only and do not apply to a specific device.These instructions for use are provided for customer information only and will only be updated or exchanged upon customer request.
Directive 93/42/EECconcerning Medical Devices
ManufacturerDrägerwerk AG & Co. KGaAMoislinger Allee 53-5523542 LübeckGermany+49 451 8 82-0
FAX +49 451 8 82-20 80http://www.draeger.com
9055985 – GA 5667.100 en© Drägerwerk AG & Co. KGaAEdition: 1 – 2017-06Dräger reserves the right to make modifications to the medical device without prior notice.