instructions for use ow100• peyronie’s disease (induratio penis plastica) trigger point...

Instructions for Use

OW100®

Revision A - January 20, 2009/hl

Instructions for Use OW100® Revision A dated January 20, 2009 Copyright© 2009 MTS Europe GmbH All rights reserved for patents or trademark registration. No part of this document may be distributed or reproduced, utilized or imparted to a third party without the prior written permission of MTS. Nonobservance will result in liability for damages. Technical features are subject to change without notice. Manufacturer Sponsor MTS Europe GmbH Tissue Regeneration Technologies Robert-Bosch-Str. 18 110 Arnold Park, Suite 400 D-78467 Konstanz, Germany Woodstock, GA 30188 Tel.: ++49-7531-36185-0 Tel.: ++1-770-966-1315 Fax: ++49-7531-36185-70 Fax: ++1-770-592-8910 Internet: www.mts-medical.com Internet: www.trtllc.com Revision History Initial Revision

Content

Content Content .......................................................................................................... 3 1 General notes ................................................................................ 7 1.1 Introduction ..................................................................................... 7 1.2 The OW100® ................................................................................... 7 1.2.1 Assembly ........................................................................................ 7 1.2.2 Function principle ............................................................................ 9 1.3 Indications..................................................................................... 10 1.4 Contraindications .......................................................................... 10 1.5 Treatment abort............................................................................. 11 1.6 Product liability .............................................................................. 11 1.7 Warranty ....................................................................................... 12 2 Safety ........................................................................................... 13 2.1 Introduction ................................................................................... 13 2.2 User responsibility......................................................................... 13 2.3 User training (experience)............................................................. 13 2.4 Caution indications in this user manual......................................... 14 2.5 Warning indications in this user manual........................................ 14 2.6 Instruction indications in this user manual..................................... 14 2.7 General safety instructions............................................................. 15 2.8 Warnings and Precautions ............................................................ 17 2.8.1 Patient Selection ........................................................................... 17 2.8.2 Treatment...................................................................................... 17 2.8.3 Maintenance.................................................................................. 19 2.8.4 Adverse effects ............................................................................. 20 2.8.5 Treatment instructions................................................................... 20 2.9 Operational safety ......................................................................... 21 2.9.1 Declaration of conformity .............................................................. 21 2.9.2 Environmental Conditions ............................................................. 21 2.9.3 Electromagnetic Compatibility (EMC)............................................ 21 2.10 Emergency procedures ................................................................. 26 2.11 Maintenance intervals ................................................................... 26 2.12 Labelling........................................................................................ 26 3 Description .................................................................................. 29 3.1 Introduction ................................................................................... 29 3.2 Design and overview..................................................................... 29 3.2.1 Shockwave generator ................................................................... 31 3.2.2 Applicator ...................................................................................... 31 3.2.3 Water circuit .................................................................................. 33 3.2.4 Front side connections .................................................................. 34 3.2.5 Rear side connections................................................................... 34 3.2.6 Side connections........................................................................... 36 3.2.7 Operating and display elements.................................................... 38 3.2.8 Footswitch..................................................................................... 39

Content 3.3 Accessories ...................................................................................40 3.4 Consumables.................................................................................40 3.4.1 Applicator.......................................................................................40 3.4.2 Incise drape for wound covering ....................................................40 3.4.3 Sterile ultrasound gel .....................................................................41 4 Operation......................................................................................43 4.1 Introduction ....................................................................................43 4.2 Note safety instructions..................................................................43 4.3 Check safety functions...................................................................43 4.4 Note regular maintenance..............................................................44 4.5 Note instructions ............................................................................44 4.6 Switching on OW100® ....................................................................44 4.6.1 Switching on out of stand-by-mode................................................46 4.7 Function check...............................................................................46 4.7.1 Self test..........................................................................................46 4.7.2 Function test ..................................................................................46 4.8 Operation cycle..............................................................................47 4.8.1 Operation of the OW100® ..............................................................47 4.8.2 Filling the applicator.......................................................................49 4.8.3 Draining the applicator...................................................................49 4.8.4 Setting the energy level .................................................................50 4.8.5 Setting the frequency.....................................................................50 4.8.6 Presetting of the shockwave numbers ...........................................51 4.8.7 Setting the coupling pressure ........................................................51 4.8.8 Display of the connected applicator ...............................................52 4.8.9 Display of the remaining number of shockwaves on the applicator53 4.8.10 Menu setup ....................................................................................53 4.9 Treatment ......................................................................................55 4.9.1 Preparation for treatment ...............................................................55 4.9.2 Release of shockwaves .................................................................55 4.9.3 Preparation for treatment of skin lesions .......................................56 4.9.4 Adjust treatment parameter for treatment of skin lesions...............57 4.9.5 Shockwave treatment for skin lesions............................................57 4.9.6 End of treatment of skin lesions.....................................................59 4.9.7 Preparation for orthopaedic treatments .........................................59 4.9.8 Shockwave treatment for orthopaedic treatments..........................60 4.9.9 End of treatment for orthopaedic indications..................................61 4.9.10 Preparation for treatment of trigger points .....................................61 4.9.11 Shockwave treatment of trigger points...........................................61 4.9.12 End of treatment of trigger points...................................................62 4.9.13 Failure during treatment.................................................................62 4.10 Shutting down the OW100® ...........................................................62 4.11 Closure functions ...........................................................................63 4.12 Switching off the OW100®..............................................................63 4.12.1 Switching the OW100® into stand-by-mode ...................................63 4.13 Interrupt power supply ...................................................................63 4.14 Longer downtime ...........................................................................63

Content

4.15 Storage of the OW100®................................................................. 63 5 Technical Data............................................................................. 65 5.1 Introduction ................................................................................... 65 5.1.1 Noise emission.............................................................................. 65 5.1.2 Mechanical Components............................................................... 65 5.1.3 Water system ................................................................................ 65 5.1.4 Shockwave generator ................................................................... 65 5.1.5 Operation and display elements.................................................... 65 5.2 Supply ........................................................................................... 66 5.3 Conditions for operation, storage and transport ............................ 66 5.4 Components.................................................................................. 66 5.5 Lifespan ........................................................................................ 67 5.6 Applicator OP155 .......................................................................... 67 5.7 Applicator OE050 .......................................................................... 68 5.8 Applicator OE035 .......................................................................... 69 6 Setting into operation ................................................................. 71 6.1 Introduction ................................................................................... 71 6.2 Prepare location ............................................................................ 71 6.3 Unpacking OW100® ...................................................................... 71 6.4 Checking parts .............................................................................. 72 6.5 OW100® delivery........................................................................... 73 6.6 Connections .................................................................................. 74 6.6.1 Connecting power supply.............................................................. 74 6.6.2 Connecting applicator ................................................................... 74 6.7 Connecting footswitch................................................................... 77 6.8 Inserting / changing water cartridge.............................................. 77 6.9 Store packaging ............................................................................ 80 6.10 Wrapping up the OW100®............................................................. 80 7 Maintenance and troubleshooting............................................. 81 7.1 Introduction ................................................................................... 81 7.2 Cleaning the OW100®................................................................... 81 7.3 Cleaning the applicator ................................................................. 81 7.4 Maintenance.................................................................................. 82 7.5 Troubleshooting ............................................................................ 82 7.6 Messages...................................................................................... 84 7.7 Ordering ........................................................................................ 87 7.8 OW100® disposal ......................................................................... 87 8 Transport ..................................................................................... 89 8.1 Introduction ................................................................................... 89 8.2 Internal transport ........................................................................... 89 8.3 External transport.......................................................................... 90 8.4 Sending back to MTS for service .................................................. 90

Content

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General notes

mts_ow100_ifu_e_a.doc 7

1 General notes 1.1 Introduction

This chapter discusses the assembly and function of the device,as well as indications and contraindications, and contains liability and warranty information.

1.2 The OW100® The OW100® is a transportable device for therapeutic shockwave treatment. It is easy to handle and simpleto operate making it very user-friendly.

1.2.1 Assembly The device (Fig. 1.2.1-1) consists of the following main components: • The housing unit (4) contains the electronic components

and the water circuit. • The applicator (1) is connected to the housing unit with a

flexible hose (2) and connector. The applicator must be changed approximately every 100 patients.

• A touch screen (3) and a touch wheel (6) serve to operate the device.

• A footswitch (5) and a shockwave release button (7) on the applicator enable the user to release shockwaves.

General notes

8 mts_ow100_ifu_e_a.doc

Fig. 1.2.1-1: The OW100® 1 Applicator 2 Flexible hose 3 Touch screen (Touch panel) 4 Housing unit 5 Footswitch 6 Touch wheel 7 Shockwave release button on applicator

1 7 4 3 6

2 5

General notes


1.2.2 Function principle The OW100® generates electro-hydraulic shockwaves by discharging high voltages (sparks) through a submerged electrode (Fig. 1.2.2-1). The sparks vaporize the medium between the electrode tips and create spherical, acousticalshockwaves. The shockwaves are then focused at the reflector. The shape of reflector determines how widely the shockwaveswill be focused.

Proper positioning of the reflector ensures the shockwaves aretransmitted to the treatment area. The applicator is coupled tothe patient (3) by the silicone membrane (4) and ultrasound gel. 1 Electrode 2 Reflector 3 Patient 4 Membrane

(coupling area)

5 Shockwave 6 Treatment

area

Fig 1.2.2-1: Function principle of shockwave creation with the OW100®

General notes


1.3 Indications The OW100®, in combination with applicators OP155, OE050,and OE035, provides safe and effective shockwave treatment for the following conditions: Skin lesions: The OW100® is a therapeutic device suitable for shockwavetherapy to promote epithelialization of non-healing, acute andchronic, post-traumatic lesions and post-operative healing disorders in soft tissue. • Post-traumatic lesions • Post-operative healing disorders Orthopaedic indications: Shock wave therapy for the treatment of bones as well as soft tissue orthopaedic indications at and below the skin surface. • Impingement syndrome with or without tendinosis

calcarea (calcifying tendinitis) • Epicondylitis humeri radialis and ulnaris • Plantar fasciitis • Achillodynia (painful heel syndrome) • Patella tip syndrome • Non-unions (pseudarthrosis) and delayed union of small

bones • Chronic infected non-unions and pseudarthrosis of small

bones• Peyronie’s disease (induratio penis plastica) Trigger point indications: • Myofascial trigger point syndrome

1.4 Contraindications • Do not use the OW100® in patients with pacemakers or

implantable defibrillators.

NOTE

Recommended Use of Applicators MTS advises use of OW100® Applicators as follows: Skin Lesions - OP155 Orthopaedic applications - OE050 Trigger point treatment - OE035 Epicondylitis humeri radialis and ulnaris - OE050 or OP155Patella tip syndrome - OE050 or OP155

General notes


• Do not use the OW100® in patients who are using devices which are sensitive to electromagnetic radiation.

• Do not use the OW100® in patients who are or suspect they may be pregnant.

• Do not use the OW100® for the treatment of vertebrae, skull bones or ribs.

• Do not aim the therapy focus on internal organs (especially the lungs).

• Do not use the OW100® for the treatment of infected pseudarthrosis in the acute state.

• Do not use the OW100® for the treatment of patients with tumors.

• Do not use the OW100® for the treatment of patients with coagulation disorders.

• Do not aim the therapy focus on large nerves. • Do not use the OW100® for the treatment of patients

younger than 18 years of age or patients with open epiphyseal plates.

• Do not aim the therapy focus on large vessels. • Do not use the OW100® for extracorporeal shock wave

lithotripsy.

1.5 Treatment abort If a patient experiences cardiac arrhythmia during treatment at a fixed shock wave repetition rate, shock wave delivery should be terminated.

1.6 Product liability Product liability and/or guarantee statutory provisions apply.Manufacturer liability is nullified if any of the following circumstances apply: • Initial operation, assembly, service, safety inspections and

warranty have been performed by anyone other than the manufacturer or authorized personnel.

• Any unauthorized changes have been made to the device.

• The device has not been used in accordance with the user manual.

• The electrical installation of the room, in which the device is used, is not in accordance with national standards.

• Any parts other than original accessories, applicators and spare parts are used with the device.

J DoddPlease delete this line. Sorry - but I couldn't figure out how to do it.

General notes


1.7 Warranty Warranty is in accordance with national law.

Safety


2 Safety 2.1 Introduction

This chapter discusses all safety details regarding the user, patient and device.

2.2 User responsibility The user must read and thoroughly understand this user manual prior to operating the device. Special attention must be given tothe safety instructions in this chapter. The user also must fullyand accurately inform the patient about the risks of the treatment with the OW100®. Regular maintenance must be performed in accordance with the instuctions in this user manual. Safety rules and operational safety must be complied with at all times.

2.3 User training (experience) The OW100® must only be used by trained physicians (medical specialists) with adequate medical and technical experience in shockwave treatments.

Safety


2.4 Caution indications in this user manual Caution indications are presented in this user manual in a box as follows:

2.5 Warning indications in this user manual Warning indications are presented in this user manual in a box as follows:

2.6 Instruction indications in this user manual Instruction indications are presented in this user manual in a box as follows:

CAUTION

This symbol alerts user to situations which can damage the device or other to the device connected devices, if operation of the device is not performed according to the specifications.

WARNING

This symbol indicates a potentially imminent danger to the life or health of the user or the patient. Failure to obey the warning will result in grave harm including serious injury or death.

NOTE

This symbol indicates additional information and/or useful tips relevant to the topic.

J DoddI don't understand what you mean by "or other to the device connected devices".

Safety


2.7 General safety instructions

WARNING

Unauthorized use! When the device is not in use, remove the mains cable to prevent unauthorized or undesired use.

CAUTION

Maintenance instructions! Before switching on the device, check that the regular necessary maintenance work has been done.

WARNING

Danger of Electric Shock! The device contains high-voltage circuits. Any repair or maintenance work performed on equipment parts must be carried out by authorized service personnel. Disregarding this warning may result in a hazard to human life! Operating the device when the side covers are open isstrictly prohibited. Ensure the mains socket to which the device is connected has a PE-connection. In case of emergency, switch the device off by turning the mains key or unplugging it from the mains socket.

WARNING

Unauthorized Maintenance Work! Only personnel who have successfully passed the service training are permitted to perform maintenance work on the device in accordance with the Service Manual and additional information obtained during the training period. Any other intervention will be considered unauthorized with all resulting consequences such action entails.

WARNING

Visual Inspection! Before using the OW100® visually check the device for damage. If damage is detected: Do not use the OW100® and call technical service.

Safety


NOTE

Informing the Patient The patient must be fully and accurately informed about the risks of this treatment.

WARNING

Explosion Hazard! Do not use the device in an environment where explosive and/or flammable substances are used or stored. In case of emergency disconnect the power plug.

CAUTION

Minimum Storage Temperature! The device contains water. Do not store the device at temperatures below 4°C (39.2°F).

WARNING

Electromagnetic Interference The device emits electromagnetic radiation when shock waves are released. Devices sensitive to electromagnetic interference should not be operated close to the device (e.g. cardiac pacemakers, etc.). If electromagnetic interference between the OW100® and nearby electronic equipment is suspected (as evidencedby erratic behavior in either device), it is recommended that the distance between the devices be increased until proper operation resumes. If it is necessary to operate an electronic device in close proximity to the OW100® during treatment, both devices should be tested for propersimultaneous operation prior to clinical use.

WARNING

Operation of the OW100® The OW100® must only be operated in the horizontal position.

Safety


2.8 Warnings and Precautions The device uses shockwaves to treat indications as specified in section 1.3. In addition to the contraindications listed in section 1.4, other precautions must be followed to prevent danger to life and/or damage of the device.

2.8.1 Patient Selection Read sections 1.3 and 1.4.

Women of childbearing potential Shockwave treatment of areas located close to the female reproductive system should be avoided in women of childbearing potential. The application of shockwaves tothis patient population could possibly result in irreversible damage to the female reproductive system and to the unborn fetus in the undiagnosed pregnancy.

2.8.2 Treatment

WARNING

Non-Desired Effects! In each particular case it is necessary to be aware of the fact that shock waves act at the boundaries of tissues with different acoustic impedance (e. g. bone-muscle, liquid-solid tissue states, tissue-gas e.g. lungs, intestines, etc). Before application all potential non-desired effects should be assessed.

WARNING

Inappropriate Application of Shock Waves! Extracorporeal shock wave treatments must always be administered by trained staff. Only the trained user is authorized to release shock waves. Operating the device must be in accordance with national regulations for shock wave devices. All treatments and operation of the device must be carried out in accordance with this manual "Instructions for Use".

WARNING

Air-Filled Interfaces in Shock Wave Path! Do not apply shock waves to air-filled areas of the body, i.e., intestines or lungs. Shock waves are rapidly dispersed by passage through an air-filled interface, which can cause bleeding and other harmful side effects.

Safety


WARNING

Danger of Electric Shock! Keep the device (especially the electronic parts) away from water that may be spilled or splashed on the device. In case of emergency switch the device off by turning the mains keyor unplugging it from the mains socket.

WARNING

Avoid Air Bubbles in Shock Wave Path! The coupling membrane of the therapy head make verygood contact with the skin to prevent loss of energy and development of hematoma. Make sure there are no air bubbles below the coupling membrane. To remove air bubbles select maximum coupling pressure and tap on the coupling membrane. Always use ultrasound gel or caster oil as a coupling meduim and make sure there are no air bubbles between the surface of the coupling membrane and the skin!

WARNING

Danger of Infection! Always clean and disinfect the device before any therapy procedure is initiated and after a therapy procedure is terminated. Any inorganic and non-flammable disinfectant may be used for this purpose. Do not spray the disinfectant directly ontothe device. Spray disinfectant onto a sponge or a cloth.

WARNING

Damaged Applicator Packing! Do not use the applicator if the packing is damaged!

WARNING

Noise Protection Measures! The release of shockwaves produces noise. To protect patients and medical personnel, take appropriate noise protection measures, e.g. provide ear protectors.

WARNING

Danger of Hearing Loss! Do not release shockwaves near the ears. Always wear ear protection.

Safety


2.8.3 Maintenance

WARNING

Cardiac Arrhythmia during Treatment! If a patient experiences cardiac arrhythmia during treatment at a fixed shockwave repetition rate, shockwave delivery should be terminated.

WARNING

Avoid Air Bubbles in Shock Wave Path! The severity of tissue damage or hematomas depends on the total energy and the energy density applied. The coupling membrane should make very good contact with the patient's skin in order to prevent loss of energy and the development of hematoma. Always use ultrasound gel or caster oil as a coupling medium and make sure there are no air bubbles between the surface of the coupling membrane and the skin. There should be no bubbles inside the coupling membrane. Any feedback from a patient who is conscious during the procedure should be taken into account. It is advisable to start the treatment at a lower energy level and trigger frequency. As the treatment continues increase energy level and trigger frequency until the desired levels are reached.

WARNING

Electric Shock Hazard! Never remove the covers of the electronics cabinet. The high voltage power supply circuits utilized by extracorporeal shock wave devices use voltages that are capable of causing serious injury or death from electric shock.

WARNING

Unauthorized Maintenance Work! Only personnel who have successfully completed the service training are permitted to perform maintenance work on the device in accordance with the Service Manual and additional information obtained during the training period. Any other intervention will be considered unauthorized with all resulting consequences such action entails.

Safety


2.8.4 Adverse effects

2.8.5 Treatment instructions Pay attention to the following treatment instructions: • Do not aim the therapy focus on internal organs

(especially lungs). • Do not aim the therapy focus on esophagus. • Do not aim the therapy focus on large vessels. • Do not aim the therapy focus on the ears. • Do not aim the therapy focus on large nerves. • Do not aim the therapy focus on the head. • Always protect patients and medical personnel with

appropriate noise protection measures (e.g. provide ear protectors).

WARNING

Adverse effects! Potential adverse effects associated with shockwave treatments include those listed below: • Transient moderate increase in pain • Redness and swelling at the treatment site • Hematoma and petechial hemorrhage at the treatment site• Headaches and fainting during extracorporeal shock

wave treatments • Short-term hypesthesia (numbness)

WARNING

Danger of Infection! Always clean and disinfect the device, before any therapy procedure is initiated and after a therapy procedure is terminated. Any inorganic and non-flammable disinfectant may be used for this purpose. Do not spray the disinfectant directly onto the device. Spray the disinfectant onto a sponge or a cloth.

WARNING

Noise Protection Measures! The release of shockwaves produces noise.To protect patients and medical personnel, take appropriate noise protection measures (e.g. provide ear protectors).

CAUTION

Cleaning agent Use only inorganic and non-flammable disinfectant. Do not use abrasive cleaners.

Safety


2.9 Operational safety

2.9.1 Declaration of conformity The device is in accordance with the following international standards (extract): DIN EN ISO 9001 DIN EN ISO 13485 DIN EN 60601-1 DIN EN 60601-1-2 DIN EN 60601-1-4 DIN EN 60601-2-36 DIN EN 60601-1-6 DIN EN ISO 14971 DIN EN 61846 DIN EN ISO 10993-1 DIN EN 1041 DIN VDE 0751-1 EC Direktive 93/42/EWG

2.9.2 Environmental Conditions

The environmental conditions for operation, storage and transport are described in section 5.3.

2.9.3 Electromagnetic Compatibility (EMC) Electronic medical equipment is subject to special precautionary measures regarding EMC (Electrical Magnetic Compatibility). The device must be installed and used in accordance with EMC regulations as detailed below. The OW100® is intended for use in an environment indicated below. Ensure the OW100® is operated in such an environment. The manufacturer explanations are contained in table 2.9.3-1, 2.9.3-2, and 2.9.3-3.

WARNING

Explosion Hazard! Do not use the device in an environment where explosive and/or flammable substances are used or stored. In case of emergency disconnect the power plug.

CAUTION

Minimum Storage Temperature! The device contains water. Do not store the device at temperatures below 4°C (39.2°F).

Safety


CAUTION

Floor surface! Floors should be wooden or concrete or be covered with ceramic tiles. If the floor is covered with a synthetic material, the relative humidity must be at least 30%.

CAUTION

Room Installation! The OW100® is designed for use in all installations, including living quarters which are directly connected to a public electricity supply that also supplies the building which is used as a residence. The quality of supply voltage should correspond to a typical business or hospital environment.

NOTE

Power Interruptions! Any break in the electrical supply can cause a "RESET" of the OW100®. In such cases the device will need to warm up (approx. 3 min.) before the application of shockwaves can be continued. If the break in electrical supply is of longer duration the device will switch off automatically. In such cases the equipment must be restarted according to the operating instructions. Both types of break in the electrical supply will cause the equipment to go into a safe condition. If the user of the OW100® needs continuous functionality even when there are interruptions in the power supply, it is recommended that the OW100® be connected to an uninterruptible power supply or a battery.

CAUTION

Electromagnetic Interactions! If the device is used in combination with other electrical equipment the entire configuration must be in accordance with EN 60601-1-1. Consult a specialist in case of doubt. The OW100® may not be used in the vicinity of, or together with, other equipment in a stacked arrangement. If it is unavoidable to stack the device in close proximity to other equipment, the OW100® should be carefully observed, in order detect any adverse effects among the devices installed in the arrangement.

CAUTION

Communication Devices and Portable Radios! Portable high frequency communication devices can affect medical electrical equipment. Portable radios should not be used in close proximity to the OW100®, this includes all cables that may be affected up to the recommended safe distance; this is calculated from the transmitter frequency used.

J DoddI'm not exactly sure what type of building/setting you are trying to describe.

Safety


Figure 2.9.3-1: Non-Ionizing Electromagnetic Radiation Symbol

CAUTION

Interferences! In this environment, interferences are possible from devices that carry the symbol for non-ionizing electromagnetic radiation (Figure 2.9.3-1).

NOTE

The OW100® uses high frequency (HF) technology for its internal functions. Devices sensitive to electromagnetic interference (cardiac pacemakers, etc.) should not be operated close to the OW100®. For details on HF interferences please note Tables 2.9.3-1, 2.9.3-2 and 2.9.3-3.

NOTE

The OW100® is intended for use in an electromagnetic environment in which HF interferences are controlled. Electromagnetic interference can be reduced by obtaining the minimum safe distance between mobile HF telecommunication devices (transmitters) and the OW100® – safe distance dependent on the output power of the communication device specified in Table 2.9.3-1.

Safety


Safe distance [d] depending on the transmitted frequencyb (in meters)

150 kHz – 80 MHz

80 MHz – 800 MHz

800 MHz – 2.5 GHz

Transmitter Powera P[W]

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23

Notes: a: For Transmitters whose maximum nominal output is not displayed in

Table 2-1, the recommended protective distance d (in Meters, m) can be calculated using the equation in the suitable column, where P is the maximum nominal output in Watts (W) as specified by the manufacturer of the Transmitter.

b: These guidelines may not apply in all cases. The propagation of electromagnetic items is affected by absorptions and reflections on buildings, objects, and people. For 80 MHz and 800 MHz the higher frequency range is valid.

Table 2.9.3-1: Recommended safety distances between Mobile HF Telecommunication Devices and the OW100®

Transmitted interference measurements Accordance

HF-emissions complying with CISPR 11 Group 1

HF-emissions complying with CISPR 11 Class B

Harmonic emissions complying with IEC 61000-3-2

Class A

Emission of voltage fluctuations/flicker complying with IEC 61000-3-3

Agrees overall

Table 2.9.3-2: Electromagnetic Interference

Safety


Examined transmitted interference

IEC 60601-proof level Compliance level

± 6 kV contact discharge ± 6 kV contact discharge Electrostatic discharge (ESD) complying with IEC 61000-4-2

± 8 kV air discharge ± 8 kV air discharge

± 2 kV for mains cables ± 2 kV for mains cables Fast transient electrical noise/Bursts complying with IEC 61000-4-4

± 1 kV for input and output cables

± 1 kV for input and output cables

± 1 kV Push pull voltage ± 1 kV Push pull voltage Surge voltage (Surges) complying with IEC 61000-4-5

± 2 kV Common mode voltage

± 2 kV Common mode voltage

< 5% UT (> 95% Collapse

of UT) for ½ cycle

< 5% UT(> 95% Collapse of

UT) for ½ cycle

40% UT (60% Collapse of

UT) for 5 cycles

40% UT(60% Collapse of

UT) for 5 cycles

70% UT (30% Collapse of

UT) for 25 cycles

Unusable (RESET)

Voltage drops, short time interruptions and fluctuations of supply voltagea complying with IEC 61000-4-11

< 5% UT (> 95% Collapse

of UT) for 5 s

Unusable (Device shut down)

Magnetic field with supply frequency (50/60 Hz) complying with IEC 61000-4-8

3 A/m Unusable

Conducted HF variable disturbances complying with IEC 61000-4-6

3 Veff

, 150 kHz to 80 MHz 3 V, 150 kHz to 80 MHz

Radiated HF variable disturbances complying with IEC 61000-4-3

3 V/m, 80 MHz to 2.5 GHz 3 V/m, 80 MHz to 2.5 GHz

Note: a: UT is the mains alternating voltage before the application of the test levels.

Table 2.9.3-3: Resistance to Electromagnetic Interference

Safety


2.10 Emergency procedures If a hazardous incident occurs, switch off the OW100® and disconnect the power connector. Lock the device against restarting and call authorized service personnel to repair.

2.11 Maintenance intervals Maintenance and safety inspections are to be conducted yearly by authorized service personnel.

2.12 Labeling The following labels are attached to the device or the applicator:

• Typical plate on the housing unit, example:

• Warning: read user manual

WARNING


WARNING

Unauthorized Maintenance Work! Only personnel who have successfully completed the service training are authorized to perform maintenance work on the device in accordance with the Service Manual and additional information obtained during the training period. Any other intervention will be considered unauthorized with the resulting consequences such action entails.

SN OW1000010 REF OW100 Voltage/Power 100-240V~/200VA Frequency 50-60 Hz

MTS Europe GmbH Robert-Bosch-Str. 18 D- 78467 Konstanz Germany

11/2007

Safety


• Typical plate on the applicator, example:

• Typical plate on the water cartridge, example: • Connection assignment for the footswitch:

• Connection assignment for the memory card: • Connection assignment for the USB interface: • Connection assignment for the primary fuses:

10/2007


SN OP15500010REF Applicator OP155

04/2010


SN KA10000001REF Water cartridge

MMC

F1 / T2A F2 / T2A 100-240V~/50-60Hz Made in Germany

Safety


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Description


3 Description 3.1 Introduction

This chapter explains the functions and the operation of the OW100®.

3.2 Design and overview

Fig 3.2-1: Components and connections of the OW100® (front view) 1 Applicator in applicator rest 2 Touch panel 3 Touch wheel with enter (confirmation) button 4 Applicator connection 5 Footswitch connection 6 Footswitch 7 Power switch 8 Shockwave release button on the applicator The OW100® contains, among other parts, the water circuit, high voltage system, electro-hydraulic shockwave generator voltage supply and microprocessor.

1 8 2 3

4 5 6 7

Description


The following parts are accessible from the outside:

• The applicator (1), in which the shockwaves are generated and modulated. The applicator is connectedto the housing unit by means of the applicator connector.The OW100® automatically recognizes the connected applicator type and shows the name on the display screen.

• Shockwaves can be released either by means of the footswitch (6) or the release button at the applicator (8).The footswitch is connected to the front of the housing unitvia the footswitch connection (5).

• The touch screen (2) can be used to adjust the treatment and device parameters.

• The touch wheel (3) also can be used to adjust the treatment and device parameters.

• The power switch (7) turns the voltage supply to the device on and off.

Fig. 3.2-2: Components and connections of the OW100® (rear view)

8 Connecting socket for detachable power cable 9 Slot for memory card (only service purposes only) 10 USB connection (for service purposes only) 11 Water cartridge

8 9 10 11

Description


• The power supply socket (8) connects the power cable to the housing unit.

• Use of the memory card slot is meant only for service purposes. The memory card buffers any erros that may appear during operation.

• The USB connector is meant only for service purposes.

• The water cartridge must be changed wheneverindicated by the device.

3.2.1 Shockwave generator

The shockwave generator is responsible for the following tasks:

• Creation and control of the high voltage for discharge at the electrode.

• Creation and control of the trigger signal. Th OW100® controls the following trigger modes:

- Shockwave release per footswitch - Shockwave release per applicator button

The shockwave release frequency varies between 0.5 and 8 pulses (shockwaves) per second.

3.2.2 Applicator The applicator is delivered as an accessory. Each applicatorwill treat approximately 100 patients before it must be changed out. The device displays the number of shockwaves still available on the applicator (chapter 4.8.9). The applicator consists of the following parts: 1 Applicator housing 2 Water membrane 3 Shockwave release button

CAUTION

Applicator hose Do not kink the applicator hose.

Description


Fig. 3.2.2-1: Applicator The applicator delivers the shockwaves to the treatment area. The shockwaves are transmitted through the water membrane (2). The applicator contains:

- Electrode (not visible in the picture) - Reflector (not visible in the picture) - Water membrane (2)

The applicator is connected to the housing unit via a connection adapter. The applicator's insulated, flexible hose contains the high voltage cable and the water supply hoses.

The applicator serves the following functions: Generating, transporting and focusing the shockwaves The applicator is filled with water to enable the generation and transport of the shockwaves. The special shape of the reflector enables the shockwaves to be reflected in a pressure field outside the applicator.

WARNING

Damaged water membrane! Applicator cannot be used if water membrane is damaged!

1 2 3

Description


Coupling to the patient Patient coupling is achieved via the water membrane and ultrasound gel applied to the treatment area. Shockwaves are released either via the connected footswitchor via the shockwave release button (3). A short push on either releases a single shockwave; pushing and holding either results in consecutive shockwaves being released; and pushing either tice releases the shockwaves under the "interval" setting.

3.2.3 Water circuit The water cartridge drawer (1) is located on the back of thedevice. The OW100® water circuit is responsible for the following functions:

Fig. 3.2.3-1: Water cartridge is located on the back of the housing unit

• Storing the water which is necessary to generateshockwaves. The water cartridge must be changedwhenever indicated by the device.

• Filling and draining the applicator.

NOTE

Air bubbles in the applicator The applicator must be free of air bubbles! To remove air bubbles, turn the applicator 30° downwards and release some shockwaves. To aide this degassing process, tap membrane with finger.

1

Description


3.2.4 Front side connections

Fig. 3.2.4-1: Front side connections of the OW100© Footswitch connection (1): The footswitch connection (1) is situated on the left. Please connect only the footswitch provided with the OW100®. The footswitch allows the release of shockwaves. Power switch (2): The power switch supplies the OW100® with voltage. When in"ON" state, a lamp on the switch is illuminated. The lamp is also illuminated if the device is in "Stand-by" mode (screen is dark).

3.2.5 Rear side connections The following connections are located on the rear side:

Fig. 3.2.5-1: Connections on the rear side

NOTE

After turning on the power switch, the OW100® will be inSTAND-BY mode. To turn the device ON, press and hold the button on the touch wheel for at least 2 seconds.

1 2

1 2 3 4

Description


Power connection socket (1): The power connection socket connects the manufacturerprovided power cable to the OW100® supplying it with voltage. The socket contains 2 primary fuses.

Memory card slot (2): SD- and MMC-memory cards fit into the memory card slot. Use of this slot is currently provided for designated service purposes only. USB-interface (3): The USB interface is provided for service purposes only.

WARNING


WARNING

Danger of Electric Shock! Keep the device (especially the electronic parts) away fromwater that may be spilled or splashed on the device. In case of emergency switch the device off by turning the mains key or unplugging it from the mains socket.

WARNING

Danger of Electric Shock! The device contains high-voltage circuits. Any repair or maintenance work performed on equipment parts must be carried out by authorized service personnel. Disregarding of this warning may result in a hazard to human life! Operating the device when the side covers are open is strcitly prohibited. Ensure the mains socket to which the device is connected has a PE-connection. In case of emergency, switch the device off by turning the mains key or unplugging it from the mains socket.

CAUTION

Local Power StandardsEnsure that the OW100® power connector is compatiblewith the existing power sockets.

WARNING

Changing Fuses - Danger of Electric Shock! Fuses are only to be changed by authorized service personnel.

Description


1 3

Water cartridge (4): The water cartridge (delivered completely filled with water) must be changed whenever such message appears on the display screen. The water cartridge is a sealed part and is not refillable.

3.2.6 Side connections The left side of the device contains the connection for the applicator.

Fig. 3.2.6-1: Applicator connection socket

Fig. 3.2.6-2: Connected applicator Applicator (1) Applicator connection socket (2) Applicator connection plug (3)

2

Description


The plug and flexible hose contain the power and water supplies for the applicator. The connection of the applicator happens by means of an automatic, which makes the connection simple and comfortable. Connect the applicator as follows:

1 Switch ON the OW100®. 2 Ensure the plug (3) is properly oriented to the socket

(2). 3 Press the plug into the socket until the embedded motor

recognizes the plug and pulls it into position. The OW100® will automatically recognize the applicator type connected and will display the name on the the screen as shown below.

Fig. 3.2.6-3: Displaying the type of applicator connected on the OW100®

screen.

Description


3.2.7 Operating and display elements

Fig. 3.2.7-1: OW100® Display The OW100® is operated through the use of the touch panel (1)or the touch wheel (2) with confirmation button (3). Both inputdevices are equally effective and either can be used. The adjustable parameters are dependent on the particular screen menu.

Fig. 3.2.7-2: OW100® Touch Panel

1 2 3

Julie DoddPlease remove extra line here.

Description


Fig. 3.2.7-3: OW100® Touch Wheel

3.2.8 Footswitch

Fig. 3.2.8-1: Footswitch Shockwaves can be released through the footswitch. The footswitch must be connected to the connection socket on the front of the OW100® (Section 6.7).

Note

Footswitch Use only the footswitch provided by the manufacturer.

Description


3.3 Accessories Following accessories are delivered with the OW100®:

3.4 Consumables The following parts are defined as consumables for thOW100® :

3.4.1 Applicator

Fig. 3.4-1: Applicator

The OW100® applicator should be changed approximatelyevery 100 patients. Upon delivery, the device will include one applicator as ordered.

3.4.2 Incise drape for wound covering Note: The incise drapes are only delivered with the OP155 applicator.

Steri-Drape™ Incision Folio Size: 10 cm x 20 cm Manufacturer: 3M Article-Nr.: 2103

WARNING

Applicator packaging Do not use the applicator, if the package is damaged.

NOTE

Retain packaging Retain packaging for return shipment after use.

Description


3.4.3 Sterile ultrasound gel Note: The sterile ultrasound gel is only delivered with the OP155 applicator.

STERILE AQUASONIC® 100, 20g packed, sterile bags, 48 per package Manufacturer: Parker Laboratories, Inc. Article-Nr.: 2104

Description


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Operation


4 Operation 4.1 Introduction

This chapter provides information about the operation and usage of the OW100®. This chapter also contains general and specific setting and treatment information.

4.2 Note safety instructions Note the following safety instructions before operating device:

4.3 Check safety functions

The device goes through an internal start-up routine to check the safety functions.

WARNING

Electrical hazard! Make sure the wall socket has a PE connection.

CAUTION

Power supply! Make sure the wall socket power matches the power required by the OW100®.

WARNING

Danger if water leakage at the applicator! Check water membrane of the applicator for damage before operating the device. If there is damage, do not operate the device.

Operation


4.4 Note regular maintenance Annual maintenance and safety inspections must be performedby authorized service personnel in accordance with the manufacturer's instructions.

4.5 Note instructions

4.6 Switching on OW100®

CAUTION

Note Maintenance Instructions! Before switching on the device check for regular required maintenance (see Chapter 7).

WARNING

Unauthorized Use! Switch off the device after use to protect against unauthorized usage.

WARNING

Unauthorized Maintenance Work! Only authorized service personnel are permitted to perform maintenance work on the OW100®. Any other intervention wil be considered unauthorized with all resulting consequences such action entails.

WARNING

Electrical hazard danger! Make sure the wall socket has a PE connection.

CAUTION

Local Power Standards! Make sure the power plug matches the wall power socket.

WARNING

Visual inspection! Check for visual damage prior to switching on. Do not switch on the device if visual damage is detected.

Operation


1. Connect the provided power cable to the OW100® power

socket and to a wall socket (Section 6.6.1). 2. Press the power switch. This starts a self-test that runs

for several seconds (section 3.2). Do not push the confirmation button whie the self-test is running.

3. Upon completion of the self-test, press the confirmationbutton for 2 seconds (Fig. 4.6.1-1). The device will briefly display the start screen (Fig. 4.6-1) followed by the operation screen (Fig. 4.8.1-1). The device is then ready for operation.

Fig. 4.6-1: OW100® start screen displaying software version

CAUTION

Note Maintenance Instruction! Prior to switching on the device check for regular required maintenance (see Chapter 7).

WARNING

Malfunction Do not use the OW100® if, after switching on the device, any message other than that shown in Fig. 4.6-1 is displayed. Switch off device, call for service and protect device from use.

Operation


4.6.1 Switching on out of Stand-by mode If the device is in Stand-by mode (screen dark, power switch illuminated and lower LED in touch wheel illuminated), press confirmation button (1) in touch wheel and hold for 2 seconds. The OW100® will start the self-test after which it is ready for use.

Fig. 4.6.1-1: Confirmation button on touch wheel

4.7 Function check This section describes the self-test performed by the OW100® after powering up and the user procedures to be undertakenprior to treating.

4.7.1 Self- test After being switched on the device performs an automatic self- test as indicated by the moving bar on the screen (Fig. 4.6-1).

4.7.2 Function test Before treating with the OW100® a function test must be performed. In order to conduct a function test an applicator must be connected to the device. - Switch on the OW100® (Section 4.6) - Fill the applicator (Section 4.8.2) - Release shockwaves without patient contact

1

Operation


4.8 Operation cycle This section details the steps necessary to operate the device during a treatment.

4.8.1 Operating the OW100® To adjust treatment parameter either the touch panel or the the touch wheel may be used.

Fig. 4.8.1-1: Touch panel of the OW100® 1. Current settings 2. Touch "Arrow" to decrease a value 3. Touch "Bar" to set a value and for a short overview in

which area the set value is (min. - max.) 4. Touch "Arrow" to increase a value 5. Touch to switch functions 6. Displays number of shockwaves applied7. Displays total energy applied (with applied

shockwaves) 8. Touch to select field (blue highlighted) 9. Displays the type of applicator connected to device and

the number of available shockwaves left on applicator. To change a value, touch one of the arrows (2, 4) or drive the bar (3) with your finger to the desired value. Pressing and holding engages the auto-repeater function, which changes the value automatically until pressure is released. A short push changes the value one step at a time.

1 2 3 4 8

5

6

7

9

Operation


Pressing the "Reset" key returns the shock counter (6) to zero. Press this key before every treatment to ensure the proper number of shockwaves are applied. Pressing the "Setup" key displays the setup menu by which individual and device-related settings can be manipulated. Pressing the "FILL" key fills the applicator with water. Pressing the "DRAIN" key drains the applicator. Operation with the touch wheel:

Fig. 4.8.1-2: OW100® Touch Wheel 1. Touch sensitive area 2. Pushbutton for confirmation In order to change a parameter in a particular field the leftmost column must be highlighted. If the column is not highlighted inblue, press the confirmation button (2). Move finger across the touch sensitive area (1), choose the field whose value you want to change. To change the value, press the confirmation button again. The field is now highlighted in gray. Move finger across touch sensitive area until desired value is displayed. After settingthe value, press the confirmation button again to save the new value.

1

2

Operation


4.8.2 Filling the applicator Execution:

In order to perform this operation the OW100® must be switched on and an applicator must be connected. 1. Press "FILL" key.

This initiates the process of filling the applicator and membrane with water.

2. Make sure that there are no air bubbles in the applicator. To remove air bubbles tilt the applicator 30°downwards and release some shockwaves.

Fig. 4.8.2-1: "FILL“ key on the display

4.8.3 Draining the applicator Execution:

In order to perform this operation, the OW100® must be switched on and the applicator must be filled. 1. Make sure, that the footswitch is not activated. 2. Press "DRAIN" key.

Hold the applicator above the level of the unit to ensure the complete drainage.

WARNING

Air bubbles! Air bubbles in the applicator scatter and absorb shockwaves. This can lead to ineffective treatment and increased risk for side effects. Therefore remove all air bubbles from the applicator.

Operation


Fig. 4.8.3-1: "DRAIN" key on the display

4.8.4 Setting the energy level Press the arrow buttons on the "ENERGY" row to increase (> right arrow) or decrease (< left arrow) the energy level. Alternatively slide the blue bar on "ENERGY" row to the right (increase) or the left (decrease) to adjust the energy. The display unit of energy can be set in the "SETUP" menu(Section 4.8.8). Unit options are "1-16" "mJ" or "mJ/mm2".

Fig. 4.8.4-1: ENERGY options on the display

4.8.5 Setting the frequency Using the arrow buttons choose the shockwave frequency on the "Frequency" row. Pressing the arrow buttons to increase (> right arrow) or decrease (> left arrow) the frequency. Values range from 0.5 to 8 Hz.

Operation


Fig. 4.8.5-1: Frequency options on the display

4.8.6 Presetting the shockwave numbers Press the arrow keys in the "Interval" row to preselect the total shock numbers for a treatment. Only the preset number of shockwaves will be applied. Pressing the left arrow button decreases the number of shocks, whereas pressing the right arrow button increases the number of shocks in increments of 100.

Fig. 4.8.6-1: Preset the number of shocks for one treatment.

4.8.7 Setting the coupling pressure Changing the water pressure varies the penetration depth of the shockwaves. By using the "Pressure" key, the coupling pressure can be varied by 10 levels. Pressing the left arrow button decreases the water pressure; pressing the right arrow button increases the water pressure. The membrane arcs outward as the water pressure increases.

Operation


• At high water pressure (high value in the display) the membrane arcs widely, causing the penetration depth of the shockwaves to be low.

• At low water pressure (low value in the display) the membrane is flat, causing the penetration depth of the shockwaves to be high.

Fig. 4.8.7-1: Setting the coupling pressure

4.8.8 Displaying the connected applicator The connected applicator will be recognized automatically by the OW100® and displayed on the screen.

Fig. 4.8.8-1: Connected applicator type displayed on the screen

Operation


4.8.9 Displaying the applicator's remaining numberof shockwaves Each applicator can treat approximately 100 patients regardless of the energy levels used. The number of shockwaves remaining on the applicator is displayed. When an applicator is used up it must be changed.

Fig. 4.8.9-1: Display of the remaining shockwaves on the applicator

4.8.10 Menu setup

Fig. 4.8.10-1: "Setup" key To get to the setup menu press the "Setup" key. Within the "Setup" menu, internal device settings and individual screen settings can be adjusted.

Operation


Fig. 4.8.10-2: Menu „Setup“ 1. In the "Language" menu select the desired language

for all displays (menus). 2. Under "Brightness" select the intensity of the backlight

illumination of the screen. 3. Under "Energy" select the unit of energy to be displayed:

"1-16" "mJ" or "mJ/mm2". Note: In this menu selectionscan only be made with the arrow buttons.

4. Select the time and date format to be displayed. Select preferred format using the arrow buttons. Note: (24h) is a 24-hour clock (13:00, 14:00, etc.).

5. In the Display Box "Applicator" shows the type of applicator currently connected to the device. "Device serial" shows the serial number of that specific OW100®. "Version SW" shows the version number of the software. "Pulse" showsthe total number of the pressure pulses released by the device.

6. Setting of the time and date. Press the key correspondingto the field that is to be changed and press the up or downarrow to select the desired value.

7. Pressing the "Back" key returns the device to operationmode and the corresponding display.

8. Pressing the "Cartridge" key releases the water cartridgeenabling it to be removed.

9. Pressing the "Applicator" key decouples the applicator from the OW 100®. If the applicator is filled it will be drained automatically. The motor will then eject the connector after which it can be removed from the socket.

6 9 7

1 2 3 4 5

8

Operation


4.9 Treatment This chapter discusses treatment precautions and preparationsfor various indications.

4.9.1 Preparation for treatment 1. Clean and disinfect the device and applicator according

to the instructions in Sections 7.2 / 7.3. 2. Connect the footswitch (Section 6.7). 3. Connect the power cord (Section 6.6.1). 4. Switch on the device (Section 4.6). 5. Fill the applicator (Section 4.8.2). 6. Set/adjust the appropriate treatment parameters

(Section 4.8). 7. Using the "Interval" key, select the preset number of

shockwaves to appy (Section 4.8.6).

4.9.2 Releasing shockwaves Execution: Make sure that an applicator is connected and filled.

Releasing shockwaves by footswitch: Press the footswitch. As long as the footswitch is pressed, shockwaves will be released. The display (..SW) in the lowerleft corner of the screen shows the number of shockwaves released. Releasing shockwaves by applicator release button: Press the button (2) on the applicator. As long as the button is pressed, shockwaves will be released. Short presses release single shockwaves. Pressing the button twice releases the number of shockwaves preset with the "Interval" key. To stopthe preset shockwaves quickly press and release the button. The display (..SW) in the lower left corner of the screen shows the number of shockwaves released so far during the treatment session.

WARNING

Pay attention to the safety instructions! It is important that the Chapter on Safety (Chapter 2), and the sections on Indications (Section 1.3) and Contraindications (Section 1.4) be read and thoroughly understood prior to operating the device.

WARNING

Noise Protection Measures! The release of shockwaves produces noise. To protect patients and medical personnel, take appropriate noise protection measures, e.g. provide ear protectors.

Operation


4.9.3 Preparation for treatment of skin lesions

1. Make sure, that the patient is prepared for the treatment and that the water membrane and applicator housing are cleaned and disinfected. For cleaning and disinfecting use inorganic and non-flammable disinfectants commonly used for medical applications.

2. Place the device close to the patient and ensure there is enough space to move the applicator over the entire treatment area. The patient may either sit or lie down for the treatment.

3. Adjust the necessary treatment parameters (Section 4.8). 4. Ensure the applicator is filled. 5. Press the RESET key on the touch screen. 6. Apply sterile ultrasound gel onto the treatment area.

Fig. 4.9.3-1: Applying sterile ultrasound gel

7. Cover the wound carefully with the incision folio. Ensure that a minimum 5 cm area around the wound is covered.

WARNING

Indications and contraindications! Read sections 1.3 and 1.4.

WARNING

Air bubbles! Air bubbles in the applicator scatter and absorb shockwaves. This can lead to uncontrolled propagation of shockwaves, ineffective treatment and increased risk of side effects. Therefore remove air bubbles from the applicator.

Julie DoddPlease remove blank line.

Operation


4.9.4 Adjusting treatment parameters for treatment ofskin lesions Good clinical results have been achieved with the following treatment protocol: The applicator should be moved over the entire treatment area, including the adjacent areas. It is also recommended that approximately 100 shockwaves per cm2 at a medium energy level be applied. This corresponds to an average energy density of approximately 0.1 mJ / mm2. If necessary, follow-up treatments can be performed at one- or two-week intervals.

4.9.5 Shockwave treatment for skin lesions

1. Apply ultrasound gel to the incision folio. Note: non-sterile ultrasound gel can be used.

WARNING

Danger of infection! To avoid contaminating the water membrane, the applicator must not come into direct contact with the wound. Always wear protective gloves! Use only 3MTM Steri-DrapeTM and incision folio.

WARNING

Avoid air bubbles in the shockwave path! The water membrane must make good contact with thesterile incision folio to avoid energy loss and hematomas. Avoid air bubbles between wound and folio.

WARNING

Danger of infection! To avoid contaminating the water membrane, the applicator must not come into direct contact with the wound. Always wear protective gloves! Use only 3MTM Steri-DrapeTM and incision folio.

WARNING


Operation


Fig. 4.9.5-1: Applying ultrasound gel

2. Adjust the necessary treatment parameters. 3. Bring the applicator in contact with the ultrasound gel

on the incision folio and release shockwaves.

Fig. 4.9.5-2: Shockwave treatment

Operation


4.9.6 Ending treatment of skin lesions 1. Carefully remove the folio. 2. Clean the wound. 3. Clean and disinfect the applicator. Use an inorganic,

non-flammable disinfectant suitable for medical applications.

4.9.7 Preparation for orthopaedic treatments 1. Location and penetration depth for the treatment must be

determined by ultrasound, X-ray or palpation. 2. Mark the region for coupling (determined in Step 1) on

the patient's skin. 3. Ensure that fat and hair in the region of the coupling

area are removed. 4. Ensure the patient is prepared for the treatment and

that the water membrane and applicator housing are cleaned and disinfected. Clean and disinfect with customary, inorganic and non-flammable disinfectants.

5. Place the device close to the patient and ensure there is enough space to move the applicator over the entire treatment area. The patient may either sit or lie down for treatment.

6. Adjust the necessary treatment parameters (Section 4.8). 7. Make sure the applicator is filled 8. Press the RESET key on the touch screen.

WARNING

Air bubbles! The water membrane must make good contact with the sterile incision folio to avoid energy loss and hematoma. Be sure to avoid air bubbles on the inside of the water membrane, particularly when the applicator is held downward. Always use ultrasound gel and make sure that there are no air bubbles between the outside of the water membrane and the folio.

WARNING

Danger of infection! Caution - once removed, the incision folio is no longer sterile!

WARNING

Danger of infection! The applicator must never be in direct contact with skin injuries or abscesses as infectious tissue can contaminatethe water membrane or the applicator, or conversely, the water membrane can contaminate the wound.

Operation


4.9.8 Shockwave treatment for orthopaedic indications

1. Adjust the penetration depth by regulating the coupling

pressure. 2. Apply ultrasound gel to the water membrane of the

applicator. 3. Select appropriate values for energy and frequency. 4. Bring the applicator in contact with the patient's skin

and release shockwaves.

WARNING


WARNING

Danger of infection! In order to avoid contaminating the water membrane, the applicator must not come in direct contact with the wound.

Always wear protective gloves! Use only 3MTM steri-drapeTM incision folio.

WARNING

Avoid air bubbles in the path of the shockwaves! The amount of tissue damage or hematomas depends on the applied total energy and the energy density. The applicator's water membrane should make very good good contact with the patient's skin in order to avoid energy loss and the development of hematomas. Ensure there are no air bubbles inside the water membrane especially in cases when the applicator is used in the uprightposition. Always use ultrasound gel and ensure there are no air bubbles between the water membrane and the patient's skin.

WARNING

Treatment parameters! Energy level, trigger frequency and number of shockwavesmust to be applied according to the published literature about shockwave treatments. Patient feedback must also be considered. It is advisableto commence treatment with low energy and low trigger frequency. As the treatment continues the settings should be increased to the desired values.

Operation


4.9.9 Ending treatment for orthopaedic indications 1. Clean the skin of ultrasound gel. 2. Clean and disinfect the water membrane of the applicator

and the applicator housing. Any inorganic, non-flammabledisinfectant may be used.

4.9.10 Preparation for treatment of trigger points 1. Localize the trigger point. 2. Mark the area for coupling on the patient's skin. 3. Ensure that fat and hair in the region of coupling area

are removed from the patient's skin. 4. Ensure that the patient is prepared for the treatment,

and that the water membrane and applicator are clean and disinfected. Use standard inorganic, non-flammable disinfectant.

5. Place the device close to the patient and ensure there is enough space for the applicator to be moved over the entire treatment area. The patient may sit or lie down for the treatment.

6. Adjust the necessary treatment parameters (Section 4.8). 7. Make sure the applicator is filled. 8. Press the RESET key on the screen.

4.9.11 Shockwave treatment of trigger points

1. Adjust penetration depth by regulating the coupling

pressure. 2. Apply ultrasound gel to the water membrane of the

applicator. 3. Select appropriate values for energy and trigger

frequency. 4. Bring the applicator in contact with the patient's skin

and release shockwaves.

WARNING

Danger of infection! The applicator must never make contact with skin lesions or abscesses as infectious tissue can contaminate the water membrane or the applicator or conversely, the water membrane can contaminate the wound.

WARNING

Indications and contraindications! Read sections 1.3 and 1.4. regarding indications and contraindications.

Operation


4.9.12 Ending trigger point treatments 1. Clean the skin of ultrasound gel. 2. Clean and disinfect the water membrane on the applicator

and the applicator housing. Any customary non-flammableinorganic disinfectant may be used.

4.9.13 Failure during treatment If any problems occur with the OW100® or the applicator during treatment, shut down the device and applicatorand take measures to ensure that it is not restarted.

4.10 Shutting down the OW100® 1. Drain the applicator then clean and disinfect it. Any

inorganic and non-flammable disinfectant can be used. 2. Press the confirmation button for about 3 seconds and

switch off the device using the power switch. 3. Clean and disinfect the device according to section 7.2.

WARNING

Danger of infection! In order to avoid contaminating the water membrane, the, applicator must not come in direct contact with the wound. Always wear protective gloves! Use only 3MTM steri-drapeTM incision folio.

WARNING

Avoid air bubbles in the path of the shockwaves! The amount of tissue damage or hematomas depends on the amount of applied energy and the energy density. The water membrane should make good contact with thepatient's skin in order to avoid energy loss and the development of hematoma. Ensure there are no air bubbles inside the water membraneespecially in cases when the applicator is used in the upright position. Always use ultrasound gel and ensure there are no air bubbles between the water membrane and patient's skin.

WARNING

Treatment parameters! Energy level, trigger frequency and number of shockwaves must be applied according to the published literature about shockwave treatments. Patient feedback must also be considered. It is advisable to commence treatment on a low energy setting and lowtrigger frequency. As the treatment continues the settings should be increased to the desired levels.

Operation


4.11 Closing procedures Drain the applicator then switch the device off or place it inStand-by mode. Clean and disinfect according to section 7.2.

4.12 Switching off the OW100® Drain the applicator and press the confirmation button for 3 seconds. The device is now in Stand-by mode. To switch it off, use the power switch.

4.12.1 Switching the OW100® into Stand-by mode If the device will be shut off only for a short time, switch it into Stand-by mode. This will enable it to quickly returnto operational mode. Restarting instructions are found in section 4.6.1. To place in Stand-by mode press the confirmation button on the touch wheel for 3 seconds.

4.13 Interruptting power supply If necessary pull power cable out of the socket.

4.14 Longer downtime For longer downtime remove the applicator and store the device in a dust-, dirt- and humidity-free environment.

4.15 Storing the OW100® Note the following conditions for downtime / storage: Temperature: 4° – 70° C (50° – 86° F)

Humidity: 10 – 98%, no condensation

Atmospheric pressure:

500 – 1060 hPa (14.76 – 31.3 inHg)

Protect the device against dust, dirt and humidity!

Julie DoddRemove blank line here.

Operation


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Technical Data


5 Technical Data 5.1 Introduction

This chapter explains the technical details and therequired conditions for storing the OW100® and itsaccessories.

5.1.1 Noise emission Stand-by: 46 dB max. Treatment: 91.7 dB max.

5.1.2 Mechanical Components Weight: 16.5 kg (36.4 lbs)

Size of housing unit: (H x W x D)

218 x 400 x 459 mm

5.1.3 Water system Closed system

Capacity of water cartridge:

450 ml Water (15.22 fl oz)

Adjustable water flow

Fill time of the reflector: 25 seconds

5.1.4 Shockwave generator General data: Water membrane couples shockwave

shockwave generator to treatment areaPrinciple: Electro-hydraulic; discharge of high voltage

condensers across underwater spark gapShockwave release frequency: 0.5 to 8 Hz.

5.1.5 Operation and display elements • Operation monitor and touch wheel located on front

of the device • Power on / off displayed by control lamp in switch • Footswitch to release shockwaves

Technical Data


5.2 Supply Voltage supply: AC 100-240 V, 50-60 Hz, ± 10 %

Single phase

Class I equipment Type B

Power consumption: 200 VA

5.3 Conditions for operation, storage and transport Conditions for operation (Device and applicator)

Temperature: 10° – 30° C (50° – 86° F)


Atmospheric pressure: 700 – 1060 hPa (20.67 – 31.3 in Hg

Conditions for storage and transport (Device and applicator)

Temperature: 4° – 70° C (39.2° – 158° F)


Atmospheric pressure: 500 – 1060 hPa (14.76 – 31.3 in Hg)

Conditions for storage and transport (Water cartridge)

Temperature: 4° – 70° C (39.2° – 158° F)


Atmospheric pressure: 500 – 1060 hPa (14.76 – 31.3 in Hg)

5.4 Components The following components are approved according to DIN EN 60601-1-2:

• Power cable length: 2.5 meters, removable. • Footswitch: manufacturer Steute, Type RF 2S-MED-AP,

2.0 meter cable, removable.

Technical Data


5.5 Lifespan Lifespan of OW100®: 5 years

5.6 Applicator OP155

Characteristics: Wide focus

Colorcode: Yellow

Energy data by energy level

Weight: With cable: 1.5 kg Without cable: 0.85 kg

NOTE

Use only the footswitch provided (Manufacturer Steute, Type RF 2S-MED-AP) with the OW100®.

NOTE

The use of other cables and accessories can lead to higher radiation and/or reduce the interference resistance.

Energy level

Total energy density

(mJ/mm2)

Total energy in

-6 dB focus(mJ)

Total energy 5 MPa (mJ)

E(5MPa) 1 0.01 0.40 0.40 2 0.01 0.53 0.60 3 0.02 0.67 0.85 4 0.03 0.83 1.05 5 0.04 1.00 1.64 6 0.05 1.19 2.35 7 0.06 1.40 3.18 8 0.07 1.62 4.13 9 0.09 1.85 5.22

10 0.10 2.10 6.45 11 0.11 2.36 7.82 12 0.13 2.64 9.33 13 0.14 2.93 11.0 14 0.16 3.23 12.8 15 0.17 3.55 14.8 16 0.19 3.88 17.0

Technical Data


5.7 Applicator OE050

Characteristic: Focused

Colorcode: Ultramarine


Energy level


(mJ/mm2)

Total energy in -6 dB focus(mJ)

Total energy

5 MPa (mJ) E(5MPa)

1 0.03 0.30 0.61 2 0.04 0.52 1.12 3 0.05 0.78 1.74 4 0.07 1.08 2.48 5 0.08 1.41 3.32 6 0.09 1.76 4.28 7 0.11 2.15 5.34 8 0.12 2.55 6.51 9 0.14 2.97 7.77

10 0.15 3.41 9.15 11 0.17 3.86 10.6 12 0.19 4.31 12.2 13 0.21 4.78 13.9 14 0.23 5.24 15.6 15 0.25 5.70 17.5 16 0.27 6.15 19.5


Technical Data


5.8 Applicator OE035 Characteristic: Focused

Colorcode: Sky blue


Energy level


(mJ/mm2)

Total energy in -6 dB focus(mJ)

Total energy

5 MPa (mJ) E(5MPa)

1 0.01 0.34 0.35 2 0.02 0.44 0.42 3 0.02 0.56 0.46 4 0.03 0.69 0.94 5 0.04 0.84 1.50 6 0.04 1.02 2.13 7 0.05 1.21 2.84 8 0.06 1.43 3.62 9 0.07 1.68 4.47

10 0.08 1.95 5.39 11 0.09 2.25 6.37 12 0.10 2.58 7.41 13 0.11 2.94 8.51 14 0.13 3.33 9.66 15 0.14 3.76 10.9 16 0.16 4.22 12.1


Technical Data


--------------------◊--------------------

Setting up


6 Setting up 6.1 Introduction

This chapter explains how to unpack and connect the OW100®.

6.2 Operating EnvironmentOperate the OW100® only within the followin environment conditions: Temperature: 10° – 30° C (50°– 86° F)


Atmospheric pressure: 700 – 1060 hPa 20.67 – 31.3 inHg)

6.3 Unpacking the OW100® Open the transport box and remove the device and accessories.

Place device on a flat, stable surface capable of supporting the weight of the device and its accessories.

WARNING

Weight of OW100® The OW100® weighs approximately 16.5 kilogram. Pleaseuse 2 people to lift from box.

NOTE

Transport box Retain the transport box for furture transport of the device.

WARNING

Operation of the OW100® The OW100® must be operated only in the horizontal position.

Setting into operation


6.4 Parts Checklist The following parts are provided with the OW100®: Note: This list may differ from the delivery note, which takesprecedence.

Name Description Quantity

OW100® 1

Applicators: OP155 or OE050 or OE035

1

Footswitch 1

Memory card (Example)

1

Power cable (Example)

1

Water cartridge (limited lifetime)

1

User manual 1

Chart 6.4-1: List of parts delivered with the OW100®

Setting up


6.5 OW100® delivery Each device is checked for full functionality by MTS Europe GmbH prior to delivery. Please read all provided documents prior to operating the device.

The parts checklist is displayed in chart 6.4-1. Variations to that list are documented in the delivery note and on thesales contract. Please check shipment for all components.

Description Quantity

OW100® 1

Applicator 1

Footswitch 1

Power cable 1

Memory card 1

Water cartridge (limited lifespan) 1

User manual MTS_OW100_IFU_E 1

Chart 6.5-1: Shipment List

WARNING

High voltage! The device contains high voltage circuits. Never open the covers. Only authorized personnel are permitted to perform repairs or maintenance work. Violation could endanger life!



6.6 Connections

6.6.1 Connecting the power supply Connect the power cable provided to the power connection socket (1) on the back of the OW100® and plug it into a wall socket. The device can be connected to voltage supplies between 110V and 240V at a supply frequency of 50 to 60 Hz. The OW100® automatically recognizes the supply voltage towhich it is connected. Make sure that the wall socket has a PE connection.

Fig. 6.6.1-1: Connecting the power supply

6.6.2 Connecting the applicator The applicator is delivered in special packaging. Store this package in a safe place for return shipment of applicator.

WARNING

Electrical hazard danger! Make sure that the designated wall socket has a PE connection!

CAUTION

Local power connections! Make sure that the power plug on the OW100® matches the wall socket.

1

Operating the OW100®


Fig. 6.6.2-1: Connected applicator To connect an applicator to the OW100®: 1. Switch on the OW100® (not Stand-by). 2. Make sure the plug is correclty positioned to the socket

on the device. 3. Press the plug against the socket, until the internal

motor recognizes the plug and pulls it into the final position.

Fig. 6.6.2-2: Inside view of the applicator connection

WARNING

Damaged applicator packaging! Do not use the applicator if, upon dleivery, the applicator packaging is damaged!



Fig. 6.6.2-3: Applicator connection socket on the OW100®

The OW100® automatically recognizes the type of applicatorconnected and displays the name.

Fig. 6.6.2-4: Displaying name of applicator connected to the OW100®

instructions for use ow100• peyronie’s disease (induratio penis plastica) trigger point...

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