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ATMOSS 351 Natal

ATMOS MedizinTechnikGmbH & Co. KG

Ludwig-Kegel-Str. 1679853 Lenzkirch / Germany

Tel. +49 (0) 7653 / 6 89-0Fax +49 (0) 7653 / 6 89-190

[email protected]

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Page1.0 Introduction1.1 Notes on operating instructions ............................31.2 Function ................................................................41.3 Explanation of symbols .........................................5 2.0 Safety information ........................................ 6 - 7

3.0 Purpose ................................................................8

4.0 Installation and commissioning4.1 Indicators and controls .................................. 9 - 104.2 Initial start-up ...............................................11 - 15

5.0 Operation5.1 Basic Operation .......................................... 16 - 265.1.1 Switching on................................................ 16 - 185.1.2 Fully automatic vacuum build up (VE Auto Mode) .......................................... 18 - 195.1.3 Semi-automatic vacuum build up (VE Semi Mode) .......................................... 20 - 215.1.4 Controlled venting (vacuum release) ..................225.1.5 Additional functions .............................................235.1.6 Use of the foot regulator in VE Mode ..................245.1.7 Vacuum build up with foot regulator ....................255.1.8 Starting automatic vacuum build up from a vacuum value preset in suction mode...... 25 - 265.2 Warning signals .......................................... 27 - 285.2.1 Vacuum drop during vacuum build up .................275.2.2 Vacuum drop after fi nal vacuum has been reached ......................................................275.2.3 Final vacuum not achieved .................................275.2.4 Electronic fi lling level monitoring .........................285.2.5 Short circuit between contact terminals ..............285.2.6 Electronic fi lter monitoring...................................285.3 Adjustments ................................................ 28 - 305.3.1 Switching on/off of alert tones .............................295.3.2 Setting the vacuum build up / release time .........295.3.3 Final vacuum.......................................................295.3.4 VE Automatic ......................................................305.3.5 Adjust unities.......................................................305.3.6 Brightness of display ...........................................305.4 Trolley operation .................................................315.5 Suction function ..................................................315.5.1 Changing the collection jar..................................325.5.2 Suction with foot regulator ..................................335.6 Faults ..................................................................345.6.1 Emergency operation ..........................................345.6.2 Overheating ........................................................345.6.3 Fault ....................................................................34

6.0 Cleaning and Maintenance6.1 Reprocessing of hoses and collection jar ........................................................356.2 Cleaning and disinfecting the outside of the unit ............................................................366.3 Recommended instrument disinfectants .............376.4 Recommended surface disinfectants ..................37

7.0 Maintenance ......................................................38

8.0 Trouble-shooting ....................................... 39 - 41 9.0 Spare Parts and Accessories .................. 42 - 459.1 Spare parts ................................................. 42 - 439.2 Accessories ................................................. 44 - 459.2.1 Jars .....................................................................449.2.2 Accessories to simplify handling .........................449.2.3 Gynaecology .......................................................459.2.4 Obstetrics ............................................................45

10.0 Technical specifi cations ..................................46

11.0 Disposal .............................................................47

12.0 Notes on EMC .............................................. 48-50

General Standard Terms and Conditions

Contents

3

ATMOS

Phone: + (49) 7653 689-0

Fax: + (49) 7653 689-190 + (49) 7653 689-393 (Service Center)

E-mail: [email protected]: http://www.atmosmed.de

MedizinTechnik GmbH & Co. KGLudwig-Kegel-Str. 1679853 LenzkirchDeutschland / Germany

1.1 Notes on operating instructions These instructions contain important information on how

to operate the ATMOS S 351 Natal safely, properly and effi ciently. It should, therefore, not only be used for new operators who have to be instructed, but also as an ongoing source of reference. These instructions will assist in avoi-ding danger and in reducing repair costs and downtime. In addition, they will increase reliability and the life of the equipment. For these reasons, the operating instructions must always be available near the equipment.

Please read Chapter 2.0 „Safety Information“ before initial start-up so that you are prepared for any potentially dan-gerous situations.

The following applies in all cases:

Careful and prudent work is the best protection against accidents!

The operational safety and availability of the equipment depend not only on your ability, but also on care and maintenance of the ATMOS S 351 Natal. For this reason, regular cleaning and maintenance work is essential. Major maintenance and repair work must be carried out only by experts authorised by ATMOS. Please insist that only origi-nal spare parts are used for repairs. This will guarantee that operational safety, usability and value of your equipment are preserved.

The ATMOS S 351 Natal carries the CE marking CE-0124 in accordance with the EU Council Directive 93/42/EEC on medical products and meets the essential requirements listed in Appendix I of this directive.

The quality management system applied by ATMOS has been certifi ed in accordance with the international stan-dards EN ISO 9001 and EN ISO 13485.

Authorised service providers are issued by ATMOS with service instructions including detailed circuit descriptions, parameter settings and service information.

Reproduction – even of excerpts – is permissible only with the written permission of ATMOS.

These operating instructions are effective from serial num-ber 2567350001.

Abbreviations / symbols in these instructions

Marks a list • Sub-division of a list/activity. The recommended sequence must be observed!

Marks particularly important information!

1.0 Introduction

4

1.2 FunctionThe ATMOS S 351 Natal is a mains-operated suction unit. The quiet, maintenance-free diaphragm pump forms the core of the ATMOS S 351 Natal. It creates a vacuum in the collection jar which assists in drawing off and collecting the secretions. The fi nal vacuum required and thus the suction power can be preselected in steps with the press of a button. The ATMOS S 351 Natal produces this vacuum with the aid of a micro-proc-essor-based controller. The pump switches off when the set value is reached. A control circuit ensures that the pump only runs when the vacuum is less than the value set.

The electronic fi lling level control, a safety jar (optional) and a bacterial fi lter prevent secretions being sucked into the unit.

Various monitoring and control functions increase the ease of operation of the ATMOS S 351 Natal and ensure safe use. These are, for example:

– Electronic fi lling level monitoring of the collection jar which provides visual and acoustic signals when the maximum level is exceeded.

– Electronic fi lter monitoring signalling a blocked (clogged) fi lter audibly and visually.

– A monitoring function which checks all main equipment functions at regular intervals and activates a service re-quest indicator if a fault is detected.

All components which come into contact with the secretion,such as hoses, collection jar, lid system or suction hoses can be autoclaved(134 °C, 3 bar, 5 min 3x fractionated prevacuum).

A special equipment trolley can be supplied for mobile use.

1.0 Introduction

5

1.3 Explanation of symbols

"max."

Caution, observe operating instructions !

Equipment safety fuse

Unit off

Unit on

Maximum vacuum

Alternating current

Protective ground terminal

System for protecting delicate tissue

Trolley

Foot regulator

Filter blocked

Full collection jar

Bacterial fi lter

Equipotential bonding

Application part Type B

Extraction cup

Ventilating the extraction cup

1.0 Introduction

!

6

The vacuum must be built up slowly in a controlled manner for vacuum extraction.

The user must continuously check the vacuum during vacuum extraction.

If the vacuum cannot be reduced despite correct adjust-ment of the equipment (defective auxiliary air valve), we recommend closing the suction hose between pump con-nection and bacterial fi lter in an air-tight manner (pinch) and then removing the suction hose from the pump connection or cutting through the suction hose on the pump connection with a scalpel. Then carefully let air back into the suction hose (carefully release the pinched suction hose) so that the vacuum is removed as slowly as possible.

The ATMOS S 351 Natal version for vacuum extraction on trolley 320.0070.0 must not be used as fl uid suction unit for operations as the electronic collection jar overfl ow monitor on this trolley does not work.

The buffer container for vacuum extraction must have a volume of at least 1 litre.

During vacuum extraction, the automatic mode can be disabled by operation of the foot regulator.

Prior to and during vacuum extraction, pay attention that connection hoses are not kinked and that no blocked fi lter is used. Prior to each application, check whether the fi lter is blocked.

Vacuum extraction may not be possible at elevated altitudes

as it may not be possible to achieve the vacuum required. Please see the appropriate table for this. It is at the discre-tion of the specialist whether an operation using the suction unit can be carried out at the fi nal vacuum obtained.

The jar overfl ow safety is not active during vacuum extrac-tion.

In case of a failure of the mains power supply or acciden-tal switching off of the equipment during extraction, this must be aborted and production of the vacuum has to be re-started after the equipment has been successfully restarted. The best way to do this is by pinching the suction hose to maintain the vacuum in the cup, venting by pressing the END button and building the vacuum again (pressing the extraction cup button) and then applying the vacuum by releasing the pinched hose. No venting must take place while the equipment is switched on again. The control unit continues to build up the vacuum or holds the vacuum.

Only approved extraction cups with CE marking in accor-dance with RL 93/42 must be used.

The system must not be ventilated suddenly with simul-taneous pulling on the extraction cup.

If the fi nal vacuum set is not achieved, the ATMOS S 351 Natal will not issue an audible signal „fi nal vacuum achieved“.

The doctor treating the patient is responsible for the pro-per surgical procedures and technology. A trained doctor has to decide in each case whether the treatment is appro-priate and how to carry it out.

The ATMOS S 351 Natal may be used only by trained staff under supervision (IEC 601-1 / EN 60601-1).

The ATMOS S 351 Natal meets the requirements of the standard IEC 601-1-2 / EN 60601-1-2 „Electromagnetic compatibility – medical electrical equipment“ with regard to resistance to interference.

Always set up the equipment in such a way that the operator can easily see the front panel and can reach it comfortably. The equipment must be placed on a fi rm, level surface.

The ATMOS S 351/S 351 Natal/S 351 Ophthal has been designed in accordance with IEC 601/ EN 60601. The equipment conforms to VDE Safety Class I. It must only be connected to a properly installed earthed socket.

Before connecting the equipment, check that the values for voltage and frequency indicated on the equipment correspond to those of the mains supply.

Use only correctly installed mains sockets and extension cables.

Check equipment, collection jar, power cable, acces-sories, connection cables and hoses for damage before start-up. Damaged cables and hoses must be replaced immediately. Check before use that the unit functions properly.

To disconnect the equipment from the mains, always pull the plug out of the wall socket fi rst. Only then disconnect the cable from the unit. Never touch plug or cable with wet hands.

After transport at low temperatures, the equipment must be left at room temperature for up to six hours before initial start-up. If the equipment has not been acclimatised, it must not be operated as the diaphragms of the pump could be damaged.

When switching on the unit, a high vacuum value might be present.

When switching on the unit, a high vacuum value might be present.

This product is not re-sterilisable. Repeated reuse of components which are marked with a is forbidden. In case of repeated reuse these components lose their function and there is a high infection risk.

2.0 Safety information

2

7

The suction hose must never come into direct contact with the patient. A suction catheter, suction attachment or medical suction instruments must always be used.

Too high vacuum values may lead to tissue damages.

Only use transparent hoses or hoses destined for vacuum extraction.

The environmental conditions listed in the specifi cations (chapter 10.0) must be observed.

The ATMOS S 351 Natal must only be operated in rooms designated for medical use. It is not designed for use in potentially explosive areas (M and G) and in oxygen rich environments. Potentially explosive areas can arise from use of fl ammable anaesthetic agents and agents used for cleaning and disinfecting skin.

If demineralised/slightly mineralised water or tap water is sucked off, the overfl ow monitoring of the ATMOS S 351 Natal does not function reliably as it works on an electrical basis.

Do not allow liquid to enter the equipment. If liquid has entered the equipment, it must be inspected by a service engineer before further operation.

When using on a patient (e.g. during surgery), an additional equivalent unit should be ready in case of failure of the unit (backup suction unit).

The level of vacuum preselected and the selection of addi-tional products must be as instructed by the specialist for all applications on a patient, e.g. for vacuum extraction.

These operating instructions correspond to the design of the equipment and the latest version of the safety standards at the time of printing. All property rights are reserved for the circuits, processes, names, software programs and equipment listed.

Particularly important notes are placed in a frame in these instructions.

The software detects a full collection jar or „shorting bet-ween the contact terminals“ and issues a warning at regular intervals. This does not interrupt the process of vacuum extraction.

Please dispose properly of all packaging.

Please note: A medical insulating transformer with earth leakage monitor or any similar safety system acc. to EN 60 601-1 is

required, if several devices are connected over one com-mon power supply. The transformer must correspond to the power consumption of all the devices to be connected.

ATMOS do not accept liability for injury to personsor damage to equipment if– non-original ATMOS parts have been used.– the information in these operating instructions has not be observed.– installation, adjustment, changes, extensions and repairs have been carried out by persons not authorised by ATMOS.

References

Medical product law (MPG) of 07.08.2002

EN 60601-1/1996: Medical electrical equipment. General safe-ty information, main section 6. Protection against the danger of ignition of fl ammable mixtures.

DIN VDE 0751 Part 1/10.90: Repair, modifi cations and testing of medical electrical equipment, Part 1: General speci-fi ca-tions.

Obtainable from: VDE-Verlag GmbH, Bismarckstraße 33, 12157 Berlin, Germany.

2.0 Safety information

8

The ATMOS S 351 Natal is especially used for the extraction cup birth and is, in addition, a suction system for use in dia-gnostic and therapeutic medicine and invasive surgery. It is especially designed for the removal by suction, collecting and fi xing of secretions, bodily fl uids, tissue parts, rinsing fl uids, gases and foreign bodies.

Special application ranges:

– Gynaecology, obstetrics: for suction curettage, aspiration biopsy, vacuum extraction, freeing of air passages and as breast pump (removal of galactostasis and removal of milk).

The suction hose must never come into direct contact withthe patient. A suction catheter, suction attachment or medical suction instruments must always be used.

The ATMOS S 351 Natal must not be used:

– Outwith human medicine.

– For removal of fl ammable or explosive liquids or gases.

– For drainage with a low vacuum (e.g. mediastinal-, thora-cic-, or pleural drainage).

3.0 Purpose

9

4.1 Indicators and controls

Fig. 1. ATMOS S 351 Natal Bracket and contact element for collection jar Pump connection Hose reducer 10 - 6 mm Bracket for collection jar Connection for hose to safety jar Connection for suction hose Release button for locking system (lid of collection jar) ON/OFF switch Indicators and control panel

4.0 Installation and commissioning

10

Fig. 2. ATMOS S 351 Natal (rear) Mains connection Equipment safety fuses Connection for potential equalization Connection for foot regulator Vent


13

12

10 11

14

1011

1213

14

11

Fig. 4. Fitting the lid

This section will explain

– how to handle the closure system of the collection jar lid,

– how to lock and insert the collection jar,

– which hoses have to be connected,

– how to connect the ATMOS S 351 Natal to mains electricity.

The closure system must tightly seal the collection jar so that the vacuum required can build up within. Fig. 3 shows the closure system with the locking handle open.

4.2 Initial start-up

Please note the safety information in Section 2.0 before initial start-up.

The anti-foaming device must be placed on the fi lling level sensor for strongly foaming secretions.

Push the closure system over the collection jar in accor-dance with Fig. 4 (take care that the cap rim (, Fig. 3) is below the bead of the collection jar) and press the locking handle downwards until it engages.

Force of the lid system can be changed by turning the knurled screw (, Fig. 3).

Fig. 3. Closure system Locking handle Knurled screw to lock the cap insert and to adjust the contact force Release button Level sensor with anti-foaming device Cap rim Opening for double connecting nipple Contacts for fi lling level sensor


12

Fig. 7. Inserting the double connecting nipple

Fig. 5. Attaching the 1.5 litre collection jar

Fig. 6. Attaching the 3 litre or 5 litre collection jar to the equipment trolley

Attach the 1.5 litre collection jar either to the left-hand or right-hand bracket in accordance with Fig. 5.

Please do not use the collection jar brackets on the ATMOS S 351 Natal and the trolley for any other purpo-ses. This will prevent malfunctions.

If you are using a 3 litre or 5 litre collection jar, attach it to the trolley in accordance with Fig. 6.

When using the trolley, the ATMOS S 351 Natal must be fi rmly connected to the trolley table using the two fi xing screws (underside of trolley table) (contacts for level sensor). The following symbol will be shown on the display .

Finally insert the double connecting nipple into the collec-tion jar cap (Fig. 7). Ensure that it engages by twisting it slightly.

It is advisable to treat the collection jar opening with vase-line or silicone so that the sealing rings seal better and are maintained.

Unit support

Fixing srews(Countersunk screw M 6x16)

Table support

Accessories rail

Castor holder

Castor

Fixer screw(Countersunk screw M 6x50alternative: cylindric screw M 6x50)

Unit fastening parts

Also contained in Scope of supply: • Fitting tool


13

Hose connections for suction mode

Only use transparent hoses to be able to assess conditionof the hoses. Replace the hoses when they are conta-minated.

Connect pump connection (, Fig. 8b) and bacterial fi lter with a short hose. Connect a second short hose to the printed side of the bacterial fi lter and join it to safety jar lid. Connect the longer hose to the vertical connection of the double connecting nipple and the connection of the safety jar.

When using the optional bacterial fi lter with the safety jar, the bacterial fi lter is not required. In this case connect the short hose to pump connection and directly to the safety jar lig .

Fig. 8b. Hose connections for suction mode

Pump connection Bacterial fi lter Safety jar lid Connection on safety jar Double connecting nipple

The ATMOS S 351 Natal must never be used without a bacterial fi lter.

Hose connections for vacuum extraction

Only use transparent hoses to be able to assess conditionof the hoses. Replace the hoses when they are conta-minated.

Connect a short hose with the pump connection (, fi g. 8a) and the bacterial fi lter . Connect a second short hose to the printed side of the bacterial fi lter and join it with the vertical connection of the double connecting nipple . Use the vacuum extraction hose to join the hori-zontal connection of the double connecting nipple with the cross handle of the extraction cup .

Fig. 8a. Hose connections for vacuum extraction Pump connection Bacterial fi lter Double connecting nipple

Vacuum extraction hose Extraction cup (incl. cross handle, chain, hose)


14

Fig. 9. Connecting the suction hose

Now fi t the suction hose to the angled connection of the double socket nipple.

The 10 mm dia. suction hose is fi tted directly to connection (, Fig. 10) the 6 mm dia. hose is fi tted via the hose reducer .

Fig. 10. Double connection nipple Connection for hose to safety jar Connection for suction hose Hose reducer for 6 mm hose


15

Fig. 11.

Fig. 12. Indicators and control panel

Button for selecting the maximum vacuum (with suction function)

Display LED of vacuum extraction functionButton for switching on the automatic vacuum build up

Button for increasing the vacuum (with suction function) Button for reducing the vacuum (with suction function)

Button for switching on the automatic vacuum releaseDisplay (graphics)

Check whether the voltage and frequency data listed on the equipment correspond to the power supply and connect the ATMOS S 351 Natal via the connector (, Fig. 11) to mains power. Secure the mains cable against accidental removal using safety clamp .

If the ATMOS S 351 is used for surgical procedures, we recommend connecting it to the equipotential bon-ding connection of the room via connection .

If you have a foot regulator, connect it to its connection(, Fig. 11).

The ATMOS S 351 Natal is now ready for operation.


16

5.0 Operation

5.1 Basic Operation

5.1.1 Switching on

After switching on, the VE mode is active. The adjustments for the vacuum to be generated (fi nal vacuum) and the available time (build-up time) correspond to the adjustments made in the service menu (see chapter adjustments 5.3, page 28). Exception: If there is already a vacuum present when switching on, this value is assumed as start value for vacuum gener-ation. Build-up time will then decrease accordingly. At factory, the fi nal vacuum is adjusted to -80kPa and build-up time to 120s.

Graphics display

All operating states are shown on the graphics display.

Please ensure that the following parts have been reprocessed before treating a new patient: – suction hose including suction attachment or suction instrument, – collection jar lid and double socket nipple, – connection hose to safety jar as well as safety jar and bacterial fi lter.

Check before each use whether the bacterial fi lter has to be replaced. You must use only a clean and dry fi lter. The electronic fi lter monitoring signals when the fi lter is blocked (clogged).

The suction hose must never come into direct contact with the patient. A suction catheter, a suction connector or medical suction instruments must always be used.

17

Fig. 13. Indication for collection jar full

Electronic fi lling level monitoring

The ATMOS S 351 Natal is equipped with an electronic fi lling level monitoring which, in VE mode, does not affect the per-formance of the pump. The vacuum is not decreased. The alarm signal for a full jar (fi g. 13) appears in regular intervals. In suction mode, the pump is switched off when the maximum fi lling level is reached. The device gives an audible signal and the indication for full jar (fi g. 13) appears. The maximum fi lling level is reached when the liquid comes into contact with the sensor (, Fig. 3, page 11) in the closure system. If a large amount of foam is generated, you should fi t the enclosed anti-foaming device over the sensor so that the unit does not switch off prematurely. As soon as the sensor is no longer in contact with the liquid (e.g. on replacing the double connecting nipple), the unit switches on again.

Changing unities

The display of the ATMOS S 351 Natal can be adjusted to 3 unities: mbar, mmHg and kPa. This switching-over is descri-bed in chapter 5.3, page 28.

Electronic fi lter monitoring

The ATMOS S 351 has an electronic fi lter monitoring which monitors whether the fi lter is blocked. The pump does not switch off when the fi lter blocked state is detected so that work can continue. Change the fi lter as soon as possible or clean the fi lter in accordance with the instructions in chapter 6.0 when this message is displayed.

Fig. 14. Indication for fi lter blocked

Filter blocked

The message is also displayed when the hose is pinched near the unit. This message is also displayed while the drainage accessories are connected. Remove the parts in question in this case.

5.0 Operation

18

5.1.2 Fully automatic vacuum build up (VE Auto Mode)

Switch on the ATMOS S 351 Natal. Make sure that the pilot lamp in the switch lights up.

Then, the switching-on menu (fi g. 15) is shown in the display for approx. 2seconds.

Fig. 15. Display directly after switching on

Function vacuum extraction

For vacuum extraction, we recommend to use a small coll-ection jar (1.5 l) to enable a quick generation of the required vacuum value.

Automatic vacuum build up

During automatic vacuum build up, the vacuum is gener-ated evenly and fi nal vacuum is reached in the preset time (standard adjustment = 120s). For changing this vacuum build-up time, refer to chapter 5.3 Adjustments, page 28. During vacuum generation, the green LED fl ashes. When the fi nal vacuum is reached the device gives an audible signal and the green LED lights up constantly.

The device offers the possibility to select between a fully automatic vacuum build-up (VE Auto Mode) and a semi-automatic vacuum build-up (VE Semi Mode) (see chapter 5.3 Adjustments, page 29).

The fully automatic vacuum build-up is standardly pre-set.

5.0 Operation

19

Fig. 17. Display during automatic vacuum generation

After having reached the base vacuum of -20kPa, the automatic vacuum build up is started and indicated by an alert tone. The remaining time (in seconds) to fi nal vacuum is shown at the top left of the display (fi g. 17).

Then, the ATMOS S 351 Natal automatically changes over into the so-called VE Auto Menu (fi g. 16).

Here, the vacuum generated is displayed (as fi gure and as bar graph). In addition, the desired vacuum build up time (default = 120 s) is shown top left and the fi nal vacuum set at the top right (default = -80 kpa).

The ATMOS S 351 Natal attempts to build up the base vacuum of -20kPa.

Apply the extraction cup.

Fig. 16. Display after automatic change over into the VE Auto Menu Time for generating the fi nal vacuum Selected mode Final vacuum, desired value Current vacuum value Bar graph for vacuum / time

Fig. 18. Display after having reached the final va-cuum Countdown time indication Selected mode Final vacuum, desired value Current vacuum value Bargraph for vacuum / time

When the fi nal vacuum is achieved the device gives an alert tone (long tone with one short break). The time displayed is 0s (fi g. 18). The fi nal vacuum is held.

5.0 Operation

20

Fig. 20. VE Semi Menu. The device attempts to ge-nerate a base vacuum of -20kPa

Fig. 21. VE Semi Menu after having reached the the base vacuum of -20kPa

Fig. 19. Extraction cup button

5.1.3 Semi-automatic vacuum build up (VE Semi Mode)

For semi-automatic vacuum build up, the start of the auto-matic vacuum build up must be confi rmed with the extraction cup button (fi g. 19).

Switch on the ATMOS S 351 Natal. Check that the indicator lamp in the switch is illuminated.

The switch-on menu (fi g. 18, page 19) is shown on the display for about 2 seconds.

The unit automatically goes to the VE Semi Mode (fi g.

20 and 21). The vacuum generated is displayed in this menu (as fi gure and as bar graph). In addition, the va-cuum build-up time (default = 120 s) is displayed at the top left and the fi nal vacuum set at the top right (default = -80 kPa). The ATMOS S 351 Natal attempts to generate the -20kPa base vacuum.

Desired vacuum build-up time Selected mode Final vacuum, desired value Current vacuum value Vacuum / time bar graph

5.0 Operation

21

Fig. 22. Automatic vacuum build up in the VE Semi Mode

After the -20 kPa base vacuum has been reached, the unit waits for the extraction cup button to be depressed. During this waiting period, an alert tone sounds syn-chronised with the fl ashing of the green LED. When the extraction cup button is pressed, the alert tone stops and the automatic vacuum build up starts (fi g. 22).

An alert tone sounds when the fi nal vacuum level has been reached (long tone with one short break). The time displa-yed is 0 seconds (fi g. 23). The fi nal vacuum is held.

Fig. 23. VE Semi Mode after having reached the fi nal vacuum

5.0 Operation

22

Fig. 24. END button

Fig. 25. Automatic vacuum release in VE Auto Mode

Fig. 26. Automatic vacuum release in VE Semi Mode

5.1.4 Controlled venting (vacuum release)

After completed vacuum extraction or at any other time in VE Mode (VE Auto Mode and VE Semi Mode), the extraction cup can be vented in a controlled manner over a preset period (default: 5 s) (fi g. 25 and 26) by pressing the END button (fi g. 24). The venting time can be altered in the Service 1 menu (see chapter 5.3 Adjustments, page 28).

Fig. 27. Display after either of the VE Modes has been exited (e.g. after venting)

After the extraction cup has been vented completely, the unit leaves the respective VE menu (fi g. 27).

The vacuum can be build up again automatically by pres-sing the extraction cup button.

5.0 Operation

23

5.1.5 Additional functions

In the VE mode of the ATMOS S 351 Natal it is possible at any time to intervene in the operation of the unit using the arrow buttons (fi g. 28). The Max button is locked.

Using the buttonsOperation of the arrow buttons in VE mode is signalled by an alert tone. The buttons have the following functions in this mode:

The vacuum build up can be delayed by pressing the button during vacuum build up. The counter for the time indication is increased accordingly. You can leave the VE mode by pressing the button several times.

The vacuum build up can be accelerated by pressing the button during vacuum build up. The counter for the time indication is decreased accordingly.

Once the fi nal vacuum has been reached, it can be reduced by pressing the button. You can leave the VE mode by pressing the button several times.

Once the fi nal vacuum has been reached, it can be in-creased by pressing the button.

The vacuum release can be accelerated by pressing the button during vacuum release. The counter for time indication is decreased accordingly. You can leave the VE mode by pressing the button several times.

The vacuum release can be delayed by pressing the button during vacuum release.

The counter for time indication is increased accordingly.

Fig. 28. Buttons for increasing / decreasing the vacuum

5.0 Operation

24

Fig. 29. If the foot regulator is moved towards the toe stop, the control of the vacuum passes to the foot regulator at about -34kPa

5.1.6 Use of the foot regulator in VE Mode

During VE mode, it is possible to transfer the control of the vacuum to the connected foot regulator. The ATMOS S 351 Natal automatically goes into Suction mode in this case.

The ATMOS S 351 Natal must be switched off before the foot regulator is connected or disconnected.

In VE mode, set the foot regulator pedal towards the positi-on which corresponds to the currently applied vacuum (fi g. 29 and 31). This transfers control over the vacuum to the foot regulator. The ATMOS S 351 Natal goes into suction mode (fi g. 30). The automatic vacuum build up mode can be restarted by pressing the extraction cup button (fi g. 19).

Fig. 30. Display after control of the vacuum has passed to the foot regulator

Fig. 31. If the foot regulator is moved towards the heel stop, the control of the vacuum passes to the foot regulator at about -52kPa

5.0 Operation

25

5.1.8 Starting automatic vacuum build up from a vacuum value preset in suction mode

It is possible for the ATMOS S 351 Natal to start the automa-tic vacuum build up from a vacuum value preset in suction mode:

Manual presetting of vacuum


After the VE menu is displayed, switch over into suction mode by pressing the END button (or the button).

Apply the extraction cup and manually build up the vacuum in steps to the level required (by pressing the button).

Change into VE mode by pressing the extraction cup sym-bol. The ATMOS S 351 Natal starts automatic vacuum build up from the vacuum value set in suction mode. The time until fi nal vacuum is shown at the top left of the display.

5.1.7 Vacuum build up with foot regulator

The ATMOS S 351 Natal must be switched off before the foot regulator is connected or disconnected. Completely depress the connected foot regulator to the heel position. Switch on the ATMOS S 351 Natal. Check that the indicator lamp in the switch is illuminated. After the VE menu is displayed, switch over into suction mode by pressing the END button (or the button). Using the button, select the required vacuum value which is to be built up with the foot regulator (see vacuum / time bar graph). Apply the extraction cup and build up the fi nal vacuum required in steps using the foot regulator (the foot regulator remains in position if you take your foot away).

5.0 Operation

26

Presetting the vacuum with the foot regulatorThe ATMOS S 351 Natal must be switched off before the foot regulator is connected or disconnected. Completely depress the connected foot regulator to the heel position.

Switch on the ATMOS S 351 Natal. Check that the lamp in the switch is illuminated.

After the VE menu is displayed, switch into suction mode by pressing the END button (or the button).

Using the button, select the vacuum value required which is to be built up with the foot regulator (see vacuum / time bar graph).

Apply the extraction cup and build up the vacuum required in steps using the foot regulator (the foot regulator remains in position if you take your foot away).

Switch into VE mode by pressing the extraction cup button. The ATMOS S 351 Natal starts automatic vacuum build up from the vacuum value set in suction mode. The time until fi nal vacuum is shown at the top left of the display.

5.0 Operation

27

5.2 Warning signals

5.2.1 Vacuum drop during vacuum build up

If the vacuum drops during automatic vacuum build up, the unit gives a warning: fast fl ashing of green LED + beeping synchronised with the LED. The time display remains on the value reached until vacuum build up can be continued. The pump output is increased, if possible, to counteract the leak.

The warning signal is cleared as soon as vacuum build up can be continued or after abortion of the action by the user.

5.2.2 Vacuum drop after fi nal vacuum has been reached

If the vacuum falls below -60kPa after the fi nal vacuum has been reached, a warning is given: fast fl ashing of green LED + beeping synchronised with the LED.

The warning signal is cleared as soon as fi nal vacuum is re-ached again or after abortion of the action by the user.

5.2.3 Final vacuum not achieved

If the time for the vacuum build up has passed and the fi nal vacuum has not been achieved, the unit will wait for about another 35 s and then issue a warning: fast fl ashing of green LED + beeping synchronised with the LED.

The warning signal indicates a leak in the system which prevents the fi nal vacuum from being achieved. The warning signal is cleared as soon as fi nal vacuum is reached again or after abortion of the action by the user.

Exception: If the fi nal vacuum is not achieved, but the vacuum achieved is greater than -70 kPa, no warning is issued.Reason: At elevated altitudes it may be possible that a high fi nal vacuum (much above -70 kPa) cannot be reached - due to atmospheric pressure - even though there is no leak in the system.

The ATMOS S 351 Natal cannot predict a loss of contact of the extraction cup. There is no warning for this.

The ATMOS S 351 Natal cannot predict a loss of contact of the extraction cup. There is no warning for this.

5.0 Operation

28

5.2.4 Electronic fi lling level monitoringSee page 17.

5.2.5 Short circuit between contact terminals

If there is a short circuit between the contact terminals, a warning is shown in regular intervals (fi g. 32) and an audible signal sounds simultaneously. The vacuum currently present is not affected (there is no vacuum release).

5.2.6 Electronic fi lter monitoring

See page 17.

5.3 Adjustments

During switching on, keep depressing the extraction cup button (fi g. 19, page 20) to reach the Service 1 menu. Here, adjustments can be made in following sub-menus (fi g. 33):

Adjusting unities (Adjust Unity) (see chapter 5.3.5, page 30).

Adjusting brightness of graphics display (LCD Bright-ness).

Switching on and off of the alert tones for the ‘start of automatic vacuum build up’ and ‘fi nal vacuum is reached’ (VE Tone) (fi g. 34).

Adjusting time period for vacuum build up and vacuum release (VE Time) (fi g. 35).

Adjusting fi nal vacuum value (VE Vac) (fi g. 36). Adjusting fully automatic or semi-automatic vacuum build

up (VE Automatic) (fi g. 37, page 30).

To reach the respective sub-menu, select with the arrow bu-ttons and confi rm with the Max button . To leave the Service 1 menu, press the extraction cup button.

Fig. 32. Warning of short circuit between contact terminals, indicating position of short circuit (here ‘→’ means at contact terminals on right)

Fig. 33. Service 1 Menu

To avoid malfunctions, use the supports on the unit for original ATMOS jars only.

5.0 Operation

29

5.3.1 Switching on/off of alert tones

The alert tones for the ‘start of automatic vacuum build up (VE Start Beep)' and ’reaching the fi nal vacuum (VE Stop Beep)' can be switched on and off in the VE Tone sub-menu (fi g. 34).

Select either the VE Start Beep or VE Stop Beep using the END button.

Switch the alert tone ON or OFF using the arrow bu-ttons.

Accept the settings by pressing the Max button and close the sub-menu.

Fig. 35. VE Time Menu

Fig. 36. VE VAC Menu

Fig. 34. VE Tone Menu

5.3.2 Setting the vacuum build up / release time

The times for vacuum build up and vacuum release can be set in the VE Time sub-menu (fi g. 35).

Select the vacuum build up time (Increase Time) or vacuum release time (Decrease Time) using the END button.

Set the time required using the arrow buttons. The setting can be changed rapidly by keeping the button depres-sed.


The vacuum build up time can be varied between 0 and 300 seconds. The default setting is 120 seconds.

The vacuum release time can be set between 0 and 60 se-conds. The default setting is 5 seconds.

If the extraction cup button is pressed, the sub-menu is closed without saving the changes.

5.3.3 Final vacuum

The level of fi nal vacuum can be set between -70kPa and -90 kPa in the VE VAC sub-menu (fi g. 36).

Set the vacuum value required using the arrow buttons. Accept the settings by pressing the Max button and close

the sub-menu.


5.0 Operation

30

5.3.5 Adjust unities

The vacuum unity displayed can be changed for the ATMOS S 351 Natal. To do this, press and hold the extraction cup button while switching on until Service 1 is displayed on the graphics display.

Then select Adjust unity using the arrow buttons and con-fi rm with the Max button.

The selection menu for the unities is displayed. You can chose between mbar, mmHg and kPa. Select the unity required using the arrow buttons and

confi rm with the Max button.

5.3.6 Brightness of display

The brightness of the graphics display of the ATMOS S 351 can be adjusted to suit the environment. To do this, press and hold the extraction cup button while switching on until Service 1 is displayed on the graphics display.

Then select LCD Brightness using the arrow buttons and confi rm with the Max button.

The selection menu for the display brightness is dis-played. You can set the brightness of the LCD display using the arrow buttons. When you have adjusted the display confi rm the setting with the Max button.

adjust unity

Fig. 37.

5.3.4 VE Automatic

You can chose between fully automatic or semi automatic vacuum build up in the VE Automatic sub-menu (fi g. 37).

Set the type of vacuum build up required using the arrow buttons.



5.0 Operation

31

5.5 Suction function

Connect the suction catheter, suction connector or suction instruments.


Select the fi nal vacuum required using one of the arrow buttons ( and , Fig. 39). If the button is kept depressed, the value changes more rapidly.

The maximum vacuum is set by pressing the Max button (, Fig. 39) .

The ATMOS S 351 Natal starts up and begins to build up the vacuum. The vacuum reached at any time is displayed. The unit switches off when the fi nal vacuum is reached. If the vacuum value exceeds 800 mbar it is possible that the ATMOS S 351 is automatically vented and the vacuum value is reduced to 800 mbar. A control circuit controls the unit during operation so that it runs only when the vacuum is less than the value set.

Observe the liquid level in the collection jar during suction. Although the electronic fi lling level monitoring switches off the unit when the maximum liquid level is reached, you should change the collection jar or empty it when it is about 2/3 full (including foam head).

Fig. 39. Indicators and control panel

Fig. 38. Trolley connected

Trolley connected

5.4 Trolley operation

If the ATMOS S 351 Natal is mounted on a trolley, the trolley symbol (Fig. 38) is shown on the display. The trolley symbol must be displayed during operation on a trolley. If the symbol is not displayed, the liquid level in the collection jar cannot be detected.

When using old trolleys (earlier than March 2000), this symbol will not be displayed, even if the system is func-tioning correctly. Our service department can convert the trolley for you in this case.

If liquid has been sucked into the unit despite the level monitoring and safety jar, the ATMOS S 351 Natal must be returned to operation only after examination by a service engineer.

5.0 Operation

32

Fig. 41. Removing the double connecting nipple

Fig. 42. Removing the collection jar

Fig. 40. Recommended maximum level

5.5.1 Changing the collection jar

Always wear protective clothing (gloves) when changing the collection jar!

Stop the suction process and switch off the pump.

Remove the double connecting nipple from the full co-llection jar (Fig. 41). Place it in the second collection jar, if attached.

To remove the collection jar, fi rst tip it slightly away from the unit and then pull it upwards (Fig. 42).

Either replace it with a new collection jar or empty it. Press the release button (3, Fig. 42) to open the locking handle. Please dispose properly of aspirated material.

Insert the double connecting nipple into the empty collection jar and continue suction.

After use

Switch off the ATMOS S 351 Natal and clean unit and accessories as described in chapter 6.0.

3

5.0 Operation

33

Fig. 43. Graphics display for foot regulator operation

5.5.2 Suction with foot regulator

The vacuum can be set with the connected foot regulator:

Connect the foot regulator to the connection (, Fig. 11, page 15).

Connect the suction catheter, suction connector or suction instruments.


Select the fi nal vacuum required using one of the arrow buttons (, and , Fig. 39, page 31). If button and is kept depressed, the value changes more rapidly.

You can now vary the vacuum between 0 and the maximum value set using the foot regulator.

5.0 Operation

34

Fig. 44. Display for emergency operation

Fig. 46. Overheating

Fig. 47. Call the ATMOS service department

5.6 Faults

5.6.1 Emergency operation

This operating mode is automatically entered if there is a malfunction in the ATMOS S 351 Natal. Please call the service department if this happens. The ATMOS S 351 Natal functions are restricted in this case. Control of the vacuum is no longer possible. The following functions are still available:

Fig. 45. Switch on pump Switch on pump Switch off pump

5.6.2 Overheating

The ATMOS S 351 Natal is designed for continuous operation. If the ventilation louvres at the bottom are blocked, the unit may overheat. Initially, a warning is given (graphics display blinks):

Check the ventilation louvres of the ATMOS S 351 Natal.

If the temperature continues to rise, the ATMOS S 351 Natal will be switched off. If this happens, the overheating display is left on the graphics display. Please call the service depart-ment if this happens.

5.6.3 Fault

If the ATMOS S 351 Natal detects a functional fault, this will be shown on the graphics display. Please call the service department if this happens.

Set up the ATMOS S 351 Natal on a clear, level surface. This will ensure free air circulation.

Please note that the Key Error is also created when a key is pressed for 7 seconds (exception: -keys).

5.0 Operation

35

6.1 Reprocessing of hoses and collection jar

Fig. 48. = Knurled screw for removing the lid insert = Contacts for fi lling level control

Grease the ‘O’ rings with vaseline after cleaning.

Always wear protective clothing (gloves) when carrying out cleaning work.

Those parts which come into contact with the secretion must be cleaned and disinfected after each use before a new patient is treated. These are:– Suction hose including suction connector or suction in-

struments,– collection jar including cap and double connecting ni-

pple,– connecting hose for safety jar (for safety jar and bacterial

fi lter, see overleaf).

Release all hose connections, remove the double connec-ting nipple from the closure system, empty the collection jar and dispose properly of the aspirated material.

Unscrew the upper part of the safety jar. Empty the jar, if required.

Remove the lid from the safety jar and take out the fi lter (if any).

Thoroughly rinse all parts under running water. Obviously, you may use a cleaning agent.

You can remove the lid insert from the closure system so that it can be cleaned thoroughly. To do so, turn the knurled screw counter-clockwise until the insert can be removed.

Disinfect the parts using the disinfectants listed on page 37. Using the cleaning agent Neodisher AN (manufactured

by Dr. Weigert, Hamburg) cleaning in an automatic cleaner and disinfecter is also possible.

Thermal disinfection is carried out at 93° C.

Reassemble the parts after that (chapter 4.1 Initial start-up).

Ensure that the contacts for the level monitoring are not contaminated.

Do not use any cleaning agents or disinfectants other than those listed on page 37.

6.0 Cleaning and Maintenance

36

If liquid has entered into the equipment, it must be in-spected by a service engineer before further operation.

6.2 Cleaning and disinfecting the outside of the unit

You must disconnect the mains plug before cleaning and

disinfecting the unit casing.

Wipe over the casing with a cloth moistened with a cleaning agent or disinfectant solution. Do not allow any liquid to enter the equipment. The cleaning agents and disinfec-tants listed on page 37 are all suitable.

Please note the instructions by the respective manu-facturer, especially with regard to concentrations and application period.


37


6.4 Recommended instrument disinfectants

Disinfectant Contents (in 100 g) Manufacturer

GIGASEPT FF succinic acid dialdehyde 11 g Schülke & Mayr, Norderstedt(concentrate) Dimethoxytetrahydrofurane 3 g Corrosion protection agents non-ionic tensides and perfume

neodisher AN non-ionic tensides < 5 g Dr. Weigert, Hamburg(Application concentrate) Phosphate > 30 g enzymes, preservative agent

6.5 Recommended surface disinfectants

Disinfectant Contents (in 100 g) Manufacturer

Green & Clean SK alkyl-dimethyl-benzyl-ammonium chloride < 1 g Metasys, Rum (Österreich)(Application concentrate) dialkyl-dimethyl-ammonium chloride

Dismozon pur magnesium monoperoxyphthalate Bode Chemie, Hamburg(Application concentrate) hexahydrate 80 g

38

7.0 Maintenance

Visually inspect the device, hoses, collection jar and power cord before each use.

For hygienic reasons, the bacterial fi lter must be replaced at least once a day !

The unit does not require any further maintenance.

MaintenanceBefore putting the device into operation, visually check unit, secretion canister and power cable, accessories, connection cables and hoses for signs of damage. Damaged cables and hoses must be replaced immediately!

A regular safety-related inspection anording EN / IEC 62353 is prescribed every 2 years. In the course of the safety-related check we recommend an inspection of the product.

ReprocessingHandling of the suction device determines to a large extent its reliability and safety. The hygiene measures described in the previ-ous chapters are necessary measures for the protection of patients and users, and to maintain functional reliability.

7.0 Maintenance

RepairsThe following may require repairs from the manufacturer or an authorized service partner. Prior to sending in the device, please contact your service partner by phone. Liquids have penetrated the device Sudden occurrence of unusual noises Operational and functional disorders which cannot be resolved by means of the hints describes in the chapter “Troubleshooting”.

Measures to be taken prior to sending in the device:

If the device has to be sent in for repair after consultation with the manufacturer or an authorized service partner, we ask you to observe the following: Please send in the complete device (see scope of delivery). Please remove all disposable parts and consumables. Thorough cleaning and disinfection Airtight packing Please enclose a detailed error description. Warranty

ATMOS cannot guarantee an error-free function nor can ATMOS be held liable for damage to people or goods if non-original ATMOS parts are used, the information in these operating instructions are disregarded, assembly, new installations, modifi cations, extensions and repairs are done by people who are not authorised by ATMOS.

39

8.0 Trouble-shooting

This section describes how to remove functional faults.

Fault

Unit does not start up(indicator light in switch not illuminated)

Alarm after start up(fi lter monitor is displayed)

Alarm after start up(fi lling level monitor is displayed)

Alarm during suction(fi lling level monitoring is displayed)

No alarm when collection jar full

Alarm during suction(fi lter monitoring is displayed)

Possible cause

– Mains plug not inserted properly

– No power

– Collection jar full

– Bacterial filter blocked or not com-pletely dry

– Drainage accessories connected


– Contact element short-circuited


– Heavy foaming

– When using the trolley, contact strip may be dirty

– Contact fault between collection jar and the ATMOS S 351 Natal

– Bacterial fi lter blocked

– Hose connection to pump kinked

Remedies

– Check mains plug

– Check mains power supply in building (fuse)

– Check equipment fuses

– Check safety and collection jars and empty, if required

– Replace bacterial fi lter

– Remove drainage accessories (thoracic drainage not possible)

– Empty collection jar

– Remove metal connection on contact (possibly also on trolley rail!). Also check the connections for trolley fi xation at the bottom of the unit.

– Empty collection jar

– Use anti-foaming device – Clean contact strip

– Check whether the collection jar and its closure system have engaged correctly in the bracket and whether the ATMOS S 351 Natal has been screwed correctly to the trolley

Please clean your ATMOS S 351 Natal before sending it for servicing.

– Clean / replace fi lter

– Attach hose in such way that it does not kink

40

Fault Possible cause Remedies

Alarm during suction, unit switches off

No trolley symbol on the graphics dis-play even though the trolley is used

Incorrect vacuum unity is displayed (mbar / mmHg / kPa)

The graphics display is too dark / can-not be read easily

Spanner displayed on graphics display

No vacuum or vacuum low

– Too much foam, foam bubbles close the contact

between sensor and double socket nipple

– The connection to the trolley has been interrupted.

– The trolley was purchased before March 2000

– The vacuum unity has been set incorrectly

– The brightness of the graphics display is not correctly adjusted

– An equipment fault has occurred

– The foot regulator is connected and in heel stop

– Place anti-foaming device on level sensor (Art. No. 444.0064.0)

– Check the contacts between the trolley and the ATMOS S 351 Natal

– Ask the service department to con-vert the trolley for operation with the ATMOS S 351 Natal

– Set the unity for the vacuum as required and as described in chapter 5.5

– Set the brightness of the graphics display as required and as described in Chapter 5.3.6

– If the display clears, the ATMOS S 351 Natal was able to remove the fault. However, a service engineer should check the suction unit

– Only emergency operation is possible as long as the display is shown (chapter 5.6.1). Call the service department

– Disconnect the foot regulator or de-press it with your toes


41

Fault Possible cause Remedies

– Check the ventilation louvres (bottom of unit). They must not be blocked

– Only use the ATMOS S 351 Natal within the temperature range stated. Try and use Auto Standby (less heat is generated)

– Call the service department

– Try and use Auto Standby (less heat is generated)

Flashing thermometer display in the graphics display (ATMOS S 351 Natal has overheated)

Continuous thermometer display in the graphics display (ATMOS S 351 Natal has overheated)

Only a low vacuum can be set with the foot regulator

Quick fl ashing of the green LED and synchronuously alarm signal

During vacuum generation resp. after having reached the fi nal vacuum value in the VE mode

– Ventilation louvres blocked

– Excessive ambient temperature

– Fan faulty

– See ‘fl ashing display’

– A low vacuum has been set with the buttons.

– Leakages in the system lead to vacuum loss or fi nal vacuum cannot be achie-ved

– Leave the unit switched on so that the fan can blow the hot air out of the unit. Wait until the display clears

– Set the nominal vacuum to a higher value (or to max.) using the + button to obtain a greater control range for the foot regulator

– Check the connection hoses and the jar on leakages

– Extraction cup may not correctly be applied


42

Fig. 49.

Fig. 50.

9.0 Spare Parts and Accessories

9.1 Spare Parts

Description Art.No.

Safety jar, standard (without fi lter, without lid) ...............................000.0504.0 Safety jar + DDS fi lter ....................................444.0646.1 . Bacterial fi lter cover .......................................444.0056.0 Bacterial fi lter lid ............................................444.0058.0 Bottle..............................................................000.0504.0 DDS bacterial fi lter / overfl ow safety ..............340.0054.0 Filter adapter..................................................340.0031.0 O-Ring ...........................................................055.0055.0 Silicone hose - f. safety jar-collection jar ..............................443.0046.0 - f. connecting nipple-fi lter..............................320.0044.0 - f. safety jar-collection jar (trolley) ................. 444.0118.0 - f. fi lter-safety kar ..........................................999.0128.0 Double connecting nipple ..............................444.0012.0 Reduction piece .............................................444.0013.0 Bacterial fi lter, disposables ............................443.0738.0

Lid system, complete .....................................444.0015.0 Lid insert ........................................................444.0052.1 Gasket ...........................................................055.0070.0 Foam protection .............................................444.0064.0

43

Fig. 51. Double connecting nipple

Description Art. No.

Double socket nipple, compl. .........................444.0012.0 O-ring 6 mm dia. (at least 5 pcs.) ..................055.0069.0 Hose reducer .................................................444.0013.0 O-ring 23 mm dia. (at least 5 pcs.) ................055.0073.0 O-ring 14 mm dia. (at least 5 pcs.) ................055.0072.0 Contact spring washer ...................................444.0079.0

Spare parts (not shown)

Fuse 230 V T 1 A/H ..............................................008.0471.0Fuse 115 V T 2 A/H...............................................008.0738.0

Power cord ...........................................................008.0629.0

Replacement bag for Receptal® Collection jar set I– Receptal® 1.5 l suction bag without integral overfl ow valve fi lter, 50 pcs. ...............310.0221.1– Receptal® 1.5 l suction bag with integral overfl ow valve fi lter, 50 pcs. ...............310.0221.2

Replacement bag for Receptal® Collection jar set II– Receptal® 2 l suction bag without integral overfl ow valve fi lter, 50 pcs. ..............443.0257.0– Receptal® 2 l suction bag with integral overfl ow valve fi lter 50 pcs. ................443.0257.2

Replacement bag for Receptal® Collection jar III– Receptal® 3 l suction bag without integral overfl ow valve fi lter,50 pcs. ................443.0153.0– Receptal® 3 l suction bag with integral overfl ow valve fi lter, 50 pcs. ...............443.0154.0

Cannula sleeves for instrument deposit ...............443.0017.0

Spare parts for safety jar

Safety jar complete with fi lter................................444.0080.0

Safety jar (glass)...................................................000.0504.0

Gasket for safety jar, O-ring..................................055.0071.0

Gasket for lid of safety jar .....................................055.0088.0

Bacterial fi lter for safety jar, can be reprocessed..444.0082.0

10 11

15

13

14

101112131415

12


44

9.2.2 Accessories to simplify handling Description

Hose bracket, for attachment on unit or trolley ............................................

Trolley (for obstetrics); kit (does not provide electronic overfl ow monitor facility) .................................

Foot regulator, electronic, waterproof IP X8, AP protected .........................

444.0450.0

320.0070.0

444.0452.0

Art. No.

9.2 Accessories

9.2.1 Jars

Description

Collection jar, glass, with graduation, 1.5 l .................................................. 444.0032.0

Jar lid*.......................................................................................................... 444.0015.0

Double connecting nipple for jar lid(incl. distal hose reduction Ø 10 / Ø 6)* ...................................................... 444.0012.0

Inline bacterial fi lter(connections hose/hose or hose/vacuum attachment) ............................... 443.0738.0

Art. No.


9.2.3 Filter combination

Standard confi guration:

Bacterial fi lter, disposables..........................................................................443.0738.0

Alternative disposable version: recommended as an oversuction protection for surgical interventions other than the vacuum extraction.Safety jar set complete, incl. adapter for DDS bacterial fi lter.......................444.0646.1

Bacterial fi lter, disposables..........................................................................340.0054.0

45

9.2.4 Gynaecology

Description

Suction curette with auxiliary air vent, external dia. 6 mm .......................... Suction curette with auxiliary air vent, external dia. 8 mm...........................Suction curette with auxiliary air vent, external dia. 10 mm.........................Suction curette with auxiliary air vent, external dia. 12 mm.........................Suction curette for sampling, 3 mm dia. ......................................................Suction curette for sampling, 4.5 mm dia. ...................................................

Twist connection for hose(adapter for above gynaecological curettes) ...............................................

Extraction hose for extraction cup Ø 6.5 dia. / L1.5m..................................

Tissue collector (curettage,...) .....................................................................

Tissue collector (collector for tissue samples for histopathological investi-gation) (disposable) .....................................................................................

401.0529.0 401.0530.0 401.0531.0 401.0532.0 401.0554.0 401.0528.0

401.0553.0

404.0146.0

444.0084.0

401.0555.0

Art. No.

9.2.5 Obstetrics Extraction cup (Malmström) 40 mm dia. with cross handle and locking pin ................................................................Extraction cup (Malmström) 50 mm dia. with cross handle and locking pin ................................................................Extraction cup (Malmström) 60 mm dia.with cross handle and locking pin ................................................................

Extraction cup (Bird), 40 mm dia., Swedish steel, complete with 1.30 m suction hose 6.5 mm dia..............................................................................Extraction cup (Bird), 50 mm dia., Swedish steel, complete with 1.30 m suction hose 6.5 mm dia..............................................................................Extraction cup (Bird), 60 mm dia., Swedish steel, complete with 1.30 m suction hose 6.5 mm dia..............................................................................

Handle with hook for Extraction cup (Bird) ..................................................

Suction hose, 6.5mm dia., L 1.5m ..............................................................

Silk cup, silicone extraction cup, 50 mm dia. ...............................................

Silk cup, silicone extraction cup, 60 mm dia. ...............................................

404.0155.0

404.0156.0

404.0157.0

404.0179.0

404.0180.0

404.0181.0

404.0182.0

404.0146.0

404.0194.0

404.0193.0


46

10.0 Technical specifi cations

Air fl ow rate

Max. vacuum

Vacuum readout

Auxiliary air control

Collection jars

Suction hoses

Voltage

Current consumption (max. )

Power consumption

Mains cable

Operating period

Fuse

Interface

Protective earth conductor resistance

Earth leakage currentCasing leakage currentPatient leakage current

Heat emission

Noise level

Ambient conditionsTransport/storage

Operation

Dimensions HxWxD

Weight

Protection class (EN 60601-1)

Applied part

Degree of protection

Classifi cation as per Appendix IXof EC Directive 93/42/EEC

CE Mark

UMDNS Code

36 ± 2 l/min.

-90 kPa** digital numeric, resolution 10 mbar / 10 mmHg / 1 kPa and quasi analog via bar graph; accuracy ± 2%

electronically controlled magnetic valve

1.5 l / 3 l / 5 l glass or 1.5 l / 2 l / 3 l Receptal® collection jar,bracket for Medi-Vac available

6mm dia., 1.30 m long; 10 mm dia., 2 m long

230 V ~ 50 HzSpecial voltage: 115 V~ 50/60 HzSpecial voltage: 127 V~ 50/60 Hz

0.6 A/230 V~ / 1.06 A/127 V~

max. 135 W

5 m

continuous operation

T 1.0

foot switch

< 0.1 Ω

< 500 µA NC< 100 µA< 10 µA

135 J/s

43.9 dB (A) @ 1m (as per ISO 7779)

-10 to +60°C; 30 to 95 % humidity, non-condensingat a pressure of 700...1060 hPa

+10 to +40°C; 30 to 95 % humidity, non-condensingat a pressure of 700...1060 hPa

300 x 330 x 200 mm, without trolley; 840 x 490 x 520, with trolley

10.2 kg, without collection jar, without trolley

I

Type B

IPX 0

IIa

CE 0124

14-317

** 1 bar ≅ 750,06 mm Hg ≅ 1000 hPa / dependent on daily air pressure* NN ≅ 1013 mbar ambient pressure

Issue of Technical Specifi cations: 27.11.2012

All values are quoted with a tolerance of ± 5 %,unless separately specifi ed.

Canadian Classifi cationDevice GroupPNCRisk ClassDescription

Obstetrics & Gynaecology85HDB2EXTRACTOR, VACUUM, FETAL

47

Please clean the equipment before disposing of it.

The ATMOS S 351 Natal does not contain any hazardous materials.

The components of the ATMOS S 351 Natal must be disposed of properly, including careful separation of the constituent materials.

11.0 Disposal

48

12.0 Notes on EMC

12.1 Guidelines and Manufacturer´s Declaration - Emissions The ATMOS S 351 Natal is intended for use in the electromagnetic environment specifi ed below. The customer or user of the ATMOS S 351 Natal should ensure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - GuidanceRF Emissions CISPR 11

Group 1 The ATMOS S 351 Natal uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11

Class B The ATMOS S 351 Natal is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonics IEC 61000-3-2 Class BFlicker IEC 61000-3-3

is conform

12.2 Guidelines and Manufacturer´s Declaration - Immunity

The ATMOS S 351 Natal is intended for use in the electromagnetic environment specifi ed below. The customer or user of the ATMOS S 351 Natal should ensure that it is used in such an environment.

Immunity Test IEC 60601-Test Level Compliance Level Electromagnetic

Environment - GuidanceESD IEC 61000-4-2

± 6 kV Contact

± 8 kV Air

± 6 kV Contact

± 8 kV Air

Floors should be wood, concrete, or ceramis tile. If fl oors are synthe-tic, the relative humidity should be at least 30%.

EFTIEC 61000-4-4

± 2 kV Mains

± 1 kV I/Os

± 2 kV Mains

Inapplicable

Mains power quality should be that of a typical commercial or hospital environment.

SurgesIEC 61000-4-5

± 1 kV Differential

± 1 kV Common

± 2 kV Differential

± 1 kV Common

Mains power quality should be that of a typical commercial or hospital environment.

Power Frequency 50/60 HzMagnetic fi eld IEC 61000-4-8

3 A/m Inapplicable Power frequency magnetic fi elds should be that of a typical com-mercial or hospital environment.

Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc. to following EMC notes.

Portable and mobile HF communication facilities can influence medical electrical equipment.

The use of other accessories, other converters and cables than stated may lead to an increased emission or a reduced interference immunity of the equipment or system.

The device may not be used directly next to other devices or piled up with other devices.If operation next to or piled with other devices is necessary, please watch the device to check its intendedoperation in this arrangement.

49

Immunity Test IEC 60601-Test Level

Compliance Level Electromagnetic Environ-ment - Guidance

Voltage Dips / DropoutIEC 61000-4-11

< 5 % UT (> 95 % Dip of the UT) for 0.5 Cycle

40 % UT(60% Dip of the UT) for 5 Cycles

70% UT(30 % Dip of the UT) for 25 Cycles

< 5 % UT (>95 % Dip of the UT) for 5 s

< 5 % UT (> 95 % Einbruch der UT) für 0,5 Periode

40 % UT(60% Einbruch der UT) für 5 Perioden

70% UT(30 % Einbruch der UT) für 25 Perioden

< 5 % UT (>95 % Einbruch der UT) für 5 s

Mains power quality should be that of a typical commercial or hospital environment. If the user of the ATMOS S 351 Natal demands continued function even in case of interruptions of the energy supply, it is recommended to supply the ATMOS S 351 Natal from an uninterruptible current supply or a battery.

NOTE UT is the mains alternating current prior to application of the test levels.

12.3 Guidelines and Manufacturer´s Declaration - Immunity The ATMOS S 351 Natal is intended for use in the electromagnetic environment specifi ed below. The customer or user of the ATMOS S 351 Natal should ensure that it is used in such an environment.

Immunity Test IEC 60601-Test Level Compliance Level Electromagnetic Environment -

GuidancePortable and mobile communications equipment should be separated from the ATMOS S 351 Natal incl. the cables by no less than the distances calculated/listed below.

Recommended distances:

d = (3,5 / V1) * √(P)d = (3,5 / E1) * √(P) 80-800 MHzd = (7 / E1) * √(P) 0,8-2,5 GHz

where „P“ is the max. power in watts (W) and D is the recommended separation distance in meters (m).

Field strengths from fi xed transmitters, as determined by an electromagnetic site (a) survey, should be less than the compli-ance level (b). Interference may occur in the vicinity of equipment containing following symbol.

Conducted RFIEC 61000-4-6

3 Veff150 kHz to 80 MHz 3 V

Radiated RFIEC 61000-4-3

3 V/m80 MHz to 2.5 GHz

3 V/m

12.0 Notes on EMC

50

12.4 Recommended separations between portable and mobile RF Communications equipment and the ATMOS S 351 Natal

NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies.

NOTE 2 These guidelines might not be applicable in any case. The propagation of electromagnetic sizes is infl uenced by absorptions and refl ections of buildings, objects and people.a The fi eld strength of stationary transmitters, such as base stations of cellular phones and mobile terrain radio equipment, amateur radio transmitters, cbm broadcast and TV stations cannot be predestined exactly. To determine the electromagnetic environment in regard to stationary transmitters, a study of the location is to be considered. If the measured fi eld strength at the location where the ATMOS S 351 Natal is used exceeds the above compliance level, the ATMOS S 351 Natal is to be observed to verify the intended use. If abnormal performance characteristics are noted, additional measures might be necessary, e. g. a changed arrangement or another location for the device.

b Within the frequency range of 150 kHz to 80 MHz the fi eld strength is to be below 3 V/m.

The ATMOS S 351 Natal is intended for use in electromagnetic environment in which radiated disturbances are controlled. The customer or user of the ATMOS S 351 Natal can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications equipment and the ATMOS S 351 Natal as stated below, according to the maximum output power of the communications equipment.

Separation distance, depending on transmit-frequency mNominal output of the

transmitter

W

150 kHz bis 80 MHz

d = [ 3,5 / 3] √P

80 MHz bis 800 MHz

d = [ 3,5 / 3] √P

800 MHz bis 2,5 GHz

d = [ 7,0 / 3] √P

0.01 0.12 0.12 0.240.1 0.37 0.37 0.741 1.2 1.2 2.410 3.69 3.69 7.38100 11.66 11.66 23.32

For transmitters for which the maximum nominal output isn´t indicated in the above table, the recommended sepa-ration distance d in meters (m) can be determined using the equation belonging to the respective column whereas P is the maximum nominal output of the transmitter in watts (W) acc. to manufacturer´s specifi cation.

NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies.

NOTE 2 These guidelines are not applicable in any case. The propagation of electromagnetic sizes is infl uenced by absorptions and refl ections of buildings, objects and people.

12.0 Notes on EMC

MedizinTechnik

This document is copyrighted. Duplication, translations, microfilming and savings on electronic systems, particularly for commercialpurposesare illegal without prior agreement of the manufacturer. All compiled data are based on manufacturers instructions. All logos,product names and designations used in this document are property of the respective manufacturer.We do not take over any warranty and liability in the case of missing inscriptions. Subject to modifications and amendments.

1. General:Our General Standard Terms and Conditions apply exclusively. Client’s terms and conditions which are contrary to or deviate from our General Standard Terms and Conditions are not recognised unless their validity is explicitly confirmed in writing. Our General Standard Terms and Conditions also apply even if we deliver to clients without reservation, in the knowledge of the client’s contrary terms and conditions. Our General Standard Terms and Conditions also apply to all future business with that client.

2. Proposal - Order Confirmation Our proposals are subject to change without notice unless otherwise stated in our order confirmation. Each order is only accepted by us following our written order confirmation.

3. Orders Every order requires an exact description of all of our product’s details. We assume no liability for errors and damage caused by inaccurate or incomplete ordering details.

4. Prices Unless otherwise stated in the order confirmation, our prices in the order confirmation are ex factory prices and exclude packaging and value added tax. Packaging is charged separately at cost price in the invoice. Value added tax is charged separately in the invoice according to the legal rate on the invoice date. We reserve the right to change prices appropriately should price reductions or increases, especially due to wage settlements, changes in the price of materials or currency fluctuations, be incurred. Proof of such changes will be provided for the client on request.

5. Payment Conditions - Balancing Unless otherwise stated in the order confirmation, our invoices are payable with a 3% discount within 10 days (except for repair and assembly services) or within 21 days from the invoice date net cash; money receipts is decisive for complying with this term. We are entitled to charge interest after the due date at a rate 2% above the relevant basic interest rate of the German Federal Bank. Should the client have payment arrears, we are entitled to charge interest on arrears at a rate 5% above the relevant basic interest rate of the German Federal Bank. Should we be able to prove higher damages due to arrears, we are also entitled to claim these. The client only has the right to balance invoices against its own claims should such claims be confirmed in a court of law or recognised by us. The client does not have the right of retention due to disputed counterclaims.

6. Delivery Periods Fulfilment of our delivery duties requires the punctual and proper fulfilment of the client’s duties. The right to defense on the grounds of an unfulfilled contract is reserved.Should the client default in accepting the goods delivery or breach other cooperation duties, we are entitled either to withdraw from the contract or claim compensation for any increased costs incurred up to that time without setting a further deadline. The right to make further claims is reserved. Furthermore, in such cases, the risk of coin-cidental destruction or a coincidental deterioration in the quality of the delivered goods is transferred to the client in the case of default in accepting such goods or payment arrears. Acts of God or stoppages (due to insufficient supplies of material, industrial disputes etc.) entitle us either to demand an appropriate extension of delivery periods or to partly or entirely dissolve the delivery contract. This does not give the client the right to claim damages. We have fulfilled delivery periods if the delivery goods have left our factory or the client has been informed of the goods’ readiness for delivery within such delivery periods. Delivery periods stipulated by the client are not recognisedby us unless they form part of our order confirmation. We adhere to legal terms and conditions in cases where, as a result of an undue delay in the delivery for which we are liable, the client is entitled to claim that his interests in a continued fulfilment of the contract have ceased. We also adhere to legal terms and conditions should a delay in delivery be caused by deliberate or grossly negligent action by us or our representatives for which we are responsible. We are also responsible for such actions by our representatives or agents. Should the delivery delay not be caused by our deliberate infringement of contractual duties for which we are responsible, our liability is limited to damage which is regarded as typical for that case. We are liable according to the legal terms and conditions if and in so far as the delivery delay for which we are responsible is caused by an infringement of a substantial contractual duty. In such cases, our liability is also limited to damage which is regardedas typical for that

case. Should the delivery delay be caused by a culpable infringement of non-substantial contractual duties, our client is also entitled to claim a one-off damage compen-sation worth 3 percentage points of the delivery value of the goods for each week’s delay, up to a maximum which is no higher than 15 percentage points of the delivery value of the goods

7. Delivery - Familiarisation In the case of the delivery of devices for the medico-technical industry which require assembly and/or familiarisation for the final customer using specialist trade personnel (such as Ear, Nose and Throat Apparatus and Suction Units), we reserve the right to deliver the goods exclusively to the relevant specialist traders. Should the trader not carry out assembly and/or familiarisation for the final customer, this is carried out by us. In such cases, we reserve the right to charge the client for the additionally created costs. Our specialist traders operate a recording system so that, if necessary, our products can be traced to the final customer. The specialist trader undertakes to immediately report to us all events and risks which must be reported in connection with our products.

8. Passage of Risk - Packaging Unless otherwise stated in our order confirmation, delivery is agreed ex factory. The risk of the goods’ damage or loss is therefore transferred to the client as soon as the goods leave the factory or the client is in default of acceptance of the goods. This also applies to cases where we confirm prepaid carriage. Transport packaging and all other packaging according to the packaging regulations is not returnable. Our client is responsible for disposing the packaging at its own cost. Our deliveries are insured by us at the client’s expense unless explicitly otherwise agreed. No insurance is arranged in the case of goods which are collected by our clients. In the case of transport damage, claims are only handled if the client receives confirmation of any damage, reduced weight or loss by the shipping company before accepting the delivery.

9. Warranty The client is responsible for examining the delivered goods immediately after receiving them to determine any eventual deficiencies or delivery errors, and to report these immediately. Should the client fulfil this examining and reporting responsibility, and should payment conditions be fulfilled, we shall be liable to the client within the scope of legal regulations. Our period of warranty shall in all cases be two years. Our client can make use of the warranty as follows, so long as he can provide first buyer proof (in the form of an invoice or delivery note) and provided that the product still has the original, unchanged serial number: a. We choose whether to fulfil our guarantee by providing repair

services free of charge - either on the client’s premises or in our factory - or replacing the product. We can also provide these guarantee services through an authorised company;

b. Should a product be returned to us, the client agrees to send the product in its original or similar packaging, offering the same protection as the original packaging, to our address or any address notified by us.

c. Our guarantee ceases to apply if changes of any kind have been made to our product, unless such changes have been made by us or a company authorised by us, or have been previously agreed upon in writing by us. Our guarantee also ceases to apply if third parties have carried out repairs to our products or replaced parts thereof. This applies regardless of the fact whether these measures individually or collectively led to a deficiency of the product;

d. We accept no responsibility for damage defects caused by - operational wear and tear; - incorrect installation or incorrect or insufficient maintenance; - incorrect operation of the product (in contradiction to the operating instructions delivered with the product); - improper use or operating faults; - inappropriate or negligent handling and care, especially with respect to dirt, lime, suction of fluids, inappropriate cleaning and sterilisation;

- using accessories and/or replacementpartswhich are not explicitly approved; - incorrect assembly and/or initial operation by the client or third parties; - the client’s negligence in handling the product; - unacceptable operating conditions, such as humidity, temperatures, the power supply, vibrations. - accidents, acts of God, especially lightening, water, fire, public unrest and insufficient ventilation. We are not liable for damage to other objects apart from our product itself, except in thecase of any deliberate or grossly negligent actions by us or our representatives or agents. Should no deliberate breach of contract be claimed, our liability

is limited to damage which is regarded as typical for tthat case. This also applies in the case of our culpable infringement of substantial contractual duties The indispensable conditions of German Liability Law remain unaffected thereby. - For second-hand equipment, the period of warranty shall be reduced to a period of twelve months.

10. Reservation of Ownership We retain ownership of our goods until the receipt of all payments arising from the business relationship, including all demands arisingfrom installation orders, subsequent orders, repairs, accessory deliveries and replacement orders. Should we have agreed upon payment on the basis of cheque and bill transactions, the ownership reservation applies until the cheque received byus has been paid in, and does not expire through our credit upon receiving the client’s cheque. In the case of a breach of contract by the client, especially payment arrears, we are entitled to repossess our goods. Repossession of our goods repre-sents a withdrawal from the contract, unless explicitly declared in writing by us. We have the right to utilise the product after its repossession, whilst the income form such use is balanced against the client’s arrears, after deducting appropriate utilisation costs.The client is responsible for handling the goods with care. Should maintenance and inspection work be necessary, the client must carry these out punctually at his own cost. Our client is entitled to sell the goods he has bought from us in a proper sale transaction. However, he must immediately assign all outstanding claims to the value of the final invoice sum (including value added tax) of our claims to his customers or third parties. The client is entitled to collect this claim even after such assignment. Our right to collect the claim ourselves remains unaffected thereby.We undertake to release the securities to which we are entitled if requested to do so by the client should the realisable value of the our securities be more than 10 percentage points higher than the outstanding claims. We reserve the right to choose the securities to be released.

11. Plans and Illustrations We retain ownership of and copyrights to all plans, illustrations, calculations and other documents which are attached to our proposals. The client must receive explicit written permission before passing these on to third parties. Imitating our legally patented products is forbidden and will be prosecuted.

12. Jurisdiction and Place of Performance Our central office is the place of performance for all disputes in connection with these General Standard Terms and Conditions and the contracts closed with clients under them. This jurisdiction excludes other jurisdiction relating to persons or subject-matter. Furthermore, our client is not entitled to bring charges against us in another court should he file counter-charges, carry out counterbalancing or declare retention. We, however, are entitled to bring charges against our client at their general place of jurisdiction or at another relevant court recognised by German or foreign law.Unless otherwise stated in the order confirmation, our central office is the place of performance.

Lenzkirch, September 2008ATMOS MedizinTechnik GmbH & Co. KG79853 Lenzkirch/Germany

ATMOS General terms and conditions

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