ATMOS C 361 Operating Instructions Index 17 June 2018

Contents

Introduction Notes on operating instructions...3 Intended use...4 Function...4 Explanation of symbols...5

2.0

For your safety...6

3.0 3.1 3.2

Setting up Operating elements...7 Connection area in unit base...8

4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13

Operation Insert / remove DDS bacterial filter / oversuction stop ...9 Using the DDS splash protector...9 Attach / remove DDS secretion canister lid...9 Attach DDS secretion canister handle...10 Close / open DDS secretion canister handle...10 Secure DDS secretion canister...10 DDS hose holder...10 Insert DDS hose adapter...11 Connect hose...11 On / off switch...11 Set vacuum...11 Suction...12 Test DDS bacterial filter / oversuction stop...12

5.0 5.1 5.1.1 5.2

Options Trolley with standard rail...13 Securing the unit ...13 Use of suction unit with disposable systems...14

6.0 6.1

6.3 6.4 6.5 6.6

Cleaning General information on cleaning and disinfection...15 Reprocessing of hoses and secretion canister...15 Cleaning and disinfecting the unit surface...15 Recommended instrument disinfectants...15 Recommended surface disinfectants...15 Recommended cleaning agents...15

7.0 7.1 7.2

Maintenance...16 Change fuse...16 Sending in the device...17

8.0

Trouble-shooting...17

9.0 9.1 9.2

Spare parts and accessories Spare parts...18 Accessories...19

10.0

Technical specifications...20

11.0

Disposal...22

6.2

ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Straße 16 79853 Lenzkirch / Germany Deutschland Tel. Fax:

+ 49 (0) 76 53 / 689-0 + 49 (0) 76 53 / 689-190 + 49 (0) 76 53 / 689-393 (Service Center)

[email protected] www.atmosmed.com

Notes on EMC General Standard Terms and Conditions

2

Page

1.0 1.1 1.2 1.3 1.4

1.0 Introduction 1.1

Notes on operating instructions

 These operating instructions contain important notes

on how to operate the ATMOS® C 361 safely, correctly and effectively. Therefore, they are intended not only for new operating personnel to be instructed in its use, but also for use as a reference manual. They help to avoid risks, and also to reduce repair costs and down-time. Furthermore, reliability and service-life of the equipment will be increased. For these reasons these operating instructions must always be kept available near the appliance. Prior to first use please peruse the chapter 2.0 “For your safety”, in order to be prepared for any possible dangerous situations. The basic principles are: Judicious and careful work provides best protection against accidents! Operational safety and readiness for use depend not only on your capabilities, but also on care and maintenance given to the ATMOS® C 361. For this reason regular cleaning and service work are a must. Major maintenance and repair work may be carried out only by expert personnel authorised by ATMOS. In case of repairs you should insist that original spare parts only are used. You will then have the warranty that operational safety, readiness for work and the value of your appliance will be preserved.

 The product ATMOS® C 361 bears CE marking CE-0124

according to the EEC guideline of the council for medical products 93/42/EEC and meets the basic requirements of annex I of this guideline.

 The product ATMOS® C 361 complies with all applicable requirements of the directive 2011/65/EC restricting the use of certain hazardous substances in electrical and electronic equipment (“RoHS”).

 The declaration of conformity and our general standard

terms and conditions can be obtained on our website at www.atmosmed.com.  The quality management system applied at ATMOS has been certified according to international standard ISO 13485.  ATMOS will supply a service manual containing detailed circuit descriptions and schematics as well as information on adjustment and servicing organizations authorized by ATMOS.  Reprints, also in extracts, only with written permission by ATMOS. Abbreviations / symbols in these operating instructions:

 Indicating a list Subdivision of a list/activity • The recommended sequence must be followed in each case!



Indicating particularly important advice!

3

1.0 Introduction 1.2

Intended use

Name: ATMOS® C 361 Main functions: Suction of secretions, rinsing fluids and temporarily collection of body fluids. Med. indications/ application: For surgeries e.g. suction of wound cavities, abscesses etc. For endoscopy e.g. suction of secretions and rinsing fluids. For spontaneous suction of body fluids. Specification of the main function: Drainage and temporarily collection of body fluids. By means of an electrical suction pump, a negative pressure will be created. The integrated secretion canister allows a temporarily collection of the derived body fluids. Application organ: Natural orifices as well as openings which are created by means of a surgery (whole body; human and animal). Application time: Short-term use on the patient (< 30 days). Application site: The application site is the clinical, outpatient, practices as well as the veterinary medicine area. The application of the device may only be performed by medical trained and introduced staff. Contraindications: No application in low-vacuum range e.g. thoracic and wound drainage. No application outside of the medical sector. No suction of flammable, corrosive and explosive substances. No application for the vacuum extraction. The product is: X active □ not active Sterility: Not necessary Single use product / reprocessing: The device and the accessories are partially reusable. For information on reprocessing, cleaning and disinfection see user manual.

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1.3

Function

 The ATMOS® C 361 is a mains-operated surgical suction unit, centering around a silent diaphragm-type pump which generates a vacuum inside the secretion canister, allowing secretions to be withdrawn and collected. Using a vacuum regulator and the vacuum-gauge, the target vacuum and thus the air-flow rate can be precisely adjusted.

 Several secretion canisters of different sizes are

available for use with the system (section 9.0 Spare parts and accessories). A hydrophobic bacterial filter in the lid of the secretion canister is implemented to prevent that secretions enter the pump resp. bacteria the interior of the unit.

 A trolley with standard rail is available for mobile use.

1.0 Introduction 1.4

Explanation of symbols

~

Attention, refer to operating instructions !

SN

Serial number

Follow operating instructions (blue)

REF

Order number

Fuse

IPX 1

Protection against penetration of damaging humidity (drop water)

Potential equalization

Professional disposal

Applied part Type BF

Eurasian conformity

Alternating current

GOST Certificate (Russia)

Unit of protection class II

Unit Off

Unit On

Observe operating instructions

0124

This product complies with the relevant requirements of EU Directives

Manufacturing date

Manufacturer

5

2.0 For your safety  The design of the ATMOS® C 361 fulfills the

requirements of IEC 601/EN 60601 and of protection class I. The device must only be connected to a properly installed socket with non-fused earthed wire.

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

 The ATMOS® C 361 may be used in supervised

operation by qualified personnel only which has been authorised by ATMOS and which has been trained for operating the appliance (IEC 601-1/EN 60601-1).

 The ATMOS C 361 may be operated only in rooms ®

used for medical purposes, but not in areas subject to explosion hazards and in oxygen rich environments. Explosion harzards may result from the use of combustible anaesthetic agents, skin cleansing agents or disinfectants.

 Liquids must not be allowed to enter the device. Should liquids have penetrated into the device, it must be inspected by an authorized service technician before being used again.

 After transport at cold temperatures (below the freezing point), the unit must acclimatize prior to first use; leave it unoperated at room temperature for a period of up to 6 hours. If the unit is not acclimatized it must not be operated as the membranes of the pump might get damaged.

 Dispose of the packaging material, observing the applicable waste-control regulations.

 Before connecting the device to the power line, check

that the voltage and frequency ratings of the power line are similar to those indicated on the device.

 Never connect the unit to defective power sockets or extension cables.

 The suction hose must never come into direct contact

with the application site. A suction catheter, attachment or a medical aspiration set must always be connected to the hose.

 When disconnecting the device from the power line, first remove the plug from the wall outlet. Then the power cord may be disconnected from the device. Never touch the plug or cord while your hands are wet.

 The ambient conditions specified in section 10.0 must be strictly observed.

 When using different canister systems there is a risk

of contamination when operating the device without overflow protection/hydrophobic bacteria filter. Do not use the device respectively the canister without bacterial filter.

6

 There is a risk of an electric shock when liquid

penetrated the overflow protection/hydrophobic bacteria filter.

 Set up the device so that the operator has a clear,

unobstructed view of and easy access to the front panel. The device must be placed on a solid, level surface.

 The ATMOS® C 361 fully complies with the

electromagnetic immunity requirements of standard IEC 601-1-2 / EN 60601-1-2 "Electromagnetic compatibility Medical Electrical Equipment".

 Warranty period for this unit: 2 years. This period is

unaffected by any repair or maintenance carried out under the terms of the warranty. Please also pay attention to our enclosed General Standard Terms and Conditions.

 The warranty will be rendered invalid in case of

damages caused due to the utilization of accessories or consumables which are not approved by ATMOS for use with this unit.

 ATMOS is not liable for personal injury and damage to

property if • no original ATMOS parts are being used, • the advice for use in these operating instructions is not being observed, • assembly, new settings, alterations, extensions and repairs have been carried out by personnel not authorised by ATMOS.

 This product is not re-sterilisable. Repeated reuse of components which are marked with a 2 is forbidden. In case of repeated reuse these components lose their function and there is a high infection risk.  Please do not store DDS filters under heavy objects since this may lead to deformation and with it to loss of function. There is a risk of contamination for the device.  ATMOS recommends always having another suction device ready to hand in case of any device failure. So you can suck even in the event of equipment failure.

3.0 Setting up

 Always set the equipment up on a secure, level surface.

Bild 1.

3.1

Operating elements

 On/Off switch with pilot lamp  Vaccuumgauge  Vacuum controller

Bild 2.





 Vacuum connection: Direct-Docking-System

 The vacuum connection between the pump and the

secretion canister is created automatically as soon as the DDS canister is positioned correctly.

Bild 3.

7

3.0 Setting up

3.2

Connection area in unit base

Connect mains cable

 Use only mains cables with angled inlet connector for non-heating appliances.

 Check that the voltage and frequency ratings of the

power line are similar to those indicated on the device.

Fig. 4.

8

4.0 Operation

4.1

Insert / remove DDS bacterial filter / oversuction stop

 Please wear gloves while changing the filter!

Fig. 5.

4.2

Using the DDS splash protector

Fig. 6.

4.3

Attach / remove DDS secretion canister lid

 With the DDS secretion canister on a firm surface,

position the lid horizontally on top (the lid may not be twisted!)

 Press down lightly onto the secretion canister using both hands until limit is reached.

Fig. 7.  To open the DDS secretion canister, hold the canister

firmly by the reinforcing clips of the securing device and then pull the secretion canister lid up and off by gripping the filter hole.

Fig. 8. 9

4.0 Operation

4.4

Attach DDS secretion canister handle

 Insert the DDS secretion canister handle into the grooves of the lid with the snap-in hooks open.

Fig. 9.

4.5

Close / open DDS secretion canister handle

 To close, secure the snap-in hooks under the edge of the secretion canister, and then press the clips downwards until they lock into place.

 To open, pull the clips upwards to release the snap-in

hooks and remove from under the edge of the secretion canister.

Fig. 10.

4.6

Secure DDS secretion canister

 For removal, lift the DDS secretion canister vertically upwards; for insert it again, allow it to slide vertically downwards into the securing device.

Fig. 11.

4.7

DDS hose holder

 In the case that you would like to use the hose holder

REF 340.0066.0 please mount it between the canister lid and the hose adapter as described in figure 11a.

Fig 11a. 10

4.0 Operation

4.8

Insert DDS hose adapter

 Press the required DDS hose adapter with 6 or 10 mm diameter into the ”patient” hole of the DDS secretion canister lid twisting slightly to ensure a tight fit.

 Twist slightly in the same manner when removing.

Fig. 12.

4.9

Connect hose

4.10

On / off switch

Fig. 13.

 Press the ”I” symbol to switch the unit on.  Press the ”0” symbol to switch the unit off.

Fig. 14.

4.11

Set vacuum

 Close the suction hose and set the desired vacuum by

turning the vacuum controller according to the direction of the arrow.

 Do not use force to turn the knob at its limits!  Test the system for leaks if the desired vacuum is not achieved.

Fig. 15. 11

4.0 Operation 4.12

Suction

 Use appropriate suction catheters, suction tips or suction instruments.

 Prior to starting suction, containers must be checked for cracks. Damaged containers may not be used.

 Keep an eye on the level of liquid in the secretion canister during suction.

 The hydrophobic bacterial filter safely prevents liquid

from getting into the pump. Nevertheless the secretion canister should be replaced when 2/3 full.

4.13

Test DDS bacterial filter / oversuction stop

 The DDS bacterial filter / oversuction stop is disposable.

 Before each use, check that the DDS bacteria filter

/ oversuction stop is clean and dry. Replace the DDS bacterial filter with a new filter if it is dicoloured, contaminated or oversucked.

 Use only original ATMOS bacterial filters!  Never operate the unit without the DDS bacterial filter / oversuction stop!

 Replace the DDS bacterial filter with every cleaning

respectively desinfection of the DDS canister systems.

12

5.0 Options

5.1

Trolley with standard rail

 A trolley with standard rail, which can also be used with

disposable systems if necessary, is available for mobile use.

 Always position the trolley on a flat, sturdy surface.

Fig. 16.

5.1.1

Securing the unit

 It is only possible to ensure safe operation as a mobile

suction unit by using the special trolley available for use with the unit!

 The suction unit is placed on the trolley so that it's feet

lock into place in the holes of the unit carrier and it can be firmly attached to the unit carrier from underneath by means of a knurled screw.

Fig. 17.

 It is imperative that the unit is securely attached to the trolley to ensure safe operation and safe movement!

 Use the lockable castors if necessary.

Fig. 18.

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5.0 Options 5.2 Use of suction unit with disposable systems  Optionally the suction unit may also be used as a

tabletop unit with a disposable system it can be attached to a standard rail.

 This requires the standard rail adapter with vacuum Fig. 19.

connector. Installation is performed in accordance with the attached installation instructions.

 Optionally the suction unit may also be used on the

trolley with a disposable system it can be attached to a standard rail.

 When using the Receptal canisters the following supports have to be used: 2 x 1.5 l REF 444.0027.0 1x 2l REF 444.0030.0 2x 2l REF 444.0028.0 1x 3l REF 444.0031.0 2x 3l REF 444.0029.0

14

6.0 Cleaning 6.1

General information on cleaning and disinfection

 For disinfection, you may use all surface and instrument

 Remove the DDS bacterial filter from the DDS secretion canister handle and dispose of it.

 All other parts, except the bacterial filter, must also be

thoroughly rinsed under running water. You may add a detergent, if you wish. Using the cleaning agent neodisher AN or neodisher MediClean forte (manufactured by Dr. Weigert, Hamburg) cleaning in an automatic cleaner and disinfecter is also possible. Thermal disinfection is carried out at 93° C.

disinfectants listed in chapters 6.4 / 6.5.

 A number of disinfection agents may cause discoloration at the secretion canister etc., however this has no effect upon the parts's function.

 Always observe the concentration specifications and instructions by the respective manufacturer !

6.2

Reprocessing of hoses and secretion canister

 Before using the device on a new patient be sure to clean and disinfect the following parts:

– DDS secretion canister including DDS secretion canister lid, DDS hose adapter and DDS secretion canister handle – Suction hose

 After disinfectation, reassemble all parts (section 4.0 "Operation").

 Autoclave all the parts referred to above

(134 °C, 3 bar, 5 min 3x fractionated prevacuum).

Max. number of reprocessing cycles: DDS secretion canisters, silicone hoses: 60 cycles.

6.3

 Always disconnect the device from the power line, before cleaning and disinfecting the surface.

 Wipe the surface clean with a cloth soaked in a cleaning solution or disinfectant. Liquids must not enter the device. All of the cleaning solutions and disinfectants listed below can be used.

 Unscrew all hose connectors, pull the DDS hose adapter out of the DDS secretion canister lid, open the lid, empty the secretion canister and dispose the suctioned material properly.

Cleaning and sterilizing the unit surface

 Should liquids have penetrated into the device, it must

be inspected by an authorized service technician before being used again.

6.4 Recommended disinfectants for instruments Disinfectant GIGASEPT FF neu (Application concentrate)

Contents succinic acid dialdehyde dimethoxy tetrahydrofurane

(in 100 g) Manufacturer 11,0 g Schülke & Mayr, Norderstedt 3,0 g

corrosion inhibitors non-ionic tensides Sekusept active

sodiumpercarbonate, phosphonates

Ecolab, Düsseldorf

non-ionic tensides

6.5 Recommended disinfectants for surfaces Disinfectant Mikrobac forte

Contents (in 100 g) Manufacturer benzyl - C12 - C18 - alkyldimeththyl - ammoniumchloride 19,9 g Bode Chemie, Hamburg N- (3-Aminopropyl) - N - dodccylpropane- 1,3 - diamine 5,0 g

Green & Clean SK (Application concentrate)

alkyl-dimethyl-benzyl-ammoniumchloride dialkyl-dimethyl-ammoniumchloride

< 1 g Metasys, Rum (Österreich)

6.6 Recommended cleaning agents Disinfectant Contents neodisher MediClean forte non-ionic tensides (Application concentrate) NTA (nitrilotriacetic acid)

(in 100 g) Manufacturer < 5 g Dr. Weigert, Hamburg 5-15 g

enzymes, preservative agent neodisher AN

Phosphate non-ionic tensides

> 30 g Dr. Weigert, Hamburg <5g

enzymes

15

7.0 Maintenance  Before 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!

 Before each use, check that the DDS bacteria filter / oversuction stop is clean and dry. Replace the DDS bacterial filter with a new filter if it is dicoloured, contaminated or oversucked.

 The unit does not require any further maintenance.  At least every 24 months a repeat test of the electrical safety should be performed according to IEC 62353. ATMOS recommends an inspection according to the manufacturer‘s specifications.

Repairs The 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 described in the chapter “Trouble shooting”.

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 damages to people or goods if  non-original ATMOS parts are used,  the information in these operating instructions are disregarded,  assembly, new installations, modifications, extensions and repairs are done by people who are not authorised by ATMOS.

7.1

Change fuse

 Remove mains cable.  Press the spring clips of the fuse holder together on both sides with a small screwdriver and pull out the fuse holder.  Replace the fuse and push the holder back in until both spring clips are locked into place.  Then reconnect mains cable.

16

7.0 Maintenance 7.2 1. 2. 3. 4. 5. 6. 7. 8.

Sending in the device Remove and properly dispose of consumables. Clean and disinfect the products and accessories according to the operating instructions. Place used accessories with the device. Fill in the form QD 434 „Delivery complaint / return shipment“ and the respective Decontamination certificate. • This form is enclosed to each delivery and can be found at www.atmosmed.com. The device must be well padded and packed in suitable packaging. Place the form QD 434 „Delivery complaint / return shipment“ and the respective decontamination certificate in an envelope. Affix the envelope to the outside of the package. Send the product to ATMOS or to your dealer.

8.0 Trouble-shooting The ATMOS® C 361 was subjected to a thorough quality control before shipment. If there is, nevertheless, some malfunction, you possibly might solve this problem yourselve if you observe the following instructions:

Problem Possible causes Remedy  Unit does not start

– Loose power plug

– Check connection to supply socket

– No power voltage

– Check inbuilding fuse

– Defective fuse

– Replace fuse

 Insufficient performance – Leakages within the hose system or in – Check secretion canister lid and hose or no suction the secretion canister lid system, replace sealing ring on secretion canister lid, if necessary – Filter is clogged – Replace filter, check filling level in (vacuumgauge indicates a vacuum) secretion canister; evacuate canister, if necessary – Secretion or blood has been sucked in – Unit has to be returned for repair and valve plates of the pump are contaminated sealed?

17

9.0 Spare parts and accessories

9.1

Spare parts

Description

Article-No.

 DDS-canister handle, grey... 340.0055.0 DDS-canister handle, blue... 340.0326.0

 DDS-bacterial filter / oversuction stop, hydrophobic, disposable part, price for 10 pcs... 340.0054.0

 DDS-hose adapter set, Ø 6 + 10 mm... 340.0057.0  DDS-canister lid with gaskets... 340.0053.0  DDS-splash protection... 340.0056.0  DDS-secretion canister, polysulphone, 1.5 l 340.0050.0  DDS-secretion canister, polysulphone, 3.0 l 340.0051.0 Expansion bellows, silicone rubber... 000.0739.0 Fuse 230 V T 0.63 A/H... 008.0634.0 Fuse 115 V T 1.25 A/H... 008.0720.0 Mains cable angle-angle, 5 m... 008.0818.0 Push-in foot for housing... 505.0337.0 Clamping ring for fixing screw... 000.0727.0 Operating instructions... 340.0001.i

Fig. 20.

18

9.0 Spare parts and accessories

9.2

Accessories

9.2.1

Canisters

Description

Article-No.

DDS-secretion canister, polysulphone, 1.5 l... 340.0050.0 DDS-secretion canister, polysulphone, 3 l... 340.0051.0 DDS-canister lid with gaskets... 340.0053.0 DDS-canister handle, grey... 340.0055.0 DDS-canister handle, blue... 340.0326.0 DDS-splash protection... 340.0056.0 DDS-hose adapter set, Ø 6 + 10 mm... 340.0057.0

9.2.2

For ATMOS® C 361 with trolley

Trolley with standard rail... 320.0070.1 DDS-standard rail adapter with vacuum connection for the use of disposable systems at the unit ... 340.0059.0 Grad. secretion canister 3 l, glass... 444.0033.0 Grad. secretion canister 5 l, glass... 444.0034.0 Secretion canister lid complete, for 3 l + 5 l glass canister... 441.0208.1 Holder for 3 l glass canister... 000.0040.0 Holder for 5 l glass canister... 000.0041.0 Receptal container set II, support with 2 x collection containers, Receptal® canister 1.5 l... 310.0221.0 Receptal® canister 2 l... 443.0256.0 Receptal® canister 3 l... 444.0157.0 Receptal® suction bag 1.5 l, not autoclavable, 50 pcs... 310.0222.2 Receptal® disposable bag 2 l, without integrated overflow protection... 443.0257.0 Receptal® suction bag 2 l, with integrated overflow protection... 443.0257.2 Receptal® suction bag 3 l, without integrated overflow protection... 444.0153.0 Receptal® suction bag 3 l, with integrated overflow protection... 444.0154.0

9.2.3

Facilities to simplify the handling

Hose holder on canister... 340.0066.0 Catheter quiver for flex. catheters, attached to trolley... 444.0140.0 Catheter quiver with holder for rail system (for catheter storing)... 443.0780.0 Quiver holder, small, incl. standard rail holder... 444.0145.0 Hose holder, for attaching to standard rail (white plastic)... 444.0450.0

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10.0 Technical specifications Air flow rate of pump

36 ± 4 l/min

Max. vacuum at sea level

-91kPa ( -910 mbar or 682,5 mmHg)*@ NN

Vacuum readout

-1...0 bar ± 16 mbar(class 1.6)

Additional air regulation

Mechanical regulating valve, ball vacuum regulator

Secretion canister

1.5 l or 3 l canisters made of polysulphone

Suction hose

ø 6 mm or ø 10 mm

Rated voltage

230 V~ 50/60 Hz, 340.0001.0

Rated current

Approx. 0.45 A for 230 V~

Power consumption

Approx. 100 W

Operating time

> 8 h of continuous operation without interruption, within 24 h

Fuses

T 630 mA/H for 230 V~

Protective earth conductor resistance

–

Earth leakage current

–

Enclosure leakage current

< 0,1 mA NC

Patient leakage current

–

Heat emission

Max. 100 J/s

Noise level

< 50 dB (A) @ 1 m (ISO 7779)

Ambient conditions Transport/Storage

-30...+50°C 5...90 % humidity, non-condensing air pressure 700...1060 hPa

Operation

+5...+35°C 20...80 % humidity, non-condensing air pressure 700...1060 hPa

Dimensions H x W x D

H 330 mm x W 240 mm x D 360 mm (with secretion canister) H 900 mm x W 410 mm x D 450 mm (with trolley)

Weight

6.3 kg (with secretion canister)

Protection class (IEC 601)

II

Applied Part

Type BF

Degree of protection

IPX 1

Period tests

Repeat test of the electrical safety every 24 months. Recommended: inspection according to the manufacturer‘s specifications.

Classification acc. to Annex IX EEC directing 93/42/EEC

IIa

CE marking

CE 0124

Rules applied

See enclosed list

UMDNS-Code

10 - 217

Reference-No.

340.0001.0

Soundlevel

< 50dB (A) @ 1 m (ISO 7779)

GMDN-Code

36777

CE marking

CE 0124

UMDNS-Code

10-217

Canadian Classification Device Group

General & Plastic Surgery

PNC

79QBU

Risk Class

2

Description

ASPIRATOR, SURGICAL

*1 bar @ 750,06 mm Hg @ 1000 hPa / depends on daily atmospheric pressure Rules applied: DIN EN 1041, DIN EN 1441, DIN EN 60601-1, DIN EN 60601-1-2, DIN EN ISO 10079-1,DIN EN 980,DIN EN ISO 10993-1 Technical Specification 12.01.2017

20