4.0 Operation
Contents
1. Take out the requested light source see above Choose the desired optics by pressing the button at the camera 0 Choose the in use light source When using the camera next time all adjustments will be taken over from prior use 4 0 Operation Amos 4 3 5 ATMOS LS 21 LED light source 600 0011 0 Please pay attention to the safety and operating notes of the attached operating manual Fig 22 ATMOS LS 21 LED 4 3 6 Heated drawer Please check the temperature of the instruments prior to application In case the temperature control is defec tive temperatures exceeding 40 C could occur If need be please contact service Type A 2 601 2300 0 Type B 2 601 2700 0 Maximum load 10 kg Mains switch is accessible after pulling out the drawer Fig 23 Heated drawer 4 3 7 Instrument wet storage optional Comprises of a removable disinfectant resistant stainless steel container with sieve Dimensions 374 mm x 289 mm x 233 mm Reservoir capacity 20 litres 4 3 8 Disposal collection The door of the disposal collection unit is equipped with a KiCk box locking mechanism By tapping on the door with your hand or foot you will open the locking mechanism and the disposal collection bin will be opened automatically Fig 24 When you close the door the kick box locking mechanism locks automatically Caution with contact or exposure to contaminated waste Danger of infections 12. 21 9 0 Cleaning and care 5 4 Cleaning and disinfection plan What How Who gt D Qualified and trained staff who are familiar c D S Recommendations with reprocessing Please fill in the Reusable parts Cleaning Disinfection Sterilisation responsible person gt use a water based overhead marker After each procedure Daily Weekly Monthly Secretion canister Monthly exchange X Secretion suction hose xX X2 49 5 Cleaning and disinfection manually or automatically xX Hose connection nozzle X X2 4 5 Cleaning and disinfection manually or automatically X Suction lid X X2 4 5 Cleaning and disinfection manually or automatically X Hand grip X X2 4 5 Cleaning and disinfection manually or automatically X Gasket X X2 4 5 Cleaning and disinfection manually or automatically X Bacterial filter Daily exchange or when filter is blocked X i Secretion collection 7 as Empty when canister is full xX canipier Cleaning and disinfection manually or automatically Immerse instruments into solution immediately after use complete wetting is required air must be removed from Gunaecsioaw me timente x x x any cavities after the contact time instruments must be x y gy cleaned with a brush and rinsed with water have to
3. 4 3 3 11 Insert remove DDS hose adapter Press the required DDS hose adapter with 6 or 10 mm diameter into the Patient hole of the DDS collection jar lid twisting slightly to ensure a tight fit see Fig 18 Twist slightly in the same manner when removing 4 3 3 12 Connect hose Fix the hose tightly to the adapter olive see Fig 19 Fig 19 16 N Operation a 4 3 3 13 Suction 4 3 3 14 Test DDS bacterial filter oversuction stop Use appropriate suction catheters suction tips or suction instruments The DDS bacterial filter oversuction stop is disposable Q Make sure to disinfect the suction hose the suction instruments and the complete secretion canisters prior to Before each use check that the DDS bacteria filter every application on a patient oversuction stop is clean and dry Wet or dirty filters must be replaced with new ones The filter is no longer in Keep an eye on the level of liquid in the collection optimum condition if the vacuum displayed is above 0 3 Q container during suction bar when the vacuum controller is in the max position and the suction hose is open The filter must then be The hydrophobic bacterial filter safely prevents liquid replaced from getting into the pump Nevertheless the collection Replace the DDS bacterial filter at least once a day Use container should be replaced when 2 3 full only original ATMOS bacterial filters
4. 601 0000 B 602 0000 B 603 0000 B 604 0000 B 2014 10 Index 11 N AMOS XY MedizinTechnik ATMOS S 41 Gyne Gynaecological Workstation contents ke XJ page 1 0 Introduction 1 1 Notes on operating instructions ccceeee 3 1 2 Intended USC cccceeccceeeeceeeseeeeseeeeseeeesaeeeaaees 4 1 3 FONCION ea E een tr oe ee 4 1 4 Explanation Of SYMONS 00 25 icccssecressceacenesdeesnes 5 2 0 For your Safety cccccccssseseeeeeeeeeeeaees 6 7 3 0 Setting up and starting 3 1 Front chee ee cee et eees snin naniii 8 3 2 Electrical CONNECTIONS ccccccceeeeceeeeseeeeeeees 9 4 0 Operation 4 1 ATMOS S 41 Gyne Basic unit ee 10 4 2 Basic functions cciecticnexs eetcciveryeedetectacevetelerdvedest 10 4 2 1 Power supply geen ee eae Ce ean meee ete 10 4 2 2 Maximum load sesccccc tic cetcccececn lta iccssecuseeccanedeandeess 10 4 3 DOI Sc ct tacos ee et nee 11 19 4 3 1 ATMOS RS 221 RF surgery 0 cc00 11 12 4 3 2 ATMOS SE 6501Waste bin optional 13 4 3 2 1 Operating elements cc cc sceccsseeeeeseeeeeees 13 4 3 2 2 UCU ON rec sciccececocssceweseacctnnccesnsescatedusacessdesdentedas 13 4 3 3 ATMOS C 401 suction system cccceeeees 14 4 3 3 1 Operating elements 4 3 3 2 On off switch pcs eccccccseactencecs atopedsas cdeeoneseerteaner es 14 43 3 3 SOU VACUO sic cssctccesneciedienesteossieosseuccendesteneldeseiges 14 4 3 3
5. Instrument tray Melamin X X3 gung eh X every day or when replacing with new instruments Recommended disinfectants Important information Surface disinfection 2 Green amp Clean SK ATMOS Wipe cleaning and wipe disinfection All surfaces have to be wiped with a clean dispos The above stated hygiene requirements are based on the regulations according for coated surfaces 2 Dismozon pur Bode Chemie able wipe which is damped with disinfectant solution the entire surface has to be wiped to the Medical Devices Act the Medical Devices Operator Ordinance 18 IfSG Kohrsolin FF Bode Chemie thoroughly and may not be dried afterwards and the recommendations of the Robert Koch Institute 2 Perform Schilke amp Mayr Definition of the required reprocessing steps result from the recommendations Terralin Protect Schulke amp Mayr 1 Please observe the manufacturer s operating instructions of the Robert Koch Institute Requirements for the reprocessing of medical P i products The medical products were categorised in the risk groups uncritical Other surfaces i ae Laat 2 Alternative to automatic cleaning and disinfection semicritical and critical The reprocessing steps stated in this diagram have onrsolin Bode Chemie cleaning and disinfection device 78 C to be performed Any additional reprocessing measures are at the operator s 2 Bacillocid rasant Bode Chemie discretion ii Mikrobac forte Bode Chemie All the recomme
6. 4 Close open DDS collection jar handle 15 4 3 3 5 Attach DDS collection jar handle 15 4 3 3 6 Secure DDS collection jar handle 15 4 3 3 7 Insert remove DDS bacterial filter OW SNS UCTION SlOD sede catsernstacrcectibactectennesgiatatenske 15 4 3 3 8 Using the DDS splash protector 00 16 4 3 3 9 Attach DDS collection jar lid eee 16 4 3 3 10 Remove DDS collection jar lid eee 16 4 3 3 11 Insert remove DDS hose adapter 16 4 3 3 12 Connect hose cociccccivescsscsnnssedsoesctecseestesveeteeess 16 71 is Sad POE 0 6 2 ee ee eee 17 4 3 3 14 Test DDS bacterial filter oversuction stop 1 4 3 4 ATMOS Cam 31 TFT display video system 17 4 3 4 1 ATMOS Cam 31 DV wcicceteiectiececeiiceeentss 18 4 3 4 2 Operating elements and front view 18 4 3 4 3 Camera NCA sicccicccccccrdcncssceacucenceeesesersctasecesuecss 18 6 0 7 0 8 0 9 0 10 0 10 1 10 2 11 0 N page Cleaning and Care cccsseceeeeeeeeeseeeeneeeees 20 21 Instructions for cleaning and disinfection 20 Cleaning the surface of the unit 00 20 Cleaning the application components 20 Secretion collection jar bacterial filter and SUCTION NOSE ccccesecceseeceeeseeeeeesereeeees 20 Instrument trays sata cua senetivwecrensipantetnaandeinnatansess 20 Recommended i
7. Never operate the unit without the DDS bacterial filter oversuction stop 4 3 4 Video system ATMOS Cam 31 DV TFT display 601 1600 0 and 534 3015 0 534 3010 0 To allow the patient to follow and visualise the findings of the endoscopic resp colposcopic procedures the ATMOS S 41 Gyne can be supplemented optionally by a video sy stem consisting of a camera as well as a display on the arm carri er A suspending of the video image can be obtained by means of activation of the foot lever camera accessory Please observe the safety and the operating instructions contained in the enclosed user manual Fig 20 TFT display and Additional devices video printer video recorder ATMOS Cam 31 DV Q computer etc to be used for the transmission of video signals must be licensed as medical products 17 Operation Amos 4 3 4 1 ATMOS Cam 31 DV Please note Read these separate operating instructions attentively and follow the stated notes for your safety to guarantee ideal and safe use of all functions 4 3 4 2 Controls and front view Buttons for selecting fends ca gt application part and I g A light source A Connection for camera head Connection for LED l light source Mains on off switch 4 3 4 3 Camera head Choose light source 1 At the treatment unit Take out the requested light source The adjustments LED Halogen have been set ex works 2 Directly at the camera
8. S 41 Gyne Options for visualisation REF ATMOS Cam 31 DV 601 1600 0 Power source for ATMOS LS 21 LED 600 0003 0 ATMOS LS 21 LED light source 600 0011 0 TFT monitor professional 534 3015 0 534 3010 0 TFT monitor basic 27 8 0 Consumables accessories and further options Amos Options for radiosurgery REF ATMOS RS 221 radiosurgery installation module 601 1700 0 Monopolar accessories set gynaecology 600 0159 0 ATMOS SE 6501 smoke evacuation system installation modul 601 1900 0 Secretion suction REF ATMOS C 401 suction module 601 1500 0 Accessories radiosurgery Loop electrode D 25 mm 600 0170 0 Ball shaped electrode D 2 3 mm 600 0472 0 Magnetic support for handles Accessories ATMOS C 401 REF 28 8 0 Consumables accessories and further option Consumables ATMOS C 401 DDS bacterial filter Tissue collector Collecting sieve for tissue samples DDS adapter for tissue collector Adapter tissue collector for Receptal Suction hose D 6mm L 2m Suction hose D 6mm L 2 1 mM not autoclavable 50 pcs Consumables ATMOS SE 6501 340 0061 0 006 0059 0 REF Main filter unit ULPA change after 150 patients 445 0040 0 Pre filter HEPA increases filter lifetime use is manadatory in combination with laser applications 50 pcs sterile single use Connection hose straight D 22 mm M to D 10 mm M Connection hose straight D 22 mm W to D 10 mm M Air hose internal dia
9. after daily practice The ATMOS S 41 Gyne may be operated only in rooms used for medical purposes but not in areas subject to explosion hazards and in oxygen rich environments The ATMOS S 41 Gyne meets the immunity to interference requirements of IEC 601 1 2 EN 60601 1 2 Electromagnetic Compatibility Medical Electrical Devices The ATMOS S 41 Gyne should not be operated with other devices which do not correspond with the norm IEC 601 1 2 EN 60601 1 2 medical electrical devices and electromagnetic compatibility medical elec trical devices No warranty rights shall exist in the event of damage or failure caused by the use of non ATMOS accessories or non ATMOS consumables ATMOS will not be liable for damage to people or property if e any non original ATMOS parts are used e the instructions for use contained in these operating instructions have been disregarded e assembly resetting alterations extensions and repairs have not been carried out by people authorised by ATMOS The operating instructions correspond to the design of the unit and are based on the status of the prescribed industrial standards dealing with safety at the time of publication and printing All listed circuits processes names software programmes and devices are protected by copyright Please pay attention to the safety notes contained in the following chapters The design of the ATMOS C 401 fulfi Ils the requirements of IEC 601 EN
10. be dried and sterilised after wards Please also observe the ATMOS operating instructions for GYNE instruments Wet storage Canister X x Manual cleaning and disinfection X Sieve xX X2 9 5 Cleaning and disinfection manually or automatically X Splash protection X x Manual cleaning and disinfection xX Visualisation ATMOS Cam 21 31 xX x Wipe cleaning and wipe disinfection X Immediate pre cleaning after each procedure Rigid scope xX x x wipe disinfection Reprocessing acc to instructions xX stated in the operating instructions Light conductor xX xX Wipe cleaning and wipe disinfection X Light source X x Wipe cleaning and wipe disinfection X Microscope Colposcope X x Wipe cleaning and wipe disinfection xX n gt Roz xX X Wipe cleaning and wipe disinfection X surface Ergonomic plastic handles xX X2 9 5 xX Wipe cleaning and wipe disinfection X Bipolar tweezers xX X2 9 5 x Immediate pre cleaning after the procedure xX or dispose of in wet disposal tray use of enzymatic Bipolar electrode x X 4 8 x detergents X Bipolar electrode cable X xX x Immediate pre cleaning after the procedure xX or dispose of in wet disposal tray use of enzymatic Neutral electrode X Ae x detergents X Immediate pre cleaning after the procedure Neutral electrode cable xX xX x or dispose of in wet disposal tray use of enzymatic X
11. cannot be alleviated with the aid of these diagrams Do not attempt to carry out any repair action yourself See also the relevant chapter contained in the separate user manual 26 oH OM Oxo attU natele toms eerste a oH Laem Ulatatsime olL ATMOS Power supply REF Option for electrical installation 230 V 601 1800 0 Option for electrical installation 100 V 127 V 601 1800 4 Drawers Drawer type A1 601 2000 0 601 2300 0 601 2200 0 601 3200 0 601 2400 0 601 2700 0 601 2600 0 601 3300 0 601 2800 0 Instrument wet storage 601 3100 0 Waste bin 601 3000 0 Drawer type A2 Drawer type A3 Drawer type A4 Drawer type B1 Drawer type B2 Drawer type B3 Drawer type B4 Drawer type C1 m TI A m Additional options Function support on swivel arm for double and three tower workstation including 601 1400 0 accessories Function support on swivel arm for single tower workstation including accessories on request 601 1300 0 601 4100 0 601 3700 0 601 3600 0 601 3500 0 Fixation bar for optional fixation of function support swivel unit Monitor support Laptop support with a short swivel arm Swivel support with two small instrument trays Swivel support with one big instrument tray Accessories REF 601 4200 0 601 4000 0 601 3900 0 on request 601 3800 0 Dispenser for disposable gloves PC support Visual cover for DDS secretion canister Stainless steel container Instrument deposit ATMOS
12. electrodes optional TFT display optional Swivel arm with deposit optional Connection for foot switch Castors for mobility optional no illustration available fN 3 0 Setting up and starting Amos 3 2 Electric connections O The power cable of the ATMOS S 41 Gyne should be connected to a shock proof plug terminal in the immedi ate vicinity of the unit max 3 m The current consumption of ATMOS S 41 Gyne is maxi mum 7 A Please provide an adequate number of shock proof plug terminals to supply the additional electrically operated units which are not defined as options at the workstation of the gynaecologist Multiple sockets with moveable connection cable may not be used please see safety notes oN CL gt 4 1 ATMOS S 41 Gyne Basic unit The unique concept of the workstation from ATMOS centra lises and integrates all the devices required for diagnosis and treatments and improves your workflow Based on your findings any outpatient treatments can be performed directly and without any long waiting time in one room The instrument storage area A storage area for medicine bottles and consumables is located at the head of the function column allowing you to use this storage area for the deposit of instruments in an optimal manner You also have the opportunity to store instruments and ac cessories which are rarely required in the drawers 8 to facilitate protecti
13. elements On off switch with control display Fig9 ATMOS C 401 Vacuum gauge Vacuum control 4 3 3 2 On off switch Press the I symbol to switch the unit on Press the 0 symbol to switch the unit off 4 3 3 3 Set vacuum Close the suction hose and set the desired vacuum by turning the vacuum controller according to the Fig 10 direction of the arrow Do not use force to turn the knob to its limits 3 T Test the system for leaks if the desired vacuum is not achieved 14 4 0 Operation Amos 4 3 3 4 Close open DDS collection jar handle To close secure the snap in hooks under the edge of the collection jar and then press the clips downwards until they lock into place see Flg 11 To open pull the clips upwards to release the snap in hooks and remove from under the edge of the collection jar 4 3 3 5 Attach DDS collection jar handle Fix the container handle into the guiding of the lid with opened snap in hook Fix the snap in hook below the container edge and press the lever towards the centre of the container until the handle snaps in Use of the second container Move the lever in the direction of the container which is not in use Fig 12 4 3 3 6 Secure DDS collection jar For removal lift the DDS collection jar vertically upwards to insert it again allow it to slide vertically downwards into the securing device see Fig 13 4
14. local mains voltage Prior to first starting up check the functional reliability and overall condition of the device Damaged cables and hoses must be replaced immediately Display instruments and valves must be tested and in spected at regular intervals to ensure correct functioning Test and inspection of the vacuum display by the service technician during every safety related test and inspection Check proper assignment when assembling country specific connections green yellow non fused earth conductor blue neutral conductor black or brown phase Please observe that the mobile parts could cause injury and contusion If there is a failure in the temperature control then higher temperatures can occur Prior to use check the tempe rature of the instrument If necessary contact an ATMOS technician If several devices are connected via a joint mains supply then depending on the input of all the devices a medical insulating transformer acc to EN 60601 1 with an insulating monitor or an equivalten safety system must be used The control panel must be visible and easy to reach for the user Pay attention to the ambient conditions specified in chapter 9 0 The suction system of the ATMOS S 41 Gyne is only designed for the extraction of irrigation fluids within the medical sector The unit must not be employed for the extraction of explosive inflammable or caustic gases or fluids Switch off all function modules
15. safety and readiness for use of your ATMOS S 41 Gyne and are therefore a must besides regular cleaning Repair work and safety inspections may only be carried out by expert personnel authorised by ATMOS By applying only original spare parts you will have the guarantee that operational safety readiness for work and the value of your ATMOS S 41 Gyne will be preserved The product ATMOS S 41 Gyne bears CE marking according to the EC Directive of the council for medical products 93 42 EEC and meets the essential requirements of annex of this directive The product ATMOS S 41 Gyne 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 can be obtained on our website at www atmosmed com e The quality management system applied at ATMOS has been certified according to international standards EN ISO 9001 and EN ISO 13485 Prior to start up please peruse chapter 2 0 For your safety in order to be prepared for any possible dangerous situations These operating instructions are valid for the following devices ATMOS S 41 Gyne Single tower module ccceeees REF 602 0000 0 Double tower module 005 REF 601 0000 0 Three tower module straight REF 603 0000 0 Three tower module angled REF 604 0000 0 Power supply 230 V ccccseeecee REF 6
16. yearly safety related control by a person assigned from the operating company and authorized by ATMOS Regular thorough cleaning and disinfection of the application parts respectively the operation in line with the operating instructions are assumed 10 2 Disposal The ATMOS S 41 Gyne is not comprised of any hazardous materials The materials of the housing can be recycled completely Prior to disposal device and accessories must be decontaminated The materials schould be separated carefully Pay attention to country specific regulations for disposal e g waste incineration Disposal within the EC The procuct described above is a high quality medical product with a long service life After its life cycle it must be disposed of in a technically correct manner According to the EC directives WEEE and RoHS the device may not be disposed of in domestic waste Please observe existing national laws and rules for disposal of old devices Disposal within the Federal Republic of Germany In order to guarantee a proper disposal of your old device please either pass on your old device to your specialised dealer or send it directly to ATMOS MedizinTechnik for a professional disposal Prior to disposal respectively before transport all parts and hoses which were in contact with patients must be thoroughly cleaned disinfected The device surface must be disinfected 31 N Notes on EMC Amos Where EMC is concerned medi
17. 01 1800 0 Power supply 100 V 127 V REF 601 1800 0 Power source ATMOS LS 21 LED REF 600 0003 0 ATMOS C 401 oo ececceeeeeeeeeeeeees REF 600 1500 0 A MI Heated drawers Drawer type A 2 ccccceeeeeeeeeeeees REF 601 2300 0 Drawer type type B 2 00 REF 601 2700 0 MedizinTechnik GmbH amp Co KG Ludwig Kegel Str 16 79853 Lenzkirch Germany Phone 49 7653 689 0 Fax 49 7653 689 190 49 7653 689 493 Service Center E Mail atmos atmosmed de Internet www atmosmed de N 1 0 Introduction Amos 1 2 Intended use Name Main functions Med indications application ATMOS S 41 Gyne Examinations and therapy in the gynaecological sector For application on human bodies Specification of the main function Positioning of instrumentation and accessories Application organ Application time Application site Contraindications The product is Sterility Illumination and visualization Extraction of substances and gas evacuation Surgical therapy by means of radio frequency Waste collection Female body Temporary In gynaecologist clinics and practices Not to be used outside medical areas Device must not be used in areas with a potential explosive hazard in rooms specified for medical treatment X active not active Not necessary Single use product reprocessing Indications for reprocessing are listed in the operating instructions 1
18. 3 3 7 Insert remove DDS bacterial filter oversuction stop 3 Use gloves The DDS bacterial filter is inserted into the DDS collection jar handle To do this separate the DDS collection jar handle and DDS collection jar lid Plug the DDS bacterial filter onto the cross in the middle of the DDS collection jar handle see image 14 put the DDS collection jar handle onto the DDS collection jar lid 15 4 0 Operation Amos 7 4 3 3 8 Using the DDS splash protector Insert the DDS splash protector into the inner part of the collection jar lid see Fig 12 4 3 3 9 Attach DDS collection jar lid With the DDS collection jar on a firm surface position the lid horizontally on top the lid may not be twisted see Fig 16 Press down lightly onto the collection jar using both hands until the limit is reached 4 3 3 10 Remove DDS collection jar lid Fig 16 Lift the complete container upwards with one hand at the container handle With the other hand the base of the container is guided in order to prevent the container from tilting when lifting it Press the lever apart see Fig 18 Unhinge the snap in hook of the container handle at the container Pull out the snap in hook with both hands and remove the container handle upwards Remove bacterial filter oversuction stop from the container handle Remove the container lid from the container with both hands Remove the splash protection Fig 17
19. 3 Function The ATMOS S 41 Gyne is started up by connecting the plug to the power supply fig 4 page 9 To determine the method of functioning of the standard units and the optional functions please consult pages 9 to 14 resp consult the relevant user manual for the respective device ATMOS Cam 31 camera ATMOS RS 221 radiofrequency surgery ATMOS C 401 suction system ATMOS LS 21 LED light source Introduction Amos 7 fN 1 4 Explanation of symbols On ue l Application part acc for direct electric supply Sron merdin ae BF P according to IEC 417 5007 IEC 417 5333 and DIN 30600 16 Off for direct electric supply O according to A Foot switch Alternating current IEC 417 5007 and DIN 30600 16 Pay attention to operating manual acc to ISO 7000 0434 DIN 30600 1008 IEC 348 Fuse according IEC 417 5016 DIN 30600 0186 Potential equalization Heat emission general heater for drawer Type B equipment acc to IEC 417 5333 Fuse according to IEC 417 5016 DIN lt gt Freeze Storing gt gt Signal output 30600 0186 Application part type BF Signal input lt gt Signal in and output IEEE l 1394 DV Connection Ground wire connection Foot switch ATMOS RS 221 Abbreviations symbols included in these operating instructions Numeration e Subdivision of a numera
20. 60601 and of protection class I The device must only be connected to a properly installed socket with non fused earthed wire fN For your Safety Amos For your safety Before putting the device into operation visually check unit collection jar 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 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 Danger of tipping over If you are transporting a straight not angled workstation with two or three modules REF 601 0000 0 REF 603 0000 0 prior to transport the drawers must be secured to prevent them from slipping out 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 The suction hose must never come into direct contact to the application area 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 fr
21. 9 N Cleaning and care Amos 5 1 Instructions for cleaning and care 5 1 3 Secretion collection jar bacterial filter and suction hose Set main switch to OFF prior to cleaning and l l disinfection Atthe end of every working day all following components must be cleaned and disinfected The described action relating to cleaning and disin PN fection resp disinfection do not substitute the relevant instructions which must be adhered to prior to operation O Secretion collection jar equipped with locking system and bacterial filter e Gently disconnect all hose couplings on the locking systems and carefully remove the collection jar ensuring that the environment is not contaminated by splashes of waste product ee e Dispose of waste in the prescribed manner O Always observe the concentration specifications Hold the locking mechanism firmly open the filter and instructions by the respective manufacturer For disinfection you may use all surface and instrument disinfectants listed on page 21 housing by turning in an anti clockwise direction and then remove the filter Rinse all parts thoroughly under running water e Disinfection with disinfectants recommended in Do not use e Disinfectants containing concentrated organic or anorganic acids or bases since these may aare oer aedon cause corrosion damages p e Disinfectants containing chloramides phenol A detergent or cleaning agent can also b
22. All separate parts or assemblies which come into direct contact with the patient and could therefore be subject to e Disinfection of the tray with disinfectants recommended contamination in chapter 5 3 for surface disinfection e collection container e secretion hose Stainless steel trays and trays made of anodized aluminium Laie n Une Sprayers can be cleaned automatically Neodisher MediClean forte OIIZE HOMME sang ap el gt They can also be disinfected thermally at a temperature of All application components can be 93 C e disinfected using the recommended instrument disinfecting solution see page 21 Trays made of melamine do not resist temperatures of All application components which come into direct 93 C contact with the patient during treatment must be ex changed immediately for hygienic reasons and disin Q fected 20 5 0 Cleaning and care Amos 5 2 Recommended instrument disinfectants The ATMOS S 41 Gyne instruments can be cleaned with disinfectants with the following active ingredients amines ammoniumchloride compounds aldehydes phosphates 5 3 Recommended surface disinfectants The ATMOS S 41 Gyne surfaces can be cleaned with disinfectants with the following active ingredients quaternary ammoniumchlorides ATMOS recommends Green amp Clean SK If using aldehyde containing or amine containing disinfectants at the same object this may result in discolourations
23. V_ 3 Vins Equation 1 d 1 2 P 150 kHz to 80 MHz Radiated HF IEC 61000 4 3 3 V m 80 MHz to 800 MHz 3 V m 800 MHz to 2 5 GHz 33 IN Notes on EMC Amos Guidance and manufacturer s declaration electromagnetic immunity P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer d is the recommen ded separation distance in metres m Field strengths from fixed transmitters as determined by an electromagnetic site surveya should be less than the com pliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz equation 2 applies At 800 MHz equation 3 applies Note 2 These guidlines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed HF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the equipment is used exceeds the applicable compliance level above the equipment should be observed to verify normal operation If abnormal performance is
24. able filter durability mind 35 h depending on flow Drawer with instrument heater Stainless steel bottom 40 C regulated Operating time Continuous operation Protective earth conductor resistance max 0 1 Q Earth leakage current max 0 5 mA Enclosure leakage current max 0 1 mA Patient leakage current max 0 1 mA Ambient conditions Transport storage 20 50 C 5 95 air humidity without condensation at air pressure 500 1060 hPa Operation t5 oon C 30 95 air humidity without condensation at air pressure 700 1060 hPa Dimensions HxWxD mm Unit 972 x 720 x 490 Mobile unit 972 x 720 x 490 Instrument deposit H 130 Function support radius min 285 max 420 Max overhang function support ca 500 Weight Complete equipment approx 150 kg double tower unit Regular safety related We recommend a yearly safety related control by a controls person assigned from the operating company and authorized by a Protection class Protection class EN 60601 1 60601 1 Degree of protection m Type B Application parts Type BF Type of protection IP XO Il b with electrical surgery device Il a with suction system ATMOS C 401 No ATMOS C 401 or electronic surgery CE marking CE 0124 UMDNS code without options 10 534 Issue of Technical Specifications 14 02 2012 Classification acc to Appendix IX EC Directive 93 42 EEC 30 Checking Disposal Amos 10 1 Checking ATMOS devices We recommend a
25. cal electrical equipment is subject to special safety measures and must be installed and com missioned according to the EMC instructions stated herein ATTENTION The use of internal cables other than those specified in the Service Manual may result in increased emissions or decreased immunity of the equipment ATTENTION The equipment should not be used adjacent to or stacked with equipment other than with that which is intended for this purpose If adjacent or stacked use is necessary the entire system AN should be observed to verify normal operation in the configuration in which it will be used Guidance and manufacturer s declaration electromagnetic immunity The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance HF emissions The equipment or system uses HF energy only for CISPR 11 its internal function Therefore its HF emissions are very low and are not likely to cause any interference in nearby electronic equipment HF emissions Class B The equipment is suitable for use in all establishments CISPR 11 including domestic establishments and those directly Barmonic Class A connected to the public low voltage power supply network EEA E that supplies buildings used for domestic purposes IEC 61000 3 2 Voltage fluctua Complies tions flicker e
26. ce N ATMOS XJ MedizinTechnik 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 arising from 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 by us 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 c
27. ct 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 recognised by 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 actio
28. d inspection testing and maintenance instruc tions stated therein 24 Fig 25 7 1 lL nx 70 Trouble shooting Amos Electrical protection The power voltage is supplied to the individual modules via an inlet connection for non heating apparatus The power supply is guaranteed by means of fusible cut outs in the inlet connection on the rear side of the unit oO Note Please observe the possible causes of malfunction and the recommended action to alleviate disturbance contained in the user manual relating to the units which are supplied as options Please check your system according to the following diagrams before you get in touch with the ATMOS Customer Service 7 2 Power supply No voltage to the unit function control lamps not activated 7 3 Heated drawer No heating control lamp activated No heating control lamp not activated No voltage at the power plug Blown fuse Power plug resp cable defective Control electronics or heater is defective Blown fuse power plug cable defectivet e Check the fuse check the terminal using other devices lamps if necessary Exchange the fuses at the rear of the unit e Check the power plug resp cable and exchange if necessary e Check the fuses of the individual units e Get in touch with ATMOS Service Get in touch with the Service Check the fuses Remove the drawer compl
29. e duration lower Output coagulation degree pulse duration higher Display output coagulation degree pulse duration Fig 5 BIPOL COAG Permanent coagulation bipolar setting of coagulation degree Pulse coagulation bipolar setting of pulse duration Output coagulation degree pulse duration lower Output coagulation degree pulse duration higher Display output coagulation degree pulse duration 11 4 0 Operation NS monopolar COAG Connection neutral electrode Connection monopolar cut Connection bipolar COAG Gynecology Recommended adjustment Recommended type of electrodes Conisation on the portio uteri ca 65 CUT COAG c3 BIO CONE ca 40 CUT COAG c3 c2 loop electrode Gynaecomasty ca 27 CUT blade electrode Multi Tip test excision vulva ca 22 CUT Rhomb electrode mamma reduction see also subcutane ca 28 30 CUT CUT COAG Needle electrode Multi Tip ous fat tissue Mamma augmentation see also subcuta ca 28 30 CUT CUT COAG Needle blade electrode neous fat tissue 12 SE 6501 Fig 7 4 3 2 ATMOS SE 6501 REF 601 1900 0 Please pay attention to the safety and operating notes of the attached operating manual Whenever the electro surgical device is used the smoke evacuation device automatically switches to extraction ope ration returning to basic suction operation after completion of the incision procedure and th
30. e employed derivatives or anionic tensides since these may e Insert the filter after cleaning smooth side cause stress cracks in the material used for the downwards housing of the unit Suction system and hose connection e Always rinse the suction system carefully after use by sucking in a little detergent e g ATMOS Special Cleaner 080 0005 0 This procedure will prevent adhesion and congestion within the suction hoses over the period of utilisation The surfaces of the ATMOS S 41 Gyne are resistant against Immersing the hose into disinfection solution all surface disinfectants listed on page 21 5 1 1 Cleaning the surface of the unit Rub the surface area of the unit with a cloth which has been moistened with cleaning agent or disinfecting l Change the filter solution Q Disinfecting sprays or cloths impregnated with disinfec A Caution with contact or exposure to contaminated tant can also be used for the cleaning and disinfection waste Danger of infection process Please note that the alcohol contained in these agents could corrode or cloud the protective covers if employed on a long term basis 5 1 4 Instrument trays Prior to disinfection rinse trays thoroughly under running water You can also use a dish liquid detergens or 5 1 2 Cleaning the application cleaner ts e Residue from these agents must be removed COMPETENTS thoroughly Application parts comprise of
31. e tracking sequence Fig 8 4 3 2 1 Operating elements Mains switch Mains filter Value higher value lower Button to adjust the value in the display 000 Indication of suction capacity 4 3 2 2 Switching on the ATMOS SE 6501 Switch on the power switch Fig 8 The ATMOS SE 6501 performs a self test All the displays illuminate Suction performance and run down time are adjustable Select the desired function Fig 8 Using the valie higher lower buttons you can change the value of the selected function The figure that you see on the display is either a percentage or seconds The percentage symbol or seconds symbol illu minates The percentage figure refers to the unit s maximum output 650 min Setting operation suction Operation suction is the suction capacity during activation of the electrosurgical unit or after manually starting the ATMOS SE 6501 The terms manual start and manual deactivation mean the use of the lt Start suction gt button Select a value between 20 and 100 100 corresponds to a suction capacity of approx 650 l min Setting the down time The operation suction runs on for a specified length of time after the ATMOS SE 6501 is deactivated This period of time is the run on time Fig 8 Select a value between 0 and 10 seconds You can also let the operation suction continue running for an indefinite period after deactivation of the electrosurgical unit or after ma
32. etely and check the cable resp plug connection 25 fN Trouble shooting Amos 7 4 Suction system Poor or no extraction shows 0 7 bar No suction although vacuummeter No extraction and suction motor does not start control lamp activated Suction hose is congested auxiliary air control open Cover of collection jar is not properly fitted bacterial filter is congested Suction coupling is leaking Hose coupling bent or snapped Secretion in suction pump Suction hose is congested Bacterial filter is congested Connection hose bent or snapped Pump motor defective Check the auxiliary air control Rinse the suction hose with water the hose can be removed for this purpose Check the level of fluid in the secretion collection jar Check the seating of the cover of the secretion collection jar Change the bacterial filter Seal the connection or replace if ne cessary Check the hose couplings eliminate kinks Have the pump cleaned by the service technician Rinse the suction hose with water you can remove the hose for this purpose Check the level of fluid in the secretion collection jar Exchange the bacterial filter Check the hose couplings eliminate any kinks Please contact your service technician recommended and authorised by ATMOS T Please get in touch with the service technician immediately if the fault
33. for commercialpurposes are 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
34. forte Dr Weigert 2 Sekusept aktiv Ecolab 2 neodisher MediClean forte Dr Weigert gt t 2 Gigasept Instru AF Schtlke amp Mayr Thermosept alka clean forte Schtlke amp Mayr ATMOS Medizin Technik GmbH amp Go KG 4 2 Gigazyme Schilke amp Mayr 2 Thermosept RKN zym Schilke amp Mayr Ludwig Kegel Str 12 14 16 18 E 79853 Lenzkirch Germany 2 Gigasept FF neu Schiilke amp Mayr Wrong concentration of disinfectants may lead to damage Phone 49 7653 689 0 Fax 49 7653 689 190 atmos atmosmed de E www atmosmed de Please see the manufacturer s instructions for concentration contact time temperature and the compatibility of materials 23 6 0 Maintenance and service The ATMOS S 41 Gyne is equipped with a maintenance free aggregate for the extraction process Nevertheless some simple maintenance work which can be carried out by the operator will still be required to ensure that the unit will continue to function correctly for a long period of time however this procedure can also be carried out by our service team if desired An annual safety test and inspection must be conducted on the ATMOS S 41 Gyne unit according to the guidelines for the prevention of accidents We also recommend an annual maintenance check according to the ATMOS S 41 Gyne instructions of service The electrical options special electrical surgical units are subject to the relevant operating manuals and the specifie
35. 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 contra
36. lancing 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 2008 ATMOS MedizinTechnik GmbH amp Co KG 79853 Lenzkirch Germany 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 replacement parts which 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 the case of any deliberate or grossly negligent actions by us or our representatives or agents Should no deliberate breach of contract be claimed our liability This document is copyrighted Duplication translations microfilming and savings on electronic systems particularly
37. m 10 mm L 1 8 m 005 0204 0 ATMOS Chair 41 Gyne Examination Chair ATMOS Chair 41 Gyne Leg holders Goepel Leg support 1 pair Leg rest extendable Colposcope holder Zeiss and Kaps Stainless steel secretion basin Doctors chair 445 0044 0 006 0689 0 006 0688 0 REF 29 Technical data Power Voltage Max one drawer with instrument heating is obtainable for 230 V 10 50 60 Hz at 230 V and 60 Hz and equipment with all function modules Special Voltage 115 V and Special Voltage 127 V Current input Cam 31 Cam 31 DV 0 15 A 35 VA Monitor 1 0 A 220 VA LS 21 LED 0 04 A 10 VA C 451 0 45 A 100 VA RS 221 0 95 A 220 VA SE 6501 1 4 A 330 VA Heated drawer max 1 0 A max 230 VA Total current fully equipped 7 A 1600 VA 230 V Power consumption fully equipped max 1600 VA Current Supply Detachable power line with shock proof plug line cord 5 m ATMOS Cam 31 module 1 3 CCD 752 x 582 pixels digital zoom x2 1 4 image storage PAL TFT monitor 15 1024 x 768 max 1600 x 1200 Light source ATMOS LS 21 LED Max 10 VA Power input Output 1 700 mA for LED Output 2 2 4 V 0 5 A for nystagmus bioculars Suction system ATMOS C 401 40 l min 10 freeflow Vacuum 90 of ambient pressure secretion container 1x1 5land1x3 01 Radiosurgery device ATMOS RS 221 module 2 2 MHz cutting 100 W and coagulating 90 W mono and bipolar Smoke evacuation module ATMOS SE 6501 640 l min adjust
38. missi ons IEC 61000 3 3 Guidance and manufacturer s declaration electromagnetic immunity The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete or ESD IEC 61000 4 2 8 kV air 8 kV air ceramic tile If floors are covered with non conductive synthetic material the relative humidity should be at least 30 Electrical fast transient burst 2 kV for power supply lines 2 kV for power supply Mains power quality should be that of a IEC 61000 4 4 1 kV for input output lines lines typical commercial or hospital environ 1 kV for input output lines ment 32 fN Notes on EMC Amos Guidance and manufacturer s declaration electromagnetic immunity Surge IEC 61000 4 5 Voltage dips short interrup tions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Note U 1 kV differential mode 2 kV common mode lt 5 U gt 95 dip in U_ for 0 5 cycle 40 U T 60 dip in U for 5 cycles 70 U T 30 dip in U_ for 25 cycles lt 5 U gt 95 dip in U for 5S 1 kV differential mode 2 kV common mode lt 5 U gt 95 dip i
39. mmunications equipment could cause interference if it is inadvertently brought into patient areas Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflec tion from structures objects and people N E 35 ATMOS General terms and conditions 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
40. n U_ for 0 5 cycle 40 U T 60 dip in U_ for 5 cycles 70 U T 30 dip in U_ for 25 cycles lt 5 U T gt 95 dip in U_ for 5s is the a c mains voltage prior to application of the test level Guidance and manufacturer s declaration electromagnetic immunity Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commer cial or hospital environment If the user of the equipment requires continued operation during power mains interrup tions it is recommended that the equipment be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels cha racteristic of a typical location in a typical commercial or hospital environment The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the equip ment should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile HF com munications equipment should be used no closer to any part of the equipment including cables than the recommen ded separation distance The separation distance is calcu lated from various equations depending on the frequency of the portable and mobile HF communications equipment Recommended separation distance Conducted HF IEC 61000 4 6 3
41. n 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 regarded as 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 rese
42. nded disinfectants which are stated herein are listed disinfec Perform Schilke amp Mayr tants VAH RKI and have been tested on their suitability of use on the ATMOS 2 Terralin Protect Sch lke amp Mayr S 41 Gyne ATMOS MedizinTechnik cannot be hold liable for any damage 2 Surface disinfection FD 312 Durr Dental caused by wrong concentration of the disinfectants or by the application of any a Quick disinfection B 30 Orochemie other disinfectants Patients with suspicion of a clinical disease or who developed a transmissible 4 Instruments manual disinfection 5 Instruments automatic disinfection spongiform encephalopathy CJK vCJK etc have to be treated at facilities which are able to provide for the necessary preventive measures against infec Korsolex AF Bode Chemie 2 Dismoclean 21 clean Bode Chemie tion The reprocessing of the reusable instruments and material may only be Korsolex basic Bode Chemie 2 Dismoclean 24 Vario Bode Chemie performed at facilities which have an externally certified QM Management acc Korsolex plus Bode Chemie 2 Dismoclean 28 alka one Bode Chemie to DIN EN ISO 13485 13488 Korsolex extra Bode Chemie 2 Dismoclean twin basic twin zyme Bode Chemie The Medical Devices Act IfSG the RKI directives BGR 250 and TRBA 250 2 neodisher Septo MED Dr Weigert 2 neodisher FA Dr Weigert always have to be considered a neodisher Septo 3000 Dr Weigert 2 neodisher FA
43. nsibility 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 maintenan
44. nstrument disinfectants 21 Recommended surface disinfectants 21 Cleaning and disinfection plan 22 23 Maintenance and service c scccesseeeeeeeees 24 Trouble shooting cccccsceeeeeeeeeeeeeeeeeeeeees 25 26 Further options accessories and consumables ccceeeeeeeeeeeeeeneeeeeees 27 29 Technical data sccawicsensasavanepoansdwidvestustvenesesanueens 30 Checking dispoOSal sseeeeeeeeeeeeeeeeneees 31 Checking ATMOS devices ccccceeseeeees 31 DSO anette nae mene E EE E Eee ne ere eee 31 Notes On EMC ccceccesecceeeeeeeeeeeneeeeneees 32 34 General Standard Terms and Conditions N Introduction Amos 1 1 Notes on operating instructions These operating instructions contain important notes on how to operate the ATMOS S 41 Gyne safely correctly and effectively Their reading helps to avoid risks and also to reduce repair costs and down time That increases amongst other things the reliability and service life of the device These operating instructions serve not only for new operating personnel to be instructed in its use but also for use as a reference manual Reproduction of these instructions even in part only with the written permission of ATMOS These operating instructions must always be kept available near the device Care and safety inspections in conjunction with professional execution provide for operational
45. nual deactivation of the ATMOS SE 6501 Fig 8 Select a period longer than 10 seconds using the lt Higher gt lt Lower gt buttons The word On appears on the display This means that the permanent operation suction mode is activated The permanent Operation suction can be switched on and off with the lt Start suction gt Fig 8 button 4 3 2 3 Suction WARNING Position the suction device or the instrument with suction device so that it cannot accidentally suck up swabs or the like Press the Start suction button The unit operates for as long as the button is pressed or activate the attached laser or electro surgical device Suction then continues for the duration of the set run down time after which basic suction takes place for the duration of the set basic suction time WARNING Never bring the suction tube into contact with the suction site It could become fixed to the tissue ATTENTION Do not suck up any liquids If there is a risk that you could suck up liquids during the operation attach an in line filter on the main filter Replace the in line filter immediately if you have sucked up any liquid For smoke evacuation we recommend the use of the ATMOS specula 13 N 4 0 Operation Amos 4 3 3 ATMOS C 401 REF 604 1500 0 Suction system with DDS System Direct Docking System Please pay attention to the safety and operating notes in the attached operating manual 4 3 3 1 Operating
46. observed additional measures may be necessary such as reorienting or relocating the equipment b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile HF communications equipment and the equipment The equipment is intended for use in an electromagnetic environment in which radiated HF disturbances are controlled The customer or the user of the equipment can help prevent electromagnetic interference This can be achieved by maintaining the minimum distance recommended below between the communications equipment transmitters and the equipment The minimum distance depends on the maximum output power and the frequency of the communications equipment Rated maximum output Separation distance according to frequency of transmitter m power of transmitter W 150 kHz to 80 MHz d 1 2 80 kHz to 800 MHz d 1 2 800 MHZ to 2 5 GHz d 2 3 P1 2 P1 2 P1 2 34 For transmitters rated at a maximum output power not listed above the recommended separation distance can be de termined using the equation applicable to the frequency of the transmitter P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the frequency bands between 80 MHz and 2 5 GHz to decrease the likelihood that mobile portable co
47. om the device Never touch the plug or cord while your hands are wet This product is not re sterilisable Repeated reuse of com ponents which are marked with a is forbidden In case of repeated reuse these components lose their function and there is a high infection risk Notes on EMC veral single medical products in one system according to your individual configuration Each installed device has been type tested for EMC Following the review of all individual test reports we can declare that a significant deterioration in the stray radiation value due to the combination of the devices in the unit is not to be expected and what is more deterioration in the interference immunity can safely be excluded Please observe the instructions relating to EMC in the relevant unit specific user manual which is enclosed with your supplied unit Q The ATMOS S 41 Gyne is an examination and treatment unit designed for use in the gynaecological sector combining se 3 0 Setting up and starting 3 1 Front view 13 14 Fig 7 ATMOS S 41 Gyne Front view Swivel mounted instrument trays optional ATMOS Cam 21 31 module optional ATMOS RS 221 radiosugery device optional ATMOS SE 6501 smoke evacuation system optional ATMOS C 401 optional Drawers heated and unheated optional Instrument deposit PC support Glove dispenser optional O Instrument deposit with cover optional Drawer for
48. on of these implements Most surface areas of the unit are coated with a special Q structural varnish which complies with the hygienic demands of the workplace However any drops which have been spilt should be removed immediately from the unit as the varnish is not resistant to all medical products and disinfectant solutions 4 2 Basic functions 4 2 1 Power supply optional The ATMOS S 41 Gyne is disconnected from the power supply by pulling out the inlet connector for unheated apparatus 4 2 2 Maximum load Fig 3 Do not lean against the ATMOS S 41 Gyne unit l danger of unit tilting Maximum load of the function carrier 12 kg 10 4 0 Operation Fig 4 ATMOS RS 221 ON l OFF 0 Symbol for operating mode neutral electrode Symbol for neutral electrode glows red at malfunction Symbol for type of device according to EN 60601 MONO CUT Cutting monopolar Monopolar cutting with coagulation setting of coagulation degree Output coagulation degree lower Output coagulation degree higher Display output coagulation degree 4 3 Options fN ioc 4 3 1 ATMOS RS 221 REF 601 1700 0 Please pay attention to the safety and operating notes in the attached operating manual 1 1 k MONO COAG Permanent coagulation monopolar setting of coagulation degree Pulse coagulation monopolar setting of pulse duration Output coagulation degree puls
49. ost 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 counterba
50. rve 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 respo
51. tion task The recommended order must be observed Please read important information A Warning special diligent notice Device classification Type a C 0124 CE mark in conformity with TA BF and defibrillator proof Meu a i ii 93 42 EEC Ko Device emits non ionising Neutral electrode amp radiation shines red by malfunetion ATMOS SE 6501 Device classification Type aa Used for communication to F CF and defibrillator proof A a ONICO ECB optional surgery device fN For your Safety Amos 7 For your safety The ATMOS S 41 Gyne is e designed in line with IEC 601 EN 60601 e assigned to VDE safety class e assigned to class Ila EWG 93 42 of the German law on medical products e assigned to class IIb by installation of ATMOS RS 221 The unit may only be connected to a protective terminal which has been installed in the prescribed manner The ATMOS S 41 Gyne is separated from the electricity network via the rubber connector Caution The heated drawers could be subject to temperatures exceeding 40 C in certain circumstances Check the temperature of the instruments prior to use Contact service if need be The ATMOS S 41 Gyne may only be used under the supervision of skilled staff who have been authorised by ATMOS and trained in its operation IEC 601 1 EN 60601 1 Prior to first starting up check whether the mains voltage specified on the type plate matches the
52. x detergents Immediate pre cleaning after the procedure GYNE electrodes xX xX X 16 or dispose of in wet disposal tray use of enzymatic xX detergents Smoke evacuation Cleaning and wipe disinfection Suction hose X x X245 manually or automatically monthly exchange X Surface filter housing xX xX Wipe cleaning and wipe disinfection xX 22 9 0 Cleaning and care What How When Who Qualified and trained staff who are familiar with reprocessing Please fill in the re sponsible person gt use a water based overhead marker c D S Recommendations Reusable parts Cleaning Disinfection Sterilisation After each procedure Daily Weekly Monthly Housing X x Wipe cleaning and wipe disinfection X Shutter X xX Wipe cleaning and wipe disinfection X Rotary arm X x Wipe cleaning and wipe disinfection X Drawers X xX Wipe cleaning and wipe disinfection X Ablagefl che X X Wipe cleaning and wipe disinfection X Halter Handschuhspender X x Wipe cleaning and wipe disinfection X PC Halterung X x Wipe cleaning and wipe disinfection X Rollen X x Wipe cleaning and wipe disinfection X Wipe cleaning and wipe disinfection Waste disposal X xX P g pas a X every day or when emptying the container Wischreinigung und desinfektion
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