ATMOS A 161 / A 261 / C 161 / C 261 Aspirator

Transcription

1 English ATMOS A 161 / A 261 / C 161 / C 261 Aspirator Operating instructions GA1GB Index:

2 Table of contents 1.0 Introduction Note of the operating instructions Function Intended use Extents of supply Transport and storage Explanation of symbols Safety advice Setting up and starting up Operating elements Connection Starting up General operation ATMOS A / C 161 / 261 Aspirator Suction hose Adjust vacuum Suction procedure Hose rinsing Operation ATMOS A / C 161 / 261 Aspirator / DDS DDS canister and bacterial filter Insertion of the DDS canister Connect hose Operation Receptal Holder for Receptal secretion canister Assembling the Receptal secretion canister set Connect hose Operation Medi-Vac / Serres Holder for Medi-Vac secretion canister Assembling the Medi-Vac secretion canister set Connect hose Holder for Serres secretion canister Assembling the Serres secretion canister set Connect hose Cleaning/Disinfection Basic information Bacterial filter Suction hose, hose connector and vacuum hose Fingertip Secretion canister Canister lid Device surface Rinsing Canister Accessories Oversuction Cleaning instructions Recommended instrument disinfections Recommended surface disinfections Cleaning and servicing plan Maintenance and servicing Maintenance and servicing Reprocessing Sending in the device Trouble-shooting Accessories, consumables, spare parts 11.1 Accessories Consumables Spare parts Technical specifications Checking / Reprocessing / Disposal Checking ATMOS suction devices Reprocessing Disposal Notes on EMC Further information, accessories, consumables and spare parts are available from: 2 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str Lenzkirch Deutschland / Germany Telefon: Fax: (Vertrieb Inland) (Export) atmos@atmosmed.de Internet:

3 1.0 Introduction 1.1 Notes on operating instructions These operating instructions contain important notes on how to operate the ATMOS A / C 161 / 261 Aspirator 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. These operating instructions must always be kept available near the device. Care and period tests in conjunction with professional execution provide for operational safety and readiness for use of your ATMOS A / C 161 / 261 Aspirator and are therefore a must besides regular cleaning. Repair work and period tests may be carried out only 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 A / C 161 / 261 Aspirator will be preserved.. The product ATMOS A / C 161 / 261 Aspirator bears CE marking CE according to the EC guideline of the council for medical products 93/42/EEC and meets the basic requirements of annex I of this guideline. The product ATMOS A / C 161 / 261 Aspirator 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 The quality management system applied at ATMOS has been certified according to international standards EN ISO 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 correspond to the design of the ATMOS A / C 161 / 261 Aspirator and the status of basic safety engineering standards on going to press. Reproduction of these instructions even in part only with the written permission of ATMOS. Subject to alterations and changes. These operating instructions are valid for the following devices: ATMOS A 161 Aspirator / DDS REF with 1 l DDS secretion canister ATMOS A 261 Aspirator / DDS REF with 1 l DDS secretion canister ATMOS C 161 Aspirator / DDS REF with 1 l DDS secretion canister ATMOS C 161 Aspirator / Receptal REF with 1.5 l Receptal canister ATMOS C 161 Aspirator / Medi-Vac REF with 1 l Medi-Vac canister ATMOS C 261 Aspirator / DDS REF with 1 l DDS secretion canister ATMOS C 261 Aspirator / Receptal REF with 1.5 l Receptal canister ATMOS C 261 Aspirator / Medi-Vac REF with 1 l Medi-Vac canister ATMOS C 261 Aspirator / Serres REF with 1 l Serres canister ATMOS C 161 Aspirator / Serres REF with 1 l Serres canister Please store this document near the device for later use 3

4 1.0 Introduction 1.2 Function The ATMOS A / C 161 / 261 Aspirator is a very handy small suction unit. It is driven by an electromotive, maintenance-free swing piston pump. During operation, the pump generates a vacuum within the hose system and the collection canister, thus sucking off secretions or fluids (e.g. by means of a suction catheter). The fluid is gathered in the collection canister. Valid for ATMOS C 161/ 261 Aspirator The final vacuum and, following, the air-flow rate can be adjusted by means of the fine control and the vacuumgauge. An overtemperature stop controlled by electronics avoids overheating of the unit. Valid for ATMOS A 161/ 261 Aspirator The final vacuum and, following, the air-flow rate can be adjusted by means of 3 step vacuum regulation. An overtemperature stop controlled by electronics avoids overheating of the unit. Fig 1a. ATMOS C 161 / 261 Aspirator / DDS Sliding cover Vacuum adjustment (individually adjustable) Vacuum gauge Hose storage Fig 1b. ATMOS A 161 / 261 Aspirator / DDS Vacuum adjustment (3-step adjustment) Hose storage Valid for ATMOS A / C 161 / 261 Aspirator / DDS: The reusable secretion canister is connected to the pump housing via direct-docking, without any pedestrian hose system. Only the suction hose has to be plugged in by the user. A bacterial filter, located in the lid of the secretion canister, avoids entering of bacterias and liquids into the pump interior. A mechanical oversuction stop integrated in the canister lid additionally avoids accidentally absorption of secretion into the pump head. 1.3 Intended use Name: ATMOS A 161 Aspirator / ATMOS A 261 Aspirator ATMOS C 161 Aspirator / ATMOS C 261 Aspirator Main functions: Temporarily and spontaneously suction of secretions, blood and body fluids which typically accumulate during respiratory tract suction and ENT treatment. Med. indications/ application: Suction of the upper respiratory tract and throat, nose, ear 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: Upper respiratory tract (oral cavity, nasopharyngeal cavity and bronchial system) and throat, nose, ear Application time: Temporary use on the patient during respiratory tract suction (< 60 min.) or short-term use at ENT treatment (up to 30 days). Application site: The application site of respiratory tract suction is the clinical, practices, nursing and home care sector. In ENT medicine the devices are used in clinic and practice. The application of the device may only be performed by medical trained and introduced staff. Contraindications: Not adapted for: the continuous operation in case of drainages in the low vacuum range (e.g. thoracic drainage or wound drainage). permanently endoscopic use. the use outside of the medical sector. the suction of flammable, corrosive and explosive substances. the suction in explosion-risk areas. The product is: x active not active Sterility: The device is not sterile. Single use product / reprocessing: The device and parts of the accessories are reusable, for information on reprocessing and disinfection please see the operating instructions. 4

5 1.0 Introduction 1.4 Scope of supply Prior to dispatch, this ATMOS device was subjected to an extensive functional test and has been carefully packed. Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt (see delivery note). In addition to the basic device, the scope of delivery comprises the following parts: DDS Medi-Vac Receptal Serres Grad. secretion canister (1 l) Medi-Vac canister (1 l) Receptal canister (1.5 l) Serres canister (1 l) Lid for secretion canister with triple oversuction safety Medi-Vac suction bag (1 l) with integrated bacterial filter Receptal suction bag (1.5 l) with integrated bacterial filter Serres suction bag (1 l) C 161 Battery 2 DDS bacterial filter C 161 Battery 1 DDS bacterial filter Support Support Support ATMOS A / C 161 / 261 Aspirator, scope of supply of all versions: silicone suction hose Ø 6 mm, L = 1.30 m mains cable for 230 V~/50-60 Hz 1.5 Transport and storage The transport of the device may be effected only in a dispatch carton upholstered and offering sufficient protection. Please document and report damages in transit immediately. For complaints or return deliveries, please use the enclosed form QD 434. The unit must be allowed to stand for up to six hours at room temperature prior to starting up for the first time following transport at temperatures below freezing. The unit may not be operated if it has not acclimatised as this might damage its diaphragms. Ambient conditions: Transport/Storage: Operation: C; % humidity non-condensing at air pressure hpa C; % humidity non-condensing at air pressure hpa 1.6 Explanation of symbols i Important information Warning, special diligent notice Protection class II Fuse Follow operating instructions (blue) SN REF Application part type BF Serial number Order number Creation date Refer to operating instructions IP 21 The CE sign shows that this product meets the appropriate requirements of the EC guidelines. ON (feed-in, power connection) OFF (feed-in, power connection) Protection against the ingress of - solid foreign objects Ø 12.5 mm - vertically dripping water 5

6 2.0 For your Safety General safety information Prior to starting up the ATMOS A / C 161 / 261 Aspirator, read these operating instructions carefully. ATMOS cannot guarantee perfect functioning neither will it be liable for damage to people or property if: Any non-original ATMOS parts are used, the user instructions given in this manual are not followed exactly or are disregarded, Assembly, resetting, alterations, extensions and repairs are not carried out by people authorised by ATMOS. Use transparent hoses exclusively. The ATMOS A / C 161 / 261 Aspirator may be operated only in rooms used for medical purposes, but not in areas subject to explosion hazards and in oxygen rich environments. The safety standard of the ATMOS A / C 161 / 261 Aspirator corresponds with recognized medical technical regulations and the directions of the law relating to medical products. The electrical outlet is in fact carried out threepole, but the middle contact pin (normally ground wire connection) in the interior of the unit is not connected. 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. No warranty rights shall exist in the event of damage or failure caused by the use of non-atmos accessories or non-atmos consumables Danger of injury Only persons instructed in medical use may apply the ATMOS A / C 161 / 261 Aspirator to patients. The ATMOS A / C 161 / 261 Aspirator has been designed for aspirating body fluids in medical ranges. Never remove explosive gases and inflammable or corrosive fluids. Sterile packed parts may no longer be used if their packing was damaged during transport or storage. Danger of infection for the patient. The unit may not be operated in splash water range. The suction hose must never come into direct contact with the application site. Always use a sterile suction catheter resp. a medical accredited aspiration set. This suction unit may not be applied without disposable bacterial filter plate. Always remove the plug from the wall socket first in order to disconnect the unit from the mains. Only then may the connecting cable be disconnected from the unit: Before cleaning the unit, before the collection canister is evacuated, before leaving the room. Never pull at the cable Never touch the plug or cable with wet hands. Danger to the device The unit may not be started: If cables or plugs are defective, if it has been dropped down before, if obvious defects might restrict safe operation. Prior to returning the device for repair, clean it. Pay attention to the ambient conditions described in chapter 1.5 Transport and storage. The unit must be checked periodically on its function and safety deficiencies, e.g. pins, secretion canister, housing, etc. The unit, collection canister, mains cable, accessories, connection cables and hoses must be checked for damage prior to starting up. Damaged cables and hoses must be replaced immediately. Prior to use, check the unit functions. Do not allow any liquid to get into the unit. If liquid has penetrated the unit, it may not be operated again until it has been checked by the customer service centre. The unit must be set up on a firm, level surface. The switched-on unit might get overheated if it is placed on an uneven surface (e.g. mattress, cushion, padded seat etc.). The main voltage specified on the type plate must match the power supply system. Never connect the unit to defective power sockets or extension cables. Avoid moisture on plug and switches. 6

7 3.0 Setting up and starting 3.0 Setting up Set up the device on a level, firm surface. 3.1 Operating elements 1 Shove blind for covering the operating elements (ATMOS C 161 / 261 Aspirator) 2 Vacuum adjustment 3 Vacuum gauge (ATMOS C 161 / 261 Aspirator) 4 Hose storage (fig. 1, page 4) 5 Suction hose storage (accessory) 6 Switch On I / Off O Fig 2a. Fig 3. 2 i 3.2 Connection The main voltage specified on the type plate must match the power supply system. Check mains cable for damages. Damaged cables must be replaced immediately Fig 2b. Fig Starting up The ATMOS A / C 161 / 261 Aspirator is delivered ready for use. Lift the unit out of the cardboard. Check whether the voltage values on the data plate correspond with the inbuilding voltage. Set up the device on a level, firm surface. Prior to first operation, pay attention to the safety information in chapter 2.0. The unit must be allowed to stand for up to six hours at room temperature prior to starting up for the first time following transport at temperatures below freezing. The unit may not be operated if it has not acclimatised as this might damage its diaphragms. ATMOS A / C 161 / 261 Aspirator / DDS: Always hold ready at least one ATMOS DDS bacterial filter, as the device may not be operated without one Fig 5. 7

8 4.0 General operation Prior to these notes please read the foregoing chapter of your respective version of the ATMOS A / C 161 / 261 Aspirator Important notes on safety Attention: Suction procedures in the respiratory tract may only be implemented after appropriate instruction by hospital or special staff. Make sure that the collection canister is evacuated in time. As soon as the canister is half-filled, it must be emptied (this principle proves right in all application ranges). When the maximum level is exceeded, the overflow safety reacts and suction is stopped. Empty the canister. Check the vacuum readout regularly If secretion has been soaked up into the pump due to improper use or manipulation, the device must be repaired from ATMOS or a service authorised by ATMOS. For aspiration use only applicable suction catheters, attachments or a medical aspiration sets. Whilst aspirating please pay attention to the filling level of the secretion canister. 4.1 Suction hose Join the suction hose ( 7 ) and the suction catheter ( 10 ) by means of the fingertip (not included in delivery) ( 9 ). 4.2 Adjust vacuum Only for C 161 / 261 Aspirator Adjust your desired vacuum by closing finger tip ( 9 ) and auxiliary air vent ( 8 ). The vacuum is then generated. Open the regulating valve / vacuum adjustment (page 4, ) until the vacuumgauge shows the desired vacuum value Only for A 161 / 261 Aspirator Adjust your desired vacuum by turning the three-steps adjustment (page 4, ) to the suitable position. -25 kpa* low, -55 kpa*medium, -75 kpa* high * depends on daily atmospheric pressure and ambient conditions Choose a suction catheter of the right size ( 10, which are available from ATMOS in 3 different sizes) or a suction instrument which is only available from specialized dealers. Fig Suction hose 8 Auxiliary air vent 9 Finger tip 10 Suction catheter 9 10 AUXILIARY AIR VENT OPEN = suction procedure is interrupted (e.g. when leading in the catheter) AUXILIARY AIR VENT CLOSED WITH THE FINGER = suction 4.3 Suction procedure Then, lead in the catheter in the same way as shown by your hospital staff and start the suction procedure. Control the suction procedure with the auxiliary air vent ( 8 ) on the fingertip. 4.4 Hose rinsing Dispose the suction catheter and rinse the suction tube with clean water or disinfection liquid after every suction procedure. We recommend to use the rinsing bottle in which you can carry clean water along with you. The hydrophobic DDS bacterial filter / oversuction stop avoids ingress of moisture. Nevertheless you should empty the canister at a fill level of 1/2. 8 The secretion canister system is designed the way that secretions flows laterally to the wall. Therefore the foam formation in the canister is reduced.

9 5.0 Operation DDS Important notes on safety for the DDS canister system Do not operate the device without a bacterial filter. We recommend you always to store at least one spare bacterial filter. Always wear disposable gloves when changing the bacterial filter Prior to each use please check whether the bacterial filter is dry and clean. Replace the bacterial filter with a new filter if it is discoloured, contaminated or oversucked. A bacterial filter may never be reused Exchange the bacterial filter when changing the patient. ATMOS recommends: Replace the bacterial filter after 14 days, even if there is no patient change. Vacuum connection Direct-Docking-System The vacuum connection between the pump and the collection canister is created automatically as soon as the DDS canister is positioned correctly. 5.1 DDS canister and DDS bacterial filter With the DDS collection canister on a firm surface, position the lid horizontally on top (the lid may not be twisted) Press down lightly onto the collection canister using both hands until limit is reached (Fig 7). Fig Insertion/Removal of the DDS canister Fig 8. The filter must be fixed to the housing. Afterwards the secretion canister is inserted. For insert the DDS collection canister, shift it horizontally onto the bacterial filter; for removal, pull it horizontally outside (Fig 8). i Tip Please note that this order is strictly observed otherwise power loss of the device could be the consequence If required the canister can be ejected even easier from the device by means of a lever instrument (e.g. plain spattle); see Fig. 9. Fig Connect hose Press the required DDS hose adapter with 6 or 10 mm diameter into the hole of the DDS collection canister lid twisting slightly to ensure a tight fit (Fig 10). Twist slightly in the same manner when removing. Fig 10. 9

10 6.0 Operation Receptal 6.1 Holder for Receptal secretion canister Plug the screw thread of the holder from the top into the borehole at the bottom side of the device. Screw it together with the provided screw nut. Fig. 11. Receptal bag 6.2 Assembling the Receptal secretion canister system Insert the Receptal bag into the Receptal canister. i Close the canister tightly at all sides. Check again for density, otherwise no vacuum can be built up. Insert the vacuum hose. Only bags with integrated bacterial filter may be used Receptal canister Fig Connect hose 11 Vacuum channel 12 Vacuum hose 13 Connection for vacuum hose The secretion is sucked off through the vacuum channel. Fig. 13. Sterile packed parts may no longer be used if their packing was damaged during transport or storage Danger of infection for the patient. Only use secretion bags with integrated bacterial filter A bacterial filter avoids divulgement of bacterias. 10

11 7.0 Operation Medi-Vac and Serres Medi-Vac bag 7.1 Holder for Medi-Vac secretion canister Plug the screw thread of the holder from the top into the borehole at the bottom side of the device. Screw it together with the provided screw nut. 7.2 Assembling the Medi-Vac secretion canister system Medi-Vac canister Insert the Medi-Vac bag into the Medi-Vac canister. Fig. 14. Fig i Close the canister tightly at all sides. Check again for density, otherwise no vacuum can be built up. Insert the vacuum hose. Only bags with integrated bacterial filter may be used 7.3 Connect hose 11 Vacuum channel 12 Vacuum hose 13 Connection for vacuum hose Fig Holder for Serres secretion canister Plug the screw thread of the holder from the top into the borehole at the bottom side of the device. Screw it together with the provided screw nut. Fig. 16a. Fig. 16b Assembling the Serres secretion canister system Insert the Serres bag into the Serres canister. i Close the canister tightly at all sides. Check again for density, otherwise no vacuum can be built up. Insert the vacuum hose. Only bags with integrated bacterial filter may be used 7.6 Connect hose 11 Vacuum channel 12 Vacuum hose 13 Connection for vacuum hose Fig. 16c. 11

12 8.0 Cleaning / Disinfection The way the suction device is used determines its reliability and safety. These hygiene measures are indispensable for protecting the patient and the user and for maintaining a safe and reliable suction device. When the suction device is used on another patient or in case the device has been oversucked a professional reprocessing by the manufacturer, by a certified ATMOS partner or by a specialist, who is authorised by ATMOS, in compliance with Medical Devices Operator Ordinance, Medical Devices Act and BV-Med rules is required (please see chapter 9.2 reprocessing). 8.1 Basic information The following cleaning measures must only be performed if the device was used. When the device is only rarely used then a function check must be conducted at least every three months. Only when you adhere to these points the function of the device can be guaranteed. We recommend you to document any maintenance work and also any of parts. Please always wear disposable gloves for any work you perform. Prior to cleaning the device please remove and dispose all disposable parts like filter, fingertip and catheter. Prior to cleaning please remove the mains cable from the device. The described measures for cleaning and disinfection do not replace valid rules for operating the device Please observe the instructions for use prescribed by the manufacturers of disinfectants. Especially regarding concentration and regarding their suitability for use. Attention: The lid parts and silicone hoses might get dyed by some disinfectants; a fact which does not take effect on the attributes of the materials. Basically all parts (canister, cover, overflow safety and hose) which come into contact with suction material must be cleaned and disinfected. Single-use parts like, for example, filters, catheter, fingertip... must be d as soon as the device is used in another patient. Please see the different instructions for cleaning (chapter 8.3). In case the suction device is used in one patient only device and accessories should, for hygienic reasons, be cleaned and disinfected. Please see the different instructions for cleaning (chapter 8.3). Cleaning in an automatic cleaner and disinfector is also possible (hose connector, secretion canister and canister lid). Thermal disinfection is carried out at 93 C Bacterial filter Exchange the bacterial filter when changing the patient. ATMOS recommends: Replace the bacterial filter after 14 days, even if there is no patient change. Replace the bacterial filter with a new filter if it is discoloured, contaminated or oversucked. Pay attention to storing a sufficient number of replacement bacterial filters Suction hose, hose connector and vacuum hose Suction hose and hose connector must always be disinfected with an instrument disinfectant recommended on page 14 in case the device is used in another patient. Prior to disinfection or autoclaving the parts must be rinsed with clear water for at least 10 seconds in order to increase cleaning efficiency. Please observe the instructions for use of the relevant disinfectant solution 12 In case the parts are used in one patient only we recommend an every 4 weeks. In addition we recommend to thoroughly rinse hose, hose connector and vacuum hose with clear water and to disinfect them at least once a day as described above Fingertip Fingertip is not included in delivery, please order separately. Prior to using the device in another patient the fingertip must be d. In case the device is used in one patient only we recommend for hygienic reasons the of the fingertip every day Secretion canister The secretion canister must always be disinfected with an instrument disinfectant recommended on page 14 in case the device is used in another patient. Prior to disinfection resp. autoclaving please take care to empty the canister and to rinse it with clear water in order to increase cleaning efficiency. Please observe the instructions for use of the relevant disinfectant solution In case the device is used in one patient only we recommend disinfection of the canister every day as described above. For hygienic reasons we recommend to empty the secretion canister after every suction procedure and to rinse it with clear water. Information on how to remove the canister you will find in chapter 5.2 on page 9. Fig Canister lid The canister lid must always be disinfected with an instrument disinfectant recommended on page 14 in case the device is used in another patient. Prior to disinfection please take care to remove the bacterial filter from the lid and to disassemble the lid into its single components (lid, float ball and hose connector). Prior to disinfection or autoclaving the parts must be rinsed with clear water for at least 10 seconds in order to increase cleaning efficiency. Afterwards the parts have to be disinfected.

13 8.0 Cleaning / Disinfection Please observe the instructions for use of the relevant disinfectant. Information on how to remove the secretion canister lid you will find in chapter 5.2 on page 9. We recommend to thoroughly rinse the lid and its components with clear water after each suction procedure in case the device is used in one patient only. Attention Please remove bacterial filter prior to this Device surface Prior to use the device in another patient the complete device surface must always be cleaned with a damp (not wet) cloth and disinfected with a surface disinfection solution stated on page 14. In case the device is used in one patient only the device surface should be cleaned if it is contaminated however at least once every week with a damp (not wet) cloth and afterwards be disinfected with a surface disinfectant stated on page 14. Discolouration of the surface could occur by some disinfectants; a fact which does not take effect on the attributes of the material. Prior to cleaning please make sure to disconnect the device from the mains The device may never be autoclaved, rinsed under running water or immersed into any liquids Rinsing Canister The rinsing canister must always be disinfected in case the device is used in another patient. Prior to disinfection please take care to empty the canister and to rinse it with clear water in order to increase cleaning efficiency. In case the device is used in one patient only we recommend disinfection of the canister every week. The rinsing canister may only be cleaned with a ph neutral cleaning liquid which does not contain the following ingredients: ammoniac, amines, amides, phenol derivates, anionic tensides. The disinfection is exclusively allowed with disinfectant which does not contain the following ingredients: alcohol, aromatic hydrocarbons, ammonia, amine. Cleaning in a dishwasher is possible when using ph neutral cleaning liquids (5 cycles) Accessories Hose rewind ( ) / Trolley ( ) / Device support ( ) The complete surface of the hose rewind, the trolley and the device support must always be cleaned with a damp (not wet) cloth and disinfected with a surface disinfectant stated on page 14 prior to use the device in another patient. In case the device is used in one patient only the device surface should be cleaned if it is contaminated however at least once every week with a damp (not wet) cloth and afterwards be disinfected with a surface disinfectant stated on page Oversuction When is a suction unit oversucked? A suction device is oversucked if suction material penetrated into the interior of the device. How can one realise that the suction device is contaminated? Generally a reduced suction capacity is a sign of possible oversuction. The ATMOS C 161 / C 261 Aspirator have a condensate collector at the bottom of the device. For visual inspection please remove the cap. The device is oversucked if humidity or contamination is visible in the condensate collector. Measures The device must be reprocessed by the manufacturer or a certified ATMOS partner if the device is oversucked or if any reservations exist regarding the hygiene condition. A contaminated suction device bears a risk for the patient as well as for the caregiver. Therefore, we recommend regular checking of the condensate collector. 8.3 Cleaning instructions for use in another patient For use in one patient contamination after suction procedure 1x per day 1x per week every 2 weeks every 4 weeks Exchange bacterial filter X X X Rinsing the suction hose X X Disinfecting/autoclaving the suction hose X X Exchanging the suction hose X Exchanging the fingertip X X Emptying the secretion canister X X Rinsing the secretion canister X X Disinfecting the secretion canister X X Rinsing the lid components X X Disinfecting the lid components X X Cleaning of the device surface X X X Wipe disinfection of the device surface X X X Rinsing the vacuum hose X X Disinfection of the vacuum hose X X Disinfection of the hose connector X X 13

14 8.0 Cleaning 8.4 Recommended disinfectants for instruments Disinfectant Contents (in 100 g) Manufacturer GIGASEPT FF Succindialdehyde 11.0 g Schülke & Mayr, Norderstedt (Application concentrate) Dimethoxytetrahydrofurane 3.0 g not for rinsing canister Corrosion inhibitors Non-ionic tensides and fragrances Sekusept PLUS 1 Glucoprotamine 25.0 g Ecolab, Düsseldorf / not for rinsing canister (Application concentrate) Non-ionic tensides Solvents, complexing agents 8.5 Recommended disinfectants for surfaces Disinfectant Contents (in 100 g) Manufacturer ATMOS Green & Clean SK Alkyldimethylbenzylammoniumchloride <1 g Metasys, Rum (Austria) (application solution) Dialkyldimehtylammoniumchloride <1 g Alkyldimethylethylbenzylammoniumchloride <1 g Dismozon pur Magnesium peroxyphthalate Bode Chemie, Hamburg (granulate) Hexahydrate 80 g End of product 12/2014 Dismozon plus Magnesium peroxyphthalate Bode Chemie, Hamburg (granulate) Hexahydrate 95.8 g Kohrsolin FF Glutaral 5 g Bode Chemie, Hamburg (application solution) Benzyl-C12-C18-alkyldimethyl- 3 g not for rinsing canister ammoniumchloride Didecyldimethylammoniumchloride 3 g Mikrozid sensitive wipes Quaternary Ammonium compounds 0.26 g Schülke & Mayr, Norderstedt Perform Pentakalium bis(peroxymonosulphate)- Schülke & Mayr, Norderstedt (application solution) bis(sulphate) 45.0 g Bacillol 30 Foam Ethanol 14.0 g Bode Chemie, Hamburg Propan-2-ol 10.0 g not for rinsing canister Propan-1-ol 6.0 g Alkylaminopropylglycine < 1 g Mikrobac forte Benzyl-C12-C18-alkyldimethyl g Bode Chemie, Hamburg ammoniumchloride N-(3-Aminopropyl)-N-dodecylpropan 1.3-diamin Discolouration may result if disinfectants containing aldehydes and amines are used on the same object. 14

15 daily, respectively after each use daily, respectively after each use daily, respectively after each use Cleaning and servicing plan for ATMOS A 161 / A 261 / C 161 / C 261 Aspirator start date: name of the item: serial number: day cleaning secretion canister cleaning canister lid cleaning of the housing of bacterial filter of fingertip of suction hose, 1.3 m name cleaning/ performed signature * * * * Before first time operation of a brand new device, respectively a technically as well as hygienically proper device. Special notes: Before operating the suction device, the user has to make sure that the device functions and is in good order and condition. The user has to observe the instructions in the operating manual as well as all other safety-related and maintenance information enclosed. For cleaning and disinfection only agents which are recommended by the manufacturer, may be used. Only sterile, single-use suction catheters may be used for suctioning. They have to be d before each suction process. During use utmost attention to hygiene (e.g. disinfection of hands, wearing single-use gloves) is indispensable. After each use the secretion canister and the hose must be rinsed thoroughly with water. During storage the contamination of the device and other products must be avoided. The intervals stated in the list are non-binding guide values. Depending on the use shorter intervals may be necessary. For each patient a new or technically as well as hygienically proper suction device must be used. Otherwise there is high and acute danger of infection for the patient, the user and any third person ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Straße 16 / D Lenzkirch Phone: +49 (0) / Fax: +49(0) / atmos@atmosmed.de

16 Important notes General information The way the suction device is used determines its reliability and safety. These hygiene measures are indispensable for protecting the patient and the user and for maintaining a safe and reliable suction device. If there is a change of patient or ownership then the device must be reprocessed acc. to Medical Devices Operator Ordinance, Medical Devices Act and BVMed guidelines. An oversucked (contaminated) device must be repaired by the manufacturer, by a certified ATMOS partner or an ATMOS authorized, specialized dealer. This cleaning and servicing plan as well as the relevant notes result from many years of experience. Depending on the use and the user s experience shorter intervals may be necessary. ATMOS recommends the following sets of consumables: According to this cleaning and servicing plan the following consumables have to be changed: bacterial filter fingertip Bacterial filter The bacterial filter prevents penetration of micro organisms and secretion into the device, respectively blowing out from it and is therefore a protection for the user and the device. Replace the bacterial filter with a new filter if it is discoloured, contaminated or oversucked. Exchange the bacterial filter when changing the patient. ATMOS recommends: Replace the bacterial filter after 14 days, even if there is no patient change. In order to increase the service life of bacterial filters, it is recommended to empty the secretion canister when it is half-full. Always use the original ATMOS bacterial filter The suction device may not be operated without bacterial filter Hose connection/fingertip The fingertip connects the suction hose to the suction catheter. As the fingertip is in direct contact with secretion and it is difficult to clean, we recommend a daily. When the device is used for another patient the fingertip must be d immediately. Suction Hose The suction hose conducts the secretion from the suction catheter to the canister. In order to prevent secretion from drying, the hose must be thoroughly rinsed with clear water after each use. The water can be sucked into the secretion canister. Please fill the secretion canister only half. Frequent cleaning and disinfection may discolour and embrittle the hose. Therefore, a monthly of the suction hose is recommended. suction catheter, length: 50 cm white Ø 4 mm green Ø 4.7 mm Suction hose 1.3 m Cleaning of the device (housing) When the device is contaminated but at least once per week the housing must be wiped off with a moist (but not wet) cloth. A weekly disinfection is recommended. Never irrigate the device with water and never emerge it into any liquid. Cleaning/disinfection To improve the cleaning effect, standard washing-up liquid can be added to the warm water. In the case of tenacious contamination the parts should be steeped in water for a length of time or they may be removed with a soft brush or cloth. After thorough cleaning, canister, fingertip and hoses can be disinfected with a disinfection agent (see operating instructions). orange Ø 5.3 Cleaning in an automatic cleaner and disinfecter is also possible (hose connector, secretion canister and canister lid). Thermal disinfection is carried out at 93 C. Disconnect the mains plug from the socket before commencing with cleaning and disinfection Please observe the notes in the operating instructions, especially regarding the recommended agents. Cleaning of the secretion canister Please empty the secretion canister after each use, rinse it thoroughly with clear water and clean it with washing-up liquid. Tenacious contaminations can be removed with a standard bottle brush. Cleaning of the canister lid The bacterial filter must be removed before cleaning, please use single-use gloves. Please demount the canister lid after each use and rinse it thoroughly. The lid must be absolutely dry before reuse. Please pay attention to a correct function of the overflow safety when mounting the lid. ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Straße 16 / D Lenzkirch Telefon: +49 (0) / Fax: +49(0) / atmos@atmosmed.de

17 9.0 Maintenance 9.1 Basic information Carry out a visual inspection of the unit prior to each use including hoses, collection canister and connection cable. Damaged cables and hoses must be replaced immediately. Maintenance, repairs and period tests may only be carried out by persons who have the appropriate technical knowledge and are familiar with the product. To carry out these measures the person must have the necessary test devices and original spare parts. ATMOS recommends: work should be carried out by an authorized ATMOS-service partner. This ensures that repairs and testing are carried out professionally, original spare parts are used and warranty claims remain unaffected. Please comply with the country-specific guidelines regarding regular testing especially for the electrical safety. ATMOS recommends a test every 24 months. For repair, this device can be returned to ATMOS. Before returning the device for repair, clean and afterwards disinfect all secretion canister parts and hose parts. The device s surface also has to be disinfected. ATMOS cannot guarantee perfect functioning neither will it be liable for damage to people or property if: Any non-original ATMOS parts are used, the user instructions given in this manual are not followed exactly or are disregarded, assembly, resetting, alterations, extensions and repairs are not carried out by people authorised by ATMOS. No warranty rights shall exist in the event of damage or failure caused by the use of non-atmos accessories or non-atmos consumables. In order to protect the user, the ATMOS A / C 161 Battery must be in good condition with regard to technics and hygiene prior to passing on. If there is a change of patient or ownership then the device must be reprocessed acc. to Medical Devices Operator Ordinance, Medical Devices Act and BVMed guidelines. An oversucked (contaminated) device must be repaired by the manufacturer, by a certified ATMOS partner or an ATMOS authorized, specialized dealer. Pay attention to regulations and instructions valid for the respective application range. 9.2 Reprocessing The way the suction device is used determines its reliability and safety. These hygiene measures described in the last chapter are indispensable for protecting the patient and the user and for maintaining a safe and reliable suction device. When you can ensure the device was not oversucked then perform a reprocessing acc. to Medical Devices Operator Ordinance, Medical Devices Act and BVMed guidelines. The reprocessing consists of cleaning, surface disinfection as well as the of consumables. An ATMOS set of consumables is available for this purpose. If you cannot exclude that the device was oversucked then the device must be repaired by the manufacturer, by a certified ATMOS partner or an ATMOS authorized, specialized dealer. Subsequently the device may be operated again. When is a suction unit oversucked? A suction device is oversucked if suction material penetrated into the interior of the device. How can one realise that the suction device is contaminated? Generally a reduced suction capacity is a sign of possible oversuction. The ATMOS C 161 / C 261 Aspirator have a condensate collector at the bottom of the device (fig 14 ). For visual inspection please remove the cap. The device is oversucked if humidity or contamination is visible in the condensate collector. Measures The device must be reprocessed by the manufacturer or a certified ATMOS partner if the device is oversucked or if any reservations exist regarding the hygiene condition. A contaminated suction device bears a risk for the patient as well as for the caregiver. Therefore, we recommend regular checking of the condensate collector. 14 condensate collector for a quick view control of a possible contamination 9.3 Sending in the device 1. Remove and properly dispose of consumables. 2. Clean and disinfect the products and accessories according to the operating instructions. 3. Place used accessories with the device. 4. 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 5. The device must be well padded and packed in suitable packaging. 6. Place the form QD 434 Delivery complaint / return shipment and the respective decontamination certificate in an envelope. 7. Affix the envelope to the outside of the package. 8. Send the product to ATMOS or to your dealer. 17

18 10.0 Trouble-shooting Prior to dispatch, the ATMOS A / C 161 / 261 Aspirator was subjected to an extensive functional test. If, nevertheless, a failure should appear, you may possibly clear it yourself if you follow these notes: Problem Possible causes Remedy Unit does not start Discharged battery Connect the battery charging power pack to the device. The battery should be recharged for 1 2 hours prior to operation with battery. Loose power plug of the charging device Check all plug and socket connections. Pay attention to the control lamp, it must be illuminated when all connections are o.k. Insufficient performance Discharged battery Recharge the battery. Filter is blocked Exchange the filter. 1. Low or no vacuum is indicated 1.1 DDS bacterial filter is missing Insert DDS bacterial filter 1.2 Leakages within the hose system or in collection canister lid Check collection canister lid and hose system on tight fitting. Connect the filter once again to the connection nozzle. Check the suction lid on tight and correct fitting. 2. High vacuum is indicated 1.3 Secretion or blood has been sucked in and valve plates of the pump are contaminated 2.1 DDS bacterial filter is blocked. 2.2 Float of overflow safety closes the collection canister inlet Unit has to be returned for repair. Exchange DDS bacterial filter Check collection canister inlet; if necessary empty secretion canister, clean the oversuction protection and check float ball for flexibility. 18

19 11.0 Accessories, consumables and spare parts REF Cover for secretion canister (incl. spare DDS filter) Rewind system for suction hoses Device support DDS bacterial filter / oversuction stop Hose connection, (fingertip) Grad. secretion canister 1 l Separate rinsing canister set Basket for catheters Trolley on 4 castors 11.1 Accessories for A and C class Grad. secretion canister, 1 l DDS, blue, PSU Grad. secretion canister, 1 l DDS, transparent, PSU Secretion canister lid, 1 l DDS, blue, with spare bacterial filter Separate rinsing canister set for ATMOS A- and C- class incl. lid and support Hose connector for hoses Ø 6 mm Hose rewind for suction hoses for ATMOS A- and C- class Power cable, 3-wire Schuko connector, 2 m Carrying bag, black Device support for ATMOS A- and C- class Trolley on 4 castors, for A- and C- class Support for Receptal external canister 1 l and 1.5 l Support for Medi-Vac external canister 1 l Support for Serres external canister 1 l Consumables Bacterial filter for ATMOS DDS secretion canister, 10 pcs Set of consumables for ATMOS A- and C-class DDS General accessories Receptal external canister 1.5 l Serres external canister 1 l Medi-Vac canister 1 l Basket for catheters, L = 340 mm Basket with standard rail holder Suction hoses / fingertip Plak-VacTM tooth brush with suction mechanism Suction hose, silicone, Ø 6 mm, minimum purchase 5 m Suction hose, silicone, Ø 6 mm, L = 1.30 m, 1 pcs Suction hose, PVC, disposable, Ø 6 mm, L = 1.30 m, 10 pcs Suction hose, PVC, disposable, Ø 6 mm, L = 2.10 m, 50 pcs Fingertip, sterile, not autoclavable, minimum purchase 10 pcs. Suction bags Receptal suction bag 1.5 l, not autoclavable, 50 pcs Medi-Vac suction bag 1 l, not autoclavable, 50 pcs Serres suction bag, 1 l, not autoclavable, 36 pcs Suction catheter Plak-Vac TM toothbrush Suction catheters Suction catheter, size: CH 12, L = 50 cm, 100 pcs. Ø 4 mm, white, straight, central opening, 2 small lateral openings, suction connection Ø 6 mm, #e, not autoclavable Suction catheter, size: CH 14, L = 50 cm, 100 pcs. Ø 4.7 mm, green, straight, central opening, 2 small lateral openings, suction connection Ø 6 mm, sterile, not autoclavable Suction catheter, size: CH 16, L = 50 cm, 100 pcs. Ø 5.3 mm, green, straight, central opening, 2 small lateral openings, suction connection Ø 6 mm, sterile, not autoclavable

20 11.0 Accessories, consumables and spare parts REF 11.3 Spare parts Hider (Valid for ATMOS C 161 / C 261 Aspirator) Self-adhesive elastic buffer 5J Plug GPN Ball for overflow protection

21 12.0 Technical specifications ATMOS A / C 161 Aspirator Air flow rate of pump 16 ± 2 l/min 26 ± 2 l/min ATMOS A / C 261 Aspirator Max. vacuum -80 kpa* ± 2 kpa -80 kpa* ± 2 kpa Vacuum readout (ATMOS C 161 / C 261 Aspirator) Additional air regulation (ATMOS C 161 / C 261 Aspirator) bar (± 25 mbar) (mmhg; kpa)* mechanical regulating valve Additional air regulation (ATMOS A161 / A 261 Aspirator) Three-steps-adjustment low= -25 kpa*, medium= -55 kpa*, high= -75 kpa*. * depends on daily atmospheric pressure and Ambient conditions Collection canister 1 l DDS secretion canister or 1.5 l Receptal canister system or 1 l Medi-Vac canister system or 1 l Serres canister system Suction hose ø 6 mm, 1.30 m length Voltage 230 V~ (+/-10%) 50/60 Hz Current input (max.) ca A (230 V~) ca A (230 V~) Power consumption ca. 170 VA (230 V~) ca. 105 VA (230 V~) Power cable 2 m Operating time Interrupted use over approx. 45 min at 230 V~, 50 Hz, 20 C cooling period approx. 60 min., depending on ambient temperature (Interrupted use over minimum 5 min. at 10 % higher rated voltage, 60 Hz, 35 C ambient temperature, 20 min. break) Fuse T 1.25 A/H (230 V~) T 1,25 A/H ( V~) Protective earth conductor resistance Earth leakage current Enclosure leakage current Patient leakage current N.C. < 0.1 ma Heat emission 100 J/s Noise level (ATMOS C161 / C 261 Aspirator) 50.0 db 1m (nach ISO 7779) Noise level (ATMOS A161 / A 261 Aspirator) 53.0 db 1m (nach ISO 7779) Ambient conditions Transport/storage Operation Dimensions HxBxT Weight Period tests Protection class (EN ) Applied Part C % humidity, non-condensing air pressure hpa C % humidity, non-condensing air pressure hpa 250 x 255 x 180 mm 3.5 kg Recommended: Testing every 24 months. II type BF Degree of protection IP 21 Classification acc. to Annex IXEEC directions 93/42/EEC IIa CE marking CE 0124 UMDNS-Code (tracheal suction device) * 1 bar 750,06 mm Hg 1000 hpa / depends on daily atmospheric pressure Issue of Technical Specifications:

22 13.0 Checking / Reprocessing / Disposal 13.1 Checking ATMOS suction devices The ATMOS suction devices are maintenance-free in the case they are used according to the operating instructions. Please comply with the country-specific guidelines regarding regular testing especially for the electrical safety. ATMOS recommends a test every 24 months Regular, thoroughly cleaning and disinfection of the hoses and the application parts respectively the operation in line with the operating instructions are assumed. (Valid for ATMOS C 161 / C 261 Aspirator) A regular check of the condensate-controller on the rear side is necessary. For visual inspection please remove the cap. The device is oversucked if humidity or contamination is visible in the condensate collector Reprocessing (in perfect technical and hygienic condition) If there is a change of patient or ownership then the device must be reprocessed acc. to Medical Devices Operator Ordinance, Medical Devices Act and BVMed guidelines. An oversucked (contaminated) device must be repaired by the manufacturer, by a certified ATMOS partner or an ATMOS authorized, specialized dealer. ATMOS MedizinTechnik GmbH & Co. KG offers their partners and customers a trouble-free and quick reprocessing and checking / period tests for ATMOS suction devices Disposal When the device is operated according to the operating instructions it has an expected service life of 5 years. A regular thorough cleaning and disinfection, respectively the operation in line with the operating instructions are assumed. The ATMOS A / C 161 / 261 Aspirator 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 are to be separated carefully. Pay attention to country-specific regulations for disposal (e. g. waste incineration). 22 Disposal within the EC The suction device described above is a high-quality medical product with a long service life. After its life cycle it must be disposed of professional. 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 the Federal Republic of Germany the law for electrical devices (ElektroG) rules the disposal of electrical devices. Since this type of product is mainly used at home for secretion suction in the respiratory tract (after laryngectomy), it must be assumed that those suction devices could be contaminated. Therefore, this type of device is excluded from the law for electrical devices. 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 secretion canisters and hoses must be thoroughly cleaned, disinfected. The device surface must be disinfected.