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Operating instructions

English

ATMOS

®

 

E 201 Thorax

312.1100.B

2015-05  Index: 32

Summary of Contents for E 201 Thorax

Page 1: ...Operating instructions English ATMOS E 201 Thorax 312 1100 B 2015 05 Index 32 ...

Page 2: ...eprocessing Disposal 24 10 1 Checking 24 10 2 Reprocessing 24 10 3 Disposal 24 11 0 Notes on EMC 25 27 1 0 Introduction 3 7 1 1 Notes on operating instructions 3 1 2 Intended use 3 4 1 3 Warnings 4 1 4 Precautions 5 1 5 Function 5 1 6 Explanation of pictures and symbols 6 1 7 Scope of supply 7 1 8 Transport and storage 7 2 0 For your safety 8 3 0 Setting up and starting up 9 10 3 1 Setting up 9 3 ...

Page 3: ...prepared for any possible dangerous situations 1 0 Introduction 1 1 Notes on operating instructions 1 2 Intended use 1 2 1 Intended use of the ATMOS E 201 Thorax Name ATMOS E 201 Thorax Main function Digital device for mobile thoracic drainage Medical indication application Recovery of the neutral vacuum in the intra pleural cavity after the occurrence of a pneumothorax or a pleural effusion by dr...

Page 4: ...MOS E S 201 Thorax Main functions Forwarding of the created vacuum into the drainage hose and finally into the patient side drain Collection of the exhausted secretion Med indications application Secretion canister for the connection to a digital device for mobile thoracic drainage Specification of the main function The vacuum generated by the pump evacuates air and secretion out of the drain The ...

Page 5: ...ocols for disposal handling and infection controI should be carefully followed The function of the device must be checked prior to use see chapter 3 0 Setting up and starting up section 3 3 Functional test When a thoracic catheter is connected leaky connections may result in an incorrect evaluation of air leaks from the lung and delay treatment time Therefore check that all the connections are air...

Page 6: ...g keys symbols of the ATMOS E 201 Thorax Serial number Order number Manufacturing date The CE sign shows that this product meets the appropriate requirements of the EC guidelines Fuse Protection class II Application part type CF defibrillator proof recovery time 10 sec REF SN Adjustment keys Reset Enter Replace Turn shift in this direction Move plug in this direction Engage check correct fit Pleas...

Page 7: ...losed form QD 434 The form QD 434 can also be downloaded from the internet www atmosmed com 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 the aggregate Ambient conditions Transport Storage 10 50 C 30 95 a...

Page 8: ... forbidden In case of repeated reuse these components lose their function and there is a high infection risk TheATMOS E 201 Thorax is designed in accordance with IEC 60601 1 EN 60601 1 It is a device which meets the VDE protection class II It may be connected to a properly installed wall power point socket Before commissioning the device drainage canister mains cables accessories connecting leads ...

Page 9: ...ition Plugs DK 2 Ia DK 2 Ia with flat phone pin or DK 2 5a socket outlets DK 1 3a 3 2 Starting up Operating panel Handle Measuring channel Suction channel Display Secretion canister Device status LED 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 atte...

Page 10: ... reached the standard screen Fig 8 Switch the pump on P ON by briefly pressing button when the target vacuum is achieved switch the pump off P OFF by again briefly pressing button 4 The actual vacuum should not fall by more than 12 mbar within 10 secs when the hose end is closed In case the leakage test was successful Fig 4 appears on the display Please confirm with key Fig 3 Display readout If th...

Page 11: ...et in 1mbar or 1kPa steps NOTE 1kPa 10mbar therefore when kPa is selected the vacuum range is 1kPa to 10kPa Important notes on safety for the secretion canister system Only use the original ATMOS single use secretion canister Vacuum connection The vacuum connection between the pump and the collection jar is created automatically as soon as the secretion canister jar is positioned correctly Please ...

Page 12: ... filling mark Reconnect the filled canister to the device as described under 4 5 3 During normal operation the filling of the water lock is optional The canister may only be removed when the pump is switched off Prior to inserting the secretion canister into the device make sure that the filler of the water lock is sealed with the plug 4 5 2 Pop off valve The pop off valve releases in case of over...

Page 13: ...suction channel A double lumen hose system is indispensable Both hoses must be connected The hose set is a single use product for use with one patient only When using other hose systems this may lead to damage of the device 4 7 Universal fastening optional The fastening can be mounted to infustion tripods wheelchairs to the bed or to the standard rail Arrest the adjusting lever hereto please pull ...

Page 14: ...kPa 10mbar therefore when kPa is selected the vacuum range is 1kPa to 10kPa 4 9 3 Leakage test Perform a leakage test see chapter 3 3 If the leakage test failed please repeat the test Only exit this menu when you wish to start the therapy 4 8 Information on the display Fig 12 Fig 13 Fig 14 Fig 15 Actual vacuum Target vacuum Text line eg pump on or off Display of airflow Battery status Key lock Ser...

Page 15: ... separately Insert the new canister fig 17 Insert the rear left edge of the canister in an angle of approx 30 to the housing wall and move the canister to the left until it engages Then move the canister towards the housing until it clicks into place The ATMOS E 201 Thorax is again ready for use Start up the pump by pressing the I O key Reopen the clamp at the suction hose Exchange the canister at...

Page 16: ...tting in pressing the enter key again You may then switch to the next menu item with the keys If all settings are made exit the settings menu in depressing the menu item exit and confirm with the enter key on the display Your settings are also saved after switch off of the ATMOS E 201 Thorax Submenus Enter Return to relevant submenus Language Default vacuum Display brightness Alarm History German ...

Page 17: ... the correct function of the optical and acoustic displays is suffici ently controlled If you have done all the above steps successfully the correct function of the optical and acoustic indication is sufficiently controlled In order to suppress the alarm in case of alarm signalling please press the key The alarm continues to be displayed until the condition for the alarm is resolved eg target vacu...

Page 18: ...ce The unit itself can be wiped off with a moist not wet cloth The surfaces of the ATMOS E 201 Thorax can be cleaned disinfected with products of the following active ingredients QAV quartanary ammonium compounds Do not use Disinfectants containing concentrated organic or anorganic acids or bases since these may cause corrosion damages Disinfectants containing chloramides or phenol derivatives sin...

Page 19: ...lth hazard Nevertheless we recommend depending on the type of application the hygienic reprocessing of the device within the scope of the inspection according to the manufacturer s specifications at least once a year Pay attention to regulations and instructions valid for the respective application range 6 2 Reprocessing The way the suction device is used determines its reliability and safety Thes...

Page 20: ...ce must be checked by the authorised service Vacuum high Excessive vacuum is fed from outside Check correct hosing Battery low Battery is flat Connect the device to the mains battery is recharged and the charge level indicator is shown in the display on the left System blocked In the display it is shown that the system is blocked Check the hose and if the filter is blocked the canister including f...

Page 21: ...g and play system Material PC Lexan 144R Resin Further component parts a Pop off valve silicone b Hydrophobic bacterial filter made of sintered PE Weight 430 g Dimensions H x W x D max 214 x 280 x 96 mm max Packaging Canister is covered with a PE bag wrapped in a printed PET PEbag with Tyvek strips Label for the identification of contents Packaging unit 10 single wrapped canisters in a brown box s...

Page 22: ...ng port g end cap luer lock sampling port PCV RO 1007 K20131 PVC U RO 1051 K20108 PVC U RO 1051 K20108 TP025AATR010AD01 GVS Housing PVC NAKAN ATA 21 Naturale Resilia PCV RO 1011 K20108 PP RO 1041 K20199 ABS TERLURAN GP 35 Weight 119 g Dimensions I D x O D x L 5 15 x 8 15 3 65 x 5 15 x 1800 Packaging Hose system in sterile packing Tyvec Sealed seam 5 mm 1 mm Label for identification of contents Pac...

Page 23: ...ximum continuous suction 1 h Battery operation time at standard operation without fistula 12 h Battery recharging time Fully recharge at least 95 in approx 2 5 h Earth leakage current Max 0 5 mA Patient leakage current Max 0 01 mA Ambient conditions Transport storage Operation 10 50 C 30 95 air humidity without condensation at air pressure 500 1060 hPa 10 35 C 30 95 air humidity without condensati...

Page 24: ...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 GmbH Co KG for a professional disposal Prior to disposal respectively before transport all secretion canisters and hoses must be removed The device surface must be disinfected 10 1 Checking ATMOS suction devices Carry out an inspection accor...

Page 25: ...ts including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonics IEC 61000 3 2 Class A Flicker IEC 61000 3 3 Match 11 2 Guidelines and Manufacturer s Declaration Immunity for ATMOS E 201 Thorax The ATMOS E 201 Thorax is intended for use in the electromagnetic environment specified below The customer or us...

Page 26: ... Guidelines and Manufacturer s Declaration Immunity The ATMOS E 201 Thorax is intended for use in the electromagnetic environment specified below The customer or user of the ATMOS E 201 Thorax should ensure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Portable and mobile communications equipment should be separated ...

Page 27: ...as P is the maximum nominal output of the transmitter in watts W acc to manufacturer s specification NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines might not be applicable in any case The propagation of electromagnetic sizes is influenced by absorptions and reflections of buildings objects and people NOTE 1 With 80 MHz and 800 MHz the higher frequency ran...

Page 28: ...ATMOS MedizinTechnik GmbH Co KG Ludwig Kegel Str 16 79853 Lenzkirch Germany Phone 49 7653 689 0 atmos atmosmed de www atmosmed com ...

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