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26

14.0

   

Notes on EMC

14.3  Guidelines and Manufacturer´s Declaration - Immunity 

The ATMOS

®

 A / C 161 Battery is intended for use in the electromagnetic environment specified below. The customer 

or user of the ATMOS

®

 C 161 should ensure that it is used in such an environment.

Immunity Test

IEC 60601-

Test Level

Compliance Level

Electromagnetic Environment 

- Guidance

Conducted RF

IEC 61000-4-6

3 V

eff

150 kHz bis 80 MHz 10 V

Portable and mobile communications 

equipment should be separated from the 

RS 221 incl. the cables by no less than the 

distances calculated/listed below.

Recommended distances:

d = 0,35 

√ 

P

d = 0,35 

√ 

80 MHz bis 800 MHz

d = 0,70 

√ 

P

800 MHz bis 2,5 GHz

where „P“ is the max. power in watts (W) 

and D is the recommended separation 

distance in meters (m).

Field strengths from fixed transmitters, as 

determined by an electromagnetic site (

a

survey, should be less than the compli-

ance level (

b

). 

Interference may occur in the vicinity of 

equipment containing following symbol

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz bis 2,5 GHz 10 V/m

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.
a      The field strength of stationary transmitters, such as base stations of cellular phones and mobile terrain radio

 

        equipment, amateur radio transmitters, cbm broadcast and TV stations cannot be predestined exactly. 

        To determine the electromagnetic environment in regard to stationary transmitters, a study of the location is to 

        be considered. If the measured field strength at the location where the ATMOS

®

 A / C 161 Battery  is used  

        exceeds the above compliance level, the ATMOS

®

 A / C 161 Battery is to be observed to verify the intended 

use.  

        If abnormal performance characteristics are noted, additional measures might be necessary, e. g. a changed  

        arrangement or another location for the device.

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

Summary of Contents for A 161 Battery DDS

Page 1: ...Gebrauchsanweisung ATMOS A C 161 Battery Operating instructions English GA1GB 310120 0 2019 04 Index 32 0124 ...

Page 2: ... 21 12 0 Technical specifications 22 13 0 Checking Reprocessing Disposal 23 13 1 Checking ATMOS suction devices 23 13 2 Reprocessing 23 13 3 Disposal 23 14 0 Notes on EMC 24 1 0 Introduction 3 1 1 Notes on operating instructions 3 1 2 Function 4 1 3 Intended use 4 1 4 Scope of supply 5 1 5 Transport and storage 5 1 6 Explanation of symbols 5 2 0 Safety advice 6 3 0 Setting up and starting up 7 3 1 ...

Page 3: ...o the EC Directive of the council for medical products 93 42 EEC and meets the basic requirements of annex I of this directive The product ATMOS A C 161 Battery 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 conditio...

Page 4: ...control elements Fig 1b ATMOS A 161 Battery DDS Vacuum adjustment On off push button Charge level indicator Battery test button Hose storage 1 3 Intended use Name ATMOS A 161 Battery ATMOS C 161 Battery 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 Su...

Page 5: ...notice Serial number Order number Application part type BF Manufacturing date Refer to operating instructions Pump On Off Battery test function Fuse Protection class II Important information Ambient conditions Transport Storage 30 50 C 5 90 air humidity non condensing at air pressure 700 1060 hPa Operation and 10 35 C battery charging 20 80 air humidity non condensing at air pressure 700 1060 hPa ...

Page 6: ...e disregarded Assembly resetting alterations extensions and repairs are not carried out by people authorised by ATMOS Prior to starting up the ATMOS A C 161 Battery read these operating instructions carefully No warranty rights shall exist in the event of damage or failure caused by the use of non ATMOS accessories or non ATMOS consumables The safety standard of the ATMOS A C 161 Battery correspon...

Page 7: ...t damage its diaphragms ATMOS A C 161 Battery DDS At least one DDS bacterial filter must always be available because the device may not be operated without filter Fig 3 Fig 2 Fig 4 Fig 5 3 4 Charging the battery The battery is charged by the 12 V low voltage connector Fig 4 Chapter 9 3 contains a reference to the battery handling 3 4 1 Charging with battery charging power pack Connect the low volt...

Page 8: ...not included in delivery 13 4 4 Hose rinsing Dispose the suction catheter and rinse the suction tube with clean water or disinfec tion liquid after every suction procedure We recommend to use the rinsing bottle in which you can carry clean water along with you A separate rinsing canister set is available REF 313 0008 0 Important notes on safety Make sure that the collection canister is evacuated i...

Page 9: ...tly 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 5 2 Insertion Removal of the DDS canister The filter must be fixed to the housing Afterwards the secretion canister is inserted For insert the DDS...

Page 10: ...rial filter A bacterial filter avoids divulgement of bacterias Sterile packed parts may no longer be used if their packing was damaged during transport or storage Danger of infection for the patient 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 Recepta...

Page 11: ...ck again for density otherwise no vacuum can be built up Insert the vacuum hose Only bags with integrated bacterial filter may be used 7 4 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 7 5 Assembling the Serres secretion canister system 7 6 Connect hose Insert th...

Page 12: ...1 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 8 1 3 Fingertip Fingertip is not included in delivery Prio...

Page 13: ...surface X X X Rinsing the vacuum hose X X Disinfection of the vacuum hose X X Disinfection of the hose connector X X 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 d...

Page 14: ... Magnesium peroxyphthalate 80 g Bode Chemie Hamburg granulate Hexahydrate End of product 12 2014 Dismozon plus Magnesium peroxyphthalate 95 8 g Bode Chemie Hamburg granulate Hexahydrate 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 ...

Page 15: ... KG Ludwig Kegel Straße 16 D 79853 Lenzkirch Telefon 49 0 7653 689 0 Fax 49 0 7653 689 292 www atmosmed de e mail atmos atmosmed de 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...

Page 16: ... and hoses can be disinfected with a disinfection agent see Never irrigate the device with water and never emerge it into any 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 finge...

Page 17: ... ATMOS C 161 Battery has a condensate collector at the bottom of the device fig 1 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 c...

Page 18: ...orm QD 434 Delivery complaint return shipment and the respective Decontamination certificate This form is enclosed to each delivery and can be found at www atmosmed com 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 p...

Page 19: ...ter 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 1 3 Secretion or blood has been su cked in and valve plates of th...

Page 20: ...s Bacterial filter for DDS secretion canister 10 pcs 340 0054 0 Set of consumables for ATMOS A and C class DDS 313 0160 0 General accessories Receptal external canister 1 5 l 310 0221 0 Serres external canister 1 l 312 0465 0 Medi Vac canister 1 l 312 0473 0 Basket for catheters L 340 mm 444 0140 0 Basket with standard rail holder 320 0075 0 Suction hoses fingertip Plak VacTM tooth brush with suct...

Page 21: ... 11 3 Spare parts Hider only for ATMOS C 161 Battery 999 1996 0 Self adhesive elastic buffer 5J 5017 000 0018 0 Bacterial filter overflow protection 340 0054 0 Plug GPN 300 000 0824 0 Ball for overflow protection 000 0839 0 Power supply cord 008 0866 0 ...

Page 22: ... V battery charging power supply or 12 V batte ry charger leads Intermittent duty after 10 min 30 min cooling down depending on ambient tempe rature Emergency operation In case of fully discharged battery mains operation is possible Power input battery charging power supply max 1 5 A Power consumption 45 AV Battery 8 4 V 6 Ah lithium ionic at least 500 charging cycles in case of partial discharge ...

Page 23: ...der 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 13 1 Checking ATMOS suction devices The ATMOS suc...

Page 24: ...her converters and cables than stated may lead to an increased emission or a reduced interference immunity of the equipment or system i Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The ATMOS A C 161 Battery uses RF energy only for its internal function Therefore its RF emis sions are very low and are not likely to cause any interference in nearby ele...

Page 25: ...UT 95 Dip of the UT for 0 5 Cycle 40 UT 60 Dip of the UT for 5 Cycles 70 UT 30 Dip of the UT for 25 Cycles 5 UT 95 Dip of the UT for 5 s 5 UT 95 Dip of the UT for 0 5 Cycle 40 UT 60 Dip of the UT for 5 Cycles 70 UT 30 Dip of the UT for 25 Cycles 5 UT 95 Dip of the UT for 5 s Mains power quality should be that of a typical commercial or hospital environment If the user of the AT MOS A C 161 Battery...

Page 26: ...ity of equipment containing following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz bis 2 5 GHz 10 V m 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 a The field strength of stationary transmitters such ...

Page 27: ...equipment Separation distance depending on transmit frequency m Nominal output of the transmitter W 150 kHz bis 80 MHz d 0 35 P 80 MHz bis 800 MHz d 0 35 P 800 MHz bis 2 5 GHz d 0 70 P 0 01 0 035 0 035 0 07 0 1 0 11 0 4 0 22 1 0 35 0 35 0 7 10 1 1 1 1 2 2 100 3 5 3 5 7 0 For transmitters for which the maximum nominal output is not indicated in the above table the recommended separation distance d ...

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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