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Atmos S 042 NPWT, Руководство по эксплуатации, Страница: 5 / 40

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User profile:

 Doctors, medical auxiliaries without restrictions.

Patient groups:

 Patients of all ages with and without restrictions.

Application organ:

 Chronic and acute wounds on the skin which do not close by primary wound 

healing.

Application time:

 Under normal conditions for a continuous application over a period of more 

than 30 days.

Application site:

 Suitable for application in clinics, medical fields and home environment. The 

application of the negative pressure device may only be conducted under physicians instructed 

and by medically trained staff.

Contraindications:

 Contraindications exist by patients with malignant tumour wounds (non 

enteric fistulas) which have not yet been examined, osteomyelitis or necrotic tissue. The ATMOS

®

 

S 042 NPWT must not be applied to exposed nerves, anastomotic areas, blood vessels or organs. 

The negative pressure device must not be used:

 

-

for non-medical applications.

 

-

in the presence of flammable or explosive gases or liquids.

The system is not evaluated for the emergency medicine in the rescue area (rescue vehicle, acci-

dent location). 

The product is:

 active

Sterility:

 Secretion canister system is sterile.

Single-use product/reprocessing:

 Secretion canisters are disposable products. 

1.3  Function

The ATMOS

®

 S 042 NPWT is a particularly convenient suction device for negative pressure wound 

therapy. The vacuum unit is operated by an electromotive maintenance-free diaphragm pump. 

During operation the pump creates a vacuum in the wound dressing, the hose system and the 

secretion canister. This vacuum is used to suck secretions. The vacuum unit automatically cre-

ates, controls and monitors the set therapy values. The secretion is collected in the respectively 

provided secretion canister. A special filter technology prevents penetration of liquids, bacteria 

and odours into the device. Therapy settings can be made using the touch screen.
The vacuum unit is equipped with a rechargeable lithium-ionic battery. Safe recharging of the 

battery is ensured by a microprocessor-controlled electronic charge system located in the vacu-

um unit.
The main performance feature is the regulation (in the normal case) and the limitation (in the 1st 

fault) of the maximum possible negative pressure of the pump to approx. -500 mmHg. 

Содержание S 042 NPWT

Страница 1: ...GA1GB 810101 0 2017 03 Index 24 These operating instructions are valid from software version 1 3 Operating Instructions ATMOS S 042 NPWT English ...

Страница 2: ...s consumables and spare parts are available from ATMOS MedizinTechnik GmbH Co KG Ludwig Kegel Straße 16 79853 Lenzkirch Germany Phone 49 7653 689 0 Fax 49 7653 689 190 49 7653 689 292 Service Centre atmos atmosmed de www atmosmed com ...

Страница 3: ...ff 19 4 1 5 Key lock 19 4 1 6 Selecting the language 20 4 1 7 Basic settings 20 4 1 8 Brightness 21 4 1 9 Day Night Mode 21 4 2 Warning messages 22 4 2 1 Battery discharged 22 4 2 2 Hose blocked 22 4 2 3 Secretion canister full 23 4 2 4 Leakage 23 4 2 5 Service required 23 4 2 6 Negative pressure 50 mmHg 23 4 2 7 Battery service life exceeded 24 4 2 8 Automatic switching off 24 4 2 9 Period tests ...

Страница 4: ... the value of your ATMOS S 042 NPWT will be preserved The product ATMOS S 042 NPWT bears CE marking CE 0124 according to the EC Directive of the council for medical products 93 42 EEC and meets the basic requirements of Appendix I of the directive The product ATMOS S 042 NPWT complies with all applicable requirements of the Directive 2011 65 EC restricting the use of certain hazardous substanc es ...

Страница 5: ...n the rescue area rescue vehicle acci dent location The product is active Sterility Secretion canister system is sterile Single use product reprocessing Secretion canisters are disposable products 1 3 Function The ATMOS S 042 NPWT is a particularly convenient suction device for negative pressure wound therapy The vacuum unit is operated by an electromotive maintenance free diaphragm pump During op...

Страница 6: ...irements of the EC Directives IP33 Type of protection Attention 1 5 Scope of delivery Prior to dispatch the ATMOS S 042 NPWT was subjected to an extensive functional test and was carefully packed Nevertheless please compare the contents of the shipment on com pleteness immediately upon receipt see delivery note Vacuum unit Battery recharging unit Operating Instruc tions Shoulder strap Mains cable ...

Страница 7: ... the device Damaged cables must be replaced immediately Only undamaged mains connection must be used Only use the provided medical power supply unit Manufacturer GlobTek Inc model GTM91099 6015 3 0 T2 Do not use an extension lead You may only disconnect the device from the power supply via the power cable The device does not have a power switch Ensure that the power supply unit is easily accessibl...

Страница 8: ...nector then please pay attention to the following Wounds which are connected to a negative pressure system via a Y connector must be regularly checked by health care professionals The device only recognizes leakages and blockages when they appear simultaneously in the hose between the device and the Y connector or in both hoses between the Y connec tor and the wound If the leakage or blockage is o...

Страница 9: ...device may continue to be used If not it may not be operated again until it has been checked by the customer service centre Before connecting the device it needs to be checked whether the requested mains voltage of the device matches the mains voltage of the mains power supply Never place the device directly beside other devices Do not stack the device After the transport of the unit in temperatur...

Страница 10: ...aning and disposal of the ATMOS S 042 NPWT or its accessories reasonable general pre cautionary measures should be taken Improper handling may result in the risk of inhalation of infectious substances or the risk of contamination to internal parts of the device The vacuum unit must only be used by a physician or upon medical request by qualified and authorised personnel The user should be correspo...

Страница 11: ...elivery Secretion canister release button Rear side 6 8 9 10 7 7 Secretion canister connections Carrying strap hinge Type plate Canister guide USB connectors no function for users Secretion canister 11 12 11 Bacterial filter 12 Canister guide The hose must not be clamped Do not use clamps Because of EP 0 853 950 B1 valid in AT BE CH DE DK ES FR GB GR IE IT LI LU MC NL PT SE ...

Страница 12: ...ing the displayed values Minus button For decreasing the displayed values Int Intermit button For activation of the intermittent vacuum treatment When activated it is framed green Cont Continuous button For activation of the continuous vacuum treatment When activated it is framed green Min 3 3 120 20 mmHg Intermittent menu Touch this button to access the intermittent menu Here you can set the inte...

Страница 13: ...olonged drastically Improper use of the device may lead to serious damage Defects which occur due to improper handling of the device are not covered by the guarantee Connect the plug of the battery recharging unit to the charging connector of the vacuum unit Connect the battery recharging unit with the supplied country specific power cable Plug the mains plug into the socket The vacuum unit then d...

Страница 14: ...e unit to patient s bed To prepare attachment to a patient s bed hook the snap link instead of snap link to the device Now you only need to connect the strap ends and to each other to attach the negative pressure unit to a patient s bed Unlocking the negative pressure unit for removal Press the unlocking device of the strap closure laterally and keep it pressed Now pull the two ends apart To make ...

Страница 15: ...Perform a slight tension test at the secretion canister to ensure that it is tightly fitted to the device Removal of secretion canister Disconnect the secretion canister as described in the chapter Connecting removing the vacuum unit with the wound dress ing set Press the release button blue at your vacuum unit and re move the secretion canister in a slightly inclined position Correctly dispose of...

Страница 16: ...sen location and course of the hose a secretion col umn in the hose can cause the negative pressure in the wound to not correspond to the selected value Therefore always place the vacuum unit at the same level or lower than the patient Turning the holder clamp The stand holder may be attached horizontally and vertically to plates e g table boards pipes and stands with a diameter up to 40 mm Pull t...

Страница 17: ...irmly attached to the desired fixture 3 3 6 Attaching removing the vacuum unit at from the universal bracket Firmly hold the vacuum unit during the whole process Place the vacuum unit onto the stand holder Ensure that the thread at the bottom of the vacuum unit is directly above the fixing screw of the stand holder Turn the fixing screw counter clockwise to fix the vacuum unit Removal of the vacuu...

Страница 18: ...y the wound dressing and the hose system need to be checked depends on the patient as well as the wound Observe the instructions from the attending physician With negative pressure values 50 mmHg it is physically impossible to transport a secretion column over a higher height difference Therefore never place the negative pressure unit higher than the patient to prevent sagging hoses 4 1 3 Starting...

Страница 19: ...change with a finger The respective field is marked in dark blue Now touch the or key to set the desired value To save the newly set values touch the key The values are only saved if the intermittent menu is closed with the key If you do not wish to accept the values you have set wait until the screen automatically returns to the main menu But do not touch the screen for this 4 1 5 Key lock The AT...

Страница 20: ...cting the language Various languages can be set on the ATMOS S 042 NPWT Proceed as follows Press the key to reach the submenu Select the field Language Enter the language selection menu Select the desired language here by touching the screen A tick appears next to the selected language To save the settings touch the key 4 1 7 Basic settings Touch the key to reach the submenu Select the field Basic...

Страница 21: ...t hand side Now set the desired value with the and keys To save the settings touch the key The screen reacts with a delay of two seconds 4 1 9 Day Night Mode The negative pressure unit has a day night mode the device adjusts automatically to the envi ronmental lighting During battery operation During battery operation the screen turns black after 5 minutes Under low ambient light condi tions displ...

Страница 22: ...ound dressing and entire hose system at regular intervals How frequently the wound dressing and the hose system need to be checked depends on the patient as well as the wound Observe the instructions from the attending physician With negative pressure values 50 mmHg it is physically impossible to transport a secretion column over a higher height difference Therefore never place the negative pressu...

Страница 23: ...ve pressure unit By touching the key this warning message can be sup pressed for 5 minutes If it is not possible to rectify the leakage with these meas ures then the wound dressing and the hose system must be replaced 4 2 5 Service required This error message will be triggered if there is any damage to the pump The negative pressure unit may no longer be ap plied and must be checked by the service...

Страница 24: ...urer as soon as possible 4 2 8 Automatic switching off If a power supply unit has not been connected in spite of repeated Battery discharged warning messages the negative pressure unit switches itself off automatically after 30 minutes The negative pressure unit can only be switched on again once a power supply unit has been connected thereby re charging the battery 4 2 9 Period tests A period tes...

Страница 25: ...form For disinfection all the surface disinfectants which are stated in chapter 5 4 Recommended disinfectants are suitable Prior to cleaning the device please remove and dispose of all disposable parts like secretion canister dressing and hoses When the device is used on another patient all parts which come into contact with the suction material must be disposed of secretion canister hoses and dre...

Страница 26: ...s sul phate 45 g Schülke Mayr Norderstedt SaniCloth Active Didecyldimethylammonium chloride 1 g Ecolab Düsseldorf Incidin Active peracetic acid 1 g Ecolab Düsseldorf Mikrozid Sensitive Wipes benzyl C12 16 alkyldimethyl chloride Didecyldimethylammonium chloride benzyl C12 14 alkyl ethylphenyl methyl dimethyl chlorides 0 26 g 0 26 g 0 26 g Schülke Mayr Norderstedt Mikrobac Tissues benzyl C12 C18 alk...

Страница 27: ... occurrence of unusual noises Operational and functional disorders which cannot be resolved by means of the hints de scribed in the chapter Troubleshooting Measures when sending in the vacuum unit If the vacuum unit has to be sent in for repair after consultation with the manufacturer or an authorized service partner we ask you to observe the following Please send in the device complete with batte...

Страница 28: ...emove and properly dispose of consumables 2 Clean and disinfect the product 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 www atmosmed com 5 The device must be well padded and packed...

Страница 29: ...y network The battery is charged and the state of charge is indicated in the display Therapy not started Switch on pump Secretion canister full Exchange secretion canister Leakage Wound dressing has a leakage Check wound dressing for any leakage if need be exchange the dressing Connection between secretion canister and vacuum unit has a leakage Check connection between vacuum unit and canister if ...

Страница 30: ... the ATMOS service or a certi fied service partner WATCH Dog Jump er Watch Dog Jumper not set Contact the ATMOS service or a certi fied service partner Device is not working Damage as a result of being dropped Contact the ATMOS service or a certi fied service partner ...

Страница 31: ...oam Kit Thin 314 1550 0 VivanoMed Abdominal Kit 314 1650 0 Hydrofilm 20 x 30 cm 314 1620 0 Hydrofilm 10 x 12 5 cm 314 1630 0 VivanoMed Foam L 314 1560 0 VivanoMed Foam M 314 1570 0 VivanoMed Foam S 314 1580 0 VivanoTec Port small 314 1590 0 VivanoTec Port 314 1600 0 VivanoTec Y Connector 314 1610 0 ATMOS Green Clean SK 534 3110 0 ATMOS Green Clean MK 534 3120 0 Spare parts REF 2 pin power cord 008...

Страница 32: ...erformance at sea level however limited mechanically and by electronic control Control of negative pressure Electronically controlled max 250 mmHg min 20 mmHg in steps of 5 mmHg secretion canister must be connected for precise vacuum control Display Graphic display colour with background lighting with adap tation to ambient lighting conditions and automatic switch off energy saving mode Operating ...

Страница 33: ... ml Secretion canister 800 ml Power supply and power cable 1 20 kg 0 16 kg 0 18 kg 0 50 kg Period tests Inspection according to the manufacturers specifications every 24 months Safety class EN 60601 1 Device II Battery recharging unit II Degree of protection The application part of the suction device is the hose canis ter system Type BF Protection category IP 33 Classification according to Ap pend...

Страница 34: ...ithin the EC The device described above is a high quality medical product with a long service life After its life cycle it must be disposed of professionally 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 in the respective country Disposal within the Federal Republic of Ger...

Страница 35: ...etwork that supplies build ings used for residential purposes Harmonic emissions accord ing to IEC 61000 3 2 Inapplicable Voltage fluctuations flicker according to IEC 61000 3 3 Corresponds 11 2 Guidance and manufacturer s declaration electromagnetic immunity The ATMOS S 042 NPWT is intended for use in the electromagnetic environment specified below The customer or user of the ATMOS S 042 NPWT sho...

Страница 36: ... of the UT for 5 s Mains power quality should be that of a typical commer cial or hospital environment If the user of the ATMOS S 042 NPWT demands contin ued function even in case of interruptions of the energy supply it is recommended to supply the ATMOS S 042 NPWT from an uninter ruptible current supply or a battery NOTE UT is the alternating maims voltage prior to application of the test levels...

Страница 37: ...e higher frequency range applies NOTE 2 These guidelines might not be applicable in all cases The emanation of electromagnetic waves is affected by absorption and reflection 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 pre...

Страница 38: ... frequency m Nominal output of the transmitter W 150 kHz to 80 MHz d 3 5 V1 P 80 MHz to 800 MHz d 3 5 E1 P 800 MHz to 2 5 GHz d 7 E1 P 0 01 0 12 0 07 0 14 0 1 0 37 0 22 0 44 1 0 1 17 0 7 1 4 10 3 7 2 2 4 4 100 11 7 7 14 For transmitters for which the maximum nominal output is not indicated in the above table the recommended safety distance d in meters m can be determined using the equation be long...

Страница 39: ...39 12 0 For your notes ...

Страница 40: ...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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