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D9U003VA0-0101_04

Symbols and Definitions

1.1 Warning Notices

1.1.1 Types of Warning Notices

Warning notices are differentiated by the type of danger using the following key words:

►

CAUTION

warns about the risk of material damage.

►

WARNING

warns about the risk of physical injury.

►

DANGER

warns about the risk of fatal injury.

1.1.2 Structure of Warning Notices

SIGNAL WORDS!

Type and source of danger!

► Measures to avoid the danger.

1.2 Instructions

Structure of instructions:

► Perform this step.

Results, if necessary.

1.3 Lists

Structure of bulleted lists:

■

List level 1

□

List level 2

●

List level 3

Содержание Air2Care 10

Страница 1: ...Air2Care Model 10 20 Mattress Replacement and Overlay Systems D9U003VA0 0101 Version 04 Publication date 2020 05 Instructions for Use and Technical Description...

Страница 2: ...0 Translation LINET 2020 All trademarks and brands are the property of the appropriate owners The manufacturer reserves the right to changes in the contents of the instructions for use that relate to...

Страница 3: ...20 6Use and Storage Conditions 21 6 1Storage 22 7Scope of Delivery and Bed Variants 22 7 1Delivery 22 7 2Contents 22 8Putting into Service 23 8 1Securing Strap System 23 8 1 1Installation Overlay Matt...

Страница 4: ...arns about the risk of material damage WARNING warns about the risk of physical injury DANGER warns about the risk of fatal injury 1 1 2Structure of Warning Notices SIGNAL WORDS Type and source of dan...

Страница 5: ...E WITH CARE THIS WAY UP KEEP DRY PROTECT FROM HUMIDITY PAPER RECYCLING SYMBOL DO NOT USE HAND TRUCK HERE DO NOT STACK DURING STORAGE MEDICAL DEVICE COMPATIBLE WITH MEDICAL DEVICE REGULATION MANUFACTUR...

Страница 6: ...NTAINING PHENOL DO NOT WRING REGULARY INSPECT THE INSIDE OF THE COVER FOR CONTAMINATION MACHINE WASH AT 71 C TUMBLE DRY ON LOW HEAT SETTING HANDWASH WITH DETERGENT INITIAL TEMPERATURE OF HOT WATER SHO...

Страница 7: ...USE AIR2CARE 20 PROTECTION AGAINST ACCIDENTS DUE TO ELECTRICAL CURRENT TYPE B APPLIED PARTS DOUBLE INSULATION POWER SWITCH I ON O OFF ALTERNATING CURRENT WEEE SYMBOL RECYCLE AS ELECTRONIC WASTE DO NOT...

Страница 8: ...Fig Serial label for Air2Care 10 100 127 V 1 Address of Manufacturer 2 1D Bar Code GS1 128 Serial Number 3 PI Product Identifier 4 DI Device Identifier GTIN Global Trade Item Number 5 Manufacturing D...

Страница 9: ...l Trade Item Number 5 Manufacturing Date Year Month Day 6 2D Bar Code GS1 DataMatrix DI PI UDI 7 Serial Number 8 Symbols Serial Label for Air2Care 20 SCU 1VAKE20000020 REF SN 20200122672 2020 02 21 01...

Страница 10: ...h Label mattress 7 3 2 5 4 6 1VAM000220200 REF SN 20200112325 2020 02 24 01 8592654070567 11 200224 21 20200112325 1 1 Address of Manufacturer 2 1D Bar Code GS1 128 Serial Number 3 PI Product Identifi...

Страница 11: ...ure pressure fault 1 8Abbreviations AC Alternating Current CE European Conformity CPR Cardiopulmonary Resuscitation dB Sound Intensity Unit DC Direct Current CUC Configuration number EMC Electromagnet...

Страница 12: ...and power supplies WARNING This medical device is not intended for oxygen enriched environment WARNING This medical device is not intended for use with flammable substances WARNING This medical device...

Страница 13: ...at installation is performed in accordance with the instructions in the instructions for use Ensure that maintenance is performed only by qualified personnel who have been trained by the manufacturer...

Страница 14: ...cm BMI 17 at moderate risk levels in the intensive care Application Environment 1 and 2 as in IEC 60601 2 52 Patients with any stage category of pressure ulcers 3 2Contraindications Mattress system is...

Страница 15: ...full length side formers Mattress system cover is water proof and vapour permeable cover made of polyurethene coated nylon which has a two 180 zip It has straps to prevent the mattress ends from movin...

Страница 16: ...bottom part non flexible resistant material top part flexible water proof material Mattress replacement system air foam 4 1 3Mattress replacement system air air The mattress replacement system is desi...

Страница 17: ...ient s weight distribution or position The SCU is equipped with an audio and or visual alarm system to detect power failures air pipe disconnections or other faults Fig SCU for Air2Care 10 Fig SCU for...

Страница 18: ...inflated 7 5 kg 6 kg 2 1 kg 3 5 kg 2 5 kg 2 cells 12 minutes 2 cells 12 minutes Environmental conditions Temperature Humidity Atmospheric pressure 10 C 40 C 30 75 795 1060 hPa Maximal load SWL Mattre...

Страница 19: ...ty of this air mattress system and lead to improper operation WARNING Mobile RF communication device including end use devices like antenna cables and external antenna should not be used closer than 3...

Страница 20: ...tions equipment IEC 61000 4 3 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz See Table 1 Fast electrical transients burst IEC 61000 4 4 2 kV for power line repetition frequency 100 kHz Surge IEC 61000 4 5 1 kV L...

Страница 21: ...5 500 5 785 5 100 5 800 WLAN 802 11 a n Pulse modulation 217 Hz 9 NOTE There are applied no deviations to requirements of IEC 60601 1 2 ed 4 NOTE There are no known other measures for keeping the basi...

Страница 22: ...suitable cover Store in a place suitable for medical devices NOTE Never store more than 4 mattresses on each other This may result by damaging the mattress or system malfunction 7Scope of Delivery and...

Страница 23: ...positioned at the Head Thigh and Foot areas of the mattress on both left and right sides Two separate straps are supplied also Each strap has a trident buckle arrangement with a fixed fema le part 1...

Страница 24: ...lated Fig Fixing of the mattress 8 2Installation of SCU System Control Unit WARNING Risk of injury when putting SCU into service Make sure that your hands are not trapped between hook and foot board w...

Страница 25: ...e sure the air connector is not in transport mode see Transport mode Insert air connector 1 in the socket 2 at an angle of approx 45 Push air connector 1 down until it clicks into place and air connec...

Страница 26: ...ing on SCU Disconnect mains cable from mains Fig Switching on SCU 8 4 2Inflation Inflation After switching ON the mattress will start to inflate the indicator is illuminated during inflation Set the p...

Страница 27: ...o lack of cleaning Ensure that no moisture gets into the mattress Ensure that no body fluids get into the mattress cover Regulary inspect the inside of the cover for contamination Mattress must be cle...

Страница 28: ...TATIC Fully inflated mattress Static mode APT Alternating pressure therapy Dynamic mode APT Alternating pressure therapy Air2Care operates by alternating pressure in a two cell system in a 12 minute i...

Страница 29: ...ee System errors 3 Mains switch I On O Off 4 Mode selection button APT Alternating pressure therapy Dynamic mode MAX Maximum inflation mode CLP Constant low pressure mode 5 Mode indicator Indicates th...

Страница 30: ...d 9 2 3Pressure Control WARNING Risk of injury due to incorrect pressure setting Consult qualified hospital staff prior to adjusting pressure The recommended pressure levels may not be the optimum for...

Страница 31: ...reater comfort then the pressure level can be reduced by turning the pressure control dial to the left then repeating the patient s sacral check Pressure Settings Changes in Patient s Position When a...

Страница 32: ...or next to MAX mode stops flashing Switch off SCU via mains switch O Disconnect SCU from mains Mattress is now in Transport mode Option 2 Disconnect air connector from the SCU and twist the end to sea...

Страница 33: ...mes Pressure fault Beep Flashes four times Problem Symptom Air2Care10 Symptom Air2Care20 Action Power failure SCU will not turn on Mains switch not illuminated No indicators on front panel illuminated...

Страница 34: ...1 1 Restart unit by turning power off and then back on If fault re occurs turn off SCU and immediately call your local appro ved service provider NOTE If any of the above problems occur and cannot be...

Страница 35: ...ase for the dynamic cushion allowing it to operate effectively and preventing the patient damaging the cushion when siting in the chair sitting down or standing up Place the Air2Care seat cushion dire...

Страница 36: ...ient Ensure that seat cushion is completely inflated Preparation Inflate seat cushion see Installation and Startup Seating of the patient Sit patient on seat cushion For an ideal sitting position Ensu...

Страница 37: ...infection control Mattress parts to be cleaned Recommended Cleaning Agents General cleaning Top Cover Seating System Standard hospital detergents Alcohol or Quaternary Ammoni um based disinfectants C...

Страница 38: ...before use Even if the cleaner instruc tions say that this is not required This prevents a build up of chemicals on the mattress surface that could reactivate during use and affect biocompatibility C...

Страница 39: ...gles 1 on each corner Mattress replacement Air Foam 4 toggles 1 on each corner holding top deck foam is loose Mattress replacement Air Air 4 toggles 1 on each corner holding both air decks Undo next t...

Страница 40: ...utside of mattress and outside of SCU for mechanical damage and signs of severe wear and tear Check if mattress and SCU are working properly Check external air filter in side of SCU for dust and dirt...

Страница 41: ...ng through an authorized company more details on www linet cz 12 2Disposal The main objective of the obligations arising from the European Directive No 2012 19 EU on Waste Electric and Electronic Equi...

Страница 42: ...aterial and manufacturing re lated failures and errors Failures and errors caused by incorrect use and external effects are not covered Justified complaints will be fixed free of charge during the war...

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