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D9U003VSX-0101_00

5.3 Environment Conditions

Use Conditions

Ambient Temperature

10°C - 40°C

Relative Humidity

30% - 75 %

Atmospheric Pressure

795 - 1060 hPa

Storage and Transport Conditions

Ambient Temperature

-40°C - 70°C

Relative Humidity

10% - 100 % (non-condensing)

Atmospheric Pressure

795 - 1060 hPa

5.4 Electromagnetic Compatibility

OptiCare X integrated mattress system is intended for hospitals except for near active HF surgical equipment and the RF

shielded room of a medical system for magnetic resonance imaging, where the intensity of EM disturbances is high.

OptiCare X integrated mattress system has defined no essential performance.

WARNING!

It is recommended to avoid the use of this device next to or in block with other device, because it could lead

to improper operation. If such use is needed, this device and the other equipment should be under surveillan-

ce to verify proper operation. (Does not apply for compatible medical bed from LINET)

List of used cables:

►

Mains cable

, maximum length 6 m

WARNING!

Use of the accessories, converters and other cables, than specified and provided by manufacturer of this Op

tiCare X integrated mattress system could lead to increase of electromagnetic emission or lower the electro

magnetic immunity of this OptiCare X integrated 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 30 cm (12 inches) from any part of this OptiCare X integrated mattress system,

including cables specified by manufacturer. Otherwise this could lead to deterioration of functionality of this

OptiCare X integrated mattress system.

WARNING!

Do not overload the OptiCare X integrated mattress system (SWL), respect the duty cycle (INT.) and consider

chapter 13 Maintenance in order to maintain the basic safety with regard to electromagnetic disturbances for

the expected service life.

5.4.1 Manufacturer Instructions - Electromagnetic Emissions

Emission Test

Compliance

RF emissions

CISPR 11

Group 1

RF emissions

CISPR 11

Class B

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions

IEC 61000-3-3

Complies

Содержание OptiCare X

Страница 1: ...Instructions for Use and Technical Description OptiCare X Integrated Mattress System for Multicare X D9U003VSX 0101 Version 00 Publication Date 2021 10...

Страница 2: ...E T s r o 2021 All rights reserved 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...

Страница 3: ...ts OptiCare X 23 7 1Delivery 23 7 2Scope of Delivery 23 8Putting into Service only OptiCare X for Multicare X 24 8 1SCU System Control Unit 26 8 2Replacing the Mattress 26 9Manipulation OptiCare X for...

Страница 4: ...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 2Structure of Warning Notices SIGNAL WORDS Type and source of d...

Страница 5: ...CARE THIS WAY UP KEEP DRY PROTECT FROM HUMIDITY PAPER RECYCLING SYMBOL DO NOT STACK DURING STORAGE DO NOT USE HAND TRUCK HERE OVERSEAS PACKAGE STACKING LIMIT BY NUMBER 3 PACKAGES FOR TRANS PORT OVERS...

Страница 6: ...SPECT THE INSIDE OF THE COVER FOR CONTAMINATION MACHINE WASH AT MAX 71 C FOR 3 MINUTES TUMBLE DRY ON LOW HEAT SETTING MAX 60 C HANDWASH WITH DETERGENT INITIAL TEMPERATURE OF HOT WATER SHOULD NOT EXCEE...

Страница 7: ...NS FOR USE DISINFECT USING SOLUTION CONTAINING LESS THAN 1000 ppm OF CHLORINE REFER TO INSTRUCTIONS FOR USE WIPE WITH WATER COVER MATERIALS ARE FIRE RESISTANT TO BS7175 SOURCE 0 1 AND 5 MATTRESS FOOT...

Страница 8: ...REFERENCE NUMBER PRODUCT TYPE DEPENDING ON CONFIGURATION SERIAL NUMBER ONLY SUITABLE FOR INDOOR USE APPLIED PARTS TYPE B WARNING READ INSTRUCTIONS FOR USE T1AH ANTI SURGE FUSE SCU FUSE ALTERNATING CUR...

Страница 9: ...Address of Manufacturer Manufacturing Date Year Month Day Product Reference Number Product Serial Number Global Trade Item Number GTIN Unique Device Identification UDI symbols and electrical specifica...

Страница 10: ...5s silence medium priority Pressure Sensor Fault fault number 4 Air Hose Disconnected fault number 101 Inflate Fault fault number 102 Kinked Air Hoses fault number 107 REPEATED BEEP 0 2s sound 10s sil...

Страница 11: ...ent ON Activation OFF Deactivation ppm parts per million millionth 1000 ppm 0 1 REF Reference Number product type depending on configuration SCU System Control Unit integrated mattress SN Serial Numbe...

Страница 12: ...rated mattress system can only be used when installed on a LINET Multicare X bed frame WARNING To avoid the risk of electric shock the Multicare X bed must only be connected to a supply mains with pro...

Страница 13: ...serious incident that has occurred in relation to the device OptiCare X integrated mattress system should be reported to the manufacturer and the competent authority of the Member State in which the...

Страница 14: ...ged when you move or adjust Multicare X bed Keep the Mattress support platform with OptiCare X integrated mattress system in the lowest position at any time when the healthcare personnel are not treat...

Страница 15: ...patients weight 40 kg height 146 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 2Co...

Страница 16: ..._00 16 4Product Description OptiCare X 1 2 6 4 7 8 3 5 1 Cover 2 Comfort Layer 3 Air Cell Sets 4 Plastazote Foam Base 5 Foam Base 6 CPR Valve 7 Base Cover 8 Heel Section Fig OptiCare X Mattress Descri...

Страница 17: ...D9U003VSX 0101_00 17 Fig Structure of the Air Cell Sets top view 1 Area A WHITE CELLS 2 Area B GREY CELLS 3 Area S BLUE CELLS 1 1 2 3 3 2 1...

Страница 18: ...ss against fluid ingress The cover base is made from water impermeable high strength non stretch material that is suitable for any demanding environ ment Additional quick release straps prevent the ma...

Страница 19: ...are X ready Multicare X bed is equipped with a dedicated power outlet for the SCU at the auxiliary power distribution point The SCU is operated via the Integrated Mattress Screen on the Multiboard X L...

Страница 20: ...ut any sounding alert signal Maximum Patient Weight 250 kg 551 lbs Minimum Mattress Load 40 kg Maximum Washing Temperature of the mattress cover ELITE MIC200 71 C Maximum Washing Temperature of the ma...

Страница 21: ...ngth 6 m WARNING Use of the accessories converters and other cables than specified and provided by manufacturer of this Op tiCare X integrated mattress system could lead to increase of electromagnetic...

Страница 22: ...0 5 cycle At 0 45 90 135 180 225 270 a 315 0 UT 1 cycle and 70 UT 25 30 cycle Single phase at 0 0 UT 250 300 cycle Table 1 IMMUNITY to RF wireless communications equipment Test frequency MHz Band MHz...

Страница 23: ...SCU is not in use Log off the mattress Unplug mains cable When mattress is not in use Unclip all 5 air pipes Undo webbing strap next to air pipes Make sure mattress has been cleaned and is completely...

Страница 24: ...ng into service is performed exclusively by manufacturer s customer service or trained hospital personnel The OptiCare X mattress system replaces any mattress on the Multicare X bed frame Remove any e...

Страница 25: ...DS Sensors in the System Control Unit SCU Area A B and ODV mattress air connectors detect that a valid air connector has been connected When all three correct air connectors are detected the SCU will...

Страница 26: ...es not come factory fitted have it installed by a service engineer authorised by LINET 8 2Replacing the Mattress If replacing the OptiCare X mattress with another mattress replacement system then you...

Страница 27: ...red with safety straps Use of the mattress without the safety straps could impair the mattresses ability to function correctly CAUTION Material damage due to dampness or contamination Make sure mattre...

Страница 28: ...clockwise in accordance with the red arrow The mattress will deflate Fig CPR valve label Fig Position of the CPR valve on the OptiCare X integrated mattress placed on the Multicare X bed Create the i...

Страница 29: ...of patient Typical deflation time for OptiCare X mattress is 15 seconds max 30 s Timer indicator counts down 1 hour during CPR Mode Fig CPR button Multiboard X To activate the CPR Mode on Multiboard...

Страница 30: ...Control Panel To activate the CPR Mode on Attendant Control Panel Press and hold CPR button on the Attendant Control Panel for at least 3 s The mattress deflates completely and mattress support platf...

Страница 31: ...egrated Mattress Screen 6 MAX Mode Icon press to enter MAX Mode 7 Mattress Status Indicator signalising mattress condition in relation to patient 8 RE OPTIMIZE Icon press to start pressure optimisatio...

Страница 32: ...X compressor is installed on the bed but OptiCare X mattress is not connected to the compressor MATTRESS DISCONNECTED screen appears If the OptiCare X mattress has been deliberately removed from the...

Страница 33: ...ess wait until MATTRESS IDENTIFICATION disappears 9 4 3MATTRESS INFLATION When OptiCare X mattress is identified it is not prepared for a patient because mattress is not inflated enough To achieve min...

Страница 34: ...nt has changed position If at any time nursing staff feel it necessary to re optimize the patient then this can be initiated manually by touching the RE OPTIMIZE Icon Optimization will stop working th...

Страница 35: ...STANDBY Screen appears in OPTIMIZE Mode Switch OptiCare X to MOBILE Mode and shortly afterwards back to the OPTIMIZE Mode If problem is still present and the STANDBY Screen remains displayed position...

Страница 36: ...TINGS IN OPTIMIZE MODE To adjust air pressure in the mattress manually for seat section A Press MINUS on the A Section Icon 1 to decrease pressure level Press PLUS on the A Section Icon 1 to increase...

Страница 37: ...DIUM 10 MIN SETTINGS OPTIMIZE MODE COMFORT ADJUSTMENT MATTRESS SCALES DISCREET MODE HIDE PATIENT WEIGHT PUMP LOG OUT UNITS kg lb 25 12 25 22 58 LCD HOME SCREEN RETURN IN SLEEP MODE DISPLAY BACKLIGHT M...

Страница 38: ...ease air pressure Press PLUS Icon under the five pressure levels to increase air pressure To adjust duration of the MOBILE Mode Press PLUS Icon next to the hourglass icon to add 1 hour to the MOBILE M...

Страница 39: ...54 40 250 Fig Five pressure levels 1 2 3 4 5 Black arrow in grey frame indicates recommended pressure level It is possible to select only the nearest higher pressure level or the nearest lower pressu...

Страница 40: ...LIMATE Make sure the patient is on his back before leaving the PRONE mode Air level will change Before leaving the PRONE Mode a pop up window will appear to remind you to check the patient s position...

Страница 41: ...dures e g physiotherapy MAX Mode causes maximum mattress air pressure for 30 minutes Countdown is displayed on the MAX Mode Screen above hourglass icon in the upper left corner of the screen OptiCare...

Страница 42: ...inflation after switching from CPR Mode to OPTIMIZE Mode To deactivate CPR Mode press CPR CANCEL Icon The mattress will inflate again and return to the mode it was in before CPR started or to the mode...

Страница 43: ...When SCU is removed from the bed or communication between the bed and the SCU is lost this alert appears with PUMP DISCO NNECTED text To remove this alert Install compressor on the bed Log out the SCU...

Страница 44: ...en this error occurs To eliminate this error Check if the scales are stabilized and if the scales works properly Check if the taring was performed without patient on the mattress Contact the service d...

Страница 45: ...GHT MAX MIN MEDIUM 10 MIN ETTINGS ZE MODE COMFORT ADJUSTMENT ESS SCALES DISCREET MODE HIDE PATIENT WEIG PUMP LOG OUT UNITS 25 12 25 22 58 LCD HOME SCREEN RETURN IN SLEEP MODE DISPLAY BACKLIGHT MAX MIN...

Страница 46: ...ral tilt of the Multicare X bed Change lateral tilt adjustment or longitudinal tilt adjustment towards the bed horizontal po sition to enable activation of the OPTIMIZE Mode Notification of the runnin...

Страница 47: ...c deflation is not available Press MUTE Icon to mute acoustic alert sounding from SCU Open manual CPR valve to enable mattress deflation Mattress Identification failed Connected mattress is not compat...

Страница 48: ...acous tic alert sounding from SCU Follow the instructions for the corresponding fault code display ed in the upper right corner of the pop up window Pxx and contact service department approved by man...

Страница 49: ...anufacturer P7 Blower Fault No MCM function assess the effect on patient Contact service department approved by manufacturer P8 Clogged Blower Filter No MCM function assess the effect on patient Conta...

Страница 50: ...ress cover by zip so it can be removed from the mattress cover when it is completely unzipped CAUTION It is forbidden to wash the X ray Pocket in the washing machine Fig Access to the X ray Pocket mat...

Страница 51: ...Quaternary Ammonium based disinfectants Chlorine based disinfectants containing up to 1000ppm Chlorine followed by rinsing with water and drying thoroughly before use Decontamination Blood spills Clos...

Страница 52: ...epair and completely disinfect mattress cover top and base if damaged Check mattress cover top and base for signs of liquid ingress Replace or clean and completely disinfect mattress cover top and bas...

Страница 53: ...tress cover by reversing the process described above Make sure all toggles are put back in their respective holes WARNING Risk of injury due to lack of support If the OptiCare X integrated mattress is...

Страница 54: ...tient can be put back on the bed if alternative non integrated mattress type is available Mattress display shows patient not in bed but patient is in bed Check the scales are showing correct patient w...

Страница 55: ...lower should be heard turning on or getting faster when MCM setting is inc reased If blower can still not be heard patient can remain on the bed but service department should be called If blower can b...

Страница 56: ...ient should now look feel that they are not in contact with the mattress support platform If in doubt this can be checked by mo ving or asking the patient to move slightly from side to side They shoul...

Страница 57: ...utside 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 If dust or dirt is visib...

Страница 58: ...ackaging through an authorized company more details on www linet cz 14 2Disposal The main objective of the obligations arising from the European Directive No 2012 19 EU on Waste Electric and Electroni...

Страница 59: ...f 24 months The warranty covers all material and manufacturing related failures and errors Failures and errors caused by incorrect use and external effects are not covered Justified complaints will be...

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