LINET OptiCare X Instructions For Use And Technical Description
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LINET OptiCare X Instructions For Use And Technical Description

Integrated mattress system for multicare x
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Instructions for Use and
Technical Description
OptiCare X
Integrated Mattress System for Multicare X
D9U003VSX-0101
Version: 00
Publication Date: 2021-10

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Summary of Contents for LINET OptiCare X

  • Page 1 Instructions for Use and Technical Description OptiCare X Integrated Mattress System for Multicare X D9U003VSX-0101 Version: 00 Publication Date: 2021-10...
  • Page 2 Želevčice 5 274 01 Slaný Tel.: +420 312 576 111 Fax: +420 312 522 668 E-mail: info@linet.cz http://www.linet.com Service department: service@linetgroup.com OptiCare X Integrated mattress system for Multicare X Author: LINET, s.r.o. Related links: www.linet.com D9U003VSX-0101 Version: 00 Publication Date: 2021-10 Copyright ©...

  • Page 3: Table Of Contents

    1.4 Symbols on the Package (OptiCare X) ....... 5 11.3 Removing the Mattress Cover ........53 1.5 Symbols and Labels on the Mattress (OptiCare X) ..6 12 Troubleshooting (OptiCare X) ........53 1.6 Serial Labels with UDI (OptiCare X) ......9 13 Maintenance (OptiCare X) .........57...

  • Page 4: Symbols And Definitions

    1 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 signal 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! ►...

  • Page 5: Symbols On The Package (Opticare X)

    1.4 Symbols on the Package (OptiCare X) FRAGILE, HANDLE WITH 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-...

  • Page 6: Symbols And Labels On The Mattress (Opticare X)

    1.5 Symbols and Labels on the Mattress (OptiCare X) DO NOT IRON! DO NOT USE PHENOL! DO NOT WRING! REGULARLY INSPECT 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 EXCEED 50°C)
  • Page 7 WIPE WITH WATER COVER MATERIALS ARE FIRE RESISTANT TO BS7175, SOURCE 0, 1 AND 5 OptiCare X MATTRESS FOOT PART (OptiCare X) WEEE SYMBOL (RECYCLE AS ELECTRONIC WASTE, DO NOT PUT INTO THE HOUSEHOLD WASTE) MEDICAL DEVICE (compatible with Medical Device Regulation)
  • Page 8 MANUFACTURING DATE 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 CURRENT THERMAL PROTECTION FOR TRANSFORMER D9U003VSX-0101_00...

  • Page 9: Serial Labels With Udi (Opticare X)

    1.6.1 Serial Label for OptiCare X (SCU and mattress) Serial label of the OptiCare X SCU is placed on the SCU under the foot board of the Multicare X bed. The serial label contains information about 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 specifications.

  • Page 10: Acoustic Signalisation (Opticare X)

    1.7 Acoustic signalisation (OptiCare X) SOUND MEANING REPEATED BEEP: 0,2s sound / 1s silence Overpressure Fault (fault number 5) (high priority) Pressure Calibration Fault (fault number 94) Solenoid Fail (fault number 98) Deflation Fault During CPR (fault number 105) REPEATED BEEP: 0,2s sound / 5s silence...

  • Page 11: Abbreviations

    1.8 Abbreviations AC ( ~ ) Alternating Current European Conformity Cardiopulmonary Resuscitation Sound Intensity Unit Direct Current DC ( Configuration number Electromagnetic Compatibility Field-effect transistor High Frequency High Pressure Laminate Intensive Care Unit INT. Duty Cycle Ingress Protection Intravenous Light Emitting Diodes Medical Electrical (Equipment) Activation Deactivation...

  • Page 12: Safety Instructions (Only Opticare X For Multicare X)

    Siderails of the Multicare X bed should be located in the „up“ position to reduce the risk of the patient acci- dentally slipping or rolling off the OptiCare X integrated mattress! WARNING! Inappropriate handling of the Multicare X power supply cord, e. g. by kinking, shearing or other mechanical  damages is hazardous! WARNING! When routing cables from OptiCare X integrated mattress system in the Multicare X bed avoid squeezing tho- se cables between parts of the Multicare X bed! WARNING! The OptiCare X integrated mattress system with Multicare X bed are intended for adults. ►  Follow the chapter Intended use.
  • Page 13 Risk of trapping or squeezing because of patient´s body constitution disproportionate to the size of mattress support platform! WARNING! During specific investigations or treatments the significant risks of reciprocal interference posed by OptiCare  X integrated mattress system with Multicare X bed may occur. WARNING! Any 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 user  and/or patient is established! WARNING! Only authorised and trained person using the tool is allowed to change fuses and power supplies of the Opti- Care X integrated mattress system!
  • Page 14 If the patient‘s condition could lead to an entrapment, leave the mattress support platform with OptiCare X integrated mattress system in the flat position whilst unattended. ► Do not exceed the maximum patient weight limit of the Multicare X and of the OptiCare X integrated mattress system at the same time. ►...

  • Page 15: Intended Use (Opticare X)

    Environment 1 and 2, as in IEC 60601-2-52) ► Patients with any stage/category of pressure ulcers 3.2 Contraindications OptiCare X integrated mattress system is contraindicated for patients: ► with cervical traction ► or unstable spinal fractures, spinal cord injury, fractures at risk of complication by a moving surface ►...

  • Page 16: Product Description (Opticare X)

    4 Product Description (OptiCare X) Fig. OptiCare X Mattress Description 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 D9U003VSX-0101_00...
  • Page 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) D9U003VSX-0101_00...

  • Page 18: Mattress Structure

    4.1 Mattress Structure The OptiCare X mattress consists of 4 sections that are held together by 6 quick release fixation toggles. The 3 sections include cover, comfort layer, air cell set and foam base which supports the leg section and side formers. Within the central cut-out of the foam base is a 10 mm high density foam sheet to protect the patient if the mattress is deflated.

  • Page 19: Transport Handles

    The SCU (System Control Unit) is installed under the leg section of the bed frame. It is possible to have the Multicare X bed delivered with the SCU factory-fitted, or to have it retrofitted by approved service personnel. OptiCare X ready Multicare X bed is equipped with a dedicated power outlet for the SCU at the auxiliary power distribution point.

  • Page 20: Technical Specification (Opticare X)

    5 Technical Specification (OptiCare X) All technical data are rated data and are subject to construction and manufacturing tolerances. WARNING! If Multicare X bed is used with OptiCare X integrated mattress system, respect values of mechanical and elect- rical specifications which can harm none of them! 5.1 Mechanical Specifications Parameter Value External dimensions of Inflated Mattress (length x width x height) 214 cm x 87 cm x 23 cm Length of the Integrated Mattress Extension 19 cm Dimensions of the X-ray Pocket (length x width) 90 cm x 92 cm External dimensions of SCU...

  • Page 21: Environment Conditions

    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.

  • Page 22: Manufacturer Instructions - Electromagnetic Susceptibility

    5.4.2 Manufacturer Instructions - Electromagnetic Susceptibility Immunity Tests Compliance level Electrostatic discharge (ESD) ± 8 kV for contact discharge IEC 61000-4-2 ± 15 kV for air discharge Radiated RF 3 V/m IEC 61000-4-3 80 MHz – 2,7 GHz 80 % AM at 1 kHz Proximity fields from RF wireless communications equipment IEC 61000-4-3 See Table 1...

  • Page 23: Use And Storage Conditions (Opticare X)

    Use exclusively Hospital Grade or Hospital Only receptacles for grounding. Multicare X with OptiCare X integrated mattress system is designed for use in rooms for medical purposes. Electrical installations must therefore meet local norms laying down the necessary conditions for electrical installations.

  • Page 24: Putting Into Service (Only Opticare X For Multicare X)

    WARNING! Risk of injury when working on the OptiCare X integrated mattress system! ► Ensure that the Multicare X bed is disconnected from the mains connection prior to putting OptiCare X integrated mattress system into service, putting it out of service and maintenance. ► Ensure that the castors are locked prior to putting OptiCare X integrated mattress system into service, putting out of service and maintenance.
  • Page 25 Mattress Detection System (MDS) 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 enter Standby Mode. In Standby Mode mattress areas A and B are inflated to a static pressure ready for a patient to be placed onto the mattress and Optimization to start.

  • Page 26: Scu (System Control Unit)

    If the SCU does not come factory-fitted, have it installed by a service engineer authorised by LINET ®. 8.2 Replacing the Mattress If replacing the OptiCare X mattress with another mattress replacement system, then you will need to cancel the Mattress Not Co- nnected alarm and log out the OptiCare X mattress.

  • Page 27: Manipulation (Opticare X For Multicare X)

    9 Manipulation (OptiCare X for Multicare X) Preparing OptiCare X for Patient DANGER! Risk of suffocation due to air-impermeable mattress cover! ► Use mattress cover correctly. ► The nursing staff are responsible for the safety of the patient on the mattress cover. WARNING! Risk of injury when positioning patient on the bed! Before positioning the patient on the bed: ►...

  • Page 28: Manual Cpr (During Transport Or Power Loss)

    9.1 Manual CPR (during Transport or Power Loss) OptiCare X is equipped with CPR valve on both sides next to the Manual Backrest Release. Fig. Position of the CPR valve on the OptiCare X integrated mattress placed on the Multicare X bed To activate manual CPR: ►...

  • Page 29: Automatic Cpr (Multicare X With Opticare X)

    Cardiopulmonary Resuscitation Mode (CPR Mode) causes the mattress to defl ate completely to facilitate resuscitation of patient. Typical defl ation time for OptiCare X mattress is 15 seconds (max. 30 s). Timer indicator counts down 1 hour during CPR Mode.
  • Page 30 Fig. CPR button (Attendant 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 defl ates completely and mattress support platform will enter the CPR position. The mattress platform will straighten up.

  • Page 31: Integrated Mattress Screen (Multicare X With Opticare X)

    9.3 Integrated Mattress Screen (Multicare X with OptiCare X) 22:58 25. 12. 25 ,5 kg RE-OPTIMIZE MICROCLIMATE HIGH OPTIMIZE MOBILE PRONE Fig. Integrated Mattress Screen - LCD touchscreen 1. OPTIMIZE Mode Icon (press to enter OPTIMIZE Mode) 2. MOBILE Mode Icon (press to enter MOBILE Mode) 3. Manual Pressure Settings Icon (press to enter Manual Pressure Settings) 4.

  • Page 32: Opticare X Mattress Controls (Multicare X With Opticare X)

    9.4 OptiCare X Mattress Controls (Multicare X with OptiCare X) Control and information on status of the OptiCare X mattress is by the display and keyboard on the Multiboard X. Yellow colour on the LCD touchscreen indicates activated function. 9.4.1 MATTRESS DISCONNECTED When OptiCare X compressor is installed on the bed but OptiCare X mattress is not connected to the compressor „MATTRESS DISCONNECTED“...

  • Page 33: Mattress Identification

    MATTRESS IDENTIFICATION Fig. Mattress Identifi cation Screen 9.4.3 MATTRESS INFLATION When OptiCare X mattress is identifi ed it is not prepared for a patient because mattress is not infl ated enough. To achieve minimum infl   ation of the mattress: ► wait until „MATTRESS INFLATION“ disappears.

  • Page 34: Optimize Mode

    9.4.4 OPTIMIZE MODE When OptiCare X has finished inflating, it will switch to Optimize Mode. This is the default mode. As long as the patient remains on the mattress automatic optimization of the mattress internal pressure continues. Optimization will occur if the patient´s position changes sufficiently to trigger Optimization Detection, or if initiated by the Optimization automatic timer.
  • Page 35 Fig. STANDBY SCREEN To perform re-optimization when patient is on the mattress and 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 patient to the middle of the bed according to the marks on the bed.
  • Page 36 MANUAL PRESSURE SETTINGS (IN OPTIMIZE MODE) 22:58 25. 12. 25 ,5 kg RE-OPTIMIZE MICROCLIMATE HIGH OPTIMIZE MOBILE PRONE Fig. Manual Pressure Settings 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. ►...

  • Page 37: Microclimate Management

    22:58 22:58 25. 12. 25 25. 12. 25 SETTINGS SETTINGS SCALES SCALES DISCREET MODE DISCREET MODE HOME SCREEN RETURN IN 22:58 HOME SCREEN RETURN IN HIDE PATIENT WEIGHT HIDE PATIENT WEIGHT 25. 12. 25 SETTINGS SLEEP MODE SLEEP MODE MEDIUM UNITS MEDIUM UNITS...

  • Page 38: Mobile Mode

    Press MINUS (-) Icon next to the hourglass icon to remove 1 hour of the MOBILE Mode operation. OptiCare X system automatically returns to the OPTIMIZE Mode after the MOBILE Mode expiration. To set unlimited duration of the MOBILE Mode: ►...

  • Page 39: Prone Mode

    ,5 kg 9.4.7 PRONE MODE 0:30:00 CAUTION! Turn the patient on their back before leaving the Prone Mode! MICROCLIMATE HIGH Fig. Five pressure levels Prone Mode is intended for patients who need to lie prone. This mode does not provide optimization in order to prevent extubation of a patient and to prevent the breathing hoses from kinking.
  • Page 40 Before leaving the PRONE Mode, a pop-up window will appear to remind you to check the patient´s position on the mattre- ► Press TICK Icon to confirm that patient is lying on his/her back. ► Press CROSS Icon to return to the PRONE Mode. 22:58 22:58 If none of these options is selected during 30 seconds, the pop-up window will disappear and the PRONE Mode will continue. 25.

  • Page 41: Max Mode

    Countdown is displayed on the MAX Mode Screen above hourglass icon in the upper left corner of the screen. OptiCare X system returns to previous mode after end of the MAX Mode. To set Maximum Mattress Air Pressure for 30 minutes: ►...

  • Page 42: Cpr Mode (Cpr Activated)

    CPR Mode period is limited to 1 hour and this period is counted down on the CPR Mode Screen. OptiCare X inflates automatically when this time is up. It is necessary to wait for the mattress inflation after switching from CPR Mode to OPTIMIZE Mode.

  • Page 43: Pump Disconnected

    9.4.10 PUMP DISCONNECTED 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 on the Settings Screen 2. See „9.4.12 SCU LOG OUT“ on the page 45. ►...

  • Page 44: Automatic Pressure Adjustment Error

    9.4.11 AUTOMATIC PRESSURE ADJUSTMENT ERROR Automatic mattress internal pressure adjustment in MOBILE Mode and PRONE Mode is not available when the Automatic Pressure Adjustment Error occurs. It is necessary to adjust the mattress internal pressure manually when this error occurs. To eliminate this error: ►...

  • Page 45: Scu Log Out

    Select Settings Icon (gear). ► Press and hold Mattress Icon 2. The green stripe above the Mattress Icon 2 indicates development of the long press. Mattress Icon 2 is removed and the OptiCare X SCU is logged out. MODE MEDIUM...

  • Page 46: Statuses (Multiboard X - Lcd Touchscreen)

    9.4.13 STATUSES (Multiboard X - LCD touchscreen) There are 2 types of pop-up windows related to the OptiCare X system according to the coloured stripe in the upper part of pop-up window. Red colour indicates warning with required action. Orange colour indicates caution with recommended action. Grey colour indicates only notification.
  • Page 47 Status (Pop-up window) Meaning How to change the status P100 OptiCare X integrated mattress does not Connect the bed to the mains work because of the bed disconnected power to enable functions of the from the mains power. OptiCare X integrated mattress! Bed disconnected. Mattress not operating.
  • Page 48 See “9.5 Fault Codes (OptiCare X inte- pop-up window (Pxx) and contact Refer to User Manual for Instructions. grated mattress)“ on the page 49.

  • Page 49: Fault Codes (Opticare X Integrated Mattress)

    9.5 Fault Codes (OptiCare X integrated mattress) Fault Code Type of the Fault Immediate Action of Operator Corrective Action of Operator Check both manual CPR valves for closing. If If problem is still present, Major Inflate Fault problem is still present, transfer patient to ano-...

  • Page 50: Equipment

    Mattress Cover ZONED could be equipped with X-ray Pocket. The X-ray Pocket is accesible from the left side and from the right side of the OptiCare X integrated mattress. The X-ray Pocket is connected to the mattress cover by zip so it can be removed from the mattress cover when it is completely unzipped.

  • Page 51: Cleaning/Disinfection (Opticare X)

    11 Cleaning/Disinfection (OptiCare X) CAUTION! Material damage due to incorrect cleaning/disinfection! ► Do not use pressure or steam cleaners. ► Follow the instructions and observe the dosages recommended by the manufacturer. Never exceed recommen- ded concentrations stated in this document. Always rinse and dry before putting the mattress back into service, even if the chemical manufacturer states their cleaning agent need not to be rinsed.

  • Page 52: Routine Cleaning And Disinfection

    11.1 Routine Cleaning and Disinfection Cleaning the mattress: ► Check mattress cover top for any signs of damage. Replace or repair and completely disinfect mattress cover top if damaged. ► Check inside of mattress cover top for signs of liquid ingress. Replace or clean and completely disinfect mattress cover top if damp inside.

  • Page 53: Removing The Mattress Cover

    Risk of injury due to lack of support! If the OptiCare X integrated mattress is empty so that the patient is lying directly on the foam base, and it is not possi- ble to solve the problem by following the troubleshooting instructions: ►...
  • Page 54 Ensure the OptiCare X If neither happens, lift foot end of mattre- cable is screwed in the right side of SCU ss, and visually check an Opticare X SCU when looking under the calfrest from the is fitted (see picture of hose connections bed right side.
  • Page 55 MCM setting is inc- maceration). reased. Lift foot end of mattress and visually check that the two blue OptiCare X air If blower can still not be heard patient can hoses are fitted correctly (see picture remain on the bed but service department of hose connections in the Intructions should be called.
  • Page 56 Problem Nurse Action Effect/Next Steps Patient feels that they are / nurse thinks Use COMFORT ADJUSTMENT controls Patient should now look/feel that they are that the patient is sitting directly on the to increase air pressure in the mattress not in contact with the mattress support bed frame and not being supported by areas A &...

  • Page 57: Maintenance (Opticare X)

    13 Maintenance (OptiCare X) WARNING! Risk of injury when working on the mattress system! ► Ensure that the mattress system is disconnected from the mains power prior to installation, putting into service, maintenance and deinstallation. WARNING! Risk of injury due to defective mattress system! ► Have a defective mattress system repaired immediately.

  • Page 58: Disposal (Opticare X)

    Based on the Directive No. 2002/96/ EC (Directive WEEE - Waste, Electric and Electronic Equipments) the company LINET, s. r. o. is registered in the List of Electric and Electronic Equipment Producers (Seznam výrobců elektrozařízení) on the Ministry of the Environment of the Czech Republic...

  • Page 59: Warranty (Opticare X)

    15 Warranty (OptiCare X) LINET ® will only be held responsible for the safety and reliability of products that are regularly serviced, maintained and used in accordance with the safety guidelines. Should a serious defect arise that cannot be repaired during maintenance: ►...

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