LINET OptiCare Instructions For Use Manual
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LINET OptiCare Instructions For Use Manual

Integrated mattress replacement system for eleganza 5 and multicare
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and Technical Description
OptiCare
Integrated Mattress Replacement System
for Eleganza 5 and Multicare
Instructions for Use
D9U003VS0-0101
Version: 01
Publication Date: 2020-05

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  • Page 1 Instructions for Use and Technical Description OptiCare Integrated Mattress Replacement System for Eleganza 5 and Multicare D9U003VS0-0101 Version: 01 Publication Date: 2020-05...
  • Page 2 Related links: www.linet.com D9U003VS0-0101 Version: 01 Publication Date: 2020-05 Copyright © LINET, s.r.o., 2020 Translation © LINET, 2020 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 relate to the product´s technical regulations.

  • Page 3: Table Of Contents

    8.1 Delivery ...............26 8.2 Scope of Delivery ............26 only OptiCare for Eleganza 5.........27 9 Putting into Service (only OptiCare for Eleganza 5) . 28 9.1 SCU (System Control Unit) .........29 9.2 Replacing the mattress ..........29 10 Manipulation (OptiCare for Eleganza 5) ....29 10.1 Manual CPR (during Transport or Power loss) ..

  • 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 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! ►...

  • Page 5: Symbols On The Package (Opticare)

    1.4 Symbols on the Package (OptiCare) 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- PORT) OVERSEAS PACKAGE: STACKING LIMIT BY NUMBER (5 PACKAGES FOR STORAGE)

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

    1.5 Symbols and Labels on the Mattress (OptiCare) 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 COVER MATERIALS ARE FIRE RESISTANT TO BS7175, SOURCE 0, 1 AND 5 MATTRESS FOOT PART (OptiCare) WEEE SYMBOL (RECYCLE AS ELECTRONIC WASTE, DO NOT PUT INTO THE HOUSEHOLD WASTE) MEDICAL DEVICE (compatible with Medical Device Regulation) MANUFACTURER MANUFACTURING DATE REFERENCE NUMBER (PRODUCT TYPE DEPENDING ON CONFIGURATION)
  • Page 8 WARNING READ INSTRUCTIONS FOR USE T1AH ANTI-SURGE FUSE ALTERNATING CURRENT THERMAL PROTECTION FOR TRANSFORMER SAFETY ISOLATING TRANSFORMER (GENERAL) D9U003VS0-0101_01...

  • Page 9: Serial Labels With Udi (Opticare)

    (21) 20190103014 20190103014 220-240 V~, 50/60 Hz, 40 VA 2020-01-28 Fig. Serial Label with UDI for OptiCare SCU (220-240 V) Address of Manufacturer Manufacturing Date (Year-Month-Day) DI (Device Identifier) / GTIN (Global Trade Item Number) 1D Bar code GS1-128 (Serial Number)

  • Page 10: Serial Label For Opticare (Mattress)

    (21) 20190103014 20190103014 100-127 V~, 50/60 Hz, 40 VA 2020-01-28 Fig. Serial Label with UDI for OptiCare SCU (100-127 V) Address of Manufacturer Manufacturing Date (Year-Month-Day) DI (Device Identifier) / GTIN (Global Trade Item Number) 1D Bar code GS1-128 (Serial Number)

  • Page 11: Wash Label (Mattress)

    1.6.3 Wash Label (mattress) 1.7 Acoustic signalisation (OptiCare) SOUND MEANING REPEATED BEEP: 0,2s sound / 1s silence mattress inflation fault (fault number 2) (high priority) mattress overpressure (fault number 5) air valves fault (fault number 14) CPR mattress deflation fault (fault number 13)

  • Page 12: 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 13: Safety Instructions (Only Opticare For Eleganza 5)

    Eleganza 5 bed with OptiCare integrated mattress replacement system should be left in its lowest position  when the patient is unattended in order to reduce risk of injury due to falls! WARNING! Siderails of the Eleganza 5 bed should be located in the „up“ position to reduce the risk of the patient acci- dentally slipping or rolling off the OptiCare integrated mattress! WARNING! Inappropriate handling of the Eleganza 5 power supply cord, e. g. by kinking, shearing or other mechanical  damages is hazardous! WARNING! When routing cables from OptiCare integrated mattress replacement system in the Eleganza 5 bed avoid squeezing those cables between parts of the Eleganza 5 bed! WARNING! The OptiCare integrated mattress replacement system with Eleganza 5 bed are intended for adults. ►  Follow the chapter Intended use. WARNING! OptiCare integrated mattress replacement system is compatible only with Eleganza 5 bed or with Multicare  bed. The OptiCare integrated mattress replacement system can only be used when installed on a LINET Ele- ganza 5 bed frame or on a LINET Multicare bed frame.
  • Page 14 ► 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  integrated mattress replacement system with Eleganza 5 bed may occur. WARNING! Any serious incident that has occurred in relation to the device (OptiCare integrated mattress replacement 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 integrated mattress replacement system! WARNING! This medical device (OptiCare integrated mattress replacement system) is not intended for oxygen enriched...
  • Page 15 If the patient‘s condition could lead to an entrapment, leave the mattress support platform with OptiCare integrated mattress replacement system in the flat position whilst unattended. ► Do not exceed the maximum patient weight limit of the Eleganza 5 and of the OptiCare integrated mattress replacement system at the same time. ►...

  • Page 16: Safety Instructions (Only Opticare For Multicare)

    Multicare bed with OptiCare integrated mattress replacement system should be left in its lowest position when  the patient is unattended in order to reduce risk of injury due to falls! WARNING! Siderails of the Multicare bed should be located in the „up“ position to reduce the risk of the patient acciden- tally slipping or rolling off the OptiCare integrated mattress! WARNING! Inappropriate handling of the Multicare power supply cord, e. g. by kinking, shearing or other mechanical  damages is hazardous! WARNING! When routing cables from OptiCare integrated mattress replacement system in the Multicare bed avoid squee- zing those cables between parts of the Multicare bed! WARNING! The OptiCare integrated mattress replacement system with Multicare bed are intended for adults. ►  Follow the chapter Intended use. WARNING! OptiCare integrated mattress replacement system is compatible only with Multicare bed or with Eleganza 5 bed.  The OptiCare integrated mattress replacement system can only be used when installed on a LINET Multicare  bed frame or on a LINET Eleganza 5 bed frame.
  • Page 17 ► 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  integrated mattress replacement system with Multicare bed may occur. WARNING! Any serious incident that has occurred in relation to the device (OptiCare integrated mattress replacement 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 integrated mattress replacement system! WARNING! This medical device (OptiCare integrated mattress replacement system) is not intended for oxygen enriched...
  • Page 18 ► When pulling the mains plug, always hold the plug, not the cable. ► Improper handling of mains cable can cause an electric shock hazard, other serious injuries or damage to OptiCare mattress replacement system. ► Ensure that the stipulated duty cycle of Multicare bed is not exceeded.

  • Page 19: Intended Use (Opticare)

    Adult 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 4.2 Contraindications OptiCare integrated mattress replacement system is contraindicated for patients: ► with cervical traction ►...

  • Page 20: Product Description (Opticare)

    5 Product Description (OptiCare) Fig. OptiCare Mattress Description 1. Cover 2. Comfort Layer 3. Air Cell Set (Area B - blue) 4. Air Cell Set (Area A - grey) 5. Foam Base 6. CPR Valve 7. Base Cover 8. Heel Section...

  • Page 21: Mattress Structure

    5.1 Mattress Structure The OptiCare mattress consists of 4 sections that are held together by 6 quick release fixation toggles. The 3 sections include co- ver, 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 22: Transport Handles

    Multicare bed delivered with the SCU factory-fitted, or to have it retrofitted by approved service personnel. OptiCare ready Elegan- za 5 bed or OptiCare ready Multicare bed are equipped with a dedicated power outlet for the SCU at the auxiliary power distribution point.

  • Page 23: Technical Specification (Opticare)

    6 Technical Specification (OptiCare) All technical data are rated data and are subject to construction and manufacturing tolerances. WARNING! If Eleganza 5 bed or Multicare bed are used with OptiCare integrated mattress replacement system, respect  values of mechanical and electrical specifications which can harm none of them! 6.1 Mechanical Specifications Parameter Value External dimensions of Inflated Mattress 214 cm x 86 cm x 22 cm External dimensions of SCU 36 cm x 22 cm x 10 cm Weight of Inflated Mattress...

  • Page 24: Electromagnetic Compatibility

    OptiCare integrated mattress replacement 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 integrated mattress replacement system, including cables specified by manufacturer. Otherwise this could lead to deterioration of functionality  of this OptiCare integrated mattress replacement system. WARNING! Do not overload the OptiCare integrated mattress replacement system (SWL), respect the duty cycle (INT.) and...

  • Page 25: Manufacturer Instructions - Electromagnetic Susceptibility

    6.4.2 Manufacturer instructions - electromagnetic susceptibility Immunity Tests Compliance level Electrostatic discharge (ESD) ± 8 kV for contact discharge IEC 61000-4-2 ± 15 kV for contact 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 26: Use And Storage Conditions (Opticare)

    Use exclusively Hospital Grade or Hospital Only receptacles for grounding. Eleganza 5 with OptiCare integrated mattress replacement system and Multicare with OptiCare integrated mattress replacement system are designed for use in rooms for medical purposes. Electrical installations must therefore meet local norms laying down the necessary conditions for electrical installations.

  • Page 27: Only Opticare For Eleganza 5

    OptiCare for Eleganza 5 D9U003VS0-0101_01...

  • Page 28: Putting Into Service (Only Opticare For Eleganza 5)

    WARNING! Risk of injury when working on the OptiCare integrated mattress replacement system! ► Ensure that the Eleganza 5 bed is disconnected from the mains connection prior to putting OptiCare integrated mattress replacement system into service, putting it out of service and maintenance. ► Ensure that the castors are locked prior to putting OptiCare integrated mattress replacement system into service, putting out of service and maintenance.

  • Page 29: Scu (System Control Unit)

    Standard control screen. If replacing the OptiCare mattress with one that is not from the LINET integrated systems range then you will need to cancel the Mattress Not Connected alarm.

  • Page 30: Manual Cpr (During Transport Or Power Loss)

    10.1 Manual CPR (during Transport or Power loss) OptiCare is equipped with CPR valve on both sides next to the Manual Backrest Release. Fig. Position of the CPR valve on the OptiCare integrated mattress placed on the Eleganza 5 bed To activate manual CPR: Open CPR valve on patient’s left- or right-hand side by turning the end of CPR valve to the right and aligning the CPR red ►...

  • Page 31: Mattress Screen (Eleganza 5 With Opticare)

    10.2 Mattress Screen (Eleganza 5 with OptiCare) 5 6 7 Fig. Mattress Display and Keyboard (iBoard Standard) OPT Mode Button Mode Icon with Mode Name MINUS Button Mattress CPR Alert Icon PLUS Button Alert Icon COMFORT Button Mattress Icon MUTE Button Status Indicator MODE Button...

  • Page 32: Opticare Mattress Controls (Eleganza 5 With Opticare)

    10.3 OptiCare Mattress Controls (Eleganza 5 with OptiCare) Control and information on status of the OptiCare mattress is by the display and keyboard on the iBoard Standard. Patient in bed detection (PIB) Patient in bed detection system detects when a patient has entered or left the bed. This automatically starts the optimization proces on patient ingress and puts the mattress into Standby mode on patient egress.

  • Page 33: Mattress Prepared For Patient

    10.3.4 MATTRESS PREPARED FOR PATIENT When „MATTRESS INFLATION“ text disappears and Mattress icon is fully green the mattress is ready for a patient. NOTE Flashing Mattress Icon with selected OPT Mode indicates continuing inflation. To use the mattress: ► position patient on the mattress. Fig.

  • Page 34: Pressure Comfort Adjustment

    10.3.7 PRESSURE COMFORT ADJUSTMENT The mattress pressure can be adjusted based on the patient´s needs. The pressure can be separately adjusted in the Area A (seat section) or in the Area B (torso and legg mattress sections). The grey arrow below the Area A or Area B Pressure Level Icons indicates the optimized pressure.

  • Page 35: Alerts

    10.3.10 ALERTS UNPLUGGED When the power cable is unplugged or mains power fails, the screen will show the following alert and „POWER“ text is scrolling on the display. This alert will automatically disappear when mains power is restored. NOTE Red triangle with exclamation mark is displayed during this alert. Fig.
  • Page 36 DISCONNECTED AIR PIPES If either the red, yellow or black air pipe is disconnected from the System Control Unit the following alert appears on the display. „MATTRESS DISCONNECTED“ text is scrolling on the display. NOTE Red triangle with exclamation mark is displayed during this alert and audio alarm sounds.

  • Page 37: Only Opticare For Multicare

    OptiCare for Multicare D9U003VS0-0101_01...

  • Page 38: Putting Into Service (Only Opticare For Multicare)

    WARNING! Risk of injury when working on the OptiCare integrated mattress replacement system! ► Ensure that the Multicare bed is disconnected from the mains connection prior to putting OptiCare integrated mattress replacement system into service, putting it out of service and maintenance. ► Ensure that the castors are locked prior to putting OptiCare integrated mattress replacement system into service, putting out of service and maintenance.

  • Page 39: Scu (System Control Unit)

    Multiboard control screen. If replacing the OptiCare mattress with one that is not from the LINET integrated systems range then you will need to cancel the Mattress Not Connected alarm.

  • Page 40: Manipulation (Opticare For Multicare)

    12 Manipulation (OptiCare for Multicare) Preparing OptiCare 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 41: Manual Cpr (During Transport Or Power Loss)

    12.1 Manual CPR (during Transport or Power loss) OptiCare is equipped with CPR valve on both sides next to the Manual Backrest Release. Fig. Position of the CPR valve on the OptiCare integrated mattress placed on the Eleganza 5 bed To activate manual CPR: ► Open CPR valve on patient’s left- or right-hand side by turning the end of CPR valve to the right and aligning the CPR red heart with the red circle.

  • Page 42: Automatic Cpr (Multicare With Opticare)

    Cardiopulmonary Resuscitation Mode causes the mattres to defl ate completely to facilitate resuscitation of patient. Typical defl ation time for OptiCare is 15 seconds (max. 30 s). After 55 minutes of CPR Mode there will be an audio alarm every 30 seconds. After 60 minutes system will return to OPT Mode or MAX Infl ate Mode.

  • Page 43: Mattress Screen (Multicare With Opticare)

    12.3 Mattress Screen (Multicare with OptiCare) Fig. Mattress Screen (Multiboard) MCM Mode Icon (LOW/HIGH/OFF) OPT Mode Button MAX Mode Button Mattress Screen Icon (to enter Mattress Screen) PLUS Button (+) Pressure Level Icon MINUS Button (-) D9U003VS0-0101_01...

  • Page 44: Opticare Mattress Controls (Multicare With Opticare)

    12.4.1 MATTRESS NOT CONNECTED When OptiCare compressor is installed on the bed but OptiCare mattress is not connected to the compressor „MATTRESS NOT CONNECTED“ screen appears. NOTE: Red strip above the mattress icon is fl ashing in this screen.

  • Page 45: Mattress Inflation

    12.4.3 MATTRESS INFLATION When OptiCare mattress is identifi ed it is not prepared for a patient because mattress is not infl ated enough. NOTE: Number above the text „MATTRESS INFLATION“ indicates infl ation countdown. To achieve minimum infl   ation of the mattress: ► wait until infl ation countdown disappears.

  • Page 46: Patient On The Mattress

    12.4.5 PATIENT ON THE MATTRESS When there is a patient on the mattress patient icon turns to black color. As long as the patient remains on the mattress automatic optimization will continue. Optimization will occur if the patient´s position changes suffi ciently to trigger Optimization Detection or if initiated by the Optimization automatic timer.

  • Page 47: Pressure Comfort Adjustment

    12.4.7 PRESSURE COMFORT ADJUSTMENT The mattress pressure can be adjusted based on the patient´s needs, press -+ icon. The pressure can be separately adjusted in the A section (seat section) or in the B section (torso and legg mattress areas). The black arrow below the A and B section level indicators indicates the optimized pressure.

  • Page 48: Cpr Mode (Cpr Activated)

    12.4.9 CPR MODE (CPR ACTIVATED) When CPR is activated the mattress will defl ate and chest compression can start immediately. NOTE: The countdown is displayed above the patient icon and indicates the amount of minutes the mattress stays defl ated. Red strip with „CPR“...

  • Page 49: Alerts

    12.4.11 ALERTS UNPLUGGED When the power cable is unplugged or mains power fails, the screen will show the following alert. This alert will automatically disappear when mains power is restored. Transport mode is activated automatically if no mains power is available to the SCU. Neither OPT Mode nor MCM Mode will be operational.
  • Page 50 DISCONNECTED AIR PIPES If either the red, yellow or black air pipe is disconnected from the System Control Unit the following alert appears in the screen. NOTE: Red strip above the mattress icon is fl ashing during this alert. NOTE: Blue air pipes disconnected from the Sytem Control Unit do not cause this alert! To remove this alert: ►...
  • Page 51 AUTOMATIC CALIBRATION Automatic Calibration occurs each 3 months. Automatic Calibration is automatically interrupted during intervention of patient or hospital staff . If the Automatic Calibration is interrupted it will appear again after 10 hours. Following screen appears during this process. To fi  ...

  • Page 52: Pop-Ups

    12.4.12 POP-UPs COMPRESSOR (SCU) NOT CONNECTED When SCU is removed from the bed or communication between the bed and the SCU is lost this POP-UP appears. NOTE: There is red triangle on this screen instead of the mattress icon during this alert. To remove this POP-UP: ►...

  • Page 53: Cleaning/Disinfection (Opticare)

    13 Cleaning/Disinfection (OptiCare) 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. ► Ensure that disinfectants are selected and applied exclusively by qualified hygiene experts.

  • Page 54: Full Cleaning And Disinfection

    ► Let mattress dry or wipe dry. ► Wipe mattress with disinfectant. ► Rinse mattress with cold water. ► Let mattress dry or wipe dry. Cleaning the SCU: ► Wipe SCU with disinfectant. ► Let SCU dry or wipe dry. 13.2 Full Cleaning and Disinfection Cleaning the mattress: ►,...

  • Page 55: Machine Washing (Hi-Mvp Slippy Mattress Cover)

    Do not open the protective covers of the electric motor or the power box. WARNING! Risk of injury due to lack of support! If the OptiCare integrated mattress is empty so that the patient is lying directly on the foam base, and it is not possible to solve the problem by following the troubleshooting instructions: ►...
  • Page 56 Repair / replace Repair / replace FOR SERVICE TECHNICIAN: Plug cable / air in bed frame and OptiCare to mains serial data cable connection outlet to start system Check SCU Auxiliary serial data cable power inlet Mattress icon and connection...
  • Page 57 D9U003VS0-0101_01...
  • Page 58 D9U003VS0-0101_01...

  • Page 59: Maintenance (Opticare)

    15 Maintenance (OptiCare) WARNING! Risk of injury when working on the mattress replacement system! ► Ensure that the mattress replacement system is disconnected from the mains power prior to installation, putting into service, maintenance and deinstallation. WARNING! Risk of injury due to defective mattress replacement system! ► Have a defective mattress replacement system repaired immediately. ► If the defect cannot be repaired, do not use the mattress replacement system.

  • Page 60: Disposal (Opticare)

    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 61: Warranty (Opticare)

    17 Warranty (OptiCare) 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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