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Summary of Contents for LINET Precioso
- Page 1 Instructions for Use and Technical Description Precioso Mattress Replacement or Overlay System - Series 2 D9U003VP0-0101 Version: 04 Publication date: 2020-05...
- Page 2 Manufacturer: LINET spol. s r. o. Želevčice 5, 274 01 Slaný Czech Republic Phone: +420 312 576 111 Fax: +420 312 522 668 E-Mail: info@linet.cz Web: www.linet.com Service department: service@linetgroup.com Precioso Mattress Replacement or Overlay System – Series 2 Author: LINET, s.r.o.
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Page 3: Table Of Contents
Table of Contents 1 Symbols and Definitions ........4 11.3 Safety Technical Checks .........38 1.1 Warning Notices ..........4 12 Disposal ..............39 1.2 Other symbols ..........4 12.1 Environment Protection........39 13 Warranty ..............40 1.3 Symbols on the Package ........5 1.4 Symbols and Labels on the Product ....6 14 Standards and Regulations .........40 1.5 Serial Label .............8 1.6 Acoustic signalisation........10... -
Page 4: Symbols And Definitions
Symbols and Defi nitions Warning Notices 1.1.1 Types of Warning Notices Warning notices are diff erentiated by the type of danger using the following key words: Caution - risk of material damage. „ Warning - risk of physical injury. „ Danger - risk of fatal injury. „ 1.1.2 Structure of Warning Notices SIGNAL WORD! Type and source of danger! ... -
Page 5: Symbols On The Package
Symbols on the Package FRAGILE, HANDLE WITH CARE THIS WAY UP KEEP DRY (PROTECT FROM HUMIDITY) PAPER RECYCLING SYMBOL DO NOT USE HAND TRUCK HERE DO NOT STACK DURING STORAGE D9U003VP0-0101_04 5/40... -
Page 6: Symbols And Labels On The Product
Symbols and Labels on the Product READ Instructions for use 2X T1AH ANTI-SURGE FUSE (250 V, TYPE 5X20MM) ALTERNATING CURRENT ACTIVATION GO BUTTON DEVICE IS CONNECTED TO MAINS IF GREEN INDICATOR IS LIT PROTECTION AGAINST ACCIDENTS DUE TO ELECTRICAL CURRENT – TYPE B APPLIED PARTS DOUBLE ISOLATION ATTENTION... - Page 7 MANUFACTURING DATE REFERENCE NUMBER (PRODUCT TYPE DEPENDING ON CONFIGURATION) SERIAL NUMBER 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) COVER MATERIALS ARE FIRE RESISTANT TO BS 7175, SOURCE 0, 1 AND 5 HANDWASH WITH DETERGENT.
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Page 8: Serial Label
The serial label is located on the back of the SCU (System Control Unit). The serial number, the model number and the voltage version can be found on the serial label. This information is required when contacting LINET®. Pictures of serial labels below serve just for explanation of the signs and fields on the serial labels. - Page 9 1VPKE20000010 (21) 20200136267 20200136267 100-127 V~, 50/60 Hz, 40 VA 2020-02-25 Fig. Serial label for Precioso SCU (100-127 V) Address of Manufacturer 1D Bar Code GS1-128 (Serial Number) PI (Product Identifier) DI (Device Identifier) / GTIN (Global Trade Item Number)
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Page 10: Acoustic Signalisation
Wash label (Precioso mattress) Acoustic signalisation SOUND MEANING CONTINUOUS SOUND mattress air connector is disconnected mattress air connector is not correctly connected mattress type is not compatible REPEATED 2 TONE SIGNAL: disconnected from the mains 1) during 1 minute: mains voltage is not available when the mains switch is... -
Page 11: Abbreviations
Abbreviations AC ( ~ ) Alternating Current Attendant Control Panel European Conformity Cardiopulmonary Resuscitation Sound Intensity Unit DC ( ) Direct Current Configuration number Electromagnetic Compatibility Field-effect transistor High Frequency High Pressure Laminate Hardware Intensive Care Unit Ingress Protection Intravenous Light Emitting Diodes Medical Electrical (Equipment) Activation Deactivation parts per million, millionth (1000 ppm = 0,1%) -
Page 12: Safety Instructions
Safety Instructions WARNING! Any serious incident that has occurred in relation to the device should be reported to the manufactu- rer 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! 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 is not portable medical electrical equipment! WARNING! Patient is allowed to use selected control elements only if hospital personnel had assessed that the patient´s physical and psychological state is in accordance with use of them and only if the hospital personnel had trained the patient in accordance with the instructions for use! 12/40 D9U003VP0-0101_04... - Page 13 Have the mattress system used only by or under supervision of trained and qualified nursing personnel who ™ have been trained according to the instructions for use. LINET® shall not assume any responsibility for any damage or injury resulting from incorrect use. ™ Exclusively use the mattress system if it is in perfect working order.
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Page 14: Intended Use
Intended use The intended use is to prevent and support treatment of pressure injuries. User population ► Caregivers (nurses, doctors, technical personnel, transport personnel, cleaning personnel) ► 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);... -
Page 15: Product Description
Product Description Mattress 4.1.1 Overlay The overlay is an air-fi lled mattress consisting of a central set of 21 transverse air cells and two separate full-length side formers. The mattress parts are covered by an air and water impermeable cover made of polyurethene-coated nylon which has a 270°... -
Page 16: Scu (System Control Unit)
4.1.2 Mattress Replacement The mattress replacement system is designed to replace a standard hospital or domestic foam mattress. It consists of the same type of air mattress as the overlay system and an additional lower 3-section foam base. The replacement sys- tem cover is air-and water-impermeable with a full 360-degree zip to allow easy access to the foam base for cleaning. -
Page 17: Technical Specifications
Technical Specifications Mechanical Specifications Dimensions Mattress replacement (inflated) 2,000 mm x 860 mm x 170 mm (78,5‘ x 33‘ x 7‘) „ Mattress overlay (inflated) 2,000 mm x 860 mm x 130 mm (78,5‘ x 33‘ x 5‘) „ Seat cushion (inflated) 450 mm x 500 mm x 125 mm (17‘... -
Page 18: Electromagnetic Compatibility
► Mains cable, maximum length 6 m WARNING! Use of the accessories, converters and other cables, than specifi ed and provided by manufacturer of this air mattress system could lead to increase of electromagnetic emission or lower the electromagnetic immunity 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 30 cm (12 inches) from any part of this air mattress system Precioso (se- ries 2), including cables specifi ed by manufacturer. Otherwise this could lead to deterioration of functio- nality of this air mattress system. WARNING! Do not overload the air mattress system (SWL), respect the bed duty cycle (INT.) and consider chapter 11 Maintenance in order to maintain the basic safety with regard to electromagnetic disturbances for the expected service life. 5.3.1... - Page 19 5.3.2 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...
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Page 20: Use And Storage Conditions
ISO 14001 2002/95/EC (RoHS) 2002/96/EC (WEEE) Electromagnetic compatibility BS EN 60601-1-2 Precioso is not suitable for indoor environments: containing flammable gases (except oxygen cylinders). „ Storage When SCU is not in use: Switch off SCU using green illuminated power switch on side of SCU. -
Page 21: Putting Into Service
Which positions and settings are safe and appropriate may vary with the type of bed frame and siderails. Before placing a patient on a Precioso mattress, always have a qualifi ed person perform a risk assessment to ensure that the support provided is appropriate and fulfi ls the applicable local stipulations. - Page 22 8.1.2 Mattress Replacement System Remove any existing mattress. ™ Ensure that there are no protruding parts or sharp objects on the bed frame to avoid damage to the mattre- ™ Put mattress on mattress platform of bed frame. ™ Prevent air pipe from getting trapped by moving parts of the bedframe or getting looped or bent in such a ™...
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Page 23: Installation Of Scu (System Control Unit)
Installation of SCU (System Control Unit) CAUTION! Risk of injury when installing SCU! Ensure that no body parts are trapped between hook and foot board when using spring-loaded SCU hanging hooks. Fix SCU securely SCU to prevent it from sliding or accidentally being knocked off . CAUTION! Material damage due to incorrect installation of SCU! ... -
Page 24: Cable Management System
Cable Management System WARNING! Risk of injury due to exposed cable! Ensure that cable is not twisted, crushed or strained. Use cable routing clips in order to avoid tripping hazards. Ensure that it is not possible for the cable to get trapped between any moving parts of the bed frame. The mattress replacement system is equipped with three cable clips on either side of the mattress cover. -
Page 25: Inflation
Inflation Ensure that SCU is not covered and air flow around SCU is not obstructed in order to avoid overheating. ™ Connect mains cable of SCU to suitable mains socket. ™ To switch on SCU: Switch on SCU using green illuminated power switch on side of SCU (see Switching on SCU). ™... -
Page 26: Manipulation
Material damage due to dampness or contamination! Ensure that no moisture gets into the mattress. Ensure that no food or drink gets into the mattress. If moisture, food or drink get into the mattress, notify LINET® Service. Preparation Infl ate mattress. -
Page 27: Controls And Indicators
Controls and Indicators 9.2.1 Control Panel The control panel of the SCU serves to control the mattress replacement system and shows errors and maintenance requirements with indicators and alarm sounds. Fig. SCU Control Panel Buttons Pressure Control Indicator CLP Mode Indicator MAX Mode Indicator APT Mode Button Mode Selection... - Page 28 Button/Indicator Function Pressure Control Button Changing air pressure in mattress. Mode Indicators Indicate selected mode: APT Alternating Pressure Therapy MAX Maximum Inflate CLP Constant Low Pressure Mode Selection Button Selects desired mode. Seat Mode Indicator Indicates that seat cushion is connected. CPR/Air Disconnected Indicator Indicates that air pipe is not connected correctly or not at all.
- Page 29 Manual Pressure Adjustment WARNING! Risk of injury due to incorrect pressure setting! Consult qualifi ed hospital staff prior to adjusting pressure. WARNING! Risk of injury due to incorrect pressure level! The recommended pressure levels may not be the optimum for all situations but should be used in conjunction with clinical judgment based on the individual patient; e.g. weight, weight distribution, position and comfort needs. ...
- Page 30 9.2.5 APT Mode (Default Mode) Once the mattress is fully inflated, a confirming signal sounds and the mattress switches automatically into APT (alterna- ting pressure therapy) mode. To select APT mode: Press button 5 once or repeatedly until indicator 4 comes on. ™ When APT mode is switched on: 3-cell mattress units will inflate and deflate in cycles of 7.5 minutes.
- Page 31 ™ 9.2.9 System error WARNING! Risk of injury due to incorrect positioning of patient! If a system error occurs, do not continue to use mattress replacement system and notify LINET® Service imme- diately. If a system error occurs: Indicator 8 fl ashes red. „ Audio alarm signal (synchronized with fl ash sequence) sounds.
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Page 32: Cpr
9.3.1 CPR (umbilical connected) Fig. CPR (SCU connected) To allow resuscitation with SCU connected: Press red CPR button. ™ Remove air connector plug from air connector. ™ Mattress deflates. 9.3.2 CPR (umbilical disconnected) To allow resuscitation in Transport mode: Rotate end of air connector and main body in opposite directions until the red symbols ▲ and o are aligned ™... -
Page 33: Transport Mode
Transport Mode WARNING! Risk of injury due to incorrect positioning of patient! Prior to more than 30 minutes of Transport mode, consult qualifi ed hospital staff . Transport mode allows disconnecting the mattress from the SCU for transporting the bed without air escaping from the mattress for up to 24 hours. NOTE In Transport mode, alternating pressure therapy is not possible. -
Page 34: Seating System
For patients who are not bed-ridden, it is possible to connect a seat cushion operating in a 2-cell cycle to the SCU instead of the mattress. The LINET® dynamic seat cushion fi ts on most standard chairs and chairs for specialist geriatric care. - Page 35 9.6.3 Initial Operation Ensure that SCU is not covered and air fl ow around SCU is not obstructed in order to avoid overheating. ™ Connect mains cable of SCU to mains. ™ To switch on SCU: Switch on SCU using green power switch on side of SCU. ™...
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Page 36: Cleaning/Disinfection
Clean electrical components carefully and allow them to dry fully. It is recommended to use the cleaning ™ wipes. Neither immerse SCU in water nor heat or steam-clean it. ™ Observe local directives concerning infection control. ™ LINET® recommends the following cleaning agents: Cleaning agents Manufacturer Presept Johnson&Johnson Terralin, Mikrozid, Thermosept Schülke&Mayr... - Page 37 10.1.1 Routine Cleaning and Disinfection Cleaning the mattress: Select Static mode in order to completely inflate all mattress cells (see MAX Mode). ™ Remove air connector and select Transport mode (see Transport Mode). ™ Check mattress cover top for any signs of damage. ™...
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Page 38: Safety Technical Checks
Maintenance 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 installati- on, 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. CAUTION! Material damage due to incorrect maintenance! ►... -
Page 39: Disposal
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 (Ministerstvo životního prostředí). -
Page 40: Warranty
Warranty LINET® will only be held responsible for the safety and reliability of products that are regularly serviced and used in accordance with the safety guidelines. Should a serious defect arise that cannot be repaired during maintenance: ► Do not continue to use the product.
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