Related Manuals for LINET CliniCare 100 HF
Summary of Contents for LINET CliniCare 100 HF
- Page 1 Instructions for Use and Technical Description CliniCare 100 HF Hybrid Mattress Replacement System D9U003VC0-0101 Version: 05 Publication Date: 2021-07...
- Page 2 Phone: +420 312 576 111 Fax: +420 312 522 668 E-Mail: info@linet.cz Web: www.linet.com Service department: service@linetgroup.com CliniCare 100 HF Hybrid Mattress Replacement System Author: L I N E T, s.r.o. Related links: www.linet.cz D9U003VC0-0101 Version: 05 Publication Date: 2021-07 Copyright ©...
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Page 3: Table Of Contents
8 Putting into Service .............21 8.1 Placing CliniCare 100 HF on the Bed ......21 8.1.1 Putting into Service – CliniCare 100 HF Mattress ..21 8.1.2 Putting into Service – SCU (System Control Unit) ... 21 8.2 Connecting Mattress with SCU ........22 8.3 Connecting Air Pipes with Mattress ...... -
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
1.4 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 D9U003VC0-0101_05... -
Page 6: Symbols And Labels On The Product
1.5 Symbols and Labels on the Product READ INSTRUCTIONS FOR USE COVER MATERIALS ARE FIRE RETARDENT TO BS7175, SOURCES 0, 1 AND 5 DO NOT IRON DO NOT USE A CLEANER CONTAINING PHENOL DO NOT WRING REGULARY INSPECT THE INSIDE OF THE COVER FOR CONTAMINATION MACHINE WASH AT 71 DEG. - Page 7 ONLY SUITABLE FOR INDOOR USE CE MARK OF CONFORMITY WITH EU REGULATION 2X 1A(T) ANTI-SURGE FUSE 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 PUT INTO THE HOUSEHOLD WASTE) MEDICAL DEVICE (COMPATIBLE WITH MEDICAL DEVICE REGULATION) RECYCLING SYMBOL...
- Page 8 THERMAL PROTECTION FOR TRANSFORMER SAFETY ISOLATING TRANSFORMER (GENERAL) MANUFACTURER MANUFACTURING DATE MATTRESS FOOT PART MAXIMUM LOAD SYMBOL (FOR 86 CM WIDE MATTRESS) MAXIMUM LOAD SYMBOL (FOR 86 CM WIDE MATTRESS) UNIQUE DEVICE IDENTIFICATION (FOR MEDICAL DEVICES) D9U003VC0-0101_05...
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Page 9: Serial Labels With Udi
This information is required when contacting LINET. 1.6.2 Wash Label (mattress) Fig. Wash label (CliniCare 100 HF - mattress) 1.7 Acoustic signalisation (CliniCare 100 HF) There are no acoustic signals in the case of CliniCare 100 HF. D9U003VC0-0101_05... -
Page 10: 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 11: Safety Instructions
2 Safety Instructions WARNING! Any serious incident that has occurred in relation to the device 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! 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 ... -
Page 12: Before Use
Use the mattress system only as specified in this manual. „ LINET shall not assume any responsibility for any damage or injury resulting from incorrect use. „ Position the power cord so that there are no loops or kinks in the cable; protect the cable from mechanical wear and tear. Impr- „... -
Page 13: Intended Use
3 Intended use The intended use is to prevent and support treatment of pressure injuries. 3.1 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 14: Product Description
4 Product Description 4.1 Mattress The CliniCare 100 HF system is designed for use in all healthcare facilities, hospitals, nursing homes and community care as an aid to the prevention and treatment of skin injuries related to pressure damage. 4.1.1 CliniCare 100 HF CliniCare 100 HF is a hybrid foam including cell system. -
Page 15: Scu (System Control Unit)
SCU is equipped with visual indicators for power failure or mattress low air pressure that may be caused by air pipe disconnection or other faults (see chapter “System Faults”). Fig. SCU for CliniCare 100 HF with MCM mode Fig. SCU for CliniCare 100 HF without MCM mode... -
Page 16: Technical Specification
5 Technical Specification 5.1 Mechanical Specification 86 CM WIDE VERSION CAUTION! Height value of the edge of not loaded inflated mattress is 20 cm and height value in the middle of the mattress is 24,5 cm. This fact does not increase the risk of patient´s falling down over the siderails. Decisive value for choice of the safe mattress in relation to the siderails is 20 cm. Parameter Value External mattress dimensions (length x width) Version 1 200 x 86 Version 2 208 x 86 Version 3 213 x 86 Mattress height (inflated) 24,5 cm Mattress height (deflated) -
Page 17: Electrical Specifications
100 CM WIDE VERSION CAUTION! Height value of the edge of not loaded inflated mattress is 18 cm and height value in the middle of the mattress is 22,5 cm. This fact does not increase the risk of patient´s falling down over the siderails. Decisive value for choice of the safe mattress in relation to the siderails is 18 cm. Parameter Value External mattress dimensions (length x width) 200 x 100 Mattress height (inflated) 22 cm Mattress height (deflated) 18 cm External dimensions of SCU (length x width x height) 30 x 12 x 22 cm Weight ■ ... -
Page 18: Electromagnetic Compatibility
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 CliniCare 100 HF, including cables specified by manufacturer. Otherwise this could lead to deterioration of functionality of this air mattress system. WARNING! Do not overload the air mattress system (Maximum Load), respect the duty cycle (INT.) and consider chapter 11 Maintenance in order to maintain the basic safety with regard to electromagnetic disturbances for the expected ... -
Page 19: Manufacturer Instructions - Electromagnetic Susceptibility
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... -
Page 20: Use And Storage Conditions
6 Use and Storage Conditions DANGER! Risk of injury due using CliniCare 100 HF system in incorrect environments! ► Never use or store CliniCare 100 HF system in environments which contains flammable gases (except oxygen cylinders). 6.1 Storage CAUTION! Incorrect storage can damage the mattress! ► Do not store mattress in compressed state (e.g. underneath other mattresses) or rolled state for long periods of time as this may affect the performance of the air/foam cells. -
Page 21: Putting Into Service
► Place the CliniCare 100 HF mattress (in good condition and free of any damage or wear) on the mattress platform, with the air pipe at the patients left foot side (foot symbol on the mattress cover determines placement) and position so that the mattress is centred. -
Page 22: Connecting Mattress With Scu
If foot board of the bed is suitable for hanging SCU: ► Hold SCU in one hand and unfold hooks on back with the other. ► Hang SCU on the foot board of the bed. If foot board of the bed is not suitable for hanging SCU: ►... -
Page 23: Connecting Air Pipes With Mattress
8.3 Connecting Air Pipes with Mattress In order to switch mattress from reactive to active it is necessary to connect air pipes from the SCU to the mattress. 8.3.1 Mattress with MCM mode Connect air pipes as follows: ► Connect all 3 air pipes with 3 air connectors on the mattress in the direction of arrow until it clicks into place. ►... -
Page 24: Mattress Without Mcm Mode
8.3.2 Mattress without MCM mode Connect air pipes as follows: ► Connect both air pipes with 2 air connectors on the mattress in the direction of arrow until it clicks into place. ► Ensure that both air pipes are connected properly by pulling them back. Fig. Connecting air pipes to the mattress without MCM mode Fig. -
Page 25: Disconnecting Air Pipes From Mattress (Aka Switching To Reactive Mattress)
8.4 Disconnecting Air Pipes from Mattress (aka Switching to reactive mattress) It is possible to disconnect air pipes and switch the mattress from active to reactive. This means the mattress can be used without SCU. The mattress then provides reactive pressure redistribution through self adjusting air cells. 8.4.1 Mattress with MCM mode Disconnect air pipes as follows: ►... -
Page 26: Mattress Without Mcm Mode
8.4.2 Mattress without MCM mode Disconnect air pipes as follows: ► Press and hold the metal plate on the air connector. ► Pull the air pipe out of the air connector. ► Repeat on the remaining air pipe. Air pipes are removed from the mattress. Fig. Disconnecting air pipes from the mattress without MCM mode Fig. -
Page 27: Inflation
Fig. Switching on SCU 8.5.2 Infl ation Infl ation: ► Select required mode (see chapter “Control panel – CliniCare 100 HF”). ► After switching ON the mattress will start to infl ate, the indicator is illuminated during infl ation. -
Page 28: Manipulation
Ensure that no body fluids get into the mattress cover. ► Mattress must be cleaned thoroughly between patients and decontaminated after patients with known or suspected infections. ► If moisture gets into the system, notify LINET Service. Preparation ► Inflate mattress (see Initial Operation). ►... -
Page 29: Control Panel - Clinicare 100 Hf With Micro-Climate Management
9.2.2 APT+MCM – Alternating pressure therapy + Micro-Climate Management In APT + MCM mode CliniCare 100 HF operates by alternating pressure in a two cell system in a 12 minute interval cycle. This imi- tates the natural movement of the patient. During this cycle reduced pressure acts on the patient which helps to prevent and treat pressure sores. -
Page 30: Control Panel - Clinicare 100 Hf Without Micro-Climate Management
9.3.1 APT – Alternating pressure therapy CliniCare 100 HF operates by alternating pressure in a two cell system in a 12 minute interval cycle. This imitates the natural move- ment of the patient. During this cycle reduced pressure acts on the patient which helps to prevent and treat pressure sores. -
Page 31: Pressure Control
9.4 Pressure 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 all situations but should be used in conjunction with clinical judgement based on the individual patient; e.g. weight, weight distribution, position and comfort needs. -
Page 32: Cpr - Cardipulmonary Resuscitation
NOTE: During initial inflation the low pressure indication will come on until the mattress has achieved its minimum pressure. This does not mean there is a fault unless the indicator has been on for more than 20 minutes after a power cycle. CliniCare 100 HF SCU Meaning... - Page 33 Problem Symptom CliniCare 100 HF SCU Action Power failure (SCU will not turn on) Power switch not illuminated Check that the Power switch on the SCU is in the on ( I ) position. Check the SCU is connected to an elect- rical wall socket and the outlet switch is in the correct position.(If necessary check...
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Page 34: Cleaning/Disinfection
10 Cleaning/Disinfection CAUTION! Incorrect cleaning/disinfection can damage the mattress and SCU! ► 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 by qualified hygiene experts only. ►... -
Page 35: Routine Cleaning And Disinfection
10.2 Routine Cleaning and Disinfection Read section “General Guidance” for more details of the recommended cleaning and disinfection processes. Cleaning the mattress: ► Check mattress cover top for any signs of damage or for liquid ingress. Any fluid contamination inside the mattress means the entire mattress must be replaced. -
Page 36: Cleaning The Air Pipe
10.3.3 Cleaning the air pipe ► Wipe air pipe cover and exposed pipes with cleaning agent or disinfectant. ► Let air pipe dry. -or- ► Remove the air pipe cover (see chapter Removing the Mattress Cover) and clean it as stated above (for the top mattress cover see chapter Machine washing of CliniCare 100HF removable top mattress cover), if full disinfection is required. -
Page 37: Maintenance
11 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 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. CAUTION! Material damage due to incorrect maintenance! ►... -
Page 38: 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... -
Page 39: Warranty
13 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. Consult the warranty provided for your country. Should a serious defect arise that cannot be repaired during maintenance: ►...
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