LINET Air2Care 10 Instructions For Use Manual
Mattress replacement and overlay systems
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- User manual and technical description (43 pages) ,
- Service manual (32 pages)
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Summary of Contents for LINET Air2Care 10
- Page 1 Instructions for Use and Technical Description Air2Care Model 10 & 20 Mattress Replacement and Overlay Systems D9U003VA0-0101 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 Air2Care 10 & 20 Mattress Replacement and Overlay Systems Author: LINET, s.r.o.
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Page 3: Table Of Contents
1.5.1 Serial labels with UDI ..........8 12.2.1 Within Europe ............41 1.5.2 Wash Label (mattress) ..........10 12.2.2 Outside Europe ............41 1.6 Acoustic signalisation (Air2Care 10) ......11 13 Warranty ..............42 1.7 Acoustic signalisation (Air2Care 20) ......11 14 Standards and Regulations ........42 1.8 Abbreviations ..............11... -
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 1.5 Symbols and Labels on the Product MEDICAL DEVICE (COMPATIBLE WITH MEDICAL DEVICE REGULATION) MANUFACTURER MANUFACTURING DATE D9U003VA0-0101_04... - Page 6 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°C TUMBLE DRY ON LOW HEAT SETTING HANDWASH WITH DETERGENT.
- Page 7 ONLY SUITABLE FOR INDOOR USE CE MARK OF CONFORMITY WITH EU REGULATION 2X 1A(T) ANTI-SURGE FUSE (AIR2CARE 10) 2X 250MA (T) ANTI-SURGE FUSE (AIR2CARE 20) PROTECTION AGAINST ACCIDENTS DUE TO ELECTRICAL CURRENT – TYPE B APPLIED PARTS DOUBLE INSULATION POWER SWITCH...
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Page 8: Serial Labels With Udi
The serial label is located on the back of the SCU (System Control Unit). The serial number and the model number 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 Serial Label for Air2Care 20 (SCU) AIR2CARE 20 (01) 8592654073056 (11) 200221 1VAKE20000020 (21) 20200122672 20200122672 220-240 V~, 50 Hz, 15 VA 2020-02-21 Fig. Serial label for Air2Care 20 (220-240 V) AIR2CARE 20 (01) 8592654073056 (11) 200221 1VAKE20000020 (21) 20200122672 20200122672 100-127 V~, 60 Hz, 15 VA 2020-02-21...
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Page 10: Wash Label (Mattress)
(01) 8592654070567 (11) 200224 (21) 20200112325 2020-02-24 Fig. Serial Label with UDI (Air2Care 10 and Air2Care 20 - mattress) Address of Manufacturer 1D Bar Code GS1-128 (Serial Number) PI (Product Identifier) DI (Device Identifier) / GTIN (Global Trade Item Number) -
Page 11: Acoustic Signalisation (Air2Care 10)
1.6 Acoustic signalisation (Air2Care 10) There are no acoustic signals in the case of Air2Care 10. 1.7 Acoustic signalisation (Air2Care 20) SOUND MEANING 3 SOUND MODES: disconnected from the mains 1) during 2 minutes: mains voltage is not available when the mains switch is turned REPEATED BEEP: lasting 0,25s / 3s (±... -
Page 12: 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 13: Before Use
Never use safety straps designed for fixing the mattress to the bed for emergency evacuation of the patient. ► LINET® shall not assume any responsibility for any damage or injury resulting from incorrect use. ► Position the mains cable so that there are no loops or kinks in the cable; protect the cable from mechanical wear and tear. -
Page 14: 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 15: Product Description
4 Product Description 4.1 Mattress The Air2Care mattress system is designed for use in all health care 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 The Overlay This system is designed to be used with current mattress. -
Page 16: Mattress Replacement System (Air + Foam)
4.1.2 Mattress replacement system (air + foam) The mattress replacement system is designed to replace a standard hospital, nursing home or domestic foam mattress. It consists of the overlay system and an additional lower 3-section foam base. The replacement system cover is water proof and vapour per- meable with a two 180°... -
Page 17: Scu (System Control Unit)
The SCU infl ates and defl ates the air mattress. It is connected to the air mattress with a custom-designed air connector. The analogue electro-mechanical controlled (Air2Care 10) or microprocessor-controlled SCU (Air2Care 20) maintains the set pressure regardless of the patient’s weight distribution or position. The SCU is equipped with an audio and/or visual alarm system to detect power failures, air pipe disconnections or other faults. -
Page 18: Technical Specification
Seat cushion 6 min Deflation time (CPR) Max. 30 s Sound Pressure Level 35 dBA 5.2 Operating pressure settings Parameter Parameter Air2Care 10 ■ 20 – 45 mmHg ■ STATIC 20 – 45 mmHg Air2Care 20 ■ 15 – 50 mmHg ■... -
Page 19: Electrical Specifications
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 surveillance 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 air ... -
Page 20: Manufacturer Instructions - Electromagnetic Emissions
5.4.1 Manufacturer instructions - electromagnetic emissions Emission Test Compliance RF emissions Group 1 CISPR 11 RF emissions Class B CISPR 11 Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations / flicker emissions Complies IEC 61000-3-3 5.4.2 Manufacturer instructions - electromagnetic susceptibility Immunity Tests Compliance level Electrostatic discharge (ESD) ±... -
Page 21: Use And Storage Conditions
Table 1 - IMMUNITY to RF wireless communications equipment Test frequency (MHz) Band (MHz) Service Modulation Immunity Test Level 380 - 390 TETRA 400 Pulse modulation 18 Hz 430 - 470 GMRS 460, FRS 460 FM ± 5 kHz deviation 1 kHz sine 704 - 787 LTE band 13, 17 Pulse modulation 217 Hz 800 - 960 GSM 800/900, TETRA... -
Page 22: Storage
6.1 Storage When SCU is not in use: ► Switch off SCU using mains switch on the control panel of SCU. ► Unplug mains cable. ► Wrap mains cable around SCU. ► Pack in suitable cover. ► Store in a place suitable for electronic medical devices. When mattress is not in use: ►... -
Page 23: Putting Into Service
8 Putting into Service 8.1 Securing Strap System WARNING! Material damage due to incorrect fastening of safety straps! ► When using mattress replacement or overlay systems, make sure to use safe and appropriate siderail positions and bed height settings. Which positions and settings are safe and appropriate may vary with the type of bed frame and siderails. -
Page 24: Installation - Mattress Replacement
8.1.2 Installation – Mattress Replacement To secure mattress on the bed: ► The two separate straps are not used in this situation, and should be removed and stored safely. ► Ensure that there are no protruding parts or sharp objects on the bed frame to avoid damage to the mattress. ►... -
Page 25: Connecting Mattress With Scu
Fig. Installation of SCU on the foot board Fig. Installation of SCU on the floor 8.3 Connecting Mattress with SCU Installation: ► Make sure the air connector is not in transport mode (see Transport mode). ► Insert air connector 1 in the socket 2 at an angle of approx. 45°. ►... -
Page 26: Inflation
8.4 Infl ation ► Connect mattress to the SCU using air connectors. ► Ensure that SCU is not covered and air fl ow around SCU is not obstructed in order to avoid overheating. ► Plug SCU power cord into suitable power socket. 8.4.1 Switching SCU ON/OFF To switch ON SCU: ►... -
Page 27: Manipulation
Regulary inspect the inside of the cover for contamination. ► 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. ►... -
Page 28: Controls And Indicators
9.2.1 Control panel - Air2Care 10 The control panel of the SCU serves to control the mattress replacement system and shows errors. Alarms are signaled by illumina- tion of the indicator 2. Fig. SCU Control Panel – Air2Care 10 Position Control / Indicator Function... -
Page 29: Control Panel - Air2Care 20
9.2.2 Control panel - Air2Care 20 The control panel of the SCU serves to control the mattress replacement system, for mode selection and shows errors. Alarms are signaled by blinking of the indicator 2 or by acoustic signal. Fig. SCU Control Panel – Air2Care 20 Position Control / Indicator Function... -
Page 30: Pressure Control
MAX – Maximum inflation mode MAX mode provides a solid and stable surface for patient treatment. MAX mode will run for 30 minutes at most. If no other mode is switched on within these 30 minutes, then the SCU will turn back into previously selected mode APT or CLP. To select MAX mode: ►... - Page 31 Select pressure as follows: With the mattress fully inflated using STATIC (A2C 10) / MAX (A2C 20) mode. ► Select the required operating mode STATIC (A2C10 only), APT or CLP (A2C 20 only). ► Set the pressure control dial vertical, pointing into the centre of the Green section of the dial. ►...
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Page 32: Cpr - Cardipulmonary Resuscitation
9.3 CPR – Cardipulmonary resuscitation Before starting resuscitation with SCU connected: ► Press red CPR button. ► Remove air connector plug from SCU. ► Mattress starts to deflate and resuscitation procedure can commence. The air in the mattress will deflate immediately after pressing patient’s chest. Fig. -
Page 33: System Faults
System faults are indicated by the amber light on the SCU. NOTE: During initial inflation the Air2Care 10 low pressure indication will come on until the mattress has achieved its minimum pressure. This does not a mean there is a fault unless it remains on for more than 30 minutes. -
Page 34: Seating System
The seat cushion consists of two sets of alternating cells on a foam base with a front support. The cover consists of vapour-permeable, water-imper- meable two-way stretch material. The cushion is only designed for LINET® SCUs. Fig. SCU and cushion 9.7.1 Function... -
Page 35: Installation And Startup
9.7.2 Installation and Startup WARNING Risk of injury due to unsuitable chair! ► Ensure that chair is suitable for seating system. ► Conduct risk evaluation if necessary. WARNING Risk of injury due to exposed cable! ► Ensure that cable is not twisted, crushed or strained. ► Ensure that cable does not present a tripping hazard. Install seating system as follows: ►... -
Page 36: Seating Of The Patient
9.7.3 Seating of the Patient WARNING Risk of injury when seating the patient! ► Ensure that seat cushion is completely inflated! Preparation: ► Inflate seat cushion (see Installation and Startup). Seating of the patient: ► Sit patient on seat cushion. For an ideal sitting position: ► Ensure that chair is suitable for patient’s size in order to guarantee correct seating position. -
Page 37: 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 38: Routine Cleaning And Disinfection
10.2 Routine Cleaning and Disinfection 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. Replace or repair and completely disinfect mattress cover top if damaged. ►... -
Page 39: Removing The Mattress Cover
10.4 Removing the Mattress Cover ► Carefully open both zippers under the flap covering the zippers of mattress cover on foot end of mattress. ► Remove top part of mattress cover. Inspect cover and clean if necessary. ► Undo corner toggles: ■... -
Page 40: 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 41: 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 42: 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. Should a serious defect arise that cannot be repaired during maintenance: ► Do not continue to use the product.
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