LINET Air2Care 10 User manual

Air2Care Model 10 & 20
Mattress Replacement and Overlay
Systems
D9U003VA0-0101
Version: 04
Publication date: 2020-05
Instructions for Use
and Technical Description

D9U003VA0-0101_042
Manufacturer:
LINET spol. s r. o.
Želevčice 5,
274 01 Slaný
Czech Republic
Phone: [phone]
Fax: [phone]
E-Mail: [email protected]
Web: www.linet.com
Service department: [email protected]
Air2Care 10 & 20
Mattress Replacement and Overlay Systems
Author: LINET, s.r.o.
Related links: www.linet.cz
D9U003VA0-0101
Version: 04
Publication date: 2020-05
Copyright © LINET, s.r.o., 2020
Translation © LINET, 2020
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. It is for this reason that the contents of the in-
structions for use may indicate di󰀨erences from the current manufacture of the product. Reproduction, also excerpts, only with prior
permission of the publisher. Subject to changes due to technical developments. All technical data are rated data and are subject to
construction and manufacturing tolerances.

D9U003VA0-0101_04 3
1 Symbols and Denitions .............................................4
1.1 Warning Notices..........................................................4
1.1.1 Types of Warning Notices ........................................4
1.1.2 Structure of Warning Notices ...................................4
1.2 Instructions..................................................................4
1.3 Lists.............................................................................4
1.4 Symbols on the Package ............................................5
1.5 Symbols and Labels on the Product ...........................5
1.5.1 Serial labels with UDI ............................................... 8
1.5.2 Wash Label (mattress) ............................................. 10
1.6 Acoustic signalisation (Air2Care 10) ...........................11
1.7 Acoustic signalisation (Air2Care 20) ...........................11
1.8 Abbreviations ..............................................................11
2 Safety Instructions.......................................................12
2.1 Before use...................................................................13
2.2 Installation...................................................................13
2.3 Usage..........................................................................13
3 Intended use.................................................................14
3.1 User population...........................................................14
3.2 Contraindications ........................................................14
3.3 Operator......................................................................14
4 Product Description.....................................................15
4.1 Mattress ......................................................................15
4.1.1 The Overlay..............................................................15
4.1.2 Mattress replacement system (air + foam)...............16
4.1.3 Mattress replacement system (air + air)...................16
4.2 SCU (System Control Unit) .........................................17
4.2.1 FIRMWARE..............................................................17
5 Technical Specication ............................................... 18
5.1 Mechanical Specication ...........................................18
5.2 Operating pressure settings........................................18
5.3 Electrical Specications ..............................................19
5.4 Electromagnetic compatibility .....................................19
5.4.1 Manufacturer instructions - electromagnetic emissions
..........................................................................................20
5.4.2 Manufacturer instructions - electromagnetic susceptibility
..........................................................................................20
6 Use and Storage Conditions ....................................... 21
6.1 Storage .......................................................................22
7 Scope of Delivery and Bed Variants........................... 22
7.1 Delivery .......................................................................22
7.2 Contents......................................................................22
8 Putting into Service .....................................................23
8.1 Securing Strap System ...............................................23
8.1.1 Installation – Overlay Mattress.................................23
8.1.2 Installation – Mattress Replacement ........................ 24
8.2 Installation of SCU (System Control Unit)...................24
8.3 Connecting Mattress with SCU ...................................25
8.4 Ination .......................................................................26
8.4.1 Switching SCU ON/OFF ..........................................26
8.4.2 Ination ....................................................................26
9 Manipulation .................................................................27
9.1 Use..............................................................................27
9.1.1 Preparing the Bed for the Patient.............................27
9.2 Controls and Indicators ............................................... 28
9.2.1 Control panel - Air2Care 10 .....................................28
9.2.2 Control panel - Air2Care 20 .....................................29
9.2.3 Pressure Control ...................................................... 30
9.3 CPR – Cardipulmonary resuscitation.......................... 32
9.4 Transport mode..........................................................32
9.5 Power failure ............................................................... 32
9.6 System faults ..............................................................33
9.7 Seating System........................................................... 34
9.7.1 Function ...................................................................34
9.7.2 Installation and Startup ............................................35
9.7.3 Seating of the Patient...............................................36
10 Cleaning/Disinfection ................................................37
10.1 General Guidance..................................................... 37
10.2 Routine Cleaning and Disinfection............................ 38
10.3 Complete Cleaning and Disinfection......................... 38
10.4 Removing the Mattress Cover ..................................39
11 Maintenance ..............................................................40
11.1 Regular maintenance ................................................40
11.2 Spare Parts ...............................................................40
11.3 Safety Technical Checks ........................................... 40
12 Disposal ...................................................................... 41
12.1 Environment Protection.............................................41
12.2 Disposal ....................................................................41
12.2.1 Within Europe ........................................................ 41
12.2.2 Outside Europe ...................................................... 41
13 Warranty......................................................................42
14 Standards and Regulations ......................................42
Table of Contents

D9U003VA0-0101_044
1 Symbols and Denitions
1.1 Warning Notices
1.1.1 Types of Warning Notices
Warning notices are di󰀨erentiated 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!
► Measures to avoid the danger.
1.2 Instructions
Structure of instructions:
► Perform this step.
Results, if necessary.
1.3 Lists
Structure of bulleted lists:
■ List level 1
□ List level 2
● List level 3

D9U003VA0-0101_04 5
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
MEDICAL DEVICE (COMPATIBLE WITH MEDICAL DEVICE REGULATION)
MANUFACTURER
MANUFACTURING DATE
1.5 Symbols and Labels on the Product

D9U003VA0-0101_046
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. INITIAL TEMPERATURE OF HOT WATER SHOULD NOT
EXCEED 50 DEG. CENTIGRADE
DISINFECT USING SOLUTION CONTAINING <1000 PPM OF CHLORINE (SEE CLEANING/
DISINFECTION)
RINSE WITH WATER
DRY
WARNING

D9U003VA0-0101_04 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
I : ON
O: OFF
ALTERNATING CURRENT
WEEE SYMBOL (RECYCLE AS ELECTRONIC WASTE,
DO NOT PUT INTO THE HOUSEHOLD WASTE)
RECYCLING SYMBOL
DO NOT POLLUTE THE ENVIRONMENT
REFERENCE NUMBER (PRODUCT TYPE DEPENDING ON CONFIGURATION)
SERIAL NUMBER

D9U003VA0-0101_048
1.5.1 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 elds on the serial labels.
Fig. Serial label for Air2Care 10 (220-240 V)
Fig. Serial label for Air2Care 10 (100-127 V)
1 Address of Manufacturer
2 1D Bar Code GS1-128 (Serial Number)
3PI (Product Identier)
4DI (Device Identier) / GTIN (Global Trade Item Number)
5Manufacturing Date (Year-Month-Day)
6 2D Bar Code (GS1 DataMatrix) DI+PI=UDI
7 Serial Number
8Symbols
Serial Label for Air2Care 10 (SCU)
1VAKE20000010
REF
SN 20200105441
2020-02-21
(01) 8592654070543
(11) 200221
(21) 20200105441
AIR2CARE 10
220-240 V~, 50 Hz, 15 VA
1VAKE20000010
REF
SN 20200105441
2020-02-21
(01) 8592654070543
(11) 200221
(21) 20200105441
AIR2CARE 10
100-127 V~, 60 Hz, 15 VA
2
2
1
1
3
3
4
4
6
6
8
8
7
7
5
5

D9U003VA0-0101_04 9
Fig. Serial label for Air2Care 20 (100-127 V)
Fig. Serial label for Air2Care 20 (220-240 V)
1 Address of Manufacturer
2 1D Bar Code GS1-128 (Serial Number)
3PI (Product Identier)
4DI (Device Identier) / GTIN (Global Trade Item Number)
5Manufacturing Date (Year-Month-Day)
6 2D Bar Code (GS1 DataMatrix) DI+PI=UDI
7 Serial Number
8Symbols
Serial Label for Air2Care 20 (SCU)
1VAKE20000020
REF
SN 20200122672
2020-02-21
(01) 8592654073056
(11) 200221
(21) 20200122672
AIR2CARE 20
100-127 V~, 60 Hz, 15 VA
1VAKE20000020
REF
SN 20200122672
2020-02-21
(01) 8592654073056
(11) 200221
(21) 20200122672
AIR2CARE 20
220-240 V~, 50 Hz, 15 VA
2
2
1
1
3
3
4
4
6
6
8
8
7
7
5
5

D9U003VA0-0101_0410
Serial Label for Air2Care 10 and Air2Care 20 (mattress)
Fig. Serial Label with UDI (Air2Care 10 and Air2Care 20 - mattress)
1.5.2 Wash Label (mattress)
7
3
2
5
4
6
1VAM000220200
REF
SN 20200112325
2020-02-24
(01) 8592654070567
(11) 200224
(21) 20200112325
1
1 Address of Manufacturer
2 1D Bar Code GS1-128 (Serial Number)
3PI (Product Identier)
4DI (Device Identier) / GTIN (Global Trade Item Number)
5Manufacturing Date (Year-Month-Day)
6 2D Bar Code (GS1 DataMatrix) DI+PI=UDI
7 Serial Number

D9U003VA0-0101_04 11
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:
1) during 2 minutes:
REPEATED BEEP: lasting 0,25s / 3s (± 1s) silence
2) during next 6 minutes:
REPEATED BEEP: lasting 0,25s / 9s (± 1s) silence
3) during next minutes:
REPEATED BEEP: lasting 0,25s / 2 min (± 5s) silence
disconnected from the mains
mains voltage is not available when the mains switch is turned
ON
mains switch is turned OFF
REPEATED BEEP: 0,25s sound / 4s silence mattress ination failure
valve rotation failure
pressure fault
1.8 Abbreviations
AC ( ~ ) Alternating Current
CE European Conformity
CPR Cardiopulmonary Resuscitation
dB Sound Intensity Unit
DC ( ) Direct Current
CUC Conguration number
EMC Electromagnetic Compatibility
FET Field-e󰀨ect transistor
HF High Frequency
HPL High Pressure Laminate
ICU Intensive Care Unit
INT. Duty Cycle
IP Ingress Protection
IV Intravenous
LED Light Emitting Diodes
ME Medical Electrical (Equipment)
ON Activation
OFF Deactivation
ppm parts per million, millionth (1000 ppm = 0,1%)
REF Reference Number (product type depending on conguration)
SCU System Control Unit (integrated mattress)
SN Serial Number
SW Software
SWL Safe Working Load
UDI Unique Device Identication (for medical devices)
USB Universal Serial Bus
WEEE Waste Electrical and Electronic Equipment

D9U003VA0-0101_0412
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 ammable 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!

D9U003VA0-0101_04 13
2.1 Before use
► It is necessary to read the instructions for use before operating the mattress system.
► Follow the instructions carefully.
► Use the mattress system only as specied in the instructions for use.
► Only use mattress with original SCU. Using mattress with non-original SCU is not allowed.
► Never use safety straps designed for xing 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.
Improper handling of mains cable can cause an electric shock hazard, other serious injuries or damage to the mattress
system.
► Position the mains cable so there is no risk of injuring the patient (e.g. choking hazard).
► Regular inspection of the mattress interior to be carried out on a regular basis.
► In case of any problem please contact manufacturer for help at installation, service or if an unexpected event occurs.
2.2 Installation
► Ensure that installation is performed in accordance with the instructions in the instructions for use.
► Ensure that maintenance is performed only by qualied personnel who have been trained by the manufacturer.
2.3 Usage
► Ensure that the mattress system is only operated by suitably qualied personnel or after receiving instruction from them.
► Only use the mattress system if it is in perfect working order.
► Only use the system in clean environment.
► Always hold SCU with scoop handle when moving.
► Only use the mattress system with the correct mains supply (see Electromagnetic Compatibility).
► Replace any damaged parts immediately with original spare parts only.
► Do not exceed the maximum patient weight (see Mechanical Specications).
► Do not use the SCU in near ammable gases. This does not apply to oxygen cylinders.
► Do not cover SCU while in use.
► Do not place SCU near extreme heat sources such as radiators.
► Never handle the mains plug with wet hands.
► Disconnect the product from the mains only by pulling the mains plug. To pull the mains plug, always hold the actual plug, not
the cable.
► Mattress and SCU must be checked at least once a day. Check that:
■ the mattress is inated to the required pressure
■ the error code indicator is not illuminated
in case of error refer to the chapter System Faults

D9U003VA0-0101_0414
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); Patients with any stage/category of pressure ulcers
3.2 Contraindications
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,
► or trauma patients where spinal injuries have not been excluded or cleared
3.3 Operator
► Caregiver

D9U003VA0-0101_04 15
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. The overlay is an air- lled mattress consisting of a central set of 21 tran-
sverse air cells and two separate full length side formers.
Mattress system cover is water proof and vapour permeable cover made of polyurethene-coated nylon which has a two 180° zip. It
has straps to prevent the mattress ends from moving when  tted on top ofa standard hospital foam or a domestic mattress.
Fig. Overlay
1. Head section
■ 3 head cells which remains in ated (static)
2. Side formers
■ 10 small full-length side formers which remain in ated (static)
3. Foot section
■ 7 lower leg/foot cells (25% smaller) which alternate in 2-cell cycle
4. Torso section
■ 11 torso/upper leg cells (9 alternating, 2 static for support of patient’s back and patient’s comfort) which alternate
in 2-cell cycle

D9U003VA0-0101_0416
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° zips to allow easy access for cleaning. Cover has straps to secure the mattress to the bed.
Overlay (top air layer):
■ air- lled overlay (see Overlay)
Base (bottom foam layer):
■ consists of hospital-grade  re-retardant foam
Cover:
■ bottom part: non- exible, resistant material
■ top part:  exible, water proof material
Mattress replacement system (air + foam)
4.1.3 Mattress replacement system (air + air)
The mattress replacement system is designed to replace a standard hospital, nursing home or domestic foam mattress. It consists
of two air layer. Upper layer is dynamic and the bottom layer is static. The replacement system cover is water proof and vapour
permeable with a two 180° zips to allow easy access for cleaning. Cover has straps to secure the mattress to the bed.
Overlay (top air layer):
■ air- lled overlay (see Overlay)
Base (bottom air layer):
■ static air- lled base
Cover:
■ bottom part: non- exible, resistant material
■ top part:  exible, water proof material
Fig. Mattress replacement system (air + air)

D9U003VA0-0101_04 17
4.2 SCU (System Control Unit)
The SCU in ates and de 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.
Fig. SCU for Air2Care 10 Fig. SCU for Air2Care 20
4.2.1 FIRMWARE
The system control unit includes  rmware that can be updated only by an authorised service technician.
This  rmware is protected against unauthorised access by mechanical housing (tool is needed to access) and by exclu-
sive compatibility with an authorised software tool and speci c cable.

D9U003VA0-0101_0418
5 Technical Specication
5.1 Mechanical Specication
Parameter Parameter
Dimensions
■ Mattress replacement (inated)
■ Overlay (inated)
■ Seat cushion (inated)
■ SCU
2 000 x 860 x 170 mm
2 000 x 860 x 93 mm
450 x 500 x 125 mm
260 x 120 x 215 mm
Weight
■ Mattress replacement (inated)
■ Overlay (inated)
■ Seat cushion (inated)
■ With optional seat plate
■ SCU
Cycle
■ Mattress (inated)
■ Seat cushion (inated)
7,5 kg
6 kg
2,1 kg
3,5 kg
2,5 kg
2 cells, 12 minutes
2 cells, 12 minutes
Environmental conditions
■ Temperature
■ Humidity
■ Atmospheric pressure
10 °C – 40 °C
30% - 75%
795 – 1060 hPa
Maximal load (SWL)
■ Mattress replacement (air + air)
■ Mattress replacement (air + foam)
■ Overlay
■ Seat cushion
210 kg
200 kg
180 kg
127 kg
Ination time
■ Mattress
■ Seat cushion
up to 30 min
6 min
Deation time (CPR) Max. 30 s
Sound Pressure Level 35 dBA
5.2 Operating pressure settings
Parameter Parameter
Air2Care 10
■ APT
■ STATIC
20 – 45 mmHg
20 – 45 mmHg
Air2Care 20
■ APT
■ CPT
■ MAX
15 – 50 mmHg
12 – 45 mmHg
45 mmHg
Pressure settings tolerance ± 5 mmHg

D9U003VA0-0101_04 19
5.4 Electromagnetic compatibility
Air mattress system is intended for hospitals except for near active HF surgical equipment and the RF shielded room of a medical
system for magnetic resonance imaging, where the intensity of EM disturbances is high.
Air mattress system has dened no essential performance.
WARNING!
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:
1. Mains cable, maximum length 6 m
WARNING!
Use of the accessories, converters and other cables, than speci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 Air2Care, including cables
specied by manufacturer. Otherwise this could lead to deterioration of functionality of this air mattress sys-
tem.
WARNING!
Do not overload the air mattress system (SWL), respect the bed duty cycle (INT.) and consider chapter 11Main-
tenance in order to maintain the basic safety with regard to electromagnetic disturbances for the expected
service life.
5.3 Electrical Specications
Parameter Parameter
Supply nominal voltage
■ Model 127V
■ Model 230V
100-127 VAC, 60 Hz
220-240 VAC, 50 Hz
Maximal power Air2Care 10
■ Model 127V
■ Model 230V
Maximal power Air2Care 20
■ Model 127V
■ Model 230V
15VA
15VA
25VA
35VA
Fuse
Air2Care 10
Air2Care 20
2x (T 1A L) anti-surge fuse
(250 V, type 5x20mm)
2x (T 500mA L) anti-surge fuse
(250 V, type 5x20mm)
Electrical safety class Class II with applied parts type B
Electrical safety In conformity with EN 60601-1

D9U003VA0-0101_0420
5.4.1 Manufacturer instructions - electromagnetic emissions
Emission Test Compliance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuations / icker emissions
IEC 61000-3-3
Complies
5.4.2 Manufacturer instructions - electromagnetic susceptibility
Immunity Tests Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8 kV for contact discharge
± 15 kV for contact discharge
Radiated RF
IEC 61000-4-3
Proximity elds from RF wireless communications equipment
IEC 61000-4-3
3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
See Table 1
Fast electrical transients / burst
IEC 61000-4-4
±2 kV for power line
repetition frequency 100 kHz
Surge
IEC 61000-4-5
± 1 kV Line-to-line
Conducted RF
IEC 61000-4-6
3 V (0,15 MHz – 80 MHz)
6 V in ISM bands between 0,15 MHz and 80 MHz
80 % AM at 1 kHz
Power frequency (50/60 Hz) magnetic eld
IEC 61000-4-8
30 A/m
Voltage dips, short interruptions on power supply input lines
IEC 61000-4-11
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° a 315°
0 % UT; 1 cycle and 70 % UT; 25/30 cycle
Single phase: at 0°
0 % UT; 250/300 cycle
NOTE: Compressor self-reset can occur in the case of Air2Care 20, no e󰀨ect to product functionality. After the reset previous mode
continues functional.