LINET Precioso Parts list manual

Precioso
Mattress Replacement or Overlay System - Series 2
D9U003VP0-0101
Version: 04
Publication date: 2020-05
Instructions for Use
and Technical Description

D9U003VP0-0101_042/40
Precioso
Mattress Replacement or Overlay System – Series 2
Author: LINET, s.r.o.
Link: www.linet.com
D9U003VP0-0101
Version: 04
Publication date: 2020-05
Copyright © LINET, s.r.o., 2020
Translation © LINET, s.r.o., 2020
All rights reserved.
All trademarks and brands are the property of the appropriate owner. 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 instructions 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.
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]

3/40D9U003VP0-0101_04
1 SymbolsandDenitions......................................4
1.1 Warning Notices..............................................4
1.2 Other symbols.................................................4
1.3 Symbols on the Package ................................5
1.4 Symbols and Labels on the Product ...............6
1.5 Serial Label.....................................................8
1.6 Acoustic signalisation......................................10
1.7 Abbreviations ..................................................11
2 Safety Instructions ...............................................12
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
4.2 SCU (System Control Unit).............................16
5 TechnicalSpecications ......................................17
5.1 Mechanical Specications...............................17
5.2 Electrical Specications ..................................17
5.3 Electromagnetic Compatibility.........................18
6 Use and Storage Conditions................................20
6.1 Storage ...........................................................20
7 Scope of Delivery and Product Variants.............20
7.1 Scope of Delivery............................................20
7.2 List of Parts.....................................................20
8 Putting into Service ..............................................21
8.1 Installation of Mattress....................................21
8.2 Installation of SCU (System Control Unit).......23
8.3 Connecting Mattress and SCU .......................23
8.4 Cable Management System............................24
8.5 Ination ...........................................................25
9 Manipulation..........................................................26
9.1 Use..................................................................26
9.2 Controls and Indicators...................................27
9.3 CPR ................................................................32
9.4 Transport Mode...............................................33
9.5 Power Failure..................................................33
9.6 Seating System...............................................34
10 Cleaning/Disinfection ...........................................36
10.1 Cleaning..........................................................36
11 Maintenance .........................................................38
11.1 Regular maintenance......................................38
11.2 Spare Parts.....................................................38
11.3 Safety Technical Checks.................................38
12 Disposal.................................................................39
12.1 Environment Protection...................................39
13 Warranty ................................................................40
14 Standards and Regulations .................................40
Table of Contents

D9U003VP0-0101_044/40
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 - risk of material damage.
Warning - risk of physical injury.
Danger - risk of fatal injury.
1.1.2 Structure of Warning Notices
1.2 Other symbols
1.2.1 Instructions
Structure of instructions:
Perform this step.
Result, if necessary.
1.2.2 Lists
Structure of bulleted lists:
List level 1
List level 2
SIGNAL WORD!
Type and source of danger!
Measures to avoid the danger!

5/40D9U003VP0-0101_04
1.3 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_046/40
1.4 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
CE MARK OF CONFORMITY WITH EU REGULATION
I
O
MAINS SWITCH
I: ON (CONNECTED TO THE MAINS SUPPLY)
O: OFF (DISCONNECTED FROM MAINS SUPPLY)
DEVICE IS CONNECTED TO MAINS WHEN GREEN INDICATOR IS ON.
RECYCLING SYMBOL
DO NOT POLLUTE THE ENVIRONMENT
WEEE SYMBOL (RECYCLE AS ELECTRONIC WASTE,
DO NOT PUT INTO THE HOUSEHOLD WASTE)
MEDICAL DEVICE (COMPATIBLE WITH MEDICAL DEVICE REGULATION)
MANUFACTURER

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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. INITIAL TEMPERATURE OF HOT WATER
SHOULD NOT EXCEED 50°C
DISINFECT USING SOLUTION CONTAINING LESS THAN 1000 PPM OF CHLORI-
NE (REFER TO INSTRUCTIONS FOR USE)
RINSE WITH WATER
DRY
MATTRESS FOOT PART

D9U003VP0-0101_048/40
1.5 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 elds on the serial labels.
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)
5 Manufacturing Date (Year-Month-Day)
6 2D Bar Code (GS1 DataMatrix) DI+PI=UDI
7 Serial Number
8 Symbols
1VPKE20000010
REF
SN 20200136267
2020-02-25
(01) 8592654112038
(11) 200225
(21) 20200136267
PRECIOSO
220-240 V~, 50/60 Hz, 40 VA
21 3 4
68 7
5
SeriallabelwithUDI(PreciosoSCU)
Fig. Serial label for Precioso SCU (220-240 V)

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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)
5 Manufacturing Date (Year-Month-Day)
6 2D Bar Code (GS1 DataMatrix) DI+PI=UDI
7 Serial Number
8 Symbols
1VPKE20000010
REF
SN 20200136267
2020-02-25
(01) 8592654112038
(11) 200225
(21) 20200136267
PRECIOSO
100-127 V~, 50/60 Hz, 40 VA
21 3 4
68 7
5
7
3
2
5
4
6
1VPM000420200
REF
SN 20200111530
2020-02-25
(01) 8592654002360
(11) 200225
(21) 20200111530
1
SeriallabelwithUDI(Preciosomattress)
Fig. Serial label for Precioso SCU (100-127 V)
Fig. Serial label for Precioso mattress

D9U003VP0-0101_0410/40
1.6 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:
1)during1minute:
CONTINUOUS SOUND: 0,5s FIRST TONE BEEP /
0,5s SECOND TONE BEEP
2)duringnextminutes:
FIRST TONE BEEP lasting 0,5s and SECOND
TONE BEEP lasting 0,5s / 1min silence
disconnected from the mains
mains voltage is not available when the mains switch is
turned ON
mains switch is turned OFF
REPEATED 2 TONE SIGNAL during 6 seconds:
FIRST TONE BEEP lasting 0,5s and SECOND
TONE BEEP lasting 0,5s
system error (number of the beeps (1-6) indicates the type of
error)
REPEATEDBEEPafter25minutesofMaxMode:
0,25s sound / 30s silence
Max Mode will be ending (rst activation of the Max Mode)
REPEATED 2 TONE SIGNAL after 25 minutes of
MaxMode:
FIRST TONE BEEP lasting 0,25s and SECOND
TONE BEEP lasting 0,25s / 30s silence
Max Mode will be ending (second activation of the Max Mode)
BEEP lasting 0,25s mode or pressure level is achieved
Washlabel(Preciosomattress)

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AC(~) Alternating Current
ACP Attendant Control Panel
CE European Conformity
CPR Cardiopulmonary Resuscitation
dBA 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
HW Hardware
ICU Intensive Care Unit
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 (active 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
1.7 Abbreviations

D9U003VP0-0101_0412/40
2 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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!

13/40D9U003VP0-0101_04
Make sure the personnel operating the mattress system has read and understood this manual.
Follow the instructions carefully.
Use the mattress system exclusively as specied in this manual.
Have the mattress system used only by or under supervision of trained and qualied 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.
Exclusively use the mattress system with the correct mains supply (see Electromagnetic Compatibility).
Ensure that the mattress system is exclusively operated by suitably qualied personnel.
Replace any damaged parts immediately with original spare parts only.
Ensure that maintenance and installation are performed exclusively by qualied personnel who have been
trained by the manufacturer.
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 exclusively by pulling the mains plug. To pull the mains plug, always
hold the actual plug, not the cable.
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.

D9U003VP0-0101_0414/40
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

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4 Product Description
4.1 Mattress
4.1.1 Overlay
The overlay is an air- 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° zip and additional elastic corner straps to prevent the mattress ends from moving when  tted on top of standard
hospital foam or a domestic mattress.
1. Head section
2. Side formers
3. Torso section
4. Foot section
Central set
Head section:
3 head cells
remains in ated (static)
Torso section:
11 torso/upper leg cells
alternates in 3-cell cycle
Foot section:
7 lower leg/foot cells (25% smaller)
alternates in 3-cell cycle
Fig. Overlay
3
4
2
1

D9U003VP0-0101_0416/40
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.
Overlay:
air-lled overlay (see Overlay)
Base:
consists of hospital-grade re-retardant foam
three-part waterproof cover
allows mattress to follow movement of mattress platform
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 con- nector
that is permanently attached to the mattress. The microprocessor-controlled SCU maintains the set pres- sure regardless
of the patient’s position by continuously monitoring and adjusting the air pressure in the mattress.
The SCU is equipped with an audio/visual alarm system for detecting power failures, air pipe disconnections or other
faults.
Fig. Mattress replacement
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exclusivecompatibilitywithanauthorisedsoftwaretoolandspeciccable.

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5 TechnicalSpecications
5.1 MechanicalSpecications
Dimensions
Mattress replacement (inated)
Mattress overlay (inated)
Seat cushion (inated)
SCU
2,000 mm x 860 mm x 170 mm (78,5‘ x 33‘ x 7‘)
2,000 mm x 860 mm x 130 mm (78,5‘ x 33‘ x 5‘)
450 mm x 500 mm x 125 mm (17‘ x 19‘ x 4‘)
135 mm x 360 mm x 290 mm (5‘ x 14‘ x 11‘)
Weight
Mattress replacement (inated)
Mattress overlay (inated)
Seat cushion (inated)
SCU
7.8 kg (17,2 lbs)
5.5 kg (12,1 lbs)
2.5 kg (5,5 lbs)
3.5 kg (7,7 lbs)
Cycle
Mattress (inated)
Seat cushion (inated)
3 cells, 7.5 min
2 cells, 12 min
Environmental conditions (operation and storage)
Temperature
Humidity
Atmospheric pressure
0 °C (32 °F) – +40 °C (104 °F)
30–75 %
700–1060 hPa
Max. load
Mattress
Seat cushion
160 kg (210 kg with additional foam base)
127 kg
Ination time
Mattress
Seat cushion
10 min–30 min
30 s
Deation time (CPR) Max. 15 s
Supply voltage
Model 127 V
Model 230 V
100-127 V AC, 50/60Hz
220-240 V AC, 50/60Hz
Nominal power
Model 127 V
Model 230 V
Max. 23 VA
Max. 20 VA
Fuse
Model 230 V
Model 127 V
2x 1A(T) anti-surge fuse
2x 1A anti-surge fuse
Electrical safety class Class 2 with applied part type B
Electrical safety In conformity with EN 60601-1
5.2 ElectricalSpecications

D9U003VP0-0101_0418/40
5.3 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.
List of used cables
► Mains cable, maximum length 6 m
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)
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.
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speciedbymanufacturer.Otherwisethiscouldleadtodeteriorationoffunctio-
nality of this air mattress system.
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.
5.3.1 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

19/40D9U003VP0-0101_04
5.3.2 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
± 2 kV Line-to-ground
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
Table1-IMMUNITYtoRFwirelesscommunicationsequipment
Test frequency
(MHz)
Band(MHz) Service Modulation Immunity Test
Level V/m
385 380 - 390 TETRA 400 Pulse modulation 18 Hz 27
450 430 - 470 GMRS 460, FRS 460 FM ± 5 kHz deviation 1
kHz sine
28
710
745
780
704 - 787 LTE band 13, 17 Pulse modulation 217
Hz
9
810
870
930
800 - 960 GSM 800/900, TETRA
800, iDEN 820, CDMA
850,
LTE band 5
Pulse modulation 18 Hz 28
1 720
1 845
1 970
1 700 - 1 990 GSM 1800; CDMA
1900; GSM 1900;
DECT; LTE band 1, 3,
4, 25; UMTS
Pulse modulation 217
Hz
28
2 450 2 400 - 2 570 Bluetooth, WLAN,
802.11 b/g/n, RFID
2450,
LTE band 7
Pulse modulation 217
Hz
28
5 240
5 500
5 785
5 100 - 5 800 WLAN 802.11 a/n Pulse modulation 217
Hz
9
NOTE There are applied no deviations to requirements of IEC 60601-1-2 ed. 4
NOTE There are no known other measures for keeping the basic safety based on EMC phenomena.

D9U003VP0-0101_0420/40
Ambient temperature 10 °C to 40 °C
Relative humidity 30% to 70%
Atmospheric pressure 795 to 1060 hPa
Dust and water protection (SCU) IP 3X
Flammability rating (mattress and seat cushion covers) BS 7175 ignition sources 0, 1 and 5
Environment 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 ammable gases (except oxygen cylinders).
6 Use and Storage Conditions
Preciosoissuitableforuseorstorageinindoorenvironmentsmeetingthefollowingrequirements:
6.1 Storage
When SCU is not in use:
Switch o󰀨 SCU using green illuminated power switch on side 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:
Deate mattress and leave air connector open (CPR position).
Roll mattress up to get air out completely.
Rotate end of umbilical air connector and main body in opposite directions.
Pack in suitable cover.
Store in a place suitable for electronic medical devices.
7 Scope of Delivery and Product Variants
7.1 Scope of Delivery
Delivery:
Upon receipt, check that the shipment is complete as specied on the delivery note.
Notify the carrier and supplier of any deciencies or damages immediately as well as in writing or make a note on
the delivery note.
7.2 List of Parts
Mattress with Dartex cover - Applied part type B
3-section foam base in cover (only for mattress replacement system) - Applied part type B
SCU (System Control Unit) - Applied part type B
Mains cable
Instructions for use