LINET Virtuoso 3 Series Parts list manual

Virtuoso®
Air Mattress System - SERIES 3
D9U003VB3-0101
Version: 04
Publication Date: 2020-05
Instructions for Use
and Technical Description

D9U003VB3-0101_042/65
Virtuoso®
Air Mattress System - SERIES 3
Author: LINET, s.r.o.
Link: www.linet.com
D9U003VB3-0101
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
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.
274 01 Slaný
Czech Republic
Phone: +420 312 576 111
Fax: +420 312 522 668
E-Mail: [email protected]
Web: www.linet.com

3/65D9U003VB3-0101_04
1 SymbolsandDenitions......................................4
1.1 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 ...............6
1.6 Labels .............................................................9
1.7 Acoustic signalisation......................................11
1.8 Abbreviations ..................................................12
2 Safety Instructions ...............................................13
3 Intended use..........................................................15
3.1 User population...............................................15
3.2 Contraindications ............................................15
3.3 Operator..........................................................15
4 Product Description .............................................16
4.1 Virtuoso Overlay .............................................17
4.2 Virtuoso Mattress Replacement (Air + Foam
Base) ......................................................................18
4.3 Virtuoso Mattress Replacement (Air + Static Air
Base) ......................................................................19
4.4 Virtuoso Mattress Replacement (Air + Alternating
Air Base) .................................................................20
4.5 Virtuoso With Head & Heel Zoner (Air + Alterna-
ting Air Base) ..........................................................21
4.6 Virtuoso Pro ....................................................22
................................24
.......................24
4.9 SCU (System Control Unit).............................25
5 Control Panel Description....................................25
6 TechnicalSpecication ........................................26
.26
Replacement (Air + Foam Base)) ...........................26
Replacement (Air + Static Air Base)) ......................26
Replacement (Air + Alternating Air Base)) ..............27
Heel Zoner (Air + Alternating Air Base))..................27
.......27
......28
................................................................................28
..................................28
6.10 Environment Conditions..................................28
6.11 Electromagnetic Compatibility.........................29
7 Use and Storage Conditions................................31
7.1 Storage ...........................................................31
8 Scope of Delivery and Product Variants.............31
8.1 Scope of Delivery............................................31
8.2 List of Parts.....................................................31
9 Putting into Service ..............................................32
9.1 Mattress ..........................................................32
9.2 SCU (System Control Unit).............................33
9.3 Connecting Mattress and SCU .......................34
9.4 Cable Management System............................34
9.5 Before Use......................................................36
9.6 FIRMWARE ....................................................36
10 Accumulator..........................................................37
10.1 Accumulator Charge Status Indicator .............37
10.2 Accumulator Back-up Pack.............................40
11 Manipulation..........................................................42
11.1 Use..................................................................42
11.2 Controls and Indicators (Control Panel)..........44
11.3 CPR/Air Disconnected Mode ..........................49
11.4 System error ...................................................49
11.5 Service............................................................49
11.6 CPR (umbilical connected) .............................50
11.7 CPR (umbilical disconnected).........................50
11.8 Transport Mode (Static and Active).................51
11.9 Power Failure..................................................51
Pro) ........................................................................52
11.11 Head Zoner / Heel Zoner...............................52
11.12 Seating System.............................................54
12 Cleaning/Disinfection ...........................................58
12.1 Cleaning..........................................................58
13 Troubleshooting....................................................60
14 Maintenance .........................................................63
14.1 Regular maintenance......................................63
14.2 Spare Parts .....................................................63
14.3 Safety Technical Checks.................................63
15 Disposal.................................................................64
15.1 Environment Protection...................................64
15.2 Disposal ..........................................................64
16 Standards and Regulations .................................65
Table of Contents:

D9U003VB3-0101_044/65
1 SymbolsandDenitions
1.1 Warning Notices
1.1.1 Types of Warning Notices
Warningnoticesaredierentiatedbythetypeofdangerusingthefollowingkeywords:
CAUTION - risk of material damage.
WARNING - risk of physical injury.
DANGER - risk of fatal injury.
1.1.2 Structure of Warning Notices
1.2 Instructions
Structure of instructions:
Perform this step.
Result, if necessary.
1.3 Lists
Structure of bulleted lists:
List level 1
List level 2
SIGNAL WORD!
Type and source of danger!
Measures to avoid the danger!

5/65D9U003VB3-0101_04
1.4 SymbolsonthePackage
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

D9U003VB3-0101_046/65
1.5 Symbols and Labels on the Product
READ INSTRUCTIONS FOR USE
2X T1AH ANTI-SURGE FUSE
(250 V, TYPE 5X20MM)
2X T2AH ANTI-SURGE FUSE
(250 V, TYPE 5X20MM)
(MODEL WITH Accumulator BACK-UP)
ALTERNATING CURRENT (AC)
ACTIVATION GO BUTTON
DEVICE IS CONNECTED TO MAINS IF GREEN INDICATOR ON THE CONTROL
PANEL IS LIT
PROTECTION AGAINST ACCIDENTS DUE TO ELECTRICAL CURRENT – TYPE B
APPLIED PARTS
DOUBLE INSULATION (CLASS II EQUIPMENT)
WARNING
CE MARK OF CONFORMITY WITH EU REGULATION
SCU MAINS SWITCH
–: ON (CONNECTED TO THE MAINS SUPPLY)
O: OFF (DISCONNECTED FROM MAINS SUPPLY)
DEVICE IS CONNECTED TO MAINS WHEN GREEN PART OF THE SWITCH IS
REVEALED.
Accumulator POWER SWITCH
–: ON (Accumulator ACTIVATED)
O: OFF (Accumulator NOT ACTIVATED)
SCU MAINS SWITCH
_______________
Accumulator POWER SWITCH
WEEE SYMBOL (RECYCLE AS ELECTRONIC WASTE,
DO NOT PUT INTO THE HOUSEHOLD WASTE)
ONLY SUITABLE FOR INDOOR USE

7/65D9U003VB3-0101_04
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
MAXIMUM PATIENT WEIGHT
MEDICAL DEVICE (COMPATIBLE WITH MEDICAL DEVICE REGULATION)

D9U003VB3-0101_048/65
RECYCLING SYMBOL
DO NOT POLLUTE THE ENVIRONMENT
MANUFACTURER
MANUFACTURING DATE
REFERENCE NUMBER (PRODUCT TYPE DEPENDING ON CONFIGURATION)
SERIAL NUMBER

9/65D9U003VB3-0101_04
1.6 Labels
The serial label is located on the back of the SCU (System Control Unit). The serial number, the reference number and
the voltage version can be found on the serial label. This information is required when contacting LINET®. Pictures of
1 Address of Manufacturer
2 1D Bar Code GS1-128 (Serial Number)
3PI
4DI
5 Manufacturing Date (Year-Month-Day)
6 2D Bar Code (GS1 DataMatrix) DI+PI=UDI
7 Serial Number
8 Symbols
1VNKE22000030
REF
SN 20200124714
2020-02-24
(01) 8592654205624
(11) 200224
(21) 20200124714
VIRTUOSO
220-240 V~, 50/60 Hz, 40 VA
21 3 4
68 7
5
SeriallabelwithUDI(VirtuosoSCU-EUversion)

D9U003VB3-0101_0410/65
7
3
2
5
4
6
1VNM000220K00
REF
SN 20200127572
2020-02-24
(01) 8592654144428
(11) 200224
(21) 20200127572
1
1 Address of Manufacturer
2 1D Bar Code GS1-128 (Serial Number)
3PI
4DI
5 Manufacturing Date (Year-Month-Day)
6 2D Bar Code (GS1 DataMatrix) DI+PI=UDI
7 Serial Number
SeriallabelwithUDI(Virtuoso-mattress)
Washlabel(Virtuoso-mattress)

11/65D9U003VB3-0101_04
1.7 Acoustic signalisation
SOUND MEANING
CONTINUOUS SOUND mattress air connector is disconnected
mattress air connector is not correctly conne-
cted
REPEATED 2 TONE SIGNAL:
1)during1minute:
CONTINUOUS SOUND: 0,5s FIRST TONE BEEP / 0,5s SECOND
TONE BEEP
2)duringnextminutes:
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
accumulator is discharged too much (only
version with accumulator)
accumulator switch is turned OFF (only versi-
on with accumulator)
BEEPafterSCUactivationifSCUispoweredjustbytheaccumu-
lator: 10s sound + 5s silence
disconnected from the mains
mains switch is turned OFF
mains power is not available
REPEATED 2 TONE SIGNAL:
FIRST TONE BEEP lasting 0,5s and SECOND TONE BEEP lasting
0,5s / 30s silence
accumulator discharge level less than 25%
(only version with accumulator)
BEEPlasting2safteraccumulatorswitchhasbeenturnedON
version with accumulator)
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)
REPEATEDBEEPafter25minutesofMaxMode:0,25ssound/30s
silence
the Max Mode)
REPEATED2TONESIGNALafter25minutesofMaxMode:
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

D9U003VB3-0101_0412/65
AC(~) Alternating Current
ACP Attendant Control Panel
CE European Conformity
CPR Cardiopulmonary Resuscitation
dBA Sound Intensity Unit
DC() Direct Current
CUC
EMC Electromagnetic Compatibility
FET
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
SCU System Control Unit (active mattress)
SN Serial Number
SW Software
SWL Safe Working Load
UDI
USB Universal Serial Bus
WEEE Waste Electrical and Electronic Equipment
1.8 Abbreviations

13/65D9U003VB3-0101_04
2 Safety Instructions
WARNING!
Any serious incident that has occurred in relation to the device should be reported to the manufactu-
rerandthecompetentauthorityoftheMemberStateinwhichtheuserand/orpatientisestablished!
WARNING!
Onlyauthorisedandtrainedpersonusingthetoolisallowedtochangefusesandpowersupplies!
WARNING!
Thismedicaldeviceisnotintendedforoxygenenrichedenvironment!
WARNING!
Thismedicaldeviceisnotintendedforusewithammablesubstances!
WARNING!
This medical device is not portable medical electrical equipment!
WARNING!
Patientisallowedtouseselectedcontrolelementsonlyifhospitalpersonnelhadassessedthatthe
patient´sphysicalandpsychologicalstateisinaccordancewithuseofthemandonlyifthehospital
personnelhadtrainedthepatientinaccordancewiththeinstructionsforuse!
WARNING!
Thepatientshouldbeunderregularsupervisionofhospitalstaduringtreatmentofskininjuries!

D9U003VB3-0101_0414/65
Follow the instructions carefully.
Ensure any user has read and understood the instructions for use completely before operating the product.
Use the mattress system only in its original state and do not modify it in any way.
have been trained according to the instructions for use.
Replace any damaged parts immediately with original spare parts only.
manufacturer.
Never use the mattress replacement system near radiators or other heat sources.
Never cover the SCU while in use.
Never handle the mains plug with wet hands.
Disconnect the product from the mains only by pulling the mains plug. When pulling the mains plug, always
hold the 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 replacement system.
Zip up whole zipper to avoid risk of contamination.

15/65D9U003VB3-0101_04
3 Intended use
The intended use is to prevent and support treatment of pressure injuries.
3.1 User population
(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:
3.3 Operator

D9U003VB3-0101_0416/65
4 Product Description
Thereare6congurationsofVirtuosomattress:
Virtuoso Overlay
Virtuoso Mattress Replacement (Air + Foam Base)
Virtuoso Mattress Replacement (Air + Static Air Base)
Virtuoso Mattress Replacement (Air + Alternating Air Base)
Virtuoso With Head & Heel Zoner (Air + Alternating Air Base)
Virtuoso Pro
VIRTUOSO AIR DECKS ALTERNATING
LAYERS
FOWLERBOOST ZONERS Accumu-
lator
MCM
Overlay Air
+
Foam
Air
+
Air
1 2 Single
point
Linear Head Foot Body
Virtuoso
Overlay
a a a optional a
Virtuoso
Mattress
Replacement
(Air + Foam
Base)
a a a
optional
a
Virtuoso
Mattress
Replacement
(Air + Static
Air Base)
a a a
optional
a
Virtuoso
Mattress
Replace-
ment (Air +
Alternating
Air Base)
a a a
optional
a
Virtuoso
With Head &
Heel Zoner
(Air + Alter-
nating Air
Base)
a a a a a
optional
a
Virtuoso Pro a a a a a a optional a

17/65D9U003VB3-0101_04
4.1 Virtuoso Overlay
Virtuoso Overlay has one layer of air cells.
21 transverse air cells
3 Static head cells
11 alternating torso and leg cells
7 Foot section cell
Fig. Mattress structure (Virtuoso Overlay)
Air Layer

D9U003VB3-0101_0418/65
4.2 VirtuosoMattressReplacement(Air+FoamBase)
Virtuoso Mattress Replacement (Air + Foam Base) has one layer of alternating air cells and one foam layer.
4.2.1 TopDeck
21 transverse air cells
3 static head cells
11 alternating torso cells
7 alternating foot section cells
4.2.2 BottomDeck
passive foam base of CMHR foam
waterproof removable cover
Fig. Mattress structure (Virtuoso Mattress Replacement (Air + Foam Base))
Air Layer
Foam Layer

19/65D9U003VB3-0101_04
4.3 VirtuosoMattressReplacement(Air+StaticAirBase)
Virtuoso Mattress Replacement (Air + Static Air Base) has two air layers.
4.3.1 TopDeck
21 transverse air cells
3 Static head cells
11 alternating torso cells
7 alternating foot section cells
4.3.2 BottomDeck
3 ribbed static air sections
Fig. Mattress structure (Virtuoso Mattress Replacement (Air + Static Air Base))
Top Air Layer
Bottom Air Layer

D9U003VB3-0101_0420/65
4.4 VirtuosoMattressReplacement(Air+AlternatingAirBase)
Virtuoso Mattress Replacement (Air + Alternating Air Base) has the same two air layers.
4.4.1 TopDeck
21 transverse air cells
3 static head cells
11 alternating torso cells
7 alternating foot section cells
4.4.2 BottomDeck
21 transverse air cells
3 Static head cells
11 alternating torso and leg cells
7 Static foot section cells
Fig. Mattress structure (Virtuoso Mattress Replacement (Air + Alternating Air Base))
Top Air Layer
Bottom Air Layer
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