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User manual and technical description

Virtuoso

Mattress Replacement System - Series 2

D9U003VB0-0101
Version: 03
Publication Date: 2018-03
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

Virtuoso
Mattress Replacement System – Series 2

Author: LINET, s.r.o.


Link: www.linet.com

D9U003VB0-0101
Version: 03
Publication date: 2018-03

Copyright © LINET, s.r.o., 2018


Translation © LINET, s.r.o., 2018
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 this manual that relate to the product´s technical regulations. It is for this reason that the contents of this
manual may indicate differences from the current manufacture of the product.

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CONTENT:
1 Symbols..................................................................4 10.7 Constant Low Pressure Mode.........................18
1.1 Warning Notices...............................................4 10.8 Backrest Raised Mode.....................................19
1.2 Other symbols..................................................4 10.9 Battery.............................................................19
1.3 Symbols and Labels on the Product................5 10.10 CPR/Air Disconnected Mode.........................22
1.4 Serial Label......................................................5 10.11 System error..................................................22
2 Safety and Dangers...............................................6 10.12 Service...........................................................22
2.1 Safety Instructions...........................................6 11 Additional Functions:............................................23
2.2 Use and Storage Conditions............................6 11.1 CPR (umbilical connected)..............................23
3 Standards and Regulations..................................6 11.2 CPR (umbilical disconnected)..........................23
4 Function..................................................................7 11.3 Transport Mode................................................24
4.1 Correct Use......................................................7 11.4 Power Failure...................................................24
4.2 Contraindications.............................................7 11.5 Head Zone Selector/Heel Zone Selector.........25
5 Product Description..............................................8 12 Seating System......................................................26
5.1 Mattress...........................................................8 12.1 Functioning......................................................26
5.2 SCU (System Control Unit)..............................8 12.2 Installation of Seat Cushion.............................26
6 Scope of Delivery...................................................9 12.3 Initial Operation................................................27
6.1 Scope of Delivery.............................................9 12.4 Use..................................................................27
6.2 List of Parts......................................................9 13 Cleaning/Disinfection............................................28
7 Installation..............................................................10 13.1 Cleaning...........................................................28
7.1 Installation of Mattress.....................................10 14 Maintenance...........................................................30
7.2 Installation of SCU (System Control Unit)........11 15 Storage...................................................................30
7.3 Connecting Mattress and SCU........................11 16 Disposal..................................................................31
7.4 Cable Management System............................12 16.1 Environment Protection...................................31
8 Initial Operation.....................................................13 16.2 Disposal...........................................................31
8.1 Inflation............................................................13 17 Warranty.................................................................31
9 Use..........................................................................14 18 EC Declaration of Conformity...............................32
9.1 Preparing the Bed for the Patient....................14 19 Technical Specifications.......................................33
10 Controls and Indicators........................................15 19.1 Mechanical Specifications...............................33
10.1 Control Panel...................................................15 19.2 Electrical Specifications...................................33
10.2 Button GO........................................................16 19.3 Electromagnetic Compatibility.........................34
10.3 Mute.................................................................16
10.4 Pressure Control..............................................16
10.5 APT Mode (Default Mode)...............................18
10.6 MAX Mode.......................................................18

D9U003VB0-0101_03 3/35
1 Symbols

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 - risk of material damage.
„„ Warning - risk of physical injury.
„„ Danger - risk of fatal injury.

1.1.2 Structure of Warning Notices


SIGNAL WORD!
Type and source of danger!
Ü Measures to avoid the danger!

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

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1.3 Symbols and Labels on the Product

Read user manual

2x T1AH anti-surge fuse


(250 V, type 5x20mm)

2x T2AH anti-surge fuse


(250 V, type 5x20mm)
(model with battery back-up)

Alternating current

Activation GO button
Device is connected to mains if green indicator is lit

Protection against accidents due to electrical current – Type B instruments

Double isolation

Attention

CE mark of conformity with EU regulation

I Mains Switch
I: ON (connected to the mains supply)
O O: OFF (disconnected from mains supply)
Device is connected to mains when green indicator is on.

1.4 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 type plate. This information is required when contacting LINET®.

Fig. 1 Serial Label

D9U003VB0-0101_03 5/35
2 Safety and Dangers

2.1 Safety Instructions


™™ Follow the instructions carefully.
™™ Ensure any user has read and understood this manual completely before operating the product.
™™ Use the mattress system only as specified in this manual and in perfect working order.
™™ Use the mattress system only with the correct mains supply (see Electrical Specifications).
™™ Use the mattress system only in its original state and do not modify it in any way.
™™ Have the mattress system used only by or under supervision of trained and qualified nursing personnel.
™™ Replace any damaged parts immediately with original spare parts only.
™™ Have the mattress system serviced and installed only by qualified personnel trained and authorized by the
manufacturer.
™™ Do not exceed the maximum patient weight limit (see Mechanical Specifications).
™™ Do not use the SCU near flammable gases. This does not apply to oxygen cylinders.
™™ 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.

2.2 Use and Storage Conditions


Virtuoso is suitable for use or storage in indoor environments meeting the following requirements:

Ambient temperature 0 °C (32 °F) to + 40 °C (104 °F)


Relative humidity 30% to 70%
Atmospheric pressure 700 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

Virtuoso is not suitable for indoor environments:


„„ containing flammable gases (except oxygen cylinders).

3 Standards and Regulations


The mattress replacement system complies with the following standards:
„„ EC directive 93/42/EEC for medical devices
„„ EC directive 89/336/EEC for electromagnetic compatibility
„„ RoHS directive 2011/65/EU

The manufacturer adheres to a certified quality management system in compliance with the following standards:
„„ EN 60601-1
„„ EN 60601-1-2
„„ EN 60601-1-6
„„ EN ISO 10993
„„ EN ISO 9001
„„ EN ISO 13485
„„ EN ISO 14004

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4 Function

4.1 Correct Use


The Virtuoso Mattress System is a dual-mode support surfaces that provides active Alternating Pressure (ALP) and
reactive Constant Low Pressure (CLP) for use in all health care settings, as an aid to patient care in the pre- vention and
treatment of skin breakdown related to pressure damage.

The mode of use is to be determined by a suitably qualified medical practitioner and by means of a risk assess- ment.
For patients who are not bed-ridden, it is possible to connect a seat cushion (based on two-cell technology) to the SCU
(System Control Unit) (see Seating System) instead of the mattress.

™™ Have Virtuoso used exclusively by or under supervision of trained and qualified nursing personnel.

Virtuoso is suitable for:


„„ Patients
„„ without restrictions in terms of health, age or condition
„„ in long-term treatment (depending on bed type)
„„ Personnel
„„ qualified medical staff
„„ any person familiar with the manual
„„ patient (condition permitting)
„„ Use
„„ intensive/critical care units
„„ hospital rooms
„„ patient transport in passive mode (without battery back-up) or active mode (with battery back-up)
„„ Transport
„„ in original bag

4.2 Contraindications
WARNING!
Risk of injury due to incorrect use!
Ü Do not use CLP mode for patients undergoing cervical traction.
Ü Use ALP mode exclusively under the direction of a qualified physician.
Ü Before placing a patient on a Virtuoso mattress, always have a qualified person perform a risk assessment to
ensure that the support provided is appropriate and fulfils the applicable local stipulations.
Ü Before using the seat cushion for persons with poor posture or pelvic deformities, always consult a specialist for
seating systems.
Ü When using mattress replacement or overlay systems, make sure to use safe and appropriate siderail positions
and bed height settings depending on the types of bed frame and siderails being used.

The Virtuoso Mattress System is contraindicated for patients with cervical traction or unstable:
„„ spinal fractures
„„ spinal cord injury
„„ fractures at risk of complication by a moving support surface

D9U003VB0-0101_03 7/35
5 Product Description

5.1 Mattress
The mattress consists of two decks that are connected with stainless steel press studs, fixation toggles and poly- uretha-
ne loops.
A two-part air and water-impermeable cover made of polyurethane-coated nylon covers both mattress decks. The top
part of the cover consists of two-way stretch material.

5.1.1 Top Deck


The top part consists of two modules:
a. Body module consisting of two sections:

Head section:
„„ 3 head cells
„„ remains inflated (static)

Torso section:
„„ 11 torso/upper leg cells
„„ alternates in 3-cell cycle

b. Foot module consisting of one section:

Foot module:
„„ 6 lower leg/foot cells
„„ alternates in 3-cell cycle
Fig. 2 Mattress

5.1.2 Bottom Deck


The bottom part consists of 5 modules.

Head module:
„„ 3 cells
„„ remains inflated (static)
„„ longitudinal cells

Leg module:
„„ 5 cells
„„ remains inflated (static)
„„ longitudinal cells

2 side formers:
„„ remain inflated (static)

Torso module:
„„ 9 cells
„„ alternates in 3-cell cycle
„„ with corresponding upper deck cells

5.2 SCU (System Control Unit)


The SCU inflates and deflates the air mattress. It is connected to the air mattress with a custom-designed air connector
that is permanently attached to the mattress. The microprocessor-controlled SCU maintains the set pressure 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.

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6 Scope of Delivery

6.1 Scope of Delivery


Delivery:
„„ Upon receipt, check that the shipment is complete as specified on the delivery note.
„„ Notify the carrier and supplier of any deficiencies or damages immediately as well as in writing or make a note on
the delivery note.

6.2 List of Parts


„„ Mattress with Dartex cover - Applied part type B
„„ SCU (System Control Unit) - Applied part type B
„„ Mains cable
„„ User Manual

D9U003VB0-0101_03 9/35
7 Installation
The Virtuoso mattress replacement system replaces any mattress on the bed frame.

7.1 Installation of Mattress


WARNING!
Risk of injury due to incorrect use!
Ü 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.
Ü Before placing a patient on a Virtuoso mattress, always have a qualified person perform a risk assessment to
ensure that the support provided is appropriate and fulfils the applicable local stipulations.

CAUTION!
Material damage due to incorrect fastening of safety straps!
Mattress overlay system
Ü Firmly fix head and foot straps exclusively around existing mattress.
Mattress replacement system
Ü Fix safety straps exclusively to movable parts of bed frame.
Ü Use all safety straps to prevent the mattress from moving when the patient is getting into or out of bed.

™™ Remove any existing mattress.


™™ Ensure that there are no protruding parts or sharp objects on the bed frame to avoid damage to the mattre-
ss.
™™ Put mattress on mattress platform of bed frame so that air pipe is located as shown in Fig. 3.
™™ Prevent air pipe from getting trapped by moving parts of the bedframe or getting looped or bent in such a
way as to block or restrict the air flow.
™™ Loosely fasten safety straps to suitable parts of the bedframe.

11
22

33

Fig. 3 Installation of Mattress

1. Head end safety strap


2. Lateral safety strap
3. Foot end safety strap

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7.2 Installation of SCU (System Control Unit)
CAUTION!
Risk of injury when installing SCU!
Ü Ensure that no body parts are trapped between hook and foot board when using spring-loaded SCU hanging
hooks.
Ü Fix SCU securely SCU to prevent it from sliding or accidentally being knocked off.

CAUTION!
Material damage due to incorrect installation of SCU!
Ü Do not install SCU in linen shelf on bed frame.

Before installing the SCU:


Fit the mains cable to the SCU as follows:
™™ Remove the connector cover on the rear of the SCU by unscre-
wing the small black wheel.
™™ Fit the mains connector onto the SCU.
™™ Replace the connector cover while ensuring that the mains cable
is fed through the slots provided in the cover and the back of the
SCU.
™™ Tighten the black wheel.

If foot end of bed frame is suitable for hanging SCU:


™™ Hold SCU in one hand and unfold hook on back with the other.
™™ Hang SCU on foot end of bed frame.

If foot end of bed frame is not suitable for hanging SCU:


™™ Put SCU on floor with integrated mounting feet.
Fig. 4 Installation of SCU

7.3 Connecting Mattress and SCU


™™ Ensure that air connector is in open mode (see Fig. 5).
™™ Insert air connector 1 in the socket 2 at an angle of approximately 45°.
™™ Push air connector 1 down until it clicks into place.

Fig. 5 Open Mode Fig. 6 Air Connector

1. Air connector plug


2. Air connector

D9U003VB0-0101_03 11/35
7.4 Cable Management System
WARNING!
Risk of injury due to exposed cable!
Ü Ensure that cable is not twisted, crushed or strained.
Ü Use cable routing clips in order to avoid tripping hazards.
Ü Ensure that it is not possible for the cable to get trapped between any moving parts of the bed frame.

Virtuoso is equipped with two cable routing clips on the side of the mattress cover. The cable routing clips pre- vent the
cable from getting twisted, crushed or strained or becoming a tripping hazard.

Safe cable routing:


™™ Route cable through cable routing clips.
™™ Ensure that cable is not hanging over head end to prevent it from getting stretched or trapped when rai-
sing or lowering the back rest.

Fig. 7 Cable routing clips

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8 Initial Operation
The SCU is operated via the SCU control panel (see Control Panel ).

8.1 Inflation
™™ Ensure that SCU is not covered and air flow around SCU is not obstructed in order to avoid overheating.
™™ Connect mains cable of SCU to suitable mains socket.

To switch on SCU:
™™ Switch on SCU using green illuminated power switch on side of SCU (see Switching on SCU).
™™ The SCU will take 30 s for the initialisation. After that the mattress will start to inflate.

NOTE On SCUs with battery back-up function, the power switch is not illuminated.

To switch off SCU:


™™ Switch off SCU using green illuminated power switch on side of
SCU (see Fig. 8).
™™ Disconnect mains cable from mains.

NOTE On SCUs with battery back-up function, the power switch is not
illuminated.

NOTE When switched on, the SCU will return to the last mode (APT) or
CLP) and pressure setting. The mode and pressure settings are only valid
when the SCU has been running with these settings for more than 5 minutes.

During the inflation process:


„„ Indicator 2 or 3 flashes yellow, depending on the last mode setting. The
inflation process takes 15 minutes at most.

Inflation Mode APT:


„„ When APT is set, indicator 3 will keep flashing during the initial inflation.
„„ Then APT indicator 4 will light and indicator 16 will flash while pressure is
adjusted to the set pressure level.
„„ When the set pressure level is reached, indicators 4 and 12 will remain
solid on.
Fig. 8 Switching on SCU

Inflation Mode CLP:


„„ When CLP is set, indicator 2 will keep flashing during the initial inflation.
„„ When the set pressure level is reached, indicators 2 and 16 will remain solid on.

When the inflation process is finished:


™™ Check if safety straps of mattress cover are too tight and correct if necessary.

If indicator 8 flashes during inflation process and audio alarm signal sounds:
™™ Check if air pipe is connected correctly.

D9U003VB0-0101_03 13/35
9 Use

9.1 Preparing the Bed for the Patient


WARNING!
Risk of injury when putting patient into bed!
Before putting the patient into bed:
Ü Ensure that mattress is completely and correctly inflated.
Ü Ensure that mattress is correctly secured with safety straps.

WARNING!
Danger of suffocation due to air-impermeable mattress cover!
Ü Use mattress cover correctly.
Ü The nursing staff are responsible for the safety of the patient on the mattress cover.

CAUTION!
Material damage due to dampness or contamination!
Ü Ensure that no moisture gets into the mattress.
Ü Ensure that no food or drink gets into the mattress.
Ü If moisture, food or drink get into the mattress, notify LINET® Service.

9.1.1 Preparation
™™ Inflate mattress (see „Initial Operation“).
™™ Put a sheet loosely on the mattress if not prescribed otherwise by qualified personnel.

9.1.2 Putting the Patient into the Bed


™™ Lay patient on mattress.

For an ideal lying position:


™™ If additional blankets or sheets are used, make sure that ease of movement is sufficient.
™™ Ensure that blankets, sheets, clothing etc. do not cause pressure sores (e.g. due to creases, seams etc.).
™™ Do not place any additional sheets, blankets etc. between mattress and patient.

14/35 D9U003VB0-0101_03
10 Controls and Indicators

10.1 Control Panel


The control panel of the SCU serves to control the mattress replacement system and shows errors and mainte- nance
requirements with indicators and alarm sounds.
1 2 3 4 5 6 7 8

16

15 9

14 13 12 11 10
Fig. 9 SCU Control Panel

1. Pressure Control Buttons


2. CLP Mode Indictor
3. MAX Mode Indicator
4. APT Mode Indicator
5. Mode Selection Button
6. Back Rest Status Indicator
7. Seat Mode Indicator
8. CPR/ Air Connector Open Indicator
9. System Error Indicator
10. Audio Mute Button
11. BAT (indicates battery back-up model)
12. Service Due Indicator
13. Power Indicator (battery back-up model only)
14. GO Button
15. Battery Charge Status Indicator (battery back-up model only)
16. Pressure Level Indicator.

D9U003VB0-0101_03 15/35
Button/Indicator Function
Pressure Control Button Changing air pressure in mattress.
Mode Indicators Indicate selected mode:
APT Alternating Pressure Therapy
MAX Maximum Inflate
CLP Constant Low Pressure
Mode Selection Button Selects desired mode.
Seat Mode Indicator Indicates that seat cushion is connected.
Backrest Status Indicator Indicates if backrest is raised.
CPR/Air Disconnected Indicator Indicates that air pipe is not connected correctly or not at all.
System Error Indicator Indicates system error.
™™ Call service engineer.
Audio Mute Button Muting audio alarm signals.
Service Due Indicator Indicates that service is due.
GO Button Activates the control panel.
Battery Charge Status Indicator Indicates charge status of battery.
(battery back-up model only)
Pressure Level Indicator Indicates air pressure set in mattress or seat cushion.

10.2 Button GO
The GO button 14 activates the SCU control panel.
After pressing button 14, the SCU control panel will remain active for 3 minutes.

To activate control panel:


™™ Press button 14.

If no button has been pressed for 3 min:


™™ Activate control panel again by pressing button 14.

10.3 Mute
To mute audio alarm signal:
™™ Press button 10.

If cause of error signal is not remedied:


„„ Audio alarm signal will switch back on after 30 min.

10.4 Pressure Control


When switched on, the SCU will inflate the mattress to the recommended pressure. Once this pressure is rea- ched,
indicator 16 will stop flashing and remain solid on, and an audio signal will sound.

In order to guarantee optimum protection, the system adjusts the pressure automatically to the patient’s weight and posi-
tion every 7.5 minutes in APT mode.

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10.4.1 Manual Pressure Adjustment

WARNING!
Risk of injury due to incorrect pressure setting!
Ü Consult qualified hospital staff prior to adjusting pressure.

WARNING!
Risk of injury due to incorrect pressure level!
The recommended pressure levels may not be the optimum for all situations but should be used in conjunction with
clinical judgment based on the individual patient; e.g. weight, weight distribution, position and comfort needs.
Ü Do not reduce pressure level setting by more than 1 step for the patient’s comfort.
Ü Regardless of the pressure level, make sure the patient is not lying directly on the foam base.

NOTE Pressure adjustment is exclusively possible in APT mode and CLP mode.

The pressure control allows the nursing staff to adjust the pressure within a pre-set range.

To adjust pressure:
™™ Press button - to decrease pressure.
™™ Press button + to increase pressure.

Recommended pressure levels:


„„ 1: 0–50 kg (0 - 110 lbs)
„„ 2: 51–80 kg (111 - 176 lbs)
„„ 3: 81–120 kg (177 - 264 lbs)
„„ 4: 120–180 kg (265 - 396 lbs)
„„ 5: 181–210+ kg (397 lbs - 462 lbs +)

During pressure adjustment:


„„ The section of the pressure control indicator corresponding to the desired pressure flashes yellow or green.

When desired pressure is reached:


„„ The section of the pressure control indicator corresponding to the desired pressure lights yellow or green.

Pressure levels:
„„ below recommended optimum pressure
„„ for small or light patients
„„ above recommended optimum pressure
„„ for big or heavy patients
„„ for patients sitting up in the bed
„„ for patient positions or body shapes that concentrate the patient’s weight on small areas of the mattress

D9U003VB0-0101_03 17/35
10.5 APT Mode (Default Mode)
Once the mattress is fully inflated, a confirming signal sounds and the mattress switches automatically into APT (alterna-
ting pressure therapy) mode.

To select APT mode:


™™ Press button 5 once or repeatedly until indicator 4 comes on.

When APT mode is switched on:


„„ 3-cell mattress units will inflate and deflate in cycles of 7.5 minutes.
„„ Indicator 4 lights yellow.
„„ Green middle section of indicator 16 flashes.
„„ Once the pre-set pressure is reached, the green middle section of indicator 16 will remain solid on.

10.6 MAX Mode


MAX mode (maximum inflation) provides a solid and stable surface for patient treatment.

MAX mode will run for 30 min at most. If no other mode is switched on within these 30 min, a confirmation signal will
sound, and the mattress replacement system will switch back to APT or CLP mode automatically. This mode interrupts
CLP.

To select MAX mode:


™™ Press button 5 once or repeatedly until indicator 3 flashes yellow.

If MAX mode is required for less than 30 min:


™™ Set new mode.

If MAX mode is required for more than 30 min:


™™ Set MAX mode again within the last 5 min.

When MAX mode is selected:


„„ SCU inflates all mattress cells to the same pre-set pressure.
„„ Indicator 3 flashes yellow until preset pressure is reached.
„„ Once the set pressure is reached, indicator 3 will remain solid on.
„„ During the last 5 min, an alarm signal will sound every 30 s.

When MAX mode is selected for the second time:


™™ During the last 5 min, a double alarm signal will sound every 30 s to remind the personnel that MAX mode
will soon end automatically.

NOTE It is not possible to select MAX mode a third time. Selecting MAX mode again is only possible when APT mode
has been running for at least 30 min.

10.7 Constant Low Pressure Mode


CLP (constant low pressure) mode keeps the mattress pressure at the level selected. The pressure is checked every 30
seconds, and adjusted if necessary.

To select CLP mode:


„„ Press button 5 once or repeatedly until indicator 2 flashes yellow.

When CLP mode is switched on:


„„ Indicator 2 flashes yellow until pre-set pressure is reached.
„„ Once the pre-set pressure is reached, indicator 2 and 16 will remain solid on.

18/35 D9U003VB0-0101_03
10.8 Backrest Raised Mode
WARNING!
Risk of injury due to incorrect pressure setting!
Ü Consult qualified hospital staff prior to adjusting pressure.

Backrest Raised mode provides increased support for the patient when sitting up in bed in APT or CLP mode. SCU acti-
vates Backrest Raised mode automatically when backrest is raised.

10.8.1 Activating Backrest Raised Mode


™™ Raise backrest.

When backrest is raised:


„„ When the backrest is raised the SCU automatically increases the mattress pressure.
„„ The Backrest raised Indicator (6) will illuminate and the pressure range indicator will start to flash until the required
pressure is achieved.
„„ Once the pressure is achieved, the pressure range indicator will be permanently on.

10.8.2 Deactivating Backrest Raised Mode


™™ Lower backrest.

When backrest is lowered:


„„ When the Backrest is lowered the SCU automatically reduces the mattress pressure.
„„ The Backrest raised Indicator (6) will extinguish and the pressure range indicator will start to flash until required
pressure is achieved.
„„ Once the pressure is achieved the pressure range indicator will be permanently on.

10.9 Battery
10.9.1 Battery Charge Status Indicator

WARNING!
Risk of injury due to insufficient power supply!
In case of power fail signal:
Ü Select Transport mode if the patient is to remain on the mattress.

CAUTION!
Damage to battery due to complete discharge!
Ü If battery is exhausted, switch off SCU or connect it to power supply to prevent complete discharging.

With the battery fully charged, the mattress replacement system will be operable in Alternating mode for at least 8 hours.
Charging the battery completely takes up to 6 hours, but one hour of charging will be sufficient for running the SCU for an
hour.
™™ Charge the battery before use.
™™ Use only batteries approved by the manufacturer.
™™ The manufacturer provides a 6-month warranty for the full function of batteries.
™™ Check the battery functionality at least once a month in accordance with the user and service manuals and
have the batteriy changed if necessary.
™™ The manufacturer recommends to replace the battery by qualified service organization after 2 (two) years
of use. After this period the supposed service life of battery ends and the manufacturer cannot guarantee
the battery service life after this period.
™™ The battery must be replaced with the new battery approved by manufacturer after maximum 5 (five) years
of use at the latest.

D9U003VB0-0101_03 19/35
To charge the battery:
™™ Connect the SCU to the mains.
™™ Turn on the SCU.
While the battery is being charged, the status indicator will indicate the battery charge status (see table below).

Power Indicator Battery Status Indicator Audio Alarm Signal Power Supply
Off Off No signal No indication
Off Off Power fail signal Power supply insufficient
No mains supply
No battery or battery charge level below
25%
™™ Connect SCU to mains.
-or-
™™ Charge battery.
On (Green) Off No signal Mains supply ok
No battery or battery fully charged
On (Green) Flashing quickly (yellow) No signal No mains supply
Battery in use
Battery fully charged
On (Green) Flashing quickly (yellow) No signal Mains supply ok
Battery not in use
Battery charge level between 50% and 90%
On (Green) Flashing quickly (yellow) Every 15 minutes No mains supply
Battery in use
Battery charge level between 50% and 90%
On (Green) Flashing quickly (yellow) No signal Mains supply ok
Battery not in use
Battery charge level between 25% and 50%
On (Green) Flashing quickly (yellow) Every 5 minutes No mains supply
Battery in use
Battery charge level between 25% and 50%
On (Green) Flashing quickly (yellow) No signal Mains supply ok
Battery not in use
Battery charge level below 25%
On (Green) Flashing quickly (yellow) Every minute No mains supply
Battery in use
Battery charge level below 25%

In case of a power failure or if the SCU is disconnected from the mains without being turned off, the status indica- tor will
continue indicating the battery charge status.
Audio alarm signals will indicate any status change. After sounding 5 times, the audio alarm signals will stop.

To mute the audio alarm signal:


™™ Mute audio alarm signal (see „Mute“).

20/35 D9U003VB0-0101_03
10.9.2 Battery Back-up Pack
SCUs with the back-up battery feature can be equipped with an optional battery back-up pack. SCUs with this feature are
identified by the label on the front panel or the battery pack connection panel on the SCU.

Fig. 10 Front panel label and connection panel

To fit the battery back-up pack:

1 2
Fig. 11 Fitting the battery pack
™™ Disconnect SCU from mains.
™™ Mute audio alarm signal (see „Mute“).
™™ Make sure the battery back’s electrical connection 1 is on top in the front right corner.
™™ Push battery pack into mounting slots 2 until it clicks into place.
™™ Switch SCU back on.

To remove the battery back-up pack:

3
Fig. 12 Removing the battery pack
™™ Switch off SCU.
™™ Pull down the battery pack’s release tab 3.
™™ Pull out battery pack while holding down release tab.

NOTE There is no need to remove the battery pack except when replacing it.

D9U003VB0-0101_03 21/35
10.10 CPR/Air Disconnected Mode
SCU activates CPR/Air Disconnected mode automatically if air pipe is not connected correctly or removed while in use.

When CPR/Air Disconnected mode is activated:


„„ Indicator 8 lights red.
„„ Uninterrupted audio alarm signal sounds.
„„ Mattress deflates.

To stop audio alarm signal:


™™ Connect air pipe correctly.
-or-
™™ Switch off SCU using green illuminated power switch on side of SCU.
™™ Mute audio alarm signal (see Mute).

10.11 System error


WARNING!
Risk of injury due to incorrect positioning of patient!
Ü If a system error occurs, do not continue to use mattress replacement system and notify LINET® Service imme-
diately.

If a system error occurs:


„„ Indicator 9 flashes red.
„„ Audio alarm signal (synchronized with flash sequence) sounds.

NOTE The number of times that the alarm sounds and indicator 9 flashes indicates the type of error. This information
will be required when contacting a service engineer.

To mute audio alarm signal:


™™ Mute audio alarm signal (see Mute).

To stop audio alarm signal:


™™ Reset system by switching SCU off and back on.

NOTE The error signal will repeat every time the device is switched on until the cause of the error is reme- died.

10.12 Service
LINET® recommends maintenance after 10,000 operating hours of the SCU. Indicator 12 lights yellow after 10,000 ope-
rating hours.

When indicator 11 lights yellow:


™™ Notify LINET® Service.

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11 Additional Functions:

11.1 CPR (umbilical connected)

Fig. 13 CPR (SCU connected)

To allow resuscitation with SCU connected:


™™ Press red CPR button.
™™ Remove air connector plug from air connector.
Mattress deflates.

NOTE During this process, it is possible that the backrest detector plug is pulled out. This does not affect the CPR
function.

11.2 CPR (umbilical disconnected)


To allow resuscitation in Transport mode:
™™ Rotate end of air connector and main body in opposite directions until the
red symbols ▲ and o are aligned and air starts to escape.
Mattress deflates.

Fig. 14 CPR (SCU connected)

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11.3 Transport Mode
WARNING!
Risk of injury due to incorrect positioning of patient!
Ü Prior to more than 30 minutes of Transport mode, consult qualified hospital staff.

Transport mode allows disconnecting the mattress from the SCU for transporting the bed without air escaping from the
mattress for up to 24 hours.

NOTE In Transport mode, alternating pressure therapy is not possible.

Fig. 15 Transport Mode

To activate Transport mode:


™™ Select MAX mode in order to completely inflate all mattress cells (see MAX Mode).
™™ Disconnect air connector plug and rotate its end and body in opposite directions until red symbol ▲ and
black symbol ● are aligned and no air is escaping.

11.4 Power Failure


WARNING!
Risk of injury due to power failure!
Alternating pressure therapy is not possible during power failures.
Ü In case of power failure, seek medical advice immediately.

In case of a power failure, the mattress will remain inflated for at least 24 hours. However, alternating pressure therapy is
not possible.

If no power supply will be available for more than 24 hours:


™™ Switch to Transport mode (see Transport Mode).

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11.5 Head Zone Selector/Heel Zone Selector
If a head/heel zone selector is fitted, it is possible to configure the head and heel section of the mattress for nursing pro-
cedures (e.g. prone positioning, intubation).
It permits setting each cell of the head or heel section separately to one of three (head zone selector) or one of two (heel
zone selector) modes.

1 2 3
Fig. 16 Head Zone

1. Deflated
2. APT
3. MAX

To configure the head section:


™™ Remove foot board of bed frame.
™™ Open flap on foot end of mattress cover.
™™ Select required setting with respective rotary control.
™™ Close flap on foot end of mattress cover.

D9U003VB0-0101_03 25/35
12 Seating System
For patients who are not bed-ridden, it is possible to connect a seat cushion
operating in a 2-cell cycle to the SCU instead of the mattress. The LINET®
dynamic seat cushion fits on most standard chairs and chairs for specialist
geriatric care.
The seat cushion consists of three sets of alternating cells on a foam base with
a front support. The cover consists of vapour-permeable, water-impermeable
two-way stretch material.

Fig. 17 Seating System

12.1 Functioning
The seating system provides alternating pressure therapy for patients that are not bed-ridden.
™™ Have seating system used only by or under supervision of trained and qualified nursing personnel.

Seat cushion:
„„ six cells (two sets of three)
„„ cells are inflated and deflated in 12 minute cycles

12.2 Installation of Seat Cushion


WARNING!
Risk of injury due to unsuitable chair!
Ü Ensure that chair is suitable for seating system.
Ü Conduct risk evaluation if necessary.

WARNING!
Risk of injury due to exposed cable!
Ü Ensure that cable is not twisted, crushed or strained.
Ü Ensure that cable does not present tripping hazard.

™™ Remove existing seat cushion if possible.


™™ Ensure that chair supports weight of seat cushion.
™™ Place the seat cushion directly on the seat base.
™™ Ensure that there are no protruding parts or sharp objects on the chair to avoid damage to the seat cushion.
™™ Put seat cushion on seat of chair so that umbilical points to the back.
™™ Push seat cushion back as far as it will go.
™™ Connect air pipe (see Connecting Mattress and SCU).
™™ Put SCU on floor next to chair.

26/35 D9U003VB0-0101_03
12.3 Initial Operation
™™ Ensure that SCU is not covered and air flow around SCU is not obstructed in order to avoid overheating.
™™ Connect mains cable of SCU to mains.

To switch on SCU:
™™ Switch on SCU using green power switch on side of SCU.
™™ Indicator 7 flashes green.
™™ Confirming signal sounds.
™™ Seat cushion is being inflated.

During the inflation process:


„„ Indicator 7 flashes green.

When the inflation process is finished:


„„ Indicator 7 lights green.
„„ Cushion is ready for placement of patient.

NOTE Pressure adjustment is not available in this mode.

If indicator 7 flashes during inflation process and audio alarm signal sounds:
™™ Check if air connector is connected correctly.

12.4 Use
WARNING!
Risk of injury when seating the patient!
Ü Ensure that seat cushion is completely inflated!

12.4.1 Preparation
™™ Inflate seat cushion (see Initial Operation).

12.4.2 Seating of 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.

D9U003VB0-0101_03 27/35
13 Cleaning/Disinfection
CAUTION!
Incorrect cleaning/disinfection can damage the mattress and SCU!
Ü Do not use pressure or steam cleaners.
Ü Use the recommended cleaning agents only.
Ü Follow the instructions and observe the dosages recommended by the manufacturer.
Ü Ensure that disinfectants are selected and applied by qualified hygiene experts only.
Ü The SCU is not sealed against fluid ingress so care must be taken to ensure that no fluid enters the SCU during
cleaning.

For safe and gentle cleaning:


™™ Disconnect SCU from mains.
™™ Do not use any strong acids or bases (optimum pH range 6 - 8).
™™ Only use detergents that are suitable for cleaning medical equipment.
™™ Do not use abrasive powders, steel wool, or other material and cleaning agents that might damage the
mattress replacement system.
™™ Never use any corrosive or caustic detergents.
™™ Never use detergents that deposit calcium carbonate.
™™ Never use detergents with solvents that might affect the structure and consistency of the plastics (benzene,
toluene, acetone, etc.).
™™ Clean electrical components carefully and allow them to dry fully. It is recommended to use the cleaning
wipes.
™™ Neither immerse SCU in water nor heat or steam-clean it.
™™ Observe local directives concerning infection control.

LINET® recommends the following cleaning agents:

Cleaning agents Manufacturer


Presept Johnson&Johnson
Terralin, Mikrozid, Thermosept Schülke&Mayr
Bacillol Plus, Bacillocid Rasant, Microbac Forte, Dismozon Pur BODE Chemie
Clinell Clorox GAMA Healthcare Ltd.

13.1 Cleaning
Type of Cleaning Parts to Clean
Routine Cleaning and Disinfection „„ exposed mattress parts
„„ exposed SCU parts
Full Cleaning and Disinfection „„ exposed mattress parts
„„ exposed SCU parts
„„ internal parts of mattress
„„ internal parts of cover

28/35 D9U003VB0-0101_03
13.1.1 Routine Cleaning and Disinfection
Cleaning the mattress:
™™ Select Static mode in order to completely inflate all mattress cells (see MAX Mode).
™™ Remove air connector and select Transport mode (see Transport Mode).
™™ Check mattress cover top for any signs of damage.
™™ Replace or repair and completely disinfect mattress cover top if damaged.
™™ Check inside of mattress cover top for signs of liquid ingress.
™™ Replace or clean and completely disinfect mattress cover top if damp inside.
™™ Leave mattress cover on mattress.
™™ Clean with 60 °C warm water and cleaning detergent.
™™ Rinse mattress with cold water.
™™ Allow mattress to dry or wipe it dry.
™™ Wipe mattress with disinfectant.
™™ Wipe mattress with cold water.
™™ Allow mattress to dry or wipe it dry.

Cleaning the SCU:


™™ Before cleaning of SCU, cover the air connector in order to prevent anything from penetrating into the air
connector during cleaning.
™™ Wipe SCU with disinfectant. Wipe SCU with cold water. It is recommended to use the cleaning wipes.
™™ Allow SCU to dry or wipe it dry.

13.1.2 Full Cleaning and Disinfection


Cleaning the mattress:
™™ Deflate mattress and remove cover (see Removing the Mattress Cover).
™™ Check mattress cover top and base for any signs of damage.
™™ Replace or repair and completely disinfect mattress cover top and base if damaged.
™™ Check mattress cover top and base for signs of liquid ingress.
™™ Replace or clean and completely disinfect mattress cover top and base if damp inside.
™™ Clean all mattress cells and pipes with 60 °C warm water and cleaning detergent.
™™ Rinse mattress with cold water.
™™ Allow mattress to dry or wipe it dry.
™™ Wipe mattress with disinfectant.
™™ Wipe mattress with cold water.
™™ Allow mattress to dry or wipe it dry.

Cleaning the mattress and cushion cover:


™™ Remove cover (see Removing the Mattress Cover).
™™ Wash cover in washing machine for 3 min at 71 °C.
™™ Tumble dry cover at low temperature.

Cleaning the air pipe:


™™ Wipe air pipe with cleaning agent or disinfectant.
™™ Rinse air pipe with cold water.
™™ Allow air pipe to dry.

Cleaning the SCU:


™™ Remove filter.
™™ Before cleaning of SCU, cover the air connector in order to prevent anything from penetrating into the air
connector during cleaning.
™™ Wipe SCU and filter with disinfectant. Wipe SCU with cold water. It is recommended to use the cleaning
wipes.
™™ Allow SCU and filter to dry.
™™ Reinsert filter.

13.1.3 Removing the Mattress Cover


™™ Carefully open zipper under side skirt of mattress cover on foot end of mattress.
™™ Remove top part of mattress cover.
™™ Open clips in bottom part of mattress cover to remove mattress cells.
™™ Remove umbilical cover.
™™ Remove bottom part of mattress cover.

D9U003VB0-0101_03 29/35
14 Maintenance
Check the following at least every 12 months:
™™ Check mattress, SCU and seat cushion externally and internally for mechanical damage and signs of seve-
re wear and tear.
™™ Check if mattress, SCU, seat cushion and air connector are fully operational.
™™ Perform electrical safety checks in accordance with local safety regulations.

Check the following every month:


™™ Check filter in top of SCU for dust and dirt.
™™ If dust or dirt are visible, replace filter.

™™ Replace any damaged parts immediately with original spare parts only.
™™ Ensure that maintenance and installation are performed only by qualified personnel trained by the manu-
facturer.

NOTE LINET® provides service documentation for qualified personnel.

15 Storage
When SCU is not in use:
™™ Switch off 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:


™™ Deflate 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.

30/35 D9U003VB0-0101_03
16 Disposal

16.1 Environment Protection


LINET® is aware of the important role that the protection of our environment plays for future generations.
The materials of this product are environmentally compatible. It does not contain hazardous substances on the basis
of cadmium, mercury, asbestos, PCB or CFC. The noise emission and the vibrations meet the directives for healthcare
premises.
The packaging materials are produced according to the respective directives. Dispose of the packaging material accor-
ding to the symbols and by delivering it to an authorised person.

16.2 Disposal

To dispose of the appliance (SCU):


™™ When you dispose of your appliance (SCU) do not put it into the household waste.
™™ Send the appliance (SCU) to the recycling of electrical appliances.

To dispose of the battery (applies only to battery back-up model):


™™ Send the battery to the recycling of Ni MH batteries.

The materials of the appliance are reusable. By reusing, material recycling or other forms of use of old appliances you
make an important contribution to the protection of our environment.
™™ Ask the responsible environmental protection authorities for the appropriate disposal point.
™™ Observe local and country-specific specifications for disposal.

17 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.

This product is covered by a 24-month warranty from the date of purchase. The warranty covers all material and manu-
facturing-related failures and errors. Failures and errors caused by incorrect use and external effects are not covered.
Justified complaints will be fixed free of charge during the warranty period. Proof of purchase, with the date of purchase,
is required for all warranty service. Our standard terms and conditions apply.

D9U003VB0-0101_03 31/35
18 EC Declaration of Conformity

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19 Technical Specifications

19.1 Mechanical Specifications


Dimensions
„„ Mattress (inflated) 2,040 mm x 860 mm x 230 mm (80‘ x 33‘ x 9‘)
„„ Seat cushion (inflated) 450 mm x 500 mm x 125 mm (17‘ x 19‘ x 4‘)
„„ SCU (without battery) 135 mm x 360 mm x 290 mm (5‘ x 14‘ x 11‘)
„„ Battery pack 98 mm x 26 mm x 254 mm (3‘ x 1‘ x 10‘)
Weight
„„ Mattress (inflated) 9.5 kg (20,9 lbs)
„„ Seat cushion (inflated) 2.5 kg (5,5 lbs)
„„ SCU (without battery) 3.5 kg (7,7 lbs)
„„ Battery pack 0.8 kg (1,7 lbs)
Cycle
„„ Mattress (inflated) 3 cells, 7.5 min
„„ Seat cushion (inflated) 2 cells, 12 min
Environmental conditions (operation and storage)
„„ Temperature 0 °C (32 °F) – +40 °C (104 °F)
„„ Humidity 30–75 %
„„ Atmospheric pressure 700–1060 hPa
Max. load
„„ Mattress 254 kg (559 lbs)
„„ Seat cushion 127 kg (279 lbs)
Inflation time
„„ Mattress 10 min–30 min
„„ Seat cushion 30 s
Deflation time (CPR) Max. 30 s

19.2 Electrical Specifications


Supply voltage
„„ Model 127 V 100-127 V, +/- 10%, 50-60Hz
„„ Model 230 V 220-240 V, +/- 10%, 50-60Hz
„„ Model 230 V with battery back-up 12 V DC (battery)
Nominal power
„„ Model 127 V Max. 23 VA
„„ Model 230 V Max. 20 VA
„„ Model 230 V with battery back-up Max. 23 VA
Fuse
„„ Model 230 V 2x 1A(T) anti-surge fuse
„„ Model 230 V with battery back-up 2x T2(T) anti-surge fuse (250 V, type 5x20 mm)
„„ Model 127 V 2x 1A anti-surge fuse
Electrical safety class Class 2 with applied part type B
Electrical safety In conformity with EN 60601-1
Battery operation At least 6 h in APT mode

D9U003VB0-0101_03 33/35
19.3 Electromagnetic Compatibility
WARNING!
Increased electromagnetic radiation or reduced electromagnetic resistance due to unsuitable accessories,
converters or cables!
Ü Consult LINET® or local dealer before using other parts than those provided by LINET®.
Ü See Virtuoso spare parts list for details.

WARNING!
Material damage due to electromagnetic radiation!
Ü Do not use the product in close proximity to:
„„ sources of radio frequency
„„ other equipment not approved according to IEC 60601-2-2:2007
„„ equipment whose performance affects this product
„„ equipment that is affected by electromagnetic fields radiating from this product

The EMC declaration of compliance for Virtuoso covers the requirements of IEC 60601-1-2, in particular § 5.2.2.1.

If it is necessary to use the bed near electrical equipment:


™™ Observe whether the bed functions normally.
™™ If any abnormal properties are observed, move or relocate the bed.

NOTE Continuing alternating inflation without excessive inflation or permanent deflation of the mattress is considered
the essential performance of Virtuoso.

Virtuoso is intended for the application in electromagnetic environment as specified below. The customer or user of the
bed is responsible for the fact that these requirements are met.

19.3.1 Electromagnetic Radiation

Radiation Test Conformity Electromagnetic Environment


High-frequency radiation Group 1 Virtuoso utilizes high-frequency energy for its internal
CISPR 11 function only. The high-frequency radiations are very low
and unlikely to cause any interference to nearby electro-
nic devices.
High-frequency radiation Class B Virtuoso is suitable for all institutions, including house-
CISPR 11 holds and objects directly connected to the public low-
Harmonic radiations IEC Class A -voltage mains supplying residential buildings.
61000-3-2
Fluctuating voltage/Flashing Conform
radiation EC 61000-3-3

34/35 D9U003VB0-0101_03
19.3.2 Electromagnetic Resistance

Resistance Test Test Level as per IEC Level of Compliance Electromagnetic Environ-
60601 ment
Electrostatic discharge (ESD) ± 6 kV for contact ± 6 kV for contact Ensure that the following
IEC 61000-4-2 ± 8 kV for air ± 8 kV for air requirements are met:
Floors: wood, concrete or
ceramic tiles
Relative humidity: >30%

Electrical fast transient ± 2 kV in feeder line ± 2 kV in feeder line Ensure that mains quality is
response/ group of impulses ± 1 kV in input/out- put line ± 1 kV in input/out- put line suitable for commercial or
IEC 61000-4-4 hospital environment.

Short-time voltage drop, ± 1 kV between lines ± 1 kV in differential mode Ensure that mains quality is
short-duration interruptions ± 2 kV between line (lines) ± 2 kV in co-phasal mode suitable for commercial or
and slow voltage changes on and earth hospital environment.
the fee- der input line
IEC 61000-4-11

Fluctuating voltage/Flashing <5 % UT (>95 % short-du- <5 % UT (>95 % short-du- Ensure that mains quality is
radiation ra- tion drop of UT) within ra- tion drop of UT) within suitable for commercial or
EC 61000-3-3 0.5 cycles 0.5 cycles hospital environments.
For permanent operation
40 % UT (60 % short-du- 40 % UT (60 % short-du- during a power failure,
ra- tion drop of UT) within ra- tion drop of UT) within connect the bed to a power
5 cycles 5 cycles generator since the back-up
battery’s capacity is limited.
70 % UT (30 % short-dura- 70 % UT (30 % short-dura-
tion drop of UT) within 25 tion drop of UT) within 25
cycles cycles

<5 % UT (>95 % short-du- <5 % UT (>95 % short-du-


ra- tion drop of UT) within ra- tion drop of UT) within
5s 5s

Magnetic field of network 3 A/m 3 A/m Ensure that the magnetic


frequency (50/60 Hz) fields of the network fre-
IEC 61000-4-8 quency conform to the nor-
mal levels of commercial or
hospital environments.

NOTE UT refers to the AC mains voltage before the test level is applied.

D9U003VB0-0101_03 35/35

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