User manual and technical description
Virtuoso
Mattress Replacement System - Series 2
D9U003VB0-0101
Version: 04
Publication Date: 2018-07
D9U003VB0-0101_042/36
Virtuoso
Mattress Replacement System – Series 2
Author: LINET, s.r.o.
Link: www.linet.com
D9U003VB0-0101
Version: 04
Publication date: 2018-07
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.
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: [email protected]
Web: www.linet.com
3/36D9U003VB0-0101_04
1 Symbols .................................................................4
1.1 Warning Notices ..............................................4
1.2 Other symbols .................................................4
1.3 Symbols and Labels on the Product ...............5
1.4 Serial Label .....................................................5
2 Safety and Dangers ..............................................6
2.1 Safety Instructions ..........................................6
2.2 Use and Storage Conditions ...........................6
3 Standards and Regulations .................................6
4 Function .................................................................7
4.1 Correct Use .....................................................7
4.2 Contraindications ............................................7
5 Product Description .............................................8
5.1 Mattress ..........................................................8
5.2 SCU (System Control Unit) .............................8
6 Scope of Delivery ..................................................9
6.1 Scope of Delivery ............................................9
6.2 List of Parts .....................................................9
7 Installation .............................................................10
7.1 Installation of Mattress ....................................10
7.2 Installation of SCU (System Control Unit) .......11
7.3 Connecting Mattress and SCU .......................11
7.4 Cable Management System............................12
8 Initial Operation ....................................................13
8.1 Ination ...........................................................13
9 Use .........................................................................14
9.1 Preparing the Bed for the Patient....................14
10 Controls and Indicators .......................................15
10.1 Control Panel ..................................................15
10.2 Button GO .......................................................16
10.3 Mute ................................................................16
10.4 Pressure Control .............................................16
10.5 APT Mode (Default Mode) ..............................18
10.6 MAX Mode ......................................................18
10.7 Constant Low Pressure Mode.........................18
10.8 Backrest Raised Mode ....................................19
10.9 Battery.............................................................20
10.10 CPR/Air Disconnected Mode ........................23
10.11 System error..................................................23
10.12 Service ..........................................................23
11 Additional Functions: ...........................................24
11.1 CPR (umbilical connected) .............................24
11.2 CPR (umbilical disconnected) .........................24
11.3 Transport Mode ...............................................25
11.4 Power Failure ..................................................25
11.5 Head Zone Selector/Heel Zone Selector ........26
12 Seating System .....................................................27
12.1 Functioning .....................................................27
12.2 Installation of Seat Cushion ............................27
12.3 Initial Operation ...............................................28
12.4 Use..................................................................28
13 Cleaning/Disinfection ...........................................29
13.1 Cleaning ..........................................................29
14 Maintenance ..........................................................31
15 Storage ..................................................................31
16 Disposal .................................................................32
16.1 Environment Protection...................................32
16.2 Disposal ..........................................................32
17 Warranty ................................................................32
18 EC Declaration of Conformity ..............................33
19 TechnicalSpecications ......................................34
19.1 Mechanical Specications...............................34
19.2 Electrical Specications ..................................34
19.3 Electromagnetic Compatibility.........................35
CONTENT:
D9U003VB0-0101_044/36
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
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!
ÜMeasures to avoid the danger!
5/36D9U003VB0-0101_04
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
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.
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_046/36
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 specied in this manual and in perfect working order.
Use the mattress system only with the correct mains supply (see Electrical Specications).
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 qualied nursing personnel.
Replace any damaged parts immediately with original spare parts only.
Have the mattress system serviced and installed only by qualied personnel trained and authorized by the
manufacturer.
Do not exceed the maximum patient weight limit (see Mechanical Specications).
Do not use the SCU near ammable 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 not suitable for indoor environments:
containing ammable gases (except oxygen cylinders).
3 Standards and Regulations
The mattress replacement system complies with the following standards:
EC directive 93/42/EEC, on medical devices
RoHS directive 2011/65/EU
EN 60601-1
EN 60601-1-2
EN 60601-1-6
EN ISO 10993
Themanufactureradherestoacertiedqualitymanagementsystemincompliancewiththefollowingstandards:
EN ISO 9001
EN ISO 13485
EN ISO 14001
7/36D9U003VB0-0101_04
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 qualied 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 qualied 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
qualied 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
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
WARNING!
Risk of injury due to incorrect use!
ÜDo not use CLP mode for patients undergoing cervical traction.
ÜUse ALP mode exclusively under the direction of a qualied physician.
ÜBefore placing a patient on a Virtuoso mattress, always have a qualied person perform a risk assessment to
ensure that the support provided is appropriate and fulls the applicable local stipulations.
ÜBefore using the seat cushion for persons with poor posture or pelvic deformities, always consult a specialist for
seating systems.
ÜWhen 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.
D9U003VB0-0101_048/36
5 Product Description
5.1 Mattress
The mattress consists of two decks that are connected with stainless steel press studs, xation 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 inated (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
5.1.2 Bottom Deck
The bottom part consists of 5 modules.
Head module:
3 cells
remains inated (static)
longitudinal cells
Leg module:
5 cells
remains inated (static)
longitudinal cells
2 side formers:
remain inated (static)
Torso module:
9 cells
alternates in 3-cell cycle
with corresponding upper deck cells
5.2 SCU (System Control Unit)
The SCU inates and deates 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.
Fig. 2 Mattress
9/36D9U003VB0-0101_04
6 Scope of Delivery
6.1 Scope of Delivery
Delivery:
Upon receipt, check that the shipment is complete as specied on the delivery note.
Notify the carrier and supplier of any deciencies 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_0410/36
7 Installation
The Virtuoso mattress replacement system replaces any mattress on the bed frame.
7.1 Installation of Mattress
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 ow.
Loosely fasten safety straps to suitable parts of the bedframe.
1. Head end safety strap
2. Lateral safety strap
3. Foot end safety strap
WARNING!
Risk of injury due to incorrect use!
ÜWhen 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.
ÜBefore placing a patient on a Virtuoso mattress, always have a qualied person perform a risk assessment to
ensure that the support provided is appropriate and fulls the applicable local stipulations.
CAUTION!
Material damage due to incorrect fastening of safety straps!
Mattress overlay system
ÜFirmly x head and foot straps exclusively around existing mattress.
Mattress replacement system
ÜFix safety straps exclusively to movable parts of bed frame.
ÜUse all safety straps to prevent the mattress from moving when the patient is getting into or out of bed.
1
2
3
Fig. 3 Installation of Mattress
1
2
3
11/36D9U003VB0-0101_04
7.2 Installation of SCU (System Control Unit)
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 oor with integrated mounting feet.
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.
1. Air connector plug
2. Air connector
CAUTION!
Risk of injury when installing SCU!
ÜEnsure that no body parts are trapped between hook and foot board when using spring-loaded SCU hanging
hooks.
ÜFix SCU securely SCU to prevent it from sliding or accidentally being knocked off.
CAUTION!
Material damage due to incorrect installation of SCU!
ÜDo not install SCU in linen shelf on bed frame.
Fig. 4 Installation of SCU
Fig. 5 Open Mode Fig. 6 Air Connector
1
2
D9U003VB0-0101_0412/36
7.4 Cable Management System
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.
WARNING!
Risk of injury due to exposed cable!
ÜEnsure that cable is not twisted, crushed or strained.
ÜUse cable routing clips in order to avoid tripping hazards.
ÜEnsure that it is not possible for the cable to get trapped between any moving parts of the bed frame.
Fig. 7 Cable routing clips
13/36D9U003VB0-0101_04
8 Initial Operation
The SCU is operated via the SCU control panel (see Control Panel ).
8.1 Ination
Ensure that SCU is not covered and air ow around SCU is not obstructed in order to avoid overheating.
Connect mains cable of SCU to suitable mains socket.
For Mains Operation (For Battery Operation see chapter 11):
Switch on SCU using largest power switch on side of SCU.
The SCU will take 30 s for the initialisation. After that the mattress will start to inate.
InationModeCLP:
When CLP is set, indicator 2 will keep ashing during the initial ination.
When the set pressure level is reached, indicators 2 and 16 will remain solid on.
Whentheinationprocessisnished:
Check if safety straps of mattress cover are too tight and correct if necessary.
Ifindicator8ashesduringinationprocessandaudioalarmsignalsounds:
Check if air pipe is connected correctly.
Fig. 8 Switching on SCU
To switch off SCU:
Switch off SCU using Mains and Battery power switch on side
of SCU.
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.
Duringtheinationprocess:
Indicator 2 or 3 ashes yellow, depending on the last mode setting. The
ination process takes 15 minutes at most.
InationModeAPT:
When APT is set, indicator 3 will keep ashing during the initial ination.
Then APT indicator 4 will light and indicator 16 will ash while pressure is
adjusted to the set pressure level.
When the set pressure level is reached, indicators 4 and 12 will remain
solid on.
D9U003VB0-0101_0414/36
9 Use
9.1 Preparing the Bed for the Patient
9.1.1 Preparation
Inate mattress (see „Initial Operation“).
Put a sheet loosely on the mattress if not prescribed otherwise by qualied 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 sufcient.
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.
WARNING!
Risk of injury when putting patient into bed!
Before putting the patient into bed:
ÜEnsure that mattress is completely and correctly inated.
ÜEnsure that mattress is correctly secured with safety straps.
WARNING!
Danger of suffocation due to air-impermeable mattress cover!
ÜUse mattress cover correctly.
ÜThe nursing staff are responsible for the safety of the patient on the mattress cover.
CAUTION!
Material damage due to dampness or contamination!
ÜEnsure that no moisture gets into the mattress.
ÜEnsure that no food or drink gets into the mattress.
ÜIf moisture, food or drink get into the mattress, notify LINET® Service.
15/36D9U003VB0-0101_04
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. 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.
Fig. 9 SCU Control Panel
1 2 3 4 5 6 7 8
1011121314
9
15
16
D9U003VB0-0101_0416/36
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 inate the mattress to the recommended pressure. Once this pressure is rea- ched,
indicator 16 will stop ashing 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.
Button/Indicator Function
Pressure Control Button Changing air pressure in mattress.
Mode Indicators Indicate selected mode:
APT Alternating Pressure Therapy
MAX Maximum Inate
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
(battery back-up model only)
Indicates charge status of battery.
Pressure Level Indicator Indicates air pressure set in mattress or seat cushion.
17/36D9U003VB0-0101_04
10.4.1 Manual Pressure Adjustment
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 ashes 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
WARNING!
Risk of injury due to incorrect pressure setting!
ÜConsult qualied 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.
ÜDo not reduce pressure level setting by more than 1 step for the patient’s comfort.
ÜRegardless of the pressure level, make sure the patient is not lying directly on the foam base.
D9U003VB0-0101_0418/36
10.5 APT Mode (Default Mode)
Once the mattress is fully inated, a conrming 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 inate and deate in cycles of 7.5 minutes.
Indicator 4 lights yellow.
Green middle section of indicator 16 ashes.
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 ination) 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 conrmation 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 ashes yellow.
IfMAXmodeisrequiredforlessthan30min:
Set new mode.
IfMAXmodeisrequiredformorethan30min:
Set MAX mode again within the last 5 min.
When MAX mode is selected:
SCU inates all mattress cells to the same pre-set pressure.
Indicator 3 ashes 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 ashes yellow.
When CLP mode is switched on:
Indicator 2 ashes yellow until pre-set pressure is reached.
Once the pre-set pressure is reached, indicator 2 and 16 will remain solid on.
19/36D9U003VB0-0101_04
10.8 Backrest Raised Mode
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 ash 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 ash until required
pressure is achieved.
Once the pressure is achieved the pressure range indicator will be permanently on.
WARNING!
Risk of injury due to incorrect pressure setting!
ÜConsult qualied hospital staff prior to adjusting pressure.
D9U003VB0-0101_0420/36
10.9 Battery
To switch on battery:
Switch on battery using smaller power switch on side of SCU.
10.9.1 Battery Charge Status Indicator
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 sufcient 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 qualied 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 (ve) years
of use at the latest.
WARNING!
Riskofinjuryduetoinsufcientpowersupply!
In case of power fail signal:
ÜSelect Transport mode if the patient is to remain on the mattress.
CAUTION!
Damage to battery due to complete discharge!
ÜIf battery is discharged, switch off SCU or connect it to power supply to prevent complete discharging.
Fig. 10 Switching on battery
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