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Nvod Na Pouitvirtuoso II LINET EN Id192pdf
Nvod Na Pouitvirtuoso II LINET EN Id192pdf
Virtuoso
D9U003VB0-0101
Version: 03
Publication Date: 2018-03
Manufacturer:
LINET spol. s r. o.
Želevčice 5,
274 01 Slaný
Czech Republic
Virtuoso
Mattress Replacement System – Series 2
D9U003VB0-0101
Version: 03
Publication date: 2018-03
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
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1 Symbols
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
Alternating current
Activation GO button
Device is connected to mains if green indicator is lit
Double isolation
Attention
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.
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2 Safety and Dangers
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
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.
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
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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.
Head section:
3 head cells
remains inflated (static)
Torso section:
11 torso/upper leg cells
alternates in 3-cell cycle
Foot module:
6 lower leg/foot cells
alternates in 3-cell cycle
Fig. 2 Mattress
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
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6 Scope of Delivery
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7 Installation
The Virtuoso mattress replacement system replaces any mattress on the bed frame.
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.
11
22
33
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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.
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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.
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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.
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.
If indicator 8 flashes during inflation process and audio alarm signal sounds:
Check if air pipe is connected correctly.
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9 Use
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.
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10 Controls and Indicators
16
15 9
14 13 12 11 10
Fig. 9 SCU Control Panel
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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.
10.3 Mute
To mute audio alarm signal:
Press button 10.
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.
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
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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.
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.
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.
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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.
10.9 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.
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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.
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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.
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.
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.
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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.
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.
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.
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11 Additional Functions:
NOTE During this process, it is possible that the backrest detector plug is pulled out. This does not affect the CPR
function.
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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.
In case of a power failure, the mattress will remain inflated for at least 24 hours. However, alternating pressure therapy is
not possible.
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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
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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.
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
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.
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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.
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).
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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.
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
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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.
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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.
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.
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.
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16 Disposal
16.2 Disposal
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.
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.
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18 EC Declaration of Conformity
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19 Technical Specifications
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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.
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.
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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
NOTE UT refers to the AC mains voltage before the test level is applied.
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