LINET Eleganza 3XC Parts list manual

User manual and technical
description
Eleganza 3XC
Positionable bed for critical care
D9U001GV0-0101
Version:07
PublicationDate:2018-05

Manufacturer:
LINET spol. s r. o. Želevčice 5,
274 01 Slaný
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
http://www.linet.com
Eleganza 3XC
Positionable bed for critical care
Author: LINET, s.r.o.
Related links: www.linet.com
D9U001GV0-0101
Version: 07
Publication Date: 2018-05
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 owners. 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. Reproduction,
also excerpts, only with prior permission of the publisher. Subject to changes due to technical developments. All
technical data are rated data and are subject to construction and manufacturing tolerances.

3
Table of Contents
1 Symbols............................................................................................................................................................5
1.1 Warning Notices........................................................................................................................................5
1.2 Other Symbols..........................................................................................................................................5
1.3 Symbols and Labels on the Product..........................................................................................................6
1.4 Serial label with UDI .................................................................................................................................7
1.5 Definitions.................................................................................................................................................8
1.6 Abbreviations............................................................................................................................................8
2 Safety and Dangers..........................................................................................................................................9
2.1 Safety Instructions...................................................................................................................................10
2.2 Conditions of use ....................................................................................................................................12
3 StandardsandRegulations .............................................................................................................................12
4 Functioning.....................................................................................................................................................13
4.1 Correct Use.............................................................................................................................................13
4.2 Incorrect Use ..........................................................................................................................................13
5 Scope of Delivery and Bed Variants ................................................................................................................14
6 Setup..............................................................................................................................................................15
6.1 Transport ................................................................................................................................................15
6.2 Setup......................................................................................................................................................15
7 Assembly........................................................................................................................................................16
7.1 Bed Ends................................................................................................................................................17
7.2 PotentialEqualisation..............................................................................................................................17
8 Operation........................................................................................................................................................18
8.1 Initial Operation.......................................................................................................................................18
8.2 Battery Operation....................................................................................................................................18
8.3 Removing the Bed from Service..............................................................................................................20
9 Manipulation...................................................................................................................................................21
9.1 Supervisor Panel.....................................................................................................................................22
9.2 Handset..................................................................................................................................................25
9.3 Foot Control............................................................................................................................................26
9.4 Integrated Control Element (Siderail) ......................................................................................................27
9.5 CPR Backrest Release...........................................................................................................................28
9.6 Siderails..................................................................................................................................................29
9.7 Eleganza Protector®...............................................................................................................................30
9.8 Undercarriage.........................................................................................................................................31
9.9 Mobi-Lift®...............................................................................................................................................32
9.10 Accessories ............................................................................................................................................33
9.11 Writing Table...........................................................................................................................................36
10 Patient Weighing (WS17)................................................................................................................................37
10.1 Weighing System Control Panel...............................................................................................................37
11 X-rayLungExamination..................................................................................................................................40
11.1 Necessary Steps before the Examination................................................................................................40
12 ExaminationwithC-arm..................................................................................................................................40
12.1 Necessary Steps before the Operation....................................................................................................40
13 Cleaning/Disinfection......................................................................................................................................41
13.1 Preparing for Cleaning ............................................................................................................................41
13.2 Cleaning .................................................................................................................................................42
14 Troubleshooting..............................................................................................................................................44
15 Maintenance...................................................................................................................................................45
15.1 Maintenance Work..................................................................................................................................45
15.2 Safety Checks ........................................................................................................................................47
16 Disposal..........................................................................................................................................................48
16.1 Environment Protection...........................................................................................................................48
16.2 Disposal..................................................................................................................................................48
17 Warranty.........................................................................................................................................................49
18 ECDeclaration of Conformity..........................................................................................................................50
19 TechnicalSpecifications..................................................................................................................................51

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19.1 Mechanical Specifications.......................................................................................................................51
19.2 Environmental conditions .......................................................................................................................51
19.3 Electrical Specifications..........................................................................................................................52
19.4 Electromagnetic Compatibility ................................................................................................................53
20 Battery Activation.............................................................................................................................................56
20.1 Placement of Control Section.................................................................................................................56
20.2 Removing the Isolating Foil ....................................................................................................................56
20.3 Isolating Foil ...........................................................................................................................................56

5
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 indicates potential damage to property.
Warning warns against bodily injury.
Danger warns against potential mortal injury.
1.1.2 Structure of Warning Notices
Type and source of danger!
Measures to avoid the danger.
Signal words
1.2 Other Symbols
1.2.1 Instructions
Structure of instructions:
Perform this step.
Results, if necessary.
1.2.2 Lists
Structure of bulleted lists:
List level 1
List level 2
Structure of numbered lists:
a. List level 1
b. List level 1
1. List level 2
2. List level 2

6
1.3 Symbols and Labels on the Product
Attention
Thermal protection of transformer
Only suitable for indoor use
Protection against accidents due to electrical current -
Applied parts type B
Safety isolating transformer, general
CE mark
Jack for attachment of conductor for potential equalisa-
tion
Safe working load
Warning against crushing or trapping
Maximum weight of patient
Use mattress recommended by manufacturer.
Weight of bed
Do not put any objects here.
Designation of hospital bed for adults

7
1.4 Serial label with UDI
Address of Distributor
1D Bar code GS1-128
(Serial Number)
Manufacturing Date
(Year-Month-Day)
DI (Device Identifier) /
GTIN (Global Trade Item
Number)
2D Bar Code
(GS1 DataMatrix)
DI+PI=UDI
Symbols
Electrical Specification
Serial Number
PI (Product Identifier)
Fig. Serial Label with UDI (Eleganza 3XC without scales)
Address of Distributor
1D Bar code GS1-128
(Serial Number)
Manufacturing Date
(Year-Month-Day)
DI (Device Identifier) /
GTIN (Global Trade Item
Number)
2D Bar Code
(GS1 DataMatrix)
DI+PI=UDI
Symbols
Electrical Specification
Serial Number
PI (Product Identifier)
Fig. Serial Label with UDI (Eleganza 3XC with scales)

8
1.5 Definitions
Basic Bed Configuration
the pricelist model configuration, not including a mattress
Bed Weight
The value depends on the product configuration,
accessories or customer adjustments.
Clearance of Undercarriage
the height from the floor to the lowest point of the
undercarriage between the castors, for the manipulation of
accessories under a braked bed in the standard position
Duty Cycle
cycle of operation of the motor: time of activity/time of rest
Ergoframe
Ergoframe is the kinematic system of Mattress support
platform Adjustment whose effect is the elimination of
pressure on the patient´s abdomen and pelvic area and
frictional forces on the patient‘s back and legs.
Maximum Patient Weight
Maximum Patient Weight depends on the application
environment according to IEC 60601-2-52. For application
environment 1 (intensive/critical care) and 2 (acute care)
reduce Safe working Load by 65 kg. For application
environment 3 (long-term care) and 5 (ambulatory care)
reduce Safe working Load by 35 kg.
Safe Working Load
the highest allowable load on the bed (patient, mattress,
accessories and the load supported by those accessories)
Siderail Height
the height of the upper crossbar or the edges of the
siderails (not the highest point of the siderail controls) from
the patient surface
Standard Bed Position
The height of the patient surface with regard to the floor
is 400 mm
The mattress support platform, including the individual
parts, has to be in a horizontal (level - 0°) position.
The siderails are always locked in the upper position.
The basic position of the integrated extension.
1.6 Abbreviations
CE
European Conformity
CPR
Cardiopulmonary Resuscitation
dB
Sound Intensity Unit
EAC
Eurasian conformity
EMC
Electromagnetic Compatibility
FET
Field-effect transistor
HF
High Frequency
ICU
Intensive Care Unit
INT.
Duty Cycle
IV
Intravenous
LED
Light Emitting Diodes
ME
Medical Electrical (Equipment)
OFF
Deactivated

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Incompatible siderails and mattresses can cause an entrapment hazard!
Inappropriate handling of the power supply cord, e. g. by kinking, shearing
or other mechanical damages is hazardous!
When routing cables from other equipment in the Eleganza 3XC bed avoid
squeezing those between parts of the Eleganza 3XC bed!
Eleganza 3XC bed should not be used with bed hoists and bed lifts!
ON
Activated
REF
Reference Number (product type depending on
configuration)
SCU
System Control Unit
SN
Serial Number
SWL
Safe Working Load
UDI
Unique Device Identification (for medical devices)
2 Safety and Dangers
Eleganza 3XC bed should be left in its lowest position when the patient is
unattended in order to reduce risk of injury due to falls!
Siderails of Eleganza 3XC should be located in the „up“ position to reduce
the risk of the patient accidentally slipping or rolling off the mattress!
WARNING!
WARNING!
WARNING!
WARNING!
WARNING!
WARNING!
The bed is intended for adults.
Follow chapter Correct Use.
WARNING!

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If this equipment is modified, appropriate inspection and testing must be
conducted to ensure continued safe use of the equipment.
An additional multiple socket-outlet or extension cord shall not be connected
to the medical electrical system.
2.1 SafetyInstructions
Follow the instructions carefully.
Only use the bed if it is in perfect working order.
If necessary, check the bed functions daily or at each shift change.
Use the bed with the correct mains supply only.
Ensure that the bed is operated by qualified personnel only.
Ensure that the patient (health permitting) has been informed about the operation of the bed and all
applicable safety instructions.
Incompatible mattresses can create hazards.
WARNING!
WARNING!
WARNING!
Do not modify this equipment without authorization of the manufacturer.
WARNING!
No modification of this equipment is allowed!
WARNING!
During specific investigations or treatments the significant risks of reciprocal
interference posed by medical electrical equipment may occur.
WARNING!
To avoid the risk of electric shock, this equipment must only be connected to
a supply mains with protective earth.
WARNING!

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Move the bed on even, hard-surfaced floors only.
Replace any damaged parts immediately with original spare parts only.
Ensure that maintenance and installation are performed only by qualified personnel who have been
trained by the manufacturer.
Do not apply excess weight or loads to the bed according to SWL.
During peak loads or unavoidable excess loads (CPR), place mattress platform in the lowest position.
Ensure that only one patient uses the bed at any time.
Take care to avoid injuries or squeezing when operating moving parts.
When using lifting poles or infusion stands, ensure that nothing will be damaged when you move or adjust
the bed.
Brake the castors when the bed is occupied.
Keep the mattress platform in the lowest position at any time when the healthcare personnel is not treating
the patient in order to prevent the patient from falling or injuries.
Ensure that siderails are operated by healthcare personnel only.
Never use the bed in areas where there is a hazard of explosion.
Enable or disable functions on the handset using the supervisor panel as appropriate for the patient’s
physical and mental state. Verify that the function is actually disabled.
Never handle the mains plug with wet hands.
Remove the mains cable by pulling on the plug only.
Position the mains cable so that there are no loops or bends 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
the bed.
Ensure that the stipulated duty cycle (on-time) is not exceeded.
Ensure that the moving parts of the bed are not blocked.
To prevent failures, use the manufacturer’s original accessories and mattresses only.
Ensure that the stipulated safe working load is not exceeded.
If the patient's condition could lead to an entrapment, leave the mattress support platform in the flat
position whilst unattended.
Close linen shelf before using the Reverse Trendelenburg position.
Always set mattress platform to its lowest position and single parts of mattress platform to horizontal
position in case the patient is left on the bed without supervision of personnel and if his health and mental
status may indicate increase risk of falling out of the bed or entrapment.
Personnel must consider overall adjustment of the bed and locking all of the positioning functions in
accordance to health and mental status of patient, especially if the patient is left without supervision (even
for short period of time) of the personnel.
Manual positioning of parts of the bed which are designed for electronic positioning (e.g. back rest) is
forbidden. Otherwise there is a risk of damaging and dysfunction of the back rest actuator or unprompted
fall of the back rest.

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2.2 Conditions of use
The bed may not be used in an indoor environment:
where there is a risk of explosion
containing inflammable anaesthetics
The bed is designed for use in rooms for medical purposes. Electrical installations must therefore meet local
norms laying down the necessary conditions for electrical installations.
Disconnect the bed from the mains during exceptional cases. (i. e. a storm).
3 Standards and Regulations
The bed complies with the following standards:
EN 60601-1:2006/A1:2013
EN 60601-1-2:2015
EN 60601-1-6:2010
EN 60601-2-52:2010
EN ISO 10993-5:2009
EN ISO 10993-10:2013
93/42/EEC
2011/65/EU
The manufacturer adheres to a certified quality management system in compliance with the following
standards:
EN ISO 9001
EN ISO 14001
EN ISO 13485

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4 Functioning
4.1 Correct Use
Eleganza 3XC is a hospital bed for critical care. It is designed for supporting the patient in several positions such
as horizontal, Trendelenburg, Cardiac Chair etc.
The stable undercarriage with 4 castors makes it possible for the bed to be controlled by one person.
Eleganza 3XC is suitable for:
Patients
with weight ≥ 40 kg
with height ≥ 146 cm
with BMI ≥ 17
whose weight (including mattress and accessories) does not exceed the SWL
Personnel
qualified medical staff
any person familiar with the manual
patient (condition permitting)
Use
intensivecare
standard care
uninterrupted operation
Location
application environments 1, 2 and 3 according to EN 60601-2-52:2010
4.2 Incorrect Use
NOTE For information concerning uses other than those outlined in the “Correct Use” section above, please
contact LINET®.
Eleganza 3XC is not suitable for:
Patients
not fulfilling conditions stated in chapter “Correct use”
Use
private use without qualified supervision
NOTE For information concerning uses other than those outlined in the “Correct Use” section above, please
contact LINET®.
LINET®’s efforts in research, design and manufacture ensure LINET®products are of the highest quality and fit
for their intended purpose. However, LINET®can take no responsibility for any damage to the products or any
harm to patients, staff or other individuals resulting from:
Not following the instructions in the manual, including warning notices.
Using the product for a purpose other than the intended purpose stated in the relevant documentation provi-
ded by LINET®(see Scope of Delivery and Bed Variants).
Risk of injury or death due to use of incorrect equipment!
Always conduct the risk assessments required for the selection of suitable equip-
ment.
Danger
Do not use the bed in private homes without qualified supervision.
NOTE For information concerning uses other than those outlined in the “Correct Use” section above, please
contact LINET®.
NOTE The manufacturer shall not be liable for any damage, injury, etc. due to incorrect use.

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5 Scope of Delivery and Bed Variants
5.1 Scope of Delivery
Delivery:
Upon receipt, check that the shipment is complete as specified on the delivery note.
Notify the carrier and supplier about any deficiencies or damages immediately as well as in writing or
enter them on the delivery note.
5.2 Bed variants
Features:
Model 1GV (model no. see product label)
Basic variants:
Scales
with scales
without scales
X-ray Cassette Holder
with x-ray cassette holder
without x-ray cassette holder
Optional bed accessories:
Castors
Tente Integral 150 mm
Tente Integral 150 mm with fifth castor
Tente Integral 150 mm with fifth retractable castor
Tente Integral 150 mm double castor
Tente Integral 150 mm double castors with fifth castor
Tente Integral 150 mm double castors with fifth retractable castor
Control Elements
Supervisor panel (nurse control panel) with position memory
Handset
Handset with adapter for simple connection (Plug and Play)
Handset with illuminated buttons
Foot control
Control element integrated in the split siderail
Satellite panel
Siderails
split plastic siderail without integrated control elements
split plastic siderail with integrated control elements
Support handles
with 1 pair Mobi-Lift®
without 1 pair Mobi-Lift®
Safety Night Light
Adapter for Eleganza Protector®
I-Brake

15
6 Setup
6.1 Transport
To avoid damage during transport, please observe the following guidelines:
Ensure that no cables are run over when moving the bed.
Ensure that the mains cable is attached with a hook (at the head end of the bed).
Ensure that the castors are unlocked before moving the bed during the loading/unloading process.
Move the bed on exclusively suitable floor surfaces.
Suitable surfaces:
Tile
Hard linoleum
Poured flooring
Unsuitable surfaces:
Too soft, unsealed or defective flooring
Soft wooden flooring
Soft and porous stone floors
Carpeted floors with underlay
Soft linoleum
For longer distances, ensure that the castor steering function (main control) is activated.
Ensure that the brakes are released while moving the bed.
6.2 Setup
Set up the bed as follows:
Unpack the bed.
Check the delivery (see Scope of Delivery and Bed Variants).
Install equipment and accessories (see Assembly).
In case of delivery with dismantled ends:
Mount the head and foot ends (see Bed Ends).
Set up the bed exclusively on a suitable floor surface (see Transport).
Ensure that the mains cable does not collide or get stretched when adjusting the bed.
Check if the plug is inserted correctly.
Do not leave any extension cables or power strips loose on the floor.
Ensure that all of the required mechanical and electrical prevention mechanisms are available on site.
There is no mains switch on the bed, i.e. the mains cable is the only means to isolate the bed from the
mains.
Ensure that the mains cable is always accessible.
Have the separable plug of the mains cable changed and maintained exclusively by qualified and trained
service technicians authorized by the manufacturer.

16
7 Assembly
Warning
Risk of injury when working on the bed!
Ensure that the bed is disconnected from the mains connection prior to assembly,
disassembly and maintenance.
Ensure that the castors are locked prior to assembly, disassembly and
maintenance.
Incorrect assembly can damage the bed!
Ensure that assembly is performed by seller´s customer service or trained
hospital personnel only.
Caution
1 2 3 4 5 6 7 8 9
17 16 15 14 13 12 11 10
Fig. Overview of Eleganza 3CX
1. Supervisor Panel
2. Removable Foot Board
3. Eleganza Protector
4. Split Siderail - Middle Section
5. Control Element Integrated in Split Siderail
6. Split Siderail - Head Section
7. Four-part Mattress Platform with Ergoframe®System
8. Removable Head Board
9. Corner Bumper
10. X-ray Cassette Holder
11. 5th Castor
12.Foot Control
13.Castor Diameter 150 mm with Castor Control Lever
14.Integrated Mattress Platform Extension
15.Bed End Locking
16.Linen Holder
17.Weighing System Control Panel
NOTE For safe, easy handling, LINET®recommends that two technicians assemble the bed.

17
7.1 Bed Ends
Crushing hazard when inserting the bed ends!
Toinsert the bed ends, hold them by the corner handles on the top of the board.
Warning
Fig. Locking the Bed Ends
Dismount the bed ends as follows:
Unlock sleeve fittings 1.
Pull bed ends from sleeve fittings.
Lock sleeve fittings 2.
Install the bed ends as follows:
Unlock sleeve fittings 1.
Slide bed ends into sleeve fittings.
Lock sleeve fittings 2.
7.2 PotentialEqualisation
The bed contains a protective conductor between all metal parts.
Fig. Ground Pin
Connect the ground wire to the ground pin under the head board.

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8 Operation
8.1 Initial Operation
Prepare the bed for service as follows:
Connect the bed to the mains.
Charge the battery.
Raise and tilt the mattress platform to the highest position.
Lower and tilt the mattress platform to the lowest position.
Check that the castors as well as the main brake work correctly.
Check that the bed extension works correctly.
Check that the head and foot boards can be removed.
Check all of the functions on the control elements (supervisor, etc.).
Check that the siderails function properly.
Dispose of all packaging (see Disposal).
NOTE If there is a substantial temperature difference between the bed (due to transport/storage) and the
installation site, allow 24 hours for the difference to balance itself before connecting the bed to the mains.
8.2 Battery Operation
For declared lifetime period of leaded accumulators is recommended during storage:
1. To prevent accumulators from deep discharging (state-of-charge under 10%) and to keep accumulators at
least partly charged by regular recharging
2. To store accumulators on dry and cold places (from 10°C to 0°C)
3. To prevent accumulators from being in the sunshine
The battery supplied with the bed is delivered uncharged. The battery serves as a backup during power failures or
while transporting the patient.
NOTE Batteries will remain in fully functional condition only for a certain period oftime which is dictated by the laws
of physics and chemistry used in this type of Dry Lead Acid battery technology and their frequency and method
of use.
The user is obliged to monitor battery functionality and to change the batteries in accordance with the user
& service manuals.
Batteries must be checked according to the user manual at least once per month.
NOTE Manufacturer provides 6 months warranty for full function of batteries.
The manufacturer takes no responsibility for any damage to the bed or battery caused by:
Not following manufacturers user manual instructions
Fitting batteries which are not approved by Linet
Batteries fitted by an unqualified service organisation.
To charge the battery:
Connect the bed to the mains.
NOTE Some bed adjustments cannot be carried out without a battery, for example, height adjustment under a
load of above 200 kg.

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Yellow LED
Battery status
Not lit
Battery capacity is sufficient (charging completed)
Short flashing (shortly lit,
longer not lit) (circa 1.8 sec.)
Battery is charging - continue charging until the LED is extinguished. In
emergency cases, the battery can be used as a backup power source for a
short period. If LED is still flashing after 12 hours of charging or stops flashing,
but you can not position with bed, battery is defective or broken. Contact
manufacturer.
Long flashing (longer lit,
shortly not lit) (circa 0.2 sec.)
Low battery voltage - battery can not be used as a backup power supply even
for a short period; battery is completely discharged or defective ( if this type of
signalisation persists, it is necessary to replace the battery - service action)
Lit continuously for several
hours (circa 10 hours), when
bed is connected to the mains
The LED indicates the battery’s charge status
:.
Battery absence or failure condition (battery is connected incorrectly, line
between the power supply and battery is broken or battery fuses are faulty);
contact service department of the manufacturer in case of such signalisation
Replacing the battery
:
Incorrect battery changing can damage the bed!
Have the battery changed exclusively by qualified personnel.
Caution
Warning
Risk of damage or destruction of battery!
If battery is faulty degassing can occur. In rare cases this can cause deformation
of the battery pack housing and mains control box.
If this occurs the bed must be immediately taken out of service and taken to an
adequately ventilated room without sparks (electricity or fire)!
Immediately inform service department of the manufacturer!
Warning
Danger of reducing battery durability due to wrong use!
Use bed on battery only in crisis situations (e.g.: power blackout, patient
complications during transport, etc.)
After reconnecting bed to the mains charge battery to full capacity (see chart
Battery charge status)
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.
Bed must only be fitted with batteries approved by the manufacturer. To get more information on how to
change battery please refer to the Service manual (contact service department of the manufacturer).

20
8.3 Removing the Bed from Service
Remove the bed from service as follows:
Disconnect the bed from the mains.
Disconnect the ground wire.
Deactivate the battery.
Remove accessories.
To prevent damage during storage:
Pack or cover the bed and accessories.
Ensure that storage conditions are the same as the operating conditions.
8.3.1 Deactivating the Battery
To avoid damaging the bed and the environment during storage:
Deactivate the battery on the supervisor panel.
To deactivate the battery on the supervisor:
Disconnect the bed from the mains.
Disconnect the ground wire.
Activate the keypad by pressing the GO button on the supervisor.
Press the Thigh Rest Up + Thigh Rest Down + Trendelenburg Position buttons at the same time and hold
them for three seconds.
The battery is deactivated.