LINET Eleganza 2 Parts list manual

User manual and technical
description
D9U001GRA-0101
Version: 04
Publication Date: 2018-02
Eleganza 2
A smart acute bed

D9U001GRA-0101_04
2
Manufacturer:
LINET spol. s r. o.
Želevčice 5
274 01 Slaný
Czech Republic
Tel.: [phone]
Fax: [phone]
E-mail: [email protected]
http://www.linet.cz
Eleganza 2
A smart acute bed
Author: LINET, s.r.o.
Related links: www.linet.cz
D9U001GRA-0101
Version: 04
Publication Date: 2018-02
Copyright © LINET, s.r.o., 2018
Translation © LINET, 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.

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Table of Contents
1Symbols .............................................................................................................................................5
1.1Warning Notices..................................................................................................................................5
1.2Other symbols.....................................................................................................................................5
1.3Symbols and Labels on the Product ...................................................................................................6
1.4Serial label with UDI............................................................................................................................7
1.5Definitions ...........................................................................................................................................7
1.6Abbreviations ......................................................................................................................................8
2Safety and Dangers...........................................................................................................................9
2.1Safety instructions.............................................................................................................................10
2.2Conditions of Use..............................................................................................................................11
2.3Specifications of Use.........................................................................................................................12
3Standards and Regulations ...........................................................................................................12
4Functioning......................................................................................................................................13
4.1Correct use........................................................................................................................................13
4.2Incorrect Use.....................................................................................................................................13
5Scope of Delivery and Bed Variants .............................................................................................14
5.1Scope of Delivery..............................................................................................................................14
5.2Bed Variants......................................................................................................................................14
5.3Applied parts type B..........................................................................................................................15
6Setup 16
6.1Transport...........................................................................................................................................16
6.2Setup………………………………………………………………………………………………………...16
7Battery Activation ...........................................................................................................................17
7.1Placement of Control Section ...........................................................................................................17
7.2Removing the Isolating Foil...............................................................................................................17
7.3Isolating Foil......................................................................................................................................17
8Assembly .........................................................................................................................................18
8.1Potential Equalisation........................................................................................................................18
8.2Mattress Platform..............................................................................................................................19
8.3Eleganza 2 (1GR) –Split Plastic Siderails........................................................................................20
8.4Eleganza 2 (1GR) –Single Collapsible Siderails..............................................................................21
8.5Bed Ends...........................................................................................................................................22
9Operation .........................................................................................................................................23
9.1Initial Operation.................................................................................................................................23
9.2Battery...............................................................................................................................................23
9.3Status Faulty Battery.........................................................................................................................25
9.4Status Discharged Battery ................................................................................................................25
9.5Removing the Bed from Service .......................................................................................................25
9.6Deactivating the Battery....................................................................................................................25
10 Manipulation....................................................................................................................................26
10.1 ACP - Supervisor control panel (nurse controller).......................................................................27
10.2 Handset .......................................................................................................................................30
10.3 Satellite Control Panel (optional).................................................................................................31
10.4 Foot Control (optional).................................................................................................................32
10.5 Control Element Integrated in Siderail (optional).........................................................................33
10.6 Eleganza 2 illumination................................................................................................................34
10.7 CPR backrest release..................................................................................................................35
10.8 Mattress Platform.........................................................................................................................36

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10.9 Siderails.......................................................................................................................................40
10.10 Integrated siderails functions (optional).......................................................................................43
10.11 Castor Control and Bed Transport...............................................................................................44
10.12 EMR Ready (optional) .................................................................................................................45
11 Accessories.....................................................................................................................................46
11.1 Lifting pole ...................................................................................................................................47
11.2 Infusion Stands............................................................................................................................48
11.3 External holder for infusion stand/pump......................................................................................48
11.4 Accessory Rail.............................................................................................................................49
11.5 Oxygen Bottle Holder...................................................................................................................50
11.6 Handy box –storage pocket for siderails ....................................................................................50
11.7 Bed End Holder ...........................................................................................................................51
11.8 Name holder ................................................................................................................................51
11.9 Chart Holder ................................................................................................................................51
11.10 Handset Holder............................................................................................................................52
11.11 Monitor Shelf................................................................................................................................52
11.12 Compressor Holder......................................................................................................................53
11.13 Towel holder ................................................................................................................................53
11.14 Extension holder..........................................................................................................................53
11.15 Soft Guards for Siderails .............................................................................................................54
11.16 Protector®.....................................................................................................................................55
11.17 Siderail extension –„Extender®“ (SR55) .....................................................................................56
11.18 X-Ray Backrest (optional)............................................................................................................57
11.19 SafeSense ...................................................................................................................................58
11.20 Mattress.......................................................................................................................................58
12 Cleaning and Disinfection..............................................................................................................59
12.1 Safety Instructions for Cleaning and Disinfection of the Bed ......................................................59
12.2 General Instructions for Cleaning and Disinfection.....................................................................60
12.3 Choosing of Detergents or Disinfections.....................................................................................61
13 Troubleshooting..............................................................................................................................62
13.1 Sound signals of the bed.............................................................................................................62
14 Maintenance ....................................................................................................................................63
14.1 Maintenance Work.......................................................................................................................63
14.2 Functioning ..................................................................................................................................64
15 Disposal ...........................................................................................................................................66
15.1 Environmental Protection ............................................................................................................66
15.2 Disposal.......................................................................................................................................66
16 Warranty...........................................................................................................................................67
17 AFSSAPS Declaration.....................................................................................................................68
18 EC Declaration of Conformity........................................................................................................69
19 Technical Specifications................................................................................................................70
19.1 Mechanical Specification (standard version)...............................................................................70
19.2 Mechanical Specification (shortened version).............................................................................70
19.3 Environmental conditions ............................................................................................................71
19.4 Electrical Specification.................................................................................................................72
19.5 Electromagnetic Compatibility.....................................................................................................72

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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
Structure of numbered lists:
a. List level 1
b. List level 1
1. List level 2
2. List level 2
SIGNAL WORDS!
Type and source of danger!

Measures to avoid the danger.

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1.3 Symbols and Labels on the Product
Read user manual.
Attention
Thermal protection of transformer
Only suitable for indoor use
Protection against accidents due to electrical current
–Type B instruments
Safety isolation transformer, general
CE mark of conformity with EU regulation
Jack for attachment of conductor for potential
equalisation
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

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Designation of hospital bed for adults
1.4 Serial label with UDI
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.

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1.6 Abbreviations
CE
European Conformity
CPR
Cardiopulmonary Resuscitation
dB
Sound Intensity Unit
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
ON
Activated
SCU
System Control Unit
SWL
Safe Working Load
UDI
Unique Device Identification (for medical devices)

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2 Safety and Dangers
WARNING!
Eleganza 2 bed should be left in its lowest position when the patient is unattended in order to reduce
risk of injury due to falls!
WARNING!
Siderails of Eleganza 2 should be located in the „up“ position to reduce the risk of the patient
accidentally slipping or rolling off the mattress!
WARNING!
Incompatible siderails and mattresses can cause an entrapment hazard!
WARNING!
Inappropriate handling of the power supply cord, e. g. by kinking, shearing or other mechanical
damages is hazardous!
WARNING!
When routing cables from other equipment in the Eleganza 2 bed avoid squeezing those between parts
of the Eleganza 2 bed!
WARNING!
Eleganza 2 bed should not be used with bed hoists and bed lifts!
WARNING!
The Eleganza 2 bed is intended for adults.
Follow chapter Correct use.
WARNING!
Incompatible mattresses can create hazards!
WARNING!
To avoid the risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
WARNING!
No modification of this equipment is allowed!

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2.1 Safety instructions
It is necessary to read the user manual before operating the bed.
Follow the instructions carefully.
Use the bed exclusively in its original condition.
If necessary, check the bed functions daily or at each staff rotation.
Use the bed exclusively with the correct mains supply.
Ensure the bed is operated by training and/or qualified personnel.
Ensure that the patient (health permitting) has been informed about the operation of the bed and all
applicable safety instructions.
Ensure the bed is only moved or positioned upon even, hard floor surfaces.
Replace any damaged parts immediately with original spare parts.
Ensure maintenance and installations are performed only by qualified personnel who have been trained by
the manufacturer.
Do not apply excess weight or load to the bed according to SWL (safe working load).
Only one adult patient can use the bed at any time.
Take care to avoid injuries or squeezing when operating moving parts.
When using lifting poles or infusion stands, ensure nothing will be damaged when you move or adjust the
bed.
Ensure castors are braked when the bed is not being moved, regardless of whether the bed is occupied or
empty.
Keep the mattress platform in the lowest position at any time when the healthcare personnel are not trea-
ting the patient in order to prevent the patient from falling or sustaining injuries.
Ensure that siderails are operated by healthcare personnel only.
Never use the bed in areas where there is a hazard or risk of explosion.
Enable or disable functions on the handset using the supervisor control panel as appropriate for the
patient’s phy- sical and mental state. Verify that the function is actually disabled.
Never handle the mains plug with wet hands.
Unplug the mains cable by pulling on the plug only.
WARNING!
Do not modify this equipment without authorization of the manufacturer.
WARNING!
If this equipment is modified, appropriate inspection and testing must be conducted to ensure
continued safe use of the equipment.
WARNING!
An additional multiple socket-outlet or extension cord shall not be connected to the medical electrical
system.
WARNING!
During specific investigations or treatments the significant risks of reciprocal interference posed by
medical electrical equipment may occur.

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Position the mains cable so there are no loops or bends in the cable; protect the cable from mechani- cal
wear and tear.
Incorrect handling of the mains cable can cause an electric shock hazard, other serious injuries or
damage to the bed.
Ensure the specified duty cycle (on-time) is not exceeded (see INT. on product label).
Ensure moving parts of the bed are not blocked.
To prevent failures, use exclusively the manufacturer’s original accessories and mattresses.
Ensure the safe working load is not exceeded.
Adjust bed height to approx. 20 cm below maximum height when transporting the bed in order to facilitate
overcoming possible obstacles.
Do not exceed the 75 kg safe working load of the mattress platform extension.
Ensure the bed and its components are exclusively modified with the manufacturer´s approval.
Any non-observance of this manual may lead to injuries or material damage.
Ensure there is no risk of crushing or otherwise injuring the patient’s limbs (e.g. between siderails and
mattress platform, between movable parts etc.) before positioning the bed or folding down the siderails.
Close linen shelf before using the Reverse Trendelenburg or Cardiac chair position.
Do not put any objects (e.g. accessories, infusions, cables) between or on siderails and movable parts. Or
between mattress platform and undercarriage of the bed.
Ensure that nobody can get injured while folding the siderails.
Ensure no injuries will occur when folding the siderails.
Use exclusively split plastic or split telescopic siderails for confused or disoriented patients or add
Protector to the single collapsible siderails.
Ensure there is no risk of damaging the cables of the supervisor control panel or handset when they are
stored on siderails or bed ends.
To prevent collisions, do not put oxygen bottle holders directly under the mattress platform.
If the patient is left without supervision of hospital personnel during sleep, adjust the mattress platform to
its lowest position with straight sleeping surface in order to prevent the patient from falling or sustaining
injuries.
If the patient is left without supervision of hospital personnel during day, adjust the mattress platform to
recommended daily position (Fowler’s position) with mattress platform in lowest position and back rest
adjusted to the angle of 30° in order to prevent the patient from falling or sustaining injuries.
The hospital personnel must consider locking all positioning functions of the bed in case the patient is left
without supervision depending on health and mental status of the patient.
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.
2.2 Conditions of Use
The bed may not be used and stored in indoor environments:
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 stan-
dards laying down the necessary conditions for electrical installations.
Disconnect the bed from the mains in exceptional cases (i.e. earthquake, lightning).

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2.3 Specifications of Use
Medical purpose:
Hospital bed for acute care, support for patient in various positions (Horizonal position, Trendelenburg,
cardiac chair, etc.)
Patient:
See chapter “Correct use”. Weight of patient + mattress + accesories can not be higher than safe working
load (SWL). Condition of patient is not important.
Personnel:
Qualified medical staff (nurse, doctor) with medical school or university (EU). Any person familiar with the
manual. Patient if the condition permits.
Location:
The bed is determined for application environments 1, 2, 3 and 5 according to EN 60601-2-52:2010. The
stable undercarriage with 4 castors makes it possible for the bed to be handled by one person. However,
the manufacturer recommends that at least two persons handle the bed.
3 Standards and Regulations
The bed complies with the following standards and directives:
EN 60601-1:2006/A1:2013
EN 60601-1-2:2007
EN 60601-1-6:2010
EN 60601-2-52:2010
EN 10993-5:2009
EN 10993-10:2010
93/42/EEC
2011/65/EU
The bed equipped with Junior Kit complies with all requirements of:
AFSSAPS (Agence française de sécurité sanitaire des produits de santé)
We declare that our product Eleganza 2 with universal twin plastic siderails equipped with Junior Kit is safe under
condition of common use in compliance with instructions and that measures have been taken to ensure the
conformity of recommendation by AFSSAPS described in letter dated 18.6.2014.
The manufacturer adheres to a certified quality management system in compliance with the following
standards:
ISO 9001
ISO 14001
ISO 13485

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4 Functioning
4.1 Correct use
Eleganza 2 is an acute care hospital bed. It is designed for supporting the patient in several positions such as
horizontal, Trendelenburg, Cardiac Chair etc.
Eleganza 2 is suitable for:
Patients
Standard bed:
With weight ≥ 40 kg
With height ≥ 146 cm
With BMI ≥ 17
Bed equipped with Junior Kit:
Older than 4 years with minimal height of 90 cm
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
Acute care
Standard care
Location
Application environments 1, 2, 3 and 5 according to IEC 60601-2-52.
4.2 Incorrect Use
Eleganza 2 is not suitable for:
Patients
Not fulfilling conditions stated in chapter “Correct use”
Use
Other than described in the user manual
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
provided by LINET® (see Correct Use).
DANGER!
Risk of injury or death due to use of incorrect equipment!

Always conduct the risk assessments required for the selection of suitable equipment.

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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 of any deficiencies or damages immediately as well as in writing or make a
note on the delivery note.
The bed is delivered with deactivated battery. To activate battery see chapter “Battery activation”.
5.2 Bed Variants
Features - Eleganza 2 Model 1GR (model no. see product label):
s = standard
o = optional
Mattress Platform
mattress platform consisting of removable plastic segments (s)
mattress platform with bed shortening (-10 cm) and with HPL on calfrest (o)
Siderails
Without siderails (s)
Split plastic siderails, with integrated controllers (o)
Split plastic siderails, without integrated illuminated controllers (o)
Single collapsible siderails, powder coated (o)
Junior Kit (o)
Bed Ends
Design Eleganza 2 –plastic panels with coloured inserts (s)
Castors
150 mm Tente Motion, with central braking sytem (o)
150 mm Tente Motion + fifth castor (o)
150 mm Tente Motion, with plastic cover (o)
150 mm Tente Motion, with plastic cover + fifth wheel (o)
150 mm Tente Integral, double castors (o)
150 mm Tente Integral, double castors + fifth wheel (o)
Control Elements
ACP Nurse control panel (supervisor control panel) (s)
Handset with illuminated keyboard (s)
Handset without illuminated keyboard (o)
Foot control (o)
Satellite control panel (o)
Integrated in siderails (o)
Mobi-Lift in head siderail (o)

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Other
Mattress platform extension (s)
Linen shelf (o)
One pair of universal accessory holders (o)
Urine bag holder integrated in siderails (s)
Universal box (o)
Segufix holders (o)
Universal handset holder (o)
Vital Monitor (o)
Linis (o)
Powder Coating Colors
RAL 9002 (grey) (s)
Powder-coated metal parts, RAL 9006 (light grey) + RAL 7043 (dark grey) (o)
5.3 Applied parts type B
All the accesories the patient can reach are type B applied parts.
List of type B applied parts:
ACP Nurse control panel (supervisor control panel)
Handset
Satellite controller
Siderails
Integrated siderail controllers
Head board and Foot board
Mattress platform

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6 Setup
6.1 Transport
For safe transport, observe the following:
Ensure no cables are run over when moving a bed.
Ensure the mains cable is attached with a hook (at the head end of the bed).
Ensure the castors are unlocked before moving the bed during the loading/unloading process (see Castor
Control and Bed Transport).
Ensure the siderails are lifted and locked while the patient is on the bed during the transport.
Move the bed only on suitable floor surfaces.
Suitable surfaces:
Tile
Hard linoleum
Hard flooring
Unsuitable surfaces:
Soft, unsealed or defective flooring
Soft wooden flooring
Soft and porous stone floors
Carpeted floors with underlay
Soft linoleum
For longer distances, ensure the castor steering function (main control) is activated.
Ensure 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).
Remove isolating foil from mains control box (see Removing Isolating Foil).
Install equipment and accessories (see Assembly).
In case of delivery with dismounted bed ends, mount the head and foot ends (see Bed Ends).
Set-up the bed only on a suitable floor surface (see Transport).
Ensure the mains cable does not collide or get stretched when adjusting the bed. Check the plug is
inserted correctly.
Do not leave any extension cords or power strips loose on the floor.
Ensure all 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 the mains cable is always accessible.
The plug on the mains cable should only be changed and maintained by qualified and trained service
technicians authorised by the manufacturer.

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7 Battery Activation
7.1 Placement of Control Section
7.2 Removing the Isolating Foil
7.3 Isolating Foil
Check if isolating foil is complete and undamaged as shown:
If isolating foil is damaged, contact the manufacturer’s service department immediately.
NOTE: It is recommended to wear gloves when removing the isolating foil.
Pull

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8 Assembly
8.1 Potential Equalisation
The bed is equipped with a standard protective connector. This connector is used for potential equalisation
between the bed and any intravascular or intracardiac device connected to the patient to protect the patient from
static electric shocks.
Fig. Potential equalisation connector –male Fig. Potential equalisation connector –female
Use equalisation connector if:
The patient is connected to any intravascular or intracardiac device.
Before connecting the patient to an intravascular/intracardiac device:
Connect the ground wire of the device to the potential equalisation connector on the bed on which
the patient in question is lying.
Use a standard hospital connector.
Make sure the connectors match.
Make sure there is no possibility of accidental disconnection.
Before moving the bed:
Disconnect the patient from the intravascular or intracardiac device.
Disconnect the potential equalisation connector.
WARNING!
Risk of injury when working on the bed!

Ensure the bed is disconnected from the mains connection prior to assembly, disassembly and
maintenance.

Ensure the castors are locked prior to assembly, disassembly and maintenance.
CAUTION!
Material damage due to incorrect assembly!

Ensure the assembly is performed only by seller´s customer service or trained hospital personnel.

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8.2 Mattress Platform
The mattress platform consists of removable plastic sections.
Fig. Correct placement of mattress platform sections
A. Back section / Calf section
B. Loins section / Thigh section
C. Seat section
NOTE: Sections A and B are replaceable. It is possible to change back section A for calf section A. Same applies
for B sections. Section C is not replaceable.
To remove/install sections of the mattress platform:
Pull out mattress platform sections.
Install mattress platform section.
The correct fitting of section is signalized by hearable “click”.
Ensure that mattress platform sections are fitted correctly by trying pull the section up with little manpower.

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8.3 Eleganza 2 (1GR) –Split Plastic Siderails
Fig. Overview Eleganza 2 –Split Plastic Siderails
1. Foot end
2. Siderail release mechanism with SoftDrop function
3. Mattress platform with removable plastic sections
4. Integrated MobiLift controller in siderails
5. Integrated control panel in siderails
6. Split plastic siderails
7. Head end
8. CPR control lever –backrest release
9. Castor control lever
10. Castor 150 mm (Tente Motion with plastic cover)
11. Angle indicator - illuminated
12. Angle indicator –without illumination
13. Fifth castor
14. Foot control
15. Linen/Supervisor control panel holder
16. Bed end unlocking mechanism
17. Protective bumber