Instructions for Use
and Technical Description
D9U001GTL-0101
Version: 12
Publication Date: 2023-01
ELEGANZA 1 LE
Hospital bed for standard care
D9U001GTL-0101_122
Manufacturer:
L I N E T spol. s r.o.
Želevčice 5
274 01 Slaný
Tel.: +420 312 576 111
Fax: +420 312 522 668
E-mail: [email protected]
http://www.linet.com
Service department: [email protected]
Authorized Representative in Great Britain:
LINET UK Ltd
11 Brunel Way
Segensworth East
Fareham
Hampshire
PO15 5TX
United Kingdom
Authorized Representative in Switzerland:
Bigla Care AG
Bernstrasse 3
CH-3421 Lyssach
Switzerland
Authorized Representative in Malaysia:
Emergo Malaysia Sdn. Bhd.
Level 16, 1 Sentral, Jalan Stesen Sentral 5
KL Sentral
50470 Kuala Lumpur
Malaysia
Authorized Representative in Peru:
Drogería Emergo Peru S.R.L.
Calle Las Orquídeas Nro. 585, Int. 1301
San Isidro, Lima
Director Técnico Renato Delgado Rivera
RUC: 205 52 75 65 35
Peru
Authorized Representative in Philippines:
Biomedica Healthcare Inc.
Unit 2103 City land 10, Tower 1
Ayala Corner, Dela Costa Street
Makati City, Metro Manila
Philippines
D9U001GTL-0101_12
3
Eleganza 1 LE
Hospital bed for standard care
Author: L I N E T, s.r.o.
Related links: www.linet.cz
D9U001GTL-0101
Version: 12
Publication date: 2023-01
Copyright © L I N E T, s.r.o., 2023
Translation © L I N E T, 2023
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 the instructions for use that relate to the product´s technical regulations. It is for this reason that the con-
tents of the instructions for use may indicate dierences 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.
D9U001GTL-0101_124
1 Symbols and Denitions .............................................5
1.1 Warning Notices .......................................................... 5
1.1.1 Types of Warning Notices ........................................5
1.1.2 Structure of Warning Notices ...................................5
1.2 Instructions ..................................................................5
1.3 Lists .............................................................................5
1.4 Symbols on the Package ............................................6
1.5 Symbols and Labels on the Bed .................................7
1.6 Acoustic signalisation (Eleganza 1 LE) .......................10
1.7 Denitions ...................................................................10
1.8 Abbreviations ..............................................................11
2 Safety Instructions .......................................................12
3 Intended use ................................................................. 15
3.1 User population ........................................................... 15
3.2 Contraindications ........................................................15
3.3 Operator ...................................................................... 15
4 Product Description ..................................................... 16
4.1 Eleganza 1 LE (1GTL) – Split plastic siderails (SR21, SR22)
..........................................................................................16
4.2 Eleganza 1 LE (1GTL) – Split plastic siderails (SR46, SR48)
..........................................................................................17
4.3 Eleganza 1 LE (1GTL) – Single collapsible siderails contro-
lled from top ......................................................................18
4.4 Eleganza 1 LE (1GTL) – Single collapsible siderails contro-
lled from bottom ................................................................19
4.5 Eleganza 1 LE (1GTLH) – Single collapsible siderails 20
4.6 Eleganza 1 LE (1GTLH) – Split plastic siderails (SR46,
SR48) ...............................................................................21
5 Technical Specication ...............................................22
5.1 Applied parts type B ....................................................22
5.2 Mechanical Specication (standard version) .............22
5.3 Safe Working Load (1GTLH) .......................................23
5.4 Safe Working Load (1GTL) .........................................23
5.5 Mass of Mobile Hospital Bed (1GTLH) .......................23
5.6 Mass of Mobile Hospital Bed (1GTL) ..........................23
5.7 Maximum Patient Weight (1GTLH) .............................24
5.8 Maximum Patient Weight (1GTL) ................................ 24
5.9 Environment Conditions .............................................. 24
5.10 Electrical Specication ..............................................24
5.11 Electromagnetic compatibility ....................................25
5.11.1 Manufacturer instructions - electromagnetic emissions
..........................................................................................25
5.11.2 Manufacturer instructions - electromagnetic susceptibility
..........................................................................................26
6 Use and Storage Conditions ....................................... 27
7 Scope of Delivery and Bed Variants ........................... 28
7.1 Scope of Delivery ........................................................ 28
7.2 Bed Variants ................................................................28
7.2.1 Eleganza 1 LE Model 1GTL Hospital Bed ................28
7.2.2 Eleganza 1 LE Model 1GTLH Hospital Bed ............. 29
8 Putting into Service .....................................................30
8.1 Head Board and Foot Board .......................................31
8.2 Mattress support platform ...........................................33
8.3 Potential Equalisation .................................................34
8.4 Before Use ..................................................................35
8.5 Transport ..................................................................... 35
8.6 Firmware .....................................................................35
9 Power Cable .................................................................36
10 Manipulation ............................................................... 37
10.1 Handset – Iproxx 2 .................................................... 37
10.1.1 Handset Iproxx 2 – 10 buttons ...............................37
10.1.2 Handset Iproxx 2 – 8 buttons with lock function .....38
10.1.3 Handset Iproxx 2 – 8 buttons without lock function 38
10.2 Handset functions .....................................................39
10.2.1 Lock function .......................................................... 39
10.2.2 Statuses of the lock and automatic lock of the handset
..........................................................................................39
10.2.3 Position Buttons .....................................................40
10.2.4 CPR backrest release ............................................41
10.2.5 Eleganza 1 CPR (optionally available) ...................42
10.3 Mattress Platform ...................................................... 43
10.3.1 Auto-Regression (Ergoframe®) ..............................43
10.3.2 Mechanical Adjustment of Calfrest ......................... 43
10.3.3 Mattress Platform Extension/Shortening ................43
10.4 Siderails ....................................................................45
10.4.1 Single collapsible siderails – controlled from the top
..........................................................................................45
10.4.2 Single collapsible siderails – controlled from the bottom
..........................................................................................45
10.4.3 Split plastic siderails (SR22) ..................................46
10.4.4 Split plastic siderails (SR46) .................................47
10.5 Castor Control and Bed Transport ............................ 48
10.5.1 Central braking control ........................................... 48
10.5.2 Individual braking control .......................................49
11 Equipment ...................................................................50
11.1 Accessory Rails ......................................................... 50
12 Mattress ......................................................................50
13 Accessories ................................................................51
13.1 Lifting Pole ................................................................52
13.2 Infusion Stands .........................................................53
13.3 Name holder .............................................................53
13.4 Urinary bottle holder ..................................................53
13.5 Eleganza Protector® ................................................. 54
13.6 Siderail extension – „Extender®“ for siderails controlled
from top (SR55) ................................................................ 55
13.7 Siderail extension – „Extender®“ for siderails controlled
from bottom (SR57) .......................................................... 56
14 Cleaning/Disinfection ................................................57
14.1 Preparing for Cleaning ..............................................58
14.2 Cleaning .................................................................... 58
14.2.1 Daily Cleaning ........................................................ 58
14.2.2 Cleaning before Changing Patients .......................59
14.2.3 Complete Cleaning and Disinfection / Cleaning before
rst use ............................................................................. 59
15 Troubleshooting ......................................................... 60
16 Maintenance ...............................................................61
16.1 Regular maintenance ................................................ 61
16.2 Spare Parts ...............................................................61
16.3 Safety Technical Checks ........................................... 61
17 Disposal ......................................................................62
17.1 Environment Protection .............................................62
17.2 Disposal ....................................................................62
17.2.1 Within Europe ........................................................62
17.2.2 Outside Europe ......................................................62
18 Warranty ......................................................................63
19 Standards and Regulations ......................................63
Table of Contents
D9U001GTL-0101_12
5
1 Symbols and Denitions
1.1 Warning Notices
1.1.1 Types of Warning Notices
Warning notices are dierentiated by the type of danger using the following key words:
► CAUTION - risk of material damage.
► WARNING - risk of physical injury.
► DANGER - risk of fatal injury.
1.1.2 Structure of Warning Notices
SIGNAL WORDS!
Type and source of danger!
► Measures to avoid the danger.
1.2 Instructions
Structure of instructions:
► Perform this step.
Results, if necessary.
1.3 Lists
Structure of bulleted lists:
■ List level 1
□ List level 2
● List level 3
D9U001GTL-0101_126
1.4 Symbols on the Package
FRAGILE, HANDLE WITH CARE
THIS WAY UP
KEEP DRY (PROTECT FROM HUMIDITY)
PAPER RECYCLING SYMBOL
DO NOT USE HAND TRUCK HERE
DO NOT STACK DURING STORAGE
D9U001GTL-0101_12
7
1.5 Symbols and Labels on the Bed
READ INSTRUCTIONS FOR USE.
ATTENTION
ONLY SUITABLE FOR INDOOR USE
PROTECTION AGAINST ACCIDENTS DUE TO ELECTRICAL CURRENT – TYPE B
INSTRUMENTS
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
D9U001GTL-0101_128
SAFETY MARK – BED CERTIFIED IN TÜV SÜD
DESIGNATION OF HOSPITAL BED FOR ADULTS
EAC MARKING (EURASIAN CONFORMITY)
REFERENCE NUMBER (PRODUCT TYPE DEPENDING ON CONFIGURATION)
SERIAL NUMBER
WEEE SYMBOL (RECYCLE AS ELECTRONIC WASTE,
DO NOT PUT INTO THE HOUSEHOLD WASTE)
MEDICAL DEVICE (COMPATIBLE WITH MEDICAL DEVICE REGULATION)
RECYCLING SYMBOL
DO NOT POLLUTE THE ENVIRONMENT
HEAD BOARD UNLOCKED OR FOOT BOARD UNLOCKED
HEAD BOARD LOCKED OR FOOT BOARD LOCKED
D9U001GTL-0101_12
9
MASS OF MOBILE HOSPITAL BED (MASS OF EMPTY BED + SAFE WORKING LOAD)
UK CONFORMITY ASSESSED (UKCA) MARKING (PRODUCT NORMATIVELY
HARMONIZED FOR GREAT BRITAIN ECONOMIC AREA)
AUTHORIZED REPRESENTATIVE IN GREAT BRITAIN
AUTHORIZED REPRESENTATIVE IN SWITZERLAND
REPCH
D9U001GTL-0101_1210
1.6 Acoustic signalisation (Eleganza 1 LE)
SOUND MEANING
BEEP discharged accumulator
1.7 Denitions
Basic Bed Conguration the pricelist model conguration, not including a mattress
Bed Weight The value depends on the product conguration, accessories or customer
adjustments.
Clearance of Undercarriage the height from the oor 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 eect 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 environ-
ment 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 oor 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.
Adult Patient having a physical size equal to or more than 146 cm, a mass equal
to or more than 40 kg and a body mass index (BMI) equal to or more than 17
(according to IEC 60601-2-52).
Mass of mobile hospital bed Sum of empty bed mass and Safe Working Load.
D9U001GTL-0101_12
11
AC ( ~ ) Alternating Current
ACP Attendant Control Panel
CE European Conformity
CPR Cardiopulmonary Resuscitation
dBA Sound Intensity Unit
DC ( ) Direct Current
CUC Conguration number
EMC Electromagnetic Compatibility
FET Field-eect transistor
HF High Frequency
HPL High Pressure Laminate
HW Hardware
ICU Intensive Care Unit
INT. Duty Cycle
IP Ingress Protection
IV Intravenous
LED Light Emitting Diodes
ME Medical Electrical (Equipment)
ON Activation
OFF Deactivation
ppm parts per million, millionth (1000 ppm = 0,1%)
REF Reference Number (product type depending on conguration)
SN Serial Number
SW Software
SWL Safe Working Load
UDI Unique Device Identication (for medical devices)
USB Universal Serial Bus
WEEE Waste Electrical and Electronic Equipment
1.8 Abbreviations
D9U001GTL-0101_1212
2 Safety Instructions
WARNING!
Eleganza 1 LE 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 1 LE should be located in the „up“ position to reduce the risk of the patient accidentally
slipping or rolling o 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 1 LE bed avoid squeezing those between parts of
the Eleganza 1 LE bed!
WARNING!
Eleganza 1 LE bed should not be used with bed hoists and bed lifts!
WARNING!
The bed is intended for adults.
► Follow chapter Intended 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 modication of this equipment is allowed.
WARNING!
Do not modify this equipment without authorization of the manufacturer.
WARNING!
If this equipment is modied, appropriate inspection and testing must be conducted to ensure continued safe
use of the equipment
D9U001GTL-0101_12
13
WARNING!
An additional MULTIPLE SOCKET-OUTLET or extension cord shall not be connected to the MEDICAL ELECTRI-
CAL SYSTEM.
WARNING!
During specic investigations or treatments the signicant risks of reciprocal interference posed by ME equip-
ment may occur.
DANGER!
Risk of injury or death due to use of incorrect equipment!
► Always conduct the risk assessments required for the selection of suitable equipment.
WARNING!
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is established!
WARNING!
Only authorised and trained person using the tool is allowed to change fuses and power supplies!
WARNING!
This medical device is not intended for oxygen enriched environment!
WARNING!
This medical device is not intended for use with ammable substances!
WARNING!
This medical device is not portable medical electrical equipment!
WARNING!
Make sure the duty cycle (2 min ON/18 min OFF) is not exceeded during bed positioning!
WARNING!
Patient is allowed to use selected control elements only if hospital personnel had assessed that the patient´s
physical and psychological state is in accordance with use of them and only if the hospital personnel had
trained the patient in accordance with the instructions for use!
D9U001GTL-0101_1214
► It is necessary to read the instructions for use before operating the bed.
► Follow the instructions for use carefully.
► Use the bed exclusively in its original condition.
► If necessary, check the bed functions daily or at each sta rotation.
► Use the bed exclusively with the correct mains supply.
► Ensure the bed is operated by training and/or qualied 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 oor surfaces.
► Replace any damaged parts immediately with original spare parts.
► Ensure maintenance and installations are performed only by qualied 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 treating 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 physical 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.
► Position the mains cable so there are no loops or bends in the cable; protect the cable from mechanical 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 specied 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 modied 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 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 or damages 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 handset when they are stored on siderails or head board and foot
board.
► To prevent collisions, do not put oxygen bottle holders directly under the mattress platform.
► 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. backrest) is forbidden. Otherwise
there is a risk of damaging and dysfunction of the backrest actuator or unprompted fall of the backrest.
► The handset cable of 1GTLH model (cross shaped lifting mechanism) must always be guided above the cross of lifting
mechanism to avoid damaging the cable when positioning the bed.
D9U001GTL-0101_12
15
3 Intended use
The intended use is the hospitalization of the patient in the acute and long-term care units, which includes above all the
following aspects:
► Adjustment of the specic positions needed for the preventive reasons, routine nursing, treatments, mobilization,
physiotherapy, examinations, sleeping, and relaxation. These positions are further specied and described in the clinical
evaluation of this device, together with their potential clinical outcomes and benets.
► Providing the safe environment for the patient during all relevant procedures. The particular requirements on patient safety
are the subject of the clinical evaluation, including evaluation of the risk/benet ratio. The relevant safety issues are the
part of the risk management le.
► Patient in-bed indoor transport out of the patient room.
► Providing the suitable working conditions for the caregivers to perform the routine and specic tasks during the patient
hospitalization.
3.1 User population
► Adult patients (weight >= 40 kg, height >= 146 cm, BMI >= 17) in the acute and long-term care units (Application
Environment 2 and 3, as in IEC 60601-2-52)
► Caregivers (nurses, doctors, technical personnel, transport personnel, cleaning personnel)
3.2 Contraindications
► The medical device is not intended for the pediatric patients use.
► Certain positions are not suitable for specic diagnoses/medical conditions (e.g. spinal cord injuries vs. Fowler position,
higher ICP patients vs. Trendelenburg). Sta expert assessment / nursing consideration is needed in all individual case of
contraindication.
3.3 Operator
► Caregiver
► Patient (based on individual patient status assessment by caregiver the patient can utilize dedicated device functions)
D9U001GTL-0101_1216
4 Product Description
4.1 Eleganza 1 LE (1GTL) – Split plastic siderails (SR21, SR22)
1. Foot Board
2. Split plastic siderails
3. Head Board
4. Castor 150 mm
5. Siderail release mechanism
6. Accessory rail
7. Castor control lever
8. Linen holder
9. Protective bumper
Fig. . Overview Eleganza 1 LE – Split plastic siderails
D9U001GTL-0101_12
17
4.2 Eleganza 1 LE (1GTL) – Split plastic siderails (SR46, SR48)
1. Head Board
2. Head Plastic Siderail
3. Foot Plastic Siderail
4. Mattress Platform (Removable Plastic Parts)
5. Foot Board
6. Linen Shelf
7. Brake Lever (optional)
8. Siderail Release Mechanism
9. Castor
10. Brake Lever (optional)
11. Corner Bumper
Fig. Overview Eleganza 1 LE – Split plastic siderails
D9U001GTL-0101_1218
4.3 Eleganza 1 LE (1GTL) – Single collapsible siderails controlled from
top
Fig. Overview Eleganza 1 LE – Single collapsible siderails controlled from top
1. Foot Board
2. Siderail release mechanism
3. Head Board
4. Castor 150 mm
5. Single collapsible siderails
6. Accessory rail
7. Castor control lever
8. Linen holder
9. Protective bumper
D9U001GTL-0101_12
19
4.4 Eleganza 1 LE (1GTL) – Single collapsible siderails controlled from
bottom
1. Foot Board
2. Single collapsible siderails
3. Mattress platform with mattress
4. Handset
5. Head Board
6. Castor 150 mm
7. Accessory rail
8. Siderail release mechanism
9. Castor control lever
10. Housing for accessories or Protector®
11. Foot board lock
12. Protective bumper
Fig. Overview Eleganza 1 LE – Single collapsible siderails controlled from bottom
D9U001GTL-0101_1220
4.5 Eleganza 1 LE (1GTLH) – Single collapsible siderails
1. Foot Board
2. Single collapsible siderails in highest positions
3. Head Board
4. Castor 150 mm
5. Single collapsible siderails in lowest position
6. Castor control lever (7.5 – 9)
7. Siderail release mechanism
Fig. Eleganza 1 LE with cross shaped lifting mechanism with single collapsible siderails
NOTE: The handset cable of 1GTLH model (cross shaped lifting
mechanism) must always be guided above the cross of lifting me-
chanism to avoid damaging the cable when positioning the bed.
Fig. Guiding of handset
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