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Summary of Contents for LINET ELEGANZA 1 LE
- Page 1 Instructions for Use and Technical Description ELEGANZA 1 LE Hospital bed for standard care D9U001GTL-0101 Version: 12 Publication Date: 2023-01...
- Page 2 274 01 Slaný Tel.: +420 312 576 111 Fax: +420 312 522 668 E-mail: info@linet.cz http://www.linet.com Service department: service@linetgroup.com Authorized Representative in Great Britain: LINET UK Ltd 11 Brunel Way Segensworth East Fareham Hampshire PO15 5TX United Kingdom Authorized Representative in Switzerland:...
- Page 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.
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Page 4: Table Of Contents
3.3 Operator ..............15 11 Equipment ..............50 4 Product Description .............16 11.1 Accessory Rails ............50 4.1 Eleganza 1 LE (1GTL) – Split plastic siderails (SR21, SR22) 12 Mattress ..............50 ..................16 13 Accessories ..............51 4.2 Eleganza 1 LE (1GTL) – Split plastic siderails (SR46, SR48) 13.1 Lifting Pole ..............52... -
Page 5: Symbols And Definitions
1 Symbols and Definitions 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 SIGNAL WORDS! Type and source of danger! ►... -
Page 6: Symbols On The Package
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... -
Page 7: Symbols And Labels On The Bed
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... - Page 8 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...
- Page 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 D9U001GTL-0101_12...
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Page 10: Acoustic Signalisation (Eleganza 1 Le)
1.6 Acoustic signalisation (Eleganza 1 LE) SOUND MEANING BEEP discharged accumulator 1.7 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... -
Page 11: Abbreviations
1.8 Abbreviations AC ( ~ ) Alternating Current Attendant Control Panel European Conformity Cardiopulmonary Resuscitation Sound Intensity Unit DC ( Direct Current Configuration number Electromagnetic Compatibility Field-effect transistor High Frequency High Pressure Laminate Hardware Intensive Care Unit INT. Duty Cycle Ingress Protection Intravenous Light Emitting Diodes... -
Page 12: Safety Instructions
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. - Page 13 WARNING! An additional MULTIPLE SOCKET-OUTLET or extension cord shall not be connected to the MEDICAL ELECTRI- CAL SYSTEM. WARNING! During specific investigations or treatments the significant 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!
- Page 14 ► 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 staff rotation. ►...
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Page 15: Intended Use
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 specific positions needed for the preventive reasons, routine nursing, treatments, mobilization, physiotherapy, examinations, sleeping, and relaxation. -
Page 16: Product Description
4 Product Description 4.1 Eleganza 1 LE (1GTL) – Split plastic siderails (SR21, SR22) Fig. . Overview Eleganza 1 LE – Split plastic siderails Foot Board Split plastic siderails Head Board Castor 150 mm Siderail release mechanism Accessory rail Castor control lever... -
Page 17: Eleganza 1 Le (1Gtl) - Split Plastic Siderails (Sr46, Sr48)
4.2 Eleganza 1 LE (1GTL) – Split plastic siderails (SR46, SR48) Fig. Overview Eleganza 1 LE – Split plastic siderails Head Board Head Plastic Siderail Foot Plastic Siderail Mattress Platform (Removable Plastic Parts) Foot Board Linen Shelf 7. Brake Lever (optional) Siderail Release Mechanism Castor 10. ... -
Page 18: Eleganza 1 Le (1Gtl) - Single Collapsible Siderails Controlled From Top
4.3 Eleganza 1 LE (1GTL) – Single collapsible siderails controlled from Fig. Overview Eleganza 1 LE – Single collapsible siderails controlled from top Foot Board Siderail release mechanism Head Board Castor 150 mm Single collapsible siderails Accessory rail Castor control lever... -
Page 19: Eleganza 1 Le (1Gtl) - Single Collapsible Siderails Controlled From Bottom
4.4 Eleganza 1 LE (1GTL) – Single collapsible siderails controlled from bottom Fig. Overview Eleganza 1 LE – Single collapsible siderails controlled from bottom Foot Board Single collapsible siderails Mattress platform with mattress Handset Head Board Castor 150 mm Accessory rail... -
Page 20: Eleganza 1 Le (1Gtlh) - Single Collapsible Siderails
4.5 Eleganza 1 LE (1GTLH) – Single collapsible siderails Fig. Eleganza 1 LE with cross shaped lifting mechanism with single collapsible siderails Foot Board Single collapsible siderails in highest positions Head Board Castor 150 mm Single collapsible siderails in lowest position Castor control lever (7.5 –... -
Page 21: Eleganza 1 Le (1Gtlh) - Split Plastic Siderails (Sr46, Sr48)
4.6 Eleganza 1 LE (1GTLH) – Split plastic siderails (SR46, SR48) Fig. Eleganza 1 LE with cross shaped lifting mechanism – Split plastic siderails Head Board Head Plastic Siderail Foot Plastic Siderail Mattress Platform (Removable Plastic Parts) Foot Board Linen Shelf 7. ... -
Page 22: Technical Specification
5 Technical Specification 5.1 Applied parts type B All the accessories the patient can reach are Type B Applied Parts. List of type B applied parts: ■ Handset, Additional Supervisor Panel, Control Element integrated in Siderail ■ Siderails ■ Head Board and Foot Board ■ ... -
Page 23: Safe Working Load (1Gtlh)
5.3 Safe Working Load (1GTLH) Safe Working Load (depending on castors) Castors Diameter Brake system 185 kg Individually operated castors 125 mm 230 kg Centrally operated castors 230 kg 150 mm Centrally operated castors 5.4 Safe Working Load (1GTL) Castors Accumulator Diameter Brake system without with Individually operated 185 kg 185 kg castors Safe Working Load 125 mm (depending on castors Centrally operated 200 kg 250 kg... -
Page 24: Maximum Patient Weight (1Gtlh)
Electrical Motor Operating Time max. 2 min. ON / 18 min. OFF Fuse 2x T1.6A L 250 V NOTE Upon request, LINET® can deliver hospital beds with electrical specifications that comply with regional standards (custom voltage, different mains plugs). D9U001GTL-0101_12... -
Page 25: Electromagnetic Compatibility
5.11 Electromagnetic compatibility Bed is intended for hospitals except for near active HF surgical equipment and the RF shielded room of a medical system for magnetic resonance imaging, where the intensity of EM disturbances is high. Bed has defined no essential performance. WARNING! It is recommended to avoid the use of this device next to or in block with other device, because it could lead to improper operation. If such use is needed, this device and the other equipment should be under surveillance to verify proper operation. -
Page 26: Manufacturer Instructions - Electromagnetic Susceptibility
5.11.2 Manufacturer instructions - electromagnetic susceptibility Immunity Tests Compliance level Electrostatic discharge (ESD) ± 8 kV for contact discharge IEC 61000-4-2 ± 15 kV for contact discharge Radiated RF 3 V/m IEC 61000-4-3 80 MHz – 2,7 GHz 80 % AM at 1 kHz Proximity fields from RF wireless communications equipment IEC 61000-4-3 See Table 1... -
Page 27: Use And Storage Conditions
6 Use and Storage Conditions 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. -
Page 28: Scope Of Delivery And Bed Variants
Notify the carrier and supplier of any deficiencies or damages immediately as well as in writing or make a note on the delivery note. 7.2 Bed Variants 7.2.1 Eleganza 1 LE Model 1GTL Hospital Bed s = standard o = optional ■... -
Page 29: Eleganza 1 Le Model 1Gtlh Hospital Bed
7.2.2 Eleganza 1 LE Model 1GTLH Hospital Bed s = standard o = optional ■ Mattress Platform □ mattress platform consisting of removable plastic parts (s) ■ Siderails □ Without siderails (s) □ Single collapsible siderails, powder coated controlled from top (o) □... -
Page 30: Putting Into Service
8 Putting into Service WARNING! Risk of injury when working on the bed! ► Ensure that the bed is disconnected from the mains connection prior to putting into service, putting out of service and maintenance. ► Ensure that the castors are locked prior to putting into service, putting out of service and maintenance. CAUTION! Material damage due to incorrect putting into service! ►... -
Page 31: Head Board And Foot Board
8.1 Head Board and Foot Board WARNING! Risk of injury when inserting the head board and foot board! ► To insert head board and foot board into corner posts, hold them by the corner handles on top with both hands. ► Install head board and foot board before the first use. WARNING! Risk of injury due to incorrectly installed head board and foot board! ►... - Page 32 1. Locked 2. Unlocked Install head board and foot board as follows: ► Unlock safety levers on corner posts. ► Slide head board and foot board into slots on corners posts with coloured panels outside. ► Lock safety levers on corner posts. Remove head board and foot board as follows: ►...
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Page 33: Mattress Support Platform
8.2 Mattress support platform Eleganza 1 bed has 4-part Mattress support platform consisting of Backrest, Seat section, Thighrest and Calfrest. The Mattress support platform has 7 removable plastic sections of Mattress support platform (1, 2, 3, 4, 5, 6 and 7). LEFT SIDE 5 6 7 RIGHT SIDE... -
Page 34: Potential Equalisation
8.3 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. -
Page 35: Before Use
8.4 Before Use CAUTION! Material damage due to temperature difference! ► If there is a considerable temperature difference between the bed and the place of operation (after transport/storage), leave bed unconnected for 24 hours to allow the temperature to equalise. Prepare the bed for service as follows: ►... -
Page 36: Power Cable
9 Power Cable CAUTION! Disconnecting bed from the mains does not stop motions of the bed! ► Stop the bed before disconnection bed from the mains. Attachment plug is means of connecting and disconnecting bed from the mains. Power supply cable (mains power cable) must be attached with a hook at the head end of the bed during transport. Where the integrity of the external protective conductor in the installation or its arrangement is in doubt ►... -
Page 37: Manipulation
10 Manipulation WARNING! Risk of injury when adjusting the bed! ► Ensure there are no body parts between the mattress platform elements and the mattress platform frame when adjusting the bed. ► Ensure there are no body parts below the mattress platform frame before adjusting the bed. ► Secure or remove any items on the bed. The bed is operated by different control elements. Control elements: ► Handset If the bed does not react to individual position settings: ► Check whether the function is disabled on the handset. 10.1 Handset –... -
Page 38: Handset Iproxx 2 - 8 Buttons With Lock Function
10.1.2 Handset Iproxx 2 – 8 buttons with lock function Handset 8 buttons version with lock function. LED Indicator of active function – is illuminated green after pressing any button 2. Backrest Positioning Buttons Thighrest Positioning Buttons 4. Auto-Contour Buttons (simultaneous setting of backrest and thighrest) Height Adjustment Buttons 6. LED Lock Indicator LED Power On NOTE: The handset does not have the automatic lock function. The handset is active the whole time until it is locked manually Fig. -
Page 39: Handset Functions
10.2 Handset functions 10.2.1 Lock function The lock function is used to lock some or all of the functions on the handset. 1. Lock To lock functions: ► Insert key 2 into the lock 1. ► Turn the key into desired position of lock- Desired lock was set up. -
Page 40: Position Buttons
10.2.3 Position Buttons WARNING! Risk of injury due to moving parts! ► Ensure no body parts are trapped between moving parts of the bed and mattress platform. ► Ensure no persons or body parts are close to the bed or accessories (e.g. infusion stand, lifting pole) when the mattress platform is moving. -
Page 41: Cpr Backrest Release
► Press the backrest down only by the mattress guard handle or the siderail. Eleganza 1 LE CPR (standard) The bed permits quick mechanical lowering of the backrest for emergency resuscitation (CPR) procedures. The CPR is placed in the middle of the backrest frame behind head of the patient. -
Page 42: Eleganza 1 Cpr (Optionally Available)
10.2.5 Eleganza 1 CPR (optionally available) Eleganza 1 CPR is optionally available. It replaces standard Eleganza 1 LE CPR. The CPR is located on the mattress platform fra- me under the thighrest part. CPR allows quick mechanical lowering of the backrest for emergency resuscitation (CPR) procedures. -
Page 43: Mattress Platform
10.3 Mattress Platform 10.3.1 Auto-Regression (Ergoframe®) To eliminate pressure on the pelvis of the patient as it is raised, the backrest moves in the opposite direction when the bed is adjus- ted. Benefits of Ergoframe®: ■ Prevents decubitus. ■ Increases the sitting area by 16 cm in the maximum upright position. 10.3.2 Mechanical Adjustment of Calfrest You can adjust the calfrest mechanically. - Page 44 Fig. Mattress Platform Extension Safety Lock 1. Locked 2. Unlocked (it is possible to set up bed extension) To lengthen/shorten the bed: ► Pull out the safety catches 1 at the foot end of both sides of the frame. ► Turn the safety catches 1 by 90° (2). The safety lock is released: ► Pull the foot board out as far as it will go.
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Page 45: Siderails
10.4 Siderails WARNING! Risk of injury due to crushing! ► Ensure that there are no objects or body parts between siderail and mattress platform when folding the siderail up or down. ► Ensure that no body part or object are under the siderail when folding the siderail down. ►... -
Page 46: Split Plastic Siderails (Sr22)
10.4.3 Split plastic siderails (SR22) WARNING! Risk of injury due to patient falling out of bed! ► Ensure that folded-up siderails are securely anchored. ► Press against siderails from inside in order to check stability. ► Hospital personnel are responsible for ensuring siderails are folded-up when the bed is occupied. The split plastic siderails are components of the bed, the siderails cannot be removed. -
Page 47: Split Plastic Siderails (Sr46)
10.4.4 Split plastic siderails (SR46) The full length siderails are components of the bed. The siderails cannot be dismounted. The hospital personnel is responsible that siderails are locked in the highest position when the patient is on the bed. WARNING! Risk of injury due to patient falling out of bed! ►... -
Page 48: Castor Control And Bed Transport
10.5 Castor Control and Bed Transport CAUTION! Material damage due to incorrect transport or involuntary movement! ► Prior to assembly, disassembly and maintenance, ensure the castors are locked. ► Ensure the castors are locked while the bed is occupied and/or not being transported. ►... -
Page 49: Individual Braking Control
Simple Castor Control Levers (optional): Fig. Simple Castor Control Lever Castor control with central braking system: Braked: All of the castors are locked. Unrestricted Movement: All of the castors are unlocked. Forward Movement: The front left castor is locked. The bed moves straight ahead. If the bed is equipped with a fifth castor, this castor determines the direction of movement. -
Page 50: Equipment
Eleganza 1 LE bed is designed for the following mattress dimensions: ■ 200 cm x 90 cm x 14 cm The manufacturer recommends the use of the following mattress systems on the Eleganza 1 LE bed: ► EFFECTACARE 10 (4PPA51100AS) ►... -
Page 51: Accessories
Risk of injury due to damaged accessories! ► Use exclusively accessories in perfect condition. NOTE: The manufacturer assumes no responsibility for the use of accessories not approved by the manufacturer. NOTE: All accessories conform to IEC 60601-2-52:2010. The following accessories are suitable for the Eleganza 1 LE: ■ Lifting pole □ powder-coated □... -
Page 52: Lifting Pole
Ensure the safety pin locks are in place. A plastic grab handle with an adjustable strap is attached to the lifting pole. NOTE: The date of manufacture is marked on the grab handle. NOTE: LINET® recommends replacing the plastic grab handle every four years. D9U001GTL-0101_12... -
Page 53: Infusion Stands
13.2 Infusion Stands WARNING! Risk of injury due to use of unsuitable accessories! ► Use infusion stands exclusively for accessories listed in the instructions for use. ► Only mount an infusion pump to the lower (wider) telescopic section of an infusion stand above the head board / foot board. ►... -
Page 54: Eleganza Protector
13.5 Eleganza Protector® WARNING! Risk of injury due to patient falling out of bed! ► Ensure that Eleganza Protector® is securely anchored to the bushing. ► To check stability, push the protector up without touching the release button. ► Always check that the siderail is properly locked. WARNING! Risk of damage to the bed or patient injury! ►... -
Page 55: Siderail Extension - „Extender®" For Siderails Controlled From Top (Sr55)
13.6 Siderail extension – „Extender®“ for siderails controlled from top (SR55) WARNING! Risk of injury or collision due to incorrect use! ► The Extender® can be used with single collapsible siderails only. The manufacturer will not be held responsible for any consequences if the Extender® is used with other types of siderails. ►... -
Page 56: Siderail Extension - „Extender®" For Siderails Controlled From Bottom (Sr57)
13.7 Siderail extension – „Extender®“ for siderails controlled from bottom (SR57) WARNING! Risk of injury or collision due to incorrect use! ► The Extender® can be used with single collapsible siderails only. The manufacturer will not be held responsible for any consequences if the Extender® is used with other types of siderails. ►... -
Page 57: Cleaning/Disinfection
14 Cleaning/Disinfection WARNING! Risk of injury when working on the bed! ► Always disable function buttons when cleaning between undercarriage and mattress platform. ► Prior to cleaning, ensure the bed is disconnected from the mains. ► Prior to assembly, disassembly, cleaning and maintenance, ensure that the adjustment function on the handset is locked. -
Page 58: Preparing For Cleaning
► Clean the bed with a damp cloth (not wet). ► Clean electrical components carefully and allow them to dry completely. Cleaning agents LINET® recommends the following cleaning agents: Cleaning Agents Manufacturer Mikrozid, Terralin Protect, Thermosept Schülke & Mayr Bacillol AF, Bacillol Rasant, Dismozon Pur, Microbac Forte,... -
Page 59: Cleaning Before Changing Patients
14.2.2 Cleaning before Changing Patients Clean the following bed parts: ► All control elements for adjusting the bed ► All handles ► Back- and thighrest handles ► CPR release handle ► Head and foot board ► Siderails (folded up) ► Freely accessible mattress surface ►... -
Page 60: Troubleshooting
15 Troubleshooting DANGER! Danger to life due to electric shock! ► If a fault occurs ensure the electric motor, power box and other electrical parts checked by qualified personnel only. ► Do not open protective covers of the electric motor or power box. Error/Fault Cause Solution Adjusting with position buttons not Handset is locked. -
Page 61: Maintenance
Ensure that maintenance is performed exclusively by manufacturer´s customer service or by authorised service personnel certified by the manufacturer. ► If the defect cannot be repaired, do not use the bed. LINET ® recommends attaching the maintenance plaque to the bed. 16.1 Regular maintenance ► Check regularly movable parts for wear. -
Page 62: Disposal
Based on the Directive No. 2002/96/ EC (Directive WEEE - Waste, Electric and Electronic Equipments) the company LINET, s. r. o. is registered in the List of Electric and Electronic Equipment Producers (Seznam výrobců elektrozařízení) on the Ministry of the Environment of the Czech Republic... -
Page 63: Warranty
18 Warranty LINET ® will only be held responsible for the safety and reliability of products that are regularly serviced, maintained and used in accordance with the safety guidelines. Should a serious defect arise that cannot be repaired during maintenance: ►...
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