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Summary of Contents for LINET Eleganza 3XC
- Page 1 User manual and technical description Eleganza 3XC Positionable bed for critical care D9U001GV0-0101 Version: 07 Publication Date: 2018-05...
- Page 2 Manufacturer: LINET spol. s r. o. Želevčice 5, 274 01 Slaný Tel.: +420 312 576 111 Fax: +420 312 522 668 E- mail: info@linet.cz 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 ©...
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Page 3: Table Of Contents
Table of Contents 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 Safety and Dangers ............................ - Page 4 19.1 Mechanical Specifications........................51 19.2 Environmental conditions ........................51 19.3 Electrical Specifications .......................... 52 19.4 Electromagnetic Compatibility ........................ 53 Battery Activation............................. 56 20.1 Placement of Control Section ......................... 56 20.2 Removing the Isolating Foil ........................56 20.3 Isolating Foil ............................56...
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Page 5: Symbols
Symbols 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! -
Page 6: Symbols And Labels On The Product
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... -
Page 7: Serial Label With Udi
DI+PI=UDI Number) Symbols Electrical Specification PI (Product Identifier) Serial Number Fig. Serial Label with UDI (Eleganza 3XC without scales) DI (Device Identifier) / 2D Bar Code Address of Distributor 1D Bar code GS1-128 Manufacturing Date GTIN (Global Trade Item (GS1 DataMatrix) -
Page 8: Definitions
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... -
Page 9: Safety And Dangers
Safe Working Load Unique Device Identification (for medical devices) 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! WARNING! Siderails of Eleganza 3XC should be located in the „up“ position to reduce... -
Page 10: Safety Instructions
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! 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. - Page 11 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.
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Page 12: Conditions Of Use
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. -
Page 13: Functioning
Functioning 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. -
Page 14: Scope Of Delivery And Bed Variants
Scope of Delivery and Bed Variants 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. -
Page 15: Setup
Setup 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). ... -
Page 16: Assembly
X-ray Cassette Holder 5th Castor Foot Control Castor Diameter 150 mm with Castor Control Lever Integrated Mattress Platform Extension Bed End Locking Linen Holder Weighing System Control Panel ® NOTE For safe, easy handling, LINET recommends that two technicians assemble the bed. -
Page 17: Bed Ends
Bed Ends Crushing hazard when inserting the bed ends! To insert 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. -
Page 18: Operation
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: ... - Page 19 The LED indicates the battery’s charge status Yellow LED Battery status Not lit Battery capacity is sufficient (charging completed) Short flashing (shortly lit, Battery is charging - continue charging until the LED is extinguished. In longer not lit) (circa 1.8 sec.) emergency cases, the battery can be used as a backup power source for a short period.
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Page 20: Removing The Bed From Service
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. ... -
Page 21: Manipulation
Manipulation Risk of injury when adjusting the bed! Ensure that there are no body parts between the mattress platform elements and the mattress platform frame when adjusting the bed. Ensure that there are no body parts below the mattress platform frame before adjusting the bed. -
Page 22: Supervisor Panel
Supervisor Panel The supervisor panel is the main control element. The supervisor panel can be hung on the foot board if required. It is possible to hold the supervisor in the hand while operating. When not in use, store the supervisor panel in the built-in linen holder below the foot end. Fig. - Page 23 9.1.2 Activating GO Button The GO button activates the keypads on all control panels. The GO button is included on a number of different control elements. The function of the GO button is identical on all control elements. After pressing the GO button, the keypad remains active for 3 minutes. During this time you can: ...
- Page 24 9.1.5 Position Buttons You can set the pre-programmed therapeutic and safety-related positions with the following buttons: Trendelenburg Position 17 Cardiac Chair Position 18 Examination Position 19 Bed Exit Position 20 CPR (Resuscitation) Position 21 Set the position as follows: ...
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Page 25: Handset
CPR (Resuscitation) Position The CPR position is for resuscitating the patient in an emergency. Settings after pressing position button 21: All mattress platform elements are retracted to their lowest position. The mattress platform is moved to the horizontal position. The bed moves into the CPR position within 30 seconds from any mattress platform position. -
Page 26: Foot Control
NOTE An adapter for the handset is available. The adapter enables quick mounting and dismounting (e.g. replacing a defective handset, using the handset for another bed). Foot Control The foot control is optional and allows you to set up the height of the bed with your feet. Fig. -
Page 27: Integrated Control Element (Siderail)
Integrated Control Element (Siderail) The integrated control element is optional. The integrated control element is attached to the split siderail. Fig. Integrated Control Element Thigh Rest Adjustment Button Backrest Adjustment Button GO Button Auto-Contour Button Height Adjustment Buttons... -
Page 28: Cpr Backrest Release
CPR Backrest Release Lowering the backrest too quickly can injure the patient! Ensure that the siderails are in the lowest position. Ensure that there are no body parts between the siderails and the backrest. Press the backrest down using the mattress guard handle only. Warning The bed permits quick mechanical lowering of the backrest for emergency resuscitation (CPR) procedures. -
Page 29: Siderails
Push the foot board in as far as it will go. Adjust the wire mattress retainer. Turn the safety catches (frame) by 90° and push them in. Siderails ® Eleganza 3XC is equipped with four plastic siderails. If necessary, a retrofit with Eleganza Protector is possible. -
Page 30: Eleganza Protector
9.6.1 Split Siderail The split siderails are components of the bed. A gas spring supports the operation of the split siderails. To operate the siderails: Fig. Fold up the Split Siderail Risk of injury due to patient falling out of bed! ... -
Page 31: Undercarriage
Risk of damaging the bed due to incorrect Protector®! Linet® delivers two different types of Eleganza 3 Protectors. For new version of Eleganza 3 made by 60601-2-52 standard is used Protector with model number 110059000ELE3. The standard the bed was made can be found in “User manual”... -
Page 32: Mobi-Lift
9.8.2 i-Brake® (optional) It is possible to equip the bed with an automatic castor brake. The automatic castor brake prevents injuries of patients and staff due to an unbraked bed. The brakes are activated automatically 60 seconds after the bed is plugged in, and 60 seconds after they have been released if the bed is not being moved. -
Page 33: Accessories
Ensure that the safety pin locks into place. A plastic grab handle with an adjustable strap shall be attached to the lifting pole. ® NOTE The date of manufacture is marked on the grab handle. LINET recommends that you replace the plastic grab handle every four years. - Page 34 9.10.2 Infusion Stands Fig. Infusion Stand You can insert infusion stands into the sleeve fittings at the head of the bed. Use only infusion stands with four hooks for hanging IV bags or for hanging a basket for intravenous solutions.
- Page 35 9.10.3 Accessory Rails The bed is optionally equipped with two accessory rails with plastic hooks. Load Capacity: Maximum load of 5 kg without leverage Maximum load of hook pair 10 kg Accessories for Hanging on the Accessory Rail: ...
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Page 36: Writing Table
9.10.5 Safety Night Light The night light is an optional accessory. It helps the nursing staff as well as the patient to orientate themselves at night. Requirements for Operation: The main room lights must be dimmed or off. Ensure that the bed is connected to the mains. -
Page 37: Patient Weighing (Ws17)
10 Patient Weighing (WS17) 10.1 Weighing System Control Panel Fig. Weighing System Control Panel Display - current weight Indicated Value Switch Button ZERO/T Button – zeroing or taring WEIGHT/CLEAR Button - cancelling Hold Button with LED indicator Bed Exit Alarm Volume Button Bed Exit Button LED indicator of Bed Exit Outer Zone LED indicator of Bed Exit Inner Zone... - Page 38 3) Displaying Verification Scale Interval is 0.5 kg. Press button 2 to display value with actual scale interval 0,1 kg for 5 s. Display shows normally actual weight if other functions are not activated. 4) Hold Mode Hold Mode must be used only when the scales are stabilized. It allows adding or removing bed accessories and other items without changing the weight value.
- Page 39 To set up the alarm volume: Press button 6 until the desired volume is reached. NOTE: If the alarm is set to minimum volume the mute mode is on. Inner Zone alarm (indicator 9) Alarm starts when patient moves from the limited area. Outer Zone alarm (indicator 8) ...
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Page 40: Ray Lung Examination
11 X-ray Lung Examination The backrest of the bed consists of HPL and is x-ray translucent. The bed is equipped with an x-ray cassette holder with 2 U-profiles under the backrest. This design allows taking x-ray images of the patient’s lungs without moving the patient. -
Page 41: Cleaning/Disinfection
(benzene, toluene, acetone, etc.). Clean the bed with a well-wrung, moist cloth. Clean electrical components carefully and allow them to dry fully. ® LINET recommends the following cleaning agents: Cleaning agents Manufacturer Schülke & Mayr Mikrozid, Terralin Protect, Thermosept... -
Page 42: Cleaning
13.2 Cleaning 13.2.1 Daily Cleaning Clean the following bed parts: All of the control elements for adjusting the bed All handles Back and calf rest handles CPR release handle Head and foot boards Siderails (in highest position) ... - Page 43 13.2.3 Complete Cleaning and Disinfection Clean the following bed parts: All of the control elements for adjusting the bed All handles Back and calf rest handles CPR release handle Head and foot boards Siderails (in highest position) ...
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Page 44: Troubleshooting
14 Troubleshooting Error/Fault Cause Solution The bed cannot be adjusted with GO button was not pressed Press the GO button. the position buttons Function disabled on supervisor Enable disabled function. panel Drive motors have no power, Check the mains connection. Defective drive motors, Notify the service department. -
Page 45: Maintenance
15 Maintenance 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. Warning A defective bed can cause injuries! ... - Page 46 15.1.4 Functioning Check that all bed adjustments reach the maximum position. If necessary, clean, lubricate or replace any worn spots and parts. 15.1.5 Electric Control Plug connections: Replace O-rings on connectors. Check plug connections for dirt and defects. ...
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Page 47: Safety Checks
® Use of the product for other than its intended purpose as stated in any documentation provided by LINET NOTE On request, the manufacturer will provide circuit diagrams, component part lists, descriptions, calibration instructions etc. for service personnel for the repair of ME equipment designated by the manufacturer as repairably... -
Page 48: Disposal
16.1 Environment Protection ® LINET is aware of the important role that the protection of our environment plays for future generations. The materials of this product are environmentally compatible. It does not contain hazardous substances on the basis of cadmium, mercury, asbestos, PCB or CFC. The noise emission and the vibrations meet the directives for premises. -
Page 49: Warranty
17 Warranty ® LINET will only be held responsible for the safety and reliability of products that are regularly serviced and used in accordance with the safety guidelines. Should a serious defect arise that cannot be repaired during maintenance: ... -
Page 50: Ec Declaration Of Conformity
18 EC Declaration of Conformity... -
Page 51: Technical Specifications
Mechanical Specifications 223 cm x 105 cm Dimensions Recommended Mattress Size 208 cm x 86 cm Mattress dimensions (Linet passive mattresses): 208 cm x 96 cm Maximum Mattress Height 23 cm Height of Split Siderail above Mattress Platform 45 cm... -
Page 52: Electrical Specifications
Version 2 2x T3.15A L 250 V for 100-127 V version ® NOTE Upon request, LINET can deliver critical care beds with electrical specifications that comply with regional standards (custom voltage, different mains plugs). Danger to life due to electric shock! ... -
Page 53: Electromagnetic Compatibility
Mobile RF communication device (including end use devices like antenna cables and external antenna) should not be used closer than 30 cm (12 inches) from any part of this bed Eleganza 3XC, including cables specified by manufacturer. Otherwise this could lead to deterioration of functionality of this bed. - Page 54 Manufacturer instructions – electromagnetic susceptibility Immunity Tests Compliance level ± 8 kV for contact discharge Electrostatic discharge (ESD) ± 15 kV for contact discharge IEC 61000-4-2 Radiated RF 3 V/m 80 MHz – 2,7 GHz IEC 61000-4-3 80 % AM at 1 kHz Proximity fields from RF wireless communications equipment IEC 61000-4-3...
- Page 55 Test Immunity test frequency Band (MHz) Service Modulation level (MHz) Pulse modulation 380 - 390 TETRA 400 18 Hz FM ± 5 kHz 430 - 470 GMRS 460, FRS 460 deviation 1 kHz sine Pulse modulation 704 - 787 LTE band 13, 17 217 Hz GSM 800/900, TETRA 800, iDEN Pulse modulation...
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Page 56: Battery Activation
20 Battery Activation 20.1 Placement of Control Section 20.2 Removing the Isolating Foil Pull 20.3 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.
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