User Manual and technical description
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User manual and technical description
Eleganza 3XC Positionable bed for critical care
9200-0243 Version: 01 Print date: 11/2009
Eleganza 3XC Positionable bed for critical care Author: LINET, s.r.o. Related links: www.linet.com Version: 01 Print date: 11/2009 Copyright © LINET, s.r.o., 2009 Translation © LINET, s.r.o., 2009 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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Symbols...5 1.1 Warning Notices...5 1.2 Other Symbols...5 1.3 Symbols and Labels on the Product...6 Safety and Dangers...7 2.1 Safety Instructions...7 2.2 Conditions of use...8 2.3 Split siderails operations...8 Standards and Regulations...9 Functioning...10 4.1 Correct Use...10 4.2 Incorrect Use...10 Scope of Delivery and Bed Variants...11 5.1 Scope of Delivery...11 5.2 Bed variants...11 Setup...12 6.1 Transport...12 6.2 Setup...12 Assembly...13 7.1 Bed Ends...14 7.2 Potential Equalisation...15 Operation...16 8.1 Initial Operation...16 8.2 Battery Operation...16 8.3 Removing the Bed from Service...17 Manipulation...18 9.1 Supervisor Panel...19 9.2 Handset...22 9.3 Foot Control...24 9.4 Integrated Control Element (Siderail)...24 9.5 CPR Backrest Release...25 9.6 Siderails...26 9.7 Eleganza Protector®...27 9.8 Undercarriage...28 9.9 Mobi-Lift®...29 9.10 Accessories...29 Patient Weighing...34 10.1 Weighing System Control Panel...34 10.2 Settings...36 X-ray Lung Examination...37 11.1 Necessary Steps before the Examination...37 Examination with C-arm...38 12.1 Necessary Steps before the Operation...38 Cleaning/Disinfection...39 13.1 Preparing for Cleaning...39 13.2 Cleaning...40 Troubleshooting...42 Maintenance...43 15.1 Maintenance Work...44 15.2 Safety Checks...45 Disposal...46 16.1 Environment Protection...46 16.2 Disposal...46 Warranty...47
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EC Declaration of Conformity... 48 Technical Specifications... 49 19.1 Mechanical Specifications... 49 19.2 Electrical Specifications... 49 Log... 50 20.1 Delivery Log... 50 20.2 Service and Maintenance Log... 51
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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 indicates potential damage to property. Warning warns against bodily injury. Danger warns against potential mortal injury. 1.1.2
Structure of Warning Notices Type and source of danger! Measures to avoid the danger.
Signal words 1.2
Other Symbols
1.2.1
Instructions
Structure of instructions: Perform this step. Results, if necessary. 1.2.2
Lists
Structure of bulleted lists: List level 1 List level 2 Structure of numbered lists: a. List level 1 b. List level 1 1. List level 2 2. List level 2
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1.3
Symbols and Labels on the Product Thermal protection of transformer
Only suitable for indoor use
Protection against accidents due to electrical current Type B instruments
Safety isolating transformer, general CE mark Jack for attachment of conductor for potential equalisation Serial label Safe working load
Warning against crushing or trapping
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2
Safety and Dangers
2.1
Safety Instructions Follow the instructions carefully. Only use the bed if it is in perfect working order. If necessary, check the bed functions daily or at each shift change. Use the bed with the correct mains supply only. Ensure that the bed is operated by qualified personnel only. Ensure that the patient (health permitting) has been informed about the operation of the bed and all applicable safety instructions. Move the bed on even, hard-surfaced floors only. Replace any damaged parts immediately with original spare parts only. Ensure that maintenance and installation are performed only by qualified personnel who have been trained by the manufacturer. Do not apply excess weight or loads to the bed according to SWL. During peak loads or unavoidable excess loads (CPR), place mattress platform in the lowest position. Ensure that only one patient uses the bed at any time. Take care to avoid injuries or squeezing when operating moving parts. When using lifting poles or infusion stands, ensure that nothing will be damaged when you move or adjust the bed. Brake the castors when the bed is occupied. Keep the mattress platform in the lowest position at any time when the healthcare personnel is not treating the patient in order to prevent the patient from falling or injuries. Ensure that siderails are operated by healthcare personnel only. Never use the bed in areas where there is a hazard of explosion. Enable or disable functions on the handset using the supervisor panel as appropriate for the patient’s physical and mental state. Verify that the function is actually disabled. Never handle the mains plug with wet hands. Remove the mains cable by pulling on the plug only. Position the mains cable so that there are no loops or bends in the cable; protect the cable from mechanical wear and tear. Improper handling of mains cable can cause an electric shock hazard, other serious injuries or damage the bed. Ensure that the stipulated duty cycle (on-time) is not exceeded. Ensure that the moving parts of the bed are not blocked. To prevent failures, use the manufacturer’s original accessories and mattresses only. Ensure that the stipulated safe working load is not exceeded. If the patient's condition could lead to an entrapment, leave the mattress support platform in the flat position whilst unattended.
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2.2
Conditions of use
The bed may be used in an indoor environment where the: Range of the surrounding temperature is from + 10°C to + 40 °C Range of relative humidity is from 30% to 75% Range of atmospheric pressure is from 700 hPa to 1060 hPa The bed may not be used in an indoor environment: where there is a risk of explosion containing inflammable anaesthetics The bed is designed for use in rooms for medical purposes. Electrical installations must therefore meet local norms laying down the necessary conditions for electrical installations. Disconnect the bed from the mains during exceptional cases. (i. e. a storm). 2.3
Split siderails operations
The caregivers are responsible for the siderails being in the upper position if a patient is in the bed. To fold the siderails up: Fold the siderail up. A clicking sound indicates that the siderail is fixed automatically. To fold the siderails down: Pull out the releasing mechanism. The siderail is folded down due to the pressure of its weight on the gas spring.
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3
Standards and Regulations
The bed complies with the following standards: EN 60601-1 EN 60601-1-2 EN 60601-2-38 EN ISO 10993 93/42/EEC 89/336/EEC 90/384/EEC The manufacturer adheres to a certified quality management system in compliance with the following standards: ISO 9001: 2000 ISO 14001: 2004 EN ISO 13485: 2003
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Functioning
4.1
Correct Use
The bed is designed for the care and treatment of inpatients at hospitals. The bed is designed for standard and intensive care use. Ensure that the bed is used only in hospitals, only by trained and qualified nursing personnel. 4.2
Incorrect Use The bed is not intended for private use without qualified supervision.
NOTE For information concerning uses other than those outlined in the “Correct Use” section above, please contact LINET®.
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5
Scope of Delivery and Bed Variants
5.1
Scope of Delivery
Delivery: Upon receipt, check that the shipment is complete as specified on the delivery note. Notify the carrier and supplier about any deficiencies or damages immediately as well as in writing or enter them on the delivery note. 5.2
Bed variants
Basic variants: Scales with scales without scales X-ray Cassette Holder with x-ray cassette holder without x-ray cassette holder Optional bed accessories: Castors Tente Integral 150 mm Tente Integral 150 mm with fifth castors Tente Integral 150 mm double castor Tente Integral 150 mm double castors with fifth castor Control Elements Supervisor panel (nurse control panel) with position memory Handset Handset with adapter for simple connection (Plug and Play) Handset with illuminated buttons Foot control Control element integrated in the split siderail Satellite panel Siderails split plastic siderail without integrated control elements split plastic siderail with integrated control elements Support handles with 1 pair Mobi-Lift® without 1 pair Mobi-Lift® Safety Night Light Adapter for Eleganza Protector® Alarm for Unbraked Bed
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Setup
6.1
Transport
To avoid damage during transport, please observe the following guidelines: Ensure that no cables are run over when moving a bed. Ensure that the mains cable is attached with a hook (at the head end of the bed). Ensure that the castors are unlocked before moving the bed during the loading/unloading process (see Undercarriage). Move the bed on suitable floor surfaces only. Suitable surfaces: Tile Hard linoleum Poured flooring Unsuitable surfaces: Too soft, unsealed or defective flooring Soft wooden flooring Soft and porous stone floors Carpeted floors with underlay Soft linoleum For longer distances, ensure that the castor steering function (main control) or fifth castor (separate control) is activated. Ensure that the brakes are released while moving the bed. 6.2
Setup
Set up the bed as follows: Unpack the bed. Check the delivery (see Scope of Delivery and Bed Variants). Install equipment and accessories (see Assembly). In case of delivery with dismantled ends, mount the head and foot ends (see Bed Ends). Set up the bed on a suitable floor surface only. Suitable surfaces: Tile Hard linoleum Poured flooring Unsuitable surfaces: Too soft, unsealed or defective flooring Soft wooden flooring Soft and porous stone floors Carpeted floors with underlay Soft linoleum Ensure that the mains cable does not collide or get stretched when adjusting the bed. Check that the plug is inserted correctly. Do not leave any extension cords or power strips loose on the floor. Ensure that all of the required mechanical and electrical prevention mechanisms are available onsite (protective wall bumpers, corner bumpers, circuit breakers, etc.).
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Assembly
Warning
Risk of injury when working on the bed! Ensure that the bed is disconnected from the mains connection prior to assembly, disassembly and maintenance. Ensure that the castors are locked prior to assembly, disassembly and maintenance. Incorrect assembly can damage the bed! Ensure that assembly is performed by customer service or trained hospital personnel only.
Caution
Fig. 1 Overview of Eleganza 3CX 1. Bed End Locking 2. Split Siderail - Head Section 3. Control Element Integrated in Split Siderail 4. Four-part Mattress Platform with Ergoframe® System 5. Split Siderail - Middle Section 6. Removable Foot Board 7. Supervisor Panel (Nurse Control Panel) 8. Linen Holder 9. Weighing System Control Panel 10. Bed End Locking 11. Integrated Mattress Platform Extension 12. Castor Diameter 150 mm with Main Control Lever 13. Foot Control 14. Accessory Rail 15. 5th Castor 16. X-ray Cassette Holder 17. Removable Head Board 18. Accessory Holder NOTE
For safe, easy handling, LINET® recommends that two technicians assemble the bed.
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7.1
Bed Ends Crushing hazard when inserting the bed ends! To insert the bed ends, hold them by the cormer handles on the top of the board.
Warning
Fig. 2
Locking the Bed Ends
Dismount the bed ends as follows: Unlock sleeve fittings 1. Pull bed ends from sleeve fittings. Lock sleeve fittings 2. Install the bed ends as follows: Unlock sleeve fittings 1. Slide bed ends into sleeve fittings. Lock sleeve fittings 2.
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7.2
Potential Equalisation
The bed contains a protective conductor between all metal parts.
Fig. 3
Ground Pin
Connect the ground wire to the ground pin under the head board.
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Operation
8.1
Initial Operation
Prepare the bed for service as follows: Connect the bed to the mains. Charge the battery. Raise and tilt the mattress platform to the highest position. Lower and tilt the mattress platform to the lowest position. Check that the castors as well as the main brake work correctly. Check that the bed extension works correctly. Check that the head and foot boards can be removed. Check all of the functions on the control elements (supervisor, etc.). Check that the siderails function properly. Dispose of all packaging (see Disposal). NOTE If there is a substantial temperature difference between the bed (due to transport/storage) and the installation site, allow 24 hours for the difference to balance itself before connecting the bed to the mains. 8.2
Battery Operation
The battery supplied with the bed is delivered uncharged. The battery serves as a backup during power failures or while transporting the patient. To charge the battery: Connect the bed to the mains. NOTE Some bed adjustments cannot be carried out without a battery, for example, height adjustment under a load of above 200 kg. The LED indicates the battery’s charge status: Display
Battery Charge
LED not lit
Sufficient battery capacity Stop charging
LED short flash (0.2 sec)
Charging battery Positioning the bed using the battery is possible in an emergency
LED long flash (1.8 sec)
Battery is completely discharged or defective Positioning the bed using the battery in an emergency is not possible, not even for a short time If the LED continues to blink, call customer service.
LED lit continuously
No voltage (missing battery, defective battery, defective fuse, bad connection) Call customer service.
NOTE
LINET® recommends that you replace the battery every two to three years. Incorrect battery changing can damage the bed! Have the battery changed exclusively by qualified personnel.
Caution
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To optimise battery performance: Disconnect the bed from the mains only during power failures or while transporting the patient. Disconnect the bed from the mains for as a brief a period as possible. After a full discharge, recharge the battery for at least 12 hours (see the LED on the supervisor panel to check the charge status). If the battery case, control panel housing or cable appear distorted by heat: Disconnect the bed from the mains. Stop using the bed (see Removing the Bed from Service). Notify the service department. 8.3
Removing the Bed from Service
Remove the bed from service as follows: Disconnect the bed from the mains. Disconnect the ground wire. Deactivate the battery. Remove accessories. To prevent damage during storage: Pack or cover the bed and accessories. Ensure that storage conditions are the same as the operating conditions. 8.3.1
Deactivating the Battery
To avoid damaging the bed and the environment during storage: Deactivate the battery on the supervisor panel. To deactivate the battery on the supervisor: Disconnect the bed from the mains. Disconnect the ground wire. Activate the keypad by pressing the GO button on the supervisor. Press the Thigh Rest Up + Thigh Rest Down + Trendelenburg Position buttons at the same time and hold them for three seconds. The battery is deactivated.
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9
Manipulation
Warning
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. Secure or remove any items on the bed.
The bed is operated by different control elements. Control elements depending on the model: Supervisor Panel (Nurse Control Panel) Handset Foot Control Control Element Integrated in Split Siderail Disabling individual functions on the supervisor panel affects all of the control elements (supervisor, handset, foot control). If the bed does not react to individual position settings: Check whether the function is disabled on the supervisor panel.
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9.1
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. 4
Supervisor control panel
1. Central STOP Button 2. Activating GO Button 3. Thigh Rest Adjustment Button 4. Thigh Rest Lock Button 5. Thigh Rest Lock LED 6. Backrest Adjustment Button 7. Backrest Lock Button 8. Backrest Lock LED 9. Height Adjustment Buttons 10. Height/Tilt Lock Button 11. Height/Tilt Lock LED 12. Auto-Contour Button 13. Foot Control Lock Button 14. Foot Control Lock LED 15. Mains Power LED 16. Battery Charge Status LED 17. Trendelenburg Position Button 18. Cardiac Chair Position Button 19. Examination Position Button 20. Mobilisation Position Button 21. CPR (Resuscitation) Position Button 22. Tilt Buttons 9.1.1
Central STOP Button
The central STOP button immediately interrupts all bed movements. When the central STOP button is pressed, the electronic stops all bed movements immediately.
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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: Adjust individual mattress platform elements by pressing the corresponding function buttons. Disable individual functions with the lock buttons. Each time you press a function button, the keypad will remain active for another three minutes. 9.1.3
Function Buttons
You can set different positions, for example the height and tilt of the mattress platform, adjust individual mattress platform elements, etc., with function keys 3, 6, 9 and 12. NOTE If you press two function buttons at the same time, the controller will recognise this as an error. The controller immediately interrupts all bed movements. Set the position as follows: Activate the keypad by pressing the GO button. Press and hold the function button until the desired position is reached. 9.1.4
Lock Keys
Disable individual functions with the lock keys 4, 7, 10 and 13 on the supervisor panel. To disable functions: Activate the keypad by pressing the GO button. Press the lock button of the selected function. The respective LED 5, 8 or 11 indicates the lock. NOTE
The individual functions are locked on each control element on the bed.
To enable disabled functions: Activate the keypad by pressing the GO button. Press the central lock button of the selected function. Lock the foot control as follows: Activate the keypad by pressing the GO button on the supervisor. Press any foot control.
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