User Manual and technical description
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User manual and technical description
Eleganza Smart universal hospital bed
9200-0181 Version: 01 Print date: 08/2009
Eleganza Smart Universal hospital bed Author: LINET, s.r.o. Related links: www.linet.com Version: 01 Print date: 08/2009 Copyright © LINET, s.r.o., 2009 Translation © LINET, 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 1.1.1. Types of Warning Notices...5 1.1.2. Structure of Warning Notices...5 1.2 Other Symbols...5 1.2.1. Instructions...5 1.2.2. Lists...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 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 5.2.1. Standard bed options...11 5.2.2. Detailed bed variants...12 Setup...13 6.1 Transport...13 6.2 Setup...14 Assembly...15 7.1 Bed Ends...16 7.2 Satellite Panel...16 7.3 Potential Equalisation...17 Operation...18 8.1 Initial Operation...18 8.2 Battery Operation...19 8.3 Removing the Bed from Service...20 8.3.1. Deactivating the Battery...20 8.3.2. Activating the Battery...20 Manipulation...21 9.1 Supervisor Panel...22 9.1.1. Central STOP Button...23 9.1.2. Activating GO Button...23 9.1.3. Function Buttons...23 9.1.4. Lock Button...23 9.1.5. Position Buttons...24 9.2 Handset...25 9.3 Satellite Panel...26 9.4 Foot Control...27 9.5 Integrated Control Element (Siderail)...28 9.6 CPR Backrest Release...29 9.7 Mattress Platform...29 9.7.1. Auto-Regression...29 9.7.2. Mechanical Adjustment of Calf Rest...30 9.7.3. Mattress Platform Extension/Shortening...30 9.8 Siderails...31 9.8.1. Single Collapsible Siderail...31 9.8.2. Split Collapsible Siderails...32 9.9 Undercarriage...33 9.9.1. Castor Control Lever...33
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9.9.2 5th Castor Control Lever... 34 9.10 Accessories... 34 9.10.1Lifting Pole... 35 9.10.2Infusion Stands... 35 9.10.3Accessory Rails... 36 9.10.4Towel Holder... 37 9.10.5Holder for Anti-decubitus Mattress Compressor... 38 9.10.6Writing Table... 38 Cleaning/Disinfection... 39 10.1 Preparing for Cleaning... 40 10.2 Cleaning... 40 10.2.1Daily Cleaning... 40 10.2.2Cleaning before Changing Patients... 40 10.2.3Complete Cleaning and Disinfection... 41 Troubleshooting... 42 Maintenance... 43 12.1 Maintenance Work... 44 12.1.1Spare Parts... 44 12.1.2Completeness... 44 12.1.3Wear... 44 12.1.4Functioning... 44 12.1.5Electric Control... 44 12.1.6Castors... 45 12.1.7Accessories... 45 12.2 Safety Checks... 45 Disposal... 46 13.1 Environment Protection... 46 13.2 Disposal... 46 13.2.1Within Europe... 46 13.2.2Outside Europe... 46 Warranty... 47 EC Declaration of Conformity... 48 Technical Specifications... 49 16.1 Mechanical Specifications... 49 16.2 Electrical Specifications... 49 16.3 EMC... 50 Log... 51 17.1 Delivery Log... 51 17.2 Service and Maintenance Log... 52
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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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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 (Safe Working Load). During peak loads or unavoidable excess loads (CPR), place the mattress platform in the lowest position. Ensure that only one person occupies the bed at any time. Take care to avoid 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. Ensure that the castors are braked when the bed is occupied and not being moved. 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 (unplugged from Plug and Play). 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. Ensure that the mains cable is not trapped or crushed and that there are no objects standing on the cable. Improper handling of mains cable can cause an electric shock hazard, other serious injuries or damage the bed. Use the bed on an electrical circuit with a residual-current circuit-breaker that has a maximum rating of 30 mA only. 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. Ensure that linen does not obstruct the moving of bed parts or the access to any control mechanisms. Ensure that the siderails are locked in the upper position when transporting the bed with a patient. Lower the foot part of the siderail before extending the mattress platform. When setting the Trendelenburg position, ensure that there is a sufficient safety distance so that no accessories or ambient objects are damaged. Ensure that the bed is disconnected from the mains connection prior to cleaning. 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
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Standards and Regulations
The bed complies with the following standards: EN 60601-1 EN 60601-1-2 EN 60601-1-4 EN 60601-1-6 EN 60601-2-38 EN ISO 10993 93/42/EEC 89/336/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, intensive and long-term care. 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®. NOTE
The manufacturer shall not be liable for any damage, injury, etc. due to incorrect use.
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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
5.2.1
Standard bed options
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Fig. 1
Eleganza Smart with single siderails
Fig 2
Eleganza Smart with split siderails without controls and fixed-height head end
Fig 3
Eleganza Smart with split siderails with controls
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5.2.2
Detailed bed variants
s=standard o=optional Basic Variants standard bed (s) bed with constant-height head end integrated in the undercarriage (o) narrow bed (possible only with single siderail) (o) Powder Coating Colors RAL 9002 grey (s) RAL 9006 silver (o) Mattress Platform mattress platform made of non-removable steel sections (s) mattress platform made from removable plastic segments (o) Bed Ends design E3 - plastic panels with coloured inserts (s) design A - aluminium framing with coloured panels (o) Siderails without siderails (s) single collapsible siderails, powder-coated (assembled on the bed) (o) split plastic siderails (o) split plastic siderails with controls (o) Castors Tente Motion 150 mm (s) Tente Motion 150 mm with fifth castor (o) Tente Motion 150 mm with plastic cover (o) Tente Motion 150 mm with plastic cover and fifth castor (o) Double castors Tente Integral 150 mm (o) Double castors Tente Integral 150 mm with fifth castor (o) Control Elements supervisor panel (nurse control panel) (s) handset without illuminated keyboard (s) handset with illuminated keyboard (o) foot control (o) satellite control panel (o) siderail control (o) Backup Battery with backup battery (s) without backup battery (not in accordance with EN 60601-2-38) (o) Mattress Platform Extension (s) Linen Shelf (o) One Pair of Universal Accessory Holders (o)
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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 by 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. If a patient is in the bed during transport: Ensure that the siderails folded up and locked. 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 the fifth castor (seperate control) is activated. Ensure that the brakes are released while moving the bed.
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6.2
Setup
Set up the bed as follows: Unpack the bed. In case of delivery of two beds in one pack: a. Carefully remove the top bed and put it beside the bottom bed. NOTE
For safe, easy handling, LINET® recommends that two technicians remove the top bed.
Check the delivery (see Scope of Delivery and Bed Variants). Read the manual. Install equipment and accessories (see Assembly). In case of delivery with dismantled ends: a. Mount the head and foot ends (see Bed Ends). In case of a bed with a mattress platform consisting of metal segments: a. Attach the plastic covers to the back and calf rest to protect the columns. 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 Observe the specified minimum distances (see Technical Specifications). 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 cables 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, etc.). Ensure that all of the required mechanical and electrical prevention mechanisms are working correctly (protective wall bumpers, corner bumpers, etc.). Check if all of the mechanical and electrical functions are working correctly. Charge the backup battery.
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Assembly 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 Incorrect assembly can damage the bed! Ensure that assembly is performed by customer service or trained hospital personnel only.
Caution 1
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Fig 4 Overview of the Hospital Bed 1. Head end 2. Siderail control 3. Satellite panel 4. Backrest 5. Seat rest 6. Thighrest 7. Calf rest 8. Split siderail folded up 9. Foot end 10. Linen holder (with stored supervisory panel) 11. Bed extension - locking mechanism 12. Castor control lever 13. 150 mm castor 14. Split siderail folded down 15. 5th castor 16. 5th castor operating lever 17. CPR contol lever unblocking the backrest 18. Protective bumper NOTE For safe, easy handling, LINET® recommends that two technicians assemble the bed.
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7.1
Bed Ends
NOTE Several variants of head and foot ends are available (see Bed variants). The bed end variant does not affect the operation procedure. Risk of injury when inserting the bed ends! To insert the bed ends into the corner posts, hold them by the corner handles on the top of the board. Install the bed ends before the first use.
Warning Risk of injury due to incorrectly installed bed ends!! Ensure that the bed ends are correctly inserted, especially when moving the bed. Ensure that the bushings on the corner posts are locked, especially when moving the bed.
Warning
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Locking the bed ends
1. Locked 2. Unlocked Install the bed ends as follows: Unlock the safety lever on the corner posts. Slide the bed ends into the slots on the corner posts. Lock the safety lever on the corner posts. 7.2
Satellite Panel
Install the satellite panel as follows: Slide the satellite panel into the safety lever behind the backrest. Fasten the satellite panel with the fastener on the right or left.
The satellite panel cable is connected to the bed’s main control box. NOTE
You can change the position of the satellite panel at any time.
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7.3
Potential Equalisation
The bed contains a protective conductor between all metal parts.
Fig 6
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 support to the highest position. Lower and tilt the mattress support 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.
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8.2
Battery Operation
The battery supplied with the bed is delivered uncharged and already connected to the power box. The battery serves as a backup during power failures or while transporting the patient. An LED on the supervisory panel indicates the battery’s charge status. Before using the bed: Charge the battery. To charge the battery: Connect the bed to the mains. The LED indicates the battery’s charge status: Display Battery Charge LED not lit
Sufficient battery capacity Stop charging
LED short flash (0.2 s)
Charging battery Positioning the bed using the battery is possible in an emergency
LED long flash (1.8 s)
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. After a maximum of 5 years, the battery has to be replaced. Incorrect battery changing can damage the bed! Have the battery changed exclusively by qualified personnel.
Caution 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 and run it on battery for as a brief a period as possible. After a full discharge, recharge the battery for at least 12 hours (see the yellow LED on the supervisor panel to check the charge status). NOTE Position adjustment of the mattress platform is possible without a connected battery. Some functions, however, cannot be cannot be carried out without a connected battery (e.g. height adjustment under a load of more than 180 kg). 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.
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8.3
Removing the Bed from Service
Remove the bed from service as follows: Disconnect the bed from the mains. Disconnect the ground wire. Hang the ground wire on the hook. Deactivate the battery (see Deactivating 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. Hang the ground wire on the hook. Activate the supervisor panel with the GO button. Press the Thighrest Up + Thighrest Down + Trendelenburg Position buttons at the same time and hold them for 3 seconds.
The battery is deactivated.
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