LINET Eleganza 2 User Manual And Technical Description
A smart acute bed
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Summary of Contents for LINET Eleganza 2
- Page 1 User manual and technical description Eleganza 2 A smart acute bed D9U001GRA-0101 Version: 04 Publication Date: 2018-02...
- Page 2 Manufacturer: LINET spol. s r. o. Želevčice 5 274 01 Slaný Czech Republic Tel.: +420 312 576 111 Fax: +420 312 522 668 E-mail: info@linet.cz http://www.linet.cz Eleganza 2 A smart acute bed Author: LINET, s.r.o. Related links: www.linet.cz D9U001GRA-0101 Version: 04 Publication Date: 2018-02 Copyright ©...
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Page 3: Table Of Contents
7.3 Isolating Foil ............................17 8 Assembly ............................18 8.1 Potential Equalisation........................18 8.2 Mattress Platform ..........................19 8.3 Eleganza 2 (1GR) – Split Plastic Siderails ..................20 8.4 Eleganza 2 (1GR) – Single Collapsible Siderails ................21 8.5 Bed Ends ............................22 9 Operation ............................23 9.1 Initial Operation ..........................23 9.2 Battery ...............................23... - Page 4 10.9 Siderails ............................40 10.10 Integrated siderails functions (optional) ..................43 10.11 Castor Control and Bed Transport ....................44 10.12 EMR Ready (optional) .........................45 11 Accessories .............................46 11.1 Lifting pole ...........................47 11.2 Infusion Stands ..........................48 11.3 External holder for infusion stand/pump ..................48 11.4 Accessory Rail ..........................49 11.5 Oxygen Bottle Holder........................50...
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Page 5: Symbols
1 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 - risk of material damage. Warning - risk of physical injury. Danger - risk of fatal injury. 1.1.2 Structure of Warning Notices SIGNAL WORDS! -
Page 6: Symbols And Labels On The Product
Symbols and Labels on the Product Read user manual. Attention Thermal protection of transformer Only suitable for indoor use Protection against accidents due to electrical current – Type B instruments Safety isolation transformer, general CE mark of conformity with EU regulation Jack for attachment of conductor for potential equalisation Safe Working Load... -
Page 7: Serial Label With Udi
Designation of hospital bed for adults Serial label with UDI 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... -
Page 8: Abbreviations
Abbreviations European Conformity Cardiopulmonary Resuscitation Sound Intensity Unit Electromagnetic Compatibility Field-effect transistor High Frequency Intensive Care Unit INT. Duty Cycle Intravenous Light Emitting Diodes Medical Electrical (Equipment) Deactivated Activated System Control Unit Safe Working Load Unique Device Identification (for medical devices) D9U001GRA-0101_04... -
Page 9: Safety And Dangers
2 Safety and Dangers WARNING! Eleganza 2 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 2 should be located in the „up“ position to reduce the risk of the patient... -
Page 10: Safety Instructions
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. WARNING! An additional multiple socket-outlet or extension cord shall not be connected to the medical electrical system. -
Page 11: Conditions Of Use
Position the mains cable so there are no loops or bends in the cable; protect the cable from mechani- cal wear and tear. Incorrect handling of the mains cable can cause an electric shock hazard, other serious injuries or damage to the bed. -
Page 12: Specifications Of Use
AFSSAPS (Agence française de sécurité sanitaire des produits de santé) We declare that our product Eleganza 2 with universal twin plastic siderails equipped with Junior Kit is safe under condition of common use in compliance with instructions and that measures have been taken to ensure the conformity of recommendation by AFSSAPS described in letter dated 18.6.2014. -
Page 13: Functioning
Always conduct the risk assessments required for the selection of suitable equipment. Eleganza 2 is an acute care hospital bed. It is designed for supporting the patient in several positions such as horizontal, Trendelenburg, Cardiac Chair etc. Eleganza 2 is suitable for: ... -
Page 14: Scope Of Delivery And Bed Variants
The bed is delivered with deactivated battery. To activate battery see chapter “Battery activation”. Bed Variants Features - Eleganza 2 Model 1GR (model no. see product label): s = standard o = optional Mattress Platform ... -
Page 15: Applied Parts Type B
Other Mattress platform extension (s) Linen shelf (o) One pair of universal accessory holders (o) Urine bag holder integrated in siderails (s) Universal box (o) Segufix holders (o) Universal handset holder (o) ... -
Page 16: Setup
6 Setup Transport For safe transport, observe the following: Ensure no cables are run over when moving a bed. Ensure the mains cable is attached with a hook (at the head end of the bed). Ensure the castors are unlocked before moving the bed during the loading/unloading process (see Castor Control and Bed Transport). -
Page 17: Battery Activation
7 Battery Activation Placement of Control Section Removing the Isolating Foil Pull 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. D9U001GRA-0101_04... -
Page 18: Assembly
8 Assembly WARNING! Risk of injury when working on the bed! Ensure the bed is disconnected from the mains connection prior to assembly, disassembly and maintenance. Ensure the castors are locked prior to assembly, disassembly and maintenance. CAUTION! Material damage due to incorrect assembly! ... -
Page 19: Mattress Platform
Mattress Platform The mattress platform consists of removable plastic sections. Fig. Correct placement of mattress platform sections A. Back section / Calf section B. Loins section / Thigh section C. Seat section NOTE: Sections A and B are replaceable. It is possible to change back section A for calf section A. Same applies for B sections. -
Page 20: Eleganza 2 (1Gr) - Split Plastic Siderails
Eleganza 2 (1GR) – Split Plastic Siderails Overview Eleganza 2 – Split Plastic Siderails Fig. 1. Foot end 2. Siderail release mechanism with SoftDrop function 3. Mattress platform with removable plastic sections 4. Integrated MobiLift controller in siderails 5. Integrated control panel in siderails 6. -
Page 21: Eleganza 2 (1Gr) - Single Collapsible Siderails
Eleganza 2 (1GR) – Single Collapsible Siderails Overview Eleganza 2 – Single Collapsible Siderails Fig. 1. Foot end 2. Siderail release mechanism 3. Single collapsible siderails 4. Mattress platform with mattress Efecta 5. Head End 6. CPR control lever – backrest release 7. -
Page 22: Bed Ends
Bed Ends NOTE: The bed ends may be delivered in several decor colour variants. WARNING! Risk of injury when inserting the bed ends! To insert bed ends into corner posts, hold them by the corner handles on top with both hands. ... -
Page 23: Operation
9 Operation Initial Operation 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 allo the temperature to equalise. Prepare the bed for service as follows: ... - Page 24 CAUTION! Risk of reducing battery durability due to incorrect use! Use bed on battery only in crisis situations (e.g. power blackout, patient complications during transport, etc.). After reconnecting bed to the mains charge battery to full capacity (see chart Battery charge status). CAUTION! Risk of damage or destruction of battery! ...
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Page 25: Status Faulty Battery
Status Faulty Battery The battery is regarded as faulty if at least one of the following conditions applies: Battery charging constantly Low voltage on battery Low charging current of battery Status “faulty battery” is indicated: By the battery status indicator being constantly lit. ... -
Page 26: 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. ... -
Page 27: Acp - Supervisor Control Panel (Nurse Controller)
10.1 ACP - Supervisor control panel (nurse controller) ACP Supervisor panel is main control panel of the bed. Nurse controller can be placed in the shelf. We recommend placing ACP panel on the bed end of the bed or hold it in the hands while controlling the bed. Fig. - Page 28 Pressing central STOP button 1 for at least 0.3 seconds immediately stops all electronic bed movements. NOTE: The bed can be stopped by pressing two different buttons even on two different controllers. If the press of the buttons is longer than 0,5 second the bed will stop all the movements immediately. 10.1.2 Activating GO Button The GO button 2 activates the keypads on all control elements except the foot control.
- Page 29 10.1.5 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.
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Page 30: Handset
Unplug handset. ® NOTE: The handset can be plugged into another LINET hospital bed with the Plug and Play slot. NOTE: If the bed is equipped with “Automatic Stop of Backrest at 30°” then this function works on every control element which allows backrest adjustment. -
Page 31: Satellite Control Panel (Optional)
10.3 Satellite Control Panel (optional) The satellite control panel is an optional control element. The satellite control panel is attached to the backrest with a flexible arm. Fig. Satellite control panel 1. Activating GO Button 2. Thighrest Adjustment Buttons 3. Backrest Adjustment Buttons 4. -
Page 32: Foot Control (Optional)
10.4 Foot Control (optional) WARNING! Risk of injury due to moving parts! Ensure no body parts are trapped between moving parts of bed and mattress platform. Ensure no persons or body parts are close to bed or accessories (e.g. infusion stand, lifting pole) when the mattress platform is moving. -
Page 33: Control Element Integrated In Siderail (Optional)
10.5 Control Element Integrated in Siderail (optional) It is possible to equip the Eleganza 2 bed with integrated illuminated controllers in the siderails.The optional control element is attached to the siderail. The controllers are positioned on both sides of the bed. -
Page 34: Eleganza 2 Illumination
10.6 Eleganza 2 illumination The bed is equipped with three-phase illumination: 1. Full intensity of illumination 2. Lowered intensity of illumination 3. Illumination is turned off The lowered intensity of illumination is set up after the bed is turned on. -
Page 35: Cpr Backrest Release
10.7 CPR backrest release WARNING! Risk of injury due to lowering the backrest too quickly! Ensure single collapsible siderails are in their lowest position. Ensure split plastic siderails are in their highest position. Ensure there are no body parts between siderails and backrest. ... -
Page 36: Mattress Platform
10.8 Mattress Platform 10.8.1 Auto-Regression To eliminate pressure on the pelvis of the patient as it is raised, the backrest moves in the opposite direction when the bed is adjusted. Benefits of auto-regression: Prevents decubitus. Increases the sitting area by 11 cm in the maximum upright position. 10.8.2 Mechanical Adjustment of Calf Rest You can adjust the calf rest mechanically. - Page 37 Fig. Mattress Platform Extension Safety Lock 1. Locked 2. Unlocked (it is possible to set up bed extension) Fig. Mattress retainer positions during bed extensions. 0 cm 2. +15 cm 3. + 32 cm To lengthen/shorten the bed: Pull out the safety catches 1 at the foot end of both sides of the frame. ...
- Page 38 Positions of the mattress retainer: Fig. Mattress retainer in the position without bed extension (default postion) Fig. Mattress retainer in the position with bed extension by 15 cm Fig. Mattress retainer in the position with bed extension by 32 cm D9U001GRA-0101_04...
- Page 39 Use the bed shortening carefully when a patient is on the bed to avoid risk of crushing, trapping or squeezing. Eleganza 2 medical bed can be delivered in the version with bed shortening. Purpose of this shortened version is to facilitate bed transport. The length of its mattress platform can be reduced by 10 cm and recommended mattress should have the length of 190 cm.
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Page 40: Siderails
10.9 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. Model variants: ... - Page 41 Do not hang anything on the prop in siderail if the bed is equipped with Junior Kit. The split plastic siderails are components of the bed, the siderails cannot be removed. The SoftDrop function enables smooth and quiet folding of the siderails. Fig. Eleganza 2 with split plastic siderails. D9U001GRA-0101_04...
- Page 42 Fig. Folding down the split plastic siderail. To fold siderails down: Unlock siderails by pulling the release handle (1). The siderail will fold down smoothly due to Soft Drop function (2). NOTE: If pressure is placed on the siderail from inside the bed (by either the mattress or patient) and it is not possible to fold down the siderail, grip the siderail by the upper section and push the siderail towards the middle of the bed and then repeat steps 1 and 2.
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Page 43: Integrated Siderails Functions (Optional)
10.10.2 Angle indicators It is possible to equip the Eleganza 2 with integrated angle indicators. The angle indicators are integrated in all siderails. The angle indicator in foot siderails is not illuminated and is used for angle measurement when the bed is positioned in the Trendelenburg and Reverse Trendelenburg positions. -
Page 44: Castor Control And Bed Transport
10.11 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 45: Emr Ready (Optional)
Always disconnect Ethernet cable from the bed before transport! Upon request it is possible to equip Eleganza 2 with EMR Ready function. This function detects informations about safe conditions of the bed (e.g. status of siderails up/down, backrest 30° angle detection, detection of lowest safe height of mattress platform etc.). -
Page 46: Accessories
Only the manufacturers original accessories can be used. 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. The following accessories are suitable for the Eleganza 2: Lifting pole ... -
Page 47: Lifting Pole
Hang the grab handle on the lifting pole. NOTE: The lifting pole is not a part of the delivery and needs to be ordered separately. NOTE: The date of manufacture is marked on the grab handle. LINET® recommends replacing the plastic grab handle every four years. -
Page 48: Infusion Stands
11.2 Infusion Stands WARNING! Risk of injury or collision due using of unsuitable accessories! Use infusion stands exclusively for accessories listed in this user manual. Do not use infusion stands for hanging infusion pumps, dosing devices etc. as this equipment might collide with movable parts of the bed. -
Page 49: Accessory Rail
11.4 Accessory Rail WARNING! Risk of injuring the personnel, patients or risk of damaging the bed due to incorrect placement of the accessories! Always ensure the accessory placed on the accessory rail is not in collision with bed or with patient. ... -
Page 50: Oxygen Bottle Holder
11.5 Oxygen Bottle Holder WARNING! Risk of injury by the oxygen bottle holder or due to incorrect use or due to careless transport! Ensure the oxygen bottle holder is correctly fitted in the correct position. Be aware of persons or objects in close proximity when moving or manipulating the bed equipped with oxygen bottle holder. -
Page 51: Bed End Holder
11.7 Bed End Holder Bed end holder is designed for hanging deferred bed end to the holder. Placement: On the upper edge of the bed end Fig. Bed end holder 11.8 Name holder Name holder is designed for placing patient’s name in the holder. Placement: ... -
Page 52: Handset Holder
11.10 Handset Holder WARNING! Risk of injuring the patient or damaging the bed due to incorrect placement! Never place handset holder on the skewed edge of bed ends. Never place handset holder to the handles near the Mobilift controller. ... -
Page 53: Compressor Holder
11.12 Compressor Holder Compressor holder is designed for handing compressor on the foot end of the bed. Placement: On the foot end of the bed, between bed end handles Load capacity: Maximum load of the holder is 10 kg. Fig. -
Page 54: Soft Guards For Siderails
11.15 Soft Guards for Siderails WARNING! Risk of damaging the guards due to incorrect use! Always take down the guards before transporting the bed. Always remove the foam insert from the guards before washing. Ensure the transparent nets are bears on the control elements of the bed. There is a risk of damaging the guards in case of their replacement. -
Page 55: Protector
® 11.16 Protector WARNING! Risk of injury due to patient falling out of bed! Ensure that Protector® is securely anchored to the bushing. To check stability, pull 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 56: Siderail Extension - „Extender " (Sr55)
® 11.17 Siderail extension – „Extender “ (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 57: X-Ray Backrest (Optional)
Backrest X-ray option Upon request it is possible to equip Eleganza 2 with x-ray translucent backrest which consists of HPL. The bed is equipped with x-ray cassette holder located under the backrest. This design allows taking x-ray images of the patient’s lungs and upper body parts without moving the patient. -
Page 58: Safesense
Sensor mat should be fixed on the seat section of mattress platform. Follow user manual for SafeSense. 11.20 Mattress The manufacturer recommends the use of the following mattress systems on the Eleganza 2 bed: EffectaCare 10, EffectaCare 20, PrimaCare 10, PrimaCare 20, CliniCare 10, CliniCare 20, CliniCare 30 NOTE: The maximum recommended height of the mattress is 14 cm for split plastic siderails and 14 cm for single collapsible siderails. -
Page 59: Cleaning And Disinfection
12 Cleaning and Disinfection WARNING! Risk of injury when working on the bed! Prior to assembly, disassembly, cleaning and maintenance, ensure that all adjustment functions are locked. Ensure the bed is disconnected from the mains during cleaning process. ... -
Page 60: General Instructions For Cleaning And Disinfection
12.2 General Instructions for Cleaning and Disinfection 12.2.1 Daily Cleaning It is recommended to clean all parts of the bed which are touched by patient or personnel (e.g. siderails, bed ends, handset, lifting pole etc.) and all handles, all control elements and accessory rails. 12.2.2 Cleaning before Changing Patients It is recommended to completely clean and disinfects all parts of the bed which are touched by patient or personnel (see Daily Cleaning), mattress platform, columns, undercarriage covers and mattress. -
Page 61: Choosing Of Detergents Or Disinfections
Risk of damaging the bed due to use of incorrect detergent! Always consult choosing of the detergent and its dilution with manufacturer of the detergents according to the material table below. Changing Part of bed – Eleganza 2 Material (*) Daily C&D Complete C&D patient C&D Siderails (stickers) ... -
Page 62: Troubleshooting
13 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... -
Page 63: Maintenance
14.1 Maintenance Work ® The connector replacement should only be carried out by service personnel trained by LINET . For service related instructions, please refer to the service documentation. Ensure the following maintenance work is performed every 12 months by the manufacturer or by a qualified service organisation trained and certified by the manufacturer. -
Page 64: Functioning
14.1.3 Wear Check all bolts and tighten if necessary. Check all locking mechanisms. Check the bed for wear, scratches or rub marks. Eliminate the cause if necessary. Have any defective parts replaced. 14.2 Functioning Check that all bed adjustments reach the maximum position. - Page 65 14.2.4 Safety checks WARNING! Incorrect safety checks can cause injuries! Ensure that safety checks are performed by qualified or authorised personnel certified by the manufacturer. Ensure that the safety checks are recorded in the service and maintenance log. WARNING! A defective bed can cause injuries! ...
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Page 66: Disposal
PCB or CFC. Noise emissions and vibrations meet the directives for ® healthcare facilities. LINET has taken care to ensure all wood used in the production of its bed systems is responsibly source (Mahagony, Jacaranda, Ebony, Teak or wood from Amazonian / rainforests are not used. -
Page 67: Warranty
16 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: Do not continue to use the bed. -
Page 68: Afssaps Declaration
17 AFSSAPS Declaration D9U001GRA-0101_04... -
Page 69: Ec Declaration Of Conformity
18 EC Declaration of Conformity D9U001GRA-0101_04... -
Page 70: Technical Specifications
19 Technical Specifications 19.1 Mechanical Specification (standard version) External dimensions With split plastic siderails and standard bumpers (10 cm) 223,3 cm x 99,5 cm Mattress dimensions 200 cm x 90 cm Maximum Height of Mattress 18 cm* Siderail length Split plastic head siderail 104,2 cm Split plastic middle siderail 95,5 cm... -
Page 71: Environmental Conditions
15° Maximum Calfrest Angle 32° Maximum Thighrest Angle Auto-regression 11 cm 16° Trendelenburg Position 16° Reverse Trendelenburg Position Weight (Depending on Equipment) 156 kg Safe Working Load (including Mattress and Accessories) 250 kg Maximum Patient Weight Application environment 1, 2 185 kg Application environment 3, 5 215 kg... -
Page 72: Electrical Specification
Eleganza 2 requires special preliminary measures pertaining to EMC that necessitates installation and commissioning in conformity with the EMC information given in this Manual. Eleganza 2 is intended for the application in electromagnetic environment as specified below. The customer or user of the bed is responsible for these requirements are met. - Page 73 The high-frequency radiations are very low and unlikely to cause any interference to nearby electronic devices. High-frequency radiation Class B Eleganza 2 is suitable for all CISPR 11 institutions, including households and objects directly connected to Harmonic radiations Class A...
- Page 74 Manufacturer’s Manual and Declaration - Electromagnetic Resistance 19.5.2 Resistance Test Test Level as per Level of Compliance Electromagnetic IEC 60601 Environment ± 6 kV for contact ± 6 kV for contact Electrostatic Ensure that the ± 8 kV for air ±...
- Page 75 Resistance Test Test Level as per Level of Electromagnetic Environment IEC 60601 Compliance Conducted high 3 Vrms 3 Vrms Portable and mobile HF frequency 150 kHz to 80 MHz communication equipment should phenomena not be used nearer than in the IEC 61000-4-6 recommended distance calculated from suitable equation for frequency...
- Page 76 RF communications equipment and the Eleganza 2 Medical Bed The Eleganza 2 Medical Bed is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Eleganza 2 Medical Bed can help prevent...
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