LINET Eleganza 3XC Page 12 User Manual And Technical Description Download

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2.2

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.



Disconnect the bed from the mains during exceptional cases. (i. e. a storm).

Standards and Regulations

The bed complies with the following standards:



EN 60601-1:2006/A1:2013



EN 60601-1-2:2015



EN 60601-1-6:2010



EN 60601-2-52:2010



EN ISO 10993-5:2009



EN ISO 10993-10:2013



93/42/EEC



2011/65/EU

The manufacturer adheres to a certified quality management system in compliance with the following
standards:



EN ISO 9001



EN ISO 14001



EN ISO 13485

Summary of Contents for 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: ...s 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 Reproduction also excerpts only with prior permission of the publis...

Page 3: ...Manipulation 21 9 1 Supervisor Panel 22 9 2 Handset 25 9 3 Foot Control 26 9 4 Integrated Control Element Siderail 27 9 5 CPR Backrest Release 28 9 6 Siderails 29 9 7 Eleganza Protector 30 9 8 Undercarriage 31 9 9 Mobi Lift 32 9 10 Accessories 33 9 11 Writing Table 36 10 Patient Weighing WS17 37 10 1 Weighing System Control Panel 37 11 X ray Lung Examination 40 11 1 Necessary Steps before the Exam...

Page 4: ...ns 51 19 2 Environmental conditions 51 19 3 Electrical Specifications 52 19 4 Electromagnetic Compatibility 53 20 Battery Activation 56 20 1 Placement of Control Section 56 20 2 Removing the Isolating Foil 56 20 3 Isolating Foil 56 ...

Page 5: ...t 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 lev...

Page 6: ... 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 Maximum weight of patient Use mattress recommended by manufacturer Weight of bed Do not put any objects here Designation of hospital bed for adults ...

Page 7: ...s Electrical Specification Serial Number PI Product Identifier Fig Serial Label with UDI Eleganza 3XC without scales Address of Distributor 1D Bar code GS1 128 Serial Number Manufacturing Date Year Month Day DI Device Identifier GTIN Global Trade Item Number 2D Bar Code GS1 DataMatrix DI PI UDI Symbols Electrical Specification Serial Number PI Product Identifier Fig Serial Label with UDI Eleganza ...

Page 8: ... 2 acute care reduce Safe working Load by 65 kg For application environment 3 long term care and 5 ambulatory care reduce Safe working Load by 35 kg Safe Working Load the highest allowable load on the bed patient mattress accessories and the load supported by those accessories Siderail Height the height of the upper crossbar or the edges of the siderails not the highest point of the siderail contr...

Page 9: ...EF Reference Number product type depending on configuration SCU System Control Unit SN Serial Number SWL Safe Working Load UDI Unique Device Identification for medical devices 2 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 Siderails of Eleganza 3XC should be located in the up position to redu...

Page 10: ...nly 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 Incompatible mattresses can create hazards WARNING WARNING WARNING Do not modify this equipment without authorization of the manufacturer WARNING No modification of this equipment is allowed WARNING During ...

Page 11: ...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...

Page 12: ...cessary conditions for electrical installations Disconnect the bed from the mains during exceptional cases i e a storm 3 Standards and Regulations The bed complies with the following standards EN 60601 1 2006 A1 2013 EN 60601 1 2 2015 EN 60601 1 6 2010 EN 60601 2 52 2010 EN ISO 10993 5 2009 EN ISO 10993 10 2013 93 42 EEC 2011 65 EU The manufacturer adheres to a certified quality management system ...

Page 13: ...pter Correct use Use private use without qualified supervision NOTE For information concerning uses other than those outlined in the Correct Use section above please contact LINET LINET s efforts in research design and manufacture ensure LINET products are of the highest quality and fit for their intended purpose However LINET can take no responsibility for any damage to the products or any harm t...

Page 14: ... Integral 150 mm with fifth castor Tente Integral 150 mm with fifth retractable castor Tente Integral 150 mm double castor Tente Integral 150 mm double castors with fifth castor Tente Integral 150 mm double castors with fifth retractable castor Control Elements Supervisor panel nurse control panel with position memory Handset Handset with adapter for simple connection Plug and Play Handset with il...

Page 15: ...g 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 exclusively on a suitable floor surface see Transport Ensure that the mains cable does not collide or get stretched when adjusting the b...

Page 16: ...7 16 15 14 13 12 11 10 Fig Overview of Eleganza 3CX 1 Supervisor Panel 2 Removable Foot Board 3 Eleganza Protector 4 Split Siderail Middle Section 5 Control Element Integrated in Split Siderail 6 Split Siderail Head Section 7 Four part Mattress Platform with Ergoframe System 8 Removable Head Board 9 Corner Bumper 10 X ray Cassette Holder 11 5th Castor 12 Foot Control 13 Castor Diameter 150 mm with...

Page 17: ...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 7 2 Potential Equalisation The bed contains a protective conductor between all metal parts Fig Ground Pin Connect the ground wire to the ground pin under the head board ...

Page 18: ...rging 2 To store accumulators on dry and cold places from 10 C to 0 C 3 To prevent accumulators from being in the sunshine The battery supplied with the bed is delivered uncharged The battery serves as a backup during power failures or while transporting the patient NOTE Batteries will remain in fully functional condition only for a certain period of time which is dictated by the laws of physics a...

Page 19: ...ct battery changing can damage the bed Have the battery changed exclusively by qualified personnel Caution Warning Risk of damage or destruction of battery If battery is faulty degassing can occur In rare cases this can cause deformation of the battery pack housing and mains control box If this occurs the bed must be immediately taken out of service and taken to an adequately ventilated room witho...

Page 20: ...e 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 Pos...

Page 21: ...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 individua...

Page 22: ...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...

Page 23: ...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...

Page 24: ...with cardiac arrhythmia and breathing difficulties Settings after pressing position button 18 The foot of the mattress platform is tilted to the lowest position The backrest and thigh rest are moved to the upright position You can disable this function If individual functions for example thigh rest adjustment are disabled they are not performed Examination Position The examination position is suit...

Page 25: ...lable with and without button illumination The button illumination of the illuminated handset is active when the bed is connected to the mains The functions of both handsets are identical Fig Handset 1 Thigh Rest Backrest Lock LED 2 Thigh Rest Adjustment Button 3 Backrest Adjustment Button 4 GO Button 5 Height Adjustment Buttons 6 Auto Contour Button 7 Height Auto Contour Lock LED 8 Button Flashli...

Page 26: ...t Control The foot control is optional and allows you to set up the height of the bed with your feet Fig Foot Control 1 Lower Mattress Platform Foot Control 2 Examination Position Foot Control 3 Protection Frame against Unwanted Activation 4 Raise Mattress Platform Foot Control Set the position as follows Press and hold the foot switch until the desired position is reached ...

Page 27: ...grated control element is optional The integrated control element is attached to the split siderail Fig Integrated Control Element 1 Thigh Rest Adjustment Button 2 Backrest Adjustment Button 3 GO Button 4 Auto Contour Button 5 Height Adjustment Buttons ...

Page 28: ...nd hold release handle 1 Press the backrest down 9 5 1 Mechanical Adjustment of Calf Rest Incorrect lowering can injure the patient Hold the calf rest by both handles at all times when lowering the calf rest Lower the calf rest carefully to prevent it from falling suddenly Warning You can adjust the calf rest mechanically A special locking mechanism allows the position to be adjusted To raise the ...

Page 29: ...Adjust wire mattress retainer Turn the safety catches frame by 90 and push them in To shorten the bed Pull out the safety catches 1 at the foot end on both sides of the frame Turn the safety catches 1 by 90 The safety lock is released 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 9 6 Siderails Eleganza 3XC is equi...

Page 30: ...he split siderail pull up the split siderail until it latches To fold down the split siderail push the siderail top towards the bed release lock buttons and fold down the split siderail slowly 9 7 Eleganza Protector Eleganza Protector is not a component of the bed Eleganza Protector is optionally available To mount Eleganza Protector Fig Mounting of Eleganza Protector Warning Risk of injury due to...

Page 31: ...rotectors cannot be replaced e g Protector 2 38 with Eleganza 3 2 52 because of risks of damaging the bed collision with movable parts of the bed and the Protector will lose his function of locking into the lock 9 8 Undercarriage Caution Incorrect transport can damage the bed Disconnect the bed from the mains before moving it Store the mains cable in a safe place plastic hook on the bed during tra...

Page 32: ...t is a support handle with a built in height adjustment button It allows the patient to raise and lower the mattress platform Fig Mobi Lift Handles 9 9 1 Operation of Support Handles Warning Risk of injury due to slipping or falling when standing up Ensure that the support handles are completely inserted in the sleeve fittings Ensure that no bed linen is caught between the sleeve fitting and the s...

Page 33: ...nt the bed from tipping over ensure that the lifting pole does not project out from the bed Replace the plastic handle every 4 years Lifting Pole Positions Over the backrest working position Parallel to the head board To install the lifting pole Insert the lifting pole in the corresponding sleeve fittings at the head of the bed corners Ensure that the safety pin locks into place A plastic grab han...

Page 34: ...ions Ensure that the weight bearing capacity of the infusion stand and the four hooks is not exceeded The maximum weight bearing capacity per hook is 2 kg Warning Risk of injury due to use of unsuitable accessories Use infusion stands exclusively for accessories listed in the instructions for use Do not use infusion stands for hanging infusion pumps dosing devices etc as this equipment might colli...

Page 35: ...don bottle basket Urine bag holder Fig Urine bag holder Stainless steel holder for suspending urine bags Redon bottle basket Fig Redon bottle basket Coated basket to hold Redon bottles 9 10 4 Holder for Anti decubitus Mattress Compressor Fig Holder for Anti decubitus Mattress Compressor The holder for the anti decubitus mattress compressor is only to be used on bed ends Suspend the holder for the ...

Page 36: ...ttress Platform Element Covers To facilitate cleaning the mattress platform cover elements are removable The cover plates provide additional support for the mattress To clean and disinfect the bed completely remove the mattress platform covers 9 10 7 Towel Holder Fig Towel Holder The towel holder is only suitable for plastic bed ends 9 11 Writing Table Fig Writing Table Writing table to be placed ...

Page 37: ...use of scales due to incomplete preparation Before each patient admission tare the scales CAUTION 2 Taring The taring is done in the range from 5kg to 249 5kg The taring is used to set 0 on the display before placing the patient on the bed It is used to show actual weight of the patient The taring must be done on the unloaded bed without patient It is recommended to position mattress platform abou...

Page 38: ...ted when the scales are stabilized Press button 5 for 2 s The display shows the original weight value and the indicator of Hold Mode is not illuminated To deactivate Hold Mode without fixing the weight value Press button 4 5 Setting Mode To set date date format time and unit of weight Press button 4 and button 5 simultaneously for 3 s The value to be changed flashes on the display To navigate in l...

Page 39: ... in tilt The bed can weight in tilt The guarantee of accuracy is secured by spirit level which is located at the head foot end of the bed If the bubble is in the highlighted circle then the weighting is accurate 10 Zeroing Scales The zeroing can be done only in the range 5kg from the factory zero The zeroing is used to reset weight on the display and also to set up user zero which sets the maximum...

Page 40: ...ly under the edge of the mattress platform Correct position of x ray cassette holder using the tooth mechanism so that the upper edge of the x ray cassette is exactly under the patient s shoulder line Adjust parameters of the x ray device 12 Examination with C arm Backrest and seat of the bed are x ray translucent The bed is equipped with a column construction This design allows C arm assisted ope...

Page 41: ...r caustic detergents Never use detergents that deposit calcium carbonate Never use detergents with solvents that might affect the structure and consistency of the plastics 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 13 1 Preparing for Cleaning Prepare for cle...

Page 42: ...ging Patients 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 Freely accessible mattress surface Mobi Lift Accessory rails All plastic mattress platform covers Plastic undercarriage covers Telescopic columns Mattress on all sides Freely accessible metal parts...

Page 43: ...iderails in highest position Freely accessible mattress surface Mobi Lift Accessory rails All plastic mattress platform covers Plastic undercarriage covers Telescopic columns Mattress on all sides Freely accessible metal parts on the mattress platform Cable ducts Lifting pole sleeve fitting Infusion stand sleeve fitting Bumpers Castors Brakes Interior parts remove the mattress platform covers for ...

Page 44: ...ery Check the mains connection Notify the service department Plug inserted incorrectly Insert the mains plug correctly Faulty power source Notify the service department Faulty control element Notify the service department Backrest cannot be lowered from the upright position There is an object under the backrest or in the drive mechanism Remove the object Locking handle is defective Notify the serv...

Page 45: ...rvice organisation immediately 15 1 Maintenance Work Ensure that the following maintenance work is performed every 12 months by the manufacturer or by a qualified service organisation trained and certified by the manufacturer 15 1 1 Spare Parts The product label is located on the inside of the longitudinal rail of the mattress platform frame The product label contains information for claims and or...

Page 46: ...laced if necessary Check cables for signs of wear and entanglement Install a new cable or have it replaced if necessary Battery Check that the battery is working properly disconnect the bed from the mains Have the battery replaced if necessary 15 1 6 Castors Clean the castors completely Grease the castors if necessary Use Caro EP 2 by DEA or an equivalent grease Check that the castors work properl...

Page 47: ...o service organisations in which the manufacturer declares that the service organisation is qualified to perform maintenance on LINET products LINET makes every reasonable effort within research design and manufacturing of beds to ensure that their products are fit for purpose and product to the highest level of quality However LINET can take no responsibility for any damage caused to the product ...

Page 48: ...according to the symbols and by delivering it to an authorised person The product consists of recyclable steel plastic and electronic components 16 2 Disposal 16 2 1 Within Europe To dispose of the appliance When you dispose of your appliance do not put it into the household waste Send the appliance to the recycling of electrical appliances The materials of the appliance are reusable By reusing ma...

Page 49: ...continue to use the bed This product is covered by a 24 month warranty from the date of purchase The warranty covers all material and manufacturing related failures and errors Failures and errors caused by incorrect use and external effects are not covered Justified complaints will be fixed free of charge during the warranty period Proof of purchase with the date of purchase is required for all wa...

Page 50: ...50 18 EC Declaration of Conformity ...

Page 51: ...cm Mattress Platform Height Adjustment 40 cm 78 cm Ergoframe 6 cm 6 cm Maximum Backrest Angle 70 Maximum Thighrest Angle 30 Trendelenburg Position 13 Anti Trendelenburg Position 13 Weight Depending on Equipment 138 kg Safe Workload including Mattress and Accessories 250 kg Max Lifting Pole Load 75 kg Maximum patient weight Application environment 1 2 Application environment 3 5 185 kg 215 kg 19 2 ...

Page 52: ...tery Fuse Version 1 Version 2 Pb ACCU 2 x 12 V 1 2 Ah Fuse 15A 2x T1 6A L 250 V for 230 V version 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 Ensure that maintenance and service of electrical parts are perfor...

Page 53: ...her 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 WARNING Use of the accessories converters and other cables than specified and provided by manufacturer of this bed could lead to increase of electromagnetic emission or lower the electromagnetic immunity of this bed and lead to imp...

Page 54: ...ansients burst IEC 61000 4 4 2 kV for power line repetition frequency 100 kHz Surge IEC 61000 4 5 1 kV Line to line 2 kV Line to ground Conducted RF IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m Voltage dips short interruptions on power supply input lines IEC 61000 4 11 0 UT 0 5 cycle At 0 ...

Page 55: ...MA 1900 GSM 1900 DECT LTE band 1 3 4 25 UMTS Pulse modulation 217 Hz 28 2 450 2 400 2 570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE band 7 Pulse modulation 217 Hz 28 5 240 5 500 5 785 5 100 5 800 WLAN 802 11 a n Pulse modulation 217 Hz 9 NOTE There are applied no deviations to requirements of IEC 60601 1 2 ed 4 NOTE There are no known other measures for keeping the basic safety based on EMC phenom...

Page 56: ...moving the Isolating Foil 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 Pull ...

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