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LINET ELEGANZA 1 Instructions For Use And Technical Description Download Page 7

D9U001GT0-0101_09

           

           7

USE MATTRESS RECOMMENDED BY MANUFACTURER

WEIGHT OF BED

DO NOT PUT ANY OBJECTS HERE

DESIGNATION OF HOSPITAL BED FOR ADULTS

ALTERNATING CURRENT

DIRECT CURRENT

EAC MARKING 

WEEE SYMBOL (RECYCLE AS ELECTRONIC WASTE, 

DO NOT PUT INTO THE HOUSEHOLD WASTE)

MEDICAL DEVICE (compatible with Medical Device Regulation)

RECYCLING SYMBOL

DO NOT POLLUTE THE ENVIRONMENT

Summary of Contents for ELEGANZA 1

Page 1: ...ELEGANZA 1 Hospital bed for standard care D9U001GT0 0101 Version 09 Publication Date 2020 02 Instructions for Use and Technical Description...

Page 2: ...ll trademarks and brands are the property of the appropriate owners The manufacturer reserves the right to changes in the contents of the instructions for use that relate to the product s technical re...

Page 3: ...he Isolating Foil 32 9 1 3Isolating Foil 32 9 2Head Board and Foot Board 33 9 3Mattress support platform 35 9 3 1Shortened Bed 36 9 4Potential Equalisation 37 9 5Before Use 38 9 6Transport 38 9 7Firmw...

Page 4: ...mage WARNING warns about the risk of physical injury DANGER warns about the risk of fatal injury 1 1 2Structure of Warning Notices SIGNAL WORDS Type and source of danger Measures to avoid the danger 1...

Page 5: ...D9U001GT0 0101_09 5 1 4Symbols on the Package FRAGILE HANDLE WITH CARE THIS WAY UP KEEP DRY PROTECT FROM HUMIDITY PAPER RECYCLING SYMBOL DO NOT USE HAND TRUCK HERE DO NOT STACK DURING STORAGE...

Page 6: ...DOOR USE PROTECTION AGAINST ACCIDENTS DUE TO ELECTRICAL CURRENT TYPE B APPLIED PARTS SAFETY ISOLATING TRANSFORMER GENERAL CE MARK OF CONFORMITY WITH EU REGULATION SAFETY MARK BED CERTIFIED IN T V S D...

Page 7: ...ANY OBJECTS HERE DESIGNATION OF HOSPITAL BED FOR ADULTS ALTERNATING CURRENT DIRECT CURRENT EAC MARKING WEEE SYMBOL RECYCLE AS ELECTRONIC WASTE DO NOT PUT INTO THE HOUSEHOLD WASTE MEDICAL DEVICE compa...

Page 8: ...D9U001GT0 0101_09 8 HEAD BOARD UNLOCKED OR FOOT BOARD UNLOCKED HEAD BOARD LOCKED OR FOOT BOARD LOCKED...

Page 9: ...rsion 1 1 5 6 7 8 9 10 4 2 3 Fig Serial Label with UDI Eleganza 1 version 2 1 5 6 7 8 9 10 4 2 3 1 Address of Manufacturer 2 Manufacturing Date Year Month Day 3 DI Device Identifier GTIN Global Trade...

Page 10: ...ent actuator overload REPEATED BEEP 0 6s sound 2 6s silence STOP error all STOP buttons are disabled REPEATED BEEP 0 1s sound 3s silence switching of the transformer winding error Brazil BEEP lasting...

Page 11: ...ER LED MEANING lit connected to the mains flashing 0 6s lit 0 6s not lit keyboard error flashing inverted to Lock LED error first fault flashing 0 1s lit 0 1s not lit service mode not lit disconnected...

Page 12: ...ccording to IEC 60601 2 52 For application environment 1 intensive critical care and 2 acute care reduce Safe working Load by 65 kg For application environ ment 3 long term care and 5 ambulatory care...

Page 13: ...dware ICU Intensive Care Unit INT Duty Cycle IP Ingress Protection IV Intravenous LED Light Emitting Diodes ME Medical Electrical Equipment ON Activation OFF Deactivation ppm parts per million million...

Page 14: ...za 1 bed avoid squeezing those between parts of the Eleganza 1 bed WARNING Eleganza 1 bed should not be used with bed hoists and bed lifts WARNING To avoid risk of electric shock this equipment must o...

Page 15: ...acturer and the competent authority of the Member State in which the user and or patient is established WARNING Only authorised and trained person using the tool is allowed to change fuses and power s...

Page 16: ...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 exclusively by pulling on th...

Page 17: ...nts on patient safety are the subject of the clinical evaluation including evaluation of the risk benefit ratio The relevant safety issues are the part of the risk management file Patient in bed indoo...

Page 18: ...ism 4 Single collapsible siderails 5 Head Board 6 Handset 7 Castor 8 Fifth Castor 9 CPR lever Backrest release 10 Central castor control lever 11 Calfrest Handle 12 Corner Bumper 13 Linen shelf 14 Min...

Page 19: ...Control element integrated in siderail 4 Head Board 5 Castors 6 Siderail release mechanism based on tipping down 7 Central castor system lever 8 Linen shelf 9 Supervisor board Fig Overview Eleganza 1...

Page 20: ...Head Plastic Siderail 3 Foot Siderail 4 Mattress Platform Removable Plastic Parts 5 Foot Board 6 Linen Shelf 7 Brake Lever optional 8 Siderail Release Mechanism based on lifting towards the user 9 Cas...

Page 21: ...echanism 3 Mattress base 4 Head board 5 Castors 6 Control element integrated in siderail 7 Single collapsible siderail 8 Central castor system lever 9 Linen shelf Fig Overview Eleganza 1 Wooden Head b...

Page 22: ...ing of fixed HPL parts 5 Head board 6 Handset 7 Protective bumper 8 Castor 150 mm 9 Lockable box for mains cable 10 Accessory rail 11 CPR lever 12 Central castor system lever 13 Linen shelf with non r...

Page 23: ...ad board 5 Protective bumper 6 Bed foot with the possibility of fixation to the floor 7 Lockable box for mains cable 8 Accessory rail 9 Siderail release mechanism 10 CPR lever 11 Linen shelf with non...

Page 24: ...siderail Foot siderail Head siderail Collapsible siderails 96 5 cm 49 5 cm 146 5 cm Siderail height Split siderail Foot siderail Head siderail Collapsible siderails 35 cm 35 cm 54 5 cm Maximum Mattre...

Page 25: ...astor diameter 150 mm 37 cm 73 5 cm 39 5 cm 76 cm Maximum Backrest Angle 70 Maximum Thighrest Angle 27 Maximum Calfrest Angle 21 Ergoframe 10 cm 6 cm Trendelenburg Angle 15 Reverse Trendelenburg Angle...

Page 26: ...2 min ON 18 min OFF Accumulator Fuse Version 1 Version 2 Version 5 Version 6 2 sealed lead batteries 12 V 15 A Fuse Capacity 1 2 Ah 2x T1 6A L 250 V 2x T3 15A L 250 V 2x T1 6A L 250 V 2x T3 15A L 250...

Page 27: ...C 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 45 90 135 180 225 270 a 315 0 UT 1 cycle and 70 UT 25 30 cycle Single phase at 0 0 UT...

Page 28: ...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...

Page 29: ...n with individual braking system s 125 mm Tente Motion with central braking system o 150 mm Tente Motion with central braking system o 150 mm Tente Motion fifth castor o Control Elements supervisor bo...

Page 30: ...der Coating Colors RAL 9002 grey s Powder coated metal parts RAL 9006 light grey RAL 7043 dark grey o 8 2 3Eleganza 1 Model 1GTD Nursing Bed s standard o optional Mattress Platform mattress platform c...

Page 31: ...unit see Accumulator Activation Install equipment and accessories In case of delivery with dismounted head board and foot board mount the head board and foot board see Head Board and Foot Board Set u...

Page 32: ...ction If isolating foil is damaged contact the manufacturer s service department immediately NOTE It is recommended to wear gloves when removing the isolating foil 9 1 2Removing the Isolating Foil 9 1...

Page 33: ...pecially when moving the bed Ensure head board and foot board locks are locked especially when moving the bed WARNING Risk of injury when removing the head board and foot board Before removing head bo...

Page 34: ...2 Unlocked Install head board and foot board as follows Unlock safety levers on corner posts Slide head board and foot board into slots on corners posts with coloured panels outside Lock safety levers...

Page 35: ...m Pull out mattress support platform plastic sections Place mattress support platform plastic sections in directions indicated by the orientation of the picture of person on the plastic sections The c...

Page 36: ...ng Eleganza 1 medical bed can be delivered in the version with bed shortening Purpose of this shortened version is to facilitate bed transport It is recommended to use mattress with length of 190 cm w...

Page 37: ...nt is connected to any intravascular or intracardiac device Before connecting the patient to an intravascular intra cardiac device Connect the ground wire of the device to the potential equalisation c...

Page 38: ...even surfaces without any gaps 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...

Page 39: ...ox opened There is a risk of damaging by usage or by a mentally unstable patient Always place the mains cable to the cut out in the doors of the box Otherwise there is a risk of damaging the mains cab...

Page 40: ...discharge cycles recurrence of deep discharge bed is often powered only by the accumulator The accumulator serves as a backup during power failures during transport of the patient or for emergency be...

Page 41: ...n or accumulator fuses are faulty contact service department of the manufacturer in case of such signa lisation To maintain maximum functionality of the accumulator Unplug the bed from the mains as le...

Page 42: ...r To avoid damaging the bed and the environment during storage Deactivate the accumulator on the Attendant Control Panel To deactivate the accumulator on the Attendant Control Panel Disconnect the bed...

Page 43: ...individual functions on the Attendant Control Panel affects all of the control elements If the bed does not react to individual position settings Check whether the function is disabled on the Attendan...

Page 44: ...lt Button mattress platform tilt only 11 CPR Resuscitation Position Button 12 Trendelenburg Position Button optional 13 Cardiac Chair Position Button 14 Accumulator Charge Status LED only for beds wit...

Page 45: ...k button 2 The respective LED flashes 1 to indicate the lock NOTE The individual functions are locked in the central control panel the satellite control the handset and the siderail control The foot c...

Page 46: ...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 Where the handset...

Page 47: ...Adjustment Buttons To set positions Activate the keypad by pressing the GO button Press and hold corresponding button until required position is reached NOTE Depending on the patient s condition the...

Page 48: ...O Button 4 Auto Contour Buttons 5 Height Adjustment Buttons Fig Control Element Integrated in the Siderail To set positions Activate the keypad by pressing the GO button Press and hold corresponding b...

Page 49: ...ng pole when mattress platform is moving It is possible to equip the bed with a foot control The foot controllers enable the adjustment of the bed height or pre programmed examination positions Fig Fo...

Page 50: ...erails and backrest Press the backrest down only by the mattress guard handle or the siderail The CPR is located on the mattress platform frame under the thignrest part CPR allows quick mechanical low...

Page 51: ...jure the patient staff or the third parties Model variants Without siderails With single collapsible siderails 3 4 siderail With single collapsible siderails controlled from the bottom With split plas...

Page 52: ...ally Check if the siderail is fixed in place 12 8 2Single collapsible siderails controlled from the bottom The single collapsible siderails are components of the bed The siderails cannot be dismounted...

Page 53: ...it latches The locking of each siderail is indicated by an audible click when locked in place Ensure that the siderail is locked properly 12 8 3Split Plastic Siderails SR22 WARNING Risk of injury due...

Page 54: ...s are components of the bed the siderails cannot be removed Fig Releasing mechanism of the split plastic siderails To fold siderails down Take hold of the siderail handle and push siderail towards mat...

Page 55: ...pace under the mattress platform To move the bed Adjust the bed height to at least 20cm below maximum height Push the bed using handles on head or foot board 12 9 1Central braking control Double sided...

Page 56: ...d 3 Forward Movement The front left castor is locked The bed moves straight ahead If the bed is equipped with a fifth cas tor this castor determines the direction of movement 12 9 2Individual braking...

Page 57: ...osition of the mattress support platform for 3 minutes After elapsing the GO period 3 minutes the green light has lowered intensity in the lowest position of the mattress support plat form NOTE The gr...

Page 58: ...steel for lifting pole 4 hooks chrome plated Telescopic IV pole 4 plastic hooks chrome plated 4 plastic hooks chrome plated S shaped top part with lock against unwanted rotation 4 metal hooks chrome p...

Page 59: ...f manufacture is marked on the grab handle NOTE LINET recommends replacing the plastic grab handle every four years 15 2Infusion Stands WARNING Risk of injury due to use of unsuitable accessories Use...

Page 60: ...d end of the bed so it will not collide when folding down the siderails 15 5 Urinary bag holder optional Urinary bag holders are situated on both sides of thighrest section of the mattress support pla...

Page 61: ...der for siderails controlled from top 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 re...

Page 62: ...m bottom SR57 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 consequence...

Page 63: ...r Install the Extender as follows Place the Extender without securing screws on the upper edge of the siderail Siderails must be in upper position Square hole is pointed into the mattress platform Ins...

Page 64: ...NTS THAT ARE INTENDED TO BE CLEANED Do not clean what is not mentioned in this column MATERIALS SURFACES OF THE MENTIONED BED COMPONENTS Competent user is responsible for check if used cleaning agents...

Page 65: ...aning mode daily before changing patient or complete Electronic parts that may be contaminated clean carefully and only their outer side Never open those connectors due to cleaning or disinfection Tho...

Page 66: ...1 Daily C D Changing patient C D Complete C D Siderails stickers Split plastic Single collapsible Siderails mechanism Head board and foot board stickers Controllers cables Mattress platform covers Und...

Page 67: ...bled function Drive motors have no power Defective drive motors Defective accumulator Check the mains connection Notify the service department of manufacturer Plug inserted incorrectly Insert the main...

Page 68: ...ulator is working properly Disconnect the bed from the mains power to check signalisation of accumulator indicator according to the instructions for use Have the accumulator replaced if it is not work...

Page 69: ...through an authorized company more details on www linet cz 19 2Disposal The main objective of the obligations arising from the European Directive No 2012 19 EU on Waste Electric and Electronic Equip m...

Page 70: ...l material and manufacturing re lated 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...

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