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Tecnomed Italia MORPHEUS, Инструкция по установке, эксплуатации и обслуживанию

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45

ENGLISH

DECLARATION OF CONFORMITY

EC DECLARATION OF CONFORMITY 93/42 CEE
MODEL: MORPHEUS SURGICAL CHAIR 

Tecnomed Italy S.r.l. declares, under its sole responsibility, that the Class I medical device 
described below

Model: MORPhEUS

Code:  ____________________

Progressive number: __________________

to which this statement refers: 
complies with the Essential Requirements (annex 1) and the provisions of the Directives 
93/42/EEC transposed by means of Legislative Decree 46/97 and 2007/47/CE transposed 
by means of Legislative Decree 37/10, and is subject to the procedures laid down in Annex 
XII of Directive 93/42 CEE a.m.

_______ / _______ /_______     Castelvecchio di Monte Porzio

                                                                                                                  
Tecnomed Italia srl

Legal Representative
Luca Riccardi

Содержание MORPHEUS

Страница 1: ...V 8 00 CODE DE1000X Installation use and maintenance manual MORPHEUS surgical chair ...

Страница 2: ...NICAL SPECIFICATIONS 5 3 1 DIMENSIONS 5 4 IDENTIFICATION PLATES 5 5 PRODUCT PROFILE 5 6 CONFIGURATION 6 INSTALLATION 6 1 PRE ASSEMBLY 6 1 1 ASSEMBLY SETUP STANDARD CONFIGURATION 6 1 2 ASSEMBLY SETUP FULL CONFIGURATION AT THE CENTRE OF THE ROOM 6 2 INSTALLATION 7 INSTRUCTIONS FOR USE 7 1 STANDARD HAND CONTROLLER 7 1 1 HAND CONTROLLER WITH MEMORIES 7 2 CHAIR MOVEMENT CONTROL WITH JOYSTICK 7 3 SEAT R...

Страница 3: ...EELS 7 14 UNINTERRUPTIBLE POWR SOURCE 8 CLEANING AND STERILISING 9 MAINTENANCE 10 TROUBLESHOOTING 10 1 FIRMWARE 11 RELATED ITEMS 12 DISPOSAL 13 WARRANTY 14 1 DECLARATION OF CONFORMITY 15 CERTIFICATE OF WARRANTY 16 ELECTRICAL TEST PAGE 34 34 34 35 36 37 38 39 43 43 44 45 46 47 ...

Страница 4: ... avoided BILOGICAL HAZARD SYMBOL This symbol indicates the possible presence of risks of contamination due to contact with infected biological fluids or materials GENERAL INFORMATION SYMBOL This symbol indicates a piece of information that allows you to use the device more efficiently DISPOSAL SYMBOL This symbol indicates that the product should not be disposed of like normal waste but it should b...

Страница 5: ...blication are not binding Tecnomed Italia s r l pursues a policy of continuous product improvement and reserves the right to make changes to the product or to this manual without prior notice as long as said changes do not affect the safe use of the device Keep the manual within reach It is also strictly forbidden any kind of reproduction or appropriation of the text and or images in the manual th...

Страница 6: ...rification after clearly writing down the reason delivery refused accepted subject to verification package with packing tape pulled off delivery refused accepted subject to verification package with visible signs of damage cardboard bent delivery refused accepted subject to verification package extremely damaged and or partially open delivery refused accepted subject to verification 2 Leave the pr...

Страница 7: ...y are 3 Do not use the product If the product is damaged but the packaging presents no visible signs of damage proceed as follows 1 Inform the transport company no later than 30 days after delivery 2 Leave the product and the packaging as they are 3 Do not use the faulty product ATTENTION If the recipient fails to comply with any of the aforementioned provisions the damage shall be considered as i...

Страница 8: ... be either fixed or mobile DANGER Comply with the conditions of use provided in the Technical Specifications chapter and do not exceed the recommended values ATTENTION Before connecting the power cord make sure the electrical contacts are perfectly dry If necessary use compressed air to dry them DANGER The electrical system available at the installation site must comply with standards CEI 64 8 7 a...

Страница 9: ...For information on technical support produzione dentalastec it 3 1 WORK ENVIRONMENT FLOOR COMPOSITION The quality of the floor must meet the capacity standards standards specified in DIN1055 sheet 3 and present the pressure resistance laid down in DIN 18560 T1 ENVIRONMENTAL REQUIREMENTS Environmental temperature from 10 C to 40 C Optimum environmental temperature from 15 C to 30 C Relative air hum...

Страница 10: ...e cleaned and or sterilised following the instructions in paragraph Cleaning and sterilising on page 46 DANGER Cut off the power supply to the equipment by pressing the green ON OFF light button placed on the base of the surgical chair before carrying out any mainte nance or cleaning operation ATTENTION After sterilising the components in the autoclave wait for them to cool down before using them ...

Страница 11: ...nician DANGER Do not disassemble the device In case of malfunction please contact an authorised Tecnomed Italia s r l centre 4 1 SAFETY REQUIREMENTS Tecnomed Italia s r l declines any liability expressed or implied and cannot be held liable for personal injury and or direct or indirect property damage deriving from failure to comply with the instructions in this manual and or from incorrect instal...

Страница 12: ... from failure to comply with the instructions in this manual and or from incorrect installation and or use of the device and its accessories and or from improper and or lack of cleaning and or maintenance 5 2 STANDARDS CERTIFICATIONS Medical device The MORPHEUS surgical chair is fitted with CE marking The Morpheus device is classified as class IIa medical device based on rule 1 of annex IX of Dire...

Страница 13: ... to install a wall mounted thermal magnetic circuit breaker of 250 Volt 30mA upstream of the unit The 6 mm2 earthing conductor must be connected to the equipotential node of the site Fuses Identification Value Dimensions Protection Position FUSE F1 T 3 15 A 250V 5x20 230 VAC on control unit On the side of the power button FUSE F2 T 6 3 A 250V 5x20 30 VDC on control unit On the side of the power bu...

Страница 14: ...14 ENGLISH 5 3 1 DIMENSIONS ...

Страница 15: ...CATION PLATES Data on the plate Name of the manufacturer Name of the device Product code Serial number Power Voltage Weight Guide to reading the serial number 1308001 Week of production Progressive number Year of manufacture ...

Страница 16: ...ller for surgical chair move ment control I Accessories locking clamp J Joystick 1 K Joystick 2 L Support feet or wheels for surgical chair movement M Stability knob only for the optional version with wheels N Thigh rests infusion stand locking knob O Identification plate P Green power button ON OFF Q Leg rest length adjustment knob R Leg rest S Accessory support rail T Thigh rests locking knob ...

Страница 17: ...100 degrees Opt Base Base with fixed feet DE1000X 2 Base with wheels Opt DE1000X 5 Side guides Right side guide with clamp Opt DE1000X 5 1 Left side guide with clamp Opt DE1000X 6 Accessories for side guides Bivalent blood sampling armrest Opt DE1000X 7 Right and left articulated thigh rests set of 2 pieces Opt DE1000X 8 Infusion stand Opt DE1000X 9 UPS power supply Built in uninterruptible power ...

Страница 18: ...ation and or use of the device and its accessories and or from improper and or lack of cleaning and or maintenance 6 1 PRE ASSEMBLY The following figures show the minimum distances from various obstacles and all necessary information on surface connections and floor anchor points 6 1 1 ASSEMBLY SETUP STANDARD CONFIGURATION VALUE MM A 362 B 322 C 105 D 8 55 cm 80 cm 220 vac 32 cm 36 cm Minimum dist...

Страница 19: ...19 ENGLISH Positioning examples for standard configuration ...

Страница 20: ...20 ENGLISH ...

Страница 21: ...wer supply line 220 VAC 3x1 5 mm 2 Suction system enabling signal 2x1 mm 3 Media communication vga usb ethernet 4 Water connection 3 8 female 5 Air connection 3 8 female only with Wek decontamination system 6 Water drain connection 40 52 mm not intended for Aspirol code DE1002X 7 Suction tubing connection 40 52 mm ATTENTION The covers for surface connection are not included in the scope of supply ...

Страница 22: ...ISH Full configuration setup at the centre of the practice 1 2 3 The control unit in the figure belongs to Maycart and Aspirol units 4 5 6 Positioning examples for full configuration at the centre of the room ...

Страница 23: ...nd concrete floors you need to use special fasteners These are not included in the scope of supply The technician is responsible for the correct fixing of the equipment using appropriate fasteners ATTENTION Minimum floor sealing 300Kg m2 1 2 3 4 5 6 ...

Страница 24: ...24 ENGLISH 7 8 9 10 11 12 ...

Страница 25: ...25 ENGLISH 13 14 15 X4 16 17 18 ...

Страница 26: ...26 ENGLISH 19 20 21 22 For the electrical cabling see the following page 18 for the fitting of standard configuration page 22 for the fitting of full configuration at the centre of the room ...

Страница 27: ...e to comply with the instructions in this manual and or from incorrect installation and or use of the device and its accessories and or from improper and or lack of cleaning and or maintenance DANGER Pay attention when using the product as the automatic movements might give rise to dangerous situations even if minor DANGER The device and its accessories are supplied non sterile At the first use an...

Страница 28: ...sition manual G Quick lying position manual H Chair up I Chair down J Trendelenburg 30 K Trendelenburg 0 7 1 1 HAND CONTROLLER WITH MEMORIES A Chair on off light indicator B Backrest up C Backrest down D Leg rest up E Leg rest down F Quick sitting position automatic G Quick lying position H Chair up I Chair down J Trendelenburg 30 K Trendelenburg 0 ...

Страница 29: ...ht to raise the backrest D Move the joystick to the left to lower the backrest Left joystick A Push the joystick down to move the trendelenburg to 0 B Push the joystick up to move the trendelenburg to 30 C Move the joystick to the right to raise the leg rest D Move the joystick to the left to lower the leg rest Illustrations of the movements Trendelenburg Backrest leg rest Up down ...

Страница 30: ...D HEADREST 1 5 c m This headrest offers optimal support to the patient during the treatment thanks to its double articulat ing system that also allows adjusting its height by up to 15 cm 1 Turn the knob E clockwise to unlock the mech anism 2 Move the headrest to obtain the perfect setup 3 Turn the knob E counterclockwise to lock the mechanism 7 5 HOLLOW HEADREST The face rest provides excellent su...

Страница 31: ...cha nism 7 7 STANDARD ARMRESTS The left armrest is fixed while the right pivoting armrest can be moved to allow the patient to sit on and get up off the chair more easily ATTENTION The maximum allowed load on the armrests is 10 Kg Do not exceed this value 7 8 RAILS The right and left rails can be installed on the side of the surgical chair They are used for installing the optional accessories infu...

Страница 32: ...k the mecha nism 7 9 Blood sampling armrests CAUTION The maximum allowed load on the blood sampling armrests is 10 Kg Do not exceed this value S To adjust the height and or the sliding and or the opening of the blood sampling armrests proceed as follows 1 Rotate the lever S counterclockwise to unlock the mechanism 2 Adjust the armrest to fit your needs 3 Turn the lever S clockwise to lock the mech...

Страница 33: ...d this value M To adjust the height of the thigh rests proceed as follows 1 Turn the knob N counterclockwise to unlock the mechanism 2 Adjust the height 3 Turn the knob N clockwise to lock the mecha nism T To adjust the inclination of the thigh rests proceed as follows 1 Rotate the levers R counterclockwise to unlock the mechanism 2 Adjust the inclination 3 Rotate the levers R clockwise to lock th...

Страница 34: ...n stand proceed as follows 1 Turn the knob N counterclockwise to unlock the mechanism 2 Adjust the height 3 Turn the knob N clockwise to lock the mecha nism 7 12 BASE WITH FEET Z Z Z Z To level the chair turn the feet Z clockwise or counterclockwise 7 13 BASE WITH WHEELS You can opt for a base with castors available as optional accessory In this version the base is fitted with anti mark swivel whe...

Страница 35: ...esistance Per bloccare il movimento della poltrona spostare con un piede la leva delle ruote verso il basso STOP 7 14 UNINTERRUPTIBLE POWR SOURCE AUTONOMIA 1 ORA The UPS allows you to control all the functions of the chair for one hour in case there is a blackout or in case you need to move the chair from one room to another in postoperative phase ...

Страница 36: ...r indirect damages to property deriving from incorrect cleaning and or use of inappropriate materials CAUTION The device must not come in contact with liquids such as water and solvents aggressive or flammable substances or gases The cleaning agents must not penetrate into the unit as they might cause short circuit or malfunctions ATTENTION Never spray directly on the surface the disinfectant migh...

Страница 37: ...ATTENTION The staff of the practice is responsible for making sure that the product is serviced in due time Tecnomed Italia s r l denies any liability expressed or implied and cannot be held liable for injuries to persons and or direct or indirect damages to property deriving from failure to perform the safety technical controls and maintenance operations The product can be used only if all the te...

Страница 38: ... controller does not respond 1 Button stuck 2 Joystick stuck 1 Turn the device off and on again 2 Press all the keys on the controller to make sure their are not stuck 3 Contact an authorised Tecnomed Italia technician No motor movement 1 The power swith is off 2 The 24 VDC 6 3A fuse is blown 1 Press the power switch 2 Replace the fuse F2 with the one supplied REF 2 3 Contact an authorised Tecnome...

Страница 39: ...39 ENGLISH 10 1 1 How to switch the chair on 10 1 FIRMWARE THE GREEN POWER INDICATOR LIGHTS PRESS THE ON OFF SWITCH ON THE CHAIR THE 24 V TRANSFORMER IS POWERED ON CONTROL CARD IS POWERED ON ...

Страница 40: ...w to move the seat down PRESS THE CHAIR DOWN BUTTON HOLD THE BUTTON OR JOYSTICK TO MOVE THE CHAIR INTO ITS FULLY DOWN POSITION RELEASE THE BUTTON OR JOYSTICK TO HALT CHAIR DESCENT IMMEDIATELY PUSH THE CHAIR S JOYSTICK DOWN ...

Страница 41: ...3 How to move the seat up PRESS THE CHAIR UP BUTTON HOLD THE BUTTON OR JOYSTICK TO MOVE THE CHAIR INTO ITS FULLY UP POSITION RELEASE THE BUTTON OR JOYSTICK TO HALT CHAIR ASCENT IMMEDIATELY PUSH THE CHAIR S JOYSTICK UP ...

Страница 42: ...ACKREST INTO ITS FULLY UP POSITION RELEASE THE BUTTON OR JOYSTICK TO HALT BACKREST ASCENT IMMEDIATELY PUSH THE CHAIR S JOYSTICK TO THE RIGHT PRESS THE BACKREST DOWN BUTTON HOLD THE BUTTON OR JOYSTICK TO MOVE THE BACKREST INTO ITS FULLY DOWN POSITION RELEASE THE BUTTON OR JOYSTICK TO HALT BACKREST DESCENT IMMEDIATELY PUSH THE CHAIR S JOYSTICK TO THE LEFT ...

Страница 43: ...nearest authorised waste collection centre for electrical and electronic equipment Disposal must be carried out in accordance with the applicable environmental regulations for waste disposal The equipment must be properly prepared disinfection sterilisation before dismantling disposal For more information on the treatment recovery and recycling of this product please contact the Ecology and Enviro...

Страница 44: ...s r l technician the power supply connection is incorrectly made or the appropriate safety devices have not been installed the serial number series or CE marking are removed erased or tampered The warranty covers the replacement free of charge of the parts of the device resulting to be defective at the origin due to manufacturing defects The Customer cannot request the replacement of the entire pr...

Страница 45: ...essive number __________________ to which this statement refers complies with the Essential Requirements annex 1 and the provisions of the Directives 93 42 EEC transposed by means of Legislative Decree 46 97 and 2007 47 CE transposed by means of Legislative Decree 37 10 and is subject to the procedures laid down in Annex XII of Directive 93 42 CEE a m _______ _______ _______ Castelvecchio di Monte...

Страница 46: ... ADDRESS MODEL SEE LABEL ON UNDERSIDE SERIAL NUMBER SEE LABEL ON UNDERSIDE DATE OF PURCHASE NAME OF DEALER DISTRIBUTOR Garanzia Guarantee Garantie Garantía ________ ____ Mesi Months Mois Meses _ Ragione sociale studio Business name Raison sociale Razón social _ Indirizzo Address Adresse Direccion Etichetta prodotto Product label Etiquette produit Etiqueta producto Tecnomed Italia s r l Via Salvado...

Страница 47: ...47 ENGLISH 16 ELECTRICAL TEST Electrical safety test of earth ground and electrical insulation ...

Страница 48: ...48 ENGLISH Tecnomed Italia s r l Via Salvador Allende n 2 61040 Castelvecchio di Monte Porzio PU Italy Phone 39 0721 95 51 25 Fax 39 0721 95 52 29 www dentalastec it ...

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