morpheus surgical chair

V.8.00

CODE DE1000X

Installation, use and maintenance manualMORPHEUS SURgical cHaiR

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CONTENTS

SECTION

1- SYMBOLS

1.1- WARNING LABELS

2- GENERAL WARNINGS

2.1 - GENERAL INSPECTION

2.2 - IN-TRANSIT DAMAGES FOR DELIVERIES IN ITALY

2.3 - IN-TRANSIT DAMAGES FOR DELIVERIES OUTSIDE ITALY

2.4 - TRANSPORT AND STORAGE CONDITIONS

3- SAFETY RULES FOR INSTALLATION

3.1 - WORK ENVIRONMENT

3.2 - MAXIMUM LOADS

4- SAFETY PROVISIONS

4.1 SAFETY REQUIREMENTS

5- PRODUCT DESCRIPTION

5.1 - INTENDED USE AND METhOD OF USE

5.2 - STANDARDS/CERTIFICATIONS

5.3 - TEChNICAL 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 ROTATION

7.4 - STANDARD hEADREST

7.5 - hOLLOW hEADREST

7.6 - LEG REST

7.7 - STANDARD ARMRESTS

7.8 - RAILS

7.9 - BLOOD SAMPLING ARMRESTS

7.10 - ThIGh RESTS

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SECTION

7.11 - INFUSION STAND

7.12 - BASE WITh FEET

7.13 - BASE WITh WhEELS

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

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1- SYMBOLS

MANUFACTURER SYMBOL. This symbol is placed on the product next to the name and address of the manufacturer.

SERIAL NUMBER SYMBOL. This symbol is placed on the product next to the serial number of the device.CE MARKING. This symbol indicates that the product has a CE marking in conformity with the provisions of Directive CEE 93/42 and subsequent amendments (Class I Devices).

Protection type against direct and indirect contacts: Class I. Protection against electric shock: Type B.

EARThING SYMBOL. This symbol indicates the presence of an earth terminal for protection against electric shock.

ALTERNATING CURRENT SYMBOL.

INSTRUCTIONS FOR OPERATION. This symbol indicates that you need to consult the user manual before using the device.

hAZARD SYMBOL. It indicates a dangerous situation that might result in moderate or severe/fatal injuries unless avoided.

WARNING SYMBOL. It indicates a dangerous situation that might result in moderate or mild injuries or damage to property unless 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 be recycled as per Directive 2002/95/ EC, 2002/96/ EC and 2003/108/ EC.

DO NOT SIT SYMBOL. This symbol indicates that it is forbidden to sit on the arm-rests.

STERILISABLE. This symbol indicates the possibility of sterilising the product in autoclave.

DEVICE ON/OFF SYMBOL. This symbol shown on the main switch indicates if the device is on (I) or off (O).

FRAGILE SYMBOL. This symbol indicates that the product inside the packaging is fragile. Avoid shocks.

PROTECT FROM hUMIDITY SYMBOL. This symbol indicates that the product must be kept away from water and humidity.

UP SYMBOL. Transport and store the product only in the direction indicated by the arrows.

DO NOT STACK SYMBOL.

TEMPERATURE LIMIT SYMBOL. From -10° to 50° C.

hUMIDITY LIMIT SYMBOL. From 10 to 90%.

ATMOSPhERIC PRESSURE LIMIT SYMBOL. From 500 to 1060 hPa.

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1.1- WARNING LABELS

It indicates a dangerous situation that might result in moderate or severe/fatal injuries unless avoided.

It indicates a dangerous situation that might result in moderate or mild injuries or damage to property unless avoided.

This symbol indicates the possible presence of risks of contamination due to contact with infected biological fluids or materials.

This icon provides information that allows you to use the device more efficiently.

2- GENERAL WARNINGS

• Read this manual carefully before carrying out any operation on the product, follow the warnings contained in it and keep it for future reference.

• This manual is intended to provide the user with instructions for correct installation and use of the product.

• The product must be used in accordance with the procedures contained in the manual and never for purposes other than those provided for therein.

• The user is responsible for the installation, operation and maintenance of the device.• The manual describes all product versions and optionals, therefore not all instructions are

applicable to your product.• The product may be equipped with additional components, which are described in this

manual.• The information, technical specifications, drawings contained in this publication 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; therefore, some of the instructions, specifications and images contained in this manual may differ slightly from the product purchased by you.

• All the materials contained in this manual are the property of Tecnomed Italia and/or of the companies represented by it. The images are not binding and are given for explanatory purposes only.

• This manual must be delivered together with the machine in case of resale.• The original text of this manual is in Italian.

DANGER! It is strictly forbidden to make changes to the device. Tecnomed Italia s.r.l. assumes NO responsibility for personal injury and/or direct or indirect property damage resulting from non-compliance with this requirement.

DANGER! 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 installation and/or use of the device and its accessories and/or from improper and/or lack of cleaning and/or maintenance.

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2.1 - GENERAL INSPECTION

ATTENTION! Check the package upon delivery and make sure it is intact and does not present signs of impact. Otherwise, follow the indications in paragraph 2.2 or 2.3.

2.2 - IN-TRANSIT DAMAGES FOR DELIVERIES IN ITALYUpon delivery, if the package/parcel shows visible signs of damage, the recipient must or may sign the delivery note conditionally, reserving the right to claim for any damages. The Italian law stipulates that “the receipt of goods by paying the amount due without reserving the right to claim for any damages, renders the rights of the recipient deriving from the contract void, except in cases of willful misconduct or negligence of the carrier” (art. 1698 CC). To reserve the right to claim for any damages, fill in the dedicated fields on the delivery note handed to you by the carrier before signing it. Each carrier has his own procedure for conditional delivery, therefore you need to ask him how to proceed. If the package presents clear signs of damage upon delivery, proceed as follows:1. Check the appearance and the condition of the packages. Make sure they are intact

and complete: if the document mentions several packages, make sure you received them all. The recipient and the carrier must sign the delivery note subject to verification 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 product and the packaging as they are. Take a photo and/or a video of the damaged package/parcel.

3. Do not use the product.4. Report the damages to the transport company.5. Report the damages to Tecnomed Italy srl ([email protected]).6. Do not return the product to Tecnomed Italy srl before receiving an answer and an

authorisation to do so.7. Send the signed delivery note to Tecnomed Italia srl.8. Leave the product and the packaging as they are.9. Do not use the product.

Note: if you suspect that the product might present hidden damages, not visible from the outside, sign the delivery note conditionally.

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 7 days after delivery.2. Report the damages to Tecnomed Italy srl ([email protected]).3. Leave the product and the packaging as they are.4. 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 if arising after delivery.

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2.3 - IN-TRANSIT DAMAGES FOR DELIVERIES OUTSIDE ITALY

ATTENTION! Tecnomed Italy srl shall not be liable for damages occurred during transit. Check the goods as soon as you receive them!If the package presents clear signs of damage upon delivery, proceed as follows:1. The recipient must note down the missing parts or the damage on the delivery note.

The recipient and the carrier must sign the delivery note. The recipient may claim the replacement of the product due to in-transit damages only based on such evidence.

2. Leave the product and the packaging as they 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 if arising after delivery.

2.4 - TRANSPORT AND STORAGE CONDITIONS

The product inside the packaging is fragile. Avoid shocks.

Keep the package away from water and humidity.

Transport and store the product only in the direction indicated by the arrows.

Do not stack.

Temperature limit: from -10° to 50° C.

humidity limit: from 10 to 90%.

Atmospheric pressure limit: from 500 to 1060 hPa.

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3- SAFETY RULES FOR INSTALLATION


ATTENTION! For safety reasons, Tecnomed Italia s.r.l., manufacturer of the Morpheus surgical chair, recommends that the installation, maintenance and repair operations are carried out only by authorised technical staff of Tecnomed Italia s.r.l.

DANGER! In case of faults, the components are to be replaced using only original spare parts.

DANGER! Any technician not authorised by Tecnomed Italia s.r.l., who makes changes to the product replacing parts or components with spare parts different from those recommended by the manufacturer, assumes a responsibility similar to that of the manufacturer.


ATTENTION! The Morpheus surgical chair can 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 and subsequent amendments. The device shall be installed only by technical staff authorised by Tecnomed Italia s.r.l.

DANGER! To avoid the risk of electric shock, this device must be connected to an earthed electrical system.

ATTENTION! Make sure the mains voltage matches the power supply voltage specified on the label .

DANGER! Do not install the device in environments subject to anaesthetic or flammable gases.

ATTENTION! Do not expose the device to direct sunlight or to sources of UV light.

DANGER! Install the device in a place protected against collisions or against accidental spills of water or liquids.

DANGER! Do not install the device next to heat sources. Install it so as to ensure proper ventilation inside it.

DANGER! Do not use the product with accessories not approved by Tecnomed Italia s.r.l. and without CE marking or fitted with standardised interfaces. The patient and the dentist might get injured or the device might get damaged. Install only accessories authorised by Tecnomed Italia s.r.l. The company assumes NO responsibility for personal injury and/or direct

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ATTENTION! In order to ensure the functionality and safety of the product and to avoid any wear-related damages, the product requires routine and extraordinary maintenance interventions (specified in this manual) that must be carried out at specified intervals by your Tecnomed Italia s.r.l. dealer. For more information, see the paragraph “Maintenance” on page 37.

DANGER! Do not disassemble the device. In case of malfunction, please contact an authorised Tecnomed Italia s.r.l. centre.

TECNOMED ITALIA S.R.L. IS RESPONSIBLE FOR THE SAFE USE OF THE PRODUCT AND GUARANTEES THE PRODUCT ONLY IF THE CONDITIONS PROVIDED IN THIS MANUAL ARE RESPECTED. For any request, always indicate the date of purchase, the model of the device and the serial number. For information on technical support: [email protected]

3.1 - WORK ENVIRONMENTFLOOR COMPOSITIONThe 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 humidity: from 30 to 75%.• Ambient pressure from 600 to 1060 hpa

3.2 - MAXIMUM LOADS• The maximum allowed load on the surgical chair is 200 Kg. Do not exceed this value.• The maximum allowed load on the sampling armrest is 10 Kg. Do not exceed this value.• The maximum allowed load on the blood sampling armrest is 10 Kg. Do not exceed this value.• The maximum allowed load on the thigh rests is 30 Kg. Do not exceed this value.• The maximum allowed load on the headrest is 8 Kg. Do not exceed this value.

DANGER! 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 comply with the indications above.

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4- SAFETY PROVISIONS


DANGER! Before using the product on patients, it is recommended to ask them if they have pacemakers or other implants!

DANGER! The device must be used exclusively by specialised and suitably trained personnel. Use the device only for the intended use that is foreseen for it. Failure to observe this prescription may cause serious injuries to the patient, the operator, and damages to the device.

DANGER! Do not use the product with accessories not approved by Tecnomed Italia s.r.l. and without CE marking or fitted with standardised interfaces. The patient and the dentist might get injured or the device might get damaged. Use only accessories authorised by Tecnomed Italia s.r.l. The company assumes NO responsibility for personal injury and/or direct or indirect property damage resulting from non-compliance with this requirement.

DANGER! The device and its accessories are supplied non-sterile. At the first use and after each treatment, the device and its accessories must be 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.

CAUTION! Use only care and cleaning products authorised by Tecnomed Italia s.r.l. Inappropriate products might damage the surface of the device, affect its operation, lead to contamination or cause injuries to the patient and/or the operator. Tecnomed Italia s.r.l. assumes NO responsibility for personal injury and/or direct or indirect property damage resulting from non-compliance with this requirement. For more information, see paragraph “Cleaning and sterilising”, on page 46.

DANGER! The electrical system available at the installation site must comply with standards CEI 64-8/7 and subsequent amendments. The device shall be installed only by technical staff authorised by Tecnomed Italia s.r.l.

ATTENTION! To avoid any electric shock risks, the device must be connected only to earthed electrical systems.

DANGER! Do not use the device in environments subject to anaesthetic or flammable gases.

ATTENTION! Do not expose the device to direct sunlight or to sources of UV light.

ATTENTION! Disconnect the pneumatic, hydraulic and electrical power supply at the end of the day (if present). Tecnomed Italia s.r.l. shall not cover damages caused by failure to comply with the indications above.

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DANGER! Before every treatment, always check that the device works perfectly and that the accessories are efficient. Always check that there is no water underneath the device. Do not perform the treatment if you notice any malfunctions. In case of anomalies, contact a service centre authorised by Tecnomed Italia s.r.l.

DANGER! Pay attention when using the product, as the automatic movements might give rise to dangerous situations, even if minor.

DANGER! The patient’s arms and the feet should rest on the padding of the surgical chair.


ATTENTION! In order to ensure the functionality and safety of the product and to avoid any wear-related damages, the product requires routine and extraordinary maintenance interventions at specified intervals (contact a service centre authorised by Tecnomed Italia s.r.l.). For more information, see the paragraph “Maintenance” on page 37.

DANGER! For any malfunctions not described herein, put the device out of service and contact an authorised Tecnomed Italia s.r.l. technician.

DANGER! Do not disassemble the device. In case of malfunction, please contact an authorised Tecnomed Italia s.r.l. centre.

4.1 SAFETY REQUIREMENTSTecnomed 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 installation and/or use of the device and its accessories and/or from improper and/or lack of cleaning and/or maintenance.

Tecnomed Italia srl cannot be held responsible, expressly or implicitly, for any type of injuries to persons and/or damages to property inflicted by the user of the product and its accessories, and which have taken place in the following cases:• If the device is used for other purposes than those for which it is intended;• If the device is not used in compliance with the instructions and requirements provided in this manual;• Lack of stock materials to be used in the event of device stop due to fault or inconveniences;• Use of accessories not authorised by Tecnomed Italia srl;• If the electrical system available at the installation site does not comply with the application standard and the appropriate requirements;• Assembly and/or repairs carried out by staff not authorised by Tecnomed Italia srl;• If the storage conditions do not comply with the requirements specified in chapter “Transport and storage conditions”.

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5- PRODUCT DESCRIPTION

5.1 - INTENDED USE AND METHOD OF USEMorpheus is a multifunctional surgical chair designed for the following sectors: Dentistry, Maxillofacial surgery, Reconstructive microsurgery, Dermatology, Otolaryngology, Gynae-cology, Sampling, Diagnostics. This device is not intended for use in potentially explosive atmospheres. It is the responsibility of the user to:1- Use only EC certified devices in perfect state.2- Protect himself, the patients and any third parties from any hazards.3- Avoid any contamination of the product.When using the device, follow the applicable regulations in force in the country of use, especially:1- The provisions in force regarding safety at work.2- The accident prevention measures in force.

DANGER! he device must be used exclusively by specialised and suitably trained personnel. Use the device only for the intended use that is foreseen for it. Failure to observe this prescription may cause serious injuries to the patient, the operator, and damages to the device.


5.2 - STANDARDS/CERTIFICATIONSMedical deviceThe 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 Directive 93/42/CEE.Protection class: Class I (EN 60601-1)Part applied: type B The surgical chair is also compliant with the following standards:

Number Title

EN ISO 14971:2012 Medical devices – Application of risk management

EN 60601-1:2006 Third Ed. Medical electrical equipment – General requirements for safety.

EN 60601-1-6:2007 Medical electrical equipment – General requirements usability

Dir. 93/42/CEE European directive concerning medical devices

Law Decree 46/97 Implementing directive 93/42

Dir 2007/47/CE Updating directive 93/42

Law Decree 37/10 Implementing directive 2007/47

EN 1041: 2010 Information supplied by the manufacturer with the Medical Devices

ISO 15223-1:2012Medical devices -Symbols to be used with medical device la-bels, labelling and information to be supplied - Part 1: General requirements

EN ISO 13485:2012 Medical devices. Quality management systems

ISO 6875:2011 Dentistry - Dental patient chair

EN 62366:2007 Application of Usability engineering to Medical Devices

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5.3 - TECHNICAL SPECIFICATIONSModel name: MorpheusPower: 90 VAVoltage: 230 Volt ~ 50-60hZMaximum air pressure: 8 barWeight: 180 KgProtection with 3,15AOperating mode: continuous operation with intermittent load, suitable for use in dental practices. Electrical power supply: 3 x1.5 mmFloor-mounted free standing end with side covering furniture: 300 mm

ATTENTION! It is essential 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 F1T 3.15 A250V

5x20230 VAC on control unit

On the side of the power button

FUSE F2T 6.3 A250V

5x2030 VDCon control unit

On the side of the power button

The scope of supply includes two spare fuses.

Packaging dimensions:•PARCEL 1 TECNOMED ITALIA- Box with cart

Dimensions 1200 x 800 x 1300 mm (width x depth x height). Weight 180 kg (approx).

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5.3.1 - DIMENSIONS

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5.4 - IDENTIFICATION 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 productionProgressive numberYear of manufacture

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5.5 - PRODUCT PROFILE

D

K

L

E

A

B

C

N M

G

hI

J

OP

Q

R

T

S

F

A. Thigh rests.B. Blood sampling armrest.C. Infusion stand.D. headrest.E. headrest adjustment knob.F. Backrest.G. Seat.h. hand controller 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.

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5.6 - CONFIGURATION

Code Item DescriptionMorpheus

CodeDE1000X

Functions4 motors, trendelenburg functions, manual movements

DE1000X. 10 Additional position reset memory Opt

Joystick2 joysticks for surgical chair movement (4 motors)

Console hand controller with 10 functions

PaddingStandard padding

31 colours

headrestDouble articulating headrest

DE1000X.3.0 Additional hollow headrest Opt

DE1000X.4Armrest

Right standard pivoting armrest Opt

DE1000X.3 Left standard fixed armrest Opt

DE1000X.1 Structure Seat rotation 100 degrees Opt

BaseBase with fixed feet

DE1000X.2 Base with wheels Opt

DE1000X.5Side 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 source (1 hour run time)

Opt

DE1000X.59Accessories for standard setup

Box for standard configuration Opt

DE1000X.5861 Box for full configuration at the centre of the practice

Opt

DE1000X.5860Accessories for setup with existing systems

Covering for centre-practice configuration

Opt

Legend

Opt optional

standard

Empty not provided

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6- INSTALLATION

DANGER! To avoid the risk of electric shock, this device must be connected to an earthed electrical system.


6.1-PRE-ASSEMBLYThe 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 vac32 cm

36 cm

Minimum distance from obstacle 200 cm



Junction box floor

Minimum distance from

obstacle 150 cm

Standardconfigurationsetup

1 2 3

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Positioningexamplesforstandardconfiguration

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6.1.2 - ASSEMBLY SETUP, FULL CONFIGURATION AT THE CENTRE OF THE ROOM

For technical data, see p. 13

Surface connection

7

5

2

4

6

3

1

15 cm

40/52SU

50

2x1SU

220VAC

40/52DR

15 cm

Legend1. Power supply line 220 VAC 3x1.5 mm2. Suction system enabling signal 2x1 mm3. Media/communication VGA-USB-ethernet4. 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.

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Fullconfigurationsetupatthecentreofthepractice

1 2 3

* The control unit in the figure belongs to Maycart and Aspirol units.

4 5* 6

Positioning examplesforfullconfigurationatthecentreoftheroom

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6.2- INSTALLATION

ATTENTION! For wood and 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!Minimumfloorsealing300Kg/m2.

1 2

3 4

5 6

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7 8

9 10

11 12

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13 14

15

X4

16

17 18

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19 20

21 22*For the electrical cabling

see the following:-page18forthefittingofstandardconfiguration

-page22forthefittingoffullconfigurationatthecentreof

the room

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7- INSTRUCTIONS FOR USE

ATTENTION! Cut off the power supply to the equipment at the end of the day, by pressing the green ON/OFF light button placed on the base of the surgical chair

ATTENTION! For any malfunctions not described herein, put the device out of service and contact an authorised Tecnomed Italia s.r.l. technician.

DANGER! Before using the equipment, read the previous sections of this manual carefully, paying particular attention to paragraph “Safety provisions” on page 10.


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 and after each treatment, the device and its accessories must be cleaned and/or sterilised following the instructions in paragraph “Cleaning and sterilising”, on page 46.

DANGER! The maximum total load on the Morpheus should not exceed 200 kg.

The product may be equipped with additional components, which are described in this manual. Tecnomed Italia s.r.l. assumes NO liability for damages (to persons or property) deriving from failure to comply with the instructions in this manual.

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7.1 - STANDARD HAND CONTROLLER

A. Chair on/off light indicator. B. Backrest up.C. Backrest down.D. Leg rest up.E. Leg rest down.F. Quick sitting position (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°.

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7.2 - CHAIR MOVEMENT CONTROL WITH JOYSTICK Right joystick

A. Push the joystick up to raise the seat.A. Push the joystick down to lower the seat.C. Move the joystick to the right 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 movementsTrendelenburg Backrest/leg rest Up/down

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7.3 - SEAT ROTATION

Seat rotation facilitates patient sitting and positioning.

U

Use the knob placed on the base of the chair to en-able chair rotation.

1. Turn the knob “U” counterclockwise to unlock the chair rotation mechanism.

2. Rotate the chair manually to help the patient sit on/get up off the chair.

3. Rotate the chair back to its initial position.

4. Turn the knob “U” clockwise to lock the chair rota-tion mechanism.

7.4 - STANDARD HEADREST

+ 15 cm

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 support to the neck and the cervical vertebrae of the patient in prone position (face down). Thanks to its special (hollow) shape, it allows the patient to breath freely while keeping his head in the correct position by gently cradling his face.

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7.6 - LEG REST

+ 10 cm

The length of the leg rest can be adjusted by about 10 cm.

P

1. Turn the knob “P” counterclockwise to unlock the mechanism.2. Adjust the leg rest to the desired length.3. Turn the knob “R” clockwise to lock the mecha-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 (infusion stand, blood sampling armrest, etc...).

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S

The guides allow proper positioning of the optional accessories, giving you the possibility to slide them to the right or to the left.

1. Rotate the lever “S” counterclockwise to unlock the mechanism.

2. Adjust the position of the optional accessory.

3. Turn the lever “S” clockwise to lock 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 mecha-nism.

Explanatory image of armrest movements.

When the clamp is blocked, the armrest turns 360°

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The band that comes with the armrest blocks the arm of the patient during the blood sampling or any operation.

7.10 - THIGH RESTS

CAUTION! The maximum allowed load on the thigh rests is 30 Kg. Do not exceed 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 the mech-anism.

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7.11 - INFUSION STAND

The infusion stand can be installed on the left or on the right guide rail, based on your needs.

ATTENTION! The maximum allowed load on the infusion stand is 8 Kg. Do not exceed this value

M

To adjust the height of the infusion 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 wheels and stainless steel rotary support with lever brake.

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Besides the wheel brake, the chair also comes with a stability device.To stabilise the chair, turn the knob clockwise until you feel some resistance.

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.

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8 - CLEANING AND STERILISING

DANGER! Cut off the power supply to the equipment before carrying out any main-tenance operation, by pressing the green ON/OFF light button placed on the base of the surgical chair.

ATTENTION! General information (in accordance with Standard DIN EN ISO 17664)The product and all the instruments must be cleaned and disinfected before use. The staff of the practice is responsible for cleaning the product to minimise the contamination risks for patients and operators. Use authorised cleaning products and greases. 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 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 might reach into the slots, damaging the paint and the electrical parts. Use a cloth dampened with disinfectant (it shouldn’t be too wet, dripping).

WhAT WhEN WhERE hOW

GREEN&CLEAN MK

After every patient. Dopo ogni paziente.

Upholstery.Casings.Arms, posts, handles.

Do not spray disinfectant directly on to surfaces as it can penetrate into cracks, degrade paint and damage electrical parts.

• Clean the upholstery of the dental unit.

Code 60030130: 1 di-spenser with 70 wipes + 1 x 750 ml bottle SK.

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9 - MAINTENANCE

DANGER! Cut off the power supply to the equipment before carrying out any main-tenance operation, by pressing the green ON/OFF light button placed on the base of the surgical chair.

DANGER! The product requires technical safety checks and extraordinary mainte-nance every 2 years, to identify any electrical faults (such as damaged cable insulations). These checks are to be carried out by an authorised Tecnomed Italia s.r.l. technician.

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 technical safety controls had positive result.

DANGER! The technical controls must also be carried out after making changes to the machine; for example, when installing new components to avoid any problems that might affect the electrical safety of the equipment.

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10- TROUBLESHOOTING

PROBLEM CAUSE SOLUTION

The device does not turn on.

1- The power swith is off.2- The power swith is damaged.3- 3.15A phase fuse blown.

1- Press the power switch.2- Replace the FUSE F1 with the one supplied (REF.1).3- Contact an authorised Tecnomed Italia technician.

The 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 Tecnomed Italia technician.

RIF. 1 - F1 DA 3,15 A FUSE REPLACEMENT

RIF. 2 - F2 DA 6,3 A FUSE REPLACEMENT

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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

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10.1.2 How 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

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10.1.3 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

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10.1.4 How to move the backrest down

10.1.5 How to move the backrest up

PRESS ThE BACKREST UP BUTTON

hOLD ThE BUTTON OR JOYSTICK TO MOVE ThE BACKREST 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

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12- DISPOSAL

This equipment complies with the European Directive 2002/96/CE on waste electrical and electronic equipment (WEEE). By ensuring this product is disposed of correctly, you will help prevent potential negative consequences to the environment and human health, which could otherwise arise from improper handling of the product at the end

of its service life. The symbol indicates that the product should not be disposed of like normal waste, but it should be sent to the 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 Environment Department or your local waste collection service or your dental equipment distributor. Illegal dumping of the product by the user entails the administrative sanctions stated by current legislation.

11- RELATED ITEMS

Tofindallitemsrelatedtothisproduct,visit:

www.dentalastec.it

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13- WARRANTY

With this document, the manufacturer certifies that the product has been built correctly, in compliance with the applicable national and European regulations in force. The product is covered by a 24-month warranty from the date of purchase specified on the stamp and on the valid fiscal document issued by the seller. According to art. 1495 c.c., the person who intends to make a warranty claim, must give notice of the failure within 8 days from its discovery. The warranty claim may be refused if the invoice has been changed, deleted or made illegible after the purchase. Disconnect the pneumatic, hydraulic and electrical power supply at the end of the day (if present). Tecnomed Italia srl shall not cover damages caused by failure to comply with the indications above. Not covered by warranty:• labour expenses, staff travel expenses, transport expenses:• operations for the installation and connection of the machine to the various power supply sources;• all parts subject to normal wear and tear (such as light bulbs, carbon brushes, cordon o-rings, suction tubing, etc...);• all those parts that are faulty due to negligence or careless use and/or maintenance; • in-transit damages;• damages caused by limescale or dirt accumulation on hydraulic and pneumatic supply circuits (if present); • malfunctions due to failure to respect the routine cleaning intervals of the filters (if any); • malfunctions caused by third-party equipment (compressors, suction systems, water sof-teners), or other circumstances unrelated to defects in the manufacturing of the device. The Warranty becomes void if:- the equipment presents damages due to fall, exposure to flames, liquid spills, lightning, natural disasters, other causes not attributable to manufacturing defects; - the installation and/or extraordinary maintenance operations and/or the technical con-trols have not been carried out by an authorised Tecnomed Italia 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 product. In case of permanent damage or repeated failure (deriving from the same cause), the manufacturer reserves the right to decide whether the equipment will be replaced or not. The coverage for the new product provided by the warranty will remain valid until the end of the original contract. For warranty service the purchaser should contact the reseller, the authorised service centers or Tecnomed Italy s.r.l. This warranty does not give the Customer the right to claim for direct or indirect damages (of any nature) to persons or property resulting from machine malfunction. Tecnomed Italia srl denies any liability, expressed or implied, and cannot be held liable for injuries to persons and/or animals and/or damages to property deriving from failure to comply with the instructions in this manual (warnings, installation safety standards, safety provisions, instructions for installation and use, information for correct cleaning and sterili-sation, maintenance information, general information, technical specifications etc...). The manufacturer reserves the right to make changes or improvements without prior notice if these changes do not affect the safe use of the device. In the event of any dispute concerning the application of the warranty or the condition of the equipment delivered, the buyer may not suspend or delay the payment of the price in full or in installments. No compensation may be claimed by the buyer for equipment downtimes. If the part to be changed is not returned, it will be charged to the buyer. Also, please see page “PAYMENT TERMS AND CONDITIONS” available on our site www.dentalastec.itAny and all disputes that may arise will be settled by the competent Court of Pesaro.

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DECLARATION OF CONFORMITY

EC DECLARATION OF CONFORMITY 93/42 CEEMODEL: 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 RepresentativeLuca Riccardi

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15- CERTIFICATE OF WARRANTY

The warranty on the dental unit must be registered. Failure to register the warranty invalidates it. To register the warranty, proceed in one of the following ways:

- BY FAXPhotocopy the warranty registration card below, fill in all sections and fax it to +39 0721 955229, marked “to the attention of the production manager”.

- BY E-MAILSend an e-mail to [email protected], providing all the following details:• BUSINESS NAME• 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 Salvador Allende n.2, 61040 Castelvecchio di Monte Porzio (PU) ItalyPhone +39 0721 95 51 25 Fax +39 0721 95 52 29 - www.dentalastec.it

Timbro del rivenditore-Dealer’s stamp Cachet d’achat-Sello del revendedor

Data d’acquisto-Purchase date Date d’achat-Fecha de compra

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16- ELECTRICAL TEST

Electrical safety test of earth (ground) and electrical insulation

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Tecnomed Italia s.r.l. Via Salvador Allende n.2, 61040 Castelvecchio di Monte Porzio (PU) ItalyPhone +39 0721 95 51 25 Fax +39 0721 95 52 29 - www.dentalastec.it

morpheus surgical chair

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