Tecnomed Italia MORPHEUS Installation, Use And Maintenance Manual

V.8.00

MORPHEUS SURgical cHaiR

Installation, use and maintenance manual

CODE DE1000X

CONTENTS

ENGLISH

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

PAGE

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

PAGE

ENGLISH

1- SYMBOLS

ENGLISH

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 uids or materials.

GENERAL INFORMATION SYMBOL. This symbol indicates a piece of information that allows you to use the device more efciently.

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 armrests.

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.

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 uids or materials.

This icon provides information that allows you to use the device more efciently.

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 specications, 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, specications 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.

ENGLISH

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.

2.1 - GENERAL INSPECTION

ENGLISH

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 ITALY

Upon 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, ll in the dedicated elds 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 verication

after clearly writing down the reason:

- “delivery refused/accepted subject to verication”

- “package with packing tape pulled off, delivery refused/accepted subject to verication”

- “package with visible signs of damage, cardboard bent, delivery refused/accepted subject to verication”

- “package extremely damaged and/or partially open, delivery refused/accepted

subject to verication”

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 (produzione@dentalastec.it).

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 (produzione@dentalastec.it).

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.

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.

ENGLISH

Do not stack.

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

Humidity limit: from 10 to 90%.

Atmospheric pressure limit: from 500 to 1060 hPa.

3- SAFETY RULES FOR INSTALLATION

ENGLISH

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.

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.

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.

ATTENTION! The Morpheus surgical chair can be either xed or mobile.

DANGER! Comply with the conditions of use provided in the “Technical Specications”

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 specied

on the label .

DANGER! Do not install the device in environments subject to anaesthetic or ammable 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 tted 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

or indirect property damage resulting from non-compliance with this requirement.persone e/o danni a cose diretti o indiretti derivati dell’inosservanza di tale prescrizione.

ATTENTION!

wear-related damages, the product requires routine and extraordinary maintenance interventions

(specied in this manual) that must be carried out at specied 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.

In order to ensure the functionality and safety of the product and to avoid any

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.

device and the serial number. For information on technical support: produzione@dentalastec.it

For any request, always indicate the date of purchase, the model of the

3.1 - WORK ENVIRONMENT

FLOOR COMPOSITION

The quality of the oor must meet the capacity standards standards specied 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.

ENGLISH

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.

4- SAFETY PROVISIONS

ENGLISH

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.

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!

s.r.l. and without CE marking or tted 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 rst 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 maintenance or cleaning operation.

ATTENTION! After sterilising the components in the autoclave, wait for them to cool

down before using them.

Do not use the product with accessories not approved 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.

standards CEI 64-8/7 and subsequent amendments. The device shall be installed only by technical staff authorised by Tecnomed Italia s.r.l.

earthed electrical systems.

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.

CAUTION! Use only care and cleaning products authorised by Tecnomed Italia

DANGER! The electrical system available at the installation site must comply with

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

DANGER! Do not use the device in environments subject to anaesthetic or ammable 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

DANGER! Before every treatment, always check that the device works perfectly

and that the accessories are efcient. 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.

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.

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 specied 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 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 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 inicted 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 specied in chapter

“Transport and storage conditions”.

ENGLISH

5- PRODUCT DESCRIPTION

5.1 - INTENDED USE AND METHOD OF USE

ENGLISH

Morpheus is a multifunctional surgical chair designed for the following sectors: Dentistry, Maxillofacial surgery, Reconstructive microsurgery, Dermatology, Otolaryngology, Gynaecology, 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 certied 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.

DANGER! Tecnomed Italia s.r.l. declines any liability, expressed or implied, and cannot

5.2 - STANDARDS/CERTIFICATIONS

Medical device

The MORPHEUS surgical chair is tted with CE marking.

The Morpheus device 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.

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

ISO 15223-1:2012

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

is classied as class IIa medical device based on rule 1 of annex IX of

Medical electrical equipment – General requirements for

Information supplied by the manufacturer with the Medical

Medical devices -Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

safety.

Devices

5.3 - TECHNICAL SPECIFICATIONS

Model name: Power: 90 VA Voltage: 230 Volt ~ 50-60HZ Maximum air pressure: 8 bar Weight: 180 Kg Protection with 3,15A Operating mode: continuous operation with intermittent load, suitable for use in dental practices. Electrical power supply: 3 x1.5 mm Floor-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

Identication Value Dimensions Protection Position

FUSE F1

FUSE F2

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).

Morpheus

T 3.15 A 250V

T 6.3 A 250V

5x20

230 VAC on control unit

30 VDC on control unit

On the side of the power button

ENGLISH

5.3.1 - DIMENSIONS

ENGLISH

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

ENGLISH

Year of manufacture

Progressive number

Week of production

+ 33 hidden pages

Tecnomed Italia MORPHEUS Installation, Use And Maintenance Manual

Specifications and Main Features

Frequently Asked Questions

User Manual