CONTOUR TYPE Dental Chair Instructions for Use 1st Edition April 2020

Dear Customers

Dear Customers Thank you for purchasing our product. This booklet explains how to use DENTAL CHAIR (CONTOUR TYPE). Before using DENTAL CHAIR (CONTOUR TYPE), carefully read the operating instructions and make sure to use the product correctly. Using the product without reading these instructions may lead to an accident. This document describes the full version of the system. It may therefore cover components that are not included in the system you purchased. This specification is subject to change without notice.

2020-04-01 (1st edition) 1E07X8A0

Table of Contents Dear Customers

1

2

General Information 1-1

Intended Use of the Product

1-2

Compliance with Regulation and Directive

1-3

Declaration of Conformity

1-4

How to Dispose of the Device

1-5

Recomendation to User

1-6

Symbols

1-7

Technical Description

Safety Consideration 2-1

Risk Level Interpretation

2-2

Safety Precautions 2-2-1 Points to remember when operating the product

3 4

2-3

EMC Information

2-4

Devices Connectable to the Product

Precautions for Use 3-1

Operating Precautions

3-2

Precautions for Using Synthetic Leathers

Specifications and Operation 4-1

CLESTA II CHAIR (EURUS TYPE) / CELEB CHAIR (EURUS TYPE) 4-1-1 Specifications 4-1-2 Dimensions 4-1-3 Name of Each Part 4-1-3-1 Chair 4-1-3-2 Headrest 4-1-3-3 Junction Unit 4-1-4 Operation 4-1-4-1 Prepation Before Use 4-1-4-2 After use 4-1-4-3 Raising/lowering the chair and raising/reclining the backrest (manual operation) 4-1-4-4 Moving the chair to the preset position (automatic operation) 4-1-4-5 Operating the headrest (manual type) 4-1-4-6 Turning the armrest 4-1-4-7 Cancellation function 4-1-4-8 Chair lock function 4-1-4-9 Setting the treatment and entry/exit positions 4-1-4-10 Setting the mouth rinsing position

Table of Contents

4-2

CLESTA II CHAIR / CELEB CHAIR 4-2-1 Specifications 4-2-2 Dimensions 4-2-3 Name of Each Part 4-2-4 Operation 4-2-4-1 Preparation Before Use 4-2-4-2 After use 4-2-4-3 Raising/lowering the chair and raising/reclining the backrest (manual operation) 4-2-4-4 Moving the chair to the preset position (automatic operation) 4-2-4-5 Headrest 4-2-4-6 Double Articulating Headrest (Optional) 4-2-4-7

Turning the armrest

4-2-4-8

Cancellation function

4-2-4-9

Safety Look Device

4-2-4-10 Auto Mode Position Adjustment 4-3

CLESTA eIII CHAIR 4-3-1 Specifications 4-3-2 Dimensions 4-3-3 Name of Each Part 4-3-4 Operation 4-3-4-1 Preparation Before Use 4-3-4-2 After use 4-3-4-3 Raising/lowering the chair and raising/reclining the backrest (manual operation) 4-3-4-4 Moving the chair to the preset position (automatic operation) 4-3-4-5 Headrest 4-3-4-6 Double Articulating Headrest (Optional) 4-3-4-7 Turning the armrest 4-3-4-8 Cancellation function 4-3-4-9

Safety Look Device

4-2-4-10 Auto Mode Position Adjustment

Table of Contents

4-4

PROGRES 4-4-1 Specifications 4-4-2 Dimensions 4-4-3 Name of Each Part 4-4-4 Operation 4-4-4-1 Preparation 4-4-4-2 After use 4-4-4-3 Raising/lowering the chair and raising/reclining the backrest (manual operation) 4-4-4-4 Moving the chair to the preset position (automatic operation) 4-4-4-5 Headrest 4-4-4-6 Chair Rotation 4-4-4-7 Cancellation function 4-4-4-8 Safety Look Device 4-4-4-9 Auto Mode Position Adjustment

5

Maintenance and Cleaning by Dental Staff 5-1

Exterior 5-1-1 Cleaning and disinfecting the surfaces

5-2

Leather part

5-3

Maintenance and inspection 5-3-1 Notes on daily maintenance and inspection (by the user) 5-3-2 Notes for periodic inspection

5-4

6

7

Maintenance by Service Engineers 6-1

After-sales service

6-2

Service life

6-3

Period of Parts Retention

Troubleshooting 7-1

8

Storage method

Troubleshooting

Accessories and Consumables 8-1

Accessories

8-2

Consumables

1 General Information

1-1

Intended Use of the Product

This product is an active therapeutic device intended for the exclusive use for diagnoses, treatments and relative procedures of dentistry. The product must be operated or handled by the qualified dentists or by dental staffs under the supervision of the dentist. Such dentists or dental staffs should instruct and/or assist the patients to approach to and leave from the product. Patients should not be allowed to operate or handle the product unless he/she is so instructed.

1-2

Compliance with Regulation and Directive

This product complies with MDR (EU) 2017/745 and RoHS Directive 2011/65/EU.

1-3

Declaration of Conformity

We hereby declare that the product listed below complies with the essential requirements of the MDR (EU) 2017/745 and RoHS Directive: 2011/65/EU based on category 8 of Annex I. Product : DENTAL CHAIR (CLASS Ⅰ) Model : CLESTA Ⅱ CHAIR / CELEB CHAIR CLESTA eⅢ CHAIR PROGRES " CLASS Ⅰ " has been defined by the rule 13 of MDR Annex VIII. The product has been designed and manufactured in accordance with the European standards as the listed in the Declaration of Conformity.

1 General Information

1-4

How to Dispose of the Device

When disposing of this product and parts replaced, carefully take infection control measures, pay attention to physical hazards such as from sharps, and handle them properly in accordance with the relevant laws and regulations (including local ordinances). In the EU area, EU Directive 2012/19/EU (Directive on Waste Electrical and Electronic Equipment [WEEE Directive]) applies to this product. Environment-conscious recycling/disposal is mandatory under this Directive.

1-5

Recomendation to User

A notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

1 General Information

1-6

Symbols

Stick switch for manual operation

Stick switch for automatic operation

Caution

General warning sign

Generally prohibited activity

Disassembly, repair or modification prohibited

Instructions for mandatory actions in general

Follow instructions for use

Type B Applied Parts contacting the patient’s body surface only

Alternating current

Date of manufacture

Catalog number

Name and address of the manufacturer

ＳＮ

Serial number

Separate collection of electrical and electronic equipment

EC REP

European Authorized Representative

Compliance with MDR (EU) 2017/745, RoHS Directive 2011/65/EU

Switch （ＯＮ）

Chair last position

Switch （ＯＦＦ）

Chair auto return

Chair preset1

Chair preset2

To raise the chair

1 General Information

① ②

To Recline the backrest

To lower the chair

To raise the backrest

Protective earthing

Functional earthing

Chair manual control

Medical Device

Product name

Rated voltage

Rated input

① Maximum activation time ② Non-continuous operation

③

1-7

Product of Japan

③ Duty cycle

Technical Description

The following are explained in the documents listed below: Item

Document

How to install this product

Installation instructions

Wiring/plumbing

Installation instructions

2 Safety Consideration

2-1 Precautions before use

Risk Level Interpretation

Make sure to carefully read the Safety Precautions and Operating Precautions and use the product correctly. These precautions are intended to ensure the safe use of the product and prevent harm or damage to users or other people. According to the magnitude of harm and damage and the degree of urgency, an incident that may be caused by misuse of the product is classified into one of the following categories: CONTRAINDICATION, WARNING, and CAUTION. All of these categories are important for safety. Always follow the instructions provided. We assume no responsibility for any accident due to failure to follow the Safety Precautions or Operating Precautions even in the event of harm or damage to users or other persons. In such case, users or other persons who use the product without observing the Safety Precautions and Operating Precautions are responsible for any harm or damage incurred. The graphical symbols are explained in detail below. Once you have fully understood this explanation, read the text.

2 Safety Consideration

Classification by degree of harm or damage and urgency

CONTRAINDICATION Use of the product without regard to this indication will create a hazardous condition that may result in death or serious injury.

WARNING Improper handling of the product without regard to this indication will create a hazardous condition that may result in death or serious injury.

CAUTION Improper handling of the product without regard to this indication will create a potentially hazardous condition that may result in moderate or slight injury or property damage.

The following graphical symbols are used to explain your responsibilities for using the product safely:

Graphical symbols for prohibited activity Generally prohibited activity

Disassembly, repair or modification prohibited

Graphical symbol for mandatory instructions Instructions for mandatory actions in general

2 Safety Consideration

2-2

Safety Precautions

CONTRAINDICATION Installing or transferring the product

Precautions regarding installation

Use and maintenance of the product

Do not use the equipment in an explosive atmosphere (e.g., in the presence of inflammable gases).

Do not install the product near electromagnetic sources such as communication facilities or elevators. Malfunction of this product may occur in the presence of electromagnetic interference waves.

Improper use in such an atmosphere may cause injury or fire.

Use with caution in the presence of electromagnetic waves. Do not use equipment generating electromagnetic waves, such as mobile phones, around this product. Malfunction of this product may occur.

Be sure to turn off the main switch (or the main switch of the unit) when HF surgical equipment is in use. Be sure to turn off the main switch (or the main switch of the unit) when HF surgical equipment is in use because the noise generated from HF surgical equipment may cause incorrect operation of this product.

Never disassemble, repair or modify the product.

Individuals other than your local authorized Belmont dealer should not disassemble or repair this product. This could lead to an accident, failure, electric shock, or fire. Never modify the product as it is extremely dangerous.

2 Safety Consideration

WARNING Installing or transferring the product

Precautions for installation

Ask your local authorized Belmont dealer to install the product. Make sure to place the product on a firm and flat floor. Placing the equipment on a non-flat floor may cause it to fall. Be sure to ground the product securely. (Ask a professional to ground the product.) Failure or electric leak may result in electric shock. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. This equipment must be connected to an appropriate power source.

Use and maintenance of the product

Keep moving parts of the product away from patients’ and users’ hands, fingers, and bodies.

Hands, fingers or bodies may become caught in the product, causing injury.

The patient must not lie on his/her stomach, kneel in the formal seiza position (with his/her buttocks on his/her heels), or sit on the product with a child in his/her arms. The chair may move unexpectedly, causing injury.

The patient must not sit on the edge of the seat.

The chair may fall or move unexpectedly, causing injury or damage to peripheral devices.

The patient must not sit in an area other than the designated location. Excessive load must not be applied to the product. The patient must not sit on the headrest, armrest or backrest. This may cause injury due to falling, or damage to peripheral devices.

Do not wash the product with water. This may cause failure or electric shock.

2 Safety Consideration

WARNING Use and maintenance of the product

Remove the patient’s glasses and any accessories (such as a necklace or bracelets) before treatment.

Failure to follow this instruction may hamper treatment and lead to an accident.

Points to remember when a patient sits on the chair

As shown in the figure on the left, instruct the patient to sit on the chair and make sure his/her body fits into the chair. Ensure that the patient maintains a good posture before moving the chair.

The patient should clasp his/her hands.

The patient should place his/her feet side by side.

For a young child, the buttocks should be placed on the seat when raising the backrest.

Pay attention to patients and children.

Keep your eyes on the patient when this product is in use. Patients (especially children) may touch the control switch or system inadvertently, leading to an accident due to incorrect operation of the product. Keep children away from this product except when giving treatment.

2 Safety Consideration

WARNING Use and maintenance of the product

Precautions for getting on and off the product.

When the patient gets on or off the chair, the chair should always be at entry/exit position,which is the lowest position with the backrest fully raised. Before moving a patient from a wheelchair to the product or vice versa, ensure that no obstacles (e.g., foot controllers) are situated around the wheelchair or the caregiver. Contact of the feet or the wheelchair castors with obstacles (such as foot controllers) may cause injury or damage to peripheraldevices. When the patient is moved from a wheelchair to the product or vice versa, he/she must be carefully monitored to prevent falling. If the patient has to get off the product at a position other than the designated position for getting on and off the product due to power failure or in the event of an emergency, he/she must be carefully monitored to prevent falling.

Precautions when raising/lowering the backrest

Before lowering the backrest, ensure that the patient’s arm or hand is not sandwiched between the backrest and the seat. Before raising the backrest, ensure that the patient’s arm or hand is not sandwiched between the backrest and the armrest.

Precautions for operating the chair and automatic operation

Before and during the chair operation, pay close attention to the operation range (seat raising/lowering direction and backrest lowering/raising direction), and ensure that the chair does not contact any body parts, hands or feet, or objects. Before operating the chair, ensure that the patient is sitting in the correct position, and keep your eyes on him/her when the chair is in use.

Precautions when using the headrest (manual) During the headrest operation, ensure that your hands, fingers, or hair do not become caught in the control lever and are not sandwiched between the headrest and the backrest.

Pay close attention to a patient who has a cardiac pacemaker or defibrillator implanted. If any abnormality occurs, immediately turn off the main switch (or the main switch of the unit) and discontinue use of the product. The product may affect the function of the pacemaker or defibrillator, leading to an accident.

2 Safety Consideration

WARNING Use and maintenance of the product

Prohibition of using this equipment adjacent to or stacked with other electronic equipment Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.If such use is necessary,this equipment and the other equipment should be observed to verify that they are operating normally. Prohibition of placing portable RF communications equipment adjacent to this product Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm(12 inches) to any part of CLESTA II CHAIR (EURUS TYPE) / CELEB CHAIR (EURUS TYPE) / CLESTA II CHAIR / CELEB CHAIR / CLESTA eIII CHAIR / PROGRES, including cables specified by the manufacturer. Otherwise,degradation of the performance of this equipment could result. Immediately wipe off any water spillage or leakage on the floor. Decreased strength of the floor may cause the product to fall, leading to injury or damage to peripheral devices. Clean the product thoroughly. Poor cleaning may cause bacteria to grow, posing a health risk. Be sure to conduct maintenance. Use of the product without maintenance may cause injury or damage to peripheral devices. Discontinue use of the product if it is broken. In the case of a broken product, immediately discontinue use and turn off the main switch (or the main switch of the unit). Then, ask your local authorized Belmont dealer to repair the product.

2 Safety Consideration

Turn off the main switch (or the main switch of the unit) during cleaning. Failure to follow this instruction may cause electric shock or ignition. The product may also move unexpectedly, causing injury. Action taken for power failure To prevent unexpected operation of the product after recovery from power failure, turn off the main switch (or the main switch of the unit). Be sure to turn off the breaker for devices when the product is not used for a long period of time. Make sure to turn off the breaker for devices in a clinic when the product is not used for a long time for reasons such as closing time and non-consultation day. If the breaker is not turned off, a fire may be caused by a leakage of electricity due to insulation deterioration.

2 Safety Consideration

CAUTION Use and maintenance of the product

Do not allow a person who exceeds the weight limit to sit on the chair. Falling or operational failure may occur. [Reference] Weight limit

Do not hit or rub the product. This may cause damage to the cover or operational failure.

Ensure that each part operates normally, with no abnormalities detected, before operation.

Always inspect the product for abnormal findings such as loose components, backlash, tilting, vibration, sound, abnormal temperature, or bad odors. If you feel something is wrong, immediately discontinue use of the product and turn off the main switch. Then, contact your local authorized Belmont dealer.

Read the Instructions for use.

Before use, make sure to carefully read the instructions for use and use the device correctly.

Be sure to operate switches manually.

Make sure to operate the switches manually, except for the foot controller operated by the foot and stick switches. Failure to operate the switches by hand may cause damage or malfunction.

Carefully operate the switches to prevent a mistake. The operator should pay close attention to people around the product and say something before operation to prevent any errors.

Precautions for armrest rotation Ensure that no obstacles are placed around the armrest and fingers do not become caught in the armrest. Do not operate the chair when the armrest is rotated. Before operating the chair, return the armrest to its original position.

2 Safety Consideration

Immediately wipe off any drug solutions or water adhered to the product.

Adherence of drug solutions or water to the product may cause operational failure or electrical leak. If drug solutions or water are adhered, immediately turn off the main switch and wipe them off with a dry, soft cloth.

Turn off the main switch (or the main switch of the unit) at the end of day or during a recess. Malfunction due to contact with the product will cause damage or injury.

2-2-1

Points to remember when operating the product

Meaning of a symbol Point to remember (locations requiring attention including moving parts, rotating parts, and detachable parts) Point to remember where an emergency stop mechanism is available Meanings of each point to remember ⑥

⑦

①

①Pay attention to prevent body parts or objects from becoming caught in the armrest (when rotating). Do not operate the chair when the armrest is rotated. ②Pay attention to prevent body parts or objects from becoming caught in the armrest (when lowering the chair). Do not place the body parts or objects at the the armrerst bracket when lowering the chair. ③Pay attention to prevent body parts or objects from becoming caught in the backrest moving parts. Do not sandwich your hands or feet between the backrest and the seat.

⑤③ ②

④

④Pay attention to prevent body parts or objects from becoming caught in the bottom of the seat. Do not place your hands or feet in the bottom of the seat.

2 Safety Consideration

③

⑤Pay attention to prevent body parts or objects from becoming caught in the rear link cover. Do not place the body parts or objects between the rear link cover and base plate. ⑥Pay attention to prevent body parts or objects from becoming caught in the headrest moving part. Ensure that your fingers and hair do not become caught in the headrest moving part. ⑦Pay attention to prevent contact with the backrest. Before operating the backrest, ensure that no obstacles are placed around the backrest.

WARNING When operating the chair, do not place the body parts or objects around the moving parts. This may cause injury.