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A-dec TE-97 LQ

W&H A-dec Alegra 300 Series, A-dec RQ-54, A-dec TE-97, A-dec TE-97 LQ, A-dec TE-98 LQ Instructions For Use Manual

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Instructions for use
300 series
Highspeed Air Handpieces
Contents
A-dec | W&H symbols .................................................................................................................................................. 4 – 5
1. Introduction ................................................................................................................................................................ 6 – 9
5. Operation ................................................................................................................................................................20 – 27
Assembly/removal, To change dental bur, Test
2
General, Pre-cleaning, Manual cleaning, Manual disinfection, Automated cleaning and disinfection, Lubrication, Sterilization
7. Maintenance ...........................................................................................................................................................44 – 45
8. A-dec | W&H accessories and spare parts ............................................................................................................46 – 52
10. Recycling and disposal...................................................................................................................................................59
Warranty .................................................................................................................................................................................60
A-dec | W&H contacts .............................................................................................................................................................61
3
A-dec | W&H symbols instructions for use
CAUTION!
(to prevent
damage occurring)
4
WARNING!
(risk of injury)
General explanations,
without risk to
persons or objects
Do not dispose of
with domestic waste
A-dec | W&H symbols handpiece / Roto Quick coupling / packaging
CE 0297 from the manufacturer
Sterilizable up to the stated temperature
Catalog number
REF
Serial number Thermal washer disinfectable
SN
Date of manufacture
UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements
Type B applied part (not suitable for direct cardiac application)
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1. Introduction
Creating customer success is a key foundation to the A-dec | W&H quality policy. In support of that effort, this A-dec | W&H product has been developed, manufactured, and subjected to final inspection according to legal regulations, quality norms, and industry standards.
For your safety and the safety of your patients
Prior to initial use please read the instructions for use completely; they explain how to use your A-dec | W&H product and ensure proper, efficient, and safe operation.
Intended use
The dental handpiece is intended for the following applications: Removal of decayed materials, cavities and crown preparation, removal of fillings, finishing of tooth and restoration surfaces.
The Roto Quick coupling is intended for the following applications: Connector for media transfer (air, water, electricity and light) between the handpiece tubing and the dental unit and air driven motors.
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Always follow the manufacturer’s recommendations for the handpiece / Roto quick coupling. Misuse may damage the handpiece / Roto Quick coupling, create risks, and pose hazards for patients, users, and others.
Qualifications of the user
We have based our development and design of the dental handpiece / Roto Quick coupling on the dentists, dental hygienists, dental employees (prophylaxis), and dental assistants target group.
Production according to EU Directive
The handpiece / Roto Quick coupling is a medical product according to the EU Directive 93/42/EEC.
Device labeling statement U.S. Federal law restricts this device to sale by or on the order of a dentist, physician, or any other practitioner licensed by the law of the state in which he or she practices to use or order the use of this device.
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Responsibility of the manufacturer
The manufacturer can only accept responsibility for the safety, reliability, and performance of the handpiece / Roto Quick coupling when it is used in compliance with the following directions:
> The handpiece / Roto Quick coupling must be used in accordance with these instructions for use. > Only the components approved by the manufacturer may be replaced (rotor, O-rings, generator, and
water filter).
> Repairs must only be undertaken by authorized A-dec | W&H repair locations.
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Skilled application
The handpiece / Roto Quick coupling is intended for use only by trained dental or medical practitioners for the purposes listed under the Indications for Use, in accordance with this document, the applicable health and safety regulations, and the valid accident prevention regulations. The handpiece / Roto Quick coupling should be prepared for use and maintained by staff who are trained in procedures for infection control, personal safety, and patient safety. Improper use, (e.g., through poor hygiene and maintenance), non-compliance with our instructions, or the use of accessories and spare parts that are not approved by A-dec | W&H invalidates all claims under warranty and any other claims.
Operating malfunction of the handpiece / Roto Quick coupling
> Correct the malfunction as described in the Maintenance section on pages 44 and 45. > If it proves impossible to correct the malfunction, please contact your local retail A-dec dealer or
A-dec customer service.
> Repairs must only be undertaken by authorized A-dec | W&H repair locations.
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2. General safety notes
> The operation of the handpiece / Roto Quick coupling is permitted only on dental units which correspond
to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2). > Use only handpiece tubings as specified by EN ISO 9168. > Use only non-contaminated, filtered, oil-free, and dry compressed drive air to operate the handpiece. > Run the rinse function for the dental unit once per day.
> Always ensure the correct operating conditions and cooling function. > Always ensure that sufficient and adequate cooling is delivered and ensure adequate suction. > In case of coolant supply failure, the handpiece must be stopped immediately.
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> Check the handpiece / Roto Quick coupling for damage and loose parts each time before using
(e.g., push-button chuck, connection between the Roto Quick coupling and handpiece tubing). > Do not operate the handpiece if it is damaged. > Do not operate the Roto Quick coupling if it is leaking. > Perform a test run each time before using. > Never touch the push-button chuck of the handpiece during operation or while it is still running down.
> Do not use the handpiece if there are soft tissue wounds in the mouth. The air pressure can cause
septic substances to enter the tissue or trigger embolisms. > Do not touch the soft tissue with the handpiece head (risk of burning due to the push-button chuck
heating up)! > Avoid overheating at the treatment site.
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Cleaning and maintenance prior to initial use
Ensure that the handpiece / Roto Quick coupling is in clean condition and sealed in polyethylene (PE) film when the product is first delivered.
> Lubricate the handpiece prior to initial use. > Sterilize the handpiece and the cleaning wire prior to initial use.
> See lubrication instructions on page 38 > See sterilization instructions on page 42
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3. Safety notes for TE-97 LQ / TE-98 LQ / RQ-54
The TE-97 LQ / TE-98 LQ handpiece requires the Roto Quick coupling RQ-54 for proper operation.
> Avoid contact between optic outlet and soft tissue (risk of burning due to the optic outlet heating up). > Do not use the handpiece as light sensor. > Do not look directly into the optic outlet.
The handpiece / Roto Quick coupling is not suitable for use in oxygen enriched atmospheres.
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Danger zones M and G
In accordance with IEC 60601-1 / ANSI/AAMI ES 60601-1, the handpiece / Roto Quick coupling is not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide.
Zone M is defined as a »medical environment« and constitutes the part of a room in which potentially explosive atmospheres may form due to the use of anaesthetics or medical antiseptics and antibacterial soaps; such atmospheres are typically localized and temporary. Zone M comprises a truncated pyramid below the operating table which is tilted outwards at a 30° angle.
Zone G, also known as an »enclosed medical gas system«, does not necessarily include areas enclosed around all sides, in which explosive mixtures are continuously or temporarily generated, directed or used in small quantities.
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Risks due to electromagnetic fields
The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillator (ICD) can be affected by electric, magnetic, and electromagnetic fields.
> Find out if patient and user have implanted systems before using the product and consider
the application. > Weigh the risks and benefits. > Keep the product away from implanted systems. > Make appropriate emergency provisions and take immediate action on any signs of ill-health. > Symptoms such as raised heartbeat, irregular pulse, and dizziness can be signs of a problem
with a cardiac pacemaker or ICD.
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4. Product description RQ-54
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Roto Quick coupling with generator
O-rings
Electrical contacts
Nut
Gasket
Water filter with resuction stop
Generator
Connections
Drive air
Water
Spray air
Exhaust
Product description TE-97 LQ / TE-98 LQ
Handpiece with light and Roto Quick connection
Push-button chuck
Spray ports
Optic outlet (LED)
Sheath
Cleaning wire
Roto Quick connection
The TE-97 LQ / TE-98 LQ handpiece requires the Roto Quick coupling RQ-54 for proper operation.
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Product description TE-97 / TE-98
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Handpiece without light and Roto Quick connection
Push-button chuck
Spray ports
Sheath
Cleaning wire
Roto Quick connection
Product description TE-97 RM / TE-98 RM
Handpiece without light and Ritter-Midwest (RM) connection
Push-button chuck
Spray ports
Sheath
Cleaning wire
Gasket
Water filter with resuction stop
Handpiece tubing
Connections
Drive air
Water
Spray air
Exhaust
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