A dec|W&H Synea 400 Series Lowspeed Electric Handpiece Instructions for Use

A dec|W&H Synea 400 Series Lowspeed Electric Handpiece Instructions for Use
Instructions for use
400 series
Lowspeed Electric Handpiece
Contents
A-dec | W&H symbols.......................................................................................................................................................... 3 – 4
1.Introduction.................................................................................................................................................................. 5 – 7
2. Safety notes................................................................................................................................................................. 8 – 9
3. Product description..........................................................................................................................................................10
4. Operation.................................................................................................................................................................. 11 – 14
Assembly/Removal, To change files/tips, Test
5. Cleaning and maintenance..................................................................................................................................... 15 – 24
General, Pre-Cleaning, Manual cleaning, Manual disinfection,
Automated cleaning and disinfection, Lubrication, Sterilization
6.A-dec |W&H accessories and spare parts.......................................................................................................................25
7. Technical data..........................................................................................................................................................26 – 28
8. Recycling and disposal....................................................................................................................................................29
Warranty................................................................................................................................................................................. 30
A-dec | W&H contacts..............................................................................................................................................................31
2
A-dec|W&H symbols instructions for use
CAUTION!
(to prevent
damage occurring)
WARNING!
(risk of injury)
General explanations,
without risk to
persons or objects
Do not dispose of
with domestic waste
UL Component Recognition Mark
indicates compliance with
Canadian and U.S. requirements
3
A-dec|W&H symbols handpiece
CE 0297
from the manufacturer
REF
Catalog number
Thermal washer disinfectable
SN
Serial number
Sterilizable up to the
stated temperature
rpm
rpm = min-1
(revolutions per minute)
Date of manufacture
4
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 handpiece is intended for the following applications:
Finishing of cavities, crown cement, and restorations, setting of inlays with vibration, finishing, and polishing in the
interdental region, and stripping.
Always follow the manufacturer’s recommendations for the handpiece.
Misuse may damage the handpiece, create risks, and pose hazards for patients, users, and others.
5
Qualifications of the user
We have based our development and design of the dental handpiece on the dentists, dental hygienists,
dental employees (prophylaxis) and dental assistants target group.
Production according to EU Directive
The handpiece 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.
Responsibility of the manufacturer
The manufacturer can only accept responsibility for the safety, reliability, and performance of the
handpiece when it is used in compliance with the following directions:
> The handpiece must be used in accordance with these instructions for use.
> The handpiece has no components that can be repaired by the user. Assembly, modifications, or repairs
must only be undertaken by authorized A-dec|W&H repair locations.
6
Skilled application
The handpiece 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 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.
Service
In the event of malfunctions contact your local retail A-dec dealer or A-dec customer service.
Service and maintenance work must only be carried out by authorized A-dec|W&H repair locations.
7
2. Safety notes
> 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.
> Use only non-contaminated, filtered, oil-free, and dry compressed air to operate the handpiece.
> Check the handpiece for damage and loose parts each time before using.
> Do not operate the handpiece if it is damaged.
> Perform a test run each time before using.
> Run the rinse function for the dental unit once per day.
8
> The operation of the handpiece with light is permitted only on dental units that correspond to the standards
IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2).
The power supply unit for the dental unit must satisfy the following requirements to be guaranteed by the
system assembler:
> The compliance with the leakage currents of the application section must be guaranteed by the
system assembler.
> The secondary voltage must be non-earthed.
> The secondary circuits must be protected against short-circuiting and overloading.
Cleaning and maintenance prior to initial use
Ensure that the handpiece is in clean condition and sealed in polyethylene (PE) film when the product is first
delivered.
> Lubricate the handpiece prior to initial use.
> Sterilize handpiece, tip ejector and cleaning wire prior to initial use.
> See lubrication instructions on page
> See sterilization instructions on page
page 21
page 23
9
3. Product description
 Spray ports
 Optic Outlet (glass rod)
Grip
 Cleaning wire
 Tip ejector
 Support tab
10
4. Operation – assembly/removal
Do not install or remove the handpiece
while the motor is running!
 Push the handpiece onto the motor and turn it until it
clicks.
 Verify that the connection to the motor is secure.
rPull the handpiece to remove it from the motor.
11
Files/tips
The files/tips operate with a reciprocating movement.
> Use only files/tips that are in excellent condition. Follow the manufacturer‘s operating instructions.
> Insert the file/tip only when the handpiece is stationary.
> Do not touch the file/tip when it is in motion.
12
Changing the files/tips
 Insert the file/tip into the contra-angle until it
engages.
> The file/tip rotates freely (360°) and can be fixed in
12 positions (30° steps) (A).
> Press the file/tip into the position required up to the
limit stop (B).
 Pull slightly on the file/tip to verify a secure
connection.
 Remove the file with the tip ejector.
13
Test
Do not hold the handpiece at eye level when testing to avoid possible injury.
> Insert the file/tip.
> Start the handpiece.
> If you observe problems, such as vibrations, unusual noise, overheating, smell, coolant supply failure, or leakage,
stop the handpiece immediately and contact your A-dec dealer or A-dec customer service.
14
5. Cleaning and maintenance
Follow your local directives, standards, and guidelines for cleaning, disinfection, and sterilization.
> You can process the handpiece manually or automatically.
> Wear protective clothing and personal protective equipment (PPE).
> Remove the handpiece from the motor.
> Remove the file/tip.
> Clean and disinfect the handpiece immediately after each patient to flush out any liquid (such as blood,
saliva, etc.) and to prevent debris from settling on the internal parts.
> Sterilize the handpiece after each patient, following manual or automated cleaning,
disinfection and lubrication.
> Sterilize the cleaning wire following manual cleaning and disinfection.
15
Pre-Cleaning
>If heavily soiled, clean first with
disinfectant cloths.
Do not use disinfectants that contain chlorine or
protein fixatives. See manual disinfection on
page 19.
Manual cleaning internal and external
Rinse and brush off under demineralized water
(< 100°F / < 38°C).
Remove any liquid residues (absorbent cloth, blow
dry with compressed air).
Do not place the handpiece in liquid disinfectant
or in an ultrasonic bath.
16
Clean spray ports
 Use the cleaning wire to carefully remove dirt and
deposits from the spray ports.
Clean and disinfect the cleaning wire in an
ultrasonic bath/disinfection bath.
Cleaning of the coolant tubes
> Use an air syringe to blow air through the coolant
tube.
In the case of clogged spray ports or coolant
tubes, contact your local A-dec dealer or A-dec
customer service.
17
Clean the optic outlet
Clean the handpiece with care and avoid
scratching the optic outlet.
 Wash the optic outlet with cleaning/disinfectant fluid
and a soft cloth.
 Dry the optic outlet with an air syringe or soft cloth.
Inspect after each cleaning process.
If the optic outlet is damaged, do not use the
handpiece and contact your local A-dec dealer
or A-dec customer service.
18
Manual disinfection
A-dec|W&H recommends wiping the
handpiece down with disinfectant.
> Use only disinfectants that do not contain chlorine
and are certified by officially recognized institutes.
Use EPA-registered surface disinfectants.
> Note the manufacturer’s specifications for the
use of the disinfectants.
After manual cleaning, disinfection, and
lubrication, you must sterilize the (wrapped)
handpiece using a steam sterilizer.
19
Automated internal and external cleaning and disinfection
The handpiece can be cleaned and disinfected in a thermal washer disinfector.
> Note the manufacturer’s specifications on equipment, cleaning agents, and detergents.
> Make sure that the handpiece is completely dry internally and externally after thermal washer
disinfection. Remove any liquid residues with compressed air.
> Lubricate the dry handpiece immediately after thermal washer disinfection.
20
Lubrication
Recommended lubrication cycles
> Essential after every internal cleaning
> before each sterilization,
or
> After 30 minutes of use or
at least once daily.
 With W&H Service Oil F1, MD-400
> Follow the instructions on the oil spray can and the
packaging.
or
 With the A-dec|W&H Assistina 301 plus
> See Instructions for use of Assistina.
21
Test following lubrication
 Place the handpiece with the head positioned
downward.
Start the handpiece for 30 seconds to remove excess
oil.
30 sec
> Repeat the complete cleaning and maintenance
process with any sign of dirt or debris.
Wipe the handpiece with gauze or soft cloth.
> Sterilize the handpiece.
22
Sterilization and storage
>
>
>
>
>
Note the instructions of the unit manufacturer.
Clean, disinfect, and lubricate before sterilization.
Place the handpiece in a standard handpiece sterilization pouch.
Make sure that you only remove dry sterile goods from the sterilizer.
Store sterile goods dust-free and dry.
The standard ISO 14457 stipulates a durability of at least 250 sterilization cycles.
We recommend that you regularly service the A-dec|W&H handpieces 1,000 sterilization cycles or one
year of use.
23
Approved sterilization procedures
Follow your local directives, standards, and guidelines.
> Dynamic-air-removal sterilzers: 270°F (132°C) for 4 minutes or
> Gravity displacement sterilizers: 270°F (132°C) for 15 minutes
> All other sterilization methods are not approved and must not be used.
Do not exceed 277°F (136°C) during sterilization.
Allow the load to dry for approximately 20 to 30 minutes before removing from the sterilizer.
24
6. A-dec|W&H accessories and spare parts
Use only original A-dec|W&H accessories and spare parts or accessories approved by W&H.
Suppliers: A-dec|W&H partners
301
10940021
01603400
02015101
02038200
Assistina
Service Oil F1, MD-400 (6 pcs)
Tip ejector
Cleaning wire
Spray cap with spray nozzle for handpieces
25
7. Technical data
WG-67 LT
Transmission ratio
Colour coding
Motor coupling
Recommended files/tips
Maximum overall length
Chuck
Maximum motor speed Spray flow rate Water setting range (recommended water pressure) **
Chip air setting range (recommended chip air pressure) **
Chip air consumption at 29 psi
(rpm)
acc. to ISO 14457 (gal/min)
(psi)
(psi)
[CFM]
2:1
1 green ring
ISO 3964
DENTATUS LDT and LTA *
determined by the files/tips available
sliding chuck *
20,000
> 0,013
7 – 29 (22)
22 – 43.5 (29)
> 0,053
* see page 27
26
* A shorter chuck length is not possible. In this case or when using other files/tips, the user must ensure by
correct selection of the operating conditions that there is no danger to the user, patient or third parties.
** The chip air / water pressure must be set at the same time
The chip air must be higher than the water pressure
rpm = min-1 (revolutions per minute)
27
Temperature information
Temperature of the handpiece at the operator side:
Temperature of the handpiece at the patient side:
Temperature of the working part (file/tip): max. 131°F (55°C)
max. 122°F (50°C)
max. 105.8°F (41°C)
Physical characteristics
Temperature for storage and transport: Air humidity for storage and transport: -40°F to +158°F (-40°C to +70°C)
8% to 80% (relativ), non-condensing
Ambient temperature during operation:
Air humidity during operation:
+50°F to +95°F (+10°C to +35°C)
15% to 80% (relativ), non-condensing
28
8. Recycling and disposal
Recycling
A-dec|W&H considers that it has a special duty towards the environment. The handpiece along with its packaging has
been designed to be as environmentally friendly as possible.
Disposal of the handpiece
Follow your local laws, directives, standards, and guidelines for the disposal of used electrical devices.
Ensure that the parts are not contaminated on disposal.
Disposal of the packaging material
All packaging materials have been selected according to environmentally compatible and disposal aspects and can be
recycled. Please send old packaging materials to the relevant collection and reprocessing system. This way, you will
contribute to the recycling of raw materials and the reduction of waste.
29
W arran ty
A-dec warrants all products in this document against defects in material or workmanship for one year from time of delivery. A-dec’s
sole obligation under the warranty is to provide parts for the repair, or at its option, to provide the replacement product
(excluding labor). The buyer shall have no other remedy. All special, incidental, and coincidental damages are excluded.
Written notice of breach of warranty must be given to A-dec within the warranty period. The warranty does not cover damage
resulting from improper installation or maintenance, accident or misuse. The warranty does not cover damage resulting from the
use of cleaning, disinfecting or sterilization chemicals and processes. Failure to follow instructions provided in the A-dec | W&H
instructions for use (operation and maintenance instructions) may void the warranty.
No other warranties as to merchantability or otherwise are made.
A-dec | W&H contacts
A-dec Inc.
2601 Crestview Drive
Newberg, OR 97132 USA
Tel: 1.800.547.1883 Within USA/Canada
Tel: 1.503.538.7478 Outside USA/Canada
Fax: 1.503.538.0276
www.a-dec.com
W&H Impex Inc.
6490 Hawthorne Drive, Windsor, Ontario, N8T 1J9
Tel: 1 800 265 6277 Within USA/Canada
Tel: 1.519.944.6739 Outside USA/Canada
Fax: 1.519.974.6121
31
Distribution
A-dec Inc.
2601 Crestview Drive
Newberg, OR 97132 USA
t 1.800.547.1883, f 1.503.538.0276
www.a-dec.com
Manufacturer
W&H Dentalwerk Bürmoos GmbH
Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria
t + 43 6274 6236-0,f + 43 6274 6236-55
[email protected] wh.com
Form-Nr. 50802 CEN
Rev. 001 / 22.08.2014
Subject to alterations
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertisement