Instructions for use
BA Optima
Contra-angle handpiece
BA60E (BA611075)
2
Contents
1. Introduction ............................................................................................................................................................... 4 – 6
2. Safety notes ............................................................................................................................................................... 7 – 8
3. Product description ..........................................................................................................................................................9
Contra-angle handpiece
4. Starting operation – attachment/detachment ............................................................................................................10
Contra-angle handpiece
5. Starting operation – Changing the rotary instrument ........................................................................................ 11 – 14
Rotary instruments, contra-angle handpieces, test run
6. Hygiene and maintenance .................................................................................................................................... 15 – 23
General, pre-disinfection, manual cleaning, manual disinfection, machine cleaning,
lubrication, sterilization and storage
3
Contents
7. Accessories and spare parts..........................................................................................................................................24
8. Technical data .........................................................................................................................................................25 – 26
9. Recycling and disposal...................................................................................................................................................27
Explanation of warranty terms .............................................................................................................................................28
Authorized B.A. International Ltd. service partners ...........................................................................................................29
Symbols .........................................................................................................................................................................30 – 31
in the instructions for use / contra-angle handpiece / on the packaging
4
1. Introduction
The B.A. International Ltd. quality policy gives customer satisfaction top priority. This B.A. International Ltd. product
has been designed, manufactured and tested in accordance with the requirements of current laws and standards.
For your safety and the safety of your patients
Please read the instructions for use before using the device for the first time. They explain how to use the product
and guarantee trouble-free, economical and safe operation.
Intended use
The contra-angle handpiece is used to clean and polish the surface of the teeth and fillings.
Misuse may damage the contra-angle handpiece and thus cause risks and hazards for the patient, users and third
parties.
5
Qualifications of the user
The dental contra-angle handpiece has been developed and designed for
dentists
,
dental hygienists
, dental employees and dental assistants.
Production according to EU Directive
The contra-angle handpiece is a medical device as defined by EU Directive 93/42/EEC.
Responsibility of the manufacturer
The manufacturer can only accept responsibility for the safety, reliability and performance of
the contra-angle handpiece if it is used in compliance with the following directions:
> The contra-angle handpiece must be used in accordance with these instructions for use.
> The contra-angle handpiece has no components that can be repaired by the user. Modifications or repairs
must only be performed by an authorized B.A. International Ltd. service partner.
6
Qualified use
The contra-angle handpiece is only intended for qualified use in dental medicine according to the applicable health
and safety regulations, accident prevention measures and in observance of these instructions for use.
The contra-angle handpiece must only be prepared and maintained by persons who have been instructed in infection
prevention, self-protection and patient safety. Improper use (e.g., due to lack of hygiene or appropriate maintenance),
non-compliance with our instructions or the use of accessories and spare parts which have not been approved by
B.A. International Ltd. will invalidate all claims made under warranty or otherwise.
Servicing
In case of malfunction, please contact an authorised B.A. International Ltd. service partner immediately.
Repair and maintenance work must be performed exclusively by an authorized B.A. International Ltd. service partner.
7
2. Initial use – safety notices
> Operation of the contra-angle handpiece is only permitted on dental units that conform to the
IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2) standards.
> Use only the filtered, oil-free and cooled air supplied by dental compressors for drive air.
> Always ensure that the correct operating conditions are provided.
> Inspect the contra-angle handpiece for damage and loose parts before every use.
> Do not operate the contra-angle handpiece if it is damaged.
> Only fit the contra-angle handpiece when the motor is at a complete standstill.
> Perform a test run prior to each treatment.
8
Hygiene and maintenance before using for the first time
The contra-angle handpiece is supplied in a clean condition sealed in PE foil.
> Lubricate the contra-angle handpiece.
> Sterilize the contra-angle handpiece.
> Oil service page 20 – 21
> Sterilization page 22 – 23
9
3. Product description
BA60E
Thread
Drive
Spanner
Sheath
10
4. Starting operation – Attachment/detachment
Contra-angle handpiece
Do not attach or detach the contraangle handpiece while in operation!
Fit the contra-angle handpiece on the motor.
Check that it is securely attached to the motor.
Remove the contra-angle handpiece by pulling it
axially.
11
5. Starting operation – Changing the rotary instrument
Rotary instruments:
> Prophy cap/brush
> The rotary instruments are disposable articles and must be discarded after use.
> Only use fault-free rotary instruments. Observe the manufacturer’s instructions.
> Only insert the rotary instrument when the contra-angle handpiece is static.
> Never touch a rotary instrument that is still rotating.
> Only use the contra-angle handpiece in forward operation. The rotary instrument can come loose in
reverse operation (risk of injury).
2
12
> The contra-angle handpiece head is equipped with a Triple Seal.
> For caps/brushes please contact your dealer.
13
BA60E contra-angle handpiece
> Prophy cap/brush
Locking the contra-angle handpiece drive:
Insert the spanner in the drive dog.
Lock the contra-angle handpiece drive.
a) Screw the cap/brush in
as far as it will go.
b) Check that it is securely attached.
c) Unscrew the cap/brush.
b)
a)
c)
14
Test run
Do not hold the contra-angle handpiece at eye level!
> Insert the rotary instrument.
> Start the contra-angle handpiece.
In the event of malfunctions (e.g., vibrations, unusual noises, overheating), stop the contra-angle handpiece
immediately and contact an authorized B.A. International Ltd. service partner.
15
6. Hygiene and maintenance
Follow your country-specific directives, standards and guidelines for cleaning, disinfection
and sterilization.
> The contra-angle handpiece can undergo manual or machine reprocessing.
> Wear protective clothing.
> Remove the contra-angle handpiece from the motor.
> Take out the rotary instrument.
> Clean and disinfect the contra-angle handpiece immediately after each treatment, to rinse out any liquid
(e.g., blood, saliva, etc.) that may have entered and to prevent the inside parts from seizing.
> After manual cleaning, disinfection and lubrication, you must carry out a thermal disinfection
(unwrapped) or sterilization (wrapped) in a class B or S steam sterilizer (as per EN 13060).
> Sterilize the contra-angle handpiece after manual or machine cleaning, disinfection and lubrication.
16
Pre-disinfection
> If heavily soiled, clean first with disinfectant
cloths.
Only use disinfectants which have no proteinfixing effect.
17
Manual cleaning inside and outside
Rinse and brush off with demineralized water
(< 38°C)
Remove any liquid residues (absorbent cloth,
blow dry with compressed air).
Do not place the contra-angle handpiece in
disinfectant solution or in an ultrasonic bath!
18
Manual disinfection
B.A. International Ltd. recommends wiping
disinfection.
> Use only disinfectants which do not contain
chlorine and which are certified by officially
recognized institutes.
> Note the manufacturer’s specifications for the use
of the disinfectant.
19
Machine cleaning and disinfection (internal and external)
The contra-angle handpiece can be cleaned and disinfected in a thermo washer disinfector.
> Follow the manufacturer’s recommendations for devices and cleaning & rinsing agents.
> Ensure that the contra-angle handpiece is completely dry, both inside and out, following thermo washer
disinfection. Remove any liquid residues with compressed air.
> Lubricate the dry contra-angle handpiece immediately after thermo washer disinfection.
20
Daily oil service
With B.A. Ultimate Spray
> Follow the instructions on the oil spray can and on
the packaging.
Recommended maintenance cycles
> After every internal cleaning without fail
> Before every sterilization
or
> After 30 minutes of use or
> At least 1x a day
21
Test run after oil service
Point the contra-angle handpiece with the contra-
angle handpiece head downwards.
Allow the contra-angle handpiece to run for
30 seconds in order to remove any excess oil.
Repeat the entire hygiene and maintenance
process if any dirt escapes.
Wipe the contra-angle handpiece with a cellulose
cloth or soft cloth.
22
Sterilization and storage
B.A. International Ltd. recommends sterilization according to EN 13060, class B.
> Note the manufacturer’s specifications.
> Clean, disinfect and lubricate the contra-angle handpiece prior to sterilization.
> Wrap the contra-angle handpiece and the accessories in sterile goods packaging according to EN 868-5.
> Make sure that you only remove dry sterile goods from the sterilizer.
> Store sterile goods dust-free and dry.
ISO 14457 stipulates a durability of at least 250 sterilization cycles.
In the case of the B.A. International Ltd. contra-angle handpiece, we recommend you have a regular service
carried out after 1,000 sterilization cycles or one year.
23
Approved sterilization procedures
Follow your country-specific directives, standards and guidelines.
> Steam sterilization class B with sterilizers in accordance with EN 13060.
Sterilization holding time minimum of 3 minutes at 135 °C.
or
> Steam sterilization class S with sterilizers in accordance with EN 13060.
The sterilizer manufacturer must expressly approve the sterilization of contra-angle handpieces.
Sterilization holding time minimum of 3 minutes at 135 °C.
24
7. Accessories and spare parts
Use only original B.A.International Ltd. accessories and spare parts or accessories approved by B.A.International Ltd.
Reference source: B.A.International Ltd. partners
BAOIL B.A. Ultimate Spray
2038200 Oil spray cap with nozzle for straight and contra-angle handpieces
1957300 Spanner
25
8. Technical data
Contra-angle handpiece BA60E
Gear ratio 4:1
Outer diameter of the sheath (mm) 20
Motor connection as per standard ISO 3964
Maximum drive speed (min-1) 5.000 – 10.000
min-1 (revolutions per minute)
26
Temperature specifications
Temperature of the contra-angle handpiece on the operator side: maximum 55 °C
Temperature of the contra-angle handpiece on the patient side: maximum 50 °C
Temperature of the working instrument (rotary instrument): maximum 41 °C
Physical characteristics
Temperature for storage and transport: -40 °C to +70 °C
Humidity for storage and transport: 8% to 80% (relative), non-condensing
Temperature in operation: +10 °C to +35 °C
Humidity in operation: 15% to 80% (relative), non-condensing
27
9. Recycling and disposal
Recycling
B.A. International Ltd. considers that it has a special duty towards the environment. The contra-angle handpiece along
with its packaging has been designed to be as environmentally friendly as possible.
Disposal of contra-angle handpiece, rotary instruments
> Follow your country-specific laws, guidelines, standards and directives concerning disposal.
> 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 avoidance of waste.
This B.A. International Ltd. product has been manufactured with great care by highly qualified specialists. A wide variety of
tests and controls guarantees faultless operation. Please note that claims under warranty can only be validated when all the
directions in the instructions for use have been followed.
As the manufacturer, B.A. International Ltd. is liable for material or manufacturing defects within a warranty period of
12 months from the date of purchase.
We accept no responsibility for damage caused by incorrect handling or by repairs carried out by third parties not authorized to
do so by B.A. International Ltd..
Claims under warranty accompanied by proof of purchase must be sent to the vendor or to an authorized B.A. International Ltd.
service partner. The provision of service under warranty extends neither the warranty period nor any other guarantee period.
Explanation of warranty terms
12 months’ warranty
29
Authorized B.A. International Ltd. service partners
You can find your nearest B.A. International Ltd. service partner at
www.bainternational.com under the service section.
Alternatively please contact us at service@bainternational.com
30
2
Symbols in the instructions for use
WARNING!
(in cases where people
could be injured)
ATTENTION!
(in cases where
something could
be damaged)
General explanations,
without risk to
persons or objects
Do not dispose of with
domestic waste
Not for re-use
31
Symbols on the contra-angle handpiece / on the packaging
Catalogue number
Serial number Thermo washer disinfectable
Sterilizable up to the
stated temperature
Date of manufacture
CE 0476
from the manufacturer
Data matrix code for
product identification, e. g.,
in the hygiene and care
process
SN
REF
Form-Nr. 50922 AEN
Rev. 000 / 19.07.2016
Subject to change
(Manufacturer)
B.A. International Ltd.
Unit 9, Kingthorpe Business Centre,
Studland Road, Kingsthorpe,
Northampton, NN2 6NE U.K.
Rev2016/07
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