Bien Air CA 1: 2.5L MS User manual

CA 1:2.5L MS
ENG INSTRUCTIONS FOR USE
Other languages available on
www.bienair.com/ifu
REF 2100337-0001/2019.11

REF 2100337-0001/2019.11 CA 1 :2.5L MS • © Bien-Air Dental SA
Set supplied (REF) CA 1 :2.5L MS
1601 055-001
Optional accessories (REF)
1600 617-006 1600036-006 1600064-006 1000001-010

1 Symbols 4
1.1 Description of symbols used 4
2 Identification & Intended Use 5
2.1 Identification 5
2.2 Classification 5
2.3 Intended use 5
3 Precautions for use 6
4 Description 7
4.1 Overview 7
4.2 Technical data 7
5 Operation 8
5.1 Changing the bur 8
6 Cleaning and servicing 9
6.1 Maintenance 9
6.1.1 Precautions for maintenance 9
6.1.2 Suitable maintenance products 9
6.2 Cleaning 10
6.3 Cleaning-disinfection 12
6.3.1 Manual cleaning/disinfection 12
6.3.2 Automatic cleaning-disinfection 12
6.4 Lubrication 13
6.4.1 Verifying cleanliness 13
6.5 Sterilisation 13
6.6 Servicing 13
7 Packing & disposal 14
7.1 Transport and storage con-
ditions 14
7.2 Disposal 14
8 General information 14
8.1 Terms of guarantee 14
8.2 References 15
8.2.1 Set supplied (see cover) 15
8.2.2 Optional accessories (see cover) 15
3
Table of contents

4
ENG INSTRUCTIONS FOR USE
1 Symbols
1.1 Description of symbols used
Sym Description Sym Description
Manufacturer. Reference number.
CE Marking with number of the no-
tified body. Serial number.
CAUTION! Sep arate collection of electric and electronic equip-
ment.
Refer to the accompanying
documents. Recyclable materials.
4-way fitting. Use rubber gloves.
Electric powered 4-way fitting
(4VLM).
After initial mechanical resistance, tighten fully in
the d irection indicated.
Thermo washer disinfectable Back and forth movement.
Movement in the direction
indicated.
Sterilisation in an autoclave up to the specified tem-
perature.
Movement to the stop in the dir-
ection indicated. Light.

2.1 Identification
Medical device manufactured in
Switzerland by Bien-Air Dental SA.
Type
Contra-angle handpiece (CA) speed mul-
tiplier ratio with light and external
irrigation.
2.2 Classification
Class IIa according to European Dir-
ective 93/42/EEC relating to medical
devices. This medical device complies
with the legislation in force.
2.3 Intended use
Product intended for professional use
only. Use in general dentistry and in
dental surgery.
CAUTION
The contra-angle must not receive
pressurized cooling air from the unit, in
order to prevent contamination of the
wound.
Any use other than that for which this
device is intended is prohibited and may
prove dangerous.
5
2 Identification & Intended Use

This medical device accessory must be
used by a competent person, in par-
ticular in compliance with the legal
provisions in force regarding oc-
cupational safety, health and accident
prevention measures, and these in-
structions for use.
In accordance with these provisions, the
user is responsible for ensuring he or
she only uses devices which are in per-
fect working order.
In the event of irregular operation, ex-
cessive vibrations, abnormal heating or
other signs suggesting that the device is
malfunctioning, work must be sus-
pended immediately.
In this case, contact a repair centre ap-
proved by Bien-Air Dental SA.
CAUTION
Install the device on an appropriate out-
let to protect against the risk of injury
or infection.
CAUTION
Medical personnel using or performing
maintenance on medical devices that
are contaminated or potentially con-
taminated must comply with universal
precautions, in particular the wearing
of personal protective equipment
(gloves, goggles, etc.). Pointed and
sharp instruments should be handled
with great care.
CAUTION
It is essential to use dry, purified com-
pressed air in order to ensure the long
working life of the device. Maintain the
quality of the air and the water by reg-
ular maintenance of the compressor
and the filtration systems. The use of un-
filtered hard water will lead to early
blockage of the tubes, connectors and
spray cones.
Note:Using unfiltered hard water will
speed up blockage of the hoses, coup-
lings and spray diffusers.
Note: The technical specifications, il-
lustrations and dimensions contained in
these instructions are given merely as
an indication. They may not give rise to
any claim.
For any further information, please con-
tact Bien-Air Dental SA at the address
given on the back cover.
6
3 Precautions for use

4.1 Overview
FIG.1
(1) Centering for the micromotor
(2) Light output
(3) Bur (not supplied)
(4) Transmission ratio marking strip
(5) Push-button
Electric power supply
VDC or VAC: 3.4 ±0.3 V. The power sup-
ply systems must be in compliance with
IEC 60601-1 and IEC 60601-1-2 stand-
ards.
7
135°C
135°
C
12
3
4
5
FIG.1 (CA 1 :2.5L MS )
4.2 Technical data
Contra-angle 1:2.5
Standard coupling As per ISO standard 3964:2016 and Short
Drive speed 40’000 rp m max.
Speed of rotation 100'000 rpm max.
Typical operating torque 1.5 Ncm
Transmission ratio Red instrument sleeve, 2.5x multiplier.
Length 88 mm
CAUTION
The handpiece must not receive pressurised cooling air from the unit, to prevent
contamination of the rea being treated.
4 Description

Bur chuck
FIG.2
Tip diameter 1.60 mm, type 3 as per
ISO 1797-1, max length 21 mm code
4/5 as per ISO 6360-1 for the 1:2.5
range (Maximum working diameter 2
mm).
CAUTION
Follow the guidelines for use, according
to the bur manufacturer's instructions.
Never use a bur if the tip is not com-
pliant, as there is a risk it can become
detached during the procedure and in-
jure the practitioner, and the patient or
third parties.
5 Operation
5.1 Changing the bur
FIG.3
Push-button bur locking.
1. Press the push-button and sim-
ultaneously pull the bur.
2. Press the push-button, insert the new
bur until locked in place and release
the push-button.
3. Check that the bur rotates freely and
check it is locked by gently pushing
and pulling the bur.
CAUTION
The use of a coolant while the in-
strument is in operation is mandatory,
failure to comply with this re-
commendation may result in
overheating and burns or product fail-
ure. Set the water quantity for the
cooling spray to at least 60 ml / min.
CAUTION
The device must not be started without
a bur inserted. Comply with maximum
lengths by always inserting the bur as
far as possible into the locking mech-
anism. If a bur is operated at high
speeds when incorrectly mounted (i.e.
not fully inserted into the locking mech-
anism, or being longer than the values
specified above) this can cause a cent-
rifugal force which may bend or break
the bur.
CAUTION
Never insert a device on a rotating mi-
cromotor.
CAUTION
Always ensure that the spray outlets
are not obstructed.
CAUTION
Always check that the bur is in place
and rotates freely. If it does not, contact
your usual supplier or Bien-Air Dental
SA for repair.
8
min. 11 mm
max. 21 mm
ø 1,60 mm
Type 3 / ISO 1797-1
Code 4-5 / ISO 6360-1
FIG.2
1=23
FIG.3

6 Cleaning and
servicing
6.1 Maintenance
Clean, lubricate and sterilise the device
separately between patients.
CAUTION
The instrument is supplied "non sterile".
6.1.1 Precautions for maintenance
lBefore first use and
IMMEDIATELY after each pro-
cedure, clean, lubricate and
sterilise the device.
lBefore using for the first time and
within a maximum of 30 minutes
after each treatment, clean, dis-
infect and lubricate the
instrument, then sterilise. Ob-
serving this procedure eliminates
any blood, saliva or saline solution
residues and prevents the trans-
mission system from being
blocked.
lOnly instruments marked with the
logo can be cleaned in a
washer-disinfector machine.
lDo not immerse in an ultrasonic
cleaner.
lOnly use original Bien-Air Dental
SAmaintenance products and
parts or those recommended by
Bien-Air Dental SA. Using other
products or parts may cause
faults during operation and/or
void the warranty.
Chuck mechanism
Carry out cleaning- disinfection- ster-
ilisation without a bur in the chuck
mechanism.
6.1.2 Suitable maintenance products
Automatic cleaning-disinfection:
Low alkaline or enzymatic detergent re-
commended for cleaning in a washer-
disinfector for dental or surgical in-
struments (pH 6 - 9.5).
Manual cleaning-disinfection:
lSpraynet.
lAquacare.
lDetergent or detergent-disinfect
(pH 6- 9.5) recommended for
cleaning-disinfection of dental or
surgical instruments. Surface-act-
ive quaternary
enzymatic/ammonium detergent.
CAUTION
lDo not use detergents that are
corrosive or contain chlorine, acet-
one aldehydes or bleach.
lDo not submerge in physiological
liquid (NaCI).
lCheck that both the steriliser and
water used are clean. After each
sterilisation cycle, remove the
device from the sterilisation unit
immediately to reduce the risk of
corrosion.
9

6.2 Cleaning
Preparation
1. Disconnect the device from the coup-
ling and remove the bur (FIG.3 step
1).
Clean under running water
FIG.4 step 1
1. Clean under runing water at <38°C.
Remove dirt / deposits
FIG.4 step 2
1. Carefully remove all traces of dirt or
deposits from the nozzles using the
Bien-Air cleaning wire.
2. Dry the nozzles with compressed air
then dry the rest of the instrument
with a cloth.
CAUTION
Do not immerse in an ultrasonic
cleaner.
Internal cleaning with aquacare
1. Shake the Aquacare before use.
2. Use the Aquacare attachment (see
FIG.5 step 1).
3. Keep the tip of the instrument point-
ing down and protect with an
absorbent cloth; press the Aquacare
button down for 2 seconds (see
FIG.5 step 2).
4. Use the Aquacare attachment (see
FIG.5 step 3).
5. Keep the tip of the instrument point-
ing down and protect with an
absorbent cloth; press the Aquacare
button down for 1 second (see FIG.5
step 4).
10
1
2
FIG.4
1
2
4
3
FIG.5

Internal and external cleaning with
spraynet
1. Shake the Spraynet before use.
2. Use the Spraynet attachment (see
FIG.6 step 1).
3. Keep the tip of the instrument point-
ing down and protect with an
absorbent cloth; press the Spraynet
button down for 1 second (see FIG.6
step 2).
4. Clean the exterior of the contra-
angle with a cloth soaked in
Spraynet (see FIG.7).
11
2
1
FIG.6 FIG.7

6.3 Cleaning-disinfection
6.3.1 Manual cleaning/disinfection
FIG.8
1. Dip the device in a tank containing ap-
propriate detergent and, using a soft
brush, clean and disinfect the device,
clean the exterior of the device in ac-
cordance with the instructions of the
detergent manufacturer (time, con-
centration, temperature, renewal,
etc.)
2. Rinse the interior and exterior of the
device with demineralised water
(<38°C) for 30 seconds.
3. Spray the interior of the device with
Spraynet to remove the rinsing wa-
ter immediately, which will prevent
damage to or blockage of the in-
ternal components, then dry the
exterior surfaces with paper towels.
6.3.2 Automatic cleaning-disinfection
CAUTION
Only for device engraved with
Washer-disinfector
Carry out automatic cleaning- dis-
infection using an approved washer-
disinfector which complies with ISO
standard 15883-1 (e.g. Miele G 7781/G
7881 or Steris Hamo LM-25).
Detergent and washing cycle
Use a low alkaline or enzymatic de-
tergent recommended for cleaning in a
washer-disinfector for dental or sur-
gical instruments (pH 6 - 9.5) (e.g.:
neodisher® mediclean).
Select the washing cycle recommended
for the device and compatible with the
detergent manufacturer's indications
(e.g.: VARIO-TD).
CAUTION
Never cool devices by rinsing them.
12
FIG.8

6.4 Lubrication
6.4.1 Verifying cleanliness
Visually inspect the device to ensure it is
clean. If necessary, clean again using a
soft brush.
6.5 Sterilisation
CAUTION
The quality of the sterilisation is highly
dependent on how clean the in-
strument is. Only perfectly clean
instruments may be sterilised.
CAUTION
Do not use a sterilisation procedure
other than the one described below.
Procedure
Enclose the device and its accessories in
sterilisation bags which are large
enough to ensure the items can move
around, and which comply with the
standards in force (e.g.: EN 868-5). Ster-
ilise using steam on a class B cycle as
per EN 13060 / ISO 17665-1.
Note: All Bien- Air Dental SA in-
struments are sterilisable in an
autoclave up to 135°C. Duration: 3 or 18
minutes, depending on the national re-
quirements in force.
FIG.10
After cleaning, disinfecting and ster-
ilising the device, and before using it,
start it up at moderate speed with a
bur in the locking mechanism for 10 to
15 seconds to distribute and remove
the excess lubricant.
6.6 Servicing
Note: Bien-Air Dental SArecommends
that the user has his or her dynamic
devices checked or serviced every
three years.
13
1
2
34
1
3
FIG.9 FIG.10

7 Packing &
disposal
7.1 Transport and storage
conditions
There are no particular transport and
storage conditions required.
Packing
Pack the device in packaging approved
for steam sterilisation.
CAUTION
If not to be used for a prolonged period,
the device must be stored in a dry en-
vironment. Clean, lubricate and sterilise
the instrument before reuse.
7.2 Disposal
The disposal and/or recycling of ma-
terials must be performed in
accordance with the legislation in force.
The contra-angle must be recycled. In
order to avoid any risk of en-
vironmental contamination, the user
must return the device to his dealer or
contact an authorized body for the
treatment and recovery of this type of
equipment.
8 General
information
8.1 Terms of guarantee
Bien-Air Dental SA grants the user a
warranty covering any operating fault,
or material or manufacturing defect.
The warranty period for this medical
device is 12 months from the date of in-
voicing.
In the event of a justified claim, Bien-Air
Dental SAor its authorised rep-
resentative will repair or replace the
product free of charge.
All other claims of any kind whatsoever,
particularly claims for damages, are ex-
cluded.
Bien-Air Dental SAcannot be held li-
able for damage or injury and the
consequences thereof, resulting from:
lExcessive wear and tear
lInfrequent or improper use
lFailure to observe the servicing,
assembly or maintenance in-
structions
lDamage caused by unusual chem-
ical, electrical or electrolytic
influences
lFaulty air, water or electrical con-
nections.
14

CAUTION
The warranty becomes null and void if
damage and its consequences result
from incorrect servicing or modification
by third parties not authorised
by Bien-Air Dental SA.
Warranty requests will only be taken
into consideration if the product is ac-
companied by a copy of the invoice or
delivery note. The following information
must be clearly indicated: purchase
date, product reference and serial num-
ber.
8.2 References
Translated from original French
Instructions for use.
8.2.1 Set supplied (see cover)
REF Legend
1601 055-001 CA 1 :2.5L MS contra-angle
8.2.2 Optional accessories
(see cover)
REF Legend
1600 617-006
Aquacare, cleaning spray for
physiological liquid 500m, box of
6 cans
1600 036-006 Spraynet, 500ml cleaning spray,
box of 6
1600 064-006 Lubrifluid, 500ml spray lub-
ricant oil, box of 6
1000001-010 Cleaning wire, box of 10
15

16

17
NOTES

18
NOTES

19
NOTES

Bien-Air Dental SA
Länggasse 60 Case postale 2500 Bienne 6 Switzerland
Tel. [phone] Fax [phone]
[e-mail]
Other adresses available at
www.bienair.com
REF 2100337-0001/2019.11 CA 1 :2.5L MS • © Bien-Air Dental SA