Bien Air CA 1:1 User manual

CA 1:1
CA 1:5
CA 10:1
EVO.15 1:1
EVO.15 1:5
HP 1:1
ENG INSTRUCTIONS FOR USE.
Other languages available on www.bienair.com/ifu
REF 2100294-0002/2020.01 Rx Only

REF 2100294-0002/2020.01 CA 1:1,CA 1:5,CA 10:1,EVO.15,HP 1:1 • © Bien-Air Dental SA
Set supplied (REF) CA 1:5
1600386-001 1600325-001 1600690-001 1600941-001 1600940-001
Set supplied (REF) CA 1:1
1600384-001 1600424-001 1600691-001 1600939-001 1600938-001
Set supplied (REF) CA 10:1
1600385-001 1600425-001
Set supplied (REF) HP 1:1
1600383-001 1600693-001
Optional accessories (REF)
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 9
5.1 Changing the bur 9
6 Cleaning and servicing 10
6.1 Maintenance 10
6.1.1 Precautions for maintenance 10
6.1.2 Suitable maintenance products 10
6.2 Preliminary cleaning 11
6.2.1 Manual preliminary cleaning 11
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
6.4.2 Lubrication 13
6.5 Sterilisation 13
6.6 Servicing 13
7 Packing & disposal 14
7.1 Transport and storage condi-
tions 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! Separate 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 d irection
indicated. Sterilisation up to the specified temperature.
Movement to the stop in the di-
rection indicated. Light.

ENG
2.1 Identification
Medical device manufactured in Swit-
zerland by Bien-Air Dental SA.
Type
Dental contra-angles (CA), push-button
bur locking, 3 sprays (4 mixed sprays on
the EVO.15 range) with or without light.
2.2 Classification
Class IIa according to European Di-
rective 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. Used in general dentistry and oral
surgery.
CAUTION
The contra-angle must not receive pres-
surized 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.
lCA 1:1, CA 10:1and EVO.15 1:1 for
prophylaxis, restoration and en-
dodontic procedures.
lCA 1:5, EVO.15 1:5 and HP 1:1 for
general dentistry and restoration
procedures.
CAUTION
The device must not be used if any open
lesions or damaged soft tissue are
present or if a recent extraction has ta-
ken place. The air current could propel
infected material into the wounds, cau-
sing infection and a risk of embolism.
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 ins-
tructions 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 conta-
minated 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
Any excess maintenance product (lu-
bricant, cleaning and disinfection
products) present on the contra-angle
could find its way into the electric brush
motor and adversely affect its
operation. Always observe the main-
tenance instructions provided with each
product. Never lubricate the electric
brush motor.
Note:The technical specifications, illus-
trations 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
contact Bien-Air Dental SA at the ad-
dress given on the back cover.
6
3 Precautions for use

ENG
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 stan-
dards.
7
135°C
1
3
4
12
3
4
5
FIG.1
4.2 Technical data
Contra-angle 1:1 1:5 10:1
Standard coupling As per ISO standard 3 964 and Micro-Series version.
Drive speed 40’000 rpm max.
Speed of rotation 40'000 rpm max. 200'000 rpm max. 4'000 rpm max.
Typical operating torque 3 Ncm 1 Ncm 3 Ncm
Cooling Air consumption (imposed) 8 - 10 Nl/min
Cooling air pressure 250 - 490 kPa (depending on motor)
Spray water consumption 70 ml/min
Spray air consumption 2 Nl/min
Spray water pressure 200 kPa
Spray air pressure 200 kPa
4 Description

Bur chuck
FIG.2
Tip diameter 2.35 mm, type 1 as per
ISO 1797-1, max length 22 mm, code 4
as per ISO 6360-1 for the 1:1 and 10:1
ranges (max. working diameter 3 mm).
Tip diameter 2.35 mm, type 3 as per
ISO 1797-1, max length for short to
long types 21 mm, code 4 as per ISO
6360-1 for the 1:5 range (max. working
diameter 2 mm).
FIG.3
Tip diameter 2.35 mm, type 2 as per
ISO 1797-1, max length for short to
long types 45 mm, code 4 as per ISO
6360-1 for the HP 1:1 (max. working dia-
meter 3 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.
8
min. 12 mm
max. 21 mm
ø 1,60 mm
Type 3 / ISO 1797
Code 4-5 / ISO 6360-1
min. 12 mm
max. 22 mm
ø 2,35 mm
Type 1 / ISO 1797
Code 4 / ISO 6360-1
FIG.2
min. 30 mm
max. 45 mm
ø 2,35 mm
Type 2 / ISO 1797
Code 4 / ISO 6360-1
FIG.3

ENG
5 Operation
5.1 Changing the bur
CA 1:1, CA 1:5, CA 10:1, EVO.15 1:1 and
EVO.15 1:5
FIG.4
Push-button bur locking.
1. Press the push-button and si-
multaneously 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.
HP 1:1
FIG.5
1. Rotate the sleeve and remove the
bur.
2. Fully insert the bur. Lock the bur
changing mechanism by fully rotating
the sleeve, it can be fully tightened af-
ter initial mechanical resistance.
3. Each time a bur is inserted, check
that the clamping sleeve is fully tigh-
tened by moving the bur back and
forth.
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.
9
1=23
FIG.4
1=23
A
B
FIG.5

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, di-
sinfect 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 wa-
sher-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- ste-
rilisation 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 ins-
truments (pH 6 - 9.5).
Manual cleaning-disinfection:
lSpraynet.
lAquacare.
lDetergent or detergent-disinfect
(pH 6- 9.5) recommended for clea-
ning-disinfection of dental or
surgical instruments. Surface-ac-
tive quaternary
enzymatic/ammonium detergent.
CAUTION
lDo not use detergents that are
corrosive or contain chlorine, ace-
tone 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 de-
vice from the sterilisation unit
immediately to reduce the risk of
corrosion.
10

ENG
6.2 Preliminary cleaning
Preparation
1. Disconnect the device from the cou-
pling and remove the bur (FIG.3 step
1).
CAUTION
If there is a large amount of debris,
clean the exterior of the device with di-
sinfectant wipes. Observe the
instructions given by the manufacturer.
FIG.6,FIG.7
1. Unblock the spray tubes using the
Bien-Air Dental SA cleaning wire.
2. Carry out manual preliminary clea-
ning (see 6.2.1 , on page 11).
6.2.1 Manual preliminary cleaning
1. Spray the exterior and interior of the
device for 1 second with Spraynet.
Carefully clean the surfaces using a
soft cloth. Disinfectant wipes may al-
so be used.
2. Leave any liquid residue to drip-dry,
then wipe the exterior with a paper
towel or move onto the cleaning-di-
sinfection step immediately (see , on
page 1).
11
EVO.15
CA 1:1, 1:5, 10:1
FIG.6
HP 1:1
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,
concentration, temperature, re-
newal, 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- di-
sinfection 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

ENG
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.
6.4.2 Lubrication
Lubricate before each sterilisation or at
least twice a day. Only the Lubrifluid
spray must be used.
FIG.9
1. Remove the bur from the device, and
place the device in a cloth to collect
the excess.
2. Select the appropriate end-piece.
3. Insert the end-piece of the can Lu-
brifluid in the rear of the device's
handle.
4. Actuate the spray for 1 second, and
clean the excess oil on the exterior.
6.5 Sterilisation
CAUTION
The quality of the sterilisation is highly
dependent on how clean the ins-
trument 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 en-
ough to ensure the items can move
around, and which comply with the stan-
dards in force (e.g.: EN 868-5). Sterilise
using steam on a class B cycle as per EN
13060 / ISO 17665-1.
Note: All Bien- Air Dental SA ins-
truments 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 ste-
rilising 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 de-
vices checked or serviced every three
years.
13
1
2
3 4
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 CA and EVO contra-angles 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 is:
l12 months for the CA 10:1 range
l24 months for the CA 1:1, CA 1:5,
HP 1:1 and EVO.15 ranges
from the date of invoicing.
In the event of a justified claim, Bien-Air
Dental SAor its authorised re-
presentative 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
liable 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 ins-
tructions
lDamage caused by unusual che-
mical, electrical or electrolytic
influences
lFaulty air, water or electrical
connections.
14

ENG
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 in-
to consideration if the product is
accompanied 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
1600939-001 EVO.15 1:1L (light)
1600938-001 EVO.15 1:1L Micro-Series
1600941-001 EVO.15 1:5L (light)
1600940-001 EVO.15 1:5L Micro-Series
1600384-001 CA 10:1(light)
1600424-001 CA 10:1 (without light)
1600385-001 CA 10:1(light)
1600425-001 CA 10:1 (without light)
1600691-001 CA 10:1 Micro-Series (light)
1600386-001 CA 10:1(light)
1600325-001 CA 10:1(without light)
1600690-001 CA 10:1L Micro-Series (light)
1600383-001 HP 1:1Standard
1600693-001 HP 1:1Micro-Series
8.2.2 Optional accessories
(see cover)
REF Legend
1600036-006 Spraynet, 500ml cleaning spray,
box of 6
1600064-006 Lubrifluid, 500ml spray lu-
bricant oil, box of 6
1600001-010 Cleaning wire, box of 1 0
15

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 2100294-0002/2020.01 CA 1:1,CA 1:5,CA 10:1,EVO.15,HP 1:1 • © Bien-Air Dental SA