Bien Air CA 1:1 User manual

0120 REF 2100294-0001/2019.08
CA 1:1 EVO.15 1:1
CA 1:5 EVO.15 1:5
CA 10:1
ENG Instructions for use
other languages available on
www.bienair.com/ifu

REF 2100294-0001/2019.08 CA 1:1, 1:5, 10:1, EVO.15 • © 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
Optional accessories (REF)
1600036-006 1600064-006 1000001-010

ENG
1
1 Symbols.......................................... 2
1.1 Description of symbols used ......2
2 Identification & Intended Use ..... 3
2.1 Identification ....................................3
2.2 Intended use ....................................3
3 Precautions for use...................... 4
4 Description..................................... 5
4.1 Overview ...........................................5
4.2 Technical data .................................5
5 Assembly and operation............. 6
5.1 Changing the bur ............................6
5.2 Operation ..........................................6
6 Cleaning and servicing ................7
6.1 Maintenance ....................................7
6.1.1 Precautions for
maintenance ........................7
6.1.2 Suitable maintenance
products ................................7
6.2 Preliminary cleaning .....................8
6.2.1 Manual preliminary
cleaning .................................8
6.2.2 Preliminary
bath cleaning .......................8
6.3 Cleaning-disinfection ....................9
6.3.1 Manual cleaning/
disinfection ...........................9
6.3.2 Automatic cleaning-
disinfection ...........................9
6.4 Lubrication .................................... 10
6.4.1 Verifying cleanliness ...... 10
6.4.2 Lubrication ......................... 10
6.5 Sterilisation ...................................10
6.6 Servicing ........................................10
7 Packing and disposal................. 11
7.1 Transport and storage
conditions ......................................11
7.1.1 Packing ............................... 11
7.2 Disposal ..........................................11
8 General information................... 11
8.1 Terms of guarantee ....................11
8.2 References .................................... 12
8.2.1 Set supplied
(see cover) .......................... 12
8.2.2 Optional accessories
(see cover) .......................... 12
Table of contents

2
ENG Instructions for use
1Symbols
1.1 Description of symbols used
Symb Description Symb Description
Manufacturer. Reference number.
CE Marking with number of the noti-
fied body. Serial number.
CAUTION! Electrical or electronic materials to
be recycled.
Refer to the accompanying
documents. Recyclable materials.
Light. Use rubber gloves.
Sterilisable in an autoclave up to the
specified temperature.
Automated cleaning and thermal
disinfection using a washer-disinfector.
Movement in the direction
indicated.
After initial mechanical resistance,
fully tighten in the direction
indicated.
Movement to the stop in the direction
indicated. Back and forth movement.
REF
0120
SN

135°C

ENG
3
2 Identification
& Intended Use
2.1 Identification
Medical devices made entirely in Switzer-
land 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.
Classification
Class IIa according to European Directive
93/42/EEC relating to medical devices.
This medical device complies with the
legislation in force.
2.2 Intended use
This product is intended solely for pro-
fessional use.
For use in dentistry:
• CA 1:1, CA 10:1 and EVO.15 1:1: for
prophylaxis, restoration and endo-
dontic procedures.
• CA 1:5 and EVO.15 1:5: for general
dentistry and restoration procedures.
CAUTION
Any use other than that for which this
device is intended is prohibited and
may prove dangerous.
CAUTION
The device must not be used if any open
lesions or damaged soft tissue are pres-
ent or if a recent extraction has taken
place. The air current could propel
infected material into the wounds, caus-
ing infection and a risk of embolism.

4
3Precautions
for use
This medical device accessory must be
used by a competent person, in particu-
lar
in compliance with the legal provisions
in force regarding occupational safety,
health and accident prevention measures,
and these instructions for use.
In accordance with these provisions,
the user is responsible for ensuring he
or she only uses devices which are in
perfect working order.
In the event of irregular operation,
excessive vibrations, abnormal heating
or other signs suggesting that the
device is malfunctioning, work must be
suspended immediately.
In this case, contact a repair centre
approved by Bien-Air Dental SA.
CAUTION
Install the device on an appropriate out-
let to protect against the risk of injury or
infection.
CAUTION
The universal precautions, in particular
wearing of personal protective equip-
ment (gloves, goggles, etc.), should be
complied with by medical personnel
using or performing maintenance on
medical devices that are contaminated
or potentially contaminated. Pointed
and sharp instruments should be han-
dled with great care.
CAUTION
Any excess maintenance product (lubri-
cant, cleaning and disinfection prod-
ucts) present on the contra-angle could
find its way into the electric brush
motor and adversely affect its opera-
tion.
Always observe the maintenance
instructions provided with each product.
Never lubricate the electric brush
motor.
CAUTION
To avoid adversely affecting the
device's service life, ensure purified,
dry compressed air is used.
Ensure the quality of the air and water
being supplied through regular mainte-
nance of the compressor and the filtra-
tion systems.
Note : Using unfiltered hard water will
speed up blockage of the hoses, cou-
plings and spray diffusers.
Note : The technical specifications,
illustrations 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 address
given on the back cover.

ENG
5
FIG. 1 (EVO.15 1:1 L)
135°C
135°
C
12
3
4
5
4Description
4.1 Overview
FIG. 1
(1) Centring for the micromotor
(2)
Light outputs
(3) Bur (not supplied)
(4) Transmission ratio marking strip
(5) Push-button
4.2 Technical data
Transmission ratio 1:1 1:5 10:1
Standard coupling As per ISO standard 3964 and Micro-Series version.
Transmission ratio Direct ratio, blue strip Speed increasing
ratio of 5, red strip
Speed decreasing
ratio of 10, green
strip
Drive speed 40,000 rpm max. 40,000 rpm max. 40,000 rpm max.
Speed of rotation. 40,000 rpm max. 200,000 rpm max. 4000 rpm max.
Weight
86 g (1:1 L)
88 g (1:1)
79 g (1:1 L Micro-
Series)
87 g (EVO.15 1:1 L)
78 g (EVO.15 1:1 L
Micro-Series)
90 g (1:5 L)
90 g (1:5)
82 g(1:1L Micro-
Series)
90 g (EVO.15 1:1 L)
81 g (EVO.15 1:1 L
Micro-Series)
86 g (10:1 L)
88 g (10:1)
Length 95 - 97 mm (86.1 - 86.2 mm for Micro-Series models)
Air consumption 8 - 10 Nl/min 8 - 10 Nl/min 8 - 10 Nl/min

6
Bur
FIG. 2
• Tip diameter 2.35 mm, type 1 as per
ISO 1797-1, max length 21 mm code
4 as per ISO 6360-1 for the 1:1 and
10:1 range.
• Tip diameter 1.60 mm, type 3 as per
ISO 1797-1, max length 22 mm code
4/5 as per ISO 6360-1 for the 1:5
range.
CAUTION
Follow the guidelines for use, according
to the tool manufacturer's instructions.
Never use a bur if the tip is not compli-
ant, as there is a risk it can become
detached during the procedure and
injure the practitioner, the patient or
third parties.
5 Assembly
and operation
5.1 Changing the bur
FIG. 3
Push-button bur locking.
1. Press the push-button and simulta-
neously pull the bur.
2.
Press the push-button, insert the
new bur until locked in place and
release the push-button.
3. Check it is correctly locked by gently
pushing and pulling the bur.
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.
5.2 Operation
CAUTION
Do not operate the device until a bur has
been inserted.
To prevent the push-button from over-
heating, which could lead to burns, it
must not be pressed accidentally when
the device is rotating. Soft tissue
(tongue, cheek, lips, etc.) must be pro-
tected by moving it away using a retrac-
tor or dental mirror.
CAUTION
Never insert a device on a rotating
micromotor.
CAUTION
Always ensure that the spray outlets
are not obstructed.
FIG. 2 FIG. 3
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
1
23

ENG
7
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
• Before first use and IMMEDIATELY
after each procedure, clean, disinfect
and lubricate the device, then ster-
ilise it. Observing this procedure
eliminates any blood, saliva or saline
solution residues and prevents the
transmission system from being
blocked.
• Only instruments marked with the
logo can be cleaned in a washer-
disinfector machine.
• Do not immerse in an ultrasonic
cleaner.
• Only use original Bien-Air Dental
maintenance products and parts or
those recommended by Bien-Air
Dental SA. Using other products or
parts may cause faults during oper-
ation and/or void the warranty.
Bur chuck mechanism (cutting tool)
Carry out cleaning – disinfection – ster-
ilisation without bur in the chuck mech-
anism.
6.1.2 Suitable maintenance products
Automatic cleaning-disinfection:
• Low alkaline or enzymatic detergent
recommended for cleaning in a
washer-disinfector for dental or sur-
gical instruments (pH 6 - 9.5).
Manual cleaning/disinfection
•Spraynet.
• Detergent or detergent-disinfectant
(pH 6- 9.5) recommended for clean-
ing-disinfection of dental or surgical
instruments. Surface-active quater-
nary enzymatic/ammonium deter-
gent.
CAUTION
• Do not use detergents that are cor-
rosive or contain chlorine, acetone,
aldehydes or bleach.
• Do not submerge in physiological liq-
uid (NaCI).
• Check that both the steriliser and
water used are clean. After each
sterilisation cycle, remove the device
from the sterilisation unit immedi-
ately to reduce the risk of corrosion.

8
6.2 Preliminary cleaning
Preparation
FIG. 4
1. Disconnect the coupling device,
remove the bur (FIG. 3, step 1.).
CAUTION
If there is a large amount of debris,
clean the exterior of the device with
disinfectant wipes.
2. Unblock the spray tubes using the
Bien-Air Dental SA cleaning wire.
3. Carry out manual preliminary clean-
ing (see 6.2.1, on page 8) or preliminary
cleaning in a bath (see 6.2.2, on page 8).
6.2.1 Manual preliminary cleaning
FIG. 5
1. Disconnect the device from its cou-
pling and remove the bur.
2. Spray the exterior and interior of the
device for 1 second with Spraynet.
Carefully clean the surfaces using a
soft cloth. Disinfectant wipes may also
be used.
3. Leave any liquid residue to drip-dry,
then wipe the exterior with a paper
towel or move onto the cleaning-disin-
fection step immediately
(see 6.3, on page 9).
6.2.2 Preliminary bath cleaning
 CAUTION
The preliminary bath cleaning should be
followed by automatic cleaning-disinfec-
tion.
1. Totally submerge the device in a
cleaning bath containing a suitable
detergent as per the manufacturer's
instructions (duration, concentration,
temperature, renewal. etc.).
2.
Rinse the interior and exterior of the
device with demineralised water
(< 38°C) for 30 seconds.
3. Leave to drip-dry and wipe the exte-
rior surfaces with a paper towel or
immediately proceed with automatic
cleaning-disinfection
(see 6.3.2, on page 9).
FIG. 4 FIG. 5
EVO.15
CA 1:1, 1:5, 10:1
12
3

ENG
9
6.3 Cleaning-disinfection
6.3.1 Manual cleaning/disinfection
1. Dip the device in a tank containing
appropriate detergent and, using a soft
brush, clean and disinfect the device,
clean the exterior of the device in
accordance with the instructions of the
detergent manufacturer (time, concen-
tration, temperature, renewal, etc.)
2.
Rinse the interior and exterior of the
device with demineralised water
(< 38°C) for 30 seconds.
FIG. 6
3.
Spray the interior of the device with
Spraynet to remove the rinsing water
immediately, which will prevent damage
to or blockage of the internal compo-
nents, then dry the exterior surfaces
with paper towels.
6.3.2 Automatic cleaning-disinfection
CAUTION
Only for devices engraved with .
Washer-disinfector
Carry out automatic cleaning-disinfec-
tion using an approved washer-disin-
fector 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 deter-
gent recommended for cleaning in a
washer-disinfector for dental or surgi-
cal instruments (pH 6 - 9.5) (e.g.: neod-
isher® 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.
FIG. 6

10
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. 7
1. Remove the bur from the device and
place the device in a cloth to remove
surplus lubricant.
2.
Select the correct end-piece and
remove the protective cap.
3. Insert the end-piece of the can Lubri-
fluid 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 device is.
Only perfectly clean instruments may be
sterilised.
FIG. 7 FIG. 8
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 contra-
angles are sterilisable in an autoclave up
to 135°C. Duration: 3 or 18 minutes,
depending on the national requirements in
force.
FIG. 8
After cleaning, disinfecting and sterilis-
ing the device, and before using it, start
it up at moderate speed with a bur in the
locking mechanism (FIG. 3, step 2.) for
10 to 15 seconds to distribute and
remove the excess lubricant.
6.6 Servicing
Never dismantle the device. For all servic-
ing or repair operations, you are advised to
contact your usual supplier or Bien-Air
Dental SA directly.
Note : Bien-AirDentalSArecommends
that the user has his or her dynamic devices
checked or serviced every three years .
1
2
34

ENG
11
7 Packing and
disposal
7.1 Transport and storage
conditions
Temperature between -40°C and 70°C
inclusive, relative humidity between
10% and 100%, atmospheric pressure
between 50 kPa and 106 kPa.
7.1.1 Packing
Pack the instrument in packaging
approved for steam sterilisation.
CAUTION
If not to be used for a prolonged period,
the device must be stored in a dry envi-
ronment. Clean, lubricate and sterilise
the instrument before reuse.
7.2 Disposal
The disposal and/or recycling of mate-
rials must be performed in accordance
with the legislation in force.
The CA and its accessories must be
recycled. Electrical and electronic
equipment may contain dangerous sub-
stances which constitute health and
environmental hazards.
Users should return devices to their dis-
tributors or directly contact an approved
body responsible for processing and
recovering this type of equipment
(European directive 2002/96/EC).
8 General infor-
mation
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:
• 12 months for the CA 10:1 range
• 24 months for the CA 1:1, CA 1:5
and EVO.15 ranges
from the date of invoicing.
In the event of a justified claim,
Bien-Air Dental SA or its authorised
representative will repair or replace the
product free of charge.
All other claims of any kind whatsoever,
particularly claims for damages or
interest, are excluded.
Bien-Air Dental SA cannot be held liable
for damage or injury and the conse-
quences thereof, resulting from:
• Excessive wear
•Infrequentuse
• Failure to observe the servicing,
assembly or maintenance
instructions
• Damage caused by unusual chemi-
cal, electrical or electrolytic influ-
ences
• Faulty air, water or electrical con-
nections.

12
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.
Claims under the terms of the warranty
will be considered only on presentation,
together with the product, of the invoice
or the consignment note. The following
information must be clearly indicated:
The date of purchase, the product refer-
ence and the serial number.
8.2 References
Translated from original French
Instructions for use.
8.2.1 Set supplied (see cover)
8.2.2 Optional accessories
(see cover)
REF Legend
1600939-001 EVO.15 1:1 L (light)
1600938-001 EVO.15 1:1 L Micro-Series
(light)
1600941-001 EVO.15 1:5 L (light)
1600940-001 EVO.15 1:5 L Micro-Series
(light)
1600384-001 CA1:1 L (light)
1600424-001 CA 1:1 (without light)
1600385-001 CA 10:1 L (light)
1600425-001 CA 10:1 (without light)
1600691-001 CA1:1 L Micro-Series (light)
1600386-001 CA 1:5 L (light)
1600325-001 CA 1:5 (without light)
1600690-001 CA 1:5 L Micro-Series (light)
REF Legend
1600036-006 Spraynet, 500 ml cleaning
spray, box of 6
1600064-006 Lubrifluid, 500 ml spray
lubricant oil, box of 6
1000001-010 Cleaning wire, box of 10

REF 2100294-0001/2019.08 CA 1:1, 1:5, 10:1, EVO.15 • © Bien-Air Dental SA

REF 2100294-0001/2019.08 CA 1:1, 1:5, 10:1, EVO.15 • © Bien-Air Dental SA
Bien-Air Dental SA
Länggasse 60
Case postale
2500 Bienne 6, Switzerland
Tel. [phone]
Fax [phone]
o[e-mail]
Bien-Air Deutschland GmbH
Jechtinger Strasse 11
79111 Freiburg, Deutschland
Tel. [phone]
Fax [phone]
[e-mail]
Bien-Air España, SAU
Entença, 169 Bajos
08029 Barcelona, España
Tel. [phone]
Fax [phone]
[e-mail]
Bien-Air USA, Inc.
5 Corporate Park
Suite 160
Irvine, CA 92606 USA
Phone [phone]-BIEN
Phone [phone]
Fax [phone]
[e-mail]
Bien-Air France Sàrl
19-21, rue du 8 Mai 1945
94110 Arcueil, France
Tel. [phone]
Fax [phone]
[e-mail]
Bien-Air Italia S.r.l.
Via Vaina 3
20122 Milano, Italia
Tel. [phone] /
52/54
Fax [phone]
[e-mail]
Bien-Air UK Ltd
Arundel House
Whitworth Road
Crawley, West Sussex
RH11 7XL, England
Tel. [phone]
Fax [phone]
[e-mail]
Bien-Air Asia Ltd.
Nishi-Ikebukuro
Daiichi-Seimei Bldg. 10F
2-40-12 Ikebukuro, Toshimaku
Tokyo, 171-0014, Japan
Tel. [phone]
Fax [phone]
[e-mail]
Beijing Bien-Air
Medical Instrument
Technology Service Co. Ltd.
Room 907, The Exchange
Beijing,
No 118 Jian Guo Lu Yi,
Chao Yang District,
Beijing 100022, China
Tel. [phone]
Fax [phone]
[e-mail]
www.bienair.com
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