Bien Air CA 1:2.5 L MS User manual

Rx Only
CA 1:2.5 L MS
ENG INSTRUCTIONS FOR USE
Other languages available on
www.bienair.com/ifu
REF 2100337-0003/2020.09

REF 2100337-0003/2020.09 CA 1:2.5 L MS • © Bien-Air Dental SA
Set supplied (REF) CA 1:2.5 L MS
1601055-001
Optional accessories (REF)
1600617-006 1600036-006 1600064-006 1000001-010

1 Symbols 5
1.1 Description of symbols used 5
2 Identification & Intended Use 6
2.1 Identification 6
2.2 Classification 6
2.3 Intended use 6
3 Precautions for use 7
4 Description 8
4.1 Overview 8
4.2 Technical data 8
5 Operation 10
5.1 Changing the bur 10
6 Cleaning and servicing 11
6.1 Maintenance - General in-
formation 11
6.1.1 Precautions for maintenance 11
6.1.2 Suitable maintenance products 11
6.2 Cleaning 12
6.3 Disinfection 13
6.3.1 Manual disinfection 13
6.3.2 Automatic disinfection 13
6.4 Lubrication 15
6.4.1 Verifying cleanliness 15
6.4.2 Lubrication with Lubrifluid 15
6.5 Sterilization 15
6.5.1 Procedure 15
6.6 Packing and storage 17
6.7 Servicing 17
7 Transport& disposal 17
7.1 Transport 17
7.2 Disposal 17
8 General information 18
8.1 Terms of guarantee 18
8.2 References 18
8.2.1 Set supplied (see cover) 18
8.2.2 Optional accessories (see cover) 18
4
Table of contents

5
ENG INSTRUCTIONS FOR USE
1 Symbols
1.1 Description of symbols used
Sym Description Sym Description
Manufacturer. Catalogue number.
CE Marking with number of the notified
body. Serial number.
WARNING:hazard that could result in ser-
ious injury or damage to the device if the
safety instructions are not correctly fol-
lowed .
Medical Device.
CAUTION:hazard that could result in light
or moderate injury or damage to the
device if the safety instructions are not cor-
rectly followed.
General symb ol for recovery/recyclable.
Use rubber gloves. After initial mechanical resistance, tighten
fully in the direction indicated.
Thermo washer disinfectable. Sterilization up to the specified tem-
perature.
Movement in the direction
indicated.
Movement to the stop in the direction in-
dicated.
Back and forth movement. Lamp; lighting, illumination.
Warning: in accordance with federal law
(USA), this device is only available for sale
upon recommendation by an accredited
practitioner.
Refer to the accompanying
documents.

ENG
2.1 Identification
Medical devices manufactured 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. Those medical devices comply
with the legislation in force.
2.3 Intended use
Product intended for professional use
only. Used in general dentistry and oral
surgery.
WARNING
Any use other than that for which this
device is intended is prohibited and may
prove dangerous.
WARNING
The contra-angle must not receive pres-
surized cooling air from the unit, in
order to prevent contamination of the
wound.
6
2 Identification & Intended Use

Those medical devices must be used by
professionals 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,
unusual noise or other signs suggesting
that the device is malfunctioning, work
must be suspended immediately.
In this case, contact a repair centre ap-
proved by Bien-Air Dental SA.
WARNING
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: 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.
7
3 Precautions for use

ENG
4.1 Overview
FIG.1
(1) Micromotor connection
(2) Light output
(3) Bur (not supplied)
(4) Transmission ratio
(5) Push-button with a
bur-locking system
8
FIG.1 (CA 1:2.5 L MS)
4.2 Technical data
Contra-angle 1:2.5
Standard coupling As per ISO standard 3964*
Drive speed 40’000 rpm 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
(*) The contra-angle can only be operated on dental motors with an ISO coupling
measuring no longer than 23 mm.
4 Description

Bur chuck
FIG.2
Shaft diameter 1.60 mm, type 3 as per
ISO 1797-1, recommended length 21
mm* code 4/5 as per ISO 6360-1 for
the 1:2.5 range (Maximum working dia-
meter 2 mm).
(*) When using longer rotary in-
struments (e.g. 25 mm surgical burs)
the user must ensure, by selecting the
correct operating conditions, that there
is no danger to the user, patient or
third parties.
WARNING
Follow the guidelines for use, according
to the bur manufacturer's instructions.
Never use a bur if the shaft is not com-
pliant, as there is a risk it can become
detached during the procedure and in-
jure the practitioner, the patient or
third parties.
9
FIG.2 FIG.3

ENG
5 Operation
5.1 Changing the bur
FIG.3
Push-button bur locking.
1. Press the push-button and sim-
ultaneously pull out the bur.
2. Press the push-button, insert the new
bur all the way to the stop and re-
lease the push-button.
3. Check that the bur rotates freely and
that it is locked by gently pushing and
pulling the bur.
WARNING
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 or remove a device while
the micromotor is rotating.
WARNING
Do not touch the dental bur while it is ro-
tating.
CAUTION
Never press the push-button while the
instrument is in operation.
CAUTION
Always check that the bur is in place
and rotates freely. If it is blocked, con-
tact your usual supplier or Bien- Air
Dental SA for repair.
CAUTION
Always ensure that the spray outlets
are not obstructed.
10

6 Cleaning and
servicing
6.1 Maintenance - General in-
formation
WARNING
The instrument is supplied "non sterile".
Clean, lubricate and sterilize the device
prior to first use and between each pa-
tients.
6.1.1 Precautions for maintenance
lBefore using for the first time and
within a maximum of 30 minutes
after each treatment, clean, dis-
infect and lubricate the
instrument, then sterilize. Ob-
serving this procedure eliminates
any blood, saliva or saline solution
residues and prevents the trans-
mission system from being
blocked.
lOnly use original Bien-Air Dental
SAmaintenance products and
parts or those recommended by
Bien-Air Dental SA.For suitable
maintenance products refer to
section 6.1.2 Suitable main-
tenance products. Using other
products or parts may cause
faults during operation and/or
void the warranty.
CAUTION
lCarry out cleaning- disinfection-
sterilization without a bur in the
chuck mechanism.
lUse detergents that are pH 8-11,
are neither corrosive nor contain
chlorine, acetone and/or al-
dehydes.
lDo not immerse in an ultrasonic
cleaner.
lDo not submerge in physiological
liquid (NaCI) nor use saline to
keep the device moist until it can
be cleaned.
lOnly instruments marked with the
logo can be cleaned in a
washer-disinfector machine.
lAs with all instruments, following
each sterilization cycle, including
drying, remove the device to avoid
excess exposure to heat which
can result in corrosion.
lUse only dynamic sterilizers: do
not use a steam sterilizer with a
gravity displacement system.
6.1.2 Suitable maintenance products
Manual cleaning:
lSpraynet.
lAquacare.
Manual disinfection:
lAlkaline detergent or detergent-
disinfectant (pH 8-11) re-
commended for cleaning-
disinfection of dental or surgical in-
struments. Disinfectant products
composed either of di-
decyldimethylammonium
chloride, quaternary ammonium
carbonate or neutral enzymatic
product. (e.g. Neodisher® med-
iclean) are also allowable.
Automatic cleaning-disinfection:
lUse an alkaline product re-
commended for cleaning in a
washer-disinfector for dental or
surgical instruments (pH 8-11).
11

ENG
6.2 Cleaning
Preparation
1. Disconnect the device from the elec-
trical motor and remove the bur
(FIG.3 step 1).
CAUTION
If there is a large amount of debris,
clean the exterior of the device with dis-
infectant wipes. Observe the
instructions given by the manufacturer.
Remove dirt / deposits
FIG.4 step 1 and 2
1. Clean the exterior and interior of the
device under tap water at 15°C-38°C
(59°F-100°F) provided that the local
tap water has a pH within the range
of 6.5 - 8.5 and a chloride content be-
low 100 mg/l. If the local tap water
does not meet these requirements,
use demineralized (deionized) water
instead. Carefully remove all traces
of dirt or deposits from the nozzles
using the Bien-Air cleaning wire (op-
tional).
2. After selecting the appropriate
nozzle, perform preliminary cleaning
of the device by using the product
Aquacare. Spray the inside and the
outside of the device and inside the ir-
rigation tube (see FIG.5).
12
1
2
FIG.4
1
2
4
3
FIG.5

6.3 Disinfection
6.3.1 Manual disinfection
1. Dip the device in a bath containing a
disinfectant product (e.g. di-
decyldimethylammonium chloride,
quaternary ammonium carbonate or
neutral enzymatic product which are
allowable chemical agents). Follow
the concentration and duration re-
commended by the fabricant of the
disinfection product.
2. Brush the device with a smooth, flex-
ible brush (e.g. soft-bristled
toothbrush). DO NOT USE a wire
brush.
3. Optional: perform additional cleaning
and disinfection of the external sur-
faces with non-woven wipes
impregnated with a disinfection
product (e.g. di-
decyldimethylammonium chloride).
4. Rinse the device twice with running
tap water (15°C-38°C) (59°F-100°F)
provided that the local tap water has
a pH within the range of 6.5 - 8.5 and
a chloride content below 100 mg/l. If
the local tap water does not meet
these requirements, use de-
mineralized (deionized) water
instead.
5. After selecting the appropriate
nozzle, spray inside the device with
Spraynet (FIG.6).
6. Dry the external surfaces with sterile
non-woven compresses (low linting
textiles).
6.3.2 Automatic disinfection
CAUTION
Only for device engraved with
Note: the automatic cleaning- dis-
infection can replace the previous steps
4 to 6.
Washer-disinfector
Carry out automatic cleaning- dis-
infection using an approved washer-
disinfector which complies with ISO
standard 15883-1.
Detergent and washing cycle
Use an alkaline or detergent re-
commended for cleaning in a washer-
disinfector for dental or surgical in-
struments (pH 8-11).
13
FIG.6

ENG
14
Recommended specifications for the thermo-disinfection cycle.
Phase Parameters
Pre-cleaning <45°C (113°F); ≥ 2 minutes
Cleaning 55°C-65°C (131°F-149°F); ≥ 5 minutes
Neutralization ≥ 2 minutes
Rinsing Tap water, ≤30°C (86°F), ≥ 2 minutes cold water
Thermal Disinfection 90°C-95°C (194°F-203°F), 5-10 minutes
Drying 18-22 minutes
CAUTION
Never cool devices by rinsing them.
CAUTION
If an automatic washer is used at the place of the washer/thermo-disinfector, re-
spect the previous program for the Pre-cleaning, Cleaning, Neutralization and
Rinsing phases. If the local tap water has a pH outside the range of 6.5-8.5 or if it
contains more than 100 mg/l chloride (Cl-ion), do not dry the device inside the auto-
matic washer but dry it manually with low linting textiles.

6.4 Lubrication
6.4.1 Verifying cleanliness
Visually inspect the device to ensure it is
clean. Repeat the cleaning and dis-
infection procedure if necessary.
6.4.2 Lubrication with Lubrifluid
FIG.7
Lubricate before each sterilization or at
least twice a day. Only the Lubrifluid
spray must be used.
1. Place the device in a sterile, non-
woven cloth to collect the excess of
lubricant.
2. Select the appropriate nozzle.
3. Insert the nozzle of the Lubrifluid can
in the rear of the device's handle.
4. Activate the spray for 1 second, and
clean the excess oil on the exterior
with a sterile, non-woven compress.
6.5 Sterilization
CAUTION
The quality of the sterilization is highly
dependent on how clean the in-
strument is. Only perfectly clean
instruments may be sterilized.
CAUTION
Do not use a sterilization procedure
other than the one described below.
6.5.1 Procedure
1. Pack the device in a packaging ap-
proved for steam sterilization.
2. Sterilize using steam, following dy-
namic air removal cycle (ANSI/AAMI
ST79, Section 2.19), i.e. air removal
via forced evacuation (ISO 17665-1,
ISO/TS 17665-2) at 135°C (275°F),
for 3 minutes. In jurisdictions where
sterilization for prions is required,
sterilize at 135°C for 18 minutes.
15
FIG.7

ENG
16
The recommended parameters for the sterilization cycle are:
lThe maximum temperature in the autoclave chamber does not exceed 137°C,
i.e. the nominal temperature of the autoclave is set at 134°C, 135°C or
135.5°C taking into account the uncertainty of the sterilizer as regards tem-
perature.
lThe maximum duration of the interval at the maximum temperature of 137°C
is in accordance with national requirements for moist heat sterilization and
does not exceed 30 minutes.
lThe absolute pressure in the chamber of the sterilizer is comprised in the in-
terval 0.07 bar to 3.17 bar (1 psia to 46 psia).
lThe rate of change of temperature does not exceed 15°C/min for increasing
temperature and -35°C/min for decreasing temperature.
lThe rate of change of pressure does not exceed 0.45 bar/min (6.6 psia/min)
for increasing pressure and -1.7 bar/min (-25 psia/min) for decreasing pres-
sure.
lNo chemical or physical reagents are added to the water steam.
CAUTION
Only use dynamic air removal cycles: pre-vacuum or steam flush pressure pulse
(SFPP) cycles.

6.6 Packing and storage
The device must be stored inside the
sterilization pouch in a dry and dust-
free environment. The temperature
must not exceed 55°C (131°F). If the
device will not be used for 7 days or
more after the sterilization, extract the
device from the sterilization pouch and
store it in the original package. If the
device is not stored in a sterilization
pouch or if the pouch is no longer
sterile, clean, lubricate and sterilize the
device before using it.
CAUTION
If the medical device has been stored re-
frigerated, allow it to warm up to room
temperature prior to its use.
CAUTION
Comply with the expiration date of the
sterilization pouch which depends on
the storage conditions and type of pack-
aging.
6.7 Servicing
Note: Bien-Air Dental SArecommends
that the user has his or her dynamic
devices checked or serviced every
three years.
7 Transport
& disposal
7.1 Transport
There are no particular transport and
storage conditions required.
7.2 Disposal
The disposal and/or recycling of ma-
terials must be performed in
accordance with the legislation in force.
All contra-angles must be recycled. In
order to avoid any risk of con-
tamination, the user must return the
device sterilized to his dealer or contact
an authorized body for the treatment
and recovery of this type of equipment.
17

ENG
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.
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
8.2.1 Set supplied (see cover)
REF Legend
1601 055-001 CA 1:2.5 L MS contra-angle
8.2.2 Optional accessories
(see cover)
REF Legend
1600617-006
Aquacare, cleaning spray for
physiological liq uid 500m, box of
6 cans
1600036-006 Spraynet, 500ml cleaning spray,
box of 6
1600064-006 Lubrifluid, 500ml spray lub -
ricant oil, box of 6
1600 001-010 Cleaning wire, box of 1 0
18

19
NOTES

ENG
20
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 2100337-0003/2020.09 CA 1:2.5 L MS • © Bien-Air Dental SA