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In these instructions, "Device" corresponds to the ca-
bles described in the heading "Type".
Type
REF
Legend
1600606-001 Cable for MX LED and MX
micromotors, sterilisable in an
autoclave, non machine washable
1601069-001 Cable for MX-i LED and MX-i
micromotors, sterilisable in an
autoclave, machine washable
1601009-001 Cable for MX-I LED 3RD GEN
micromotor, sterilisable in an
autoclave, machine washable
1600755-001 MX-i LED micromotor with LED
sterilisable in an autoclave,
machine washable
1601008-001 MX-I LED 3RD GEN micromotor
with LED, sterilisable in an
autoclave, machine washable
1600825-001 MX-i micromotor without light,
sterilisable in an autoclave,
machine washable
Important
These cables must only be used with Bien-Air Dental
motors and electronic controls. Otherwise, perfor-
mance or safety can not be guaranteed.
Intended use
Device intended for professional use only. Use in en-
dodontics, implantology and oral surgery.
Technical data and assembly
Classification
Class IIa in accordance with European Directive
93/42/EEC concerning medical devices.
Junction
Connecting to the motor: Check that the rear of the
motor and the cable connector are clean. Position the
motor as shown in fig. 1.
Rotate it to find the exact position and push the
connector in fig. 2.
Tighten the nut to the stop fig. 3.
Connection to the device: Check the cleanliness of
the pin on the cable and the plug on the device. Po-
sition the cable correctly and press the pin until you
feel the locking 'click' fig. 4.
Standards
Complies with the ISO 14457 (Dentistry - Handpieces
and motors)(MX-I LED 3RD GEN cable only). The de-
vice must be classified as type B applied part. The
corresponding terminology is defined in section
3.132 of the IEC 60601-1 (Medical electrical equip-
ment – Part 1: General requirements for basic safety
and key performances).
Dimensions
Length 2.05 m.
Weight
115 g (1600606-001) / 120 g (1601009-001).
Dielectric strength according to IEC 60601-1
500 Vac / 1 min.
Maximum current
10A peak /10s.
Maintenance
Important
• The instrument is delivered "non sterile".
• Before using for the first time and within a maxi-
mum of 30 minutes after each treatment, clean,
disinfect the attachment, then sterilise. Observing
this procedure eliminates any blood, saliva or
saline solution residues.
• Do not immerse in an ultrasonic bath.
• Only use original Bien-Air Dental maintenance
products and parts or those recommended by Bien-
Air Dental. Using other products or parts may cause
operational failure and/or void the guarantee.
t2
Important
In the event of prolonged disuse, the device must be
stored in a dry environment. Sterilise the instrument
before reuse.
Precautions of use
Medical personnel using or performing maintenance
on medical devices that are contaminated or poten-
tially contaminated must comply with universal pre-
cautions, in particular the wearing of personal pro-
tective equipment (gloves, goggles, etc.). Pointed
and sharp instruments should be handled with great
care.
Visually check that the steriliser and the water that is
used are clean. After each sterilisation cycle, remove
the device from the sterilising apparatus immediate-
ly, in order to reduce the risk of corrosion.
Suitable detergent for manual cleaning-disin-
fection:
• Detergent or detergent-disinfectant (pH 6- 9.5)
recommended for cleaning-disinfection of dental
or surgical instruments. Quaternary ammonium-
and/or enzyme-based surfactants.
• Do not use detergents that are corrosive or con-
tain chlorine, acetone aldehydes or bleaches.
Do not use any product containing silicone.
• Do not soak in physiological liquid (NaCl).
1 Cleaning-disinfection
Preparation
• Disconnect the power cable from the box and it is
recommended to unscrew the cable from the
motor.
• Perform a manual cleaning-disinfection process.
Manual cleaning-disinfection
Maintenance and sterilisation:
Clean and disinfect the outside of the cable with a
wipe soaked in suitable detergent following the man-
ufacturer's instructions (duration, concentration,
temperature ...).
Rinsing:
Rinse the cable with cold running water
(< 35 °C / < 95 °F) for about 30 seconds.
Drying:
Spray with Spraynet fig. 6 to remove the rinsing
water immediately. If required, wipe with a sterile
non-woven wipe.
Automatic cleaning-disinfection
Note:
only for instruments engraved with
fig. 7.
Cleaner - disinfectant
Use a validated cleaner-disinfectant with the ade-
quate detergent.
Washing cycle
Select the specified washing cycle for these instru-
ments which should be compatible with the deter-
gent manufacturer's instructions.
Recommended temperatures:
Pre-wash
Water: cold to maximum 35°C (95°F) – Duration 2
mins.
Wash
Water: 50 to 65°C (122 to 149°F) – Duration 5 mins.
Rinsing
Water: cold to maximum 35°C (95°F) – Duration 2
mins.
Thermal disinfection
Water: 80 to 97°C (176 to 206.6°F ) – Duration 5 mins.
Drying
Air: 65 to 75°C (149 to 167°F) – Duration 25 mins.
Note: Never rinse the devices to cool them.
Checks and conditioning process
2
Verifying cleanliness
Visually check the cleanliness of the instrument. If
required, re-clean with a soft brush.
Conditioning process
Roll-up the cable (minimum crown radius 50 mm)
fig. 5 and stow immediately in approved packaging
for steam sterilisation.
Sterilisation
3
Important
The quality of the sterilisation depends very
much on the cleanliness of the device.
Only perfectly clean devices may be sterilised.
Do not use a sterilisation procedure other than
the one described below.
Procedure:
Fractionated pre-vacuum steam sterilisation, Class B
cycle acc. to EN13060. The procedure has been vali-
dated according to ISO 17665. The cables are steril-
isable in an autoclave up to 135°C (275°F). Duration:
18 min., depending to the national requirements in
force.
Overhaul
Never disassemble the device. For any modification
and repair, we recommend that you contact your reg-
ular supplier or Bien-Air Dental directly. Bien-Air
Dental asks the user to have its dynamic instruments
checked or inspected at least once a year.
Transport
Temperature between -40°C (-40°F) and 70°C
(158°F), relative humidity between 10% and 100%,
atmospheric pressure 50 kPa to 106 kPa (7.3 to 15.3
psi).
Other precautions for use
The device must be used by a qualified professionnal
in accordance with the current legal provisions con-
cerning workplace health and accident prevention
measures, and these working instructions. In accor-
dance with these requirements, the operators:
• must only use operating devices that are in per-
fect working order; in the event of irregular func-
tioning, excessive vibration, abnormal heating or
other signs indicating malfunction of the device,
the work must be stopped immediately; in this
case, contact a repair centre that is approved by
Bien-Air Dental;
• must ensure that the device is used only for the
purpose for which it is intended, must protect
themselves, their patients and third parties from
any danger, and must avoid contamination
through the use of the product.
The device is intended for medical treatment only;
any use other than that for which this device is in-
tended is unauthorised and may be dangerous. The
medical device meets all the current legal require-
ments.
Rest the device on a suitable support to avoid risks of
infection for yourself, the patient or third parties.
The disposal and/or recycling of materials
must be performed in accordance with the leg-
islation in force.
This device must be recycled. Electrical and
electronic equipment may contain dangerous
substances which constitute health and envi-
ronmental hazards. The user must return the device
to its dealer or establish direct contact with an ap-
proved body for treatment and recovery of this type
of equipment (European Directive 2012/19/EU).
Guarantee
Terms of guarantee
Bien-Air Dental grants the operator a guarantee cov-
ering all functional defects, material or production
faults. The device is covered by this guarantee for 12
months from the date of invoicing.
In the event of justified claim, Bien-Air Dental or its
authorised representative will fulfil the company's
obligations under this guarantee by repairing or re-
placing the product free of charge. Any other claims,
of whatever nature, in particular in the form of a
claim for damages and interest, are excluded.
Bien-Air Dental shall not be held responsible for
damage or injury and the consequences thereof, re-
sulting from:
• excessive wear and tear
• improper use
• non-observance of the instructions for installa-
tion, operation and maintenance
• unusual chemical, electrical or electrolytic influ-
ences
• poor connections, whether of the air, water or
electricity supply.
The guarantee does not cover flexible "optical fibre"
type conductors, or any parts made of synthetic ma-
terials.
The guarantee shall become null and void if the dam-
age and its consequences are due to improper ma-
nipulation of the product, or modifications to the
product carried out by persons not authorised by
Bien-Air Dental. Claims under the terms of the guar-
antee will be considered only on presentation, to-
gether with the product, of the invoice or the con-
signment note, on which the date of purchase, the
product reference and the Serial No. should be clear-
ly indicated.
Français
Dans le présent mode d'emploi, le terme « disposi-
tif » désigne les câbles décrits dans la rubrique
« Type ».
Type
REF
Légende
1600606-001 Câble pour micromoteurs MX LED
et MX, stérilisable en autoclave,
non lavable en machine
1601069-001 Câble pour micromoteurs MX-i LED
et MX-i, stérilisable en autoclave,
lavable en machine
1601009-001 Câble pour micromoteur MX-I LED
3RD GEN stérilisable en autoclave,
lavable en machine
1600755-001 Micromoteur MX-i LED avec LED
stérilisable en autoclave,
lavable en machine
1601008-001 Micromoteur MX-I LED 3RD GEN
avec LED, stérilisable en
autoclave, lavable en machine
1600825-001 Micromoteur MX-i sans lumière,
stérilisable en autoclave,
lavable en machine
Important
Ces câbles peuvent être utilisés uniquement avec
des moteurs et une commande électronique Bien-Air
Dental. Dans le cas contraire, les performances ou la
sécurité ne peuvent pas être garanties.
Emploi prévu
Dispositif destiné uniquement à un usage profes-
sionnel. Il est utilisable en endodontie, implantologie
et chirurgie orale.
Données techniques et montage
Classification
Classe IIa, en conformité avec la directive du Conseil
européen 93/42/CEE sur les dispositifs médicaux.
Branchements
Connexion au moteur : Vérifier que l'arrière du mo-
teur et le connecteur du câble sont propres et secs.
Positionner le moteur comme illustré sur la fig. 1.
Le tourner pour trouver la position précise et insérer
le connecteur (fig. 2).
Serrer l'écrou en butée (fig. 3).
Connexion au dispositif : Vérifier la propreté des
broches sur le moteur et du connecteur du câble. Po-
sitionner le câble correctement et insérer le con-
necteur en butée jusqu'à sentir le clic de verrouillage
(fig. 4).
Normes
Conforme à la norme ISO 14457 (Médecine bucco-
dentaire – Pièces à main et moteurs) (câble MX-i
LED 3RD GEN uniquement). Le dispositif doit être
classé comme une partie appliquée de type B. La ter-
minologie correspondante est définie à la section
3.132 de la norme CEI 60601-1 (Appareils élec-
Bien-Air Dental SA REF 2100163-0008/2020.03
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