Bien Air 1601098-001 User manual

Rx Only
RECIPROCATING MICROSAW
ENG INSTRUCTIONS FOR USE
REF 2100358-0001/2021.08

REF 2100358-0001/2021.08 RECIPROCATINGMICROSAW • © Bien-Air Dental SA
Set supplied (REF) RECIPROCATINGMICROSAW
RECIPROCATING
MICROSAW
REF 1601098-001
Irrigation ring
REF 1502918-001
O-rings
REF 1308430-001
Optional accessories (REF)
Spraynet®
REF 1600036-006
Lubrifluid®
REF 1600064-006
Aquacare
REF 1600617-006
Irrigation line
REF 1500984-010
Irrigation ring
REF 1502918-001

1 Symbols 5
1.1 Description of symbols used 5
2 Identification & Intended Use 6
2.1 Identification 6
2.2 Intended use 6
2.3 Intended patient population 6
2.4 Intended User 6
2.5 Intended medical condition 6
2.6 Patient contra-indications 6
2.7 In case of accidents 6
3Warnings and Precautions of
use 7
3.1 General information 7
3.2 Warnings 7
4 Description 8
4.1 Overview 8
4.2 Technical data 8
4.3 Performances 9
5 Operation 10
5.1 Operating conditions and pro-
cedure 10
5.2 Changing the cutting tool 11
5.3 Changing the irrigation line 11
5.3.1 Removing the irrigation line and
(optionally) the irrigation ring 12
5.3.2 Connect a new irrigation line 12
5.4 Changing the O-rings 13
5.4.1 Missing or damaged O-rings 13
5.4.2 Replacing the O-rings 13
6 Cleaning and servicing 14
6.1 Maintenance - General in-
formation 14
6.1.1 Precautions for maintenance 14
6.1.2 Suitable maintenance products 14
6.1.3 Microsaw and irrigation ring 15
6.2 Cleaning 15
6.3 Disinfection 16
6.3.1 Manual disinfection 16
6.3.2 Automatic disinfection (optional) 17
6.4 Lubrication 18
6.4.1 Verifying cleanliness 18
6.4.2 Lubrication with Lubrifluid® 18
6.5 Sterilization 18
6.5.1 Procedure 19
6.6 Packing and storage 20
6.7 Servicing 20
7 Transport& disposal 20
7.1 Transport 20
7.2 Disposal 20
8 General information 21
8.1 Terms of guarantee 21
8.2 References 21
8.2.1 Sets supplied (see cover) 21
8.2.2 Optional accessories (see cover) 21
4
Table of contents

5
ENG INSTRUCTIONS FOR USE
1 Symbols
1.1 Description of symbols used
Sym Description Sym Description
Manufacturer. Catalogue numb er.
Sterilizable in a steam sterilizer (auto-
clave) up to the specified temperature. Serial number.
Caution: in accordance with federal law
(USA), this device is only available for sale
upon recommendation by an accredited
practitioner.
Data Matrix code for product information
including UDI (Unique Device Iden-
tification).
CAUTION: hazard that could result in light
or moderate injury or damage to the
device if the safety instructions are not cor-
rectly followed.
Washer-disinfector for thermal dis-
infection.
WARNING: hazard that could result in ser-
ious injury or damage to the d evice if the
safety instructions are not correctly fol-
lowed.
General symbol for recovery/recyclable.
Water tap, open (to be cleaned under an
open water tap) Wear protective gloves.
Refer to the accompanying
documents. Back and forth movement.

ENG
2.1 Identification
Medical device manufactured by Bien-
Air Dental SA.
Type
Reciprocating microsaw* handpiece,
with internal irrigation, without light, to
be connected to a E type short mi-
cromotor (ISO 3964).
*Hereafter: Microsaw
Classification
Class I according to FDACode of
Federal Regulations 21 CFR 878.4820
relating to medical devices. This med-
ical device complies with the legislation
in force.
2.2 Intended use
The Microsaw is intended to be used in
oral and maxillofacial surgery for cut-
ting bone and hard tissues.
2.3 Intended patient
population
The intended patient population of the
Microsaw includes any person visiting a
dental or medical practitioners’ office
to receive treatment in line with the in-
tended medical condition. There is no
restriction concerning subject age,
race, or culture. The intended user is re-
sponsible to select the adequate device
for the patient according to the specific
clinical application.
2.4 Intended User
The microsaw is intended to be used by
oral and maxillofacial surgeons and
plastic surgeons in an operating room.
2.5 Intended medical
condition
Correction of craniofacial deformities,
including but not limited to bone tumor,
sleep apnea, cleft palate and bone graft-
ing therapy.
The main treatments may include:
lOrthognathic surgery
lGenioplasty
lRhinoplasty
2.6 Patient contra-
indications
No specific patient contra-indication ex-
ist for the Microsaw device family when
the device is used as intended.
2.7 In case of accidents
The Microsaw system (microsaw and
cutting tools) must not be used until re-
pairs of the microsaw have been
completed by a qualified and trained
technician authorized by the man-
ufacturer. Damaged or deformed
cutting tools must be disposed of.
If any serious incident occurs in relation
to the device, report it to a competent
authority of your country, as well as the
manufacturer through your regional
distributor. Observe relevant national
regulations for detailed procedures.
6
2 Identification & Intended Use

3.1 General information
The device must be used by qualified
professionals in compliance with the
current legal provisions concerning oc-
cupational safety, health and accident
prevention measures, and these in-
structions for use. In accordance with
such requirements, the operators:
lmust only use devices that are in
perfect working order; in the
event of irregular functioning,
coolant failure, excessive vi-
bration, abnormal heating,
unusual noise or other signs that
may indicate malfunction of the
device, the work must be stopped
immediately; in this case, contact
a repair center that is approved
by Bien-Air Dental SA and have
the service personnel carry out re-
pair work.
lmust 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.
3.2 Warnings
WARNING
Any use other than that for which this
device is intended is prohibited and may
prove dangerous.
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.
WARNING
Any modification of the medical device
is strictly forbidden.
CAUTION
Only operate the drive motor with a
maximum speed as indicated in §4.2.
WARNING
In order to prevent necrosis caused by
the heat on the bone and blockage of
the cutting tool with bone material, we
recommend continuous irrigation dur-
ing use.
WARNING
Use physiological, sterile cooling fluid.
WARNING
Always use sterile, single- use cutting
tools and irrigation lines recommended
by Bien-Air Dental SA. Replace blunt or
bent cutting tools.
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 Warnings and Precautions of use

ENG
4.1 Overview
FIG.1
(1) Irrigation line (connected to the
peristaltic pump)
(2) Irrigation line cut portion
(3) Cutting tool
(4) Irrigation ring
(5) Reciprocating microsaw
(6) Clamping ring
8
FIG.1
4.2 Technical data
The following technical data and performances apply to the reciprocating mi-
crosaw device (the dispersion affecting these quantities is below or equal to 5%).
Technical data Reciprocating microsaw
1601098-001
Irrigation ring
1502918-001
Weight 118 g 12.3 g
Overall length 117 mm 34.9 mm (19 mm W/O tubes)
Maximum diameter 19.6 mm 23.5 mm (cylindrical: 21 .2
mm)
Coupling type ISO 3964 N/A
Multip lication ratio 2.6:1 N/A
Maximum reciprocating
frequency
(motor running at 40’000 rpm)
15200 cycle/min N/A
Stroke length 2.7 mm N/A
Maximum torque consumption
in no-load ‹ 1.2 Ncm (*) N/A
4 Description

9
4.3 Performances
Performances Reciprocating microsaw
Cutting speed ≥ 5.5 mm/s (***)
Maximum distribution of physiological liquid ≥ 100 ml/min (**)
Minimum distribution of physiological liquid ≥ 50 ml/min (**)
Noise in no-load (at 1 meter) ‹ 75 dBA (*)
Hand-transmitted vibrations in no-load ‹ 20 m/s2 (*)
(*) Measurement realized in combination with motor MX-i LED REF1600755, elec-
tronic console Chiropro L REF1600613 and cutting tool REF1502679, with motor
speed 40000 rpm and without irrigation.
(**) Measurement realized with the irrigation ring REF1502918 and the irrigation
line REF1500984, in combination with motor MX-i LED REF1600755, electronic con-
sole Chiropro L REF1600613 and cutting tool REF1502679, with motor speed
40000 rpm. The Chiropro irrigation levels ‘2 drops’ and ‘5 drops’ correspond to the
minimum and maximum distribution, respectively.
(***) Measurement realized with the irrigation line REF1500984 (without the ir-
rigation ring REF1502918), in combination with motor MX-i LED REF1600755,
electronic console Chiropro L REF1600613 and cutting tool REF1502679, with mo-
tor speed 40000 rpm and the Chiropro irrigation level ‘2 drops’. A bloc of Sawbone
PCF 30 (20x20mm) is cut by applying a constant force of 9.5 N.

ENG
5 Operation
5.1 Operating conditions and
procedure
Before operating the device, follow this
procedure:
1. Check that the ambient temperature
ranges between +10°C to +35°C
(+50°F to +95°F) and that it is under
standard humidity conditions (re-
lative humidity below 80%, without
condensation).
2. Check that the settings parameters
of the irrigation system are set so
that the irrigation flow supplies the
blade at least 60 ml/min. (Note: If the
internal irrigation is used in com-
bination with a Chiropro console, this
corresponds to the irrigation level: «
2 drops »).
3. If required by the clinical operation, in-
sert and push the irrigation ring on
the microsaw to set the irrigation
ring on the cylindrical part of the mi-
crosaw (as shown in the FIG.1, the
irrigation ring must be pushed at
least until the end of the front-side ir-
rigation tube of the irrigation ring is
aligned with the last knurled pat-
tern).
4. Connect the irrigation line to the ir-
rigation tube of the microsaw device
and, if the irrigation ring is mounted,
to the 2 irrigation tubes of the ir-
rigation ring.
5. Fix a suitable Bien-Air cutting tool to
the microsaw (which should already
be equipped with the irrigation ring,
if necessary) and orient the irrigation
tube of the microsaw and the ir-
rigation ring so as to ensure a
comfortable grip.
6. Connect the microsaw system (after
having mounted the irrigation ring
and the cutting tool) to a micro-mo-
tor compatible with ISO 3964.
7. Operate without load the microsaw
system for at least 5 seconds and
check that it performs properly.
CAUTION
Check the Microsaw handpiece for dam-
age and loose parts before each use.
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 coolant quantity for the
cooling irrigation to at least 60 ml / min.
CAUTION
Depending on the angular position of
the clamping ring, a difference of flow
rate may be noticed for high flow rate.
CAUTION
Before each use, always check that the
physiological solution flows freely and
without leak out of the cutting tool.
CAUTION
Perform a test run during 5 seconds be-
fore each use. If the irrigation of the
surgical site will be realized through the
cutting tool, also activate the irrigation
during the test run and check the ir-
rigation flow.
10

5.2 Changing the cutting tool
1. Pull the clamping ring to the rear and
gently insert the cutting accessory in
the microsaw handpiece up to the
thrust stop. Then release the clamp-
ing ring, which should freely return
to its initial position (FIG.2 step 1).
2. Gently push and pull the cutting tool
to check it is correctly attached
(FIG.2 step 2).
3. If the cutting tool is not correctly in
place, pull the clamping ring to the
rear, remove it and start operation
again.
WARNING
Follow the guidelines for use, according
to the Bien- Air cutting tool’s in-
structions. Never use a non- original
Bien-Air cutting tool if the tip is not com-
pliant, as there is a risk it can become
detached during the procedure and in-
jure the practitioner, the patient or any
third parties.
WARNING
The use of a non-original Bien-Air cut-
ting tool will prevent proper irrigation
of the surgical site through the orifice
of the cutting tool.
11
FIG.2 Description of pictograms used
WARNING
Make sure that the cutting tool is cor-
rectly inserted by moving and rotating
the latter back and forth. The cutting
tool must remain in place.
WARNING
Avoid applying too much force as the
temperature may significantly increase.
This entails a risk of thermal necrosis.
CAUTION
The microsaw must be activated before
it is put on the bone. Perform cutting op-
erations with a slight pressure exerted
in the direction of the bone or hard tis-
sues.
WARNING
Never touch a cutting tool on a mi-
crosaw in motion.
5.3 Changingtheirrigation line
WARNING
Irrigation lines are single use. The ir-
rigation ring is reusable.
CAUTION
Prior to changing the irrigation line and
ring, always remove the cutting tool, as
it may damage the irrigation ring O-
rings.

ENG
5.3.1 Removing the irrigation line and
(optionally) the irrigation ring
1. Gently pull out the irrigation line from
the rear side of the irrigation ring
(FIG.3 step 1).
2. Gently pull out the irrigation line cut
portion from the front tube of the mi-
crosaw (FIG.3 step 1).
3. a) If the irrigation ring stays on the
microsaw, gently pull out the re-
maining irrigation line from the
irrigation ring).
b) If the irrigation ring does not stay
on the microsaw, carefully slide
the irrigation ring toward the
front side of the microsaw (FIG.3
step 2), then gently pull out the re-
maining irrigation line cut portion
from the other tube of the re-
moved irrigation ring ( FIG.3 step
3).
5.3.2 Connect a new irrigation line
1. a) If the irrigation ring has been re-
moved before reprocessing the
device, inspect the irrigation ring.
Make sure the two O-rings are in
the grooves. Cut off an irrigation
line portion of 50-60mm (about 2
inches) with sterile scissors, insert
on the front side tube of the ir-
rigation ring ( FIG.4 step 1) and
insert the irrigation ring on the mi-
crosaw by sliding it from the front
side to the rear side (FIG.4 step
2).
b) If the irrigation ring has not been
removed before reprocessing the
device, cut off an irrigation line
portion of 50- 60mm (about 2
inches) with sterile scissors. Insert
on the tube in the front side of the
irrigation ring.
2. Connect the irrigation line portion of
the irrigation ring to the front tube of
the microsaw. Make sure the ir-
rigation line is loose enough to allow
the reciprocating motion of the mi-
crosaw nose (FIG.4 step 3).
3. Connect the remaining irrigation line
to the rear side of the irrigation ring
(FIG.4 step 3).
12
FIG.3 FIG.4

13
5.4 Changing the O-rings
5.4.1 Missing or damaged O-rings
In case of insufficient irrigation and leakage:
lMake sure that all O-rings are on the irrigation ring and are undamaged.
lIf at least one O-ring is missing on the irrigation ring or damaged: replace the
O-rings.
5.4.2 Replacing the O-rings
1. Use a removal tool such as a dental hook or tweezers to extract the O-ring from
its groove.
2. Carefully pull the O-ring out. Avoid scratching the metal.
3. Insert the new O-ring by gently pressing it between your fingers to form a loop.
Do not use a tool to prevent O-ring damage.
CAUTION
Improper care of the O-rings may lead to insufficient irrigation and leakage.
1. Do not use Vaseline or other grease oil.
2. The O-rings on the irrigation ring may only be lubricated with a cotton ball wetted
with Bien-Air Dental Lubrifluid® or Lubrimed®.

ENG
6 Cleaning and
servicing
6.1 Maintenance - General in-
formation
WARNING
The microsaw and the ring are supplied
"non sterile". Clean, dry and sterilize the
device prior to first use.
6.1.1 Precautions for maintenance
lWithin a maximum of 30 minutes
after each treatment, clean and
disinfect the instrument (lub-
rication and sterilization can be
done later). Observing this pro-
cedure eliminates any blood,
saliva or physiological 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 the cleaning- dis-
infection- sterilization processes
without a cutting tool or an ir-
rigation line in the chuck
mechanism.
lUse detergents that are pH 8-11,
are neither corrosive nor contain
chlorine, acetone and/or al-
dehydes.
lDo not submerge in physiological
liquid (NaCl) nor use saline solu-
tion to keep the device moist until
it can be cleaned.
lClean using manual cleaning or
automated washer/disinfector
only (do not use ultrasonic
cleaner).
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 or alkaline
enzymatic product. (e.g. neod-
isher® MediClean) 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).
14

6.1.3 Microsaw and irrigation ring
lFor cleaning, disinfection, and ster-
ilization, if present, the irrigation
ring may be either cleaned sep-
arately or left on the microsaw.
For the last case, after a maximal
amount of 25 uses, the irrigation
ring must be disconnected,
checked, and the microsaw with
the irrigation ring must be
cleaned, disinfected, and sterilized
separately.
WARNING
At any time, if the irrigation ring is in a
clogged state or damaged, proceed to
change with a new one.
6.2 Cleaning
Preparation
FIG.5
1. Disconnect the microsaw from the
motor.
2. Remove the cutting tool (see FIG.5).
3. Disconnect the irrigation line from
the microsaw (see FIG.5).
4. If present, the irrigation ring may be
either cleaned separately or left on
the microsaw.
5. After selecting the appropriate
nozzle, perform preliminary cleaning
of the microsaw by using the product
Aquacare. Spray the inside and the
outside of the device and inside the ir-
rigation tube.
6. Check that the coolant outlets are
rinsed out.
7. Dry the microsaw with non-woven
compress.
Internal and external cleaning
1. After selecting the appropriate
nozzle, spray the inside and the out-
side of the device as well as the
inside of the clamping ring with the
product Spraynet®.
2. Dry with non-woven compresses.
15
FIG.5

ENG
6.3 Disinfection
6.3.1 Manual disinfection
1. Dip the devices (both the microsaw and the irrigation ring), separately or as-
sembled in a bath containing a disinfectant product (e.g.
didecyldimethylammonium chloride, quaternary ammonium carbonate or neut-
ral enzymatic product which are allowable chemical agents). Follow the
concentration and duration recommended by the fabricant of the disinfection
product.
2. Brush the outside of the microsaw and, if separated, the interior of the ir-
rigation ring with a smooth, flexible brush (e.g. soft- bristled toothbrush)
especially the grip surfaces, recesses and corners and clean the interior of the
microsaw on the drive side with an appropriate swab (FIG.6 step 1). The use of
an alkaline product at low concentration and at room temperature for a dur-
ation of 5-10 minutes is recommended (for example, Neodisher® Mediclean
Forte at 0.5% for 5-6 minutes).
3. Check the freedom of movement of the clamping ring. To do this, pull it several
times to full stop and release it. It must always return to the starting position
(FIG.6 step 2).
4. Optional:
a) Rinse the device 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 re-
quirements, use demineralized sterilized water instead (FIG.6 step 3).
b) Perform additional cleaning and disinfection of the external surfaces with
non- woven wipes impregnated with a disinfection product (e.g. di-
decyldimethylammonium chloride).
c) Rinse the external surfaces with sterile non-woven compresses impregnated
with sterile, demineralized water.
16
123
FIG.6

if steps 1-3 are properly and timely realized.
Washer-disinfector
Carry out automatic cleaning-disinfection using an approved washer-disinfector
which complies with ISO standard 15883-1.
Detergent and washing cycle
Use an alkaline or enzymatic detergent recommended for cleaning in a washer-
disinfector for dental or surgical instruments (pH 8-11).
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.
17
5. Eliminate the excess of disinfectant (e.g. foam residue) over the external sur-
faces of the device by spraying it with Spraynet® and drying it with sterile non-
woven compresses.
6. Spray inside the irrigation tube of the microsaw (and inside the tubes of the ir-
rigation ring, if this latter has been left on the microsaw during reprocessing)
with Spraynet®, using the appropriate nozzle.
7. Dry the external surfaces with sterile non-woven compresses.
6.3.2 Automatic disinfection (optional)
Note: The automatic cleaning-disinfection can replace the previous steps 4 to 6
but is not necessary for obtaining a proper cleaning and disinfection of the device,

ENG
6.4 Lubrication
6.4.1 Verifying cleanliness
Before lubrication, visually inspect the
device to ensure it is clean. Repeat the
cleaning and disinfection procedure if
necessary.
6.4.2 Lubrication with Lubrifluid®
Before each sterilization lubricate with
Lubrifluid®. Never lubricate after ster-
ilization. If the irrigation ring is left on
the microsaw during cleaning- dis-
infection, it should be left on the
microsaw during lubrication as well.
FIG.7
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 can Lubri-
fluid® in the rear of the microsaw
and activate the spray for about 1
second.
4. Clean the excess oil on the exterior
with a sterile, non-woven compress.
Note: If, during the test run of the mi-
crosaw before the clinical treatment,
an excess of lubricant is ejected from
the microsaw, prolongate the test run
until the ejection stops. Then, modify
the lubrication procedure, by reducing
the quantity of lubricant inserted be-
fore sterilization or operate the
microsaw for 2 seconds after lub-
rication and before sterilization.
6.5 Sterilization
WARNING
The quality of the sterilization is highly
dependent on how clean the in-
strument is. Only perfectly clean
instruments may be sterilized. To im-
prove the effectiveness of the
sterilization, make sure the device is
completely dry before and after the
sterilization.
CAUTION
Do not use a sterilization procedure
other than the one described below.
18
FIG.7

19
6.5.1 Procedure
1. Pack the device in a packaging approved for steam sterilization. If the irrigation
ring has be removed before reprocessing, the microsaw and the irrigation ring
should be packed in two different sterilization pouches. If the irrigation ring is left
on the microsaw during cleaning/decontamination and lubrication, it should be
left on the microsaw during steam sterilization as well.
2. Sterilize using steam, following dynamic air removal cycle (ANSI/AAMI ST79, Sec-
tion 2.19), i.e. air removal via forced evacuation (ISO 17665-1, ISO/TS 17665-2)
at 135°C (275°F), for 3 minutes or at 132°C (269.6°F) for 4 minutes. In jur-
isdictions where sterilization for prions is required, sterilize at 135°C(275°F) for
18 minutes.
The recommended parameters for the sterilization cycle are:
lThe maximum temperature in the autoclave chamber does not exceed 137°C
(278.6°F), i.e. the nominal temperature of the autoclave is set at 134°C
(273.2°F), 135°C (275°F) or 135.5°C (275.9°F) taking into account the un-
certainty of the sterilizer with regard to temperature.
lThe maximum duration of the interval at the maximum temperature of 137°C
(278.6°F) is in accordance with national requirements for moist heat ster-
ilization 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 (59°F/min) for
increasing temperature and - 35°C/min (- 31°F/min) for decreasing tem-
perature.
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.

ENG
6.6 Packing and storage
The device must be stored inside the
sterilization pouch in a dry and dust
free environment. If 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 use.
CAUTION
Comply with the expiration date of the
sterilization pouch which depends on
the storage conditions and the type of
packaging.
6.7 Servicing
Never dismantle the device. For all ser-
vicing or repair operations, you are
advised to contact your usual supplier
or Bien-Air Dental SA directly.
Note:The microsaw should be returned
for servicing at least one time per two
years due to possible wear. This op-
eration is strongly recommended for
maintaining the device in optimal work-
ing condition.
Note: It is recommended that the ir-
rigation ring be replaced regularly, at
least after every 50 patients treated.
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.
The device must be recycled. In order to
avoid any risk of contamination, the
user must return it sterilized to his
dealer or contact an authorized body
for the treatment and recovery of this
type of equipment.
20

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
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 Sets supplied (see cover)
REF Legend
1601098-001 RECIPROCATING MICROSAW
1502918-001 Irrigation ring
1308430-001 O-rings
8.2.2 Optional accessories
(see cover)
REF Legend
1502671-001 Short Microsaw Blade 17x0.4mm
1502672-001 Short Microsaw Blade 21x0.4mm
1502673-001 Short Microsaw Blade 25x0.4mm
1502674-001 Short Microsaw Blade 17x0.6mm
1502675-001 Short Microsaw Blade 21x0.6mm
1502676-001 Short Microsaw Blade 25x0.6mm
1502677-001 Long Microsaw Blade 17x0.4mm
1502678-001 Long Microsaw Blade 21x0.4mm
1502679-001 Long Microsaw Blade 25x0.4mm
1502680-001 Long Microsaw Blade 17x0.6mm
1502681-001 Long Microsaw Blade 21x0.6mm
1502682-001 Long Microsaw Blade 25x0.6mm
1500984-010 Pack of 10 disposable sterile ir-
rigation lines (1x)
1600036-006 Spraynet®, 500ml cleaning spray,
box of 6
1600064-006 Lubrifluid®, 500ml spray lub-
ricant oil, box of 6
1600617-006
Aquacare, cleaning spray for
physiological liquid 500ml, box
of 6 cans
21