Bien Air Micromotor MX2 Mode D'emploi page 6

2 Sterilization
CAUTION
The quality of the sterilisation
pends very much on the cleanliness of the
device. Only perfectly clean devices may
be sterilised fig. 6. To improve the effec-
tiveness of the sterilization, make sure
the motor is completely dry.
CAUTION
Do not use a sterilization procedure
other than the one described below.
Procedure
1 Pack the device in a packaging
approved for steam sterilization.
2 Sterilize using steam, following
dynamic air removal
(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.
The instrument has been designed to
keep on functioning correctly after
more than 500 sterilizations.
The recommended parameters for
the sterilization cycle are:
• The maximum temperature in the
autoclave chamber does not exceed
137°C (279°F), i.e. the nominal tem-
de- perature of the autoclave is set at
134°C (273°F), 135°C (275°F) or
135.5°C (275°F) taking into account
the uncertainty of the sterilizer as
regards temperature.
• The maximum duration of the inter-
val at the maximum temperature of
137°C (279°F) is in accordance with
national requirements for moist
heat sterilization and does not
exceed 30 minutes.
• The absolute pressure in the cham-
ber of the sterilizer is comprised in
the interval between 0.07 bar to
cycle 3.17 bar (1 psia to 46 psia).
• The rate of change of temperature
does not exceed
(59°F/min) for increasing tempera-
ture and -35°C/min (-31°F/min) for
decreasing temperature.
• The 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 pressure.
• No 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.
3 Lubrication
WARNING
The Bien-Air Dental motor MX2 is main-
tenance free.
CAUTION
Do not spray any lubricant or cleaning
solution into the motor fig. 7!
Packing and storage
The device must be stored inside the
sterilization pouch in a dry and dust
15°C/min 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 ster-
ile, clean, dry and sterilize the device
before using it.
CAUTION
If the medical device has been stored
refrigerated, 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
packaging.
Servicing
CAUTION
Never disassemble the device. For all
modification and repair, we recom-
mend that you contact your regular
supplier or Bien-Air Dental directly.
Bien-Air Dental asks the user to have
its dynamic instruments checked or in-
spected at least once a year.
Transportation and storage condi-
tions
Refer to "Transportation and storage
conditions" table at the end of section.
Information
The technical specifications, illustra-
tions and dimensions contained in
these instructions are given only as a
guide. They may not be the subject of
any claim. The manufacturer reserves
the right to make technical improve-
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