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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

Summary of Contents for 1601098-001

Page 1: ...Rx Only RECIPROCATING MICROSAW ENG INSTRUCTIONS FOR USE REF 2100358 0001 2021 08...

Page 2: ...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 Aquac...

Page 3: ...2 5 3 2 Connecta new irrigationline 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 1...

Page 4: ...x 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 r...

Page 5: ...g 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...

Page 6: ...ove 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 w...

Page 7: ...ice 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...

Page 8: ...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 4...

Page 9: ...table 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 ensu...

Page 10: ...rd 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 pictogramsused W...

Page 11: ...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 scis...

Page 12: ...ool 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 finger...

Page 13: ...tergents that are pH 8 11 are neither corrosive nor contain chlorine acetone and or al dehydes l Do not submerge in physiological liquid NaCl nor use saline solu tion to keep the device moist until it...

Page 14: ...icrosaw 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...

Page 15: ...duct 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 cla...

Page 16: ...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...

Page 17: ...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...

Page 18: ...he 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 steri...

Page 19: ...ckaging 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 retur...

Page 20: ...uests 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...

Page 21: ...Bien Air Dental SA L nggasse 60 Case postale 2500 Bienne 6 Switzerland Tel 41 0 32 344 64 64 Fax 41 0 32 344 64 91 dental bienair com Other adresses available at www bienair com...

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