RECIPROCATING MICROSAW Instructions for Use

Set supplied (REF) RECIPROCATING MICROSAW

RECIPROCATING MICROSAW REF 1601098-001

Irrigation ring REF 1502918-001

O-rings REF 1308430-001

Lubrifluid® REF 1600064-006

Aquacare REF 1600617-006

Optional accessories (REF)

Spraynet® REF 1600036-006

Irrigation line REF 1500984-010

Irrigation ring REF 1502918-001

REF 2100358-0001/2021.08

RECIPROCATING MICROSAW • © Bien-Air Dental SA

Table of contents 1 Symbols 1.1 Description of symbols used

5 5

2 Identification & Intended Use 6 2.1 Identification 2.2 Intended use 2.3 Intended patient population 2.4 Intended User 2.5 Intended medical condition 2.6 Patient contra-indications 2.7 In case of accidents

3

6 6 6 6 6 6 6

Warnings and Precautions of use 7 3.1 General information 3.2 Warnings

4 Description 4.1 Overview 4.2 Technical data 4.3 Performances

5 Operation

5.4 Changing the O-rings 5.4.1 Missing or damaged O-rings

13

14

6.1 Maintenance - General information 14 6.1.1 Precautions for maintenance 6.1.2 Suitable maintenance products 6.1.3 Microsaw and irrigation ring

6.2 Cleaning 6.3 Disinfection 6.3.1 Manual disinfection 6.3.2 Automatic disinfection (optional)

6.4 Lubrication 6.4.1 Verifying cleanliness 6.4.2 Lubrication with Lubrifluid®

14 14 15

15 16 16 17

18 18 18

7 7

6.5 Sterilization

8

6.6 Packing and storage 6.7 Servicing

20 20

7 Transport& disposal

20

8 8 9

10

5.1 Operating conditions and procedure 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 5.3.2 Connect a new irrigation line

5.4.2 Replacing the O-rings

6 Cleaning and servicing

6.5.1 Procedure

7.1 Transport 7.2 Disposal

18 19

20 20

8 General information

21

8.1 Terms of guarantee 8.2 References

21 21

8.2.1 Sets supplied (see cover) 21 8.2.2 Optional accessories (see cover) 21

12 12

13 13

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ENG INSTRUCTIONS FOR USE 1 Symbols 1.1 Description of symbols used Sym

5

Description

Sym

Description

Manufacturer.

Catalogue number.

Sterilizable in a steam sterilizer (autoclave) 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 Identification).

CAUTION: hazard that could result in light or moderate injury or damage to the device if the safety instructions are not correctly followed.

Washer-disinfector for thermal disinfection.

WARNING: hazard that could result in serious injury or damage to the device if the safety instructions are not correctly followed.

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.

2 Identification & Intended Use Medical device manufactured by BienAir Dental SA. Type Reciprocating microsaw* handpiece, with internal irrigation, without light, to be connected to a E type short micromotor (ISO 3964). *Hereafter: Microsaw

2.5 Intended medical condition Correction of craniofacial deformities, including but not limited to bone tumor, sleep apnea, cleft palate and bone grafting therapy. The main treatments may include: l l

Classification Class I according to FDA Code of Federal Regulations 21 CFR 878.4820 relating to medical devices. This medical device complies with the legislation in force.

2.2 Intended use The Microsaw is intended to be used in oral and maxillofacial surgery for cutting bone and hard tissues.

ENG

2.1 Identification

l

Orthognathic surgery Genioplasty Rhinoplasty

2.6 Patient contraindications No specific patient contra-indication exist 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 repairs of the microsaw have been completed by a qualified and trained 2.3 Intended patient technician authorized by the manpopulation ufacturer. Damaged or deformed The intended patient population of the cutting tools must be disposed of. Microsaw includes any person visiting a If any serious incident occurs in relation dental or medical practitioners’ office to the device, report it to a competent to receive treatment in line with the in- authority of your country, as well as the tended medical condition. There is no manufacturer through your regional restriction concerning subject age, distributor. Observe relevant national race, or culture. The intended user is re- regulations for detailed procedures. 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.

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3 Warnings and Precautions of use 3.1 General information The device must be used by qualified professionals in compliance with the current legal provisions concerning occupational safety, health and accident prevention measures, and these instructions for use. In accordance with such requirements, the operators: l

l

must only use devices that are in perfect working order; in the event of irregular functioning, coolant failure, excessive vibration, 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 repair work. 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.

3.2 Warnings

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 during 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, illustrations and dimensions contained in these instructions are given merely as WARNING Any use other than that for which this an indication. They may not give rise to device is intended is prohibited and may any claim. prove dangerous. For any further information, please contact Bien-Air Dental SA at the address WARNING given on the back cover. Medical personnel using or performing maintenance on medical devices that are contaminated or potentially contaminated must comply with universal precautions, in particular the wearing of personal protective equipment (gloves, goggles, etc.). Pointed and

7

ENG

FIG. 1

4 Description 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

4.2 Technical data The following technical data and performances apply to the reciprocating microsaw 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

2.6:1

N/A

15200 cycle/min

N/A

2.7 mm

N/A

‹ 1.2 Ncm (*)

N/A

Multiplication ratio Maximum reciprocating frequency (motor running at 40’000 rpm) Stroke length Maximum torque consumption in no-load

8

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, electronic 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 console 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 irrigation ring REF1502918), in combination with motor MX-i LED REF1600755, electronic console Chiropro L REF1600613 and cutting tool REF1502679, with motor 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.

9

5.1 Operating conditions and procedure Before operating the device, follow this procedure:

7. Operate without load the microsaw system for at least 5 seconds and check that it performs properly. CAUTION Check the Microsaw handpiece for damage and loose parts before each use.

1. Check that the ambient temperature WARNING ranges between +10°C to +35°C (+50°F to +95°F) and that it is under The use of a coolant while the instandard humidity conditions (re- strument is in operation is mandatory, lative humidity below 80%, without failure to comply with this recondensation). commendation may result in overheating and burns or product fail2. Check that the settings parameters of the irrigation system are set so ure. Set the coolant quantity for the that the irrigation flow supplies the cooling irrigation to at least 60 ml / min. blade at least 60 ml/min. (Note: If the internal irrigation is used in comCAUTION bination with a Chiropro console, this Depending on the angular position of corresponds to the irrigation level: « the clamping ring, a difference of flow 2 drops »). rate may be noticed for high flow rate. 3. If required by the clinical operation, insert and push the irrigation ring on CAUTION the microsaw to set the irrigation ring on the cylindrical part of the mi- Before each use, always check that the crosaw (as shown in the FIG. 1, the physiological solution flows freely and without leak out of the cutting tool. irrigation ring must be pushed at least until the end of the front-side irCAUTION rigation tube of the irrigation ring is aligned with the last knurled pat- Perform a test run during 5 seconds before each use. If the irrigation of the tern). surgical site will be realized through the 4. Connect the irrigation line to the irrigation tube of the microsaw device cutting tool, also activate the irrigation and, if the irrigation ring is mounted, during the test run and check the irto the 2 irrigation tubes of the ir- rigation flow. 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 irrigation 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-motor compatible with ISO 3964.

ENG

5 Operation

10

FIG. 2

Description of pictograms used

5.2 Changing the cutting tool

WARNING Make sure that the cutting tool is correctly inserted by moving and rotating the latter back and forth. The cutting tool must remain in place.

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 clamping 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 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 operations with a slight pressure exerted in the direction of the bone or hard tissues.

WARNING Follow the guidelines for use, according WARNING to the Bien- Air cutting tool’s instructions. Never use a non- original Never touch a cutting tool on a miBien-Air cutting tool if the tip is not com- crosaw in motion. pliant, as there is a risk it can become detached during the procedure and in- 5.3 Changingtheirrigation line jure the practitioner, the patient or any WARNING third parties. Irrigation lines are single use. The irrigation ring is reusable. WARNING The use of a non-original Bien-Air cutCAUTION ting tool will prevent proper irrigation of the surgical site through the orifice Prior to changing the irrigation line and of the cutting tool. ring, always remove the cutting tool, as it may damage the irrigation ring Orings. 11

FIG. 4

ENG

FIG. 3

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

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5.4 Changing the O-rings 5.4.1 Missing or damaged O-rings In case of insufficient irrigation and leakage: l l

Make sure that all O-rings are on the irrigation ring and are undamaged. If 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®.

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l

6.1 Maintenance - General information 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 l Within a maximum of 30 minutes after each treatment, clean and disinfect the instrument (lubrication and sterilization can be done later). Observing this procedure eliminates any blood, saliva or physiological solution residues and prevents the transmission system from being blocked. l Only 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 maintenance products . Using other products or parts may cause faults during operation and/or void the warranty. CAUTION Carry out the cleaning- disinfection- sterilization processes without a cutting tool or an irrigation line in the chuck mechanism. l Use detergents that are pH 8-11, are neither corrosive nor contain chlorine, acetone and/or aldehydes. l Do not submerge in physiological liquid (NaCl) nor use saline solution to keep the device moist until it can be cleaned. l Clean using manual cleaning or l

l

automated washer/disinfector only (do not use ultrasonic cleaner). As with all instruments, following each sterilization cycle, including drying, remove the device to avoid excess exposure to heat which can result in corrosion. Use only dynamic sterilizers: do not use a steam sterilizer with a gravity displacement system.

ENG

6 Cleaning and servicing

6.1.2 Suitable maintenance products Manual cleaning: l Spraynet®. l Aquacare. Manual disinfection: l Alkaline detergent or detergentdisinfectant (pH 8- 11) recommended for cleaningdisinfection of dental or surgical instruments. Disinfectant products composed either of didecyldimethylammonium chloride, quaternary ammonium carbonate or neutral or alkaline enzymatic product. (e.g. neodisher® MediClean) are also allowable. Automatic cleaning-disinfection: l Use an alkaline product recommended for cleaning in a washer-disinfector for dental or surgical instruments (pH 8-11).

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FIG. 5 6.1.3 Microsaw and irrigation ring 6.2 Cleaning l For cleaning, disinfection, and ster- Preparation ilization, if present, the irrigation ring may be either cleaned sep- FIG. 5 arately or left on the microsaw. 1. Disconnect the microsaw from the motor. 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.

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 irrigation 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 outside of the device as well as the inside of the clamping ring with the product Spraynet®. 2. Dry with non-woven compresses.

15

2

3

FIG. 6

ENG

1

6.3 Disinfection 6.3.1 Manual disinfection 1. Dip the devices (both the microsaw and the irrigation ring), separately or assembled in a bath containing a disinfectant product (e.g. didecyldimethylammonium chloride, quaternary ammonium carbonate or neutral 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 irrigation 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 duration 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 requirements, 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. didecyldimethylammonium chloride). c) Rinse the external surfaces with sterile non-woven compresses impregnated with sterile, demineralized water.

16

5. Eliminate the excess of disinfectant (e.g. foam residue) over the external surfaces of the device by spraying it with Spraynet® and drying it with sterile nonwoven compresses. 6. Spray inside the irrigation tube of the microsaw (and inside the tubes of the irrigation 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, 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 washerdisinfector for dental or surgical instruments (pH 8-11). Recommended specifications for the thermo-disinfection cycle. Phase Pre-cleaning Cleaning Neutralization Rinsing Thermal Disinfection Drying

Parameters <45°C (113°F); ≥ 2 minutes 55°C-65°C (131°F-149°F); ≥ 5 minutes ≥ 2 minutes Tap water, ≤30°C (86°F), ≥ 2 minutes cold water 90°C-95°C (194°F-203°F), 5-10 minutes 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, respect 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 automatic washer but dry it manually with low linting textiles.

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ENG

FIG. 7

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 sterilization. If the irrigation ring is left on the microsaw during cleaning- disinfection, it should be left on the microsaw during lubrication as well. FIG. 7 1. Place the device in a sterile, nonwoven cloth to collect the excess of lubricant. 2. Select the appropriate nozzle. 3. Insert the nozzle of the can Lubrifluid® 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.

the quantity of lubricant inserted before sterilization or operate the microsaw for 2 seconds after lubrication and before sterilization.

6.5 Sterilization WARNING The quality of the sterilization is highly dependent on how clean the instrument is. Only perfectly clean instruments may be sterilized. To improve 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.

Note : If, during the test run of the microsaw 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 18

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, 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 or at 132°C (269.6°F) for 4 minutes. In jurisdictions where sterilization for prions is required, sterilize at 135°C(275°F) for 18 minutes. The recommended parameters for the sterilization cycle are: l

l

l

l

l

l

The 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 uncertainty of the sterilizer with regard to temperature. The maximum duration of the interval at the maximum temperature of 137°C (278.6°F) is in accordance with national requirements for moist heat sterilization and does not exceed 30 minutes. The absolute pressure in the chamber of the sterilizer is comprised in the interval 0.07 bar to 3.17 bar (1 psia to 46 psia). The 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 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.

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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.

7 Transport & disposal 7.1 Transport There are no particular transport and storage conditions required.

7.2 Disposal The disposal and/or recycling of materials must be performed in accordance with the legislation in force.

ENG

6.6 Packing and storage

CAUTION If the medical device has been stored refrigerated, allow it to warm up to room The device must be recycled. In order to avoid any risk of contamination, the temperature prior to use. user must return it sterilized to his dealer or contact an authorized body CAUTION for the treatment and recovery of this Comply with the expiration date of the type of equipment. sterilization pouch which depends on the storage conditions and the type of packaging.

6.7 Servicing Never dismantle the device. For all servicing 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 operation is strongly recommended for maintaining the device in optimal working condition. Note : It is recommended that the irrigation ring be replaced regularly, at least after every 50 patients treated.

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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.

8.2 References 8.2.1 Sets supplied (see cover) REF

Legend

1601098-001

RECIPROCATING MICROSAW

1502918-001

Irrigation ring

1308430-001

O-rings

The warranty period for this medical 8.2.2 Optional accessories device is 12 months from the date of in(see cover) voicing. REF Legend In the event of a justified claim, Bien-Air Dental SA or its authorised rep- 1502671-001 Short Microsaw Blade 17x0.4mm resentative will repair or replace the 1502672-001 Short Microsaw Blade 21x0.4mm product free of charge. All other claims of any kind whatsoever, particularly claims for damages, are excluded. Bien-Air Dental SA cannot be held liable for damage or injury and the consequences thereof, resulting from: l l l

l

Excessive wear and tear Infrequent or improper use Failure to observe the servicing, assembly or maintenance instructions Damage caused by unusual chemical, 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 BienAir Dental SA. Warranty requests will only be taken into consideration if the product is accompanied by a copy of the invoice or delivery note. The following information must be clearly indicated: purchase date, product reference and serial number.

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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 irrigation lines (1x)

1600036-006

Spraynet®, 500ml cleaning spray, box of 6

1600064-006

Lubrifluid®, 500ml spray lubricant oil, box of 6

1600617-006

Aquacare, cleaning spray for physiological liquid 500ml, box of 6 cans