PMAM and PMRM Handpieces Operating Instructions

English Device manufactured entirely in Switzerland by: Bien-Air Surgery SA, rue de l’Ouest 2b, CH–2340 Le Noirmont.

Type of bur fig. 1 - 3 Diameter of shaft 2.35 mm (0,09 in) type 2, in accordance with ISO 1797-1 - total length 44.5 mm (1.75 in) (code 4, in accordance with ISO 6360/1) Type - total length 70 mm (2.75 in) (code 6, in accordance with ISO Straight and angled handpieces, 6360/1) with external spray, without light for - special lengths 95 mm and 125 microsurgery. mm. Intended use For recommended lengths, see Medical device for professional use, table below. for operations in the areas of otorhi- Inserting/removing fig. 4 and 5. nolaryngology, otoneurology, plastic surgery, maxillofacial surgery, reDo not exceed the stipulated construction, head and neck, and diameters and speeds. Bien-Air Surhand and foot. gery SA declines all responsibility if burs of another brand are used. Assembly instructions Maximum speed for all Bien-Air Type of coupling Surgery SA burs: The most commonly used coupling Diameter Speed in the world as per ISO Standard < Ø 4.5 mm 80.000 rpm 3964. Ø 5.0 mm 60.000 rpm Ø 5.5 mm 50.000 rpm Drive Ø 6.0 mm 40.000 rpm By any motor with ISO 3964 type Ø 6.5 mm 30.000 rpm coupling. Ø 7.0 mm 20.000 rpm

Changing the bur Turn the ring completely in the direction of arrow and insert the bur up to the thrust stop: A: unlocking fig. 4 B: insert the bur up to the thrust stop C: locking up to the thrust stop fig. 5

than the values specified above) this can cause a centrifugal force which may bend or break the bur. Do not exceed the maximum operating speed authorised by the bur manufacturer.

Important Check The device must not be started wiPull on the bur and check that it is thout a bur inserted into the chuck. correctly in position. Never mount an instrument on a roThe bur must be in perfect tating motor. condition: shape, surface condition and cut. The user is fully responsible Never adjust the clamping/ for: unclamping ring while the instru• ensuring that the bur meets the ment is rotating, since this could Bien-Air Surgery SA specifica- damage the mechanism or destroy tions; the motor. • ensuring that it rotates without vibration at the speed at which it Never close the chuck mechanism will be used. without the bur in place, or it may get damaged. Comply with maximum lengths by always inserting the bur as far as Recommendations possible into the locking mecha- Comply with the recommendations nism. If a bur is operated at high for use, in accordance with the inspeeds when incorrectly mounted structions of the tool manufacturer. (i.e. not fully inserted into the locking mechanism, or being longer 22

Before using the instrument, place it in operation at moderate speed with a tool in the bur locking mechanism for a few seconds, so as to spread the lubricant and remove any excess. Technical data Classification Class IIa in accordance with European Directive 93/42/EC concerning medical devices.

Handpiece reference

Max. bur length mm

Ratio

Max. motor speed RPM

Max. bur speed RPM

REF 1600202 REF 1600206 REF 1600207 REF 1600295 REF 1600328 REF 1600329 REF 1600336 REF 1600337 REF 1600338 REF 1600339 REF 1600340 REF 1600341 REF 1600612

70 70 70 70 125 125 95 125 95 125 95 125 44,5

10 : 1 1:1 1:1 1:2 1:1 1:1 1:1 1:1 1:2 1:2 1:1 1:1 1:1

80’000 80’000 80’000 40’000 10’000 10’000 80’000 80’000 40’000 40’000 80’000 80’000 40’000

8’000 80’000 80’000 80’000 10’000 10’000 80’000 80’000 80’000 80’000 80’000 80’000 40’000

Length handpiece without bur mm 130 111 128 131 209 187 152 182 156 186 131 161 85

Handpiece weight g 94 84 94 100 112 103 97 104 108 115 87 94 69

Noise level According to ISO 7785-1, < 75 dBA (incl. BASCH or 80K motor) at 45 cm Operating times b Do not exceed the maximum During the surgical operation, if (17,72 in) distance. To avoid exceeding 40°C (104°F) on speed of rotation permissible for the irrigation tube becomes clogged, Transmission ratio the outer surface of the micromotor the handpiece. use the cleaning wire and a long 1 : 1 blue ring and handpieces used at full power c Adequate irrigation is strongly cleaning curette to clear, fig. 7. 1 : 2 red ring and at maximum speed, the follorecommended. 10 : 1 green ring wing rules should be complied with: d Period of continuous operation: 10-15 minutes at low load. a Limit the maximum speed of 5-7 minutes at medium load. Dimensions rotation according to the bur dia1-2 minutes at high load followed Ø 20 mm meter as indicated on the packaby a pause of at least 30 seconds. For other technical information, see ging and/or in the present operafollowing table: ting instructions. EN

Bien-Air Surgery SA REF 2100029/06.09

23

Cleaning, sterilisation and maintenance The instrument is delivered “non sterile”. Before use, please comply with these instructions. The cycles described below are compatible with the PMAM and PMRM. The sleeves and clipped tubes undergo the same treatment as the instrument.

ments should be handled with great These detergents should be used in caution. the concentration recommended by the detergent manufacturer. Personal Protective Equipment (PPE) should be worn when hand- Comments: ling or working in the presence of Detergents used pure or insufficientcontaminated or potentially conta- ly diluted and those of pH greater minated equipment, instruments or than 8 are likely to tarnish metal inmaterials. PPE includes a laboratory struments. coat, a mask, goggles, gloves and overboots. Do not use detergents that are corrosive or contain chloriAgents required for cleaning / ne, acetone or bleach (aldehydic disinfection: products, alcohols).

Clean, lubricate and sterilise the in- • Detergents strument before first use and before Used for automatic cleaning: each further use. Enzymatic detergent of pH 6 to 8 recommended for cleaning as a surgiAfter each use, perform maintenance cal instrument washer/disinfector. of the instrument as soon as possible For example a detergent containing (within a maximum period of proteolytic enzymes. two hours) to facilitate cleaning. Use for manual cleaning: Detergent of pH 6 to 8 recommended Precautions of use The standard precautions must be for cleaning surgical instruments complied with by hospital personnel (detergent: surfactant → quaternary working with contaminated or po- ammonium / alkylaminoacid). tentially contaminated medical instruments. Pointed and sharp instru-

• Water The quality of the water should be monitored and adapted according to the objectives: - Preliminary cleaning: water from the tap - Preliminary rinsing: water from the tap - Enzymatic detergent bath: water from the tap or deionised water - Final rinsing: sterile water

and non-aggressive to avoid damaging the device. Preferably use nylon brushes with flexible hairs or soft bristles. Use the cleaning gun with the appropriate nozzles for the various ducts. As soon as you have finished using the instrument, proceed as follows: Disconnect the instrument from the drive motor, remove the bur and leave the locking mechanism in open position fig. 4. Perform preliminary cleaning of the instrument. Do not place stainless steel instruments in physiological salt water solutions (NaCl solution), because prolonged contact may cause corrosion.

• Brush / swab / cleaning gun The brushes and swabs should be in sound condition, cleaned, disinfected 24

0 Pre-cleaning

or

This operation is important to facilitate the subsequent cleaning stage Pre-cleaning by bath (it prevents dirt from drying and sticking to the equipment). • Wipe the outside of the instrument with the spray and disposable comIt should be performed as soon as possible after the surgical act. presses or paper. • Submerge the instrument in a cleaning bath containing a suitable deterA preliminary cleaning must be followed by automatic or gent. manual cleaning. • On removing it from the bath, rinse the inside and outside of the instrument in running water (max. temperature 35°C (95°F)) for about 30 seconds. Manual pre-cleaning • Spray (with Spraynet) or/and blow filtered air into the instrument channels to remove the rinsing water. Use the Spraynet product from Bien-Air Surgery SA. • Dry by swabbing with non-woven towelettes. • Spray the interior and exterior of the instrument fig. 6 to remove residue. • Perform an automatic or manual cleaning. • Clean the outside of the instrument with the spray and disposable compresses or paper. • Dry by swabbing with non-woven towelettes. • Perform manual or automatic cleaning.

EN

Bien-Air Surgery SA REF 2100029/06.09

25

1 Cleaning-disinfection

or Automatic cleaning Complete cleaning can lower the initial microbial load, eliminate organic Possible only with parts bearing the matter and prevent biofilm formation. This stage is essential and influences “machine washable” symbol the quality of the disinfection procedure as a whole. Cleaning combines the physico-chemical action of the product and the mechanical action of Rinse the parts on the inside and outside with cold water (max. temperatubrushing and rinsing. re 35°C (95°F)/minimum duration 3 min.), rubbing lightly with a brush. Not suitable for ultrasonic bath. Place the parts in the appropriate washer/disinfector tray and treat via a Note : Automatic cleaning greatly reduces parts’ lifetime by comparison with standard instrument washer/disinfector cycle (place the handpiece upright, manual cleaning. with the tip downward). Use a validated washer/disinfector exclusively. Manual cleaning Stages of the automatic washer/disinfector cycle: • Rinse all abundantly with cold water (max. temperature 35°C (95°F)/ 1. Pre-wash: softened cold water; 2x1 minute with drainage between two minimum duration 3 minutes). pre-washes. • Steep the handpiece with its cable in a detergent solution. Minimum 2. Washing: with detergent and with softened hot water, 50°C to 65°C duration 30 minutes and maximum 1 h (the detergent solution must be (122°F to 149°F), for 5 minutes. renewed for each use). 3. Rinsing: softened cold water (max. 35°C (95°F)) for 1 minute. • Brush the outside of the handpiece with a cleaning brush (especially in 4. Thermal disinfection by rinsing: softened hot water, 93°C (80°C to 97°C) the corners of the part, for at least 5 min.). (199°F (176°F to 207°F)), for at least 5 minutes. • Clean the interior of the handpiece with an appropriate swab and rub 5. Ventilated dynamic drying, approx. 100°C (212°F), at least 25 minutes. with rotation movements all along the part for at least 5 minutes (make sure not to scratch or damage the interior of the part). Comments: • Remove from the bath and rinse the interior and exterior of the hand- - Comply with the washer/disinfector loading instructions provided by the manufacturer. piece with sterile water for at least 3 minutes. • Hold the handpiece with the front end directed downward and spray the - Make sure that all the instruments have been correctly attached to the trays. interior of the handpiece with Spraynet. • Dry the exterior of the handpiece by swabbing with a sterile non-woven - Make sure that the instruments do not touch one another. towelette. Dry the interior with a round brush wrapped in a sterile non- - Remove the instruments from the washer or disinfector immediately and move on rapidly to points 3 and 4 below, after the machine stops to avoid woven towelette. corrosion. • Ventilated dynamic drying, approx. 100°C (212°F), at least 25 minutes. 26

2 Inspection, lubrication and testing

leave the locking mechanism in open position fig. 4.

3

B type cycles

Temperature [°C]

Pressure [bar]

Exposure time [minutes]

2

Minimum drying time

Carefully inspect each part to make sure that all visible contamination has been eliminated. Check in particular that the channels are clear. If contamination is present, repeat the cleaning process.

Packing for sterilisation: 2.2 Separate packing: 18 134°C 15 Wrap the instrument immediately in 1 Preliminary vacuum (273°F) separate packing for steam sterilisation. Recommended water and steam Autoclavable products are designed Or to be sterilised by steam in accordanPacking in stiff boxes and trays with quality as per EN 285:1996 After each cleaning operation and defined, pre-configured lids and 1 Parameters recommended by the ce with the following standards: before each sterilisation, lubricate apertures. Bien-Air Surgery SA can World Health Organisation for - US Standard ANSI/AAMI ST46 the instrument with Lubrifluid spray provide a sterilisation tray designed treating instruments in the event - British Standard BS 3970 from Bien-Air Surgery SA. for this type of item. of contamination by Non- - European Standard EN 285 / DIN 58946 Conventional Transmissible To absorb any excess lubricant, apply 3 Sterilisation Agents (NCTA). Parameters a cloth over the instrument's aperturecommended by Bien-Air Do not exceed a temperature of 138°C (280°F). res. Insert the Lubrifluid spray plastic Sterilisation by steam/damp heat is Surgery SA. end fitting in the rear of the instru- the preferred and recommended me- 2 This time should be increased if the load is large. The instrument must be allowed to ment's handle fig. 8 and actuate the thod for this instrument. Refer to the spray for about 0.5 seconds. following table for the sterilisation 3 In accordance with EN285 and cool to ambient conditions, without EN13060 standards, for the sterili- forced cooling, before being re-used. parameters recommended by BienThen leave the instrument upright to Air Surgery SA to provide a sterility sation of objects of solid, hollow -6 rest for at least 5 minutes. or porous form, packed in single Never rinse instruments in cold assurance level (SAL) of 10 . or double packaging. water to cool them. Check the action of moving parts: Local or national specifications Insert a bur in the instrument and should be complied with when the The instructions of the steriliser maclamp the tool with the ring fig. 5. steam sterilisation requirements are nufacturer concerning operation more stringent or more conservative and the load configuration should Check that the bur remains in place than those listed in this table: be complied with explicitly. when pulled. Remove the bur and EN

Bien-Air Surgery SA REF 2100029/06.09

27

4 Storage

regulations). A double sterile packa- se contact Bien-Air Surgery SA at the ging as per DIN 58 946, section 9, ex- address indicated on the back cover. Ambient conditions of storage tends the shelf life after sterilisation General information • Store the equipment in a clean, Environmental conditions dry place at ambient temperature Working The device must be used by a compe(10–40°C (50–104°F), 30–80% • Temperature: tent person in accordance with the humidity). +10°C (50°F) to +40°C (104°F) current legal provisions concerning • Do not expose the equipment to • Relative humidity: 30% to 80%, industrial safety, health and accident direct sunlight. including condensation prevention regulations, and these • Do not expose the equipment to • Atmospheric pressure: working instructions. In accordance permanent X-ray irradiation. 700 hPa to 1060 hPa with these requirements, the opera• Do not store the equipment in Transport and storage tors: places that could be reached by • Temperature: • must only use operating devices liquid splashes. -40°C (-40°F) to +70°C (158°F) that are in perfect working order; • Do not store the equipment in the • Relative humidity: 10% to 100%, in the event of irregular functiofollowing ambient conditions: including condensation ning, excessive vibration, abnor- Dust • Atmospheric pressure: mal heating or other signs indica- Saline or sulphurous atmosphere 500 hPa to 1060 hPa ting malfunction of the device, • Do not store the equipment in a the work must be stopped immelocation where there is a risk of Information diately; in this case, contact a release of flammable gases. The technical specifications, illustrarepair centre that is approved by tions and dimensions contained in Bien-Air Surgery SA; Shelf life of sterilised instru- these instructions are given only as a • must ensure that the device is ments guide. They may not be the subject of used only for the purpose for The shelf life of stored sterilised in- any claim. The manufacturer reserwhich it is intended, must protect struments depends on the type of ves the right to make technical imthemselves, their patients and packaging used and the storage con- provements to its equipment, withird parties from any danger, and ditions (refer to the DIN 58 953 stan- thout amending these instructions. must avoid contamination dard, section 9 or the existing local For all additional information, pleathrough the use of the product.

The device is intended for medical treatment only; any use other than that for which this product is intended is unauthorised and may be dangerous. The medical device meets all the current European legal requirements. Rest the device on a suitable support to avoid risks of infection for yourself, the patient or third parties. This equipment needs to be recycled. The user must be return the equipment to its dealer or establish direct contact with an approved body for treatment and recycling of this type of equipment (European Directive 2002/96/EC).

28

sation would make the instrument Problem Solution completely unusable, clean the inOverhaul strument as carefully as possible and There is no trans- Check that the motor by itself operates. No component of the handpiece may mark it accordingly to indicate that mission of movement. Check that there is a bur in the locking mechanism and that it is in “clamp” position fig. 5. be changed by the user; never di- it has not been decontaminated. sassemble the handpiece. Impossible to insert the Check that the chuck mechanism is in open poToubleshooting For all servicing and repairs, it is re- Use the table below to solve any pro- bur in the instrument. sition fig. 4. commended that you contact your blem encountered. Check that there is no part jammed inside the customary supplier or Bien-Air Surclamp and that the latter is clean. gery SA directly. If the problem is insoluble, stop Check that the stem of the bur is in sound using the product and contact a condition and of the correct diameter. Bien-Air Surgery SA invites users to repair centre approved by Bien-Air The bur does not rotate Check that the locking mechanism ring is fully have their dynamic instruments Surgery SA. freely. checked or serviced at least once a inserted fig. 5. year. Check that the part is clean and lubricated with Lubrifluid. Only use maintenance products and The instrument heats Check that the part has been correctly cleaned components from Bien-Air Surgery abnormally. SA. The use of other products and and lubricated. components can void the guarantee. Excessive vibration Stop the motor and pull on the bur to check that Hygiene it is correctly in position, or change/reduce the For the safety of the repair centre’s speed of rotation. personnel, the instrument should be cleaned and sterilised completely before being returned for repair. Servicing and repair

If that proves impossible, for example because a disinfection or steriliEN

Bien-Air Surgery SA REF 2100029/06.09

29

General terms of guarantee

The notice of defect must be received in writing by Bien-Air Surgery SA within the aforementioned period and must contain the customer's name, the date of purchase, and the product reference and serial number.

Bien-Air Surgery SA endeavours to provide its customers with products of impeccable quality, which it guarantees within the limits of the present general terms and the particular agreements signed, against any ope- In the event of claims, Bien-Air Surrating fault, material or manufactu- gery SA or its authorised representaring defect on its devices. tive shall perform product repair or replacement free of charge, after The guarantee period is 12 months analysing the justification for the from the date of invoice. claim. In general, the guarantee does not exempt the customer from the obligation of obtaining information from Bien-Air Surgery SA in case of doubt and in particular when the product is used in conditions not explicitly provided for originally. The buyer must check the goods received within 8 days following their receipt. If the goods are not checked within the period mentioned above, the customer shall be deemed to have accepted the goods, barring hidden defects.

• faulty air or water seals or electri- Jurisdiction cal connections. CH-2340 Le Noirmont, Switzerland. In any case the guarantee becomes null and void in the event of inappropriate servicing or modifications to the product carried out by third parties not authorised by Bien-Air Surgery SA. In case of dispute as so whether or not the defect exists, it shall be incumbent on the customer to prove the existence of the defect.

All other claims of whatsoever kind, and in particular claims for dama- Guarantee claims shall be taken into ges, shall not be accepted. consideration only upon presentation, with the product, of a copy of Bien-Air Surgery SA may not be held the invoice or delivery slip on which responsible for damage or injury and should appear clearly the date of the consequences thereof, resulting purchase and the product reference in particular from: and serial number. • excessive wear; • inappropriate use; Governing law • failure to comply with operating Swiss domestic law ("Code des obliinstructions, assembly instruc- gations") shall be applicable in adtions or maintenance instruc- dition to the general terms and partions; ticular agreements between the cu• exceptional chemical, electrical stomer and Bien-Air Surgery SA. or electrolytic influences; 30

REF

Legend

List of Bien-Air registered trade mark products ®:

1600207-001 1600336-001 1600337-001 1600328-001 1600329-001 1600295-001 1600338-001 1600339-001 1600202-001 1600206-001 1600340-001 1600341-001 1600612-001 1600477-001 1600306-001

PMAM 1122-70 PMAM 1122-95 PMAM 1122-125 PMAM 1122 (en-DCR) PMRM 1122 (en-DCR) PMAM 1221-70 PMAM 1221-95 PMAM 1221-125 PMAM 10121-70 PMRM 1122-70 PMRM 1122-95 PMRM 1122-125 PMRM 1124 Sterilisation try Bur holder autoclavable for 16 burs, tail dia. 2.35 mm (0.09 in) Nose cone without tube PMRM 1124 Lubricant duct 70 Lubricant duct 95 Lubricant duct 125 Lubricant duct PMRM 1124 Adaptor-sleeve Wire probe, box of 10 wires Long cleaning brush Spraynet, cleaning spray 500 ml, box of 6 cans Lubrifluid, lubricant 500 ml, box of 6 cans Set supplied (cover page) Optional accessories (last page)

Lubrifluid® Spraynet®

1500003-001 1500096-001 1500097-001 1500098-001 1500552-001 1500596-001 1000001-010 1000009-010 1600036-006 1600064-006 a b

EN

OSSEODOC® OSSEODUO®

OSSEOPRO® OSSEOUNO®

Symbols CAUTION! Refer to the accompanying documents

Wear rubber gloves

Sterilisable in autoclave up to the specified temperature

Machine washable Movement in the direction indicated

0120

CE Marking with number of the notified body

Recyclable materials Movement fully to the stop, in the direction indicated

Rx Only Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner. For further information concerning microsurgery devices and their accessories, please contact your local Bien-Air Surgery SA representative or visit our website www.bienairsurgery.com Bien-Air Surgery SA REF 2100029/06.09

31

Notes

52