OSSEODOC Operating Instructions Aug 2016

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TABLE OF CONTENTS 1. 2. 3. 4. 5.

DESCRIPTION OF THE DEVICE ... 4 AVAILABLE SETS ... 5 SYMBOLS USED ... 6 CE / UL CONFORMITY ... 7 GENERAL ... 7 5.1. 5.2. 5.3.

6.

System description ... 7 Intended use ... 7 Contraindication ... 7

PRECAUTIONS - WARNINGS ... 7 6.1. 6.2. 6.3.

7.

Warnings, Precautions for use ... 7 Environmental protection and indications for device disposal ... 8 Precautions regarding electromagnetic compatibility (EMC) ... 8

CONTROL UNIT ... 10 7.1. Technical data...10 7.2. Set-up ...11 7.2.1. Unpacking and checking ...11 7.2.2. Preparation ...11 7.2.3. Use of the irrigation line ...12 7.3. Use ...13 7.3.1. Power up ...13 7.3.2. Continuous irrigation synchronized with the motor ...13 7.3.3. Intermittent irrigation ...13 7.3.4. Adjustment of the irrigation flow ...13 7.3.5. Configurable options ...13 7.3.6. Foot pedal...14 7.3.7. Power down...14

8.

BASCH / BASCH-1 MICROMOTOR ... 15 8.1. 8.2. 8.3. 8.4.

9.

Technical data...15 Connection of the cable to the motor...16 Handpiece insertion and removal on the BASCH-1 micromotor ...16 DRILL mode ...16

CLEANING / MAINTENANCE / STERILIZATION ... 17 9.1. General indications ...17 9.2. OSSEODOC control unit and foot pedal ...19 9.3. BASCH Micromotor ...20 9.3.1. Preliminary cleaning ...20 9.3.2. Cleaning ...20 9.3.3. Inspection, lubrication and testing ...21 9.3.4. Sterilization ...21 9.4. BASCH-1 Micromotor ...22 9.4.1. Preliminary cleaning ...22 9.4.2. Cleaning ...22 9.4.3. Inspection, lubrication and testing ...23 9.4.4. Sterilization ...23

10. 11. 11.1. 11.2.

12. 13. 13.1. 13.2. 13.3.

14. 15.

MAINTENANCE... 24 MALFUNCTIONS AND ERRORS ... 25 OSSEODOC control unit ...25 BASCH / BASCH-1 micromotor...25

OPTIONS / ACCESSORIES ... 26 GENERAL TERMS OF GUARANTEE ... 27 Generalities ...27 Governing law ...27 Jurisdiction ...27

ACCOMPANYING DOCUMENTS ACCORDING TO EN 60601-1-2, CHAPTER 6 28 BLOCK DIAGRAM ... 31

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1. DESCRIPTION OF THE DEVICE 7

5

6

4

OSSEODOC control unit

3

2

E

1 11

8

9

10

Multifunction foot pedal

BASCH Micromotor with cable REF 1700074-001

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BASCH-1 Micromotor with cable REF 1700502-001

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2. AVAILABLE SETS Set OSSEODOC BASCH with pump REF 1700168-001 Includes: • 1 control unit OSSEODOC with pump REF 1600331-001 • 1 BASCH micromotor (sterilizable) REF 1600076-001 • 1 cable for BASCH micromotor (sterilizable) REF 1600342-001 • 1 watertight pedal with 2 buttons, multifunction REF 1600407-001 • 1 irrigation stand REF 1500017-001 • 1 set of 10 irrigation lines with 2 flow rate ranges, REF 1100037-010 • 1 set of 10 irrigation clips REF 1300064-010

Set OSSEODOC BASCH without pump REF 1700169-001 Includes: • 1 control unit OSSEODOC without pump REF 1600332-001 • 1 BASCH micromotor (sterilizable) REF 1600076-001 • 1 cable for BASCH micromotor (sterilizable) REF 1600342-001 • 1 watertight pedal with 2 buttons, multifunction REF 1600407-001

Set OSSEODOC BASCH-1 with pump REF 1700525-001 Includes: • 1 control unit OSSEODOC with pump REF 1600331-001 • 1 BASCH-1 micromotor (sterilizable) REF 1600884-001 • 1 cable for BASCH-1 micromotor (sterilizable) REF 1600342-001 • 1 watertight pedal with 2 buttons, multifunction REF 1600407-001 • 1 irrigation stand REF 1500017-001 • 1 set of 10 irrigation lines with 2 flow rate ranges, REF 1100037-010 • 1 set of 10 irrigation clips REF 1300064-010

Kit pump (for OSSEODOC REF1700169-001) REF 1700170-001 Includes: • 1 peristaltic pump REF 1600333-001 • 1 irrigation stand REF 1500017-001 • 1 set of 10 irrigation lines with 2 flow rate ranges, REF 1100037-010 • 1 set of 10 irrigation clips REF 1300064-010

For further information concerning microsurgery instruments and their accessories, please contact your Bien-Air Surgery SA local distributor or consult our homepage www.bienairsurgery.com.

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3. SYMBOLS USED CE Marking with number of the notified body

UL Classification Mark for the United States and Canada Protective earth (ground) Connector for potential equalization lead Main switch ON: The device is energized OFF: The device is de-energized Fuse Ø 5 x 20 mm Alternating current

Rx Only

Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner Device of type B CAUTION! Dangerous voltage Component sensitive to electrostatic discharge CAUTION! Refer to the accompanying documents Danger of catching fingers Do not put your fingers in rotating parts Water cooling - Irrigation Follow/Consult instructions for use Materials to be recycled The disposal and/or recycling of materials must be performed in accordance with the directives and the legislation in force Electrical or electronic materials to be recycled Manufacturer Sterilizable in autoclave up to the specified temperature Cleaning in machine authorized Coupling ring opening direction

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4. CE / UL CONFORMITY CE Marking with number of the notified body testifying that the device complies with European standards for electro medical devices and the 93/42 EEC directives: - General safety rules EN 60601-1 - Electromagnetic compatibility EN 60601-1-2

Classified by Underwriters Laboratories Inc. with respect to electric shock, fire and mechanical hazards only in accordance with ANSI/AAMI ES60601-1 (2005, 3rd ed.) and CAN/CSA-C22.2 No. 60601-1 (2008).

5. GENERAL 5.1.

System description

5.2.

Easy to use and small in size, the new OSSEODOC control for bone microsurgery is practical and efficient. Touch-sensitive keys make it possible to select 4 motor speeds, the direction of rotation, two irrigation options and 4 peristaltic pump deliveries. The same functions are also available on the foot control. Pilot lamps and audible signals indicate the functions activated.

Intended use

Product intended for professional use. The OSSEODOC system has been designed for shaping bones as part of surgical operations in the areas of: ENT, neurosurgery, head and neck surgery, such as otorhinolaryngology, otoneurology and maxillofacial surgery.

5.3.

Contraindication

None known as of today.

6. PRECAUTIONS - WARNINGS 6.1.

Warnings, Precautions for use

Technical specifications, illustrations and dimensions contained in this document are given only as an indication. They cannot originate any complaint. The manufacturer reserves the right to bring technical improvements to his equipment without modifying the present instructions. This user manual has been translated from the original French version and may contain some minor discrepancies. The binding document is the original French version. For additional information, please contact Bien-Air Surgery SA at the address indicated on the back-cover of this document. Do not use this device in the presence of a flammable gas.

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The device and its accessories should be used only by duly trained and competent medical personnel, in particular in compliance with the legal provisions in force regarding occupational safety, health and accident prevention measures, and the present user manual. According to these measures, the user has the following obligations: 



To only use devices in perfect working condition. In the event of irregular operation, excessive vibrations, abnormal overheating or other signs suggesting malfunctioning of the device, work must be suspended immediately. In this case, contact a repair center approved by Bien-Air Surgery. Make sure that the device is used only for the purpose for which it is intended, protect yourself, patients and third parties from all danger and avoid contamination by the product.

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The device and its accessories are designed solely for medical treatment. Any use not in conformance with the intended use is unauthorized and may prove dangerous. This medical device complies with the European legal provisions in force. Do not modify this equipment without authorization of the manufacturer. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. Never submerge the OSSEODOC control unit in disinfection solutions. Install the control unit on an appropriate mounting to prevent risks of injury or infection for yourself, the patient or third parties. Use only Bien-Air Surgery SA original maintenance products, accessories and/or spare parts. The use of other products, accessories or parts could void the guarantee and/or endanger the patient or the operator. To avoid the risk of electrical shock, this equipment must only be connected to a supply main with protective earth. For USA, use a power supply cord type SJT, AWG18, C13, 2m length, Nema 5 15P Hospital grade, UL classified. For Canada, use a power supply cord complying with the applicable requirements of CSA C22.2 No 21 and not smaller than AWG18. Use a power supply cord respecting regulation and norms of the country where the OSSEODOC unit is used. Do not lift the pedal by its connection cable! Danger of electrocution: Never open the device when it is connected to the mains power outlet.

6.2.

Environmental protection and indications for device disposal

This equipment must be recycled. The disposal and / or recycling of materials must be performed in accordance with the directives and the legislation in force. Electrical and electronic equipment may contain dangerous substances which constitute health and environmental hazards. The user can return the device to his distributor or call directly on a firm accredited for the treatment and recovery of this type of equipment (European directive 2002/96/EC).

6.3.

Precautions regarding electromagnetic compatibility (EMC)

Medical electrical equipment requires special precautions regarding EMC and must be installed and put into operation in accordance with the appropriate information provided in the service manual and in the present document. The OSSEODOC control unit complies with the EMC requirements according to EN 60601-1-2. Radio transmitting equipment, cellular phones, etc. should not be used in the immediate vicinity of the device, since this could affect its operation. Special precautions should be taken when using strong emission sources such as highfrequency surgical equipment and other similar equipment, to ensure that HF cables are not routed above or near the device. If in doubt, please contact a qualified technician or Bien-Air Surgery SA. The OSSEODOC control unit should not be used adjacent to or stacked with other equipment. If adjacent or stacked conditions of use are necessary, the OSSEODOC should be monitored to verify that it operates normally in the configuration in which it will be used. Pins of connectors identified with ESD warning control symbol should not be touched and connections should not be made

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to these connectors unless ESD precaution procedures are used. WARNING! The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Bien-Air Surgery SA as spare parts for internal components, may result in increased emissions or reduced immunity of the OSSEODOC control unit. See "Accompanying documents on EMC" at the end of the manual.

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7. CONTROL UNIT 7.1.

Technical data

Subject to modifications of the models and technical amendments. Environmental conditions: Work Temperature:

Transport

Storage

+10°C -25°C (-13°F) +10°C (50°F) (+50°F) to to +70°C to +30°C +30°C (86°F) (158°F) (86°F)

Multifunction pedal Protection class: IPX8 as per CEI 529. Functions: Direction of motor rotation selection speed control, irrigation pump start/stop and flow rate selection.

Relative humidity (including 20% to 80% condensation):

10% à 100% 20% à 80%

Size / Weight: (W x H x D) 160 x 170 x 55 mm / 0,830 kg.

Atmospheric pressure:

500 hPa to 1060 hPa

Cable length: 295 cm ±5 cm.

700 hPa to 1060 hPa

500 hPa to 1060 hPa

Control unit Marking: CE 0120 as per 93/42 EEC directive. Supply voltage: 115 - 230 Vac / 1.5A – 0.8A / 50-60 Hz. Fuses: 2 fuses T 2.5 AH 250 VAC (for 230 VAC). 2 fuses T 3.15 AH 250 VAC (for 115 VAC). Motor power supply: 1 push-pull type connectors / <50 Vdc. Electrical insulation class: Class I. Applied parts: Type B. Medical class: IIa as per 93/42 EEC directive. Protection class: IP 40. Size / Weight: (W x H x D) 261 x 110 x 300 mm (height with irrigation stand: 510 mm) / 5,0 kg with pump, 4.1 kg without pump. Irrigation pump: Delivery from 15 to 130 ml/min, 4 + 4 irrigation flow rate values (with two-speed Bien-Air Surgery SA irrigation line). Irrigation stand: Stainless steel.

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Fig. 1

7.2.

Fig. 2

Fig. 3

Set-up

7.2.1. Unpacking and checking 1. When unpacking the cardboard box, check its content against the delivery voucher. If items are missing or if the equipment is damaged, notify the sender immediately. If the shipment box is damaged, notify the carrier. 2. After unpacking, keep the shipment box and the packing materials. They could be useful for returning the device.

Depending of the country’s regulation, attach the ground wire to the potential equalization connector 14 (Fig. 3). The purpose of the potential equalization connector is to equalize potentials between different metal parts that can be touched simultaneously, or to reduce differences of potential which can occur during operation between the bodies of medical electrical devices and conductive parts of other objects.

7.2.2. Preparation 1. Place the OSSEODOC control unit on a table, on a carriage or on any other surface, but in no case on the floor. 2. Check the fuse value (115 / 230 Vac) and position the voltage selector according to the voltage (Fig. 1). 3. The control unit is powered by your line voltage (115 / 230 Vac). Place the main switch 9 (Fig. 2) in position 0 and connect the power cable to the plug 12 (Fig. 3). 4. Connect the pedal cable to output 13 (Fig. 3) on the back of the unit, align the plug with the connector according to the marks. 5. Connect the BASCH or BASCH-1 motor cable to output 10 (Fig. 2) on the front on the right. 6. Align and attach the bracket to the housing 15 (Fig. 3) provided on the back of the box and suspend the bag or bottle. Before performing any operation on the device, touch a metallic surface to eliminate any static electricity.

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Fig. 4

Fig. 5

Fig. 6

7.2.3. Use of the irrigation line 1. Check the integrity of the irrigation line packaging and the use-by date (Fig. 4). Only Bien-Air lines ensure troublefree operation. 2. Remove the disposable sterile irrigation line from its bag. Use a new irrigation line for each patient, a reuse could lead to a cross contamination. 3. Connect the flexible hose to the spray tube of the handpiece or contra-angle. 4. Install the white or green silicone segment on the irrigation pump and close the pump cover. Check the “V” location in the chuck mechanism (Fig. 5).

Irrigation line with 2 flow rates (Fig. 6). 100% Flow rate using the white silicone segment: From 30 to 130 ml/min. ~ 50% Flow rate using the green silicone segment: From 15 to 65 ml/min. Bien-Air Surgery SA handpieces allow the connection of an irrigation line. For that, insert the end of the irrigation line into the spray tube.

Caution: Risk of hose perforation Caution! Do not operate the pump when the cover is open. Danger of catching fingers! 5. Remove the spike protection, and perforate the bottle cap. 6. Attach the irrigation line to the motor cable using the provided irrigation clips.

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Fig.7

7.3.

to activate or acknowledgment.

Use

7.3.1. Power up At power-up (switch A Fig. 7 in position 1), a green light will turn on inside the switch. Various keys located under a watertight membrane can be used to select the work mode and to perform the appropriate adjustments depending on the planned operation. To each selected mode corresponds a specific LED.

deactivate

audible

7.3.5. Configurable options Keyboard beep on each button press on keyboard or foot pedal: To activate or deactivate the keyboard beep, press key 6 for 5 seconds until beep.

7.3.2. Continuous irrigation synchronized with the motor Press the key 6 to activate and deactivate the continuous irrigation. The irrigation flow is symbolized by green LED. This function is also activate / deactivate by the left foot pedal button. Remark: When irrigation is stopped, the pump's direction of rotation is reversed to "suck up the drop". 7.3.3. Intermittent irrigation Press the key 7 to activate and deactivate the intermittent irrigation function. The irrigation pump is activated only at the end of the pedal rocker's travel by applying a stronger pressure to it. 7.3.4. Adjustment of the irrigation flow A press on the key 8 increases the irrigation flow. The flow is symbolized by the LED (1 to 4) displayed on the left of the key. Remark: For instruments without peristaltic pump (without irrigation), keys 6, 7, 8 and 12 are inactive. However, key 6 remains valid

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Fig. 8

Fig. 9

Fig. 10

7.3.6. Foot pedal

7.3.7. Power down

The pedal functions allow the surgeon to change setting without the assistance of another person.

To switch off the control unit, turn the switch A Fig. 10 in position 0.

Remark: The foot pedal must always be connected. For good pedal stability and operation, make sure to place your foot correctly in the center of the pedal (Fig. 8)! Left button for irrigation control (Fig. 9): A) Long press on the button: (ca. 2sec.): Activation or deactivation of the last selected "IRRIGATION" function. B) Short press on the button: Flow rate increased. Right button for motor control (Fig. 9): A) Long press on the button: (ca. 2sec.): Change of direction of motor rotation B) Short press on the button: Change in motor rotation speed. Variable speed drive (rocker switch): Variable motor speed control. When intermittent irrigation is activated, the irrigation pump starts only at the end of the pedal rocker's travel (by applying a stronger pressure to it).

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8. BASCH / BASCH-1 MICROMOTOR

The BASCH micromotor is designed to drive various types of surgical handpieces with E type as per ISO 3964 coupling. The BASCH-1 micromotor is designed to drive the PM2 surgical handpieces. It’s connected to the OSSEODOC control unit by a specific cable. The BASCH/BASCH-1 micromotor are delivered "non sterile". Clean, lubricate and sterilize the BASCH/BASCH-1 micromotor with the cable before first use.

8.1.

Technical data

Subject to modifications of the models and technical amendments Environmental conditions: Work Temperature:

Transport

Storage

+10°C -25°C (-13°F) +10°C (50°F) (+50°F) to to +70°C to +30°C +30°C (86°F) (158°F) (86°F)

Relative humidity (including 20% to 80% condensation) :

10% à 100% 20% à 80%

Atmospheric pressure:

500 hPa to 1060 hPa

700 hPa to 1060 hPa

500 hPa to 1060 hPa

Type: Direct current, brushless, selfventilated Power supply: 0 - <24 Vdc 7 A max. Applied parts: All housing surfaces of micromotor are considered “applied parts” of Type B. Motor torque: Max. 40 mNm. Speed: 500 to 40’000 rpm +/- 5%. Noise level: As per ISO 11498: < 62 dBA at 45 cm. Period of operation: To avoid overheating of the applied parts and the associated risk of burn injuries of patient or surgeon, the 21.081.E_MdE_OSSEODOC_(EN).docx

following rules must be respected: a) Limit the maximum speed of rotation according to the bur diameter as indicated on the packaging and/or in the present operating instructions. b) Do not exceed the maximum handpiece allowed speed of rotation. c) Adequate irrigation is recommended. d) Period of continuous operation: 10-15 minutes at low load. 5-7 minutes at medium load. 1-2 minutes at high load followed by a minimum interruption period of 30 seconds. When the micromotor external surface temperature rises more than ca. 21°C (69,8°F) above the ambient temperature, an alarm is ringing (see § 11 for further explanations). The micromotor can still be used for a short period but under the surgeon’s full responsibility. In this case beware of not touching the patient with the micromotor (high risk of burn injuries). Coupling: E Type as per ISO 3964, without internal spray, without light for the BASCH; PM2 Bien-Air Surgery for the BASCH-1. Size / Weight: BASCH: Diameter 21 mm, length 100 mm, including coupling / 120 g, without cable and without handpiece. BASCH-1: Diameter 21 mm, length 77 mm, including coupling / 115 g, without cable and without handpiece. Motor / cable: Push-pull type connector at OSSEODOC end, length 295 cm ±5 cm.

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8.2.

Connection of the cable to the motor

Before connecting the specific motor cable, check the cleanliness of the rear of the micromotor and the cable plug. Present the BASCH/BASCH-1 micromotor suitably oriented (align the cable reference with the reference on the motor). Insert the plastic connector in position. Tighten the connector nut as far as possible. Before using the micromotor, place it in operation at moderate speed without the handpiece connected for a few seconds, so as to spread the lubricant and remove any excess.

8.3.

Handpiece insertion and removal on the BASCH-1 micromotor

1. Insert the handpiece on the micromotor nose and rotate it to have a correct coupling of this one. 2. To remove the handpiece, pull the coupling ring backward and remove the handpiece. Connect the flexible hose of the irrigation line to the spray tube of the handpiece up to the thrust stop. Attach the irrigation line to the motor cable using the provided irrigation clips.

8.4.

DRILL mode

The practitioner can adjust irrigation functions, the speed and direction of rotation of the bur. Direction of rotation In DRILL mode, rotation is continuous. Rotation is continuous in clockwise by default. Press the key 5 to activate and deactivate the counterclockwise motor rotation. An alternate beep is ringing when the key is active. Speed adjustment Key 1 : Selection of speed range from 500 to 7'000 rpm Key 2 : Selection of speed range from 500 to 15'000 rpm Key 3 : Selection of speed range from 500 to 20'000 rpm Key 4 : Selection of speed range from 500 to 40'000 rpm

Important note: Never insert an instrument on a rotating micromotor.

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9. CLEANING / MAINTENANCE / STERILIZATION 9.1.

General indications Do not place the BASCH / BASCH1 in an ultrasonic bath. Never rinse instruments in cold water to cool them. Never submerge the BASCH / BASCH-1 in disinfection solutions. Do not place stainless steel instruments or motors in physiological salt water solutions (NaCl solution), because prolonged contact may cause corrosion.

Customary precautions Hospital procedures must be followed. The universal precautions must be complied with by hospital personnel working with contaminated or potentially contaminated medical instruments. Pointed and sharp instruments should be handled with great caution. Agents required for cleaning: • Detergents Enzymatic detergent recommended for cleaning surgical instruments in washer / disinfector. For example, a detergent containing proteolytic enzymes. Detergents should be used in the concentration, temperature and duration recommended by the detergent manufacturer. Do not use detergents that are corrosive or contain chlorine, acetone or bleach, aldehydic products or alcohols. • Lubricant: Exclusively use "Lubrifluid" from Bien-Air Surgery SA. • Brush / cleaning gun The brushes should be non-aggressive to avoid damaging the device. Preferably use nylon brushes with flexible hairs or soft bristles. Use the cleaning gun with 21.081.E_MdE_OSSEODOC_(EN).docx

the appropriate nozzles for the various ducts. Storage: Bien Air Surgery SA strongly advises storing only sterilized devices so as to reduce the risks of corrosion. Ambient conditions of storage after sterilization • Store the equipment in a clean, dry place at ambient temperature (10–30°C (50– 86°F), 20–80% humidity). • Do not expose the equipment to direct sunlight. • Do not expose the equipment to permanent X-ray irradiation. • Do not store the equipment in places that could be reached by liquid splashes. • Do not store the equipment in the following ambient conditions: - Dust - Saline or sulphurous atmosphere • Do not store the equipment in a location where there is a risk of release of flammable gases. Preliminary cleaning precautions: This operation is important to facilitate the subsequent cleaning stage (it prevents dirt from drying and sticking to the equipment). Cleaning precautions: Complete cleaning can lower the initial microbial load, eliminate organic matter and prevent biofilm formation. This stage is essential and influences the quality of the disinfection procedure as a whole. Cleaning combines the physico-chemical action of the product and the mechanical action of brushing and rinsing. Comment for automatic cleaning: - Comply with the washer/disinfector loading instructions provided by the manufacturer. - Make sure that all the instruments have been correctly attached to the baskets.

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- Wind up the cable correctly and without any tension (minimum inner diameter 8 cm). - Make sure that the instruments do not touch one another, that the cable does not touch the sides of the washer / disinfector and that internal canal are properly rinsed. - Remove the instruments from the washer or disinfector immediately after the machine stops and move on quickly to lubrication and sterilization, to avoid corrosion. Sterilization precautions: The shelf life of stored sterilized instruments depends on the type of packaging used and the storage conditions (refer to the DIN 58953 standard, section 9, or the existing local regulations). Since no reprocessing methods have been validated for removal of transmissible spongiform encephalopathy (TSE) agents from medical devices, this device should not be used for patients with known or suspected TSE agent disease, including CJD and vCJD. Bien-Air Surgery recommends incineration of devices that have directly contacted patients suspected or confirmed with TSE/CJD diagnosis. The instructions of the sterilizer manufacturer concerning operation and the load configuration should be complied with explicitly. Do not exceed a temperature of 138°C (280°F). Before re-using, the instrument must be allowed to cool to ambient conditions, without forced cooling. Packing for sterilization: Separate packing: Wrap the instrument with its cable immediately after cleaning in an individual packing such as a paper/plastic pouch or sterilization wrap, for steam sterilization. Make sure that the cable does not touch the sides of the sterilizer.

Packing in stiff boxes and trays with defined, pre-configured lids and apertures and wrap the stiff boxes or tray. Bien-Air Surgery SA can provide a sterilization tray designed for this type of item. In the USA, FDA approved sterilization wraps or container must be used. BASCH / BASCH-1 delivered “non sterile”.

micromotors

Before it is used, please comply with the present section. The cycles described below are compatible with the BASCH / BASCH-1 micromotors and their cable: - Clean, lubricate and sterilize the instrument with the cable before first use. - Clean, lubricate and sterilize the instrument with the cable before each further use. - After each use, perform cleaning maintenance and sterilization of the handpiece as quickly as possible. As soon as you have finished using the BASCH / BASCH-1, proceed as follows: - Disconnect the motor power cables from the OSSEODOC control unit. - Do not disconnect the power cable on BASCH / BASCH-1 side. *** (see below comment). - Disconnect the irrigation and suction lines from the handpiece. - Separate the instrument from the BASCH / BASCH-1 and treat it in accordance with its instructions. *** Comment (Only if sterilization 134°C during 18 min): To ensure the cleanliness of the rear of the micromotor/ handpiece and the cable plug, the motor specific electric power cable must be disconnected after 10 to 15 sterilizations or once a month. If necessary, clean with a detergent solution, and dry the two parts with nonwoven towelettes. Connect the motor cable again. For instruction per instrument see chapter 9.2 to 9.4.

Or

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are

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Fig. 1

9.2.

Fig. 2

OSSEODOC control unit and foot pedal

Use the "Spraynet" cleaning product from Bien-Air Surgery SA. Spray the outside to clean residues. Use enzymatic detergents with a neutral pH (6.0-8.0). Soak a clean cloth and carefully clean the surfaces and also under the pedal's rocker switch (see Fig. 1 and Fig. 2). The OSSEODOC control unit and the foot pedal are not sterilizable!

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9.3.

BASCH Micromotor

9.3.1. Preliminary cleaning

9.3.2. Cleaning

It should be performed as soon as possible after the surgical act. Preliminary cleaning should be followed by manual or automatic cleaning. Never submerge the BASCH micromotor in disinfection solutions. Always hold the micromotor with front end down (minimum 45°). - Rinse the motor and its cable under running tap water (cold) and brush with a nylon brush as long as soil is still visible on the outside surfaces. - After brushing, rinse briefly under running tap water (cold). - Wipe the motor and cable with nonwoven towelettes. - Perform manual or automatic cleaning.

Manual cleaning: Hold the micromotor with the front end pointing downward and wash it with the cable abundantly with detergent solution (max. temperature 35°C (95°F)) as follows: - Without clamping, rub the whole cable with a non-woven towelettes that is soaked with detergent, one to-and-fro movement. - Brush the micromotor outside with a soaked, soft nylon brush (especially in the corner, edges and openings) during 30 seconds. - Rinse the cable during 20 seconds with cold water. - Rinse the micromotor (by flushing the rear ventilation openings) at least 20 seconds. Hold the micromotor always with the front end pointing downward allowing the water to run out. - Blow clean air inside and outside the micromotor. Dry the micromotor and the power cable by wiping with a clean and dry non-woven towelette. - If the part is not immediately sterilized, perform a dynamic drying under ventilation, at about ~100°C (121°F), for a minimum of 25 minutes. Automatic cleaning: Place the micromotor with its cable in the appropriate washer/disinfector basket and treat via a standard instrument washer /disinfector cycle (place the micromotor with the tip downward minimum angle 45°). Use exclusively a validated washer / disinfector.

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