OSSEODUO Operating Instructions May 2021

TABLE OF CONTENTS 1 SYMBOLS USED... 3 2 CE/UL CONFORMITY... 4 3 GENERAL ... 4 3.1 System description ... 4 3.2 Intended use ... 4 3.3 Indication for use ... 4 3.4 Contraindications ... 4

4 PRECAUTIONS-WARNING... 5 4.1 Warnings and precautions for use ... 5 4.2 Environmental protection and indications for device disposal ... 5 4.3 Precautions regarding electromagnetic compatibility (EMC) ... 6

5 DESCRIPTION OF THE OSSEODUO MULTIFUNCTION SYSTEM ... 7 5.1 Micromotor with cable ... 7 5.2 Available sets ... 8

6 CONTROL UNIT AND FOOT PEDAL... 9 6.1 Technical data ... 9 6.2 Set-up ... 10 6.2.1 Unpacking and checking ... 10 6.2.2 Preparation ... 10 6.2.3 Use of the irrigation line ...9

6.3 Use 11 6.3.1 Power-up... 11 6.3.2 Initialization screen ... 11 6.3.3 Selection of work mode - “PUMP only” ... 12 6.3.4 Selection of work mode ... 13 6.3.5 Continuous irrigation synchronized with the motor ... 14 6.3.6 Intermittent irrigation ... 14 6.3.7 Adjustment of the irrigation flow ... 14 6.3.8 Operating mode of the foot pedal rocker switch ... 14 6.3.9 Configurable options ... 14 6.3.10 Foot Pedal ... 15 6.3.11 Power down ... 15

7 NANO MICROMOTOR ... 16

11.5 11.6 11.7

Surgical shaver blades and burs ... 25 Blade or bur insertion and removal on the S120 ... 25 SHAVER mode ... 25

12 CLEANING/MAINTENANCE/STERILIZATION ... 26 12.1 12.2 12.3

General indications ... 26 OSSEODUO control unit and foot pedal ... 28 NANO / RAPIDO / 80K micromotor... 29

12.3.1 12.3.2 12.3.3 12.3.4 12.3.5

12.4

PM PERFO ... 31

12.4.1 12.4.2 12.4.3 12.4.4 12.4.5

12.5

Point of use cleaning ... 31 Pre-cleaning... 31 Cleaning ... 31 Inspection, lubrication and testing ... 31 Sterilization ... 32

OSSEOSTAP ... 33

12.5.1 12.5.2 12.5.3 12.5.4 12.5.5

12.6

Point of use cleaning ... 29 Pre-cleaning... 29 Cleaning ... 29 Inspection, lubrication and testing ... 29 Sterilization ... 30

Point of use cleaning ... 33 Pre-cleaning... 33 Cleaning ... 34 Inspection, lubrication and testing ... 34 Sterilization ... 35

S120 ... 36

12.6.1 12.6.2 12.6.3 12.6.4 12.6.5

Point of use cleaning ... 36 Pre-cleaning... 36 Cleaning ... 37 Inspection, lubrication and testing ... 38 Sterilization ... 38

13 MAINTENANCE ... 39 14 MALFUNCTIONS AND ERRORS ... 40 14.1 14.2 14.3 14.4 14.5

OSSEODUO control unit ... 40 NANO / RAPIDO / 80K micromotor... 41 PM PERFO ... 41 OSSEOSTAP ... 42 S120 ... 42

7.1 Technical data ... 16 7.2 Motor cable connection ... 16 7.3 Attachment insertion and removal on the NANO micromotor ... 17 7.4 S-M DRILL mode ... 17

15 OPTIONS / ACCESSORIES ... 43 16 GENERAL TERMS OF GUARANTEE... 45

8 80K/RAPIDO MICROMOTOR ... 18

17 ACCOMPANYNG DOCUMENTS ACCORDING TO IEC 60601-1-2:2014, CHAPTER 5 ... 46

8.1 Technical data ... 18 8.2 Motor cable connection ... 18 8.3 Attachment insertion and removal on the RAPIDO micromotor ... 19 8.4 DRILL mode ... 19

16.1 16.2 16.3

General Information... 45 Governing law ... 45 Jurisdiction ... 45

9 PM PERFO ... 20 9.1 Technical data ... 20 9.2 Motor cable connection ... 20 9.3 Cranial perforator insertion and removal on the PM PERFO 21 9.4 DRILL mode ... 21

10 OSSEOSTAP ... 22 10.1 10.2 10.3

Technical data ... 22 Tool connection and removal ... 23 OSSEOSTAP mode ... 23

11 S120 ... 24 11.1 11.2 11.3 11.4

Technical data ... 24 Motor cable connection... 24 Irrigation ... 24 Suction ... 25 2

1 SYMBOLS USED Symbol

Rx Only

Description

Symbol

Description

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.

Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner.

Type B device.

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.

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.

Consult the accompanying documents.

Follow instructions for use.

Manufacturer.

Coupling ring opening direction.

Cleaning in machine authorized.

MR Unsafe – keep away from magnetic resonance imaging (MRI) equipment.

Sterilizable in autoclave up to the specified temperature.

3

2 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/IEC/EN ES60601- 1 (2012, 3.1 ed.) and CAN/CSA-C22.2 No. 60601-1 (2014). Essential Performances according to EN IEC 60601-1: Reliable activation/deactivation of the motor using the foot control. Variations in the device speed and incorrect functioning do not represent unacceptable risks.

3 GENERAL 3.1 System description This “high-tech” medical device has been developed and produced in Switzerland by Bien-Air Surgery SA. Three in one! This innovative, efficient system, developed in close cooperation with specialist surgeons, allows easy selection of Shaver / OSSEOSTAP /S-M DRILL or DRILL mode. You not only benefit from a remarkable system, but you also eliminate unnecessary instruments and gain space. The refinement of the S120 or OSSEOSTAP ensures high- precision work in the most difficult places. The power of the 80K micromotor greatly reduces operating time. The Bien- Air Surgery SA coupling on the NANO and RAPIDO micromotors reduces the attachment size for perfect handling and balance of the device in the surgeon's hand. Combined with the PM PERFO, these motors are the best tools to support neurosurgeons in carrying out a fast craniotomy. Compact and practical, the OSSEODUO control unit is easy to use. Its latest generation electronics guarantees optimum operation in complete safety. All the functions can be viewed and accessed by simply pressing keys. The LCD display provides a perfect overall view of the defined functions. Intuitive and personalized programming; capability for extremely precise settings for the most delicate operations. Note: With software versions V3.0X and higher, the OSSEODUO will automatically detect the S80, S120, NANO and OSSEOSTAP.

3.2 Intended use The OSSEODUO System is intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium.

3.3 Indication for use Product intended for professional use. The OSSEODUO system used with attachment and microsaws, shaver blades and burs, burs and perforators has been designed for shaping bones and for the resection of soft and hard tissues as part of surgical operations in the areas of ENT, head and neck, neuro and spine surgery such as otorhinolaryngology, maxillofacial surgery, rhinoplasty, spine and cranium surgical operation. The OSSEOSTAP has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. S120 is not intended for use in neurosurgical procedures.

3.4 Contraindications None currently known.

4

4 PRECAUTIONS-WARNING 4.1 Warnings and precautions for use For additional information, please contact Bien-Air Surgery SA at the address indicated on the back cover of this document.

CAUTION Handle the pedal with care, making sure not to throw it on the floor.

CAUTION Do not use this device in the presence of a flammable gas. Avoid potential ignition or explosion of gases.

CAUTION Danger of electrocution: Never open the device when it is connected to a mains power supply.

CAUTION Avoid excessive pressure on the tool. The use of a tool with excessive pressure may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue. See tools instruction for use for further information. 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 SA. • 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 from the product. The device and its accessories are designed solely for medical treatment. Any use not in conformity 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 from the manufacturer. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. CAUTION Never submerge the OSSEODUO 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. CAUTION To avoid the risk of electrical shock, this equipment must only be connected to a supply main with a protective earth. For USA, use a power supply cord type SJT, AWG18, C13, 2m length, Nema 5 15P Hospital grade, UL classified. Use a power supply cord that complies with regulations and norms in force in the country where the OSSEODUO unit is used. CAUTION Do not lift the pedal by the connection cable!

Use only original maintenance products, accessories and/or spare parts approved by the legal manufacturer. The use of other products, accessories or parts could void the guarantee and/or endanger the patient or the operator. MR unsafe: Keep the device away from magnetic resonance imaging (MRI) equipment. To use the DRILL and SM-DRILL modes between 50,000 and 80,000 rpm, special precautions must be taken and appropriate burs and attachment adapted to such speeds must be used. Before going to a higher speed range, check that the attachment and the rotary instrument are appropriate for that speed range, that the instrument is correctly inserted in the attachment up to the thrust stop and is perfectly fixed. Only Bien-Air Surgery SA tools and instruments guarantee problem-free operation. See also the recommendations in the attachment and tools manual. E-type attachments: Maximum rotation speeds for standard round 2.35 mm shank based on bur diameter. Diameter

Speed

< Ø 4,5 mm

80,000 rpm

Ø 5,0 mm

60,000 rpm

Ø 5,5 mm

50,000 rpm

Ø 6,0 mm

40,000 rpm

Ø 6,5 mm

30,000 rpm

Ø 7,0 mm

20,000 rpm

PM2 attachments: Do not exceed the maximum rotation speed as stated in the instructions for use or packaging for the PM2 burs. PM2 80K burs can be used in every extension length up to 80,000 rpm, but for an optimum drill precision, we advise to fully insert the bur in the attachment at the minimum exposure, when used at speeds above 50,000 rpm.

4.2 Environmental protection indications for device disposal

and

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 the distributor or use a firm accredited for the treatment and recovery of this type of equipment (European directive 2012/19/EU). 5

4.3 Precautions regarding electromagnetic compatibility (EMC) Regarding the EMC, and in order to maintain basic safety and the essential performances (refer to the Chap. 17 ACCOMPANYNG DOCUMENTS ACCORDING TO IEC 60601-1-2:2014, CHAPTER 5 for more information) for the expected service life of 10 years, the medical electrical equipment requires special precautions 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 OSSEODUO control unit complies with the EMC requirements according to IEC 60601-1-2:2014. Radio-transmitting equipment, cellular phones, etc. should not be used in the immediate vicinity of the device as this could affect its operation. Special precautions should be taken when using strong emission sources such as high frequency 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. CAUTION The use of the OSSEODUO control unit adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the OSSEODUO and other equipment should be observed to verify that they are operating normally. Pins of connectors identified with the ESD warning control symbol should not be touched and connections should not be made to these connectors unless ESD precaution procedures have been followed. CAUTION Use of accessories, transducers and cables other than those specified or provided by Bien-Air Surgery SA could result in increased electromagnetic emissions or a decreased electromagnetic immunity of the equipment and result in improper operation. See Chap. 17 ACCOMPANYNG DOCUMENTS ACCORDING TO IEC 60601-1-2:2014, CHAPTER 5.

6

5 DESCRIPTION OF THE OSSEODUO MULTIFUNCTION SYSTEM G

H A B C D E F

F

E D

I

OSSEODUO control unit Mode 1 SHAVER/ S-M DRILL / OSSEOSTAP Mode 2 DRILL Continuous irrigation Intermittent irrigation Clockwise /oscillating rotation

C

B

A

K

J G H I J K L

L Counter-clockwise /oscillating rotation Foot pedal work mode Rotation speed Irrigation flow rate Screen Multifunctional foot pedal

5.1 Micromotor with cable

NANO: 1700501

RAPIDO: 1700503

80K: 1700263

S120: 1700302

OSSEOSTAP: 1600685

PM PERFO: 1700500

7

5.2 Available sets S120 + RAPIDO set

REF 1700521

1 control unit OSSEODUO

REF 1600513

1 S120 + cable

REF 1700302

1 micromotor RAPIDO + cable

REF 1700503

S120 + NANO set

REF 1700522

1 control unit OSSEODUO

REF 1600513

1 S120 + cable

REF 1700302

1 micromotor NANO + cable

REF 1700501

DRILL RAPIDO set

REF 1700523

1 control unit OSSEODUO

REF 1600513

1 micromotor RAPIDO + cable

REF 1700503

DRILL NANO set

REF 1700524

1 control unit OSSEODUO

REF 1600513

1 micromotor NANO + cable

REF 1700501

S120 + 80K set

REF 1700249

1 control unit OSSEODUO

REF 1600513

1 S120 + cable

REF 1700302

1 micromotor 80K + cable

REF 1700263

SHAVER S120 set

REF 1700250

1 control unit OSSEODUO

REF 1600513

1 S120 + cable

REF 1700302

DRILL 80K set

REF 1700251

1 control unit OSSEODUO

REF 1600513

1 micromotor 80K + cable

REF 1700263

All sets include: 1 watertight multi-function pedal with 2 buttons

REF 1600517

1 irrigation stand

REF 1500017

1 set of 10 irrigation lines with 2 flow rate ranges

REF 1100037

1 set of 10 irrigation clips

REF 1302844

8

6 CONTROL UNIT AND FOOT PEDAL 6.1 Technical data Subject to technical amendments and modifications of the models.

Control unit OSSEODUO

Environmental conditions:

CE 1639 as per 93/42 EEC directive.

Marking: Supply voltage:

Environmental conditions:

Operation

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

0°C (50°F) to +40°C (86°F)

Fuses:

Temperature: Relative humidity (including condensation)

20% to 80%

10% to 90%

10% to 90%

2 push-pull type connectors / <50 Vdc.

Atmospheric pressure:

700 hPa to 1060 hPa

600 hPa to 1060 hPa

600 hPa to 1060 hPa

Transport

Storage

100 - 240 Vac / 2A - 1A / 50/60 Hz. 2 T fuses 2,5 AH 250 Vac.

Motor power supply: Electrical insulation class: Class I.

Applied parts: Type B.

Medical class: IIa as per 93/42 EEC directive.

Protection class: IP 41 as per CEI 529.

Size / Weight: (W x H x D) 370 x 115 x 270 mm (height with irrigation stand: 485 mm) / 4,6 kg.

Irrigation pump: Delivery from 8 to 135 ml/min, adjustable in 10% increments (with two-speed Bien-Air Surgery SA irrigation line).

Irrigation stand: Stainless steel

Multi-function pedal Protection class: IPX8 as per CEI 529.

Functions: Drill motor forward/reverse selection, SHAVER, DRILL, S-M DRILL or OSSEOSTAP mode selection, shaver continuous/oscillating rotation, speed control irrigation pump start/stop and flow rate selection.

Size/Weight: (W x H x D) 160 x 55 x 170 mm / 0.830 kg.

Cable length: 295 cm. ±5 cm.

9

FIG. 1

6.2 Set-up 6.2.1 Unpacking and checking 1. When unpacking the cardboard box, check its contents 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.

6.2.2 Preparation CAUTION Before operating the device, it should be stored for 24 hours according to operation environmental conditions.

FIG. 2 CAUTION Before performing any operation on the device, touch a metallic surface to eliminate any static electricity. 5. Align and insert the irrigation stand in the support E (FIG.1) provided at the rear of the control unit and suspend the bottle there. Depending on the country’s regulations, attach the ground wire to the potential equalization connector F (FIG.1). 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.

1. Place the OSSEODUO control unit in the non-sterile area, on a table, on a carriage or on any other surface, out of reach of the patient, with the main switch and power cord always accessible. The OSSEODUO control unit must never be placed on the floor. 2. The OSSEODUO control unit is powered by the mains (100 to 240 VAC). It is protected by 2 fuses located in box A (FIG.1). Check that the main switch B (FIG.1) is in position 0 and connect the power cord to connector C (FIG.1). 3. Connect the pedal cable to connector D (FIG.1) provided on the rear panel, making sure to align the red markings on the connector and the plug. CAUTION When control unit has label G (FIG.1), use a foot pedal with serial number greater than or equal to 19H0001. Serial number is composed of the production year (19 for 2019) a letter representing the month (A January, B February…) and number. 4. Depending on the planned operation, connect the S120 / NANO / OSSEOSTAP or 80K / RAPIDO motor cable, or both, ensuring that the colors of the connectors and sockets correspond and making sure to align the red markings (FIG.2). Protect the unused connector using the cap enclosed with the device.

10

FIG. 3

FIG. 4

FIG. 5

6.2.3 Use of the irrigation line

Irrigation line with 2 flow rates FIG.3.B

1. Check the integrity of the irrigation line packaging and the useby date FIG.3.A Only Bien-Air lines ensure trouble-free operation.

100% flow rate using the white silicone segment: From 16 to 135 ml/min.

2. Remove the disposable sterile irrigation line from its bag. Use a new irrigation line for each patient, reuse could lead to a cross contamination. 3. Connect the flexible hose to the spray tube of the attachment or contra-angle.

~50% flow rate using the green silicone segment: From 8 to 110 ml/min. Bien-Air Surgery SA attachment allows the connection of an irrigation line. For this, insert the end of the irrigation line into the spray tube (FIG.5).

4. Install the white or green silicone segment on the irrigation pump and close the pump cover (FIG.4). Check the location of the “V” in the chuck mechanism. CAUTION Risk of hose perforation! DANGER Do not operate the pump when the cover is open. Danger of catching fingers! CAUTION Before connecting the irrigation line to the handpiece, the user must fully prime the tubing until air is completely purged and a small amount of liquid comes out the tip. CAUTION Use proper irrigation fluid. Irrigants with preservatives are contraindicated for use on nervous tissue, specialist must verify adequation before using, and this responsibility is under the hospital. 5. Remove the spike protection, and perforate the bottle cap. 6. Attach the irrigation line to the motor cable using the irrigation clips provided.

9

FIG. 6

FIG. 7

FIG. 8

6.3 Use 6.3.1 Power-up At power-up (switch A FIG.6), the initialization screen lights up, displays OSSEODUO and the software version (FIG.7B).

6.3.2 Initialization screen No motor is connected Initialization screen remains displayed until a work mode is selected (SHAVER / OSSEOSTAP/ S-M DRILL, DRILL or PUMP alone, 3 LEDs are flashing). Both motors are connected Initialization screen remains displayed until a work mode is selected (SHAVER / OSSEOSTAP / S-M DRILL or DRILL, 2 LED are flashing). Only the connector of the S120 is connected The screen for the SHAVER mode with the default program is displayed after approx. 2 seconds (FIG.7C). The LED of the “M1” key lights up and “SHAV” appears on the screen. Only the 80K / RAPIDO / PM PERFO is connected The screen for the DRILL mode with the default program is displayed after approx. 2 seconds. (FIG.7D). The LED of the “M2” key lights up and “XL-M” appears on the screen. Only the connector of the OSSEOSTAP is connected The screen for the OSSEOSTAP mode with the default program is displayed after approx. 2 seconds (FIG.8E). The LED of the “M1” key lights up and “STAP” appears on the screen. Only the connector of the NANO micromotor is connected The screen for the S-M DRILL mode with the default program is displayed after approx. 2 seconds (FIG.8G). The LED of the “M1” key lights up and “S-M” appears on the screen. NOTE : If “M” is lit up SHAVER; DRILL; S- M DRILL or OSSEOSTAP (FIG.8F) see Chap. 6.3.9 Configurable options for further information.

11

FIG. 9

6.3.3 Selection of work mode - “PUMP only” Press the key D) Continuous irrigation to activate the “PUMP only” mode (FIG.9). This mode is only available upon power-up of the OSSEODUO control unit and if no motor is connected. This mode allows using the irrigation pump alone to fill the irrigation line before the surgery. Pressing the key J) Irrigation flow rate - or + respectively reduces or increases the irrigation flow. The flow is represented by the drops (1 to 10) displayed at the bottom of the screen. See also 6.3.10 Foot Pedal for setting the flow using the foot pedal. Pressing the key H) Foot pedal work mode left or right changes the operating mode of the foot pedal rocker switch: Variable (VAR) mode: The irrigation flow varies according to the rocker position. The maximum flow is pre-defined using key J) Irrigation flow rate. Continuous (CON) mode: The irrigation flow is equal to the pre-defined value that was set using key J) Irrigation flow rate. To exit “PUMP only” mode, the OSSEODUO control unit must be switched OFF.

12

FIG. 10

FIG. 11

6.3.4 Selection of work mode The change of the operating mode must be acknowledged, except when the power is switched on. The following two symbols appear at the bottom of each operating mode selection screen: Confirm by pressing + of button I) Rotation speed Cancel and remain in the current working mode by pressing - of button I) Rotation speed

SHAVER, SM-DRILL or OSSEOSTAP mode Key B) Mode 1 SHAVER / S-M DRIL / OSSEOSTAP NOTE: The detection of the available mode is automatic depending on the connected instrument. 1. Press M1 key.

FIG. 12

FIG. 13

DRILL Mode Key C) Mode 2 DRILL 1. Press M2 key. • 80K/RAPIDO or PM PERFO: DRILL Mode (FIG.11). 2. Confirm by pressing the + of button I) Rotation speed. 3. Wait ~2 sec. for the parameters to be taken into account. • The LED under the C) Mode 2 DRILL button lights up. NOTE : If "M" is displayed in SHAVER; DRILL; S-M DRILL or OSSEOSTAP mode, see Chap. 6.3.9 Configurable options for further information. Various keys located under a waterproof membrane allow the user to select the working mode and make the appropriate adjustments according to the operation envisaged. Each mode selected corresponds to a screen and a specific use of the motor control keys.

• S120: SHAVER mode (FIG.10). • NANO: SM-DRILL mode (FIG.12). • OSSEOSTAP: OSSEOSTAP mode (FIG.13). 2. Confirm by pressing the + of button I) Rotation speed. 3. Wait ~2 sec. for the parameters to be taken into account. • The LED under the B) Mode 1 SHAVER / S-M DRILL / OSSEOSTAP button lights up.

13

6.3.5 Continuous irrigation synchronized with the motor Press key D) Continuous irrigation to activate and deactivate the simultaneous pump start and stop function with the selected motor. This is shown by 4 “full” drops. This function is also controlled by the left foot pedal button. NOTE: • When irrigation is stopped, the pump's direction of rotation is reversed to draw off the excess liquid. • Activation of this function cancels the “Intermittent irrigation” function if it was active.

6.3.6 Intermittent irrigation Press the key E) Intermittent irrigation to activate and deactivate the intermittent irrigation function. It is shown by 4 “empty” drops. The LED on the key flashes. The irrigation pump is activated only at the end of the pedal rocker's travel by applying a stronger pressure to it. This function is also controlled by the left foot pedal button.

Remember last adjustments before OSSEODUO control unit is switched off: To activate or deactivate the memory storage function, proceed as follows: 1. Select DRILL mode (see Chap. 6.3.4 Selection of work mode) 2. Press key F) Clockwise / oscillating rotation for 5 seconds until a beep sounds. When the memory storage feature is active, a small “m” is displayed on the top left.

Audible signal ("keypad beep") To activate or deactivate the keyboard beep, proceed as follows: 1. Select DRILL mode (see Chap. 6.3.4 Selection of work mode). 2. Press key D) Continuous irrigation for 5 seconds until a beep sounds.

NOTE: • If the motor is not connected, the pump does not operate. • Activation of this function cancels "Synchronized irrigation" if it was active.

6.3.7 Adjustment of the irrigation flow Pressing the key J) Irrigation flow rate - or + respectively reduces or increases the irrigation flow. The flow is represented by the drops (1 to 10) displayed at the bottom of the screen.

6.3.8 Operating mode of the foot pedal rocker switch A press on the key H) Foot pedal work mode left or right changes the operating mode of the rocker: Variable (VAR) mode: The motor speed varies according to the rocker position. The maximum speed is pre-defined using key I) Rotation speed. Continuous (CON) mode: The motor speed is equal to the pre-defined value that was set using key I) Rotation speed.

6.3.9 Configurable options “M” mode (Motor type) activation/deactivation (See Chap. 6.3.10 Foot Pedal for further information): If “M” mode is activated, it allows you to swap motors (SHAVER/S- M DRILL/ OSSEOSTAP to DRILL and vice versa) with a long press on the right foot pedal button. If “M” mode is deactivated, a long press on the right foot pedal button will change direction of rotation. To activate or deactivate “M” mode proceed as follows: 1. Select DRILL mode (See Chap. 6.3.4 Selection of work mode). 2. Press key G) Counter-clockwise / oscillating rotation for 5 seconds until a beep sounds. The letter “M” is displayed on the top left of the screen if “M” mode is activated.

14

FIG.14

FIG.15

FIG.16

6.3.10 Foot Pedal The pedal functions allow the surgeon to change settings without the assistance of another person.

2. Short press on the button:

NOTE: The foot pedal must always be connected.

OSSEOSTAP

For good pedal stability and operation, make sure to place your foot correctly in the center of the pedal (FIG.14)!

Left dual-function button for irrigation control (FIG.15): 1. Long press on the button: (approx. 2 sec): Activation or deactivation of the last-selected “IRRIGATION” function (LED 3 or 4). 2. Short press on the button: Change in flow rate in 20% increments (corresponding to 2 drops on display) in increasing order if one of the PUMP functions is activated.

Right dual-function button for continuous motor control (FIG.15):

1. Short press on the button: • Speed increase in 1,000 rpm increments. 2. Long press on the button (approx. 2 sec): • Swap to DRILL if “M” mode is activated. or • Nothing happens if standard mode is activated.

Variable speed drive (rocker switch): • Variable motor speed control if “VAR” is selected. or • Motor start/stop if “CON” is selected.

SHAVER

or

1. Long press on the button: (approx. 2 sec): • Swap between “continuous rotation “oscillating mode” in standard mode.

• Speed increase in 10,000 rpm increments.

clockwise”

and

or • Swap to DRILL if “M” mode is activated. 2. Short press on the button: • In “continuous rotation mode”: speed increase in 1,500 rpm increments.

• Intermittent irrigation (SHAVER, DRILL and S-M DRILL mode only). 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).

6.3.11 Power down To switch off the control unit, put the switch to 0 (FIG.16 A).

or • In “oscillating mode”: speed increase in 500 rpm increments (frequency, 0.5Hz.).

DRILL / S-M DRILL 1. Long press on the button: (approx. 2 sec): • Change of direction of rotation in standard mode. The arrow on the screen flashes and an alternating beep sounds. or • Swap to SHAVER / S-M DRILL / OSSEOSTAP or DRILL if “M” mode is activated. 15

7 NANO MICROMOTOR

The NANO micromotor is designed to drive the PM2 attachments. It is connected to the OSSEODUO control unit by a specific cable. The NANO micromotor is delivered “non-sterile”. Clean, lubricate and sterilize the NANO micromotor and the cable before first use.

7.1 Technical data

2.

Subject to technical amendments and modifications of the models.

Do not exceed the maximum permitted speed of rotation for the attachment

3.

Sufficient irrigation is recommended.

Environmental conditions:

4.

Duty cycle: For room temperatures up to 30°C (86°F), the motor under full load is rated for intermittent operation with a maximum ON time of 2 minutes followed by a minimum OFF time of 20 minutes.

Environmental conditions:

Operation

Temperature:

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

0°C (50°F) to +40°C (86°F)

Relative humidity (including condensation)

20% to 80%

10% to 100%

10% to 90%

Atmospheric pressure:

700 hPa to 1060 hPa

600 hPa to 1060 hPa

600 hPa to 1060 hPa

Transport

Storage

When the micromotor external surface temperature rises to more than approx. 21°C (69.8°F) above the ambient temperature, an alarm sounds (see Chap. 14.1 OSSEODUO control unit for further information). The micromotor can still be used for a short period but under the surgeon’s full responsibility. In this case avoid touching the patient with the micromotor (high risk of burn injuries).

Size/Weight:

Direct current, brushless and sensorless.

Diameter 17 mm, length 74 mm, including coupling/80 g, without cable and without attachment.

Applied parts:

Motor/cable:

Type: All housing surfaces of micromotor are considered “applied parts” of Type B.

Push-pull type connector at OSSEODUO end, length 295 cm ±5 cm.

Power supply:

7.2 Motor cable connection

0 – <50 VDC 4.5 A max.

Coupling: PM2 Bien-Air Surgery.

Before connecting the specific motor cable, check the cleanliness of the rear of the micromotor and the cable plug. 1.

Present the micromotor in correct alignment (align the cable reference with the reference on the motor).

Speed:

2.

Insert the plastic connector in position.

4’000 to 80’000 rpm, +/- 5%.

3.

Tighten the connector nut as far as possible.

Noise level:

4.

Before use, run the micromotor at moderate speed for a few seconds to distribute and remove excess lubricant.

Motor torque: Max. 15 mNm.

As per ISO 11498: < 62 dBA at 45 cm.

Period of operation: To avoid the applied parts overheating and the associated risk of burn injuries to patient or surgeon, the following rules must be respected: 1.

Limit the maximum speed of rotation according to the bur diameter as indicated on the packaging and/or in the present operating instructions.

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7.3 Attachment insertion and removal on the NANO micromotor 1.

Insert the attachment on the micromotor nose and turn it to ensure proper coupling.

2.

Connect the irrigation line to the attachment to the thrust stop.

3.

Insert the irrigation line into the openings of the fixing flanges previously laid on the power cable.

4.

To remove the attachment, pull the micromotor coupling ring back and remove the attachment.

CAUTION Never insert an instrument onto a rotating micromotor.

7.4 S-M DRILL mode Once the S-M DRILL mode is activated, the practitioner can adjust irrigation functions, the speed and direction of rotation of the bur.

Direction of rotation: Key G) Counter-clockwise / oscillating rotation: Activation of continuous motor rotation counterclockwise. The arrow flashes. An alternating beep sounds. Key F) Clockwise / oscillating rotation: Activation of continuous motor rotation clockwise.

Speed adjustment: Pressing the key I) Rotation speed - or + respectively reduces or increases the speed of rotation in 1,000 rpm increments. NOTE: When keys I) Rotation speed are pressed and held, the values are scrolled on the screen. NOTE: If "M" is displayed in SHAVER; DRILL; S-M DRILL or OSSEOSTAP mode, see Chap. 6.3.9 Configurable options for further information.

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8 80K/RAPIDO MICROMOTOR

The 80K micromotor is designed to drive various types of attachment with E type as per ISO 3964 coupling. The RAPIDO micromotor is designed to drive PM2 attachment. It is connected to the OSSEODUO control unit by a specific cable. The 80K/RAPIDO micromotor is delivered “non-sterile”. Clean, lubricate and sterilize the 80K/RAPIDO micromotor and the cable before first use.

8.1 Technical data

2.

Subject to technical amendments and modifications of the models.

Do not exceed the maximum permitted speed of rotation for the attachment.

3.

Sufficient irrigation is recommended.

Environmental conditions:

4.

Duty cycle: For room temperatures up to 30°C (86°F), the motor under full load is rated for intermittent operation with a maximum ON time of 2 minutes followed by a minimum OFF time of 20 minutes.

Environmental conditions:

Operation

Temperature:

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

0°C (50°F) to +40°C (86°F)

Relative humidity (including condensation)

20% to 80%

10% to 100%

10% to 90%

Atmospheric pressure:

700 hPa to 1060 hPa

600 hPa to 1060 hPa

600 hPa to 1060 hPa

Transport

Storage

Type: Direct current, brushless and sensorless, self-ventilated.

Applied parts: All housing surfaces of micromotor are considered “applied parts” of Type B.

Power supply: 0 – <50 VDC 4.5 A max.

Coupling: E Type as per ISO 3964, without internal spray, without light for the 80K; PM2 Bien-Air Surgery for the RAPIDO.

Motor torque:

When the micromotor external surface temperature rises to more than approx. 21°C (69.8°F) above the ambient temperature, an alarm sounds (see Chap. 14.1 OSSEODUO control unit for further information). The micromotor can still be used for a short period but under the surgeon’s full responsibility. In this case avoid touching the patient with the micromotor (high risk of burn injuries).

Size/Weight: • •

80K: Diameter 21 mm, length 100 mm, including coupling / 120 g, without cable and without attachment. RAPIDO: Diameter 21 mm, length 77 mm, including coupling / 115 g, without cable and without attachment.

Motor/cable: Push-pull type connector at OSSEODUO end, length 295 cm ±5 cm.

8.2 Motor cable connection Before connecting the specific motor cable, check the cleanliness of the rear of the micromotor and the cable plug. 1.

Present the micromotor in correct alignment (align the cable reference with the reference on the motor).

4’000 to 80’000 rpm, +/- 5%.

2.

Insert the plastic connector in position.

Noise level:

3.

Tighten the connector nut as far as possible.

As per ISO 11498: < 62 dBA at 45 cm.

4.

Before use, run the micromotor at moderate speed for a few seconds to distribute and remove excess lubricant.

Max. 40 mNm at 30'000 rpm.

Speed:

Period of operation: To avoid the applied parts overheating and the associated risk of burn injuries to patient or surgeon, the following rules must be respected: 1.

Limit the maximum speed of rotation according to the bur diameter as indicated on the packaging and/or in the present operating instructions.

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8.3 Attachment insertion and removal on the RAPIDO micromotor 1.

Insert the attachment on the micromotor nose and turn it to ensure proper coupling.

2.

Connect the irrigation line to the attachment to the thrust stop.

3.

Insert the irrigation line into the openings of the fixing flanges previously laid on the power cable.

4.

To remove the attachment, pull the micromotor coupling ring back and remove the attachment.

CAUTION Never insert an instrument onto a rotating micromotor.

8.4 DRILL mode Once the DRILL mode is activated, the practitioner can adjust irrigation functions, the speed and direction of rotation of the bur.

Direction of rotation: Key G) Counter-clockwise / oscillating rotation: Activation of continuous motor rotation counterclockwise. The arrow flashes. An alternating beep sounds. Key F) Clockwise / oscillating rotation: Activation of continuous motor rotation clockwise.

Speed adjustment: Pressing the key I) Rotation speed - or + respectively reduces or increases the speed of rotation in 1,000 rpm increments. NOTE: When keys I) Rotation speed are pressed and held, the values are scrolled on the screen. NOTE: If "M" is displayed in SHAVER; DRILL; S-M DRILL or OSSEOSTAP mode, see Chap. 6.3.9 Configurable options for further information.

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