ORIGO Instructions for Use Oct 2022

TABLE OF CONTENTS 1. SYMBOLS USED ... 2 1.1 Control unit and foot pedal ... 2 1.2 Irrigation line ... 3

2. CE/UL CONFORMITY ... 4 3. GENERAL ... 4

18.1 General Information ... 29 18.2 Governing law ... 29 18.3 Jurisdiction ... 29

19. ACCOMPANYING DOCUMENTS ACCORDING TO IEC 60601-1-2:2014, CHAPTER 5 ... 30

3.1 System description ... 4 3.2 Intended use ... 4 3.3 Indication for use ... 4 3.4 Contraindications ... 4 3.5 Patient population ... 4 3.6 Intended users ... 4

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

5. DESCRIPTION OF THE ORIGO SYSTEM ... 7 5.1 Compatible micromotors ... 8 5.2 Device references:... 8

6. CONTROL UNIT AND FOOT PEDAL ... 9 6.1 Technical data ... 9 6.2 Set-up ... 11 6.2.1 Unpacking and checking ... 11 6.2.2 Preparation ... 11 6.2.3 Use of the irrigation line ... 12

6.3 Use ... 13 6.3.4 Power-up ... 13 6.3.5 Initialization screen ... 13 6.3.6 Power off ... 13

7. NANO INTERFACE ... 14 7.1 General settings ... 14 7.2 Motor control ... 14 7.3 Irrigation control ... 14

8. RAPIDO-80K INTERFACE... 15 8.1 General settings ... 15 8.2 Motor control ... 15 8.3 Irrigation control ... 15

9. PM PERFO INTERFACE ... 16 9.1 General settings ... 16 9.2 Motor control ... 16

10. OSSEOSTAP INTERFACE ... 17 10.1 General settings ... 17 10.2 Motor control ... 17

11. S120 INTERFACE ... 18 11.1 General settings ... 18 11.2 S120 control ... 18 11.3 Irrigation control ... 18 11.4 Window control... 18

12. SETTING MENU ... 20 12.1 General settings ... 20 12.2 Sound and display setting ... 20 12.3 Profile setting... 21 12.3.1 NANO – RAPIDO / 80K profile setting... 21 12.3.2 NANO – RAPIDO / 80K test menu ... 21 12.3.3 S120 profile setting ... 22

12.4 System setting ... 22

13. HELP MENU ... 23 13.1 Micromotors help menu ... 23 13.2 Other help menu ... 23

14. REPROCESSING ... 24 15. MAINTENANCE ... 25 16. MALFUNCTIONS AND ERRORS ... 26 17. OPTIONS / ACCESSORIES... 28 18. GENERAL TERMS OF GUARANTEE ... 29 1

1. SYMBOLS USED 1.1 Control unit and foot pedal Symbol

Description

Symbol

Description

CE Marking with number of the notified body.

UL Classification Mark for the United States and Canada.

Rx Only

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

Potential equalization terminal.

IP X1

Control Unit : protection against vertically dripping.

Alternating current

IP X6

Foot Pedal : protection against jetting.

Type BF device.

CAUTION! Dangerous voltage.

Danger of catching fingers. Do not put your fingers in rotating parts.

CAUTION! Refer to the accompanying documents.

Electrical or electronic materials to be recycled.

Materials to be recycled. The disposal and/or recycling of materials must be performed in accordance with the directives and the legislation in force.

Follow instructions for use.

Consult the accompanying documents.

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

Manufacturer.

Fragile; handle with care.

Keep away from rain.

Humidity limitation.

Temperature limit.

Atmospheric pressure limitation.

Authorized representative in the European Community / European Union

Medical device

Date of manufacture

2

1.2 Irrigation line Symbol

Rx Only

Description

Symbol

Description

CE Marking with number of the notified body.

Sterilized using ethylene oxide

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

Do not re-use

Do not use if package is damaged

Do not contain PHT/DEHP

Use by date

Manufacturer

Do not resterilize

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 European regulation 2017/745 on medical devices: • 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.), CAN/CSA-C22.2 No. 60601-1 (2014) and IEC 60601-1-6:2010 (Third Edition) + A1:2013.

3. GENERAL 3.1 System description The ORIGO system used in conjunction with NANO / RAPIDO / 80K micromotors and their attachment and burs, PM PERFO and perforator tool, OSSEOSTAP and burs is a powered drill system that will remove bone during surgical procedure. The ORIGO system combined with S120 and its shaver blades and burs is a shaver system that will remove soft tissues and hard tissues during surgical procedures. The system consists of a control unit, foot pedal, power cable and irrigation stand. The ORIGO system integrates an irrigation pump for irrigation of the surgical sites. The system offers the possibility to connect and switch between 3 motors at once. The touchscreen allows users to visualize and adjust the different parameters. The foot pedal allows the surgeon to run the connected motor and to interact directly with the control unit by means of two buttons.

3.2 Intended use The ORIGO system is a software-controlled surgical system that is an active device transforming power supply energy into electrical energy to electronically control micromotors or motorized handpieces including their attachments and tools for cutting soft tissue and bone and bringing irrigation fluid to the surgical site.

3.3 Indication for use The ORIGO system is a software-controlled motorized surgical system that includes attachments and tools for cutting soft tissue and bone, and provides irrigation fluid to the surgical site. The ORIGO system is used in the following surgical fields: • for cutting and shaping bones and resection of soft and hard tissues in the fields of head & neck/ENT (otology, rhinology, laryngology) and maxillofacial surgeries. • for cutting bones in neuro (cranial) and spinal surgeries.

3.4 Contraindications None currently known.

3.5 Patient population The ORIGO system is intended to be used on all patients (adults including pregnant women and children).

3.6 Intended users The ORIGO system is intended to be used by professional users, such as surgeons operating on patients in operating room and OR nurses who install or clean the device.

4

4. PRECAUTIONS-WARNINGS 4.1 Warnings and precautions for use For additional information, please contact Bien-Air Surgery SA at the address indicated on the front cover of this document. ORIGO instructions for use is only printed in English version. Other languages may be printed on request at the address indicated on the cover of this document and sent within 7 days. You also can obtain other languages on Bien-Air Surgery’s website surgery.bienair.com/ifu. For information about the compatible micromotors check below instructions for use on Bien-Air Surgery’s website surgery.bienair.com/ifu: • 2100391 for NANO, RAPIDO and 80K micromotors • 2100392 for OSSEOSTAP • 2100393 for PM PERFO • 2100394 for S120. CAUTION Do not use this device in the presence of a flammable anesthetics. Avoid potential ignition or explosion of gases. 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, 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 dangers and avoid contamination from the product.

Use the power supply cord deliver with the ORIGO system (see chap. 6.1 Technical data for more information). CAUTION Do not lift the pedal by the connection cable. CAUTION Danger of electrocution: Never open the device when it is connected to a mains power supply. MR unsafe: Keep the device away from magnetic resonance imaging (MRI) equipment. CAUTION Use adequate irrigation. The use of a tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue. See tools instruction for use for further information. CAUTION Only use Bien-Air Surgery’s irrigation lines REF 1502152. Use of other irrigation lines is not possible and will damage the irrigation pump. CAUTION Rotation direction must be set according to instruments type and surgical tissues/bone which will be removed with the instrument. Refer to dedicated instruments instruction for use for more details.

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 ORIGO 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. 5

4.2 Environmental protection indications for device disposal

and

4.3 Precautions regarding electromagnetic compatibility (EMC)

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.

Regarding the EMC, and in order to maintain basic safety (refer to the Chap. 19 ACCOMPANYING DOCUMENTS ACCORDING TO IEC 60601-1-2:2014, CHAPTER 5 for more information) , the medical electrical equipment requires special precautions and must be installed and put into operation in accordance with the appropriate information provided in the present document. The ORIGO control unit complies with the EMC requirements according to IEC 60601-1-2:2014.

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/EC).

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 ORIGO 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 ORIGO and other equipment should be observed to verify that they are operating normally. 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.

6

5. DESCRIPTION OF THE ORIGO SYSTEM I

H

G

A

A B C D E F G H I J K L M N

B

C

D

E

Power button motor connector 1 motor connector 2 motor connector 3 Foot pedal connector Peristaltic pump Touchscreen Irrigation stand support Control unit handle Pole clamp Potential equalization terminal Fuses access Power cord connector USB Port

O Foot pedal holder P Irrigation button Q Motor selection button / Shaver blade opening button R Foot pedal rocker

F

J

K

L

M

N

O

P

Q

R

7

5.1 Compatible micromotors Below micromotors are compatibles with the ORIGO system.

NANO: REF. 1700645 (Motor REF 1600777 + cable 1600927)

RAPIDO: REF. 1700646 (Motor REF 1600895 + cable 1600929)

80K: REF. 1700648 (Motor REF 1600518 + cable 1600929) 80K reference is not available in the US.

S120: REF. 1700302 (S120 REF 1600614 + cable 1600629)

OSSEOSTAP: REF. 1600685

PM PERFO: REF. 1700650 (PM PERFO REF 1600832 + 1600930)

5.2 Device references: Control unit ORIGO + irrigation stand + power cable

REF. 1601048

Multi-function pedal with 2 buttons

REF. 1601082

8

6. CONTROL UNIT AND FOOT PEDAL 6.1 Technical data Environmental conditions:

Control unit ORIGO

Environmental conditions:

Operation

Temperature:

+0°C (32°F) +10°C (50°F) -25°C (-13°F) to to to +40°C +30°C (86°F) +70°C (158°F) (104°F)

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

700 hPa to 1060 hPa

Transport

Storage

Supply voltage: 100 - 240 Vac / 4.5A - 2A / 50/60 Hz

Fuses: Two 5x20mm (0.197x0.787in) T fuses 5A H 250 Vac

Motor power supply:

10% to 90%

10% to 90%

Three push-pull type connectors / <50 Vdc

600 hPa to 1060 hPa

600 hPa to 1060 hPa

Applied parts:

Electrical insulation class: Class I Type BF

Protection class: IPX1 as per IEC 60529

Size / Weight: (W x H x D) 248 x 385 x 264 mm (height with irrigation stand: 483 mm) / 6.5 kg ((W x H x D) 9.764 x 15.157 x 10.394in (height with irrigation stand 19.016 In) / 14.33 lbs)

Multi-function pedal Protection class: IPX6 as per IEC 60529

Size / Weight: (W x H x D) 162 x 187 x 197 mm (foot holder included) / 1.02 kg ((W x H x D) 6.378 x 7.362 x 7.756 in (foot holder included / 2.205 lbs)

Power cable: Plug type

Cable length

Reference

3 meters (118.11in)

1308244

3 meters (118.11in)

1308246

3 meters (118.11in)

1308248

9

FIG. 1

FIG. 2

FIG. 3

FIG. 4

FIG. 5

FIG. 6

FIG. 7

FIG. 8

FIG. 9

10

FIG. 10

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.

3.

Remove the protective film of the screen.

6.2.2 Preparation 1.

Verify Operating Room setup (FIG. 1 for cranial surgery, FIG. 2 for spine surgery, FIG. 3 for otology, FIG. 4 for rhinology); Place the ORIGO control unit in the non-sterile area, on a table, on a pole, on a cart or on any other surface, out of reach of the patient, with the power button and power cord always accessible. The ORIGO control unit must never be placed on the floor.

3.

Press on both sides of the foot pedal holder base to make it smaller and attach it to the foot pedal axis (FIG. 10).

4.

Connect the pedal cable to connector FIG. 7.E making sure to align the red markings on the connector and the plug.

5.

Depending on the planned operation, connect up to 3 motors on the ORIGO control unit. The NANO / RAPIDO-80K / PM PERFO motor cable can be connected to FIG. 7.B or C connector. The OSSEOSTAP / S120 cable can be connected to FIG. 7.D connector. Make sure to align the red markings of the cable and ORIGO control unit (FIG. 8).

CAUTION Before connecting a RAPIDO-80K to the control unit, check that “RAPIDO-80K” is engraved on the cable connector on motor side. Before connecting a PM PERFO to the control unit, check that “PM PERFO” is engraved on the cable connector on motor side. If not, check Chap. 16 MALFUNCTIONS AND ERRORS for further information.

CAUTION Never carry the control unit by the irrigation pump lid.

CAUTION Connection of USB device to the USB port is forbidden. Only Bien-Air Surgery’s approved after-sales dealer department are authorized to connect USB device to update the software according to Bien-Air Surgery’s procedure. Not respecting this caution may affect the device security.

CAUTION When ORIGO control unit is mounted on an irrigation I.V pole following recommendation must be followed (FIG. 5):

Align and insert the irrigation stand in the support (FIG. 9.H) provided at the rear of the control unit and suspend the irrigation or coolant bag there.

•

Mount the irrigation and coolant bags above the ORIGO control unit to ensure adequate flow.

•

All items must be mount as low as possible to increase stability during use. It is recommended to use a pole with a base diameter 53 cm and weight 11 kg.

•

For transport or uneven floor conditions greater than 10 degrees, maximum height to mount the control unit is 78 cm (FIG. 5.1) if irrigation and coolant bags are hold at maximum 225cm (FIG. 5.2) from the floor.

Depending on the country’s regulations and according to IEC 60601-1:2012, attach a ground wire to the potential equalization terminal (FIG.6.K). The purpose of the potential equalization terminal 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.

2.

The ORIGO control unit is powered by the mains (100 to 240 VAC). It is protected by 2 fuses located in box FIG. 6.L. Connect the power cord to connector FIG. 6.M.

Use the handle placed at the back of the control unit to carry it.

11

FIG. 11

FIG. 12

6.2.3 Use of the irrigation line CAUTION Do not use irrigation line if packaging is opened or damaged.

9.

FIG. 13 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 Do not use irrigation line after the expiry date written on the labelling. CAUTION Irrigation lines are single use devices and cannot be reused and re-sterilized to prevent contamination. 1.

Check the integrity of the irrigation line packaging FIG. 11.1. and the use-by date FIG. 11.2. Only Bien-Air lines REF. 1502152 are compatible with the ORIGO irrigation pump.

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 irrigation tube of the attachment FIG. 12.

4.

Open the pump lid.

5.

Install the peristaltic cassette in the peristaltic pump. Check that the cassette is clipped properly and that it is well inserted on the 2 pins FIG. 13.1.

6.

Close the pump lid FIG. 13.2. If there is resistance to close, open the lid again and check the correct positioning of the cassette. When the lid is correctly closed, the user should hear a click sound.

DANGER Do not run the pump when the lid is open. Danger of catching fingers CAUTION Use an appropriate irrigation fluid. Irrigation fluids with preservatives are contraindicated for nerve tissue. The specialist must check the suitability before use, and this is the responsibility of the hospital. 7.

Remove the spike protection from the irrigation line, and perforate the bottle cap.

8.

Attach the irrigation line to the motor cable using irrigation clips.

12

FIG. 14

FIG. 15

FIG. 16

6.3 Use 6.3.4 Power-up To power-up the ORIGO control unit press the power button FIG. 14.A, the initialization screen lights up and the power button will light green.

6.3.5 Initialization screen No foot pedal connected Screen in FIG. 15 remains displayed until the foot pedal is connected.

No motor connected Screen in FIG. 16 remains displayed until a micromotor is connected.

Two or three motors are connected Screen in FIG. 17 remains displayed until a motor is selected. To select one motor, click on the corresponding motor icon. CAUTION When two or three motors are connected and before pressing on the foot pedal, check that the name written on the motor you have in hand is the one selected on the screen. If 2 motors of the same name are connected, hold both motor in hand, press on the foot pedal to identify which one is active.

FIG. 17 Motor type

Icon

NANO

6.3.6 Power off To power-off the ORIGO control unit, press the power button FIG. 14.A.

RAPIDO/80K

PM PREFO

OSSEOSTAP

S120

13

7. NANO INTERFACE 2 3

1 4

6

5 7

11

8 9 10

12

13 14

FIG. 18

FIG. 19

7.1 General settings

Minimum speed is displayed on the left down to the slider.

If no profile has been created, the icon FIG. 18.1 will show “DEFAULT PROFILE” and default setting will be used. If one or more profile have been created, press on the arrow of the drop-down menu FIG. 18.1 to select the needed profile or “DEFAULT PROFILE” (See chap. 12.3 Profile setting to set up profiles).

Maximum speed is displayed on the right down to the slider.

Press on icon FIG. 18.2 to go to setting menu. Press on icon FIG. 18.3 to go to help menu. The area in FIG. 18.13 is showing the foot pedal functions: Blue left button is used to reduce the irrigation flow. Once irrigation OFF, new press on the button will set the irrigation flow at the maximum. Green right button is used to switch to the next connected motor if any. Foot pedal rocker mode will be displayed (continuous or on/off, see chap. 12.1 General setting for further information). The active motor name is displayed on top of the motor selection icon (FIG. 18.14). To select another motor if more than one motor is connected to the ORIGO control unit, press on the motor icon displayed on FIG. 18.14.

7.2 Motor control To set the motor in clockwise rotation (FIG. 19.1), press on the icon FIG. 18.4. To set the motor in counterclockwise rotation (FIG. 19.2), press on the icon FIG. 18.5. The speed (FIG. 18.6) can be set in 3 different methods as follows: • Press on the round part of the slider and slide the finger on the screen to the right to increase the speed, or the left to reduce it. • Press on the left of the round part of the slider to reduce the speed or on the right to increase it. • For a precise speed setting, press on the – button to reduce the speed, or on the + button to increase it.

7.3 Irrigation control Irrigation can be set in 4 different modes: • OFF (FIG. 18.7). There is no irrigation when the micromotor is on. • Continuous (FIG. 18.8): The irrigation pump brings continuous irrigation fluid according to the flow set on the screen. • Intermittent (FIG. 18.9): When the foot pedal rocker is pressed, the irrigation pump brings intermittently irrigation fluid, according to the flow set on the screen (irrigation flow shown on the screen in this function is the flow when the irrigation pump is ON). • On demand (FIG. 18.10): The irrigation pump is running only when the foot pedal rocker is fully pressed. When irrigation is stopped in every irrigation mode, the pump’s direction of rotation is reversed to draw off the excess liquid. Before starting the surgery, user can press on the Prime icon FIG. 18.12 to fill the irrigation line with irrigation fluid. One press on the prime button stops filling of the irrigation line. Once the Prime button has been pressed and irrigation line is full, the icon will be replaced by the “flush icon”. By making a short press on this icon, the irrigation pump runs of one step. By doing a long press, the irrigation pump runs as long as the icon is pressed. The irrigation flow (FIG. 18.11) can be set from 0 to 70 ml/min in 3 different methods as follow: • Press on the round part of the slider and slide the finger on the screen to the right to increase the irrigation flow, or the left to reduce the irrigation flow. • Press on the left of the round part of the slider to reduce the irrigation flow, or on the right to increase it. • For a precise irrigation flow setting, press on the – button to reduce the irrigation flow, or on the + button to increase it.

Motor speed expressed in rpm is displayed on top of the slider. Default speed is 80’000 rpm. 14

8. RAPIDO-80K INTERFACE 2 3

1 4

6 5 7

11

8 9 10

12

13 14

FIG. 20

FIG. 21

8.1 General settings

Minimum speed is displayed on the left down to the slider.

If no profile has been created, the icon FIG. 20.1 will show “DEFAULT PROFILE” and default setting will be used. If one or more profile have been created, press on the arrow of the drop-down menu FIG. 20.1 to select the needed profile or “DEFAULT PROFILE” (See chap. 12.3 Profile setting to set up profiles).

Maximum speed is displayed on the right down to the slider.

Press on icon FIG. 20.2 to go to setting menu. Press on icon FIG. 20.3 to go to help menu. The area in FIG. 20.13 is showing the foot pedal functions: Blue left button is used to reduce the irrigation flow. Once irrigation OFF, new press on the button will set the irrigation flow at the maximum. Green right button is used to switch to the next connected motor if any. Foot pedal rocker mode will be displayed (continuous or on/off, see chap. 12.1 General setting for further information). The active motor name is displayed on top of the motor selection icon (FIG. 20.14). To select another motor if more than one motor is connected to the ORIGO control unit, press on the motor icon displayed on FIG. 20.14.

8.2 Motor control To set the motor in clockwise rotation (FIG. 21.1), press on the icon FIG. 20.4. To set the motor in counterclockwise rotation (FIG. 21.2), press on the icon FIG. 20.5. The speed (FIG. 20.6) can be set in 3 different methods as follow: • Press on the round part of the slider and slide the finger on the screen to the right to increase the speed, or the left to reduce it. • Press on the left of the round part of the slider to reduce the speed or on the right to increase it. • For a precise speed setting, press on the – button to reduce the speed, or on the + button to increase it. Motor speed expressed in rpm is displayed on top of the slider. Default speed is 80’000 rpm.

8.3 Irrigation control Irrigation can be set in 4 different modes: • OFF (FIG. 20.7). There is no irrigation when the micromotor is on. • Continuous (FIG. 20.8): The irrigation pump brings continuously irrigation fluid according to the flow sets on the screen. • Intermittent (FIG. 20.9): When the foot pedal rocker is pressed, the irrigation pump brings intermittently irrigation fluid, according to the flow sets on the screen (irrigation flow shown on the screen in this function is the flow when the irrigation pump is ON). • On demand (FIG. 20.10): The irrigation pump is running only when the foot pedal rocker is fully pressed. When irrigation is stopped in every irrigation mode, the pump’s direction of rotation is reversed to draw off the excess liquid. Before starting the surgery, user can press on the Prime icon FIG. 20.12 to fill the irrigation line with irrigation fluid. If user pressed by mistake on the key, the irrigation pump can be stopped by making a short press on the icon. Once the Prime button has been pressed and irrigation line is full, the icon will be replaced by the “flush icon”. By making a short press on this icon, the irrigation pump run of one step. By doing a long press, the irrigation pump run as long as icon is pressed. The irrigation flow (FIG. 20.11) can be set from 0 to 70 ml/min in 3 different methods as follow: • Press on the round part of the slider and slide the finger on the screen to the right to increase the irrigation flow, or the left to reduce the irrigation flow. • Press on the left of the round part of the slider to reduce the irrigation flow, or on the right to increase it. • For a precise irrigation flow setting, press on the – button to reduce the irrigation flow, or on the + button to increase it.

15

9. PM PERFO INTERFACE 1 2 3

4

5

FIG. 22

9.1 General settings Press on icon FIG. 22.1 to go to setting menu. Press on icon FIG. 22.2 to go to help menu. The area in FIG. 22.4 is showing the foot pedal functions: Green right button is used to switch to the next connected motor if any. Foot pedal rocker mode will be displayed (continuous or on/off, see chap. 12.1 General setting for further information). The active motor name is displayed on top of the motor selection icon (FIG. 22.5). To select another motor if more than one motor is connected to the ORIGO control unit, press on the motor icon displayed on FIG. 22.5.

9.2 Motor control The maximum speed (FIG. 22.3) can be set in 3 different methods as follow: • Press on the round part of the slider and slide the finger on the screen to the right to increase the speed, or the left to reduce it. • Press on the left of the round part of the slider to reduce the speed or on the right to increase it. • For a precise speed setting, press on the – button to reduce the speed, or on the + button to increase it. Motor speed expressed in rpm is displayed on top of the slider. Default speed is 800 rpm. Minimum speed is displayed on the left down to the slider. Maximum speed is displayed on the right down to the slider.

16

10. OSSEOSTAP INTERFACE 1

2

3

5

4

6

7

FIG. 23

FIG.24

10.1 General settings Press on icon FIG. 23.1 to go to setting menu. Press on icon FIG. 23.2 to go to help menu. The area in FIG. 23.6 is showing the foot pedal functions: Green right button is used to switch to the next connected motor if any. Foot pedal rocker mode will be displayed (continuous or on/off, see chap. 12.1 General setting for further information). The active motor name is displayed on top of the motor selections icon (FIG. 23.7). To select another motor if more than one motor is connected to the ORIGO control unit, press on the motor icon displayed on FIG. 23.7.

10.2 Motor control To set motor clockwise rotation (FIG. 24.1), press on the icon FIG. 23.3. To set the motor counterclockwise rotation (FIG. 24.2), press on the icon FIG. 23.4. The speed (FIG. 23.5) can be set in 3 different methods as follow: • Press on the round part of the slider and slide the finger on the screen to the right to increase the speed, or the left to reduce it. • Press on the left of the round part of the slider to reduce the speed or on the right to increase it. • For a precise speed setting, press on the – button to reduce the speed, or on the + button to increase it. Motor speed expressed in rpm is displayed on top of the slider. Default speed is 12’000 rpm. Minimum speed is displayed on the left down to the slider. Maximum speed is displayed on the right down to the slider.

17

11. S120 INTERFACE 1

2 3

4

7

5 6 8

11

9

12 13

10

1 2 14 15

FIG. 25

FIG. 26

11.1 General settings If no profile has been created, the icon FIG. 25.1 will show “DEFAULT PROFILE” and default setting will be used. If one or more profile have been created, press on the arrow of the drop-down menu FIG. 25.1 to select the needed profile or “DEFAULT PROFILE” (See chap. 12.3 Profile setting to set up profiles). Press on icon FIG. 25.2 to go to setting menu. Press on icon FIG. 25.3 to go to help menu. The area in FIG. 25.14 is showing the foot pedal functions: Blue left button is used to reduce the irrigation flow. Once irrigation OFF, new press on the button will set the irrigation flow at the maximum. Green right button is used to switch to the next connected motor if any (green right button has different function if the window control is activate, see chap. 11.4 Window control). Foot pedal rocker mode will be displayed (continuous or on/off, see chap. 12.1 General setting for further information). The active motor name is displayed on top of the motor selection icon (FIG. 25.15). To select another motor if more than one motor is connected to the ORIGO control unit, press on the motor icon displayed on FIG. 25.15.

11.2 S120 control To set S120 in oscillating mode, press on the icon FIG. 25.4. To set S120 in clockwise rotation (FIG. 27.1), press on the icon FIG. 25.5. To set the S120 counterclockwise rotation (FIG. 27.2), press on the icon FIG. 25.6. The speed (FIG. 25.7) can be set in 3 different methods as follow: • Press on the round part of the slider and slide the finger on the screen to the right to increase the speed, or the left to reduce it. • Press on the left of the round part of the slider to reduce the speed or on the right to increase it. • For a precise speed setting, press on the – button to reduce the speed, or on the + button to increase it.

FIG. 27

Motor speed expressed in rpm is displayed on top of the slider in continuous and oscillating mode. Default speed in oscillating is 3’500 rpm and 12’000 rpm in continuous. Minimum speed is displayed on the left below the slider. Maximum speed is displayed on the right below the slider.

11.3 Irrigation control Irrigation can be set in 2 different modes: • OFF (FIG. 25.8). There is no irrigation when the micromotor is on. • Continuous (FIG. 25.10): The irrigation pump brings continuous irrigation fluid according to the flow set on the screen. When irrigation is stopped, the pump’s direction of rotation is reversed to draw off the excess liquid. Before starting the surgery, user can press on the Prime icon FIG. 25.11 to fill the irrigation line with irrigation fluid. If user pressed by mistake on the key, the irrigation pump can be stopped by making a short press on the icon. Once the Prime button has been pressed and irrigation line is full, the icon will be replaced by the “flush icon”. By making a short press on this icon, the irrigation pump run of one step. By doing a long press, the irrigation pump run as long as icon is pressed. The irrigation flow (FIG. 25.9) can be set from 0 to 120 ml/min in 3 different methods as follow: • Press on the round part of the slider and slide the finger on the screen to the right to increase the irrigation flow, or the left to reduce the irrigation flow. • Press on the left of the round part of the slider to reduce the irrigation flow, or on the right to increase it. • For a precise irrigation flow setting, press on the – button to reduce the irrigation flow, or on the + button to increase it.

11.4 Window control In default setting the window control (FIG. 25.12) option is OFF. The internal shaver blade will stop in random position. If the shaver blade window control is on (FIG. 25.13), the internal shaver blade will always stop in the position set by the user. The position can be set on the screen by pressing the clockwise or 18

counterclockwise arrow on FIG. 26.2 or by pressing on the green right foot pedal button FIG. 26.1. Short press will rotate the internal shaver blade of 15° counterclockwise. Internal shaver blade will rotate counterclockwise continuously at low speed as long as you press the button.

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