Piezoelectric System Instructions for Use

Table of Contents

Introduction

Maintenance

Piezoelectric System

2

• Intended use • Features and benefits

2 2

Technical Description

4

Warnings

8

Installation

10

Functions and Settings

12

• Startup • Settings • Irrigation function • Light function • Piezoelectric System function  • Toolbox • Piezoelectric mode • Safety • Shutting down the device • Cutting tips

12 12 12 12 13 14 15 15 15 16

Maintenance

17

• Sterilization  • Irrigation line maintenance • Device maintenance • Handpiece maintenance • Preventive and corrective maintenance • Fuse replacement • Operating faults

17 17 17 18 19 19 20

Electromagnetic Compatibility

Additional Information

Product Information

Electromagnetic Compatibility

21

• Table 1: Emission • Table 2: Immunity (all devices) • Table 3: Immunity (not life-supporting devices) • Table 4: Recommended separation distances • Cable lengths

21 22 23 24 24

Additional Information

25

• Disposal and recycling • Manufacturer’s liability • Regulations

25 25 25

Symbols

26

Cleaning and Sterilization 

28

Cutting tips

37

Instruments

43

Ordering Information

44

Piezoelectric System Instructions for Use DePuy Synthes

1

Piezoelectric System. Ultrasonic handpiece with cutting tips for a broad range of applications. Intended use The Piezoelectric System distributed by Synthes is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone and bone substitutes. It can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical, spine, and ­plastic / reconstructive surgery. To maximize the benefits of this device and ensure it has a long working life, read this manual carefully before using the system.

Features and benefits Cruise Control® System • No loss of power regardless of the environment and / or treatment performed • Active only on mineralized tissue, with reduced risk to soft tissue • Minimum pressure required, resulting in higher precision and reduced hand fatigue for the clinician • Four power setting modes: 3 for bone cutting based on bone density and 1 for soft tissue detachment LED handpiece • Up to 60 watts of power for efficient osteotomies • No heat generation and vibration free, reduces surgeon discomfort • Six powerful LEDs for enhanced vision at the operative site • Attached cable

2

DePuy Synthes Piezoelectric System Instructions for Use

Progressive, multifunction foot pedal • Real-time adjustment of the ultrasonic power according to the anatomical constraints encountered • The power of the ultrasonics can be precisely adapted for areas where nerves, arteries or membranes are present • Total control of the console through the foot pedal, which allows hands-free operation in the sterile field, without touching the console screen Cutting tips • No heat generation, reduces the risk of necrosis • Narrow kerf for highly precise bone surgery procedures • Broad range of applications Console • User-friendly touch-sensitive LCD screen for ease of operation • Cable connectors for up to two handpieces, eliminating the need to change cutting tips during procedures • Two peristaltic pump housings • Two brackets for irrigation solution

Piezoelectric System Instructions for Use DePuy Synthes

3

Technical Description

a) LCD touch screen The LCD touch screen is used to define the settings of the Piezoelectric System. The Piezoelectric System settings are adjusted by applying reasonable pressure to the screen keys. Identification functions Reduce or increase the irrigation flow rate in ml/min Flush or prime irrigation ON/OFF irrigation

or

Select a program: D1, D2, D3, D4 D1 is the most powerful setting for dense bone D4 is for detachment of soft tissue Reduce

or increase

power within a program

Handpiece light ON/OFF Progressive

or full ON/OFF power

Save settings

­­

4

DePuy Synthes Piezoelectric System Instructions for Use

Startup screen Identification of key areas: Toolbox mode Toolbox Identification of information display • Audio volume symbol and value • Screen brightness symbol and value • Light off/time-out symbol and value • Software version • Reset factory configuration • Validate configuration

b) Control unit back panel The power receptacle with its grounding pin is used to connect the console to the power supply using a plug-in power cord 1. The foot pedal connector is used to connect the console to the multifunction control foot pedal 2. The fan 3, protected by a metal grille, keeps the Piezoelectric System at its optimum performance level. The irrigation pole holders 4 hold the irrigation poles. The power switch is used to switch the console ON or OFF 5. A potential equalization connector for an equipotential earth plug is integrated in the console 6.

4

2

3

6 1 5 4

Piezoelectric System Instructions for Use DePuy Synthes

5

Technical Description

c) Irrigation pumps The irrigation pumps 7 are located on either side of the console, and accommodate Synthes supplied irrigation tubing with cassettes. The irrigation cassettes are installed by lifting the pump covers and inserting the cassettes horizontally into the cassette housings. d) Front panel The two cable connectors 8 accept the connector of the Piezoelectric System handpiece cable.

7

8

e) Control foot pedal The functions on the control foot pedal allow the user to work in a sterile environment. Once the settings have been adjusted on the console, the user does not need to touch the LCD screen. Foot pedal button definition 1 Handpiece control (ON/OFF or progressive) 2 Flush/prime irrigation 3 Change program (D1– D4) 4 Select left or right handpiece 5 Irrigation ON/OFF

5 4 3 2 1

6

DePuy Synthes Piezoelectric System Instructions for Use

f) Technical characteristics Manufacturer: SATELEC Distributor: Synthes GmbH Device name: Piezoelectric System Electrical power supply Voltage: 100 VAC to 230 VAC Frequency: 50 Hz / 60 Hz Rated power: 150–150 VA Piezoelectric System function Operation • Intermittent service: 10 min. ON / 5 min. OFF Output characteristics • No-load voltage: 250 volts (nominal value without handpiece) • Min. ultrasonic frequency: 28 kHz • Irrigation flow rate: 10 to 120 ml/min. (nominal value) • Adjustment in 10 ml/min. steps (nominal value) • Flush flow rate: 120 ml/min. (nominal value)

Overall dimensions Control unit • Width: 472.9 mm • Height: 149.5 mm • Height with bracket: 471.1 mm • Depth: 339.9 mm • Weight: 5 kg without accessories Handpiece cable • 2.9 meters Temperatures • Operation: +10 °C to +30 °C • Storage: 0 °C to +50 °C Humidity • Operation: 30% to 75% • Storage: 10% to 100% including condensation Atmospheric pressure • Operation: 800 hPa to 1060 hPa • Storage: 500 hPa to 1060 hPa

Protection • Electrical equipment class: Class I • Type BF applied part Safety devices • Safety shut off if internal malfunction • 2 fuses (power receptacle): • 5 mm × 20 mm / T2AL 250 VAC • 1 internal fuse not accessible to the user • Reference F1: 5 mm × 20 mm – T10AL 250 VAC

Piezoelectric System Instructions for Use DePuy Synthes

7

Warnings

Device users

To reduce the risk of accidents, the precautions stipulated below must be taken.

Attention • The Piezoelectric System must not be used if the patient and/or the operator has a cardiac stimulator (pacemaker) or any other active implant (e.g. a cochlear implant). • Use of the Piezoelectric System is restricted solely to qualified, trained and competent health care practitioners in the normal context of their work with the Piezoelectric Surgery System. • If you have received this device in error, please contact your local Synthes representative.

Electrical connection To avoid risk of electric shock, this device must be connected to an electrical power supply with a protective ground. • The electric supply to which the device is connected must comply with the standards in force in your country. • If loss of electrical power during use is likely to generate an unacceptable risk, the device must be connected to a suitable power source (e.g. UPS).

Interactions • The device complies with applicable electromagnetic compatibility standards. However, the user should ensure that any potential electromagnetic interference does not cause an additional risk (presence of radiofrequency emitters, electronic devices, etc.). • The device is not designed to withstand shocks delivered by an electric defibrillator. • Do not attempt to connect to the Piezoelectric System connectors any accessories other than those supplied by Synthes. • The tips are specifically designed for the Piezoelectric ­System. The system is not compatible with other manufacturers’ system tips. • Cutting saw and scalpel tips are ultra sharp instruments and must be used with caution. It is recommended to use diamond and decorticating tips in sensitive clinical areas.

Using the device • Do not use the device if it appears to be damaged or faulty. • Turn the device OFF before unplugging the power cord. • To unplug the power cord, grip the cord plug and hold the wall socket. • Never use any irrigation solution containers other than those intended for suspension from the supplied brackets. • The device must only be used with bottles or bags of physiological saline or sterile water. • The capacity of the irrigation solution containers used must not exceed one liter per bracket. • When the device is not to be used for a long period of time, unplug the console from the electric supply. • Do not exert excessive force on the screen. • Do not move the console during use.

8

DePuy Synthes Piezoelectric System Instructions for Use

Overheating, burns To avoid any risk of burns or overheating, irrigation must ­always be switched ON and active when the handpiece is in use. The user shall regularly control the level of irrigation to ensure its coolant action to the tip. A lack of irrigation presents a hazard to the patient. Environment • Do not cover the console or obstruct the ventilation vents. • Do not immerse the device in liquid, and do not use it outdoors. • Do not tilt the console at an angle greater than 5°. • Do not place the console near a heat source. • Ensure that the cables and power cord are not in a traffic path. • The device must not be stored or operated in an explosive atmosphere. • Do not expose the console to water vapor, or splashes. • Condensation inside an electrical device may be dangerous. • If the console must be moved from a cool place to a hot place, allow it to warm up to the new room temperature before use. • The device is not designed to work near ionizing radiation. • Do not insert metal objects into the device (risk of electric shock, short-circuit or emission of hazardous substances).

Maintenance • Before and after each procedure, ensure that all accessories are cleaned and sterilized. Accessories • The device and accessories have been designed and developed together to ensure maximum safety and performance. • Use of accessories from other manufacturers is a potential hazard to the user, the patient and the device. Repairs Do not attempt to repair or to modify the device without ­authorization by Synthes. When the device is modified or repaired, specific checks and verifications must be performed to ensure that the device can be used safely. The device should be sent to the Synthes office for repair if it is faulty or malfunctions. Use of un­authorized repairers could damage the system and void the warranty. If in doubt, contact your local Synthes representative. Faulty devices may not be used. If it is no longer possible or feasible to repair the tool it should be disposed of. (Cf. the section “Disposal and recycling” in the chapter “Additional Information”, p. 25). Other than the above mentioned care and maintenance no further maintenance work can be carried out independently or by third parties. Caution: The manufacturer shall assume no responsibility for damage resulting from unauthorized maintenance.

Piezoelectric System Instructions for Use DePuy Synthes

9

Installation

Unpacking the device Upon receipt of the device, check for any damage caused in transit. Contact your local Synthes representative if necessary. Recommendations The electrical connection of the Piezoelectric System must comply with the applicable standards in your country. Warning: To avoid any risk of electric shock, this device must be connected to an electrical power supply with a protective ground. Installation Important: Do not place the Piezoelectric System close to or on top of another device. Do not place the power cord and the foot pedal cable in a wire cover or in a cable guard. Do not operate the handpiece unless the irrigation is switched to the ON position. Do not disconnect the handpiece cables when the device is switched ON and the foot pedal is pressed. Do not insert or remove cutting tips when the handpiece is ON. The handpiece, wrench and Vario Case must be cleaned and sterilized before each use. Do not use the system with parts other than those supplied by Synthes. Check the integrity of the device and its accessories before and after each use in order to detect any problems.

11

DePuy Synthes Piezoelectric System Instructions for Use

• Position the console on a fixed horizontal surface, or one with a slope of no more than 5°. • Check that the power switch is in the OFF position. • Connect the power cord to the receptacle on the back of the console. • Connect the power cord to a grounded power outlet. • If necessary, connect the equipotential earth plug to the potential equilization connector on the console. • Connect the foot pedal cable to the foot pedal connector on the back of the console. • Position the foot pedal so that it is easily accessible for use. • Insert the irrigation poles into the bracket holders. • Connect the handpiece cable to the connector on the front of the console. The default setting is for the right connector. • Ensure that the console is close enough to the work area to be used without pulling on the cables or power cord. • Place the handpiece on the sterile field.

The pump housings are designed to accommodate Synthes supplied irrigation tubing with cassettes. • Lift the pump cover and insert the irrigation tubing cassette horizontally into the cassette housings. • Insert the sterile spike into the connection on the irrigation bag. Avoid touching the spike. • Connect the irrigation tubing to the irrigation port on the handpiece. Use the sterile clips provided to attach the tubing to the handpiece cable. • Suspend the irrigation bottles or bags from the irrigation poles. • Adjust the position of the console to suit your angle of view. Handpiece function • Thread the selected cutting tip onto the handpiece by turning the tip. Use the flat wrench or the torque wrench to tighten the tip. Turn the flat wrench gently clockwise to tighten and ensure not to overtighten the tip. When using the torque wrench, turn it clockwise. Optimum torque is reached after one click. Do not overtighten the tip once the click is heard. Overtightening of the tip can damage the threads on the tip or the handpiece. To remove the tip, turn the wrench counterclockwise. • Prime the irrigation circuit by pressing the flush/prime button on the console screen or the multifunction foot pedal. • When the irrigation solution reaches the end of the tip, release the foot pedal or the button. • Use the Piezoelectric System in accordance with good medical practices.

Piezoelectric System Instructions for Use DePuy Synthes

11

Functions and Settings

Startup

The flow rate can be adjusted while the device is being used.

Important: After turning the console off, wait four seconds before restarting it.

c) Irrigation ON/OFF

By default, when the device is switched on, the righthand handpiece is selected if two handpieces are connected.

Important: To avoid any risk of burns or overheating, irrigation must a ­ lways be switched ON and active when the handpiece is in use.

If only one handpiece is connected, the device selects the correct side. If no handpiece is connected, the device selects the right side in Piezoelectric System mode.

The irrigation is switched ON or OFF by pressing button or the foot pedal button.

Settings The settings are saved when each program is configured and are retrieved whenever that program is selected.

When irrigation is not selected, the symbol is shown. ­Irrigation must always be switched ON and active when the handpiece is in use. Damage to the tip or necrosis may result if irrigation is not used.

Irrigation function The Piezoelectric System is not designed to administer drugs. It must be used only with bottles or bags of physiological saline or sterile water with an individual capacity not exceeding one liter. The Piezoelectric System must only be used with Synthes supplied irrigation tubing that is designed for the system. a) Flush/prime The flush/prime function is located on the LCD screen and on the foot pedal. Press button or the foot pedal button to switch on the flush/prime function.

When irrigation is selected, the symbol

Light function The light function is displayed on the LCD screen. Pressing button switches the light function available for the Piezoelectric system functions ON or OFF. The light function has a default light-off time-out of nine seconds. The light function switches OFF when the time-out has elapsed. If necessary, you can change the light time-out by changing the settings in the Toolbox section of the console screen option.

The flush/prime function stays on as long as the button is pressed. The flush can be switched on while the device is being used. b) Flow rate adjustment The irrigation flow rate is adjusted using buttons .

or

Each time the corresponding button is pressed, the flow rate is adjusted. Press and hold buttons or to scroll the flow rate values. The adjusted value is displayed on the LCD screen 1 and stored in the current program.

11

DePuy Synthes Piezoelectric System Instructions for Use

is shown.

1

2

Piezoelectric System function Important: The Piezoelectric System function settings can be customized by the user. The Piezoelectric System function settings can be adjusted whether or not a handpiece is connected to the console. The program giving the highest power is D1. Power Level

Program

Very powerful

D1

Powerful

D2

Medium

D3

Low

D4

Main functions

Osteotomy, osteoplasty

Soft tissue detachment

The Fine Tuning 2 gives the possibility to adjust the level of power energy within each mode from 1 to 5. The power value is a percentage of the maximum power value (D1– D4). Select the left or right Piezoelectric System function by pressing the Synthes button or the foot pedal button. Important: In progressive mode, for programs D1 to D3, the delivered power ranges between power level 1 of program D3 and the configuration defined by the user (program and power level). In progressive mode, the power delivered by program D4 ranges only between levels 1 and 5, according to the value defined by the user. Select handpiece light ON/OFF, by pressing button

Programs correspond to the following level of powers:

Confirm the new settings by pressing button

Program Mode

D1

Level of Fine Tuning

1

3

The saving of the various settings is confirmed by an audible signal and a visual signal (button flashing).

Power value

82% 86% 90% 95%

2

Frequency Modulation

60 Hz

Program Mode

D2

Level of Fine Tuning

1

3

Power value

64% 68% 72%

2

Frequency Modulation

60 Hz

Program Mode

D3

Level of Fine Tuning

1

3

Power value

44% 48% 52%

2

Frequency Modulation

60 Hz

Program Mode

D4

Level of Fine Tuning

1

2

3

Power value

41%

46% 51%

Frequency Modulation

4

5 100%

4

5

74%

78%

4

5

56%

60%

4

5

56%

60%

.

.

Repeat this sequence if necessary in order to adjust all the programs.

30 Hz

Piezoelectric System Instructions for Use DePuy Synthes

11

Functions and Settings

Toolbox Important: The Piezoelectric System has a Toolbox function used to make various adjustments, including brightness, light off/time-out, audio volume and factory configuration reset. To access the Toolbox function, switch the device OFF, wait four seconds, switch device ON, then press button on the welcome screen within 2 seconds. a) Audio volume adjustment Adjust audio volume value using buttons or . Audio volume is adjustable from 0% to 100%. The relative value of the audio volume is displayed. b) Screen brightness adjustment Adjust the brightness value using buttons or . Brightness is adjustable from 30% to 100%. The brightness level setting is displayed. c) Light off/time-out adjustment Adjust the time-out length value by using buttons or . The length of the time-out function can be adjusted from nine (9) to eighteen (18) seconds. d) Storing settings To store the modified settings, press button ­welcome screen will reappear.

. The

e) Factory configuration reset Press button to restore the factory configuration ­settings. The factory configuration for the Piezoelectric ­System functions becomes effective when button is pressed. The welcome screen will reappear.

11

DePuy Synthes Piezoelectric System Instructions for Use

f) Software version The version of the software is displayed at the bottom of the Toolbox Screen. The Piezoelectric System is configured in the factory with the following settings:

Shutting down the device Upon completion of the medical procedure: • Remove the bottles or bags of irrigation from the brackets. • Remove the irrigation line spike from the bottle or bag. • Immerse the irrigation line spike in a vessel containing distilled or sterile water.

Piezoelectric mode Power level

Program

Fine Tuning

Irrigation in ml/min

Very D1 ­powerful

3

60

­Powerful D2

3

60

Medium

D3

3

60

Low

D4

3

60

Main functions

Osteotomy, osteoplasty

Soft tissue detachment

Safety The console is equipped to detect malfunctions of the device. If an internal operation error occurs, the transmission fault symbol is displayed in the error zone and the device beeps four times. To cancel this default, simply switch OFF the device from the ON/OFF button. Wait a few seconds and switch ON again to restart the device.

Important • Rinse to remove saline solution from the handpiece by running the prime/flush function until the vessel and the irrigation line are completely empty. • Switch the device OFF (position O). • Remove the irrigation tubing clips. • Disconnect the irrigation tubing from the handpiece and dispose in a safety container for soiled medical items. • Disconnect the handpiece from the console. • Disconnect the ultrasonic cutting tips. Dispose in a safety container for soiled, sharp, medical instruments.

When the handpiece is disconnected, the handpiece missing icon is displayed in the error zone and the device beeps four times.

Piezoelectric System Instructions for Use DePuy Synthes

11

Functions and Settings

Cutting tips The cutting tips are divided in four categories: • Cutting saw tips • Cutting diamond tips • Cutting scalpel tips • Decorticating tips These cutting tips can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical, spine, and plastic/ reconstructive surgery.

Cutting saw and diamond tips The intended uses of the tips are osteotomy and osteoplasty. Use a “brush-stroke” movement: • Place the tip perpendicular to the surface to be treated 1. • Move the tip with a slow back and forth movement, in line with the cut 2. • Apply only very slight pressure – never use force. NEVER USE THE TIP AS A LEVER: use only the appropriate ­elevator to lift the bone graft.

Caution: The tips are specifically designed for the Piezoelectric System. The system is not compatible with other manufacturers’ system tips. Principles of utilization

1 90°

Important: An efficient use of these ultrasonic tips requires very slight pressure to be effective. The power of the Piezoelectric System applied to each cutting tip should be set on the console screen according to the recommended mode, fine tuning and irrigation level. Refer to page 37 for recommended power settings. To avoid any risk of burns or overheating, irrigation must always be switched ON and active when the handpiece is in use. The user shall regularly control the level of irrigation to ensure its coolant action to the tip. A lack of irrigation represents a hazard to the patient. The irrigation level is given as a minimum and must be increased when necessary. Duration of use Synthes recommends using a new cutting tip for every surgery. The maximum power and minimum irrigation settings must be strictly followed. Caution: The sterile cutting tips are provided for single use only. Do not resterilize or re-use the single-use tips.

11

DePuy Synthes Piezoelectric System Instructions for Use

2

Cutting scalpel tips The intended uses of this tip category are osteotomy, osteoplasty and bone harvesting. Use a repeated, short pulling movement. • Apply slight pressure. • Never use force. • Never use the tip as a lever. Decorticating tips The intended use of this tip category is soft tissue decortication. During its use, it is essential to keep contact with the soft tissue and the bone. • Apply slight pressure. • Never use force. • Never use the tip as a lever.

Maintenance

Sterilization

Device maintenance

Important: The device must be switched OFF during reprocessing procedures. Do not use disinfection agents containing flammable substances.

Important: Never use an abrasive cleaning agent on the console or the foot pedal. Do not use sprays or liquids to clean and disinfect the console. Do not immerse the console or foot pedal. Do not sterilize the console, brackets or the foot pedal.

Caution: The sterile cutting tips are provided for single use only. Do not resterilize or re-use the single-use tips. The maintenance and/or sterilization instructions provided in this guide must be applied before each use of the device. Sterilized items must be allowed to dry and cool to room temperature before use. Universal precautions for handling contaminated/biohazardous material should be observed. Caution: The tips are specifically designed for the Piezoelectric System. The system is not compatible with other manufacturers’ system tips.

The console, foot pedal and brackets must always be cleaned and disinfected after each procedure, using alcohol disinfectant wipes for medical use. Regular monitoring of the Piezoelectric System is necessary in order to detect any problem. Keep the console ventilation vents clean, to avoid abnormal heating. The handpiece and cable can be sterilized in an autoclave. For minimum sterilization requirements refer to page 28.

Irrigation line maintenance Sterile irrigation tubing

Caution: After multiple uses, and during successive sterilizations, make sure before use that the handpiece-cable assembly is not damaged.

Caution: The irrigation tubing supplied by Synthes is for single use only, and must always be discarded after use. Do not resterilize the single-use irrigation tubing. Do not attempt to modify the irrigation tubing. The re-use of irrigation tubing is a potential hazard to the surgeon, patient and the device.

Piezoelectric System Instructions for Use DePuy Synthes

11

Maintenance

Handpiece maintenance Important: Handpiece must be disassembled prior to cleaning and sterilization. After each use, the handpiece irrigation circuit must be rinsed with distilled or sterile water for a minimum of 20 seconds. Important: Before medical procedures, test the LED to verify the correct positioning of the LED ring on the handpiece. Assembly • Connect the LED ring to the handpiece, making sure it is positioned correctly (align the “+” marks on the LED ring and on the handpiece body near the LED ring electrical contacts). • Insert the light diffuser over the LED ring as shown. • Screw the nose cone onto the handpiece.

11

DePuy Synthes Piezoelectric System Instructions for Use

Cleaning and disinfection The handpiece must be cleaned and disinfected after each procedure by manual cleaning or automatic washer. For handpiece sterilization, refer to the minimum sterilization requirements for the system (page 28). Cutting tip must always be discarded after use. Do not attempt to modify the cutting tip. The re-use of the tip may lead to the decrease of its performance and proper characteristics. The re-use of tips is a potential hazard to the surgeon, ­patient and the device.