operator’s manual - traumapro · this manual is intended to aid the operator in the use of, and...

Operator’s Manual

12K Shaver

This manual is intended to aid the operator in the use of, and minor diagnostic testing of, the PowerTek™ II Plus System. This manual should be used as an aid, and is not intended to replace hands-on in-service training by a qualified instructor.

This operator’s manual is your written guide to the PowerTek™ II Plus System. Read the entire manual carefully before operating any part of the system. Recommended settings are offered only as guidelines, not to restrict appropriate clinical application.

It is important to understand and follow the notices and warnings contained in this manual. They are set in boldface type throughout the text.

Note:Operation of this device may cause electromagnetic interference or other interference with adjacent equipment requiring the operator to take whatever steps necessary to correct the interference.

1Preface

This manual contains general information together with assembly, operation, maintenance and troubleshooting instructions for the PowerTek™ II Plus High Speed Shaver System. It is essential that all material in this manual be read and understood before any attempt is made to operate or maintain the PowerTek™ II Plus System.

Section 1: Introduction ............................................................................................ 2

Section 2: Description .............................................................................................. 3

Front Panel .............................................................................................. 3 Alpha/Numeric Display ........................................................................ 4 Rear Panel ................................................................................................ 4 Internal Details ........................................................................................ 5 High Speed Suction Control Shaver Handpiece ........................... 5 Foot Switch .............................................................................................. 6

Section 3: Setup and Operation ............................................................................... 7

Setup ......................................................................................................... 7 Intra-Operative Adjustments .............................................................. 7

Section 4: Cleaning and Sterilization ....................................................................... 9

Cleaning the Shaver Handpiece ........................................................ 9 Material Compatibility .......................................................................... 9 Sterilization .............................................................................................. 9 Re-Use of Shaver Handpiece .............................................................. 9 Cleaning the Console ........................................................................... 10 Re-Use of Console .................................................................................. 10 Cleaning the Foot Switch .................................................................... 10 Re-Use of Foot Switch........................................................................... 11

Section 5: Troubleshooting ...................................................................................... 12

Section 6: Specifications .......................................................................................... 14

Section 7: Product Listing ........................................................................................ 21

Section 8: Biomet Sports Medicine Limited Warranty ............................................. 22

Section 9: Repair of Biomet Sports Medicine Products ........................................... 23

2 Introduction

The intended purpose of the PowerTek™ II Plus High Speed Shaver System (Figure 1-1) is to provide a shaver unit that will meet the surgeon and patient’s needs for abrasion arthroplasty, synovectomy or intra-articular cutting and shaving. A full line of limited reusable and disposable shaver blades and burs are available for use with the PowerTek™ II Plus Shaver Handpiece. Contact your Biomet Sports Medicine Sales Representative for a complete listing of available blades and burs.

Operable from a foot pedal or button equipped shaver handpiece, the shaver system is capable of speeds up to 12,000 RPM for efficient bone removal and meniscal cutting. Read this manual carefully before using the shaver system. It will describe how to safely and efficiently operate the shaver for its intended use and care for the unit. Routine and preventative maintenance take little time and effort and may allow for more optimum performance and many hours of reliable operation.

Section 1

3

The Power Tek II™ Plus Arthroscopic Shaver system contains three major elements: the control console, the foot control, and the high speed suction control handpiece with control buttons.

Control Console Houses the microprocessor, shaver driver, mode and speed controls, and operator display.

Foot Switch Waterproof foot pedal to control the on/off and forward/reverse/oscillate mode of operation of the control unit and high speed shaver handpiece.

Shaver Handpiece Controllable from the front of the control console or the foot switch, capable of running from 400 to 12,000 RPM, and linear suction control for debris aspiration. Control buttons on handpiece allow the user to control major functions of the system from the sterile field.

Description

Section 2

Figure 2-1. Front Panel

Front Panel 1. Power Switch: Shaver chassis is placed in or removed from standby mode here. Primary AC Power is

applied from switch on rear panel.

2. Standby Light: When lit, indicates primary AC is present and system is in low power standby mode.

3. Alpha/Numeric Display: Displays shaver mode, shaver on/off status, shaver set speed and any messages from the internal computer.

4. Foot Switch Receptacle: Plug foot switch connector here.

5. Shaver Receptacle: Plug high speed shaver connector here.

6. On/Off Button: Shaver handpiece can be turned on or off by pressing this switch. Current state is displayed on alpha/numeric display.

7. Mode Button: Pressing the mode button cycles through the forward, reverse, oscillate, shaver modes. Shaver must be off to change modes.

8. Up or Down: Increases or decreases the shaver RPM.

9. Menu Button: Displays current software revisions and provides function option menus.

10. Attention: Indicates that manual should be consulted prior to operating this equipment.

4

1. Handpiece Icon: When lit indicates system self tests have completed and system is ready for use. When covered with an X indicates no handpiece detected.

2. Handpiece Active Icon: > < indicates handpiece off. > > indicates handpiece running in forward mode. < < indicates handpiece running in reverse mode. < > indicates handpiece running in oscillate mode.

3. ON/OFF: Indicates ON when handpiece is running. Indicates OFF when handpiece is not running.

4. Mode Indicator: Currently selected mode is highlighted. Indicates Forward mode Indicates Oscillate mode Indicates Reverse mode

5. Numeric RPM Display: Displays current speed setting of handpiece.

6. Tool Mode: Displays current tool selected.

7. Message Area: Displays handpiece selected or error messages from the CPU. Refer to Section 5 for a complete listing of error messages.

Rear Panel

Alpha/Numeric Display

Figure 2-2. Alpha/Numeric Display

1. A/C Mains (On/Off Switch): The ON/OFF switch is located on the upper right of the rear panel. Stick indicates ON. Ball indicates OFF.

2. Fuse Holder: Holds two fuses.

Figure 2-3. Rear Panel

Description

Section 2

1

2

5Description

Section 2

Internal DetailsMotor Control Loop: The motor operation parameters are controlled by the internal microprocessor. Monitoring the actual motor speed and comparing with the set speed accomplish motor speed regulation. Motor speed is controlled by a pulse width modulation scheme that controls the average current to the motor coils. The brushless motor improves efficiency.

Microprocessor: The internal microprocessor executes all commands and controls. Programs and video display format are stored in electronic memory for ease of upgrade.

Audio Alerts: The system will produce a beep when the user changes operating modes. Attempting to enter an illegal mode will produce a double beep.

High Speed Suction Control Shaver HandpieceThe handpiece is a lightweight shaver with brushless motor that runs up to 12,000 RPM. The handpiece has a 5mm aspiration port that supports clog free operation. The handpiece is equipped with a suction control lever to set aspiration flow to surgeon preference. Control buttons on the handpiece allow the surgeon to change modes, and Bur/Blade operation, as well as activating and deactivating the shaver handpiece.

The suction control valve is provided to allow the surgeon control of suction and outflow when this handpiece is used with a vacuum collection container and hospital wall suction. Suction and outflow can be adjusted linearly from OFF to full ON as indicated on the handpiece body.

WARNING: Operating the handpiece without fluid flowing through it may cause excessive heat and may damage the handpiece.

Handpiece Button FunctionsNote: A quick press of any handpiece button while shaver is ON will turn shaver OFF. A press and hold of the Up or Down buttons will ramp speed up or down accordingly in both shaver ON and shaver OFF modes.

Buttons have two modes. “Quick press and release” mode and “press and hold” mode.

Front Button: FORWARD Mode ON (With handpiece OFF) Pressing this button quickly will turn the handpiece ON in forward mode. Press and HOLD to increase speed.

Center Button: OSCILLATE Mode ON (With handpiece OFF) Pressing this button quickly will turn the handpiece ON in oscillate mode. Press and HOLD to switch between bur and blade modes. Note: Maximum speed in Oscillate Mode is 3,500 RPM.

Rear Button: REVERSE Mode ON (With handpiece OFF) Pressing this button quickly will turn the handpiece ON in reverse mode. Press and HOLD to decrease speed.

Figure 2-4. High Speed Suction Control Handpiece

Control Buttons

Suction Valve

Outflow Tube Connector

6 Description

Section 2

NOTE: During each use of the system, the last used speed and rotation mode used in both BLADE and Bur Mode will be retained in memory until the shaver console is turned off. This provides a quick method to switch between two often used speeds.

NOTE: There is a high speed warning at speeds above 5000 RPM when in Blade Mode. “WARNING; BLADE USE NOT RECOMMENDED AT THIS SPEED.”

Changing Burs and Blades 1. Insert bur or blade by first sliding the silver collet at the front of the handpiece backwards toward the cable end.

This action will open the collet of the handpiece for proper bur or blade insertion.

2. Insert entire blade/hub assembly into the motor drive. Push blade hub firmly into the handpiece to cause the inner hub to align with the drive hub. NOTE: The blade can be dialed into the handpiece in any position. The arrow on the outer hub that points to the cutting window provides orientation. Make sure that the most distal ring on the outer hub is completely hidden inside the motor drive. If not, the blade will not function properly and suction will be compromised. Release the collet on motor drive and pull back until seated in original position.

3. Use the handpiece bur/blade button to change shaver unit to correct tool mode. The selected mode will be displayed on the control unit display.

4. Remove the bur or blade by sliding the collet of the handpiece backward. The spring in the bur/blade will pop the entire blade assembly out. Release the collet.

Foot SwitchThe waterproof foot switch allows the surgeon to control the on/off, forward/reverse/ oscillate mode of operation of the control unit and high speed shaver handpiece.

Reverse: Pressing the REVERSE switch (left) places the console in reverse mode and causes the handpiece to run at the speed selected on the console display.

Oscillate: Pressing the OSCILLATE switch (center) places the console in oscillate mode and causes the handpiece to run at the speed selected with an oscillating cycle of 200 ms (approx. five times a second). Note: Handpiece RPM must be 3,500 or less in oscillate mode.

Forward: Pressing the FORWARD switch (right) places the console in forward mode and causes the handpiece to run at the speed selected on the console display.

Figure 2-5. Foot Switch

7Setup and Operation

Section 3

The PowerTek™ II Plus has built in redundant controls allowing operation of the shaver system from the console front panel, the handpiece control buttons, or the foot switch. In the following procedures where redundancy is available the appropriate command is given for each available control unit; FP = Front Panel, HP = Handpiece Buttons, FS = Foot Switch.

Setup 1. Connect AC Mains cord to appropriate source. Press rear panel AC Mains switch to ON. Console standby light will

illuminate.

2. Connect foot switch cable to console foot switch connector.

3. Connect shaver handpiece cable to console handpiece connector.

4. Connect the vacuum tube from the collection bottle to the aspiration port on the shaver handpiece.


5. On the console front panel press and release the POWER switch. Standby light will go out. Console will enter self test mode. A series of power on self tests will run to check all functions of the console. Console will display:

“SELF TEST VERSION X.00”

If any test fails, the system will lock and display the test that failed. Refer to Section 5 for troubleshooting instructions.

6. At the completion of self test, the console will display the following pre-set values:

Handpiece Icon: if handpiece connected. if no handpiece

Handpiece Running Icon: > <

Handpiece Active Icon: OFF

Mode Indicator: (Oscillate)

Numeric RPM Speed: 2,500 RPM

Message: HIGH SPEED SHAVER or NO SHAVER

Tool Mode: TOOL MODE: BLADE

7. The system is ready for surgery.

Intraoperative AdjustmentsThe following adjustments can be made during the procedure:

Note: Pressing any handpiece button while handpiece is ON will turn handpiece OFF. Note: Handpiece button functionality may be turned OFF by pressing menu on the console front panel. Select “Buttons Off” and press menu again.

To Activate Handpiece (ON): FP: Press shaver On/Off button HP: Press appropriate button FS: Press appropriate pedal

To Adjust Rotation Mode: FP: Press mode button to cycle through HP: (With handpiece OFF) press and release the desired mode button quickly. FS: Press appropriate pedal (Note: Cannot oscillate above 3,500)

Note: Shaver must be off to change modes.

8

To Adjust Shaver Speed: FP: Press RPM UP ( ) or RPM DOWN ( ) button HP: Press and hold the up or down arrow button FS: RPM cannot be adjusted with the foot switch

To Change Tool Mode: FP: Tool mode cannot be changed from the front panel HP: (With handpiece OFF) Press and hold the middle button to toggle between blade (low speed) or bur (high speed) modes. FS: Tool mode cannot be changed from the foot switch

NOTE: Factory default for tool mode: Shaver 2,500, bur 8,000 RPM.

NOTE: Maximum speed for oscillate mode is 3500 rpm.

NOTE: If the operator attempts to raise RPM speed above 4,900 RPM while in shaver mode the console will freeze at 5000, beep twice and display WARNING: BLADE USE NOT RECOMMENDED AT THIS SPEED. Manufacturers of burs/blades may have separate instructions for recommended speeds. The operator must then release the RPM up ( ) button and press again to raise RPMs above this level.

NOTE: During each use of the system the last used speed and rotation mode used in both blade and bur mode will be retained in memory and become the default RPM and rotation modes until the shaver console is turned off.

Handpiece Aspiration: The aspiration valve on the handpiece can be adjusted to accommodate the requirements of the surgery.


Setup and Operation

Section 3

9Cleaning and Sterilization

Section 4

Cleaning Shaver HandpiecePreparation at Point of Use

1. As soon as possible after use, wipe soil away from handpiece using a moist sponge or towel.

2. Place handpiece in an instrument basket or tray and cover with a towel moistened with distilled water to prevent blood and body fluids from drying.

3. Transport tray or basket to processing area.

Rinse Blood and Body Fluids from Device

1. As soon as possible after use, rinse outside of device in cold tap water. Do not immerse device.

2. After rinsing, wipe outside surfaces with moist, soft cloth and brush as necessary with a soft bristled brush. Use small bottle brush for inside fluid path of handpiece.

3. After wiping and brushing, rinse with cold tap water. Open and close valve while running water down inside fluid path on handpiece.

Clean with Enzymatic Cleaner Until No Visible Soil Remains

1. Use a neutral PH enzymatic cleaner (such as Orthozime® Enzymatic Cleaner made by Ruhof Corp mixed per manufacturer’s instructions).

2. Brush or wipe handpiece with cleaner. Open valve and brush inside fluid path.

3. Let moist, enzymatic covered devices sit for one minute.

Rinse Away Enzymatic Cleaner and Extraneous Debris and Dry Handpiece

1. Rinse all surfaces under hot tap water. Open and close valve while running water down and through fluid path. Ensure fluid path is clean.

2. Visually inspect to ensure handpiece is completely free of all particles of adhering tissue, dried blood, scale and accumulations of lime salts. If handpiece is not completely clean and free of particulate matter, repeat cleaning process.

Material CompatibilityThe handpiece is compatible with steam autoclave, the STERIS® system from Steris Corp, EtO, and the STERRAD® and CIDEX® systems from Johnson & Johnson Corp. Note that the user will be responsible for validating the sterility assurance of any method other than pre-vacuum steam autoclave.

SterilizationSterilize using the following procedure.

1. Pre-Vacuum Steam Sterilize: Sterilize the handpiece at 132˚ C (270˚ F) for five minutes of exposure time.

Re-Use of Shaver Handpiece 1. The shaver handpiece should be inspected and tested for proper function prior to use.

2. After cleaning and prior to sterilization, plug the shaver handpiece into the console.

3. Turn the console on and wait to complete self test.

4. Set speed for 1,000 RPM.

5. On the console, press the [On/Off] button to make sure the shaver activates and deactivates.

WARNING: DO NOT RUN HANDPIECE FOR LONGER THAN 30 SECONDS WITHOUT ASPIRATION FLUID FLOW.

10

6 On the handpiece, press the mode buttons and make sure the handpiece activates in each of the modes selected. Quick press each to turn shaver OFF.

7. Turn the suction valve to OFF then back to ON position to verify valve is operational.

8. Turn the console OFF and prepare the handpiece for sterilization.

Cleaning the Console 1. Disconnect from electrical source.

2. Wipe with clean damp cloth. Do not immerse or sterilize.

Re-Use of Console 1. The console should be inspected and tested for proper function prior to use.

2. Connect AC Mains cord to appropriate source. Press rear panel AC Mains switch to ON. Console standby light will illuminate.



5. On the console front panel press and release the [POWER] button. Standby light will go out. Console will enter self test mode. A series of power on self tests will run to check all functions of the Console. Console will display:

“SELF TEST VERSION X.00”

If any test fails, the system will lock and display the test that failed. Refer to Section 5 for troubleshooting instructions.

6. At the completion of self test, the console will display the following pre-set values:

Handpiece Icon: if handpiece connected. if no handpiece

Handpiece Running Icon: > <

Handpiece Active Icon: OFF

Mode Indicator: (Oscillate)

Numeric RPM Speed: 2,500 RPM

Message: HIGH SPEED SHAVER or NO SHAVER

Tool Mode: TOOL MODE: BLADE

7. The system is ready for surgery.

WARNING: DO NOT RUN HANDPIECE WITHOUT IRRIGATION.

Cleaning the Foot Switch 1. Wipe with clean damp cloth. Do not sterilize or immerse in disinfectant solution.

Cleaning and Sterililzation

Section 4

11

Re-Use of Foot Switch 1. The foot switch should be inspected and tested for proper function prior to use.



4. Set speed for 1,000.

5. Press forward pedal of foot switch. Shaver handpiece should run in forward mode at selected speed.

WARNING: DO NOT RUN HANDPIECE FOR LONGER THAN 30 SECONDS WITHOUT IRRIGATION.

6. Press reverse pedal of foot switch. Shaver handpiece should run in reverse mode at selected speed.


7. Press OSCILLATE pedal of foot switch. Shaver handpiece should run in oscillate mode at selected speed.


8. If all tests pass, the system is operating properly.

Cleaning and Sterilization

Section 4

12 Troubleshooting

Section 5

Problem Corrective Action

No Power to Console If standby light is ON, press front panel power button.

If standby light is OFF, set rear panel power switch to ON.

Check that AC cord from console is securely plugged into wall outlet.

Check that AC cord is securely plugged into rear panel of console.

Check the two fuses located inside the power entry module just above the AC Cord on the rear panel.

FAILED: WATCHDOG TEST Component failure. Unit must be returned to the factory for repair.

FAILED: MEMORY TEST Component failure. Unit must be returned to the factory for repair.

FAILED: POWER TEST Component failure. Unit must be returned to the factory for repair.

FAILED: FRONT PANEL KEY STUCK” Problem is in the front panel of the console, the unit must be returned to factory for repair.

FAILED: FOOT SWITCH PEDAL STUCK Disconnect foot switch and retest. If the foot switch failure goes away, the foot switch has failed, replace.

SHAVER STALL ERROR Turn front panel power switch OFF then ON. If problem reappears, replace handpiece.

If problem reappears with second handpiece, console must be returned to factory for repair.

SHAVER RUN ERROR Turn front panel power switch OFF then ON. If problem reappears, replace handpiece.


SHAVER DRIVER ERROR Turn front panel power switch OFF then ON. If problem reappears, replace handpiece.


OS QUEUE ERROR Turn rear panel AC Mains switch OFF; wait 10 seconds, then ON. If problem reappears, console must be returned to factory for repair.

OS TIMER ERROR Turn rear panel AC Mains switch OFF; wait 10 seconds, then ON. If problem reappears console must be returned to factory for repair.

FAILED: CODE TEST Turn rear panel AC Mains switch OFF; wait 10 seconds, then ON. If problem reappears console must be returned to factory for repair.

HANDPIECE KEY STUCK Disconnect handpiece and retest. If test passes, the handpiece failed. Replace handpiece. Note: System will allow operation in “no button mode” with a handpiece in this condition.

13Troubleshooting

Section 5

Shaver does not run or has no cutting power.

Check handpiece cord to insure it is securely plugged into console.

Check foot switch cord to insure it is securely plugged into console.

Check blade to see if it is jammed or bent. Replace if necessary.

Replace handpiece.

If second handpiece fails as well, the console will have to be returned to the factory for repair.

Foot switch does not work. Check foot switch cord to insure it is securely plugged into console.

Check handpiece cord to insure it is securely plugged into console.

Attempt to run handpiece from handpiece buttons or front panel of console. If handpiece runs from either replace foot switch.

T E C H N I C A L S U P P O R T 1 . 8 0 0 . 7 6 6 . 7 6 5 6

14 Specifications

Section 6

Overall dimensions: 34.29cm wide x 41.66 cm deep x 8.26 cm tall

Approximate weight: 5.23kg

Operational Environment:

Temperature: 10°C to 40°C Humidity: 30%-85%, non-condensing. Pressure: 500 hPa to 1060 hPa

Storage and Transport Environment:

Pressure: 500 hPa to 1060 hPa Temperature: -35°C to 70°C Humidity: 0% to 90% relative humidity, non-condensing.

Electrical Requirements: 100-120 VAC 50/60 Hz 750 VA 220-240 VAC 50/60 Hz 750 VA

Fuses 100-120 VAC T6.3 250V 5x20mm 220-240 VAC T6.3 250V 5x20mm Mfg. Bussmann GDC-6.3

Pump Interface: Switch input max. 28Vdc

Medical System Classification:

Protection against electric shock: Class I Protection against harmful ingress of water: Ordinary Degree of safety in the presence of flammable Not suitable for the use in the presence of anesthetics or oxygen: flammable anesthetics or oxygen Mode of operation: Continuous Type of applied part: BF

All parts of the PowerTek™ II Plus Arthroscopic High Speed Shaver System are designed for use in the patient environment.

Biomet Sports Medicine will supply on request, circuit diagrams, component part lists, descriptions, calibration instructions, or other information which will assist the users appropriately qualified personnel to repair those parts of equipment which are designated by the manufacturer as repairable.


15Specifications

Section 6

This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2001. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

•Reorientorrelocatethereceivingdevice.• Increasetheseparationbetweentheequipment.•Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichtheotherdevice(s)areconnected.•Consultthemanufacturerorfieldservicetechnicianforhelp.

WARNING: The use of ACCESSORIES, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the EQUIPMENT or SYSTEM as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the EQUIPMENT or SYSTEM.

Guidance and Manufacturer’s Declaration—Electromagnetic Emissions

The PowerTek™ II Plus System is intended for use in the electromagnetic environment specified below. The customer or the user of the PowerTek™ II Plus System should assure that it is used in such an environment.Emissions Test Compliance Electromagnetic Environment—Guidance

RF Emissions CISPR 11

Group 1 The PowerTek™ II Plus System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11

Class B The PowerTek™ II Plus System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic Emissions IEC 61000-3-2

Class A

Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

Complies

16

Guidance and Manufacturer’s Declaration—Electromagnetic Immunity

The PowerTek™ II Plus System is intended for use in the electromagnetic environment specified below. The customer or the user of the PowerTek™ II Plus System should assure that it is used in such an environment.Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment—Guidance

Electrostatic Discharge (ESD)

IEC 61000-4-2

+/-6 kV Contact

+/- 8 kV Air

+/-6 kV Contact

+/- 8 kV Air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material the relative humidity should be at least 30%.

Electrical Fast Transient/Burst

+/-2 kV for Power Supply Lines

+/-1 kV for Input/Output Lines

+/-2 kV for Power Supply Lines

+/-1 kV for Input/Output Lines

Mains power quality should be that of a typical commercial or hospital environment.

Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Lines

<5% UT(>95% Dip in UT) for 0,5 Cycle

40% UT (60% dip in UT) for 5 cycles


<5% UT (>95 % dip in UT) for 5 sec

<5% UT(>95% Dip in UT) for 0,5 Cycle



<5% UT (>95 % dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the PowerTek™ II Plus requires continued operation during power interruptions, it is recommended that the PowerTek™ II Plus be powered from an uninterruptible power supply.

Power frequency (50/60 Hz) Magnetic field IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

Specifications

Section 6

17

Guidance and Manufacturer’s Declaration—Electromagnetic Immunity

The PowerTek™ II Plus System is intended for use in the electromagnetic environment specified below. The customer or the user of the PowerTek™ II Plus System should assure that it is used in such an environment.Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment—Guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 KHz to 80 MHz

3V/m

80 MHz to 2.5Ghz

3 V/ms

3V/m

Portable and mobile RF communication equipment should be used closer to any part of the PowerTek II Plus (including cables) than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

80 MHz to 800 MHz

800 MHz to 2,5 GHz

Where the P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m)

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey should be less than the compliance level in each frequency range

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

A Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength on the location in which the PowerTek™ II Plus System is used exceeds the applicable RF compliance level above, the PowerTek™ II Plus System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocation the PowerTek™ II Plus System.

B Over the frequency range 105 KHz to 80 MHz, field strengths should be less than 3 V/m

Specifications

Section 6

18

Power Requirements Labels These labels contain voltage and current requirements, fuse requirements, system model type, manufactured revision, manufactured date, manufacturers part number, serial number, grounding requirements, electrical hazards and cautions, sales restrictions and customer/technical service locations.

Figure 6-1. Power Requirements Label

Figure 6-2 Fuse Rating Label

Specifications

Section 6

19

WARNING: Possible explosion if used in the presence of flammable anesthetics. Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

Manufacturer’s Identification: Identifies manufacturing company and parent company.

Device Manufacturing Data Label: Includes model name, manufacturing revision, manufactured date, manufacturer’s part number, and manufacturer’s serial number.

Service Information Label: Identifies contact for technical service or repairs.

Warnings, Cautions, Restrictions Label: Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “hospital grade.”

This symbol on the product means this product shall not be treated as municipal waste. At the end of its life this product is considered as Waste Electrical and Electronic Equipment (WEEE) and must be separately collected, disposed of, recovered and/or recycled in accordance with the requirements of the WEEE+ Directive 2002/96/EC. WEEE may contain substances that can be hazardous if released into the environment through improper disposal. By ensuring this product is disposed of correctly you will minimize any potentially negative effects on the environment and to human health. You may also help to conserve natural resources. For more detailed information about how to properly dispose of this product, please contact your local Biomet Sports Medicine distributor.

Specifications

Section 6

20

Safety Information:It is important to read, understand, and comply with all of the following safety precautions.

Failure to follow these precautions could result in injury to the patient or user or damage to the PowerTek™ II Plus Arthroscopic High Speed Shaver System.

The handpiece and foot switch are designed to be used in the patient environment. Do not touch the patient with other parts of the system. Components of the system that are meant for patient contact are constructed from biocompatible materials.

To avoid fire hazard and electrical shock:•Useonlythepowercordspecifiedforthisproduct.•Useonlythefusetypeandratingspecifiedforthisdevice.•Unplugthepowercordfromtheoutletwhenperforminganykindofcleaningormaintenance.•Donotoperatethisproductwithcoversorpanelsremoved.•Donotapplyaninputvoltagethatisoutsidethespecifiedrange.•Donotoperatethedeviceinanexplosiveatmosphere.•Donotallowforeignobjectsinsidethedevice.•Donotdisassemblethedevice.•Neverspillliquidsofanykindonthedeviceorimmerseitinliquids.•Connecttoaproperlygroundedhospital-gradeoutletonly.

To avoid personal injury and damage to this device:•Donotplaceonanunstablesurface,cart,standortable.AlwaysplaceandkeepthePowerTek™ II Plus Arthroscopic

High Speed Shaver System on a flat, level and secure surface so that it will not roll or tip over.•Donotoperatewithsuspectedfailures.Ifyoususpectthereisdamagetothisproduct,haveitinspectedbyqualified

personnel.•Donotblockventilationslotsoropenings—provideproperventilation.

Unplug the device from the wall outlet if any of the following occur:•Thepowercordisdamaged.•Liquidhasbeenspilledonthedeviceorithasbeenexposedtorainorothermoisture.•Thedevicehasbeendropped.•Theproductdisplaysadistinctchangeinperformance.•Theproductdoesnotoperateproperlywhentheoperatinginstructionsarefollowed.•ThePowerTek™ II Plus Arthroscopic High Speed Shaver System is not intended to be used with high-frequency surgery

equipment or laser equipment.•Beforeeachuse,checktheoutersurfaceoftheportionsoftheshaverforunintendedroughsurfaces,sharpedgesor

protrusions that could create a hazard.•Usecautionnottodamagetheshaverwhenitisusedsimultaneouslywithothersurgicaltools.

Specifications

Section 6

21Product Listing

Section 7

PowerTek™ II Plus High Speed Shaver System (Includes Console, Shaver Handpiece, and Foot Switch)

906064

PowerTek™ II Plus Console

906062

PowerTek™ II Plus Shaver Handpiece

906063

PowerTek™ II Plus Foot Switch

906061

22 Limited Warranty

Section 8

Biomet Sports Medicine Inc. warrants that its products shall be free from defects in material and workmanship under normal use of and service for the warranty period stated below beginning from the date of invoice. Biomet Sports Medicine’s obligation shall be limited to repair or replacement, at Biomet Sports Medicine’s option, of any product that within the warranty period is found to be defective in material or workmanship upon written notification by buyer identifying each and every defect. Any alteration, abuse, modification or misuse of the product shall void this limited warranty. This limited warranty shall also be void if repair work has been performed by sources other than Biomet Sports Medicine or by a repair facility not approved by Biomet Sports Medicine. THE FOREGOING LIMITED WARRANTY IS EXPRESSLY MADE IN LIEU OF ANY AND ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION OF ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WHICH ARE HEREBY DISCLAIMED. Biomet Sports Medicine SALES REPRESENTATIVES AND AGENTS ARE NOT AUTHORIZED TO MAKE WARRANTIES.

THE ABOVE STATED LIMITED WARRANTY IS THE SOLE AND EXCLUSIVE REMEDY FOR ANY CLAIMS BE THEY CONTRACT, WARRANTY NEGLIGENCE, TORT, OR STRICT LIABILITY FOR ANY LOSS ALLEGED TO ARISE OUT OF THE MANUFACTURE, SALE, DELIVERY OR USE OF AN BIOMET SPORTS MEDICINE PRODUCT. IN NO EVENT SHALL BIOMET SPORTS MEDICINE BE LIABLE FOR LOSS OF USE OR PROFITS, LOSS OF BUSINESS, EXPENSE OR COSTS ARISING FROM OR ALLEGED TO ARISE FROM BUSINESS INTERRUPTION, ATTORNEYS’ FEES AND EXPENSES OR CONSEQUENTIAL, CONTINGENT, INCIDENTAL, SPECIAL OR PUNITIVE DAMAGES ASSOCIATED WITH THE USE OF AN BIOMET SPORTS MEDICINE PRODUCT.

Biomet Sports Medicine’S OBLIGATIONS UNDER THIS LIMITED WARRANTY SHALL NOT INCLUDE PAYMENT OF SURGICAL AND/OR HOSPITALIZATION FEES OR EXPENSES, PATIENT REHABILITATION FEES AND/OR EXPENSES OR ANY OTHER FEES OR EXPENSES RELATED TO Biomet Sports Medicine FOR ITS REPLACEMENT.

THIS LIMITED WARRANTY SHALL NOT BE ENLARGED, OR AFFECTED BY, AND NO LIABILITY OR OBLIGATION SHALL ARISE FROM, Biomet Sports Medicine’S RENDERING OF ANY ADVICE OR SERVICE IN CONNECTION WITH ANY OF ITS PRODUCTS.

THIS LIMITED WARRANTY CANNOT BE ASSIGNED OR TRANSFERRED.

Limited Warranty PeriodsCapital Equipment: 1 Year; PowerTek™ II Plus console, PowerTek™ II Plus shaver handpiece, PowerTek™ II Plus foot switch.

23Product Repair

Section 9

Biomet Sports Medicine offers repair services for products as listed below, unless they are obsolete. Products to be repaired should be returned to the appropriate address below. Owner is responsible for associated costs of repair for out-of-warranty products.

ReturnsShip the product freight or postage-prepaid by the sender, to Biomet Sports Medicine, and provide the reason(s) for its return. The addresses for returns are provided below. Include the original or a copy of the purchase order or invoice. The product must be returned clean and sterile, if applicable. If contaminated with biohazardous material, the product will be cleaned and sterilized at the sender’s expense.

Implants and Related Instruments:Biomet Sports Medicine-Warsaw 56 East Bell Drive Warsaw, IN 46582 800-348-9500

Pump Cassette, Shaver Blades, Manual Forceps, Optical Couplers, Items not listed for Redding or Warsaw:Biomet Sports Medicine-Ontario 4861 East Airport Drive Ontario, CA 91761 800-535-8692

IES System, Shaver/Pump, Camera/light Source, Shaver, Cameras, Anything containing electrical wires:Biomet Sports Medicine-Redding 6704 Lockheed Drive Redding, CA 96002 800-766-7656

All products returned to Redding require authorization prior to shipment. Contact Technical Service at 800-766-7656.

Repairs of Sony Products:All Sony repairs covered by warranty or not, must be handled directly with Sony. For support, please phone the Sony Medical National Technical Support Department, Monday through Friday 8:00 a.m. – 5:00 p.m. EST.

Sony Medical Systems 3 Paragon Drive (S200) Montvale, NJ 07645 800-535-SONY 201-358-4961

Authorized Representative For regulatory requirements related to the Medical Device Directive, Biomet Sports Medicine’s Authorized Representative with the European Community is:

Biomet U.K. Ltd. Waterton Industrial Estate Bridgend South Wales CF31 3XA, U.K.

24

Notes

25

Notes

P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 ext. 1501 • ©2006, 2007 Biomet Sports Medicine, Inc. All Rights ReservedForm No. Y-BMT-1004R/013106

This material is intended for the Biomet Sports Medicine Sales Force and surgeons only. It is not intended to be redistributed without

the express written consent of Biomet Sports Medicine.

PowerTek™ is a trademark of Biomet Sports Medicine, Inc.

Steris® is a trademark of Steris Corp.

Sterrad® and Cidex® are trademarks of J&J Corp.

Orthozine® is a trademark of Ruhof Corp.

www.biometsportsmedicine.com

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