Operators Manual
28 Pages
Preview
Page 1
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.
Preface
1
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
Section 3:
3 4 4 5 5 6
Setup and Operation...
Section 4:
Front Panel... Alpha/Numeric Display... Rear Panel... Internal Details... High Speed Suction Control Shaver Handpiece... Foot Switch...
Setup... Intra-Operative Adjustments...
7 7
Cleaning and Sterilization...
Cleaning the Shaver Handpiece... Material Compatibility... Sterilization... Re-Use of Shaver Handpiece... Cleaning the Console... Re-Use of Console... Cleaning the Foot Switch... Re-Use of Foot Switch...
7
9
9 9 9 9 10 10 10 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
Section 1 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 2 Description 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.
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.
3
Section 2 4
Description Alpha/Numeric Display
Figure 2-2. Alpha/Numeric Display
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
1 2
Figure 2-3. Rear Panel
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.
Section 2 Description
5
Internal Details Motor 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 Handpiece The 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.
Suction Valve
Outflow Tube Connector
Control Buttons
Figure 2-4. High Speed Suction Control Handpiece
WARNING: Operating the handpiece without fluid flowing through it may cause excessive heat and may damage the handpiece.
Handpiece Button Functions Note: 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.
Section 2 6
Description 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 Switch The 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
Section 3 Setup and Operation
7
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. WARNING: Operating the handpiece without fluid flowing through it may cause excessive heat and may damage the 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.
Handpiece Running Icon:
><
Handpiece Active Icon:
OFF
Mode Indicator:
if no handpiece
(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 Adjustments The 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: HP: FS:
To Adjust Rotation Mode: FP: HP: FS:
Press shaver On/Off button Press appropriate button Press appropriate pedal Press mode button to cycle through (With handpiece OFF) press and release the desired mode button quickly. Press appropriate pedal (Note: Cannot oscillate above 3,500)
Note: Shaver must be off to change modes.
Section 3 8
Setup and Operation To Adjust Shaver Speed: FP: HP: FS:
Press RPM UP ( ) or RPM DOWN ( ) button Press and hold the up or down arrow button RPM cannot be adjusted with the foot switch
To Change Tool Mode: FP: HP: FS:
Tool mode cannot be changed from the front panel (With handpiece OFF) Press and hold the middle button to toggle between blade (low speed) or bur (high speed) modes. 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.
WARNING: Operating the handpiece without fluid flowing through it may cause excessive heat and may damage the handpiece.
Section 4 Cleaning and Sterilization Cleaning Shaver Handpiece Preparation 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 Compatibility The 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.
Sterilization Sterilize 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.
9
Section 4 10
Cleaning and Sterililzation 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. 3. Connect foot switch cable to console foot switch connector. 4. Connect shaver handpiece cable to console handpiece connector. 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.
Handpiece Running Icon:
><
Handpiece Active Icon:
OFF
Mode Indicator:
if no handpiece
(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.
Section 4 Cleaning and Sterilization Re-Use of Foot Switch 1. The foot switch should be inspected and tested for proper function prior to use. 2. Connect foot switch cable to console foot switch connector. 3. Connect shaver handpiece cable to console handpiece connector. 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. WARNING: DO NOT RUN HANDPIECE FOR LONGER THAN 30 SECONDS WITHOUT IRRIGATION. 7. Press OSCILLATE pedal of foot switch. Shaver handpiece should run in oscillate mode at selected speed. WARNING: DO NOT RUN HANDPIECE FOR LONGER THAN 30 SECONDS WITHOUT IRRIGATION. 8. If all tests pass, the system is operating properly.
11
Section 5 12
Troubleshooting 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. If problem reappears with second handpiece, console must be returned to factory for repair.
SHAVER DRIVER 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.
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.
Section 5 Troubleshooting Shaver does not run or has no cutting power.
13 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.
TECHNICAL SUPPORT
1.800.766.7656
Section 6 14
Specifications Overall dimensions:
34.29cm wide x 41.66 cm deep x 8.26 cm tall
Approximate weight:
5.23kg
Operational Environment: Temperature: Humidity: Pressure:
10°C to 40°C 30%-85%, non-condensing. 500 hPa to 1060 hPa
Storage and Transport Environment: Pressure: Temperature: Humidity:
500 hPa to 1060 hPa -35°C to 70°C 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: Protection against harmful ingress of water: Degree of safety in the presence of flammable Mode of operation: Type of applied part:
Class I Ordinary Not suitable for the use in the presence of anesthetics or oxygen: flammable anesthetics or oxygen Continuous 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. WARNING: Operating the handpiece without fluid flowing through it may cause excessive heat and may damage the handpiece.
Section 6 Specifications
15
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: • Reorient or relocate the receiving device. • Increase the separation between the equipment. • Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. • Consult the manufacturer or field service technician for help. 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
Harmonic Emissions IEC 61000-3-2
Class A
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.
Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3
Complies
Section 6 16
Specifications 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)
+/-6 kV Contact
+/-6 kV Contact
+/- 8 kV Air
+/- 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%.
+/-2 kV for Power Supply Lines
+/-2 kV for Power Supply Lines
Mains power quality should be that of a typical commercial or hospital environment.
+/-1 kV for Input/ Output Lines
+/-1 kV for Input/ Output Lines
<5% UT (>95% Dip in UT) for 0,5 Cycle
<5% UT (>95% Dip in UT) for 0,5 Cycle
40% UT (60% dip in UT) for 5 cycles
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
70% UT (30% dip in UT) for 25 cycles
IEC 61000-4-2 Electrical Fast Transient/Burst
Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Lines
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.
<5% UT (>95 % dip in <5% UT (>95 % dip in UT) for 5 sec UT) for 5 sec Power frequency (50/60 Hz) Magnetic field IEC 61000-4-8
3 A/m
3 A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Section 6 Specifications
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
3 Vrms
3 V/ms
IEC 61000-4-6
150 KHz to 80 MHz
Radiated RF
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.
IEC 61000-4-3
80 MHz to 2.5Ghz
3V/m
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
Section 6 18
Specifications 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
Section 6 Specifications
19 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. 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.