Operator’s Manual

The PowerPump™ DP maximizes visibility during arthroscopy through the SmartVision® technology by Medical Vision R&D AB, Sweden.

The PowerPump™ DP detects factors that impede visibility during surgery, and automatically compensates for them. When engaged, the SmartVision® function automatically moderates flow and pressure to obtain maximum view.

The PowerPump™ DP controls the Intra-Articular Pressure (IAP); not the pressure at the pump. The IAP is displayed on the pump display.

The user can easily change the flow/pressure settings during surgery, if needed.

The PowerPump™ DP supports interface connection to shaver systems.

1Table of Contents

Description, Indications for Use, and Contraindications .............................................................................. 2Description ............................................................................................................................................................................................................................................................ 2Indications for Use .............................................................................................................................................................................................................................................. 2Contraindications ................................................................................................................................................................................................................................................ 2

System Overview .............................................................................................................................................. 3 – 5Connection Diagram with PowerTek™ II Plus ............................................................................................................................................................................................. 3Connection Diagram with shaver other than PowerTek™ II Plus ......................................................................................................................................................... 4Shaver control by use of the pump’s foot control.................................................................................................................................................................................... 4Connection Diagram with shaver other than PowerTek™ II Plus ......................................................................................................................................................... 5Shaver control by use of the pump’s foot control or hand control. .................................................................................................................................................. 5

Principle of Operation ...................................................................................................................................... 6

Warnings, Precautions, and Adverse Events .................................................................................................. 7 – 8Warnings ................................................................................................................................................................................................................................................................. 7Precautions ............................................................................................................................................................................................................................................................ 7Adverse Events ..................................................................................................................................................................................................................................................... 8

Controls, LEDs, and Alarms .............................................................................................................................. 9 – 12Controls & LEDs .................................................................................................................................................................................................................................................... 9Unpacking .............................................................................................................................................................................................................................................................. 12Assembly and System Check ........................................................................................................................................................................................................................... 12

Instructions for Use .......................................................................................................................................... 13 – 20Operator Training Requirements ................................................................................................................................................................................................................... 13Starting the Procedure ..................................................................................................................................................................................................................................... 13Load the cassettes. .............................................................................................................................................................................................................................................. 13Joint Selection ...................................................................................................................................................................................................................................................... 13Cassette Loading and Unloading .................................................................................................................................................................................................................. 13Loading a Day Cassette ..................................................................................................................................................................................................................................... 14Connecting the Irrigation Tubing .................................................................................................................................................................................................................. 15 Loading a Patient Cassette ............................................................................................................................................................................................................................... 16PowerPump™ DP Function and Adjustment During Procedure ........................................................................................................................................................ 18Changing Default Settings ............................................................................................................................................................................................................................... 19Cassette Removal ................................................................................................................................................................................................................................................ 20System Shut Down .............................................................................................................................................................................................................................................. 20

Shaver Interface Box Instructions ................................................................................................................... 21PowerPump™ DP Control of Shaver.............................................................................................................................................................................................................. 21Shaver Control of the PowerPump™ DP ...................................................................................................................................................................................................... 21Cleaning Instructions ......................................................................................................................................................................................................................................... 21Troubleshooting Guide Shaver Interface Box ........................................................................................................................................................................................ 21

Alarms................................................................................................................................................................ 22

System Care ....................................................................................................................................................... 23System Environmental Requirements ......................................................................................................................................................................................................... 23Equipment Disposal ........................................................................................................................................................................................................................................... 23Surface Cleaning & Disinfection of Pump and Foot Control ................................................................................................................................................................ 23

Maintenance and Troubleshooting ................................................................................................................. 24Maintenance ......................................................................................................................................................................................................................................................... 24Troubleshooting Guide ..................................................................................................................................................................................................................................... 24System Does Not Power Up After the Power Switch is Set to On. ..................................................................................................................................................... 24Fuse Replacement ............................................................................................................................................................................................................................................... 24Front Cover Replacement ................................................................................................................................................................................................................................. 24Error Codes ............................................................................................................................................................................................................................................................ 24

Technical Specifications ................................................................................................................................... 25

Symbols Key ...................................................................................................................................................... 26

Pump Classification and Safety Verification ................................................................................................... 27Classification ......................................................................................................................................................................................................................................................... 27Safety Verification ............................................................................................................................................................................................................................................... 27

Ordering Information ....................................................................................................................................... 28

Customer Service .............................................................................................................................................. 29Warranty Information ........................................................................................................................................................................................................................................ 29Product Complaints ............................................................................................................................................................................................................................................ 29Distributed by: ...................................................................................................................................................................................................................................................... 29

2 Description, Indications for Use, and Contraindications

DescriptionThe PowerPump™ DP provides liquid irrigation and aspiration for endoscopic procedures in one unit through two individual roller pumps. Both roller pumps are software controlled and automatically manage fluid and joint pressure based on procedure settings chosen by the user. If needed, both flow and pressure settings can be individually adjusted.

By controlling both inflow and outflow, the PowerPump™ DP accurately regulates pressure and flow in the joint. The PowerPump™ DP also provides suction when used in conjunction with a shaver.

The PowerPump™ DP consists of the following articles:

1) PowerPump™ DP Unit2) Reusable, non-sterile Foot Control

3) Reusable, non-sterile Mains cablePowerPump™ DP Disposables (sold separately):

1) PowerPump™ DP Patient Cassette inclusive sterile irrigation tubing 2) PowerPump™ DP Day Cassette3) PowerPump™ DP irrigation tubing

The disposable sterile Patient Cassette with sterile irrigation tubing, Day Cassette and irrigation tubing is supplied separately.

Reusable, non-sterile shaver interfaces for compatible shaver systems are available and supplied separately. For a list of available interfaces, please contact your Biomet Sports Medicine authorized representative.

Indications for UseThe PowerPump™ DP is a dual arthroscopic pump system intended to provide fluid distention and irrigation of knee, shoulder, hip, elbow, ankle, and wrist joint cavities, and fluid suction during operative arthroscopic procedures.

Contraindications• DO NOT use the PowerPump™ DP for procedures such as gynecological, urologic, endoscopic temporomandibular

joints, or any other non arthroscopic procedure.• DO NOT use the PowerPump™ DP in instances where capsular integrity is suspect.• DO NOT use the PowerPump™ DP with a gas distension medium. Use only with sterile irrigation solution for

distension of the operative site.• DO NOT use the PowerPump™ DP to administrate drugs, IV-fluids, blood or blood substitutes.

3System Overview

Connection Diagram with PowerTek™ II Plus

1 PowerPump™ DP 2 Mains Cable3 Foot Control: a) Shaver Reverse b) Shaver Forward c) Cannula d) Rinse4 Shaver from PowerTek™ II Plus5 Shaver Handpiece

6 Shaver Interface Cable

4 System Overview

Connection Diagram with shaver other than PowerTek™ II PlusShaver control by use of the pump’s foot control.

1 PowerPump™ DP 2 Mains Cable3 Foot Control: a) Shaver Reverse b) Shaver Forward c) Cannula d) Rinse4 Shaver other than PowerTek™ II Plus5 Shaver Handpiece6 Shaver Interface Cable

5System Overview

Connection Diagram with shaver other than PowerTek™ II PlusShaver control by use of the pump’s foot control or hand control.

1 PowerPump™ DP 2 Mains Cable3 Foot Control: a) Shaver Reverse b) Shaver Forward c) Cannula d) Rinse4 Shaver other than PowerTek™ II Plus5 Shaver Handpiece6 Shaver Interface Box7 Shaver Foot Control

6 Principle of Operation

The PowerPump™ DP can operate in two different modes:

1) Irrigation only2) Double pump

During Inflow only, the PowerPump™ DP regulates the pressure using the PowerPump™ DP Day Cassette only.

The PowerPump™ DP Day Cassette is connected to the sterile saline bags and the irrigation tubing, which is connected to the arthroscope sheath. The irrigation tubing is delivered individually or in the PowerPump™ DP Patient Cassette package.

During double pump mode, the PowerPump™ DP regulates pressure and flow using the Day and Patient Cassettes. The PowerPump™ DP Day Cassette is connected to the sterile saline bags and the irrigation tubing to the arthroscope sheath. The PowerPump™ DP Patient Cassette discharges the liquid from the joint into a waste collection system.

The PowerPump™ DP has the SmartVision® feature. SmartVision® will detect blood and/or debris when it emerges from the joint. It will automatically elevate pressure and flow into the joint when blood is detected, or elevate flow when debris is detected. SmartVision® can be disabled if desired.

The pump also has an Outflow Tracking feature, which regulates inflow to the joint to precisely replace liquid removed by the outflow pump. The result is a constant volume of fluid in the distended joint. This helps to prevent collapse of the joint in cases with compliant joint capsule. Outflow Tracking can be disabled if desired.

Furthermore, the system automatically compensates for liquid resistance in the irrigation system. This means that the pressure value displayed is actual joint pressure, not the pressure by the pump or in the Day Cassette.

For more information about the PowerPump™ DP features please visit www.biometsportsmedicine.com

7Warnings, Precautions, and Adverse Events

The following is a list of Warnings and Precautions that apply to the general operation of the Biomet Sports Medicine PowerPump™ DP.

Warnings• Theequipmentmayonlybeoperatedbypersonneltrainedinarthroscopyprocedures.• Failuretofollowallapplicableinstructionsmayresultinserioussurgicalconsequencesforthepatient.• DO NOT operate this device in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions,

or any material susceptible to ignition due to electrical sparking.• DO NOT use the pump if dropped or if it shows signs of damage.• Extravasationorotherpatientinjurymayoccurifinstructionsandwarningsarenotfollowed.Ifextravasationoccurs,

orthopedic literature supports management by elevation and serial compression wrapping. Fasciotomy is rarely indicated.

• DO NOT allow the pump to run unattended. Patient safety requires the pump to be continuously monitored throughout operation.

• Forelectricalsafetyreasonsalwaysuseanon-conductivewastecontainerforwastefluid.• Ifanerrorcodeappearsonthedisplay,DO NOT use the pump. Gravity may be used for an emergency procedure to

irrigate the joint directly from saline bags. The shaver, if used, may then be connected to an external vacuum source.

The equipment has been tested and found in compliance with limits for medical devices according to the IEC60601-1-2 standard. These limits are designed to provide reasonable protection, in a typical medical installation, against harmful interference between equipment in the vicinity of each other. If the pump does cause harmful interference to other devices, which can be determined by turning it ON and OFF with the mains switch, try to reduce the interference by relocating the system or separating it from other devices—or both. If you cannot resolve the problem, please contact Customer Service.

Precautions• Priortoinitialuse,ensurethatallpackageinserts,warnings,precautions,andInstructionsforUsearereadand

understood.• Consultmedicalliteraturerelativetotechniques,complications,andhazardspriortoperforminganyprocedure.• Evaluatepatientsforpredisposingmedicalconditionsthatmaybecomeaggravatedbythestressofsurgery.• Wheninstrumentsandaccessoriesfromdifferentmanufacturersareemployedtogetherinaprocedure,verify

compatibility prior to initiation of the procedure. Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g. IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any individual who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical service department or your authorized Biomet Sports Medicine representative.

• Whenendoscopesareusedwithendoscopically-usedaccessories,thepatientleakagecurrentsmaybeadditive.• ThePowerPump™DPisaClassIdevicewithTypeBFappliedpart,accordingtotheElectricalSafetyStandardIEC

60601-1 for medical devices. Ensure that you are using only Biomet Sports Medicine approved Interface Cables and Interface Boxes when connecting to a Shaver System.

• DO NOT connect the device to a power source that is not properly earthed (grounded).• Topreventelectricalshockhazard,unplugtheMaincablefromthepowersourcebeforedetachingthecablefrom

the pump. Disconnect the device from the main power source when cleaning, servicing, or inspecting.• DO NOT connect or disconnect the foot control when the pump is powered on.• DO NOT connect or disconnect interface cables to a Shaver System when the pump is powered on.• DO NOT remove the cover of the pump. Refer servicing to qualified personnel.

8 Warning, Precautions, and Adverse Events

• Toavoidriskoffire,onlyreplacethefuseswiththesametypeandrating.• Annualpreventivemaintenancemustbeperformedbyqualifiedtechnicalservicepersonnel.• Beforeuse,ensurethatthemaincableplugisproperlyconnectedtothepumpreceptacle.CheckthatallPumpLED

lights and audio signals are functional at start-up.• AvoidfluidcontactwiththePowerPump™DP.Incaseofliquidspillagethatresultsinariskthatliquidhasentered

the pump, it must be immediately turned off and Main cable removed. Contact an authorized service technician.• IfatanytimeyoufeelthatthePowerPump™DPisnotoperatingcorrectly,toohighpressureissuspected,orthe

system is sounding alarms that can not be resolved, stop fluid flow immediately by pressing the ‘Run/Stop’ button. If this does not stop the pump, turn it off with the On/Off switch on the Rear panel. This will stop fluid inflow, allowing the problem to be investigated.

• IfthePowerPump™DPistakenoutofserviceduringaprocedure,gravitymaybeusedforanemergencyprocedureto irrigate the surgery area directly from the saline bags. The shaver, if used, may then be connected to an external vacuum source.

• Inspectequipmentandcablesforwearpriortoeachuse.Ifdamageisnoted,replaceandreturntoBiometSportsMedicine authorized representative.

• DO NOT operate the pump with the roller assembly cover removed or damaged.• Ifthepumpoperateswithoutacassetteinplace,contactanauthorizedBiometSportsMedicinerepresentative.• DO NOT insert foreign objects into the PowerPump™ DP. This constitutes a safety hazard and can cause extensive

damage or injury.• DO NOT scratch or press the two pressure transducers (white discs) fitted on the front panel of the pump where the

Day Cassette is placed.• DO NOT insert fingers into the pump rollers. • DO NOT use cassettes other than the PowerPump™ DP Day Cassette, PowerPump™ DP Patient Cassette and Pow-

erPump™ DP irrigation tubing provided by Biomet® Sports Medicine. Usage of unauthorized cassettes may cause patient or user injury and equipment damage or malfunction.

Adverse EventsAs a consequence of diagnostic and operative arthroscopic procedures, damage to surrounding tissue through iatrogenic injury could occur.

9Controls, LEDs, and Alarms

Controls & LEDsThe PowerPump™ DP incorporates the following controls and LEDs:

Front Panel

1. Day Cassette button This button opens or closes the Day Cassette pressure arm. The blue LED adjacent to the button indicates the following status:

•OffwhentheDayCassetteisnotpositionedinthepumpandthepressurearmisopen•BlinkingwhentheDayCassetteiscorrectlypositionedinthepumpandthepressurearmisclosing•BlinkingiftheDayCassetteisincorrectlypositionedinthepumpandthepressurearmisclosed•OnwhentheDayCassetteiscorrectlyloadedandpressurethearmisclosed

2. On/Standby button This button toggles the PowerPump™ DP between On or Standby mode. From Standby, press the button once to

turn the pump On. To enter Standby, press and hold the button for two seconds. The green LED adjacent to the button will blink in Standby state and illuminate when the PowerPump™ DP is ‘ON’.

3. Outflow Mode Tracking button This button activates/deactivates the Outflow Tracking function. The blue LED is illuminated when Outflow Tracking

is on.4. Pressure increase/decrease buttons These buttons adjust the pressure setting controlled by the pump.5. Soft Keys The function of these buttons is indicated by the adjacent text in the Display. The functions vary as the Display

text changes.6. Display This Display indicates settings, soft key functions, alarm situations, pressure and flow values.

10 Controls, LEDs, and Alarms

7. Flow increase/decrease buttons These buttons adjust the flow setting controlled by the pump. The Flow adjustment is only available if a Patient

Cassette is being used.8. SmartVision®button This button activates/deactivates the SmartVision® function. The blue LED is illuminated when SmartVision®

monitoring is on.9. Run/Stop button This button starts and stops the fluid flow and pressure control. When the pump is running, the green LED light will

illuminate and blink when the pump stops.10. Patient Cassette button

This button loads and unloads the Patient Cassette pressure arm. The blue LED adjacent to the button indicates the following status:

•OffwhenthePatientCassetteisnotpositionedinthepumpandthepressurearmisopen•BlinkingwhenthePatientCassetteiscorrectlypositionedinthepumpandthepressurearmisclosing•BlinkingifthePatientCassetteisincorrectlypositionedinthepumpandthepressurearmisclosed•OnwhenthePatientCassetteiscorrectlyloadedandthepressurearmisclosed

11. Pump Foot Control Receptacle The pump Foot Control plugs into this receptacle located on the front of the pump.

Rear Panel

12. On/Off Switch This switch turns the AC power On and Off. Note that the pump may be put in a standby mode with On/Standby

button on the front panel. If the green LED on the front panel is blinking, the pump is in standby mode, press On/Standby button to turn the pump On.

13. Serial communications port This connector is only for use by technical personnel. DO NOT connect anything to this connector.

14. Acoustic Volume Control The Volume Control regulates tone volume for acoustic alarms and indications. To increase volume, turn the knob

clockwise. To reduce volume, turn the knob counterclockwise.

11Controls, LEDs, and Alarms

15. Mains Cable Receptacle / Fuse Holder The pump Mains cable plugs into this receptacle. The fuse holder is located between the Mains cable receptacle and

the On/Off switch.16. Equipotential Ground Conductor

This conductor is used to bond the equipment to earth ground.17. Shaver interface box Receptacle

Receptacle for shaver interface box. The interface itself is connected to the front panel output connector on the shaver controller. The shaver handpiece is then connected to the interface.

18. Shaver Interface Cable Receptacle Connector for bidirectional communication with the PowerTek™ II Plus Shaver System. For other shaver brands an

interface cable is connected to this receptacle and the opposite end of the cable is connected to the foot switch receptacle of the shaver controller. When instruments and accessories from different manufacturers are employed together, please see the precautions on page 7 with respect to requirements in the standard IEC 60601-1-1.

Foot Control

Shaver Reverse Pedal The first black pedal to the left side on the foot control activates a connected shaver system. The shaver blade will

rotate counter clockwise. Shaver Forward Pedal This second black pedal on the foot control activates a connected shaver system. The shaver blade will rotate

clockwise. Shaver Oscillate Pressing Reverse and Forward simultaneously will initiate the oscillating mode of the shaver. Change speed of connected shaver system Press Cannula and Forward simultaneously to decrease speed Press Cannula and Rinse simultaneously to increase speed Cannula Pedal This blue pedal activates the Cannula function of the pump Rinse Pedal This red pedal activates/deactivates the Rinse function of the pump Signal Tones One short tone: Rinse Mode is activated Two short tones: Rinse Mode is deactivated

12 Unpacking, Assembly, and System Check

UnpackingVerify that all items have been received and are not damaged. Damage should be reported immediately to the carrier and to Biomet Sports Medicine authorized representative. Save all containers and packaging material. They will be required if it is necessary to return the equipment.

Assembly and System Check1. Before first use, inspect the PowerPump™ DP for possible damage. Inspect the mains cable and all cables for wear

or cuts.2. Connect the mains cable to the receptacle (15) on the rear panel of the pump. Connect the other end of the main

cable to the electrical outlet. If it is necessary to use a mains cable other than the one supplied with the pump, the alternate mains cable must comply with appropriate electrical standards and be suitable for hospital use. Attach the pump Foot Control Receptacle on the front panel (11).

3. There are three alternatives on connecting a shaver system to the PowerPump™ DP as shown in the Connection diagram on page 5.

4. If a PowerTek™ II Plus shaver from Biomet Sports Medicine is used, the Shaver Interface Cable must be used. This is Y-configured and connects to the rear and to the front of the shaver . The other end connects to receptacle (18) at the rear of the PowerPump™ DP. This setup allows both control of the pump and shaver with the pump Foot Control, and finger control with the shaver handpiece, when applicable.

5. For other shavers to be controlled by the PowerPump™ DP Foot Control: From the selection of Shaver interface cables. See separate leaflet from Biomet Sports Medicine for correct selection of Interface cable. Connect the ap-propriate Shaver Interface cable (6) to the Shaver Interface receptacle (18), and connect the other end to the foot control connector of the shaver (4) (Ref page 4).

6. If the shaver has a finger controlled handpiece, a corresponding Shaver interface box (6) must be used. See separate leaflet for correct selection of shaver interface box. It is connected to connector (17) at the rear of the pump. The other end is fitted on the front panel of the shaver system (4), and the shaver handpiece is connected to the box of the interface as shown in the Connection diagram. Attach the pump Foot Control to the pump Foot Control Recep-tacle (11) on the front panel (Ref page 5).

7. Turn the On/Off Switch on the rear panel of the pump to the ‘On’ position. The pump is now in Standby. Press the On/Standby button (2) on the front panel and the system will proceed through a Power On Self Test routine, and PowerPump™ DP and software version number will be displayed. During this sequence, verify that the display and LED lights are working properly and that the alarm tone is audible. The Display should show ‘START’ and ‘setup’ options associated with the Soft Keys (5). If an error code appears instead, the pump may not be used. Contact Biomet Sports Medicine authorized representative, and report the error code number (Ref page 9).

8. If the PowerPump™ DP malfunctions or shows signs of damage, contact Biomet Sports Medicine service center or Biomet Sports Medicine authorized representative.

13Instructions for Use

Section 5

Operator Training RequirementsThe operator should be experienced in arthroscopic techniques. The user shall endeavor to remain current with advances in orthopedic procedures. Additional training on the use of the PowerPump™ DP from a Biomet® Sports Medicine authorized representative is recommended.

Starting the Procedure Press the Soft Key ‘START’. The pump can be used for Inflow only (single pump) or for both Inflow and Outflow (double pump).

Load the cassettes.To use only Inflow mode, only load the Day Cassette and connect the irrigation tubing to the Day Cassette. To use both Inflow and Outflow, load the Day Cassette, and the Patient Cassette, connect the Irrigation Tube to the Day Cassette.

See Cassette loading and Unloading below. ‘OK’ will be visible on the Display next to a Soft Key. Press the Soft Key ‘OK’ to continue to the procedure selection menu. Pressing the Soft Key will return to the cassette loading menu.

Joint SelectionThe procedure selection menu provides four options for joint type: 1) Shoulder 2) Knee 3) Hip 4) Small Joint. Each of these procedure types have specific default settings for pressure and flow. Changing the default settings is described in ‘Changing Default Settings.’

Select the appropriate joint type by moving the arrow with the Soft Keys. When the arrow is adjacent to the appropriate joint type, press the Soft Key corresponding to ‘OK’ to continue to the Run/Stop menu. Pressing the Soft Key will return to the cassette loading menu.

Cassette Loading and UnloadingThe cassette loading menu can be accessed by either pressing one of the Soft Keys ‘START’ on the Display, or by pressing either the Day Cassette or Patient Cassette button on the key board. When the cassette loading menu is visible on the Display, the loading status of the cassettes will be shown.

NOTE: From the cassette loading menu, the Soft Key can be pressed to return to the START/setup menu.

NOTE: Before opening the sterile cassettes and Irrigation Tube, carefully examine the shipping package and sterile wrap. If the package is damaged, the sterile seal is broken, or if the expiration dates has passed, do not use. Sterility is guaranteed only if the cassette loading and unloading procedures are performed according to the set-up described.

14 Instructions for Use

Loading a Day Cassette1. Open the individual package. Use aseptic technique when opening the package. The Day

Cassette can be used a whole operating day. Maximum eight hours.2. Remove the cassette and related tubing from the package.3. Close all three clamps on the cassette.

4. Remove the cap from one of the spikes and connect the spike to a sterile saline bag. The second spike can be connected to a secondary bag in the same way.

5. Open the clear front cover of the pump. Push the cassette tubing loop completely over the left pump wheel. Push the cassette in place. The cassette should snap in place. The blue LED light beside the Day Cassette button will blink when the Day Cassette is cor-rectly positioned in the pump.

6. Close the front cover.

7. Press the Day Cassette button on the pump. Proper loading is verified in the display. 8. Open the clamp for the primary saline bag.

15Instructions for Use

Connecting the Irrigation Tubing1. Open the individual package. Use aseptic technique when opening the package. The

package for the PowerPump™ DP Patient Cassette includes also the irrigation tubing.

2. Sterile operator: Remove the irrigation tubing from the package, and then remove the transparent wrapping from the irrigation tubing.

3. The distal end of the Day Cassette shall be connected to the irrigation tubing.

4. Sterile operator: Ensure that the transparent luer lock connection between the tubing and the valve is tightened.

5. Sterile operator: Close the red clamp on the irrigation tubing and hand over the proxi-mal end (end with blue cap) of the tubing to the non-sterile operator.

6. Non-sterile operator: If present, remove any used one-way valve from the Day Cassette. Remove the blue cap from the irrigation tubing and connect the blue swivel connector to the transparent female luer lock connector on the distal end of the Day Cassette.

7. Non-sterile operator: Open the white clamp near the Day Cassette and the red clamp on the irrigation tubing.

8. The Day Cassette and irrigation tubing can now be filled with sterile saline per the pump priming procedure. When the tube is filled, the red clamp on the irrigation tubing can be used to open or close the flow.

9. The distal end of the cassette should be connected to the irrigation tubing contained in PowerPump™ DP Patient Cassette or the separate packing of the irrigation tubing.

16 Instructions for Use

Loading a Patient Cassette1. Non-sterile operator: Open the individual package as shown. Use aseptic technique

when opening the package. The package consists of an irrigation tubing and a Patient Cassette.

2. Sterile operator: The irrigation tubing is loaded as described above.

3. Sterile operator: Remove the Patient Cassette from the package. Keep the Cannula, and Shaver tubing, and hand the cassette to the non-sterile operator to load into the pump.

4. Non-sterile operator: Open the clear front cover of the pump. Push the cassette tubing loop completely over pump wheel to the right. Push the cassette in place. The cassette should snap in place. The blue LED light adjacent to the Patient Cassette button will blink when the Patient Cassette is correctly positioned in the pump.

5. Non-sterile operator: The three tubings attached to the left side of the Patient Cassette will align with the slots on the pump. Push the tubing completely into the slots as far as they will go. Align the tubing together where they exit the slot and hold them in position by closing the slide lock.

17Instructions for Use

6. The correct tubing setup is shown in this figure.7. Non-sterile operator: Connect the tubing marked WASTE to the waste collection

container.

8. Non-sterile operator: Close the front cover.

9. Non-sterile operator: Push the Patient Cassette button on the pump. Proper loading is verified in the Display.

10. Sterile operator: Connect the end of the OUTFLOW CANNULA tubing to the cannula. The tubing marked SHAVER is connected to the suction port of the shaver. If a shaver is not used, the tubing can remain disconnected.

Priming the Day Cassette and Irrigation Tube

1. To prime the Day Cassette and irrigation tubing with saline, press the Soft Key ‘Prime’ on the Run/Stop menu. The pump will automatically prime the tubing, counting down from 10 sec. It is possible to stop the priming, press the Soft Key as the Priming time is counting down. When priming stops, the Display will return to the Run/Stop menu. Priming can be repeated if necessary.

Adjusting the Initial Pressure and Flow Settings

2. The Run/Stop menu displays the initial pressure and flow settings for the selected joint type. The initial settings can be adjusted using the Pressure increase/decrease buttons and the Flow increase/decrease buttons. Flow adjustment is only available if a Patient Cassette is being used (double pump mode).

Starting the Fluid Flow

3. To start the fluid flow, press the Run/Stop button on the keyboard while in that mode. When the Run/ Stop button is pressed, the pump will control the pressure and fluid outflow. Fluid outflow is only controlled if a Patient Cassette is being used.

Stopping the Fluid Flow

4. To stop the fluid flow, press the Run/Stop button on the keyboard. When the flow is stopped, pressing the Soft Key will return to the selection menu.

Removing the Irrigation Tube When the Day Cassette will be Used Again the Same Day

1. Stop the pump and close all clamps on the Day Cassette and the red clamp on the Irrigation Tube.2. Disconnect the Irrigation Tube near the one-way valve, leaving the used one-way valve attached to the Day Cassette.3. Discard the disconnected Irrigation Tube in accordance with hospital regulations.

18 Instructions for Use

PowerPump™ DP Function and Adjustment During ProcedureAutomatic Outflow Switching If a Patient cassette is used, the outflow from the joint is via the Cannula. If a Shaver is used and active, the outflow from the joint is switched over to pass through the shaver Handpiece. A “*” symbol on the display indicates outflow path; Shaver or Cannula.

Pressure Adjustment The pressure setting can be adjusted with the Pressure increase/decrease buttons (4).

Flow Adjustment The flow setting can be adjusted with the Flow increase/decrease buttons (7). The buttons will adjust the outflow of the mode that is currently active: If the Outflow Cannula is active, the flow for the Outflow Cannula will be adjusted. If the Shaver is active, the flow for the shaver will be adjusted. The Flow adjustment is only available if a Patient Cassette is used.

Shaver Flow Setting When the Shaver is not active, the flow setting can be modified by pressing the Soft Key ‘Shaver’ on the Display. A shaver flow menu will appear on the display, and the flow setting can be modified with the Flow increase/decrease buttons. Soft Key ‘OK’ can be pressed to return to the procedure screen.

Cannula Function When a Patient Cassette is used, pressing and holding the Cannula pedal will increase flow through the joint without increasing joint pressure. This feature is useful for eliminating debris in the joint. The Display will indicate when Cannula function is active. The Pressure and Flow cannot be adjusted when Cannula function is active.

Rinse Function When a Patient Cassette is used, pressing the Rinse pedal will activate the Rinse mode for 120 seconds. Rinse mode will increase the flow and pressure in the joint. This feature is useful for removing blood and controlling bleeding in the joint. When active, Rinse function can be turned off by pressing any of the foot pedals. The Display will indicate when Rinse function is active, and the Pressure and Flow settings cannot be adjusted when Rinse function is active. Rinse function pressure and flow values can be changed in the Setup Menu.

SmartVision® SmartVision® Technology is a function to automatically increase flow and pressure in the joint if debris or blood is detected. This feature can be turned On and Off with the SmartVision® Technology button(8), and related LED is illuminated when SmartVision® Technology monitoring is on. If blood is detected this is indicated in the display. The pressure is increased by a set value in mmHg, and flow is increased by 50 ml/min.

When the liquid is clear of blood, the flow and pressure resumes the previously selected values. If the liquid is not clear of blood within 8 seconds, the flow is further increased by 50 % of selected flow. The pressure increment can be adjusted in the setup menu (factory setting is 50 mmHg increase).

If debris is detected this is indicated in the display, and flow is increased by a set value.

If necessary, this can be adjusted in the setup menu (factory settings is 50 ml/min increase).

Outflow Tracking

The LED adjacent to the Outflow Tracking button(3) on the keyboard indicates the status of Outflow Tracking. If the LED is on, Outflow Tracking is active. The status of Outflow Tracking can be changed by pressing the Outflow Tracking button. This function regulates inflow to the surgery area to precisely replace liquid removed by the outflow pump. The result is a constant volume of fluid in the distended joint. Outflow Tracking is available only when the Patient Cassette is used. High Flow Sheath for Arthroscopy is recommended for best performance.

Last Procedure Setting Memory The PowerPump™ DP will remember the procedure settings from the last procedure if power to the pump remains on and the same joint type as the previous procedure is chosen. If the standby mode is selected all flow and pressure settings go back to default setting.

19Instructions for Use

Section 6

Changing Default SettingsWhen the PowerPump™ DP is turned on, default values of Pressure and Flow will be used. At delivery, initial default settings (factory settings) were selected to ensure safe and effective operation. These settings are based on experience and should be used as a guideline and are not intended to replace the experience or expertise of the user. See Table 1 for intial default settings.

Table 1. Initial Default Settings for PowerPump™ DP

Joint Joint Pressure (mmHg)

Outflow Cannula Flow Rate (ml/mm)

Shaver Suction Setting (ml/mm)

Shoulder 100 130 250

Knee 70 100 250

Hip 130 130 250

Small Joint 70 50 250

Default settings can be modified for the four selectable joint types, and for the flow when a shaver is used. To access the default settings, turn the pump on and press the Soft Key “Setup” (5) on Start/Setup menu.

Select the joint type by moving the arrow with the Soft Keys. When this is selected, press the Soft Key “OK” to view the default settings. The suction level can also be adjusted for Shaver usage.

For each joint type, the following default settings are available:

1) Pressure level 2) Flow level 3) SmartVision® Technology On or Off 4) Outflow Tracking On or Off

Pressure and Flow settings are available on the first screen, and SmartVision® Technology and Outflow Tracking are available on the second screen. Press the Soft Key “More” to access the second screen. The pressure settings are changed with the Pressure increase/decrease buttons. The flow settings are changed with the Flow increase/decrease buttons. SmartVision® Technology and Outflow Tracking On or Off settings are changed by pressing the Soft Keys “+/-”

The Shaver suction settings are changed with the Flow increase/decrease buttons.

To store new values and settings press “S” in the respective menu.

Other settings

The following are also possible to change in the Setup menu:

•Shaversuction:Levelinml/minwhenaShaverisactive•Rinsepedal:Flowincreasein%andpressurelevelincreasein%ofsetvalueswhenRinsepedalisactivated•Cannulapedal:Flowincreasein%ofsetvalue•DebrisDetect:Flowincreasein%whendebrisisdetectedbySmartVision®Technology•HaemoDetect:PressureincreaseinmmHgwhenbloodisdetectedbySmartVision®TechnologyTheflowis

not adjustable.Service Modes

In Service Mode 1, an authorized person can select the language for the display, read a event log for error codes and other alarms and also reset all default values back to the initial (factory) settings. This is not a user option.

Service Mode 2 is strictly for engineering purpose, but has no calibration or maintenance functions.

20 Instructions for Use

Cassette RemovalStop the pump and close all clamps on the cassette tubing. If the cassette loading screen is not visible on the Display, push either the Day Cassette or Patient Cassette button on the keyboard.

When the cassette loading screen is visible on the Display, press the Patient Cassette or Day Cassette button as appropriate to open the pump pressure arm from the cassette.

If another procedure is intended during the day, only the Patient Cassette is to be removed.

Open the cover and remove the cassettes. Remove the cassette from the pump by unlatching the cassette with the lever and pulling the cassette toward the latch and away from the pump. Unloading is verified in the display. Discard the cassettes in accordance with the hospital regulations.

System Shut Down Remove the spike from the saline bag (s). Discard according to hospital regulations.

Turn off the System with the On/Standby button.

21Shaver Interface Box Instructions

PowerPump™ DP Control of ShaverPlease refer to interconnection Diagram on page 3. The Shaver Interface Cable (6) is an accessory to the PowerPump™ DP (1) that sends signals to a Shaver controller (4). When the Foot Control (3) is used to activate the shaver system, the liquid outflow from the joint is taken from the shaver handpiece (5) instead of a cannula. This selection is achieved by the pinch valves by the patient cassette. Also, flow is temporarily elevated to effectively remove debris resulting from the shaver usage. Signals are sent to the foot control receptacle of the shaver controller. This mimics foot switch activity to the shaver controller and starts the shaver in forward or reverse rotation, or oscillating mode. Shaver functions are activated by the 4-pedal foot control (3), with the following functions: Left black pedal 3a = Reverse; Right black pedal 3b = Forward; Left and Right black pedals = Oscillating.

Shaver Control of the PowerPump™ DPShaver may be commanded by foot control of the shaver controller or by fingertip control of the handpiece. The PowerPump™ DP needs to know when the shaver is active for outflow control as described above. To achieve detection of shaver activity, a shaver interface box (6) (Ref page 5) is needed in this case. This detects motor voltage, and signals to the PowerPump™ DP that the shaver is active. This results in pinch valve activation and increased flow as described above.

WARNING:

• Electricalsafetytestingshouldbeperformedbyabiomedicalengineerorotherqualifiedperson.• DisconnecttheShaverinterfaceboxfromtheShaverControllerandfromthePowerPump™DPbeforecleaning,

servicing or inspecting.• Inspectperiodicallycablesforwear,nicksandouterjacketdamage.Replacetheunitifdamageisnoted.• DO NOT use flammable agents when cleaning the Shaver interface box.• DO NOT attempt to disassemble the Shaver interface box. There are no serviceable parts inside.

PRECAUTIONS:

• BesureyouareusingthecorrectShaverinterfaceboxwhenyouareconnectingthepumptoaShaverController.• Inspectperiodicallyconnectorsforbentorbrokenpins.ReplacetheShaverinterfaceboxifdamageisnoted.• AvoidfluidcontactwiththeHandpieceInterfacebodyorconnectors.• DO NOT immerse the Handpiece Interface in water or sterilizing solution.

Cleaning InstructionsDisconnect the Shaver interface box from the pump. Wipe off the Interface body, cable and connector with a soft cloth damped with a neutral-Ph detergent. Rinse the surfaces with a cloth damped with distilled water. Never use alcohol, hard-surface or chlorine-based detergents. DO NOT IMMERSE THE UNIT OR THE CONNECTOR IN LIQUID.

Troubleshooting Guide Shaver Interface Box

Problem Cause Possible Solutions

The shaver runs but the pump does not react.

Pump or shaver interface box fault. Verify that connections (6) - (5) are prop-erly mated and tight.

If the pump still does not react, contact authorized representative.

The shaver does not run. Shaver controller or shaver handpiece defective.

Disconnect (6) - (5), then connect straight (5) to shaver.

If shaver still does not run, contact the shaver manufacturer’s service (try another handpiece if available).

If shaver runs, contact authorized repre-sentative.

22 Shaver Interface Box Instructions

Cause of Alarm Alarm Description How to Resolve

Front cover is opened while the pump is running.

The pump stops and “close cover” appears on the display.

Close the front cover and press Run/Stop to continue.

Low Pressure Warning:

Pressure in the joint can not reach 40mmHg.

Acoustic alarm sounds. The pump stops. To mute for one minute: Press soft key M.

Low Pressure Warning appears on Display

A“*” symbol indicates that the alarm is muted.

Check saline bag and replace bag if empty. Check for kinked tubing or closed clamps by the spikes.

Press Run/Stop button again.

High Pressure Warning:

Pressure in surgical site exceeds 250mmHg.

Acoustic alarm sounds. The pump stops. To mute for one minute: Press soft key M.

High Pressure Warning appears on Display

A“*” symbol indicates that the alarm is muted.

Check that flow to and from the joint is not obstructed. Check the condition of the joint.

Press Run/Stop again.

Overpressure Alarm:

Pressure in Day Cassette exceeds 400mmHg.

The pump stops and a continuous acous-tic alarm sounds.

Overpressure Alarm ERROR CODE XXXXXXXXXX

“Read operator’s manual and switch off” appears on display.

Close all clamps, turn off and then on the pump. If the alarm comes back, take note of the ERROR CODE, turn off pump and contact authorized representative

Internal Hardware Error. The pump stops and a continuous acous-tic alarm sounds.

Hardware Error ERROR CODE XXXXXXXXXX

“Read operator’s manual and switch off” appears on display.

Take note of the ERROR CODE, turn off pump and contact authorized representative.

Alarms

23System Care

System Environmental RequirementsThe PowerPump™ DP may be safely stored and transported at an ambient temperature range of -40°C (-40°F) to +70°C (+158°F), relative humidity between 10 and 85%, and atmospheric pressure of 500 hPa (7.2 psi) to 1060 hPa (15.3 psi). It is not safe to store or operate the PowerPump™ DP outside these temperature ranges.

The PowerPump™ DP may be safely operated at an ambient temperature range of 10°C (65°F) to 40°C (104°F), relative humidity between 10 and 85%, and atmospheric pressure of 700 hPa (10.1 psi) to 1060 hPa (15.3 psi).

Equipment DisposalThe PowerPump™ DP contains electronic printed circuit board assemblies and should not be disposed in any waste container. It should be disposed of in accordance with any applicable national or institutional policies relating to obsolete electronic equipment. Contact authorized representative for return of the PowerPump™ DP for proper disposal. Discard the disposables in accordance with hospital regulations for potentially contaminated items. The PowerPump™ DP does not contain NiCd or lead batteries.

Surface Cleaning & Disinfection of Pump and Foot ControlWipe the pump clean with a soft cloth and mild detergent as needed. Use detergents and disinfectants according to standard practices. Disinfect with liquid chemical disinfectants such as chlorine solutions, iodophors, glualdehydes and hydrogen peroxides. Follow manufacturer guidelines for concentration and length of exposure.

If needed, the pressure transducers on the front panel of the PowerPump™ DP may be cleaned. These are the two white plastic discs inside the Day Cassette. DO NOT apply pressure or use any sharp objects, as damage may result.

24 Maintenance and Troubleshooting

MaintenanceOther than mains fuse and transparent front cover replacement, the PowerPump™ DP has no user-serviceable parts. Do not remove any covers. If the PowerPump™ DP malfunctions or shows signs of damage, contact your authorized representative.

Biomet Sports Medicine strongly recommends an annual inspection of the PowerPump™ DP to assess its functionality and technical safety. Please contact Biomet Sports Medicine authorized representative for instruction on the annual inspection.

Troubleshooting GuideIf you are experiencing problems with the PowerPump™ DP, you may want to use the following troubleshooting guide to help identify or eliminate the problem before contacting authorized representative:

System Does Not Power Up After the Power Switch is Set to On.Check that the mains cable is properly connected to the pump and plugged into an appropriately grounded outlet. If the unit is plugged in properly, check if the fuses have blown. To change the fuses, follow the instructions for Fuse Replacement below.

Fuse ReplacementIf the pump display does not illuminate when the pump On/Off Switch on the rear panel is in the ‘On’ position, a fuse may have broken. The fuse holder is located on the back of the PowerPump™ DP in the fuse holder between the mains cable receptacle and the On/Off switch on the rear panel. To replace a fuse, turn off the power to the PowerPump™ DP and unplug the mains cable at the rear of the PowerPump™ DP. After waiting at least 10 seconds, pull the fuse holder out. Replace both fuses with T 2A; 5 x 20 mm fuses. Reinsert the fuse holder. Reconnect the mains cable and restore power to the PowerPump™ DP. If a fuse breaks again, disconnect all power to the PowerPump™ DP and contact your authorized Biomet Sports Medicine representative.

Front Cover ReplacementIf the transparent front cover is cracked or broken, it can be replaced. To do so, open fully and grab firmly at the hinges, and pull it straight out. To fit the new front cover by pressing it in place in the fully opened position.

Error CodesIf the PowerPump™ DP detect technical failure a continuous two tone alarm is generated, the PowerPump™ DP stops, the keyboard is disabled and an error code is displayed. If this occurs PowerPump™ DP can not be used.

Should this happen, do the following:

• Makenoteoftheerrorcode.Itcanbeveryhelpfulinformationfortheserviceengineertoidentifythefault.• Turnoffthepumpbytherearmainsswitchandclosetheclamp(s)bythesalinebag(s).RelievetheDaycassettefrom

pressure by the arthroscope if the cassette already has been pressurized.• VerifythattheDayCassettehasbeenproperlyinsertedeg.byopeningthefrontcoverandbypressingtheday

cassette. Upper and lower clasps and the locking lever must click to ensure that the Day Cassette is well in place. If the Day cassette is not properly in place, an error code can be generated. Correct the insertion.

• Tryandstartthepumpagainbyturningthemainpoweron,andbyusinginstructions«AssemblyandSystemcheck»point 7, to restart the procedure.

• Ifanerrorcodeappearsagain,turnoffmainpower.Thepumpmaynotbeused,butthesurgicalprocedurecancontinue by use of gravity: Close all clamps remove both cassettes and continue the surgery after opening the clamps again. The “Waste” connection on the Patient Cassette should be connected to a vacuum source if a shaver is used in this case.

25

PowerPump™ DP

Input Voltage 100–120/220–240V~

Input Frequency 50/60 Hz

Power Consumption 230 VA (Peak)

Fuse Rating T 2A; 5 x 20mm

Maximum Pressure 180mmHg

Maximum Flow 600 mi/min

PowerPump™ DP Dimensions

Weight 18 kg (40.5 lbs)

Height (front panel closed) 18.1 cm (7.1 inches)

Width 47.1 cm (18.5 inches)

Length 39.7 cm (15.5 inches)

Main Cable

Length 3.3m (10 ft)

Foot Control

Foot Control Cable Length 4.7m (15 ft)

Interface Cable for Shaver (Optional)

For different shaver systems, length 2.9m (9.5 ft)

Shaver Interface Box (Optional)

For different shaver systems

Technical Specifications

26 Symbols Key

Name, Address and Country of Manufacturer

Name Model of the Product

Unit Serial Number

Product Code

Caution, consult accompanying documents/instructions for use.

Type BF according to Electrical Safety Standard EN60601 1

Equipotential Ground Symbol

Do not dispose in waste container

27Pump Classification and Safety Verification

Classification

It has been developed and it is compliant with the following standards:

According to EN IEC 60601-1, the PowerPump™ DP is classified as follows:

• Typeofprotectionagainstelectricalshock:ClassIequipment• Degreeofprotectionagainstelectricalshock:TypeBFappliedparts

Degree of protection against harmful ingress of water:

• ThePowerPump™DPmeetsrequirementsofIEC/EN60601-1,subclause44.3.• FootControlmeetsrequirementsofIEC/EN60601-1,watertightconstruction(IPX8).

Equipment not suitable for use in the presence of a flammable anesthetic mixture.

Mode of operation: capable of continuous operation.

Safety Verification Biomet Sports Medicine strongly recommends an annual preventive maintenance of the PowerPump™ DP to assess its functionality and technical safety.

Please contact Biomet Sports Medicine for instructions on the annual inspection.

EN IEC 60601-1:1998 General requirements for safety

EN IEC 60601-1-1:2001 General requirements for safety—Collateral standard: Safety requirements for medical electrical systems.

EN IEC 60601-2:2001 General requirements for safety—Collateral standard: Electromagnetic compatibility—Requirements and tests

28 Ordering Information

PowerPump™ DP Power Cord941050 PowerPump™ DP IEC PowerCord941051 PowerPump™ DP UK PowerCord941052 PowerPump™ DP DK PowerCord941053 PowerPump™ DP Korean PowerCord 941054 PowerPump™ DP Chinese PowerCord941055 PowerPump™ DP US–Canadian PowerCord

Shaver Interface Box* 941915G Interface Box, Type 2941018G Interface Box, Type 5941023G Interface Box, Type 3941025G Interface Box, Type 4941038G Interface Box, Type 1

Shaver Interface Cable* 941027G Interface Cable, Type 2941030G Interface Cable, Type 4941033G Interface Cable, Type 5941034G Interface Cable, Type 6941035G Interface Cable, Type 7941036G Interface Cable, Type 3941037G Interface Cable, Type 1

PowerPump™ DP Unit

941010 Global

*Shaver Interface Cross Reference Chart

Shaver Name Interface Box Part No.

Interface Cable Part No.

Akman Shaver 16-2050 DP Interface _________ 941035G

Arthrex APSII DP Interface 941025G 941033G

Atlantech Revlt DP Interface 941025G 941034G

BSM PowerTek™ II Plus DP Interface 941023G 941036G

ConMed Advtg DP HP Interface 941015G 941027G

Dyonics Power II Interface 941038G 941037G

S&N EP-1 DP Interface 941018G 941030G

S&N Power Shaver DP HP Interface 941038G 941037G

Stryker Core DP HP Interface 941023G _________

Stryker TPS DP HP Interface 941023G _________

PowerPump™ DP Foot Control941040

PowerPump™ DP Cassette941012 Day Cassette (10 pk) 941013 Patient Cassette (10 pk)

PowerPump™ DP Irrigation Tubing941014 Package of 10

PowerPump™ DP Unit Shield941044

29Customer Service

Warranty InformationThe PowerPump™ DP and Foot Control are warranted for one year from the date of shipment to the original purchaser. Any component of the System, which develops defects resulting from defective material or workmanship during these time periods will be replaced or repaired without charge.

Product ComplaintsAll questions or concerns related to the quality, reliability and/or durability of this product should be directed to Biomet Sports Medicine Service Center or an authorized Biomet Sports Medicine representative. Please contact Biomet Sports Medicine for a return authorization.

Distributed by:Biomet Sports Medicine 56 E. Bell Drive P.O. Box 587 Warsaw, IN 46581 USA

Customer Service: 800.766.7656

www.biometsportsmedicine.com

Manufactured By:

Medical Vision Ha stholmsva gen 32-SE-131 30 Nacka

Tel. +46 (0)8 452 49 50

All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. SmartVision® is a registered trademark of Medical Vision R&D AB.

This material is intended for the sole use and benefit of the Biomet sales force and physicians. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet.

For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert herein and Biomet’s website.

P.O.Box587,Warsaw,IN46581-0587•800.348.9500ext.1501 ©2010SportsMedicine•www.biometsportsmedicine.com

FormNo.BSM0235.2•REV121510

www.biometsportsmedicine.com

One Surgeon. One Patient.SM

The PowerPump™ DP is covered by Patent No. SWE/0600718-1 and pending European and US Patent applications owned by Medical Vision R&D AB.

This manual refers to PowerPump™ DP Software PP_2.1.0 and PP_2.2.0

Biomet Sports Medicine, as the manufacturer of medical devices, does not practice medicine and does not recommend this or any other surgical device for use on a specific patient. The surgeon who performs any procedure is responsible for determining and

utilizing the appropriate techniques for such procedure for each individual patient.

This publication and all contents, artwork, photographs, names, logos and marks contained in it are protected by copyright, trademarks, and other intellectual property rights owned by Biomet Sports Medicine or its affiliates. This brochure must not be

used, copied, or reproduced in whole or part for any purposes other than marketing or education by Biomet Sports Medicine or its authorized representatives. Any other purposes are prohibited.