PowerPump dp System Operators Manual sw PP_2.1.0 and 2.2.0 Rev121510

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.

Table of Contents

1

Description, Indications for Use, and Contraindications...

2

System Overview...

3–5

Principle of Operation...

6

Warnings, Precautions, and Adverse Events...

7–8

Description... Indications for Use... Contraindications... Connection Diagram with PowerTek™ II Plus... Connection Diagram with shaver other than PowerTek™ II Plus... Shaver control by use of the pump’s foot control... Connection Diagram with shaver other than PowerTek™ II Plus... Shaver control by use of the pump’s foot control or hand control...

Warnings... Precautions... Adverse Events...

2 2 2 3 4 4 5 5

7 7 8

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

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

13 13 13 13 13 14 15 16 18 19 20 20

Shaver Interface Box Instructions...

21

Alarms...

22

System Care...

23

Maintenance and Troubleshooting...

24

Technical Specifications...

25

Symbols Key...

26

Pump Classification and Safety Verification...

27

Ordering Information...

28

Customer Service...

29

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

21 21 21 21

System Environmental Requirements... 23 Equipment Disposal... 23 Surface Cleaning & Disinfection of Pump and Foot Control... 23 Maintenance... Troubleshooting Guide... System Does Not Power Up After the Power Switch is Set to On... Fuse Replacement... Front Cover Replacement... Error Codes...

24 24 24 24 24 24

Classification... 27 Safety Verification ... 27

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

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Description, Indications for Use, and Contraindications Description The 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 Unit 2) Reusable, non-sterile Foot Control 3) Reusable, non-sterile Mains cable PowerPump™ DP Disposables (sold separately): 1) PowerPump™ DP Patient Cassette inclusive sterile irrigation tubing 2) PowerPump™ DP Day Cassette 3) 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 Use The 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 • • • •

 O NOT use the PowerPump™ DP for procedures such as gynecological, urologic, endoscopic temporomandibular D 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.

System Overview Connection Diagram with PowerTek™ II Plus

1 PowerPump™ DP 2 Mains Cable 3 Foot Control: a) Shaver Reverse b) Shaver Forward c) Cannula d) Rinse 4 Shaver from PowerTek™ II Plus 5 Shaver Handpiece 6 Shaver Interface Cable

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System Overview Connection Diagram with shaver other than PowerTek™ II Plus Shaver control by use of the pump’s foot control.

1 PowerPump™ DP 2 Mains Cable 3 Foot Control: a) Shaver Reverse b) Shaver Forward c) Cannula d) Rinse 4 Shaver other than PowerTek™ II Plus 5 Shaver Handpiece 6 Shaver Interface Cable

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

1 PowerPump™ DP 2 Mains Cable 3 Foot Control: a) Shaver Reverse b) Shaver Forward c) Cannula d) Rinse 4 Shaver other than PowerTek™ II Plus 5 Shaver Handpiece 6 Shaver Interface Box 7 Shaver Foot Control

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Principle of Operation The PowerPump™ DP can operate in two different modes: 1) Irrigation only 2) 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

Warnings, 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 • • • • •

• • •

The equipment may only be operated by personnel trained in arthroscopy procedures. Failure to follow all applicable instructions may result in serious surgical consequences for the patient. 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. Extravasation or other patient injury may occur if instructions and warnings are not followed. If extravasation occurs, 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. For electrical safety reasons always use a non-conductive waste container for waste fluid. If an error code appears on the display, 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 • • • •

• •

• • • • •

Prior to initial use, ensure that all package inserts, warnings, precautions, and Instructions for Use are read and understood. Consult medical literature relative to techniques, complications, and hazards prior to performing any procedure. Evaluate patients for predisposing medical conditions that may become aggravated by the stress of surgery. When instruments and accessories from different manufacturers are employed together in a procedure, 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. When endoscopes are used with endoscopically-used accessories, the patient leakage currents may be additive. The PowerPump™ DP is a Class I device with Type BF applied part, according to the Electrical Safety Standard IEC 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). To prevent electrical shock hazard, unplug the Main cable from the power source before detaching the cable from 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.

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Warning, Precautions, and Adverse Events • • • • •

•

• • • • • • •

To avoid risk of fire, only replace the fuses with the same type and rating. Annual preventive maintenance must be performed by qualified technical service personnel. Before use, ensure that the main cable plug is properly connected to the pump receptacle. Check that all Pump LED lights and audio signals are functional at start-up. Avoid fluid contact with the PowerPump™ DP. In case of liquid spillage that results in a risk that liquid has entered the pump, it must be immediately turned off and Main cable removed. Contact an authorized service technician. If at any time you feel that the PowerPump™ DP is not operating correctly, too high pressure is suspected, or the 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. If the PowerPump™ DP is taken out of service during a procedure, gravity may be used for an emergency procedure to irrigate the surgery area directly from the saline bags. The shaver, if used, may then be connected to an external vacuum source. Inspect equipment and cables for wear prior to each use. If damage is noted, replace and return to Biomet Sports Medicine authorized representative. DO NOT operate the pump with the roller assembly cover removed or damaged. If the pump operates without a cassette in place, contact an authorized Biomet Sports Medicine representative. 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 PowerPump™ DP irrigation tubing provided by Biomet® Sports Medicine. Usage of unauthorized cassettes may cause patient or user injury and equipment damage or malfunction.

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

Controls, LEDs, and Alarms Controls & LEDs The 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: • Off when the Day Cassette is not positioned in the pump and the pressure arm is open • Blinking when the Day Cassette is correctly positioned in the pump and the pressure arm is closing • Blinking if the Day Cassette is incorrectly positioned in the pump and the pressure arm is closed • On when the Day Cassette is correctly loaded and pressure the arm is closed 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.

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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: • Off when the Patient Cassette is not positioned in the pump and the pressure arm is open • Blinking when the Patient Cassette is correctly positioned in the pump and the pressure arm is closing • Blinking if the Patient Cassette is incorrectly positioned in the pump and the pressure arm is closed • On when the Patient Cassette is correctly loaded and the pressure arm is closed 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.

Controls, 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

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Unpacking, Assembly, and System Check Unpacking Verify 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 Check 1. 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 Yconfigured 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 appropriate 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 Receptacle (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.

Section 5 Instructions for Use

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Operator Training Requirements The 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 Selection The 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 Unloading The 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.

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Instructions for Use Loading a Day Cassette 1. 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 correctly 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.

Instructions for Use Connecting the Irrigation Tubing 1. 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 proximal 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.

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Instructions for Use Loading a Patient Cassette 1. 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.

Instructions 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.

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Instructions for Use PowerPump™ DP Function and Adjustment During Procedure Automatic 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.