AngioJet System Drive Unit Series 3000 Operations Manual Rev 03

All information, drawings, and ideas herein constitute a confidential disclosure of POSSIS MEDICAL INC. (PMI), and are its exclusive property, and must not, without written authorization, be divulged, reproduced, copied or appropriated in whole or in part for any purpose. Warranty:

Refer to your Limited Warranty and Disclaimer and/or Certificate of Extended Warranty, if applicable.

Manufactured and Distributed by:

Possis Medical, Inc. 9055 Evergreen Blvd. NW Minneapolis, Minnesota 55433-8003 USA Phone: 763-780-4555 Toll Free: 1-800-810-7677 Fax: 763-780-2227

ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM DRIVE UNIT OPERATOR’S MANUAL CAUTION: Federal (USA) Law restricts this device to sale by or on the order of a physician.

TABLE OF CONTENTS 1.

DEVICE DESCRIPTION ...2-4 Figure 1. AngioJet System Drive Unit (Front and Back) Figure 2. AngioJet System Drive Unit (Side Views) Figure 3. Control Panel Detail Figure 4. AngioJet System Disposable Components Figure 5. Control Panel with Labels

Authorized European Representative: CEpartner4U BV Esdoornlaan 13, 3951 DB Maarn, The Netherlands Phone: +31(0) 6 516 536 26 Fax: +31(0) 343 442 162

Figure 6. Load Pump into Drive Unit Figure 7. Inflow Bubble Detector Figure 8. Roller Pump in Open/Unlocked Position Figure 9. Roller Pump In Closed/Locked Position Figure 10. Attach Catheter to Pump Set 2.

INDICATIONS AND USAGE ...5

3.

CONTRAINDICATIONS ...5

4.

WARNINGS and PRECAUTIONS ...5

5.

ADVERSE EVENTS...5

6.

DRIVE UNIT SPECIFICATIONS...6

7.

CLINICIAN USE INFORMATION ...7 7.1 Drive Unit Power Up...7 7.2 Pump Set Loading ...8-9 7.3 Catheter Attachment and Priming ...10 7.4 System Dismantling...11 7.5 System Diagnostics ...12-13 7.6 Drive Unit Alarms/Alert and Management ...13-14 7.7 Glossary ...15-16 7.8 Symbols ...17 7.9 Maintenance ...17

8.

HOW SUPPLIED ...17

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1.

DEVICE DESCRIPTION

This manual provides the operator with the basic principles of operation and instructions for use of the AngioJet Rheolytic Thrombectomy System (AngioJet System or System), with specific focus on the AngioJet System Drive Unit. The AngioJet System consists of the following components intended to be used together:

A. The AngioJet System Catheter (Catheter) (several models available) The disposable Catheter utilizes high velocity saline jets at the distal tip to entrain, break up, and remove thrombus. The Catheter shaft consists of dual lumen tubing: one lumen is used to supply pressurized sterile saline to the Catheter tip, the other lumen is used for the evacuation of thrombus debris and for guide wire passage.

Figure 1. AngioJet System Drive Unit (Front and Back) Power Switch

Pump Bay

Control Panel

Upper Rear Door (Control Panel Access)

Roller Pump

Inflow Bubble Detector Drip Tray

Outflow Bubble Detector Pump Capture Block

B. The AngioJet System Pump Set (Pump Set or Pump)

Lower Rear Door (Drive/ Power Supply Access)

The disposable Pump Set consists of a positive-displacement Pump, Inflow tubing, a dual-lumen paratube, and a collection bag. A sterile saline bag (not included) supplies the Pump with saline through the Inflow tubing. The Pump pressurizes the saline and directs it through the supply lumen of the paratube to the Catheter. The Outflow lumen of the paratube transports the thrombus debris from the Catheter to the collection bag for ultimate disposal.

C. The AngioJet System Drive Unit (Drive Unit)

Figure 2. AngioJet System Drive

The Drive Unit is a multiple-use component that controls Catheter and Pump Set operation. It drives the Pump, regulates fluid inflow and outflow, and provides the operator with System setup prompts, Pump operating pressure, total infused saline volume, and System malfunction warnings. The System is activated by pressing a foot switch.

Saline Bag Bay

Unit

Drip Tray

(Side Views) Main Power Circuit Breaker Switch

Power Cord Collection Bag Bay

Foot Switch

2

3

Figure 3. Control Panel Detail

2.

INDICATIONS AND USAGE

The Drive Unit is intended to be used in conjunction with an AngioJet Catheter and AngioJet Pump Set. Refer to the individual Catheter Information for Use Manual for specific clinical applications.

3.

CONTRAINDICATIONS

Refer to the individual Catheter Information for Use Manual for specific contraindications.

4.

WARNINGS AND PRECAUTIONS

5.

ADVERSE EVENTS

Figure 4. AngioJet System Disposable Components Saline Supply Bag Spike and Drip Chamber

Disposable Pump

From Sterile Saline Bag

• The AngioJet System should be used only by operators who have received appropriate training on its installation and use. • Use the Drive Unit only with an AngioJet Catheter and the AngioJet Pump Set. • Do not attempt to bypass any of the Drive Unit safety features. • The Drive Unit should be moved using the drip tray on the front as a handle. Take extra care when crossing over uneven surfaces to avoid tipping the Drive Unit. Move it at an angle over uneven surfaces. • If the Catheter is removed and/or inoperative, the Outflow lumen, guide catheter, and sheath should be flushed with sterile solution to avoid thrombus formation and maintain lumen patency. Reprime the Catheter by submerging the tip in sterile solution and operating it for at least 20 seconds before reintroduction to the patient.

Bubble Detector Inflow Line

Supply Line and Outflow Tubing

Thrombotic Debris

Saline Flow

Refer to the individual Catheter Information for Use Manual for specific observed and/or potential adverse events.

Thrombotic Debris Roller Pump

Catheter

Effluent Line Luer Lock Connector Bag Tubing Thrombotic Debris Vent

Bubble Detector

Collection for Thrombotic Debris

4

5

6.

DRIVE UNIT SPECIFICATIONS

Model Number

3000A

DxWxH

20.25” x 18.5” x 54.0” (51.4 x 47.0 x 137 cm)

Weight

250 lbs (114 kg)

Power Requirements

Refer to markings on the identification label on the Drive Unit.

Logic Power Backup outage

Up to 30 seconds for conditions of power

Equipment Class

Class 1

Degree of protection against electrical shock

Refer to markings on the identification label on the Drive Unit to determine rating.

Enclosure Protection against Ingress of liquid

IPX1

Foot Switch Protection against Ingress of liquid

IPX8

Mode of (Electrical) Operation

Continuous

7.

CLINICIAN USE INFORMATION

A thorough understanding of the System components is required for proper operation of the System. Read this Manual and the Information for Use supplied with the Pump Set and Catheter before attempting to use any of the components of the System.

Figure 5 – Control Panel Detail PRESSURE – KPSI Displays pressure readings during the case POWER Power Switch ALARMS/ALERTS Illuminate as a result of improper System set up START UP Lighted prompts to guide user through set up

EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE.

7.1 DRIVE UNIT POWER UP

TOTAL INFUSED VOLUME – ML Volume infused in ML during the case. Can be reset at anytime

MODE SELECT Determined by catheter choice

SYSTEM DIAGNOSTICS System detects abnormal state during self-test

Preparation of the System requires the assistance of a sterile and a nonsterile technician, and a defined sterile field. The following directions are for the nonsterile technician unless otherwise noted. Improper System preparation will result in illumination of System alarms. Please refer to the Drive Unit Alarms/Alert and Management Section in this Manual for corrective action. 1. Plug in the Drive Unit and ensure the main power circuit breaker switch is turned ON. (Figure 2). 2. Ensure no System components are installed onto Drive Unit. 3. Rotate the control panel power switch to the ON position. All indicators on the control panel will illuminate for 3 seconds. The FAILED SELF TEST indicator will stay on for an additional second. •

6

Then the LOAD PUMP indicator will illuminate.

7

7.2 PUMP SET LOADING

Prior to Pump Set Loading, refer to the Information for Use included with the Pump Set, Inspection Prior to Use – Precautions section. 1. Sterile technician: Once the Pump Set has been removed from its sterile package and inspected for damage, ensure the Catheter connection of the paratube (High Pressure Connector and Outflow Luer Lock Connector) remains in the sterile field. If a clamp is used for this purpose, ensure that the clamp does not crush/deform the tubing. Hand the Pump body and Inflow tubing with the saline bag spike to the nonsterile technician for installation in the Drive Unit.

5. Hang the collection bag on the collection bag recess hooks on the lower right side of the Drive Unit. Connect the collection bag tubing to the outflow tubing near the roller pump using the green collection bag luer lock connectors. 6. Open the roller pump by rotating the roller pump lever counter clockwise. Install the collection bag tubing into the roller pump so that the luer fitting is secure in the notch of the outflow bubble detector mounting bracket (Figure 8).

2. Nonsterile technician: Grasp the Pump body (not the piston head) from the sterile technician. Load the Pump into the Drive Unit by sliding the piston head into the ram and pushing the Pump body into the Pump capture block (Figure 6). It may be necessary to extend the piston from the Pump body to allow loading. Lock the Pump into position.

Figure 8

Figure 9

Roller pump in the Open/Unlocked position

Roller pump in the Closed/Locked position

Figure 6 •

The CONNECT SALINE SUPPLY indicator will illuminate.

3. Hang a sterile, roomtemperature saline bag (not included with the System, 1.0 liter is recommended) on the saline bag recess hook on the left side of the Drive Unit (Figure 2). Heparinize saline at a suggested rate of 5000 units per liter of saline and mix contents. Physician discretion with regard to the use of heparin is advised.

Ensure that the collection bag tubing is aligned with the inverted-V notches on the left and right side of the top half of the roller pump. Close the roller pump by rotating the lever clockwise until it locks (Figure 9). •

Figure 7

4. Close the clamp on the Inflow tubing. Push the Inflow tubing into the Inflow Bubble Detector (Figure 7) on the Drive Unit. Remove the cap from the saline bag spike and insert the spike into the saline bag. Saline will fill the drip chamber. Release the clamp to allow saline to flow and prime the Pump. •

The SELECT MODE indicator will illuminate.

7. Select the proper operating mode by pressing the appropriate button on the control panel. Refer to Catheter product label or the catheter’s strain relief for specific Drive Unit operation mode selection. •

The READY indicator will illuminate.

8. Place the foot switch within easy access of the physician for System activation. Choose a location that will best minimize accidental activation.

The Drive Unit will prime the Pump by completing one cycle. The INSTALL ROLLER PUMP TUBING indicator will illuminate. Saline may flow from the high pressure connector during the prime cycle.

Note: If the INSTALL ROLLER PUMP TUBING indicator fails to illuminate and System set up is inhibited, squeeze the saline bag to initiate saline flow. 8

9

7.3 CATHETER ATTACHMENT AND PRIMING

1. Remove the Catheter from its package using standard sterile technique. The Catheter, the catheter-end of the paratube, and the fluid path through all components should be maintained sterile. 2. Attach the Catheter to the Pump Set using the high pressure and outflow luer lock connectors and tighten by hand (Figure 10). If saline leaks from these connections, tighten further by hand only - use of any tools may damage the components.

Figure 10

7.4 SYSTEM DISMANTLING

Follow proper precautions for the handling of infectious waste; reuse of Catheter or Pump Set is prohibited due to risk of contamination by blood waste products. After use, disassemble the components as follows: 1. Turn off power switch. 2. Open the roller pump and remove the collection bag tubing. 3. Unlock the pump body from the capture block, and withdraw it gently from the Drive Unit. 4. Unhook the saline supply and Collection Bag and dispose of the Pump Set, Catheter, saline bag and Collection Bag as a unit. 5. Unplug the power cord from the wall outlet and coil the cord on the hooks in the power cord and foot switch recess. Place the foot switch into the storage bracket at the bottom of the recess. 6. Clean the Drive Unit surfaces thoroughly with a standard, mild germicidal cleaning agent. Do not clean with harsh detergent or chemical agents.

3. Prime the Catheter by completely submerging the tip in Heparinized saline and activating the Catheter by pressing the Drive Unit foot switch for approximately 20 seconds. The outflow alert may illuminate during priming until air is purged past the outflow bubble detector. The Catheter hemostasis valve should be sufficiently tight to prevent leakage. Note: During priming or normal use the control panel will display the pump pressure in Kpsi (1.0 Kpsi = 68.0 atm = 6,895 kPa) and the total saline volume which has passed through the pump in ml.

THE SYSTEM IS NOW READY FOR USE

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7.5 SYSTEM DIAGNOSTICS

The Control Panel displays information pertaining to start up, operation, alarms, alerts and diagnostics of the AngioJet System. One or more of the following indicators may illuminate and prevent the Drive Unit from operating (see Figure 3 Control Panel Detail). Failed Self-Test Pump Sensor Error Inflow Sensor Error Outflow Sensor Error

Primed Sensor Error Pressure Sensor Error Rear Door Open Pump Bay Blocked

Under Pressure Over Pressure Inflow Outflow

The operator can correct set-up errors, reset alarms, or replace the Catheter or Pump Set to remedy these situations. Refer to the following table for management of particular alarm and alert situations. PROBLEM

PROBABLE CAUSE

SOLUTION

FAILED SELF TEST

1. One or more other indicators may illuminate to show location of sensed abnormal state.

1. See illuminated error lights.

Drive Unit detects abnormal state during self test. These indicators are explained below. (If no other indicators are illuminated, notify Tech Support) INFLOW SENSOR ERROR (active only during self test) Drive unit detects an abnormal state of the inflow detector during the self test. OUTFLOW SENSOR ERROR (active only during self test) Drive Unit detects an abnormal state of the outflow bubble detector during the self test. REAR DOOR OPEN

SYSTEM DIAGNOSTICS PROBLEM

PROBABLE CAUSE

SOLUTION

PRESSURE SENSOR ERROR

1. Internal sensor/logic failure.

1. Have Drive Unit serviced by qualified personnel.

1. Foreign object in pump bay during System self test.

1. Remove object and restart System.

2. Internal sensor/logic failure.

2. Have Drive Unit serviced by qualified personnel.

3. Foreign object in pump bay during System use.

3. Remove object.

Drive Unit detects an abnormal state of the pressure sensor during initial power up of Drive Unit. PUMP BAY BLOCKED Drive Unit detects abnormal state of pump bay optical sensor.

7.6 DRIVE UNIT ALARMS/ALERT AND MANAGEMENT

Note: Alarm state: Alarm light will illuminate and cause Unit to stop. Alert state: Alarm light will illuminate but Unit will continue to operate.

1. Tubing in the inflow detector during initial power up of Drive Unit.

1. Remove tubing and restart System.

2. Internal sensor/logic failure.

2. Have Drive Unit serviced by qualified personnel.

PROBLEM

PROBABLE CAUSE

SOLUTION

UNDER PRESSURE Alarm:

1. Tubing in outflow detector during initial power up of Drive Unit.

1. Remove tubing and restart System.

Pump peak pressure or pressure rate increase is below minimum.

1. Loose high pressure connection at Catheter manifold.

1. Hand-tighten connector and reset alarm.

2. Internal sensor/logic failure.

2. Have Drive Unit serviced by qualified personnel.

Unit stops.

2. Restricted inflow tubing.

2. Restore flow to the pump and reset alarm.

3. Internal failure of Catheter high pressure lumen.

3. Replace Catheter and reset alarm.

4. Internal Pump Set failure.

4. Replace Pump Set and restart System.

5. Air in pump chamber.

5. Remove pump, extend piston, allow flow to purge bubble out of pump, replace piston and reinstall pump.

6. Incorrect operating mode selected.

6. Check Catheter labeling and select correct operating mode.

1. Incorrect operating mode selected.

1. Check Catheter labeling and select correct operating mode.

Unit stops.

2. Kinked/restricted Catheter or Pump Set.

2. Replace damaged product and reset alarm.

INFLOW Alarm:

1. Air in inflow tubing.

1. Remove pump, extend piston, allow flow to purge bubble out of tubing, replace piston, reinstall pump and reset alarm.

2. Inflow tubing not completely in bubble detector.

2. Reinsert tubing into bubble detector and press Inflow reset.

1. Rear door(s) open.

1. Close door and continue procedure.

One of rear Drive Unit doors is opened at startup or during normal operation. PUMP SENSOR ERROR Drive unit detects abnormal state of pump sensor.

PRIMED SENSOR ERROR Drive Unit detects abnormal state of primed sensor.

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1. Pump already installed in Drive Unit prior to startup.

1. Remove pump and restart System.

2. Internal sensor/logic failure.

2. Have Drive Unit serviced by qualified personnel.

3. Pump not locked properly.

3. Resecure pump into capture block.

4. Pump sensor dirty.

4. Wipe off pump capture block area.

1. Pump already installed and primed in Drive Unit prior to startup.

1. Remove pump and restart equipment.

2. Internal sensor/logic failure.

2. Have Drive Unit serviced by qualified personnel.

Inflow bubble detector senses a gas bubble.

3. Prime sensor dirty.

3. Wipe off white prime sensor pump in the back of the capture block

Unit stops.

OVER PRESSURE Alarm: Pump peak pressure exceeds maximum limit.

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DRIVE UNIT ALARMS ALERT AND MANAGEMENT

7.7 GLOSSARY

Alarm: A recoverable or nonrecoverable fault occurring when one of the System safety sensors responds to abnormal operation of a component. Alarm results in unit shut down and requires mitigation. Alert: A recoverable fault occurring when one of the System safety sensors responds to abnormal operation of a component. Unit will not shut down.

PROBLEM

PROBABLE CAUSE

SOLUTION

OUTFLOW Alarm:

1. Internal failure of roller pump drive/sensor Outflow tubing not completely in bubble detector.

1. Have System serviced by qualified personnel Have System serviced by qualified personnel.

2. Incorrect tubing installed in the roller pump.

2. Align green striped tubing with the inverted V notches of the roller pump. Press Outflow reset.

3. Outflow tubing not properly installed in roller pump.

3. Check that tubing is properly seated and reset alarm.

1. Outflow tubing not completely in bubble detector.

1. Insert outflow tubing in bubble detector.

Diagnostic Display: The area on the control panel which displays abnormal conditions.

2. Activation of Catheter in air.

2. Submerge tip of Catheter in saline, and reactivate Catheter.

Drive Unit: The component of the system which powers and controls the Catheter and Pump Set components.

3. Partial/complete occlusion of Catheter outflow lumen due to a kink.

3. Replace Catheter; attempting to straighten kink may result in Catheter rupture.

Error: A nonrecoverable fault which has occurred because of improper pump/tubing installation, priming or operation, or Drive Unit internal malfunction.

Alarm light will illuminate and System will stop

OUTFLOW Alert: Outflow bubble detector senses a gas bubble 10 seconds after activating foot switch (Indicator light will illuminate but System will not stop) Monitor thrombotic debris/fluid flow exiting the Catheter via the Outflow tubing. If blood is not visible in the Outflow tubing during activation, the Catheter may be occlusive within the vessel; verify Catheter position, vessel diameter and thrombus status.

4. Partial/complete occlusion of Catheter outflow lumen due to thrombotic debris.

4. Monitor Outflow Tubing. Remove the Catheter from body, (remove guidewire if needed) and reprime.

5. Partial/complete occlusion of Pump Set outflow tubing due to a kink/restriction.

5. Remove kink/restriction.

6. Partial/incomplete connection of Pump Set outflow tubing.

6. Check/tighten all connection on the outflow tubing side.

Collection Bag Tubing: The green striped tubing which is inserted in the roller pump and transports the extracted thrombus from the outflow tubing to the collection bag. Collection Bag: The bag which collects the extracted thrombus being removed by the Catheter. The bag hangs on the lower right hand side of the Drive Unit. Connect Saline Supply: An indicator which instructs the operator to install the inflow tubing into the inflow bubble detector, tap the saline supply bag with the bag spike, and release the clamp to initiate gravity flow of saline into the pump. Control Panel: The operator interface on the upper front of the Drive Unit.

Failed Self Test: An indictor which illuminates if the Drive Unit self test has failed due to an internal malfunction, or due to a sensor being in an abnormal state. Inflow Bubble Detector: The black bracket that is located to the left of the disposable pump bay. It is used to detect gas bubbles in the inflow line before they reach the pump. Inflow Tubing: The tubing which transports saline from the saline bag through the inflow bubble detector to the pump. Inflow Sensor Error: A non-recoverable fault caused by incorrect installation of the inflow tubing. Inflow Alarm: A recoverable alarm caused by a gas bubble in the inflow tubing or the tubing is not completely seated in sensor. Install Roller Pump Tubing: An indicator instructing the operator to hang the collection bag, connect the collection bag tubing to the outflow tubing, load the collection bag tubing in the roller pump and outflow bubble detector, and lock the roller pump. Load Pump: An indicator instructing the operator to install the pump into the Drive Unit. Mode: A set of operator parameters calibrated to maximize the performance of the selected Catheter. Refer to Catheter product label or strain relief for specific Drive Unit operation mode selection. Nonrecoverable: A condition or error which prevents any further operation of the Drive Unit without restarting it. Repair of the Drive Unit may be required if operation cannot be resumed. Outflow Alarm: A recoverable or nonrecoverable alarm caused by an internal malfunction of the Drive Unit or by incorrect collection bag tubing installation in the outflow bubble detector . This occurs during operation when the outflow rate from the patient becomes significantly less than the infused saline rate.

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15

GLOSSARY

Outflow Alert: A fault caused when the outflow bubble detector senses a gas bubble in the outflow tubing 10 seconds after activating foot switch. It is important to monitor the outflow tubing to prevent the outflow rate from becoming significantly less than the infused saline rate.

7.8 SYMBOLS

Outflow Bubble Detector: The black bracket located on the left of the roller pump. It is used to detect partial or complete occlusion of the outflow tubing/lumen by sensing cavitation bubbles on the intake side of the roller pump. Outflow Sensor Error: A nonrecoverable fault caused by an internal malfunction of the Drive Unit or by incorrect collection bag tubing installation in the outflow bubble detector occurring during self-test.

No.

Symbol

1

Protective earth (ground)

2

Earth (ground)

3

IPX 1

Protected against dripping water

4

IPX 8

Protection against the effects of permanent immersion in water

Outflow Tubing: The portion of the paratube assembly which transports the thrombus from the Catheter manifold to the collection bag tubing. Over Pressure Alarm: A recoverable condition occurring when an abnormally high pressure has been detected in the pump, supply line, or catheter high pressure lumen. Replacement of one of the disposable components may be necessary. Paratube: Dual-lumen tube portion of the Pump Set in which one lumen is used to supply pressurized sterile saline to the Catheter manifold and the other lumen is used for the evacuation of thrombus debris from the Catheter manifold to the collection bag.

5

ON (power: connection to the mains)

6

OFF (power: connection to the mains)

7

Standby

8

TYPE BF EQUIPMENT

Pressure Display: The lighted upper numerical display on the control panel which displays the operating pressure of the pump in Kpsi (thousands of pounds per square inch). Note: 1.0 Kpsi = 68.0 atm = 6.895 kPa.

9

TYPE CF EQUIPMENT

Pressure Sensor Error: A nonrecoverable fault caused by an internal malfunction of the Drive unit.

10

DEFIBRILLATOR PROOF TYPE CF EQUIPMENT

Primed Sensor Error: A nonrecoverable fault caused by either a pump being loaded in the capture block at startup, or an internal malfunction of the Drive Unit.

11

Dangerous voltage

Pump Bay Blocked: An indicator which illuminates if the pump bay is obstructed an any time during a procedure.

12

Attention, see Operators Manual

Pump Capture Block: The Drive Unit component into which the pump body is installed.

13*

Alternating Current

Pump Sensor Error: A nonrecoverable error caused by either an incorrectly loaded/locked pump, or an internal malfunction of the Drive Unit.

14*

Equipotentiality

Pump Set: The disposable component of the System which delivers pressurized saline to the Catheter and removes debris from the Catheter. It consists of the saline bag spike, inflow tubing, pump, paratube, and collection bag. Rear Door Open: An indicator which illuminates when the lower or upper door on the back of the Drive Unit is opened.

*Symbol added to Drive Units manufactured after February 2004.

7.9 MAINTENANCE

Refer to your Limited Warranty and Disclaimer and/or Certificate of Extended Warranty, if applicable, for information on servicing the Drive Unit. There are no user serviceable parts inside the Drive Unit. The Drive Unit doors should only be opened by trained service personnel.

8.

NON-STERILE, MULTIPLE USE

Recoverable: A condition which can be remedied without disturbing the setup sequence or procedure. Select Mode: A section of the control panel which allows the operator to choose the operating mode of the Drive Unit based on chosen Catheter model. Refer to Catheter product label or strain relief for specific Drive Unit operation mode selection.

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Description (one or more of these symbols may appear on the Drive Unit).

HOW SUPPLIED

CONTENTS:

One (1) Drive Unit

Self Test: An operation performed by the Drive Unit to examine the fidelity and the state of its circuit paths and sensors. An appropriate indicator will be illuminated if any abnormality is detected.

One (1) Drive Unit Operator’s Manual

Total Infused Volume: The numerical display at the bottom of the control panel which displays the total volume of saline infused in ml.

One (1) Power Cord

Under Pressure Alarm: A recoverable condition occurring when an abnormally low pressure has been detected.

Two (2) Cabinet keys

One (1) Foot switch with cord One (1) System Set-up Guide

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©2002 Possis Medical, Inc. Trademark rights are claimed in Rheolytic and Cross-Stream. AngioJet and Xpeedior are registered trademarks of Possis Medical, Inc. The AngioJet System includes several catheter models, which are variously marketed in the US for thrombectomy of AV access conduits, peripheral arteries, coronary arteries, and sapheneous vein grafts. See Information For Use manuals for specific 104261-001 03 and complete prescribing information.

Manufactured and Distributed by: Possis Medical, Inc. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA phone: 1.800.810.7677 fax: 1.763.780.2227 Authorized European Representative: CEpartner4U BV Esdoornlaan 13, 3951 DB Maarn, The Netherlands phone: +31(0) 6 516 536 26 fax: +31(0) 343 442 162