Shockwave IVL Operator'S Manual Download Page 16 | Manualshive

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PN 62393 Rev A

Manufactured by Shockwave Medical, Inc.

48501 Warm Springs Blvd., Suite 108

Fremont, CA 94539, USA

www.shockwavemedical.com/patents

MedPass SAS

95 bis Boulevard Pereire

75017 Paris

France

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Summary of Contents for IVL

Page 1: ...ion and Test 9 6 Maintenance 10 6 1 Daily Maintenance 10 6 1 1 Charging and Testing the Internal Battery 10 6 1 2 Testing the IVL Generator 11 6 1 3 Inspecting the IVL Generator 11 6 1 4 Cleaning the IVL Generator 11 6 2 Monthly Maintenance 11 6 3 Other Maintenance 12 6 4 Product Useful Life 12 7 Troubleshooting 12 8 Appendix A Electromagnetic Compatibility Guidance 13 9 Appendix B Symbols 14 10 A...

Page 2: ...result in serious personal injury or death CAUTION Hazards or unsafe practices that may result in minor personal injury product damage or property damage 2 2 Contraindications There are no specific contraindications for use of the IVL Generator and Connector Cable However users should read and understand the specific indications contraindications warnings and precautions included with the applicab...

Page 3: ...rature and humidity conditions for at least twenty four hours before use See Appendix C for specified operating conditions Operating the equipment outside of these environmental conditions may cause equipment malfunction or damage IMPROPER DEVICE PERFORMANCE HAZARDS Using other manufacturers cables catheters power adapters or batteries may cause the device to perform improperly and may invalidate ...

Page 4: ...ailable Counts down from available Pulse Count Per Catheter during treatment as each pulse is delivered Refer to applicable IVL Catheter IFU for the Max Pulse Count THERAPY STATUS Indicator On green when the device is ready to deliver therapy Flashes to indicate therapy is in process On yellow when therapy is paused or deactivated See Section 4 Steps 5 9 3 3 Front Panel Connectors FEATURE DESCRIPT...

Page 5: ...NECTOR end of the Connector Cable to the THERAPY CONNECTOR Orient the connector and gently push in The connector is magnetic and will engage as the magnet gets close Push gently to confirm connector is fully engaged Slide CONNECTOR DOOR to left to reveal the THERAPY CONNECTOR THERAPY CONNECTOR Step 5 Prepare IVL Catheter for Use Prepare the catheter for use following the instructions in the IVL Ca...

Page 6: ...nt as indicated in the IVL Catheter IFU CAUTION EQUIPMENT DAMAGE The IVL Generator delivers low energy short duration high voltage pulses to the IVL Catheter through the IVL Connector Cable The system is designed not to deliver pulses unless an IVL Catheter connector is mated with the IVL Connector Cable and IVL Generator It is important not to allow the contacts or internal surfaces of unmated co...

Page 7: ...unting the IVL Generator to an unstable IV pole could present a tip over hazard to staff or patients 5 1 IV Pole Mounting STEP 1 Locate and identify mounting hardware see image below Two identical sets of IV pole mounting hardware are provided One set is used to mount the IVL Generator and one set is used to mount the battery Charger Module IV Pole Mounting Hardware STEP 2 Determine the IV pole di...

Page 8: ...econd bracket so that it rests on top of the first bracket Orient the brackets so that they are facing opposite directions STEP 4 Mount the IVL Generator to the top bracket Align the holes in the mounting plate on the right side of the IVL Generator with the bracket mounting studs Push the IVL Generator towards the bracket to engage the mounting studs then push the IVL Generator down to lock in pl...

Page 9: ...orage so that the battery will not discharge to an unacceptably low voltage level which could ultimately result in battery damage 5 4 Environment Conditioning The IVL Generator is designed to be used indoors in a controlled environment Refer to Appendix C for specified operating conditions Allow the IVL Generator to be stored in the ambient conditions of the usage environment for at least 24 hours...

Page 10: ...IVL Generator Spilled liquids may cause the IVL Generator to perform inaccurately or malfunction 6 Maintenance This section describes the maintenance that clinical and or biomedical staff should be familiar with performing on a regular basis Recommendations for regular maintenance and maintenance intervals are noted below NOTE The battery is self discharging and requires periodic recharges even du...

Page 11: ... this button for three seconds is required Step 4 Confirm Output Test Result The output test requires approximately 15 seconds to complete During this time the THERAPY STATUS indicator will remain on green Upon successful completion of this test the IVL Generator will sound four beeps If no error message appears on the display then this test has passed successfully 6 1 3 Inspecting the IVL Generat...

Page 12: ...required Low BATTERY CAPACITY indicated when the battery symbol is Empty Battery requires charge Connect Charger Module to the IVL Generator and to AC Mains Allow the IVL Generator to charge at least twelve hours prior to use System Error displayed and red light around POWER ON OFF button Built in tests have detected a malfunction within the IVL Generator Turn IVL Generator off wait one second and...

Page 13: ... hospital environment If the user of the Generator Model 825DP requires continued operation during power mains interruptions it is recommended that the Generator Model 825DP be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typic...

Page 14: ...affected by absorption and reflection from structures objects and people Essential Performance Generator Model 825DP maintains safe and effective performance in the delivery of IVL therapy when operated in the electromagnetic environment specified in the table above 9 Appendix B Symbols The IVL Generator bears the following symbols Symbol Description Symbol Description Refer to instruction manual ...

Page 15: ...stance 10 mL saline from above Generator 100 mL saline from any angle Connector Cable distal end Weight 15 pounds 6 8 kg 10 2 Appendix C2 Performance Specifications This appendix contains the specifications and performance characteristics for the Shockwave Medical IVL Generator Model 825DP Specifications Performance Characteristics Battery Rechargeable Smart Lithium Ion Battery Pack 14 4V 6 6Ah Ch...

Page 16: ...PN 62393 Rev A Manufactured by Shockwave Medical Inc 48501 Warm Springs Blvd Suite 108 Fremont CA 94539 USA www shockwavemedical com patents MedPass SAS 95 bis Boulevard Pereire 75017 Paris France ...

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