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LBL 61876 rev. E, March 2018  

EN 

13 

 

8.

 

Appendix A: Electromagnetic Compatibility Guidance 

 

Electromagnetic Compatibility Guidance - Emissions 

Guidance and manufacturer’s declaration – electromagnetic emissions 

The Generator Model 825DP is intended for use in the electromagnetic environment specified below. 

The customer or the user of the Generator Model 825DP should assure that it is used in such an environment. 

Emissions test   

Compliance 

Electromagnetic environment – guidance 

RF emissions CISPR 11 

Group 1 

The Generator Model 825DP uses RF energy only for its internal function. Therefore, its RF emissions 

are very low and are not likely to cause any interference in nearby electronic equipment. 

RF emissions CISPR 11 

Class A 

The Generator Model 825DP is suitable for use in all establishments other than domestic and those 

directly connected to the public low-voltage power supply network that supplies buildings used for 

domestic purposes. 

Harmonic emissions IEC 61000-3-2 

Class A 

Voltage fluctuations/flicker emissions IEC 61000-3-3 

Complies 

 

Electromagnetic Compatibility Guidance – Power Supply Immunity 

Guidance and manufacturer’s declaration – electromagnetic immunity 

The Generator Model 825DP is intended for use in the electromagnetic environment specified below. The 

customer or the user of the Generator, Model 825DP should assure that it is used in such an environment. 

Immunity test 

IEC 60601 test level 

Compliance level 

Electromagnetic environment –guidance 

Electrostatic discharge (ESD) 

IEC 61000-4-2 

± 6 kV contact 

± 8 kV air 

± 6 kV contact 

± 8 kV air 

Floors should be wood, concrete or ceramic tile. If floors are 

covered with synthetic material, the relative humidity should 

be at least 30 %. 

Electrical fast transient/burst 

IEC 61000-4-4 

± 2 kV for power supply lines 

± 1 kV for input/output lines 

± 2 kV for power supply lines 

± 1 kV for input/output lines 

Mains power quality should be that of a typical commercial or 

hospital environment. 

Surge  

IEC 61000-4-5 

± 1 kV line(s) to line(s) 

± 2 kV line(s) to earth 

± 1 kV line(s) to line(s) 

± 2 kV line(s) to earth 

Mains power quality should be that of a typical commercial or 

hospital environment. 

Voltage dips, short 

interruptions and voltage 

variations on power supply 

input lines  

IEC 61000-4-11 

<5 % UT (>95 % dip in UT) for 0,5 cycle 

40 % UT (60 % dip in UT) for 5 cycles 

70 % UT (30 % dip in UT) for 25 cycles 

<5 % UT (>95 % dip in UT) for 5 s 

<5 % UT (>95 % dip in UT) for 0,5 cycle 

40 % UT (60 % dip in UT) for 5 cycles 

70 % UT (30 % dip in UT) for 25 cycles 

<5 % UT (>95 % dip in UT) for 5 s 

Mains power quality should be that of a typical commercial or 

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 typical commercial or 

hospital environment. 

NOTE: UT is the A.C. mains voltage prior to application of the test level. 

 

 

Electromagnetic Compatibility Guidance – RF Immunity 

Guidance and manufacturer’s declaration – electromagnetic immunity 

The Generator, Model 825DP is intended for use in the electromagnetic environment specified below. The customer or the user of the Generator, Model 825DP should assure that it is used in 

such an environment. 

Immunity test 

IEC 60601 test level 

Compliance level 

Electromagnetic environment – guidance 

Conducted RF  

IEC 61000-4-6 

 

Radiated RF  

IEC 61000-4-3 

3 Vrms 150 kHz to 80 MHz 

 

3 V/m 80 MHz to 2,5 GHz 

[V1=3] V 

 

[E1=3] V/m 

Portable and mobile RF communications equipment should be used no closer 

to any part of the Generator Model 825DP, including cables, than the 

recommended separation distance calculated from the equation applicable to 

the frequency of the transmitter. 

Recommended separation distance 

 

where P is the maximum output power rating of the transmitter in watts (W) 

according to the transmitter manufacturer and d is the recommended 

separation distance in meters (m). Field strengths from fixed RF transmitters, 

as determined by an electromagnetic site survey

a

, should be less than the 

compliance level in each frequency range

Interference may occur in the 

vicinity of equipment marked with the following symbol: 

 

 

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. 

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast 

cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the 

measured field strength in the location in which the Model 825DP is used exceeds the applicable RF compliance level above, the Model 825DP should be observed to verify normal operation. 

If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model 825DP. 

b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. 

 

 

 

 

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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