Appendix C: Specifications; Appendix C1: General Specifications; Appendix C2: Performance Specifications - Shockwave Medical 825D Manuel D'utilisation

This appendix contains the specifications and performance characteristics for the Shockwave Medical Lithoplasty
Generator Model 825D. All specifications are typical at 20°C unless otherwise stated.

Appendix C1: General Specifications

Specifications
Alarms
Classification, Product
Classification, Applied Parts
Connectors (Connector Cable)
Data Log
Enclosure
Environmental
Electrical Safety
EMC Compatibility
Mobility
Power
Size
Shock
Splash Resistance
Weight

Appendix C2: Performance Specifications

This appendix contains the specifications and performance characteristics for the Shockwave Medical
Lithoplasty Generator Model 825D.
Specifications
Battery
Diagnostics
Emitter Drive Channels
Output
Output Voltage
Accuracy
Output Limits
Therapy Settings
LBL 60780 rev. B

APPENDIX C: SPECIFICATIONS

Performance Characteristics
Built in tests and monitors are designed to detect and annunciate designated malfunctions of
subsystems within the Generator. The Generator is designed to interrupt therapy delivery in
the event a malfunction is detected. In addition, visual annunciators (CATH or SYS) will
activate and three beeps will sound. See Sections 4.1 (Tones), 7.0 (Troubleshooting)
Class II ME Equipment
Type CF
OnAnOn 150PT series with proprietary keyway
No data associated with patient cases is logged
Non-ventilated, polymeric enclosure, molded from flame retardant UL 94V-0 rated material
Altitude: 0 - 2000 meters
Humidity, operating: 10 – 70% non-condensing
Temperature, operating: 10° to 35°C
Temperature, storage / shipping: -20° to 65°C
ISO 60601-1 (2012) edition 3.1 standards
See Appendix A
Product is designed to be mounted to a stable mobile or stationary IV pole. An IV pole with
five casters located in a circular pattern with a diameter of at least 23 inches (58 cm), such as
the I.V. League Ventilator Stat-Stand™ model 1059 (or equivalent) is recommended.
110 – 240 VAC; 50-60Hz; Single Phase, 15A service
Protectively earthed
11" (28.0 cm) high x 6" (15.2 cm) wide x 11.5" (29.2 cm)deep
Shipping Shock per EXD-007C ASTM D 4169-09
10 mL saline from above (Generator)
100 mL saline from any angle (Connector Cable distal end)
15 pounds (6.8 kg)
Performance Characteristics
Rechargeable Smart Lithium Ion Battery Pack (14.4V, 6.6Ah)
Charge time less than twelve hours to full charge
Fully charged battery capacity 12 patient cases
(patient case: 900 therapy pulses delivered over one hour)
80% capacity after 300 full charge/discharge cycles
Meets requirements for transport via commercial aircraft
(UN Manual of Tests and Criteria part III subsection 38.3)
Built in tests and monitors are designed to detect and annunciate designated malfunctions of
subsystems within the Generator. The Generator is designed to interrupt therapy delivery in the event
a malfunction is detected.
Four channels, one to four channels may be used depending on catheter model connected.
Proprietary pulse delivery system. Output voltage 1000 – 3000 volts peak to peak, pulse duration ~
1uS, pulse frequency 1, 2 or 4 Hz depending on catheter model connected.
The open circuit voltage at the Generator THERAPY CONNECTOR: 5% of pre-programmed set point.
System is designed to override user input and limit the number of continuous pulses delivered based
on the Lithoplasty Catheter model connected. Refer to Lithoplasty Catheter IFU.
Proprietary pulse delivery system. No user adjustable settings. Pulse delivery settings are pre-
programmed, based on Lithoplasty Catheter model connected. Settings and Lithoplasty Catheter
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