LBL 61876 rev. E, March 2018
EN
15
10.
Appendix C: Specifications
This appendix contains the specifications and performance characteristics for the Shockwave Medical IVL Generator Model 825DP. All specifications are typical at 20°C unless
otherwise stated.
10.1
Appendix C1: General Specifications
Specifications
Performance Characteristics
Alarms
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)
Classification, Product
Class II Medical Electrical (ME) Equipment
Classification, Applied Parts
Type CF
Connectors (Connector
Cable)
OnAnOn 150PT series with proprietary keyway
Data Log
No data associated with patient cases is logged
Enclosure
Non-ventilated, polymeric enclosure, molded from flame retardant UL 94V-0 rated material
Environmental
Altitude: 0 - 2000 meters
Humidity, operating: 10 – 70% non-condensing
Temperature, operating: 10° to 35°C
Temperature, storage / shipping: -20° to 65°C
Electrical Safety
ISO 60601-1 (2012) edition 3.1 standards
EMC Compatibility
See Appendix A
Mobility
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.
Power
110 – 240 VAC; 50-60Hz; Single Phase, 15A service
Protectively earthed
Size
11” (28.0 cm) high x 6” (15.2 cm) wide x 11.5” (29.2 cm)deep
Shock
Shipping Shock per EXD-007C ASTM D 4169-09
Splash Resistance
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)
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)
Diagnostics
Built in tests and monitors are designed to detect and annunciate designated malfunctions of subsystems within the IVL Generator. The IVL Generator
is designed to interrupt therapy delivery in the event a malfunction is detected.
Emitter Drive Channels
Four channels, one to four channels may be used depending on catheter model connected.
Output
Proprietary pulse delivery system. Output voltage 1000 – 3000 volts peak to peak, pulse duration ~ 1μS, pulse frequency 1, 2 or 4 Hz depending on
catheter model connected.
Output Voltage Accuracy
The open circuit voltage at the IVL Generator THERAPY CONNECTOR: 5% of pre-programmed set point.
Output Limits
IVL System is designed to override user input and limit the number of continuous pulses delivered based on the IVL Catheter model connected. Refer to
IVL Catheter IFU.
Therapy Settings
Proprietary pulse delivery system. No user adjustable settings. Pulse delivery settings are pre-programmed, based on IVL Catheter model connected.
Settings and IVL Catheter model detection employ redundant features.
Shockwave Medical, Inc.
48501 Warm Springs Blvd., Suite 108
Fremont, CA 94539, USA
www.shockwavemedical.com
MedPass SAS
95 bis Boulevard Pereire
75017 Paris
France
