Appendix B: System Components; Appendix C: Product Specifications - HeartWare Ventricular Assist System Instructions For Use Manual

HeartWare
APPENDIX A: QUICK REFERENCE GUIDE FOR ALARMS - cont'd
Alarm
Alarm Tone
Symbol
Solid
Yellow
Intermittent beep
•
- gradual increase in
alarm volume over
time if not muted
• Able to mute alarm
for 5 minutes

APPENDIX B: SYSTEM COMPONENTS

Pump
1 HVAD Pump: Supplied Sterile – ETO
®
Outflow Graft
1 10mm gel impregnated polyester graft: Supplied Sterile – ETO
Surgical Tools and Accessories
(Supplied ETO sterilized)
1 Tunneler Rod and Handle
1 Sewing Ring Torque Wrench
1 Coring Tool
1 Driveline Extension Cable
1 Driveline Cap
1 Hex Driver
1 Strain Relief
1 Sewing Ring
1 Inflow Cap
Driveline Cover
Instructions for Use

APPENDIX C: PRODUCT SPECIFICATIONS

Physical Pump
Mass (or weight) 160 g
Volume 50 cc
Materials Titanium, Titanium Nitride, PEEK
Outflow Graft
Gel impregnated polyester graft
Length 60 cm
Diameter (or size) 10 mm
Materials Gelatin sealed polyester
Strain Relief
Material PEEK , titanium
®
Driveline
Length 119 cm
Diameter 4.8 mm
Materials ETFE (Ethylene tetrafluoroethylene) PTFE-coated MP35N DFT
wire in a silicone inner sleeve with a polyurethane outer
sleeve along with a polyester sleeve
Sewing Ring
Materials Titanium, polyester
Controller
Weight 0.5 kg
Dimensions 13.4 x 10.5 x 5.1 cm
Material Plastic (ABS)
Battery
Type Li Ion, rechargeable
Weight 0.5 kg
Dimensions 9.9 x 8.9 x 4.6 cm
Indicators Battery level LEDs
Ratings 14.8V, 51.8Wh or
14.4V, 63.4Wh see battery label
I
34 HeartWare Ventricular Assist System
®
LCD Display LCD Display
Line 1 Line 2
Alarm Type: Low
Low Replace
• Battery power is low
Battery 1 Battery 1
Low Replace
Battery 2 Battery 2
Power Reconnect • Power source is disconnected or
Disconnect Power 1 malfunctioning
Power Reconnect
Disconnect
Power 2
and ceramic
®
Potential Causes
• Replace low battery
• Reconnect power source
• Replace power source
• Replace controller
All Externals are Supplied Non-Sterile
Controller
1 Controller
1 Controller AC Adapter / Power Cord
1 Alarm Adapter
Controller AC Adapter
Controller DC Adapter
Patient Pack (carrying case)
Shower Bag
Battery Charger
Capacity 4 batteries
Recharge Time 5 hours, fully depleted
Weight 1.3 kg
Dimensions 28.6 x 13.4 x 10.2 cm
Electrical Ratings 19 VDC, 4 A input; 16.8 VDC, 4 A output
Battery Charger AC Adapter
Weight 0.7 kg
Dimensions 12.1 x 7.5 x 5.1 cm
Electrical Ratings 100-240 V, 50-60 Hz, 190 VA input; 19 V, 4.2 A output
Controller AC Adapter
Weight 0.7 kg
Dimensions 12.1 x 7.5 x 5.1 cm
Electrical Ratings 100-240 V, 50-60 Hz, 140 VA input; 15 V, 3.3 A output
Controller DC Adapter
Weight 0.7 kg
Dimensions 12.1 x 7.5 x 5.1 cm
Electrical Ratings 12-15.6 VDC, 7 A Input; 15 V, 2 A output
Monitor REF1511 (no longer being
placed on the market)
Operating System QNX
Weight 2.5 kg
Dimensions 29.9 x 23.5 x 4.5 cm
Electrical Ratings 19 V, 3 A maximum input
Monitor AC Adapter
Weight 0.7 kg
Dimensions 16.6 x 9.6 x 5.6 cm
Electrical Ratings 100-240 V, 50-60 Hz, 215 VA input; 19 V, 4.7 A output
Potential Actions
Monitor
1 Monitor
1 Monitor AC Adapter / Power Cord
1 Data Cable
1 Display Case
Monitor AC Adapter
Battery Charger
1 Battery Charger
1 Battery Charger AC Adapter / Power Cord
Battery Charger AC Adapter
Battery
USB Flash Drive
Data Cable
Explant Kit
REF1521
QNX
3.0 kg
28.5 x 21.0 x 4.1 cm (without case)
29.9 x 29.9 x 6.4 cm (with case)
19 V, 3.4 A maximum input