Appendix D: Emc Manual Requirements Guidance Document - HeartWare Ventricular Assist System Instructions For Use Manual

Software Parameters, Ranges & Factory Default Settings
Parameter Range
Pump Speed 1,800 to 4,000 RPM
Low Flow Alarm 1.0 to 9.9 L/min
High Power Alarm 1.0 to 25 Watts
Limit
Suction Detection OFF, Alarm
Hematocrit 20-50%
Notes: All dimensions are given as length x width x height.
PEEK is a registered trademark of Victrex plc.
IEC 60601-1 Classifications:
Type of protection against electric shock:
Controller AC adapter – Class II
Controller DC adapter – Class II
Controller – Class II, Internally Powered
Battery charger AC adapter – Class II
Monitor AC adapter – Class I
Degree of protection against electric shock:
Type CF Defibrillation-Proof Applied Parts
Degree of protection against the ingress of water:
IP27 (controller, battery pack)
IP65 (driveline extension cable)
IP22 (controller AC adapter, controller DC adapter, monitor AC adapter, data cable)
IP21 (battery charger, battery charger AC adapter, monitor)
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
CAUTION:
Recommended environmental conditions for general use:
Temperature range/humidity for:
Monitor REF1511 (no longer being placed on the market): 0ºC to +50ºC, 0% to 95% humidity
◗ ◗
Monitor AC Adapter: 0ºC to +40ºC, 15% to 95% humidity
◗ ◗
Driveline Extension Cable: 0ºC to +40ºC, 10% to 90% humidity
◗ ◗
Battery Charger and Charger AC adapter: +10ºC to +40ºC, 15% to 95% humidity
◗ ◗
All other components (including monitor REF1521): +5ºC to +40ºC (+41ºF to +104ºF). Relative humidity range within 15% to 95% (non-condensing).
◗ ◗
Atmospheric pressure range within 700 to 1060 hPa (20.70 to 31.30 in Hg). Altitude less than 3,000 Meters.
◗ ◗
Environmental conditions for transport and storage:
Temperature range within -40°C to 70°C (-40°F to 158°F) for monitor, data cable, battery charger, driveline extension cable, and power adapters.
◗ ◗
Temperature range within -20°C to 50°C (-4°F to 122°F) for controller, battery (transport only).
◗ ◗
Temperature range within -20°C to 25°C (-4°F to 77°F) for battery (storage only).
◗ ◗
Driveline Extension Cable, Monitor and Monitor AC adapter: Relative humidity range within 10% to 90%. All other components: Relative humidity range within 10% to 93%.
◗ ◗
Atmospheric pressure range within 500 to 1060 hPa (14.76 to 31.30 in Hg).
◗ ◗
The box label details conditions for transport and storage.

APPENDIX D: EMC MANUAL REQUIREMENTS GUIDANCE DOCUMENT

Electromagnetic Compatibility
Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this
user manual.
Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment.
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
The HVAD ® Pump is intended for use in the electromagnetic environments specified below. The customer or the user of the HVAD
Emissions Test Compliance
RF Emissions Group 1
CISPR 11
RF Emissions Class B
CISPR 11
Harmonic Emissions Complies
IEC 61000-3-2
Voltage Fluctuations/ Complies
Flicker Emissions
IEC 61000-3-3
Radiated Emissions Category M
Avionics RTCA/DO-160G
Section 21
Resolution Factory Default
20 RPM 2,500 RPM
0.1 L/min 1.0 L/min
0.5 Watts 16.0 Watts
N/A Off
1% 30%
Guidance
The HVAD ® Pump 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.
The HVAD ® Pump is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
The HeartWare ® System with 2 battery packs or one battery pack and controller AC adapter is compliant with all related FAA safety
requirements and will not interfere with aviation electronics, per Section 21, Category M of the RTCA document number RTCA/D0-160G, as
specified in "Use of Portable Electronic Devices Aboard Aircraft" AC number 91.21-1B, Section 8A.
Ventricular Assist System
® Pump should assure it is used in such an environment.
Instructions For Use
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