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9
8
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6
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4
3
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1
Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
Pump Overview
Introduction
148 HVAD® Instructions for Use
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.
Appendix C: EMC Manual Requirements Guidance Document
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The HVAD
®
or the user of the HVAD
®
Pump should assure it is used in such an environment.
RF Emissions CISPR 11 Compliance Guidance
RF Emissions
CISPR 11
Group 1 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.
RF Emissions
CISPR 11
Class B 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.
Harmonic Emissions IEC
61000-3-2
Complies
Voltage Fluctuations/
Flicker Emissions IEC
61000-3-3
Complies
Radiated emissions
Avionics RTCA/DO-160F,
Section 21
Category M The HeartWare
™
HVAD
™
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
Portable Electronic Devices Aboard Aircraft” AC number 91.21-
1B, Section 8A.
Appendix B: Product Specifications (continued)
Recommended environmental conditions (continued)
Component Temperature Range Relative Humidity Atmospheric Pressure
Battery Charger C
F)
Operating: 30% - 75% Operating: 700 -1060 hPa
Storage and Transport:
F)
Storage and Transport:
10% - 93%
Storage and Transport:
500 -1060 hPa
Monitor and
Monitor AC Adapter
C
F) Monitor only;
F)
Monitor AC Adapter only
Operating: 15% - 95% Operating: 700 -1060 hPa
Storage and Transport:
F)
Storage and Transport:
10% - 90%
Storage and Transport:
500 -1060 hPa
Do not store HeartWare equipment in an area exposed to ultraviolet light.
The box label details conditions for transport and storage.
The device label details the environmental condition limits under which the device should be operated.
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