Conformance To Regulatory Standards - Welch Allyn HR100 Directions For Use Manual

20 Directions for Use
Table 8. Protection against ingress of water—compliant with IEC 60529
Holter recorder
Patient Cable
Table 9. Device Classification
AECG Device Type
EMC
IEC Type

Conformance to Regulatory Standards

International Electrotechnical Commission
• CAN/CSA C22.2 No. 601.1-M90
• IEC 60601-2-47 , 2001
• USA: UL60601-1
• IEC 601-1-2, conforms to EN 55011
• EN 61000-4-2:1999
• EN 61000-4-3, 1995
• EN 61000-4-5, 1995
American Advancement of Medical Instrumentation
• ANSI/AAMI EC38-1998 (Device is not defibrillator protected. This device does not
support Defibrillator Protection requirements defined in section 4.2.5.2 of the
requirement.)
Australian Electromagnetic Compatibility
• AZ/NZS 3200-1-0
IPX0
IPX0
Type I
Class IIb
Type BF
Welch Allyn Holter Recorder