Welch Allyn TMX428CP Trackmaster Medical Treadmill - User Manual - Manual (Page 4)

Safety Information TRACKMASTER
ii TMX428 Owner’s Manual July 2014
TRACKMASTER ® meets the following safety and regulatory standards for FDA Class 1 motor operated
physical medicine machines. TRACKMASTER
®
has been tested by Intertek Testing Services N.A Inc., and is
listed by Engineering Testing Laboratories (ETL). However, the ultimate conformance to IEC 6060-1 2005-3
rd
edition is the responsibility of the system integrator when combined with other equipment. Additionally, all
motorized equipment is potentially dangerous if used incorrectly. Before using the TRACKMASTER
®
, follow
all precautions listed in this chapter and read the entire Owner’s Manual thoroughly. Use the
TRACKMASTER
®
only as described.
UL 1647
Issue: 2008/01/23 Ed: 4 UL Standard for Safety for Motor-Operated Massage and
Exercise Machines
CAN/CSA C22.2#68
Issue: 2009/09/01 Ed: 7 Motor-Operated Appliances (Household and Commercial)
General Instruction No.1: 2010/02/01 - General Instruction No.2: 2010/09/28
CSA C22.2#60601-1
Issued: 2008/02/01 Ed: 3 Medical Electrical Equipment - Part 1: General
Requirements for basic Safety and essential performance
ICES 003 Industry Canada (IC) Verification
Issue: 2004/01/01 Issue No.4 Interference-Causing Equipment Standard, Digital
Apparatus
IEC 60335-1 Low Voltage Directive for the European Union (EU)
Issued: 2004/07/01 Ed: 4.1 Household and Similar Electrical Appliances - Safety -
Part 1: General Requirements; Corrigendum 1: 12/2005; Amendment 2: 05/2006;
Corrigendum: 08/2006
IEC 60601-1
Issued: 2005/01/01 Ed: 3 Medical electrical equipment Part 1: General requirements
for basic safety and essential performance Australia and Israel,
IEC 60601-1-2
Issued: 2007/03/01 Ed: 3.0 Medical Electrical Equipment - Part 1-2: General
Requirements for Basic Safety and Essential Performance - Collateral
Standard: Electromagnetic Compatibility - Requirements and Tests
AAMI ES60601-1
Issued: 2005/01/01 Medical electrical equipment Part 1: General requirements for
basic safety and essential performance.
IEC CISPR 11-1 EMC Directive for the European Union (EU)
Issued: A1:2010 Electromagnetic Compatibility Requirements for Household
Appliances, Electric Tools and Similar Apparatus Part 1: Emission Edition 5.0;
Federal Communications Commission (FCC) Verification for the United States
FCC 47CFR 15A
Issued: 2011/04/21 Title 47 CFR Part 15 Subpart A General Radiators Class A
Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC
Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in
accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which case the user will be required to correct the interference at owner’s expense.
Regulatory and Safety Conformance