Regulatory And Safety Conformance - GE T2100-ST1 Operator's Manual

Category
Degree of safety of application in the
presence of a flammable anesthetic
mixture with air or with oxygen or
with nitrous oxide
Method(s) of sterilization or
disinfection recommended by the
manufacturer
Mode of operation

Regulatory and Safety Conformance

T2100-ST1 and T2100-ST2 treadmills meet the following safety and
regulatory standards for FDA Class 1 motor operated physical
medicine machines. They have been tested by Intertek Testing
Services N.A Inc., and are listed by Engineering Testing Laboratories
(ETL). However, the ultimate conformance to IEC 6060-1 2005-3
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 T2100-
ST1 or T2100-ST2 treadmill, follow all precautions listed in this
manual and read the entire Operator's Manual thoroughly. Use the
T2100-ST1 and T2100-ST2 treadmills only as described.
UL 1647
Issue: 2011/04/21 Ed: 5 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
2097937-001 Rev E
12 June 2017
T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V
Classification
Equipment is not suitable for use in the
presence of a flammable anesthetic
mixture with air or with oxygen or with
nitrous oxide.
Not applicable
Continuous operation.
Introduction
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