Classification Of Medical Device; Emi/Emc/Rf Safety Information - GE T2100 Service Manual

Introduction

Classification of Medical Device

The device is classified as follows, according to IEC 60601-1:
Medical Device Classifications
Category
Type of protection against electrical shock
Degree of Protection Against Electrical Shock Type B applied part
Degree of protection against harmful ingress
of water
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

EMI/EMC/RF Safety Information

This system is designed and tested to comply with applicable regulations regarding
EMC and must be installed and put into service according to the EMC information
stated in the Electromagnetic Compatibility appendix of the Service and/or Operator's
manual. Changes or modifications to this system not expressly approved by GE
Healthcare could cause EMC issues with this or other equipment. Mains power should
be a standard commercial or hospital environment.
Before installing or using the device or system, be aware of the proximity of known RF
sources, such as the following:
• Radio and TV stations
• Portable and mobile RF communication devices (cell phones, two-way radios)
• X-ray, CT, or MRI devices
20
Classification
Class I
IPx0
Ordinary equipment (enclosed equipment
without protection against ingress of water)
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
The Elevation motor is not rated for
continuous operation. A one minute
elevation ON time should be followed by a
ten minute OFF time. In normal operation,
the treadmill elevation motor operates for
much less than 1 minute at a time.
All other parts of the treadmill (including the
belt drive motor) are rated for continuous
operation, and do not have an ON/OFF duty
cycle requirement.
T2100 Treadmill
2021403-120F