Legal Notice - GE MAC 800 Operator's Manual

Introduction
Classification
NRTL Certification Mark
Biocompatibility

Legal Notice

1-10
The unit is classified, according to IEC 60601-1, as follows:
Type of protection against
electrical shock
Degree of protection
against electrical shock
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 nitrous oxide
Method(s) of sterilization or
disinfection recommended
by the manufacturer
Mode of operation
Medical Equipment
With respect to electric shock, fire and mechanical
hazards only in accordance with UL 60601-1, and
CAN/CSA C22.2 NO. 601.1.
The parts of the product described in this operator's manual, including
all accessories, that come in contact with the patient during the intended
use, fulfill the biocompatibility requirements of the applicable standards.
If you have questions in this matter, please contact GE or its
representatives.
Our equipment contains several fields which can be filled in before
performing an ECG. While some of these fields are required, some are
optional and left to the user to assess whether they are needed to
perform the exam. A field RACE is one of these optional fields. It has
been acknowledged by the medical profession as useful to analyze some
MAC™ 800 Resting ECG Analysis System
Class I, internally powered equipment
Type CF defibrillation-proof applied part
Ordinary Equipment (enclosed equipment without
protection against ingress of water).
Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or
nitrous oxide
Not applicable
Continuous operation
2031504-182F