User's Manual

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7 Accessories
1. One pulse Pulse Oximeter
2. Two batteries（optional）
3. One manual
8 EMC Specification
The instructions for use shall include the following:
1： (a statement of the environments for which the Pulse oximeter is suitable. Relevant exclusions, as
determined by RISK ANALYSIS, shall also be listed, e.g. hospitals except for near active HF SURGICAL
EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging, where the intensity
of EM DISTURBANCES is high.)
2： (the performance of the Pulse oximeter that was determined to be ESSENTIAL PERFORMANCE and a
description of what the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to
EM DISTURBANCES (the defined term “ESSENTIAL PERFORMANCE” need not be used).
3: (a list of all cables and maximum lengths of cables (if applicable), transducers and other ACCESSORIES
that are replaceable by the RESPONSIBLE ORGANIZATION and that are likely to affect compliance of the ME
EQUIPMENT or ME SYSTEM with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY).
ACCESSORIES may be specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by
MANUFACTURER and MODEL OR TYPE REFERENCE).)
WARNING:
1. a warning statement to the effect that “WARNING:
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result
in improper operation. If such use is necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.
2. a warning statement to the effect that “WARNING:
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
the Pulse oximeter could result in increased electromagnetic emissions or decreased electromagnetic immunity of
this equipment and result in improper operation
3. a warning statement to the effect that: “WARNING:
Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the Pulse oximeter, including cables specified by
the manufacturer. Otherwise, degradation of the performance of this equipment could result