MobileCare™ Monitor Operator’s Manual
Copyright 2008 © AFrame Digital, Inc.
iii
Warnings and Precautions
Contraindications
Do not use the device in an MR environment.
Do not use this device in an explosive atmosphere or in the presence of flammable
anesthetics or gases.
This device is not defibrillation proof per IEC 60601-1:1990 clause 17h.
Warnings
Use within its designated range.
This device is intended only as an adjunct in patient assessment. It must be used in
conjunction with other methods of assessing clinical signs and symptoms.
Operation of this device below the minimum amplitude of 0.3% modulation may give
inaccurate results.
The use of batteries other than those specified in these instructions may result in
increased electromagnetic emission and/or decreased immunity of this device.
This device should not be used adjacent to or stacked with other equipment. If adjacent
or stacked use cannot be avoided the device should be observed carefully to verify
normal operation.
Cautions
Inspect the device at least every 6 to 8 hours to ensure correct device alignment and
skin integrity. Patient sensitivity to the device may vary due to medical status or skin
condition.
Factors that may degrade the performance or affect the accuracy of the measurement,
include the following:
-
excessive light, such as sunlight or direct home lighting
-
excessive motion
-
moisture in the device
-
improperly applied device
Do not sterilize, autoclave, or immerse this device in liquid.
Do not use caustic or abrasive cleaning agents or any cleaning products containing
ammonium chloride.
This equipment complies with IEC 60601-1-2:2004 for electromagnetic compatibility for
medical electrical equipment and/or systems. This standard is designed to provide
reasonable protection against harmful interference in a typical medical installation.
However, because of the proliferation of radio-frequency transmitting equipment and
other sources of electrical noise in health care and other environments, it is possible that
high levels of such interference due to close proximity or the strength of a source might
disrupt the performance of this device. Medical electrical equipment needs special
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