Cautions - Nonin Sensmart H500 Operator's Manual

Indications for Use

Cautions

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When using this device in an operating room, it must remain outside the sterile field.
This equipment complies with IEC 60601-1-2 for electromagnetic compatibility (EMC) 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 healthcare and other environments, it is possible that high levels of such
interference due to close proximity or strength of a source might disrupt the performance of
this device. Medical electrical equipment needs special precautions regarding EMC, and all
equipment must be installed and put into service according to the EMC information specified
in this manual.
The H500 is designed and manufactured not to exceed the emission limits for exposure to
radio frequency (RF) energy set by the United States FCC. These limits are part of
comprehensive guidelines and establish permitted levels of RF energy for the general
population. The guidelines are based on the safety standards previously set by both U.S.
and international standards bodies. This device has been shown to be compliant for
localized specific absorption rate (SAR) for uncontrolled environment/general population
exposure limits specified in ANSI/IEEE Std. C95.
Factors that may degrade oximeter performance include the following:
- excessive ambient light
- excessive motion
- electrosurgical
interference
- moisture in the sensor
- improperly applied sensor
- blood flow restrictors
(arterial catheters, blood
pressure cuffs, infusion
lines, etc.)
Batteries are a fire hazard if damaged. Do not damage, mishandle, disassemble, service, or
replace with non-specified components.
Do not charge Li-Ion batteries at a temperature of 0 °C (32 °F) or less as this may result in
significantly reduced battery life.
Do not apply sensor over open wound, incision, or compromised skin. Inspect the sensor
site prior to applying the sensor.
Inspect the sensor application site in accordance with the sensor instructions for use to
ensure correct sensor alignment and skin integrity. Patient sensitivity to the sensor may vary
due to medical status or skin condition.
Do not autoclave, sterilize, immerse, or spray this device with liquid or use caustic or
abrasive cleaning agents. Do not use cleaning agents or cleaning products that contain
ammonium chloride.
Follow local, state and national governing ordinances and recycling instructions regarding
disposal or recycling of the device and device components, including batteries.
- incorrect sensor type
- poor pulse quality
- venous pulsations
- anemia or low hemoglobin
concentrations
- cardiovascular dyes
- dysfunctional hemoglobin
- artificial nails or fingernail
polish
- residue (e.g., dried blood,
dirt, grease, oil) in the light
path
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