Nonin Sensmart H500, Руководство оператора

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4
Indications for Use
Declaration of Conformity with FCC and Canadian
Ministry of Health Rules for Electromagnetic
Compatibility
• Nonin Medical, Inc., of 13700 1st Avenue North, Plymouth, Minnesota,
55441, declares under its sole responsibility that the Model H500, to which
this declaration relates, comply with part 15 of the FCC Rules. Operation
is subject to the following two conditions: (1) this device may not cause
harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
• Ministry of Health (Canada), Safety Code 6: standards include a
substantial safety margin designed to ensure the safety of all persons,
regardless of age and health. The exposure standard for wireless mobile
phones employs a unit of measurement known as the Specific Absorption
Rate, or SAR. The SAR limit set by the FCC is 1.6 W/kg.
In compliance with the European Directive on Waste Electrical and Electronic Equipment
(WEEE) 2002/96/EC, do not dispose of this product as unsorted municipal waste. This
device contains WEEE materials; please contact your distributor regarding take-back or
recycling of the device. If you are unsure how to reach your distributor, please call Nonin for
your distributor’s contact information.
A functional tester can only be used to assess the performance of the SpO
2
-only sensors.
If this device fails to respond as described, discontinue use until the situation is corrected by
qualified technical professionals.
For monitoring, the device may not work when circulation is reduced. Warm or rub the finger,
or reposition the device.
In some circumstances, the device may interpret motion as good pulse quality during
monitoring. Minimize patient motion as much as possible.
Do not simultaneously touch the accessible connector pins and the patient.
The device has been designed for use within the specified accuracy ranges. Use outside of
these ranges has not been tested and may result in improper oximeter performance.
All parts and accessories connected to the serial port of this device must be certified
according to at least IEC Standard EN 60950, IEC 62368-1, or UL 1950 for data processing
equipment.
Ensure time and date value is correct.
Implants may affect performance.
Cautions (Continued)
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