INSTRUCTION MANUAL
PULSE OXIMETER
MD300I
MD300I
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Note - Provides application tips or other useful information to ensure that you get the
most from your product.
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Warnings!
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Before use, carefully read the manual. This device is intended for use by persons
trained in professional health care. Our company will assume no warranty for using
this equipment improperly.
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The handheld pulse oximeter is to be operated by qualified personnel only.
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Operation of the handheld pulse oximeter may be affected by the use of an
electrosurgical unit (ESU).
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Sensor malfunction may cause inaccurate data possibly resulting in patient injury or
death, so pay close attention to the sensor and inspect it often.
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Do not use the handheld pulse oximeter in an MRI or CT environment.
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Although the pulse oximeter has alarms, it is not suggested for long time continuous
monitoring.
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Do not use the handheld pulse oximeter in an explosive atmosphere.
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The handheld pulse oximeter is intended only as an adjunct in patient assessment.
It must be used in conjunction with other methods of assessing clinical signs and
symptoms.
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Check the pulse oximeter sensor application site every 4 hours to determine the
positioning of the sensor and circulation and skin sensitivity of the patient.
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When link this equipment to other peripherals, make sure you are sophisticated
operator to handle this device. Any peripherals should be in the light of protocol of IEC
950 and IEC 601-1-1. Any input/output device should be following the protocol of IEC
601-1-1.
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Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing
the device in liquid. The device is not intended for sterilization.
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Follow local ordinances and recycling instructions regarding disposal or recycling of
the device and device components, including batteries.
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This equipment complies with IEC 60601-1-2:2007 for electromagnetic compatibility
for medical electrical equipment and/or systems. 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.
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Portable and mobile RF communications equipment can affect medical electrical
equipment.
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You should operate the equipment according to the EMC information provided in the
accompanying documents.
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This equipment should not be used adjacent to or stacked with other equipment.
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This equipment is not intended for use during patient transport outside the healthcare
facility
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When connecting this device to other peripherals, make sure that you are qualified to
operate this device. Any peripheral must be certified according to the protocol of IEC
950 and IEC 601-1-1. Any input/output device should follow the protocol of IEC 601-1-
1.
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Rx only: “Caution: Federal law restricts this device to sale by or on the order of a
physician.”
Cautions:
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The handheld pulse oximeter must be able to measure the pulse properly to obtain an
accurate SpO2 measurement. Verify that nothing is hindering the pulse measurement
before relying on the SpO2 measurement.
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Worn-out data cables may also cause inaccurate data, so if the data is used as a
reference to treat a patient, pay special attention to data cable and check it more
frequently.
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Do not tangle the SpO2 cable with the wires of ES (Electrosurgery) equipment.
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Single use accessories should never be reused.
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Only use SpO2 sensors specified by the manufacturer. Other SpO2 sensors may
cause improper performance.
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Unplug the sensor from the monitor before cleaning or disinfecting to prevent sensor
or monitor from being damaged, and to prevent user under safety situation.
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Alarm must be set up according to different situation of individual patient. Make sure
that audio sound can be activated when alarm occurs.
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To avoid an electrical hazard, never immerse the unit in any fluid or attempt to clean it
with liquid cleaning agents. Always take out the batteries before cleaning.
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If oximeter becomes accidentally wet during use, stop operation of the oximeter until
all affected components have been cleaned and permitted to dry completely. Contact
your local representative if additional information is required.
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Portable and mobile RF communications equipment can affect medical electrical
equipment.
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This equipment is not intended for use during patient transport outside the healthcare
facility
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This equipment should not be used adjacent to or stacked with other equipment.
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Do not disassemble, repair or modify the equipment without authority.
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These materials that contact with the patient’s skin contain medical silicone and
ABS plastic enclosure are all pass the ISO10993-5 Tests for invitro cytotoxicity and
ISO10993-10 Tests for irritation and delayed-type hypersensitivity.
Notes:
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Optical cross talk can occur when two or more sensors are located in adjoining areas.
It can be eliminated by covering each site with opaque material. Optical cross talk may
