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Choice Medical MD300I Handheld Pulse Oximeter Safety Information

Safety Information

Warning, Precaution and Notice

Warning, Precaution and Notice in the manual are special information that prompts the operatorís attention.

Warning - Information concerning something that could possibly hurt the patient or operator.

Precaution - Reminds the user to pay close attention to device operation, failure of which may cause abnormal function of the instrument.

Notice - Informs the user of other important information by suggestion, requirement and supplement.

Warning

  • Please read this manual carefully before using this device. The user must check that the equipment functions safely and ensure that it is in proper working condition before being used.
  • Do not use the pulse oximeter in an explosive atmosphere.
  • Do not use the pulse oximeter in an MRI or CT environment.
  • The pulse oximeter is indicted for use by medical professionals only.
  • The device has no SpO2 alarms or PR alarms, it is not for continuous monitoring, as indicated by the symbol.
  • Prolonged use of the probe/sensor or the patientís condition may require changing the sensor site periodically. Change the sensor site and check skin integrity, circulatory status, and correct alignment at least every 4 hours. Prolonged use may cause blisters, skin deterioration, and discomfort.
  • When connecting this monitor to any instrument, verify proper operation before clinical use. Refer to the instrumentís user manual for full instructions. The equipment connected to the pulse oximeterís data interface must be certified according to the respective IEC standards, i.e., IEC950 for data processing equipment or IEC 601-1 for medical electrical equipment. All combinations of equipment must be in compliance with IEC601-1-1 systems requirements.
  • Sensor malfunction may cause inaccurate data possibly resulting in patient injury or death, so pay close attention to the sensor and inspect it often.
  • 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.
  • Do not tangle the SpO2 cable with the wires of ES (Electrosurgery) equipment.
  • Single use accessories should never be reused.

Precautions

  • Autoclaving, ethylene oxide sterilizing, or immersing the sensors in liquid may cause inaccurate readings.
  • The operator must be thoroughly familiar with the information in this manual before using the device.
  • Unplug the sensor from the monitor before cleaning or disinfecting it.
  • If liquid is accidentally spilled on the unit, clean and dry thoroughly before reuse.
  • Do not try to use the SpO2 and NIBP measurement on the same arm at the same time. This could potentially affect measurement accuracy.

Notices

  • Operation of this device in an electromagnetic field may influence its accuracy.
  • SpO2 measurements may be influenced by high ambient light, especially sunlight. Shield the sensor area as necessary.
  • Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, and fluorescein, may influence the accuracy of the SpO2 reading.
  • Any condition that restricts blood flow, such as use of a blood pressure cuff or extremes in systemic vascular resistance, may cause a failure to determine accurate pulse rate and SpO2 readings.
  • Remove fingernail polish or artificial fingernails before applying SpO2 sensors. Fingernail polish or artificial fingernails may cause inaccurate SpO2 readings.
  • 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 adversely affect the accuracy of the SpO2 readings.
  • Obstructions or dirt on the sensorís red light or detector may cause a sensor failure. Make sure there are no obstructions and the sensor is clean.
  • For routine equipment maintenance, please refer to the service procedures at the associated section as indicated in the manual.
  • As to the other concerns for attention, please carefully look through the specific chapter in this instruction.

Electromagnetic Compatibility

This oximeter is designed and tested in compliance with the EMC standard, complying with the international standard for the EMC of the medical electrical device - IEC 60601-1-2. However, because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in the health-care and home environments (e.g. cellular phones, mobile two-way radios, electrical appliances) it is possible that high levels of such interference due to close proximity or strength of a source, may result in disruption of performance of this device. This apparatus complies with the IEC 60601-1-2 international standard. The requirements of this international standard are: CISPR11, GROP1, and CLASS B.

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