3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use Page 7
Section 1 Indications, Warnings and Cautions
• If using the Oxygen Assist Module during full body irradiation, keep the SpO2sensor out of the
radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the
device might read zero for the duration of the active irradiation period.
• Variation in measurements may be profound and may be affected by sampling technique as
well as the patient's physiological conditions. Any results exhibiting inconsistency with the
patient’s clinical status should be repeated and/or supplemented with additional test data.
Blood samples should be analyzed by laboratory instruments prior to clinical decision making
to completely understand the patient’s condition.
• Do not submerge the Oxygen Assist Module or any associated accessories in any cleaning
solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any
other method. This will seriously damage the device.
• Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of patient-
applied circuits and the system are within acceptable limits as specified by the applicable
safety standards. The summation of leakage currents must be checked and in compliance
with IEC 60601-1 and UL60601-1. The system leakage current must be checked when
connecting external equipment to the system. When an event such as a component drop of
approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest before
further use. Injury to personnel could occur.
• Disposal of product - Comply with local laws in the disposal of the device and/or its
accessories.
• To minimize radio interference, other electrical equipment that emits radio frequency
transmissions should not be in close proximity to the Oxygen Assist Module.
• Replace the SpO2cable or sensor when a replace sensor or when a low SIQ message is
consistently displayed while monitoring consecutive patients after completing troubleshooting
steps listed in this manual.
Notes:
• A functional tester cannot be used to assess the accuracy of the SpO2measurement on the
Oxygen Assist Module.
• High-intensity extreme lights (such as pulsating strobe lights) directed on the SpO2sensor,
may not allow the Oxygen Assist Module to obtain an accurate reading.
• Do not loop the SpO2patient cabling into a tight coil or wrap around the device, as this can
damage the patient cabling.
• Additional information specific to the Masimo sensors compatible with the Oxygen Assist
Module, including information about parameter/measurement performance during motion and
low perfusion, may be found in the sensor's directions for use (DFU).
• SpO2cables and sensors are provided with X-Cal™ technology to minimize the risk of
inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor
DFU for the specified duration of the patient monitoring time.
This device is covered under one or more patents as set forth at: www.masimo.com/patents.htm
NO IMPLIED LICENSE: Possession or purchase of this device does not convey any express or
implied license to use the device with unauthorized sensors or cables which would, alone or in
combination with this device, fall within the scope of one or more of the patents relating to this
device.
