USER SAFETY INFORMATION
vi
To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes,
disposable SpO
2
sensors) must not be reused. To maintain safety and effectiveness, electrodes and SpO
2
sensors must not be used beyond their expiration date.
FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the device.
A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.
The device has not been designed for use with high-frequency (HF) surgical equipment and does not provide a
protective means against hazards to the patient.
The quality of the signal produced by the device may be adversely affected by the use of other medical
equipment, including but not limited to defibrillators and ultrasound machines.
There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.
Operations may be affected in the presence of strong electromagnetic sources such as electrosurgery equipment.
The battery operated device transmits data reflecting a patient’s physiological condition to a receiving device.
During operation failure, data transmission and LCD information will cease to occur. In mission critical
conditions, it is advisable to have a backup device available.
There is a potential pinch hazard when applying the top cover to the device that could result in minor injury.
Care should be taken to avoid entrapment of fingers when performing this operation.
The device is restricted to use on one patient at a time.
Pulse oximetry sensors must be checked a minimum of every 4 hours and moved to a new site as necessary.
Pulse oximetry sensors are susceptible to high ambient light interference including ambient photodynamic
therapy. Shield the sensor area as necessary.
SpO
2
measurement may be adversely affected by dyes (e.g., methylene blue, indocyanine green, indigo,
carmine, fluorescein) introduced into the bloodstream.
If the sensor is wrapped too tightly or supplemental tape is applied, venous pulsations may lead to inaccurate
saturation measurements.
The length of the SpO
2
sensor cable is designed for routing from the patient waist through the sleeve of the
patient’s clothing. There is a hazard potential and care should be taken to ensure that the cable does not
compromise or obstruct the patient’s airway, and does not dangle to cause injury or to be run over by other
equipment causing damage to the cable.
SpO
2
signal inadequacy is indicated by error messages displayed on the LCD of the device.
The performance of the device may be compromised by excessive motion.
Nail polish and/or artificial fingernails can affect the accuracy of pulse oximetry and should be removed.
Use only recommended battery cells. Use of other cells may present a risk of fire or explosion.
Summary of Contents for T12
Page 14: ...GENERAL CARE xii ...
Page 42: ...SECTION 3 22 ...
Page 46: ...APPENDIX A 26 ...
Page 52: ...APPENDIX B 32 ...