USER SAFETY INFORMATION
ix
Note(s)
Proper patient preparation is important to proper application of ECG electrodes, pulse oximetry sensors, and
operation of the device.
If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged,
display will indicate a lead fault for the lead(s) where the condition is present.
Pulse oximetry sensors are latex free.
The pulse oximeter equipment is calibrated to display functional oxygen saturation.
Functional SpO
2
testers (simulators) are useful to measure how accurately a particular monitor is reproducing
the calibration curve but cannot be used to assess the accuracy of a type of probe or monitor. If there is
independent demonstration that a particular calibration curve is accurate for the combination of a pulse
oximeter monitor and a pulse oximeter probe, then a functional tester can measure the contribution of a monitor
to the total error of a monitor/probe system. The functional tester can then measure how accurately a particular
pulse oximeter monitor is reproducing that calibration curve.
The following information is especially useful for clinicians:
Reusable Sensor Measurement Wavelength and Output Power
Red:
660nm at 3.5 - 4.5mW nominal
Infrared: 905nm at 3.5 - 4.5mW nominal
Disposable Sensor Measurement Wavelength and Output Power
Red:
660nm at 3.5 - 4.5mW nominal
Infrared: 890nm at 3.5 - 4.5mW nominal
If no SpO
2
or pulse rate is present, alarm conditions are provided at the receiving monitoring device. There is
no alarm condition provided at the transmitting device.
For additional instructions and warnings, refer to the user manual of the receiving monitoring device.
As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:
- Class I equipment or internally powered
- Type BF (SpO
2
) and CF (ECG) defibrillation-proof applied parts
- IPX2 with regards to the harmful ingress of water
- Equipment not suitable for use in the presence of a flammable anesthetic mixture
- Continuous operation
The device will automatically turn off (blank screen) if the batteries have been severely discharged.
The device is UL classified:
Medical Equipment
WITH RESPECT TO ELECTRIC SHOCK, FIRE, AND MECHANICAL HAZARDS
ONLY, IN ACCORDANCE WITH UL 60601-1, CAN/CSA C22.2 No. 601.1,
IEC60601-1, IEC60601-2-25 AND IEC60601-2-49.
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 ...