Operator’s Manual Page 11 of 89
OXY-2-USM-1, REV K
The T.Ox ™ Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO
2
) in a volume of tissue. This
is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services.
The T.Ox™ Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle
or when there is a suspicion of compromised circulation.
The value of these measurements in disease states has not been demonstrated.
Section II. Safety
A. Contraindications, Warnings, and Cautions
1. Contraindications
There are no known contraindications for the use of the T.Ox™ Tissue Oximeter.
2. Warnings
Warnings are identified by a label or symbol. Refer to the Glossary of Symbols at the end of this document. Warnings alert the operator
to potential serious outcomes to the patient or operator.
Inspect the sensors before each use for visible damage.
Make sure the lasers are off when inspecting, in order to avoid
damage to the eyes.
Do not use the sensor if it has visible damage.
Avoid direct exposure to the laser light beam in the sensor. Looking at it directly could cause permanent damage to the eyes.
To prevent damage, do not bend or apply torque on the fiber optic cables.
Use only ViOptix manufactured sensors. These sensors are manufactured to meet the calibration requirements for the T.Ox™
Tissue Oximeter. Use of other manufacturers’ sensors may cause improper performance.
Hard knocks, particularly at the distal end of the sensor, may result in damage to the delicate fiber-optic cables, which could
affect instrument performance. Do not use if there is visible damage to the cables.
When inspecting, make sure that the lasers
are off, to avoid damage to the eyes.
Do not allow any liquid to pass into any electrical connections.
Allow wet surfaces to thoroughly dry before plugging in the
system.
Do not immerse or soak sensors in liquid solutions.
Avoid extreme changes in temperature and/or humidity.
Summary of Contents for T.Ox OXY-2-USM-1
Page 32: ...Operator s Manual Page 32 of 89 OXY 2 USM 1 REV K Figure 7 Low Signal Quality Alarm ...
Page 37: ...Operator s Manual Page 37 of 89 OXY 2 USM 1 REV K Figure 11 Review StO2 Screen ...
Page 46: ...Operator s Manual Page 46 of 89 OXY 2 USM 1 REV K Figure 15 View Numerics Screen Single Mode ...
Page 72: ...Operator s Manual Page 72 of 89 OXY 2 USM 1 REV K Figure 33 Discard Confirmation Screen ...
Page 75: ...Operator s Manual Page 75 of 89 OXY 2 USM 1 REV K Figure 35 Reboot Recovery Screen ...
Page 76: ...Operator s Manual Page 76 of 89 OXY 2 USM 1 REV K Figure 36 Sensor Data Disposal ...
Page 84: ...Operator s Manual Page 84 of 89 OXY 2 USM 1 REV K ...
