Справочник Пользователя для Guided Therapeutics Inc 13500
November 2013, CNDS-0-635-MAN_3
Page 14 of 78
3.5 Warnings, Cautions and Notes
3.5.1 LuViva Diagnostic Use Warnings
WARNING: LuViva is not intended to replace primary screening tests such as the Pap smear/test.
WARNING: The LuViva device should not be used in patients with Pap results with high risk for
severe dysplasia/dyskaryosis.
severe dysplasia/dyskaryosis.
WARNING: LuViva should only be operated by healthcare professionals.
WARNING: LuViva is not intended for use as a colposcope.
WARNING: Do not pinch vaginal or cervical tissue between the edges of the speculum blades and the
cervical guide. Patient injury may occur.
WARNING: Support the HHU in accordance with instructions. Motion during use may cause
misdiagnosis of and injury to the patient.
3.5.2 Frequency of Use—Number of Tests per Day
WARNING: LuViva should not be used on a single patient for more than three LuViva scans per 24
hour period.
3.5.3 Operator Use Cautions
WARNING: LuViva is not intended for use in areas where gaseous anesthesia, oxygen or nitrous
oxide is used. Due to the nature of the light source, an explosion may result.
CAUTION: Lock the wheels after positioning in the exam room, prior to use on a patient.
CAUTION: LuViva results depend upon the os of the cervix remaining in the field of view during the
test. Movement by the patient may cause misdiagnosis. If patient moves, test should be repeated.
CAUTION: Instruct the patient to be as still as possible to minimize potential injury during the test.
CAUTION: Use handle of HHU to place HHU into Docking Station to avoid pinching or crushing
CAUTION: LuViva results depend upon the os of the cervix remaining in the field of view during the
test. Movement by the patient may cause misdiagnosis. If patient moves, test should be repeated.
CAUTION: Instruct the patient to be as still as possible to minimize potential injury during the test.
CAUTION: Use handle of HHU to place HHU into Docking Station to avoid pinching or crushing
fingers between the HHU and the cradle.
CAUTION: Always wear gloves and use sterile field methods when using LuViva to protect the
CAUTION: Always wear gloves and use sterile field methods when using LuViva to protect the
operator and patient from potential cross-contamination.
NOTE: Ensure the Calibration Cap is fully seated on Cervical Guide before beginning calibration. Do
NOTE: Ensure the Calibration Cap is fully seated on Cervical Guide before beginning calibration. Do
not remove or discard the Calibration Cap until calibration has completed.