Справочник Пользователя для Guided Therapeutics Inc 13500
November 2013, CNDS-0-635-MAN_3
Page 25 of 78
6. Operating Environment
6.1 Operating Environment
The best environment for safe and comfortable operation of LuViva is in an air-conditioned, clinical setting with
gynecologic examination equipment present and available and medical waste disposal capabilities.
gynecologic examination equipment present and available and medical waste disposal capabilities.
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.
oxide is used. Due to the nature of the light source, an explosion may result.
6.1.1 Room Temperature Requirements
LuViva operates best in a room with air-conditioning, at or below 77ºF (25ºC). LuViva can be stored in rooms with
less controlled temperatures. Please see Environment Specifications for more information.
6.1.2 Visibility Conditions
LuViva does not require specific lighting conditions; light levels needed for a gynecological exam are sufficient to
operate the device and its accessories.
TECHNIQUE TIP: A lower lighting level may be helpful during the diagnostic test in order to avoid an Ambient
TECHNIQUE TIP: A lower lighting level may be helpful during the diagnostic test in order to avoid an Ambient
Light Error.
6.1.3 Minimize Noise Level and Distractions during Test
LuViva incorporates both visible and audible cues throughout the test sequence. Maintaining an environment that is
free of loud ambient noise or any activities that may cause distractions is recommended.
7. Performing a Test
To perform a LuViva test, you must use the touchscreen to start and navigate through the screens. Some screens will
include instructions for you to follow in order to proceed to the next step of the test. Please follow all instructions
shown. Additional Warnings, Notes and Technique Tips are given in the next sections of the manual to assist you in
completing each test accurately. Each test should take approximately 5 minutes from start to finish.
completing each test accurately. Each test should take approximately 5 minutes from start to finish.
7.1 Accessories
7.1.1 Cervical Guides
7.1.1 Cervical Guides
In order to use LuViva, you will need a cervical guide for every patient. The disposables are provided in cases of 20,
and may be ordered by contacting a Guided Therapeutics, Inc. authorized distributor or customer service at Guided
Therapeutics, Inc. Each case contains instructions for use for the disposable.
LuViva Cervical Guides are non-sterile, single-use devices intended for use with a speculum and LuViva Advanced
Cervical Scan during a gynecological exam.
Therapeutics, Inc. Each case contains instructions for use for the disposable.
LuViva Cervical Guides are non-sterile, single-use devices intended for use with a speculum and LuViva Advanced
Cervical Scan during a gynecological exam.
7.1.2 Specula
NOTE: Confirm the compatibility of specula before using with LuViva.
7.1.3 USB Drive
NOTE: The results for the patient are NOT saved on LuViva. Ending the test closes the program and deletes results.
The operator shall be given an option to save the results output in PDF format on a USB thumb drive. A USB 2.0
thumb drive is supplied by Guided Therapeutics, Inc. See Specifications Section.
thumb drive is supplied by Guided Therapeutics, Inc. See Specifications Section.
7.2 Patient and Operator Positioning
LuViva is accessible by the operator in the standing or seated position. The patient shall be in a position for a
gynecological exam, positioned so that the operator can easily manipulate the HHU into the speculum while accessing
gynecological exam, positioned so that the operator can easily manipulate the HHU into the speculum while accessing
the touchscreen.