Guided Therapeutics Inc 13500 Manuale Utente
November 2013, CNDS-0-635-MAN_3
Page 7 of 78
2.2 Components
2.2.1 Cart
2.2.1.1 Wheels
2.2.1 Cart
2.2.1.1 Wheels
The LuViva has four (4) wheels. All wheels are lockable.
2.2.1.2 Handle
The handle that surrounds the Base Unit allows for LuViva to be moved from room to room, or positioned as needed
in the examination room.
2.2.2 Docking Station
The Docking Station is the storage station for the HHU.
2.2.3 Base Unit
The Base Unit is the under the Base Unit Cover. It contains the majority of the electrical equipment. It contains a
computer system with LuViva software, the light source and most of the electronics and the hardware necessary to
conduct a diagnostic test.
2.2.4 Main Power Switch on Base Unit
The Main Power Switch is used to enable the power to be turned on using the Stand-by Power Switch above on
LuViva. LuViva cannot be turned on with the Stand-by Power Switch if the Main Power Switch is not also turned on.
2.2.5 Monitor
The touchscreen allows the operator to progress through a LuViva diagnostic test, to display the result, to access the
Help system, and to turn off LuViva after use.
2.2.6 Hand Held Unit
The Hand Held contains the camera, lenses and hardware needed to capture images of the cervix for the LuViva
diagnostic test. It has a single activation button in the handle that can be used to advance through the test. It has a
touchpad for screen navigation.
touchpad for screen navigation.
2.2.7 LuViva Stand-by Power Switch on HHU
Turn On
The Stand-by Power Switch is used to turn on LuViva. Press and release the Stand-by Power Switch to turn on
The Stand-by Power Switch is used to turn on LuViva. Press and release the Stand-by Power Switch to turn on
LuViva.
Turn Off
Typically, the LuViva software is used to turn off LuViva; however, the main power switch may also be used to turn off
the LuViva in an emergency. Press and hold the main power switch for ten seconds to turn off LuViva.
Turn Off
Typically, the LuViva software is used to turn off LuViva; however, the main power switch may also be used to turn off
the LuViva in an emergency. Press and hold the main power switch for ten seconds to turn off LuViva.
2.2.8 Cable
The cable connects the Hand Held Unit to the Base Unit, and provides the pathways for light and electrical
communications between the electronics in both the units. It is tethered to the front column of the Cart.
communications between the electronics in both the units. It is tethered to the front column of the Cart.
2.3 Accessory: CG (Cervical Guide)
The CG is attached to the front of the Hand Held Unit in order to conduct a diagnostic test. It is a non-sterile Type B
Applied Part accessory to the LuViva device. It is a single-use disposable that is immediately discarded after use. The
Applied Part accessory to the LuViva device. It is a single-use disposable that is immediately discarded after use. The
Calibration Cap provides an internal target used to provide a reference measurement to LuViva. The Cap is removed
as part of the test sequence.