Technical Description:

Girgis Scope DBL Is originally a rigid McCoy Flexi tip laryngoscope with added second movable blade and ratchet spring lock.
GSV200.DBL is Girgis Scope DBL with added camera and DVR monitor.
GSV200.DBL is reusable and unsterilized with two sizes MAC # 3 and MAC # 4.
The movable blade attached to movable handle and articulates with stationary blade so movement in movable handle transmitted to the movable blade to create a pathway.
A small camera and illumination light waterproof bonded with epoxy 301 into distal end of camera arrangement (camera shell, connector and camera conduit and wire with medical grade connector) respectively, which can be lodged and dislodged from the movable blade groove.
The removal of camera arrangement is soak-able and can be high level disinfected. A waterproof cap is provided to protect the medical grade connector during cleaning disinfection.
The monitor can be disconnected from ball joint, which is attached to stationary handle for cleaning. The stationary handle includes a battery and switch that can be removed and the rest of the metal handle and blades of GSV200.DBL can be sterilized in autoclave.Girgis Scope LLC believes this product does not raise any new safety or effectiveness issues from predicate Girgis scope DBL. All materials that may come into contact with human tissue during normal use are biocompatible and are suitable for intubation procedure.
The manufacturer will provide circuit diagram component part lists descriptions, calibration instruction to assist to service personnel in parts repair.

Software development:

The system software runs on an embedded processor dedicated for video capture by CSR plc. The software is written in C code and compiled using SDE 6 on Windows. Software was debugged using Windows simulator. The device makes use of source code provided by the chip manufacturer.

This source code is compiled with the custom software such that the user of the device has no opportunities to interact directly with this software or replace it by other versions of the software. This source code is an integral part of the solution that has been verified and validated.

Device Features:

The device is a specially designed camera intended to guide patient intubation. The system software provides access to the device functionality by graphical user interface controlled by 6 content sensitive buttons on the device.

Logically, the software is divided into three features:

1. Recording mode.

2. Playback mode.

3. Setup.

Recording mode:

The software automatically starts up in recording mode. This provides live footage from the video camera that can optionally be recorded to internal memory for future reference. The user can also save still images on the device memory by pressing the provided button.

If the user chooses to save the video to memory, the software compresses the video stream and saves it to internal flash memory.

Playback mode:

The Playback mode feature makes it possible to playback previously recorded video footage and view previously taken still photos. To enter this mode, going to the main menu of the device accesses it:

If My Files is chosen, the user enters playback mode.

List of previously recorded videos and images is provided, each item identified with date. The user can choose any item from the list, video or still images for immediate review.

The playback mode provides access to standard video playback controls:

1. Play.

2. Fast Forward.

3. Fast Backward.

4. Pause.

All functions are provided through the 6 content sensitive buttons

Setup:

The Setup feature allows the user to change the device settings.

The setup menu provides access to video related settings:

Pixels: Resolution of video image. (720x576, 720x480, 640x480)
FPS: Frames pr. second of recorded video. (15, 25 or 30)
Bit Rate: Quality vs. memory consumption (low, medium, high)
Video Sound: Sound on or off.
Video Time: Stop video recording after fixed time (10, 20, 30 minutes)
Storage: Choose to store to internal memory or an SD card.
Date Time: Set the internal clock.
TV Out: Choose NTSC or PAL for TV out function.
Brightness LCD: Adjust screen brightness.
Memory Info: Shows amount of available flash memory
Version: Displays software version.
Language: Choose language (English, Chinese)

Girgis Scope Video DBL: DVR features:

#	Name	Functiont
1	Medical adaptor	Medical grade connector that connects to the camera module that is placed inside the secondary movable blade of Girgis Scope Video-DBL
2	On/Off	Switch to power on the DVR Screen
3	Button control	Soft touch hard key buttons for user to navigate DVR module.
4	Speakers	Enhanced external sound for playback of video footage.
5	External display port	External Display port allows user to duplicate DVR screen on an external display for multiple users.
6	Charging port	Designed to charge internal rechargeable battery for DVR.
7	Mini-B port	Port available for user to connect device to a PC for footage upload.
8	SD card slot	SD memory card expansion slot for storing pictures and videos taken during procedure
9	LCD Display	A LCD display presents the image for viewing by the user.
10	Power Unit	The rechargeable battery and associated electronics are contained within the housing of the DVR
11	Green trans-illumination LED	Green LED indicating DVR device is powered on and ready for visible display with camera module

Customer Service :

Phone:732-710-9724