Healthmark FIS-007HB - User Manual

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Instructions for Use: Flexible Inspection Scope Kit-HDMI

Brand Name of Product

Flexible Inspection Scope Kit-HDMI

Generic Name of Product

Flexible Inspection Scope Kit-HDMI

Product Code Number(s)

FIS-007H, FIS-007HB, CT-101, CT-102, CT-103

Intended Use

For visually inspecting items.

Range of Applications for

Product

Enhance visual inspection by providing lighted magnification, image capture and the option

for documentation in hard-to-see crevices, channels, and lumens in the areas if instruments

that are not visible to the unaided eye.

Key Specifications of Product

Flexible Inspection Scope™ FIS-007H

 CT-101 1.90 mm OD and 110 cm Length

 CT-102 1.06 mm OD and 110 cm Length

 Optical

o Resolution Format

o CT-102 1.06 mm: 40,000 pixels (or 200- x 200 pixels)

o CT-101 1.90 mm: 160,000 pixels (or 400- x 400 pixels)

o Field of View: 120° in air

o Angle of view: 0°

HDMI Control Module (2 mm): Control module housing Camera processor and LED

illumination HDMI

 Dimensions: 5.24- x 3.90- x 1.85 inches

 Weight: 1.20 pounds

 Digital Inspection Scope Connection

 Illumination Control

 Power Cycle

 Power Input: 100- to 240 volts (V) alternating current (ac), ≈1 ampere (A), 47- to

63 hertz (Hz) (from wall outlet)

 Power Output: 5 V, 2 A (to enclosure)

 System Power Button

 All scope lengths and both diameters

 HDMI Mini to HDMI Cable

 Easily change from small and large diameter scopes

Light Settings:

There are four light settings operated by one-button.

Blinking Light:

Indicates transmitting video data

 Splash proof (IPX5 Rating)

 Requires external power.

Box Features:

 No Documentation capabilities

 Power plug

 Power Button (on top of the Box)

 Catheter Holders- Integrated rubber catheter holder

Flexible Inspection Scope Software Requirements:

 Compatible with Windows 10 Operating System.

 No Software-plug into any HDMI monitor.

Shipping & Storage

Document

Version

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The Healthmark Industries Flexible Inspection Scope Kit-HDMI is a device designed for visual inspection, particularly in hard-to-see crevices, channels, and lumens where traditional visual inspection is difficult. It provides enhanced visual inspection capabilities, image capture, and the option for documentation, making it suitable for various applications including healthcare, industrial, and quality control settings.

Function Description

The Flexible Inspection Scope Kit-HDMI allows users to visually inspect areas that are not visible to the unaided eye. It connects to a control module and features a flexible working length with a camera lens at the distal end. The device provides illumination for clear viewing and can capture images and videos for documentation purposes. The HDMI control module is the central unit that manages the inspection scope's functions, including power, illumination, and connectivity to an external display.

Important Technical Specifications

The Flexible Inspection Scope Kit-HDMI comes with two main flexible working lengths:

Large: 1.90 mm O.D. and 110 cm length
Small: 1.06 mm O.D. and 110 cm length

The HDMI Control Module has the following specifications:

Dimensions: 5.24- x 3.90- x 1.85 inches
Weight: 1.20 pounds
Digital Inspection Scope Connection: For connecting the flexible inspection scope.
Illumination Control: Manages the light output from the scope.
Power Cycle: Button to reset the camera.
Power Input: 100- to 240 volts (V) alternating current (ac), ≈1 ampere (A), 47- to 63 hertz (Hz) (from wall outlet).
Power Output: 5 V, 2 A (to enclosure).
System Power Button: For turning the device on/off.
All scope lengths and both diameters: Compatible with both large and small flexible inspection scopes.
HDMI Mini to HDMI Cable: For connecting to an external display.
Easily change from small and large diameter scopes: Allows for quick interchangeability.

The illumination system offers 5-light settings, with the 5th setting turning the light OFF.

Storage and Transport Conditions:

Humidity: 10- to 100% relative humidity (rh) (or condensing)
Temperature: -20- to 60 °C
Air Pressure: 600- to 900 hectopascals (hPa) (or millibars [mb])

Normal Operation Conditions:

Humidity: Zero (0)- to 100% rh
Temperature: 5- to 40 °C

Usage Features

The device is designed for ease of use with several user-friendly features:

Light/Illumination Settings: The control module includes a button to cycle through 5 light settings, allowing users to adjust illumination based on inspection needs. The 5th setting turns the light off.
Power Cycle Button: A dedicated button on the control module allows users to reset the camera, which can be useful for troubleshooting or restarting the device.
Flexible Inspection Scope Plug: The scope connects to the control module via a plug that also provides LED light for illumination. The plug is designed for secure connection and easy interchangeability between different scope lengths and diameters.
Distal Camera: The flexible inspection scope features a camera lens at its distal end, enabling clear visual inspection of internal structures.
Rotating Device to Avoid Obstacle: The scope can be gently manipulated or rotated to avoid obstacles during insertion, ensuring thorough inspection without damaging the device or the inspected item.
Image Capture and Documentation: The system supports image and video capture, which can be stored and used for documentation, training, or quality assurance purposes.
Software Compatibility: Compatible with Windows 10 Operating System, and no software-plug into any HDMI monitor is required, simplifying setup and operation.

Maintenance Features

Proper maintenance is crucial for the longevity and performance of the Flexible Inspection Scope Kit-HDMI. The device is designed with specific cleaning and disinfection protocols:

Cleaning:
- Manual Cleaning: Requires wiping down the Flexible Inspection Scope™ with a compatible wipe. The control module and cable should also be wiped down with appropriate wipes.
- Automated Cleaning: N/A (not supported for automated cleaning).
Disinfection:
- Manual Disinfection: The Flexible Inspection Scope™ is not sterile as supplied and must be cleaned and disinfected or sterilized before use. It is compatible with various disinfectants, including alcohol ethoxylates, enzymatic cleaning solutions, glutaraldehyde, accelerated hydrogen peroxide (AHP), peracetic acid, sodium xylene sulfonate, and trisodium nitrilotriacetate.
- High-Level Disinfection: The device is compatible with various high-level disinfectants. Users must follow the instructions for use (IFU) for appropriate wipe usage and chemical compatibility chart (PDF) for approved cleaning agents.
- Sterilization: The Flexible Inspection Scope™ is compatible with Low Temperature Sterilization Systems such as STERIS® 100S System (Standard), STERRAD® NX System (Standard, Advanced), and STERIS® V-PRO® Low Temperature Sterilization Systems (Non-Lumen Cycle).
Drying: After cleaning and disinfection, the scope should be dried with a sterile, non-linting wipe or sponge. The distal tip and proximal ends must be ensured dry. Air drying could leave deposits on optical surfaces, which could result in a degraded image.
Maintenance, Inspection, and Testing:
- Prior to use: Inspect the external surfaces of the Flexible Inspection Scope™ and any accessories to ensure they are smooth and free of any wear or damage (e.g., prominent or sharp edges).
- Serviceable parts: The Flexible Inspection Scope™ has no user-serviceable parts beyond cleaning.
- Refer all service or replacement needs to Healthmark Industries.
- Light leads: May be common and noticeably noticeable when inspecting the flexible portion of the Flexible Inspection Scope™. This does not influence its function but should be monitored for light output.
- Overly dark images: May be caused by damaged light leads and may require repair or replacement of the Flexible Inspection Scope™.
Troubleshooting: The manual provides a troubleshooting guide for common issues such as no image, low light, overly bright image, blurry image, image does not capture, and rapidly takes pictures automatically, along with corresponding causes and corrections. For example, if there is no image, the main window may be black, indicating that the inspection scope was not connected to the computer when the software was opened. The correction involves unplugging the USB connection on the camera cable and plugging it in again.

Reassembly Instructions: N/A (no reassembly required after cleaning/disinfection).

Packaging: Do not autoclave the Flexible Inspection Scope™.

Healthmark FIS-007HB Specifications

General

Brand	Healthmark
Model	FIS-007HB
Category	Laboratory Equipment
Language	English