Statement of Work
HealthMark Inspection Scope
- General Description of Performance Requirements and Features of the System: The Healthmark Inspection Scope is designed to visually inspect internal channels of potentially soiled or damaged items, provides enhanced light, vision, and magnification. The borescope also offers users the option to document photos and videos of lumens and crevices not visible to the unaided eye. It has a modular design with interchangeable flexible inspection scope attachments available in diameters of 1.06mm and 1.9mm. These scopes have a working length of 110cm and attach to a 13.3W x 9.9L x 4.7H cm control box, allowing for light level adjustments, image capture*, and video recording*. The 1.06mm scope is designed to inspect internal channels of 1.1mm in diameter or larger, and the 1.9mm scope is designed to inspect internal channels of 2.0mm in diameter or larger. *These features are only available for the USB control box with FIS-007 software, which is included and installs on Windows 10 PC’s
This solicitation uses a Brand Name of the product required.
The Eastern Kansas Health Care System requests to purchase Healthmark Digital Inspection Scope. Each time a medical device is processed, it should be visually inspected for cleanliness and integrity. Enhanced inspection with magnification, borescopes, or other inspection methods to verify cleanliness and integrity may be used. Borescopes or other methods may be used to check internal channels of instrumentation for cleanliness and integrity unless otherwise recommended in the instrument manufacturer’s written IFU and the borescope manufacturer’s written IFU. When recommended in the instrument manufacturer’s written IFU, enhanced inspection should be used and the enhanced visualization tool manufacturer’s written IFU should be followed. Healthcare facilities should have a method of ensuring cleanliness and integrity of every instrument and medical device used in every procedure.
**Quote attached with packet: Quote denotes 2 eachcof each item but each campus is requesting only 1 each. The quote attached represents the total quantity needed and each campus.
Items Needed: FIS-007USK – USB Control Box Kit 2/1.9mm Catheter
CT-102 – Catheter, 1.06 mm Dia 110 cm length, Flexible Inspection Scope
FIS-007SPT – Storage & Protection Tray
- Requirements:
- Must comply with AAMI ST79 (2017) Amendment 2:
- 8.2 Inspection of Instruments
- Each time a medical device is processed, it should be visually inspected for cleanliness and integrity.
- Enhanced inspection with magnification, borescopes, or other inspection methods to verify cleanliness and integrity may be used.
- Borescopes or other methods may be used to check internal channels of instrumentation for cleanliness and integrity unless otherwise recommended in the instrument manufacturer’s written IFU and the borescope manufacturer’s written IFU.
- When recommended in the instrument manufacturer’s written IFU, enhanced inspection should be used and the enhanced visualization tool manufacturer’s written IFU should be followed.
- Healthcare facilities should have a method of ensuring cleanliness and integrity of every instrument and medical device used in every procedure.
- Must provide lighted magnification and be able to document photos and videos of lumens and crevices not visible to the unaided eye.
- Must be able to inspect internal channels of 1.1mm in diameter and larger.
- Must be easily cleanable between uses.
- Must be compatible with Scope Viewer Software.
- Must be compatible with Windows 10 or higher.
