Inactive

Rev:103019 - STERIS Instrument Management Services, Inc. 3316 2nd Avenue North, Birmingham, AL 35222, 1-800-783-9251, VerifEye@steris.com Distributed by STERIS IMS STATEMENT OF WORK Sterile Processing... Rev:103019 - STERIS Instrument Management Services, Inc. 3316 2nd Avenue North, Birmingham, AL 35222, 1-800-783-9251, VerifEye@steris.com Distributed by STERIS IMS STATEMENT OF WORK Sterile Processing Service under Boston Healthcare System is need of 5 Borescope. 2 Jamaica Plain, 2 for West Bury and one for Brockton. Instructions for Use Product Name VerifEyeTM Camera Control Unit (CCU) and Inspection Unit Type of product Borescope system Product numbers VEYE101-101 VerifEyeTM Inspection Unit VEYE101-102 VerifEyeTM Inspection Unit (Brand New Repair/Exchange) VEYE101-112 VerifEyeTM Inspection Unit 1.2m VEYE101-113 VerifEyeTM Inspection Unit 1.2m (Brand New Repair/Exchange) VEYE101-103 VerifEyeTM Camera Control Unit (CCU) Intended use Assist in visual inspection of medical device cannulas and lumens. Range of applications Medical instruments and devices that require visual inspection by providing illumination, magnification and optional documentation in channels and lumens that are not visible to the unaided eye. Product Specifications Overall length of borescope: Working length: 1.9m (VEYE101-101, VEYE101-102), 1.2m (VEYE101-112, VEYE101-113) Distal camera diameter: 1.6mm Max Weight: Inspection Unit 0.3125 lbs. (141.75 g), CCU 1.3125 lbs. (595.34 g) Resolution: 400 x 400 pixels Brightness control: To increase or decrease illumination Optical angle of view: 120 degrees Connections: HDMI Out x 1, USB3.0 x 1, DC In x 1 VEYE101-101, VEYE101-112 VerifEyeTM Inspection Unit IP rating: IPx7 VEYE101-102, VEYE101-113 VerifEyeTM Inspection Unit (New Repair/Exchange) IP rating: IPx7 VEYE101-103 VerifEyeTM Camera Control Unit (CCU) IP rating: IPx4 Image capture: Via USB3.0 and VerifEyeTM viewer Video clip recording: Via USB3.0 and VerifEyeTM viewer Package contents Camera Control Unit Diagrams Connector to Illumination Inspection Unit control USB 3.0 port Power switch Power adapter HDMI output connector Inspection Unit Diagrams Flexible insertion tube CCU Cable ¼-20 Mounting hole Shipping and Storage Shipping requirements Inspection Unit and CCU should be shipped in original packaging. Storage requirements -18 degrees C to 60 degrees C, 15% to 90% relative humidity. Packing conditions Inspection Unit and CCU should be packed in original foam packaging and protective coil. Protective coil is for shipping purposes and long- term storage only and not for use as a daily storage solution. Instructions for Use Description of Use(s) Assist in visual inspection of medical device cannulas and lumens. Preparation for Use Before connecting the Inspection Unit, verify that the VerifEye viewer software is installed (if optional tablet was purchased) by clicking on Windows>All Programs>VerifEye. VerifEye viewer software can only be installed on a tablet purchased from STERIS IMS. If the VerifEye viewer software is not installed, contact STERIS IMS for support. Inspection prior to use Inspection of the Inspection Unit should be performed prior to each use. Inspect the Inspection Unit head for cracks. Inspect the Inspection Unit insertion tube for kinks and illumination performance. Inspect the video image by powering on the unit prior to insertion into the device that is being inspected. If any damage is noted to any part of the Inspection Unit, discontinue use immediately and contact STERIS IMS for service. Operation 1. Mount the Inspection Unit onto a mounting fixture using the ¼-20 mounting hole (if optional stand was purchased). 2. Connect the HDMI output from the CCU to an HDMI display (if using an HDMI monitor). 3. Connect the USB3.0 from the CCU to a USB3.0 port on a Windows PC using a USB3.0 cable (if using the optional tablet and VerifEye viewer software). 4. Connect the DC power input on the CCU to an AC power plug using the included power adapter. 5. Remove the connector cable cap and connect the Inspection Unit to the CCU by inserting the metal connector on the Inspection Unit cable into the CCU Camera Input. 6. Power on the Inspection Unit by turning the power switch to the ON (I) position. 7. Verify a live image is displayed on the HDMI monitor (if connected) or on the optional tablet using the VerifEye software. 8. Adjust the illumination level by rotating the brightness control knob (clockwise to increase illumination, counter clockwise to decrease illumination). 9. Grasp the Inspection Unit near the flexible distal end and gently insert into the intended device. Take care not to bend or kink the flexible distal portion. Operation for VerifEye Touchscreen with Live Viewing software (tablet) The following instructions apply to the optional tablet with the viewer software installed. Before launching the VerifEye Viewer, check that all connections are properly connected. Power adapter to tablet USB 3.0 cable between CCU and tablet Power on the tablet by pressing the tablet On/Off button. Sign on to the Steris login by clicking Sign In. Power on the CCU by turning on the power switch located on the rear of the CCU. Launch the VerifEye viewer by double clicking on the VerifEye Viewer icon on the desktop. The live camera image will appear in the viewing window of the software. To change the default directory for saving images and video clips, click the Folder button in the viewer software. To capture an image, click the Snapshot button. 9. To capture a video clip, click the Record button. To stop recording, click the Stop Record button. To play back recorded video, click the Play button. After clicking the play back window, select the video file you want to playback. The playback window will open. The playback window has several controls including: Rewind Slow motion mode Snapshot Delete file Previous file Close Zoom in Zoom out Zoom 1:1 Cleaning and Maintenance Cleaning Regarding the cleaning and disinfection of the VerifEye Video Borescope Inspection Unit (VEYE101- 101/VEYE101-102/VEYE101- 112/VEYE101-113) the VerifEye Video CCU (VEYE101-103) and related accessories, it is up to the end user to determine when to clean, disinfect and/or do both based on the facility s protocol. VEYE101-101/102/112/113 VerifEyeTM Inspection Unit Wipe off any gross soil and wipe down with enzymatic solution, such as Prolystica® HP Neutral or Prolystica® 2X Concentrate Neutral Detergents, after every use. Rinse under clean water. The Inspection Unit can be submerged with the secure cap. Inspection Unit IP rating: IPx7. Follow the disinfectant manufacturers IFU for use with scopes. Dry with clean, lint-free towel. VEYE101-103 VerifEyeTM Camera Control Unit (CCU) Wipe down with moist antibacterial wipes according to OEM IFU for contact time. DO NOT submerge this unit. Dry with clean, lint-free towel. CCU IP rating: IPx4 Tablet The tablet can be sanitized by using one of the following recommended solutions PDI Sani-Cloth Plus, CaviWipes, Covidien Alcohol Prep Pads, any similar wipes with IPA (Isopropyl Alcohol) solution under 70%, Total Solutions Full Spectrum Disinfectant Wipes, or Clorox Healthcare Bleach Germicidal Wipes--without risk of damaging the device. HDMI Cable Wipe down with moist antibacterial wipes according to OEM IFU for contact time, paying careful attention not to get the cable contacts wet. DO NOT submerge this unit. Dry with clean, lint-free towel. USB3.0 Cable Wipe down with moist antibacterial wipes according to OEM IFU for contact time, paying careful attention not to get the cable contacts wet. DO NOT submerge this unit. Dry with clean, lint-free towel. Power adapter Wipe down with moist antibacterial wipes according to OEM IFU for contact time, paying careful attention not to get the cable contacts wet. DO NOT submerge this unit. Dry with clean, lint-free towel. Stand Wipe down with moist antibacterial wipes according to OEM IFU for contact time. Dry with clean, lint-free towel. Disinfection of VEYE101-101/102/112/113 VerifEyeTM Inspection Unit Wipe down with moist antibacterial wipes according to OEM IFU for contact time. The Inspection Unit can be submerged with the secure cap. Inspection Unit IP rating: IPx7. Follow the disinfectant manufacturers IFU for use with scopes. Dry with clean, lint-free towel. Sterilization of VEYE101-101/102/112/113 VerifEyeTM Inspection Unit Validated in STERIS V-PRO maX/maX2 Low Temp Sterilization System. Validated in STERIS SYSTEM 1E Liquid Chemical Sterilant System. Follow the OEM IFU for sterilization settings and cycle time. Disinfection of VEYE101-103 VerifEyeTM Camera Control Unit (CCU) Wipe down with moist antibacterial wipes according to OEM IFU for contact time. DO NOT submerge this unit. Dry with clean, lint-free towel. Maintenance The VerifEyeTM Camera Control Unit (CCU) and Inspection Unit and all components are designed as non-user serviceable parts and components. For service, please contact your STERIS IMS representative or call 800-783-9251. Storage Store the VerifEyeTM Camera Control Unit (CCU) and Inspection Unit in a dry environment with a temperature of no higher than 60 degrees C or no lower than -20 degrees C. Store the Inspection Unit loosely coiled in the designated storage container or in a way that the insertion portion won't be damaged. Special Warnings and Cautions Do not modify or disassemble the unit. Do not subject the distal end of the Inspection Unit to impact or bending, which may cause damage to the CMOS camera located at the distal tip. Do not tightly coil or kink the insertion portion of the unit. Do not allow the CCU to come in contact with excessive amount of water. This may cause damage to the CCU or electrical shock. CCU IP rating: IPx4. Do not set any equipment on the Inspection Unit. FCC information This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. VerifEyeTM Camera Control Unit (CCU) and Inspection Unit is CE Marked Service For service, please contact your STERIS IMS representative, call 800- 783-9251, or email VerifEye@steris.com . Warranty The VEYE101-101/102/112/113 VerifEyeTM Inspection Unit carries a 365 day warranty against defects for parts and labor. The VEYE101- 103 VerifEyeTM Camera Control Unit (CCU) carries a 365-day warranty against defects for parts and labor. Lifetime The lifetime of VerifEyeTM Camera Control Unit (CCU) and Inspection Unit is determined by their adequate functionality and careful care during use. End of lifetime is determined by wear and damage due to the use. Improperly functioning, damaged, or excessively worn VerifEyeTM Camera Control Unit (CCU) and Inspection Unit should not be used. VerifEyeTM Camera Control Unit (CCU) and Inspection Unit are distributed by STERIS IMS. VerifEye is a trademark of STERIS Instrument Management Services (IMS). Prolystica is a registered trademark of STERIS Corporation.