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Instructions for Use
Read carefully prior to use
Part Number: MI-195-EN-US Rev C
Mucosal Integrity
Testing System
Diversatek Healthcare
Technical Research & Training Center
9150 Commerce Center Circle, Suite 500
Highlands Ranch, CO 80129 USA
P 800.558.408 or 303.470.7020
technicalsupport@diversatekhc.com
clinicalsupport@diversatekhc.com
clinicaleducation@diversatekhc.com
DiversatekHealthcare.com
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Table of Contents
Related Manuals for Diversatek Healthcare MiVu
Summary of Contents for Diversatek Healthcare MiVu
- Page 1 Mucosal Integrity Testing System Instructions for Use Read carefully prior to use Diversatek Healthcare Technical Research & Training Center 9150 Commerce Center Circle, Suite 500 Highlands Ranch, CO 80129 USA P 800.558.408 or 303.470.7020 technicalsupport@diversatekhc.com clinicalsupport@diversatekhc.com clinicaleducation@diversatekhc.com DiversatekHealthcare.com Part Number: MI-195-EN-US Rev C...
- Page 2 MiVu™ Mucosal Integrity Testing System Instructions for Use Notes, Notices, and Cautions in this Guide NOTE: A NOTE indicates important information that helps you make better use of your system. NOTICE: A NOTICE indicates either potential damage to hardware or loss of data and tells you how to avoid the problem.
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Page 3: Abbreviations And Acronyms
® PriZm ® manometry acquisition system. Balloon Probe Patient applied sensor device. ® Diversatek Healthcare’s software suite for data acquisition and analysis with the PriZm ® system. Page 3 of 23 MI-195-EN-US, Rev C, Edited 16 February 2023, ECO 223-004... - Page 4 Trademarks used in this text: inSIGHT Ultima®, PriZm®, Zvu®, and MiVu™ are trademarks of Diversatek Healthcare, Inc.; Dell is a trademark of Dell Inc.; Intel, Pentium are registered trademarks of Intel Corporation; Microsoft and Windows are registered trademarks of Microsoft Corporation.
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Page 5: Table Of Contents
Preparation ........................... 14 Intubation ............................14 Data Acquisition..........................15 3.3.1 Troubleshooting During Data Acquisition................15 Extraction............................15 CLEANING AND DISINFECTING THE COMPONENTS OF THE MIVU™ MUCOSAL INTEGRITY TESTING SYSTEM............................. 17 Single-use, Disposable Items ....................... 17 PriZm ® , Cart and Computer......................17 MiVu™... -
Page 6: Introduction
1 Introduction 1.1 How to Use This Guide This guide is designed to help you use the MiVu™ Mucosal Integrity Testing System. It is intended for health-care professionals trained in performing clinical procedures utilizing the MiVu System and the Zvu ®... -
Page 7: Caution: Safety Instructions
CAUTION: Do not attempt to use the MiVu Cable unit with any system other than the PriZm System. Failure to do so could damage the unit or result in injury to the user or patient. -
Page 8: Product Description
1.3.3 Contraindications There are no known contraindications, but it must be used in accordance with the indications for use. There are no known contraindications for patient contact reactions. The MiVu Balloon Probe is not made with natural rubber latex. 1.3.4 Potential Complications... - Page 9 MiVu™ Mucosal Integrity Testing System Instructions for Use CAUTION: The MiVu Balloon Probe utilizes nickel that is plated with gold. This use of nickel may pose risks for people with certain allergies to nickel. Page 9 of 23 MI-195-EN-US, Rev C, Edited 16 February 2023, ECO 223-004...
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Page 10: Getting Started
The MiVu™ Mucosal Integrity Testing System consists of the PriZm® System, the MiVu Cable and the MiVu Balloon Probe. This chapter describes how to connect the MiVu Cable to the PriZm and attach the MiVu Balloon Probe. It also covers proper positioning of the MiVu Balloon Probe within the patient and describes the user controls available to the operator. - Page 11 Connecting to the PriZm® Central Unit The MiVu™ Cable will connect to the PriZm Central Unit using the Port 1 connector. When the device is properly connected, the Port 1 indicator LED on the side panel of the PriZm Central Unit will illuminate in blue.
- Page 12 Connect the MiVu Inflation Syringe to the Extension Tube. b) Connect the Extension Tube to the luer fitting on the MiVu Regulator. c) Connect the clear air supply line from the MiVu Cable to the output port fitting on the MiVu Regulator.
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Page 13: Mivu™ Regulator Pressure Indicator
2.3.3 MiVu™ Regulator Control Handle The control handle on the MiVu Regulator is a position switch which controls how the air flow from the MiVu Inflation Syringe to the MiVu Balloon Probe is controlled. Set the handle pointed to the Inflate position when inflating the balloon. -
Page 14: Mucosal Integrity Conductivity Test (Mi) Procedure
Study using the Diversatek Healthcare MiVu™ Mucosal Integrity Testing System with Zvu® Software. Note: The MiVu Balloon Probe utilizes a security feature that limits the probe to a single use. When the Acquire button in Zvu is first clicked when using a probe, the probe has a one-hour period during which it must be used. -
Page 15: Data Acquisition
Data Acquisition Please refer to the PriZm® User’s Manual (H20-0195) for additional information concerning the operation of the PriZm System and the Zvu® Software. Refer to the MiVu™ Mucosal Integrity Acquisition and Analysis Guide for details on data acquisition. After powering up the PriZm System, launch the Zvu Software. Create a Mucosal Integrity workflow and add a study to the patient using the workflow. - Page 16 MiVu™ Mucosal Integrity Testing System Instructions for Use Carefully extract the MiVu Balloon Probe from the patient. Stop the extraction if there is any resistance that might lead to patient injury. Disconnect the MiVu Balloon Probe from the cable by pressing down on the silver retention tab and pulling the connector shells apart.
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Page 17: Cleaning And Disinfecting The Components Of The Mivu™ Mucosal Integrity Testing System
The MiVu™ Mucosal Integrity Balloon Probe is a single-use, non-sterile device that does not require cleaning before use. This device must be disposed after use and cannot be reprocessed. The MiVu Inflation Syringe that connects to the MiVu Regulator is a single use, non-sterile disposable device and must be disposed of after use. -
Page 18: Validated Cleaning And Disinfection Solution
2. Use a new wipe (from the list above) to thoroughly clean and scrub the MiVu Cable. Clean all visible soil from the MiVu Cable and continue to clean until the MiVu Cable is thoroughly clean and free of any visible soil. -
Page 19: Low-Level Disinfection Procedure
If any damage is found, STOP the disinfecting steps and contact Technical Support. 7. Allow the MiVu Cable and MiVu Regulator to dry for a minimum of five (5) minutes in ambient air before storing in a cool, dry location. -
Page 20: Preventative Maintenance
The MiVu Balloon Probe contains electronics and must be disposed of in accordance with local regulations. The MiVu Cable, MiVu Regulator, and PriZm Central Unit do not require decommissioning to remove from service. The MiVu Cable, MiVu Regulator, and the PriZm Central Unit contain electronics and must be disposed of in accordance with facility policies and local regulations. -
Page 21: Cybersecurity
6.1 Software Environment Maintain all operating systems by regularly downloading updates. 6.2 Firewall Use a firewall on all computers running Diversatek Healthcare software. Diversatek Healthcare software does not require any ports to be open. 6.3 User Access Control All users of Diversatek Healthcare software are recommended to have uniquely assigned accounts. -
Page 22: Technical Support
MiVu™ Mucosal Integrity Testing System Instructions for Use 7 Technical Support You can contact Diversatek Healthcare by mail, telephone or e-mail. Please see the listings below for complete contact information. Diversatek Healthcare strives to provide customers with the highest quality, state-of the-art instrumentation, backed by service, support and training. -
Page 23: Appendix
MiVu™ Mucosal Integrity Testing System Instructions for Use 8 Appendix 8.1 Specifications Please refer to the PriZm® System Installation and User’s Guide (H20-0195) for additional information about the system. 8.1.1 MiVu Cable Diversatek Healthcare Part Number: MI-CAB-01 Dimensions: Length: 6 ft (1.8 m)
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