Diversatek Healthcare MiVu MI-CAB-02 Instructions For Use Manual

Esophageal endo cap mucosal integrity testing system

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Instructions for Use

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Part Number: MI-ESO-CAP-195-EN-US Rev A

Esophageal Endo Cap

Mucosal Integrity

Testing System

Diversatek Healthcare

Technical Research & Training Center

9150 Commerce Center Circle, Suite 500

Highlands Ranch, CO 80129 USA

P 800.558.6408 or 303.470.7020

technicalsupport@diversatekhc.com

clinicalsupport@diversatekhc.com

clinicaleducation@diversatekhc.com

DiversatekHealthcare.com

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Page 1 Esophageal Endo Cap 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 800.558.6408 or 303.470.7020 technicalsupport@diversatekhc.com clinicalsupport@diversatekhc.com clinicaleducation@diversatekhc.com DiversatekHealthcare.com...
Page 2 MiVu™ Esophageal Endo Cap 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.
Page 3 Analog-to-Digital converter; an electronic circuit or device that converts an analog input signal into a digital signal. ® ® PriZm PriZm manometry acquisition system. Diversatek Healthcare’s software suite for data acquisition and analysis with the ® ® PriZm system. Esophageal Endo Cap Endoscope cap for MiVu™ Esophageal Testing.
Page 4 Diversatek Healthcare to notify any person of such revisions or changes. Trademarks used in this text: 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.
Page 5: Table Of Contents
MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use Contents INTRODUCTION ........................... 7 How to Use This Guide ........................7 CAUTION: Safety Instructions ....................... 8 Product Description ........................10 1.3.1 Overview and Intended Use ....................10 1.3.2 Indications for Use ......................... 10 1.3.3 Contraindications ........................
Page 6 MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use Specifications ..........................30 8.1.1 MiVu Endo Cap Cable ......................30 8.1.2 MiVu Esophageal Endo Cap ....................30 Page 6 of 30 MI-ESO-CAP-195-EN-US, Rev A, Edited 6 April 2023, ECO 222-023...
Page 7: Introduction
MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use 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 ® healthcare professionals trained in performing clinical procedures utilizing the MiVu System and the Zvu Software.
Page 8: Caution: Safety Instructions
MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use 1.2 CAUTION: Safety Instructions The MiVu™ System is a sensitive electronic instrument. Please use the following safety guidelines to help ensure your own personal safety and to help protect your MiVu System and working environment from potential damage.
Page 9 MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use CAUTION: Any serious incidents that occur in relation to the MiVu System should be reported to Diversatek and the Competent Authority. CAUTION: Do not use the MiVu System in close proximity to common RF emitters such as RFID readers, NFC systems, wireless power transfer/charger systems, electrocautery, MRI, electrosurgical and diathermy equipment as this may affect the performance of the MiVu System and the data collected.
Page 10: Product Description
The system includes associated signal conditioning hardware and software for measuring and displaying information. Diversatek Healthcare’s MiVu Mucosal Integrity Testing System utilizing the MiVu Esophageal Endo Cap is used in conjunction with an endoscope procedure. The MiVu Esophageal Endo Cap acquires impedance readings across a 3 cm length.
Page 11: Biocompatibility
MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use 1.3.5 Biocompatibility The patient contacting components of the MiVu System utilize common materials with no known biocompatibility issues. However, the following cautions should be observed: CAUTION: The MiVu Esophageal Endo Cap utilizes nickel that is plated with gold.
Page 12: Getting Started
MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use Getting Started The following chapters describe how to connect the different accessories to the PriZm System and the basic procedural steps of a mucosal integrity study. 2.1 User Manuals In addition to this manual, please refer to the H20-0195: PriZm System Installation and User’s Guide for additional information.
Page 13: Mivu™ Esophageal Endo Cap Configuration
Endo Cap device. This chapter describes how to connect the accessories to the MiVu PriZm System and the basic procedural steps for a study. Note: For MiVu Mucosal Integrity study acquisition, Diversatek Healthcare recommends that two people be present to conduct the study. While the physician is operating the endoscope with the Esophageal Endo Cap device attached, an assistant must operate the software to capture measurements.
Page 14: Connecting To The Prizm System
MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use 3.1 Connecting to the PriZm System 3.1.1 MiVu™ Endo Cap Cable The MiVu Endo Cap Cable is a signal conditioning accessory for use with the MiVu System. All patient-connected sensors utilized with the MiVu System are Type BF patient applied parts. Type BF indicates that the patient applied part is floating from electrical ground.
Page 15 MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use 3.1.1.1 Connecting MiVu Endo Cap Cable to the PriZm® Central Unit The MiVu Endo Cap 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 16 MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use 3.1.1.2 Connecting the MiVu Esophageal Endo Cap to the MiVu Endo Cap Cable The MiVu Esophageal Endo Cap connects to the MiVu Endo Cap Cable and is secured by a locking ring. Do not try to force the connectors together if the two connectors do not slide together easily.
Page 17: Mucosal Integrity Conductivity Test (Mi) Procedure Using The Mivu Esophageal Endo Cap
MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use 3.2 Mucosal Integrity Conductivity Test (MI) Procedure using the MiVu Esophageal Endo Cap This section describes the basic procedural steps to record the necessary data for a Mucosal Integrity - Esophageal study using the MiVu™...
Page 18: Post-Procedure
MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use a) Begin the upper endoscopy procedure. As the endoscope passes through the oral cavity, the sensor surface should be in contact with the patient’s tongue. As the endoscope approaches the larynx and the esophageal inlet, the sensor surface is oriented anteriorly.
Page 19 MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use Dispose of the MiVu Esophageal Endo Cap according to the institution’s procedure for disposable medical equipment. The MiVu Esophageal Endo Cap is a single-use device and must not be re-used. Page 19 of 30 MI-ESO-CAP-195-EN-US, Rev A, Edited 6 April 2023, ECO 222-023...
Page 20: Cleaning And Disinfecting The Components Of The Mivu™ Mucosal Integrity Testing System
The MiVu Endo Cap Cable must be reprocessed immediately after each patient use. CAUTION: Clean and disinfect the MiVu Endo Cap Cable using only the cleaning and disinfection solutions approved by Diversatek Healthcare as listed below. Failure to use approved solutions can result in damage to the devices.
Page 21: Validated Cleaning And Disinfection Solution
Instructions for Use 4.3.2 Validated Cleaning and Disinfection Solution The following table lists the cleaning and disinfection solution validated by Diversatek Healthcare for use with the MiVu™ Endo Cap Cable. Failure to use this approved solution may damage the devices and void the warranty.
Page 22: Low-Level Disinfection Procedure
MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use 4.3.4 Low-Level Disinfection Procedure Carefully follow the instructions below. Not following these instructions may result in ineffective disinfection or damage to the MiVu Endo Cap Cable. 1. Users should wear appropriate protective gear (gloves at a minimum) as recommended by facility policy throughout the disinfection process.
Page 23: Preventative Maintenance
Visually inspect all system components for damage, corrosion, cuts, and punctures. If any damage is found, do not use the system, and contact Technical Support for assistance. Contact Diversatek Healthcare for replacement devices or repair services. 5.1 Service ®...
Page 24: Cybersecurity
6.1 Software Environment Maintain all operating systems by regularly downloading upgrades. 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 25: Technical Support
Instructions for Use 7 Technical Support 7.1 Contact Information 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 26: Emc Information
MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use 7.2 EMC Information ® The MiVu System incorporates the PriZm System components which includes the PriZm Central Unit, isolation transformer, rolling cart, PC and monitor. Refer to the IFU for the PriZm System (H20-0195) for additional information.
Page 27: Electromagnetic Immunity
MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use 7.2.2 Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The MiVu System is intended for use in the electromagnetic environment specified below. The customer or the user of the MiVu System should ensure that it is used in such an environment.
Page 28 MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use Guidance and manufacturer’s declaration – electromagnetic immunity The MiVu System is intended for use in the electromagnetic environment specified below. The customer or the user of the MiVu System should ensure that it is used in such an environment. IEC 60601 Electromagnetic environment - Immunity test...
Page 29: Recommended Separation Distances
MiVu™ Esophageal Endo Cap Mucosal Integrity Testing System Instructions for Use 7.2.3 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment the MiVu System The MiVu System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
Page 30: Appendix
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 Endo Cap Cable Diversatek Healthcare Part Number: MI-CAB-02 Dimensions: Length: 6 ft (1.8 m) Weight: 0.5 lb...

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