HORIZON XVu USER MANUAL Jan 2010

Conformity according to the Council Directive 93/42/EEC concerning Medical Devices Manufacturer’s Name: Mennen Medical Ltd. 4 Hayarden Street, Yavne, 81228 P.O. Box 102, Rehovot, 76100, Israel Tel.: +972-8-9323333 Fax: +972-8-9328510

European Representative: Charter-Kontron Limited Unit 18 Avant Business Centre 21 Denbigh Road Milton Keynes MK1 1DT England Tel.: 01908 646070 Fax: 01908 646030

US Representative: Mennen Medical Corp 950 Industrial Boulevard Southampton, PA 18966 Phone: 215-259-1020X1026

Toll Free: 800-223-2201

Fax: 215-675-6212 Publication No. 960-OPT-885 Ver 1.4 Revision: January 2010 Copyright © Mennen Medical Mennen Medical Ltd. 2010. All RIGHTS RESERVED

Registered trademarks are the intellectual property of their respective holders.

Horizon XVu User Manual

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Important Notice This document is delivered subject to the following conditions and restrictions: The Horizon XVu User Manual contains proprietary information of Mennen Medical Ltd. This information is supplied solely for the purpose of assisting authorized users of Mennen Medical Ltd. products. The instructions presented in this guide should in no way supersede established medical protocol concerning patient care. No part of the contents hereof may be used for any other purposes, disclosed to any person or firm, or reproduced by any means, without the express prior written permission of Mennen Medical Ltd. The text and drawings herein are for the purposes of illustration and reference only. The specifications on which they are based are subject to change without notice.

Trademarks Horizon XVu is a registered trademark of Mennen Medical Ltd. Other company and brand, product and service names are for identification purposes only and may be trademarks or registered trademarks of their respective holders. Data is subject to change without notice.

Responsibility of Manufacturer Mennen Medical, Ltd. considers itself responsible for the effects on safety, reliability, and performance of the equipment only if:

• Repairs are carried out by authorized Mennen Medical personnel only. • Electrical installation of the room in which the system is installed complies with all aspects of the relevant internationally-recognized electrical safety standards, as well as specific hospital requirements. • The equipment is used in accordance with instructions for use.

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Table of Contents Horizon XVu User Manual Responsibility of Manufacturer... 1-2

Chapter 1 - What You Should Know Use of the Horizon XVu ... 1-1 Environmental Specifications ... 1-4 Where to Find Information ... 1-6

Chapter 2 - Warnings and Precautions Prescription Notice... 2-1 Biocompatibility... 2-1 Radiation ... 2-2 Electrode and Transducer Protection ... 2-2 Degree of Protection against Ingress of Water ... 2-3 Safety Warnings ... 2-3 Patient Safety Caution ... 2-3 Explosion Hazard ... 2-3 Disconnecting the Printer ... 2-3 Electrical Shock Hazards... 2-4 Risk of Permanent Loss of Data ... 2-4

Safety Rating Identification Label... 2-5

Chapter 3 - System Description Horizon XVu Cathlab System ... 3-1 Basic System Hardware Components ... 3-3 Central Console... 3-3 CFE ... 3-5 Physician's Display Monitor ... 3-10 Physician Keyboard for Emergency Access (optional)... 3-11 System Specifications... 3-11

Chapter 4 - Technician's Screen Overview ... 4-1 Running the Horizon XVu Application ... 4-2 Activating Horizon XVu Functions ... 4-3 Techniques for Using the Mouse ... 4-5 Working with Menus ... 4-6 Scrolling... 4-6 Toggling... 4-6 Using Dialog Boxes ... 4-7 Print Buttons ... 4-7 Show Dr. ... 4-7 Areas of the Technician's Screen... 4-8 Technician Screen Layouts... 4-9 Default (Coronary)Display ... 4-9 Large Waveform display (no Notes)... 4-10 Large Notes display... 4-11 Large Heart Diagram (Pediatric)Display ... 4-12 Header Area ... 4-13 Layout Icons... 4-13 Timers... 4-14 Measurement Buttons ... 4-15 Waveform Controls... 4-16 ECG Waveform Configuration ... 4-17 BP Waveform Configuration ... 4-20 Waveform Area... 4-21 Heart Diagram... 4-22 Printer Controls Area ... 4-23 ii

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Notes Area ... 4-23 Footer: Messages Area ... 4-24 Footer: Menus... 4-24 The Horizon XVu Compact System ... 4-25

Chapter 5 - Physician’s Display Monitor and Configuration Overview ... 5-1 Information Viewed on the Physician’s Display Monitor ... 5-2 Areas of the Physician's Display Screen ... 5-4 Upper Information Area ... 5-4 Patient Information ... 5-4 Timers ... 5-4 Date ... 5-5 Time ... 5-5 Waveform Display Area... 5-6 Heart Rate ... 5-6 BP Values... 5-6 BP Waveforms and ECG Traces... 5-6 Lower Information Area... 5-7 Sweep Speed Indicator... 5-7 Messages ... 5-7 Configuring Waveform Display Area... 5-8 Configuring Digital Measurements ... 5-11 Adding, Moving or Erasing Waveforms and Traces... 5-11 Setting up Screen Options ... 5-16 Pre-defined Waveform Display Configurations ... 5-19

Chapter 6 - Physician Keyboard for Emergency Access Emergency Access Keyboard - Introduction ... 6-1 Keyboard Keys... 6-2 Starting a Case ... 6-3 Procedure Keyboard Functionalities ... 6-4 Zero Pressure ... 6-4 All ECG ... 6-4 NIBP ... 6-4 AO ... 6-4 LV... 6-5 Horizon XVu User’s Guide

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Auto LV- AO ... 6-5 Print... 6-5 Gain... 6-5 Select Lead... 6-6 Mark Event ... 6-6 Dismissing a Patient ... 6-6

Chapter 7 - Procedure Control Configuration Overview ... 7-1 Clinical Parameters Setup - Overview ... 7-2 Analysis Parameters Setup ... 7-3 Acquisition Period ... 7-4 Full Disclosure Setup... 7-5 Waveform Print Setup ... 7-5 ECG All Printout Setup ... 7-6 Associate Sites of Right / Left Side to Specific BPs ... 7-6 Automatic Pullback Setup ... 7-8 Setup Medical Parameters ... 7-9 Cardiac Output (Thermodilution)... 7-11 EDP Button Setup ... 7-12 BP Labels Menu Setup channels ... 7-13

Chapter 8 - Patient Registration Overview ... 8-1 Registering a New Patient ... 8-3 Retrieving a Patient Record... 8-6 Selecting a Patient Record ... 8-6 Importing a Patient from Another Lab ... 8-12 Editing a Patient Record ... 8-12 Deleting a Patient Record ... 8-13 Acquiring Patient Demographic Data from an External Source ... 8-16 Dismissing a Patient Record... 8-18 Adding a New Procedure ... 8-19

Chapter 9 - Blood Pressure Analysis Overview ... 9-1 Before You Start... 9-2 iv

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Calculating Valve Area and Gradients ... 9-2 Acquisition Modes... 9-2 Zeroing BP Transducers ... 9-2 Activating BP Analysis ... 9-4 BP Data Acquisition ... 9-5 Analysis Window and Its Functionalities ... 9-8 Beat number buttons ... 9-9 Site Label Buttons... 9-10 ECG Location Setup ... 9-10 Scroll Bar ... 9-10 Time Scale ... 9-10 Editing the Waveforms... 9-12 Selecting Representative Beats ... 9-12 Atrial Fibrillation ... 9-13 Atrial Pulmonary... 9-14 Various Value Messages Area Options ... 9-15 Completing the BP Analysis Process... 9-19 Saving the Analyzed Waveform Image... 9-20 Displaying BP Analysis Results to the Physician ... 9-20

Chapter 10 - Pullback Data Analysis Overview ... 10-1 Stages of Pullback Data Analysis Procedure ... 10-2 Pullback Data Acquisition ... 10-2 Pullback Window in Acquisition Mode ... 10-5 Editing the Pullback Waveform ... 10-6 Pullback Waveform Sites... 10-6 Adding a Label... 10-7 Removing a Label ... 10-9 Message Area Options ... 10-9 Activating the Pullback Analysis Process... 10-10 Pullback Window in Analysis Mode ... 10-11 Stages of Pullback Analysis... 10-12 Viewing the Pullback Waveform ... 10-13 Editing Pullback Analysis Functions... 10-13 Completing the Pullback Analysis Process... 10-14 Performing Re-analysis... 10-14 Accepting the Analysis and Saving the Results... 10-15 Horizon XVu User’s Guide

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Displaying Pullback Analysis Results to the Physician... 10-15 Automatic LV - AO Pullback... 10-15 Mode of Operation and Setup... 10-15 Retrospect ("Backward") Pullback Analysis... 10-17

Chapter 11 - Fractional Flow Reserve FFR - Overview... 11-1 Evaluating Stent Effectiveness ... 11-2 FFR Operation... 11-3 FFR Configuration... 11-3 FFR Operation ... 11-10

Chapter 12 - Cardiac Output Overview ... 12-1 Methods of Cardiac Output Calculation... 12-2 Selecting a Calculation Method ... 12-2 Thermodilution Method ... 12-3 Cardiac Output Window and Menus ... 12-4 Measuring Cardiac Output... 12-6 Thermodilution Derived Parameters ... 12-7 Displaying Cardiac Output Calculation Results to the Physician ... 12-8 Fick Method ... 12-9 C.O. Manual Entry Method ... 12-12

Chapter 13 - Oximetry Overview ... 13-1 Oximetry Functionality... 13-2 Invoking the Oximetry Program... 13-6 Selecting Oximetry Sites and Sub-sites ... 13-8 Calculating Oximetry Data & Displaying Results... 13-10 Re-calculating Oximetry Results ... 13-12 Oximetry View ... 13-13 Accessing Oximetry View ... 13-14 Selecting Data for Oximetry Re-analysis ... 13-17 Performing Flow & Resistance Calculations... 13-18 Reviewing Flow & Resistance Calculations... 13-20 Saving a Heart Diagram with Oximetry Calculation Results ... 13-23 vi

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Chapter 14 - Vital Signs and NIBP Measurements and Documentation Vital Signs... 14-1 Inserting Vital Signs in the Patient Record... 14-1 Vital Signs Setup and Activation ... 14-2 Vital Signs Results ... 14-3 Non-invasive BP (NIBP) ... 14-6 Non-invasive Blood Pressure (NIBP) Setup ... 14-6 Setting Up NIBP... 14-7 NIBP Results ... 14-8

Chapter 15 - ST Segment Elevation- ST Analysis ST Configuration ... 15-2 ST Calculated Values ... 15-3 ST Results... 15-5 ST Alarm Setup ... 15-8 ST Manual Mode... 15-9

Chapter 16 - Re-analysis Overview ... 16-1 Selecting Items for Re-analysis... 16-3 BP or Pullback ReAnalysis ... 16-5 Gradient Re-analysis ... 16-6 C.O. ReAnalysis... 16-8

Chapter 17 - Intra-cardiac ECG Overview ... 17-1 Configuring the Screen for ICECG Channels... 17-2 Caliper Measurements ... 17-4

Chapter 18 - End Tidal CO2 (EtCO2) Microstream Principles of Operation ... 18-1 Microstream EtCO2 Circuits ... 18-2 FilterLine ... 18-2 Hydrophobic Filter ... 18-2 Drying Element ... 18-2 Horizon XVu User’s Guide

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Status Indication... 18-2 Sample Line ... 18-2 FilterLine Recognition Safeguard... 18-3 Airway Adapter... 18-3 Patient Preparation Checklist ... 18-3 Sampling tubes for intubated patients ... 18-4 EtCO2 Sampling tube for non intubated patients ... 18-4 Cautions and Warnings ... 18-4 Interfering Gasses... 18-5 Cleaning... 18-5 Airway Adapter ... 18-5 EtCO2 Calibration ... 18-5 Non-intubating Sidestream Monitoring... 18-8 Intubated Sidestream Monitoring ... 18-8 ETCO2 Configuration... 18-8

Chapter 19 - Full Disclosure Recordings Overview ... 19-1 Full Disclosure Process ... 19-2 Data Recorded during Full Disclosure... 19-2 Configure Functions ... 19-3 Zeroing Waveforms ... 19-3 Full Disclosure Recording... 19-3 Full Disclosure Archiving ... 19-4 Full Disclosure Playback... 19-6

Chapter 20 - Waveforms Printing Overview ... 20-1 Physician Screen Printout... 20-2 Continuous Waveforms Print ... 20-2 Waveform Printer Control Panel... 20-6 Start/Stop button... 20-7 Print One Page... 20-7 Print Screen ... 20-7 Auto Off ... 20-7 Cancel... 20-8

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Chapter 21 - Pediatric and Peripheral Diagrams Overview ... 21-1 Pediatric Diagrams ... 21-3 Peripheral Diagrams ... 21-4 Working with Pediatic/Peripheral Diagrams ... 21-7 Selecting a Pediatric/Peripheral Diagram... 21-8 Defining Site Locations ... 21-11 Displaying a Pediatric/Peripheral Diagram to the Physician ... 21-13 Creating Custom Diagrams ... 21-14 Saving a Pediatric/Peripheral Diagram ... 21-14

Chapter 22 - Procedure Documentation Notes ... 22-2 Notes Menus and Tools ... 22-2 Selecting Notes from the Categories Area... 22-4 Analysis Notes- Entered Automatically... 22-6 Writing Notes ... 22-7 Editing Notes ... 22-7 Using the Start Case and End Case Buttons ... 22-9 Using the Conditions Button... 22-9 Inserting Vital Signs in the Patient Record ... 22-10 Inserting NIBP Measurements in the Notes List ... 22-11 Inserting Event Marker Notes ... 22-11 Filtering the Notes Display by Category ... 22-13 Automatic Update of Notes in the HemoCIS Scheduler ... 22-13 Converting Bar Code Data to a Regular Inventory Note ... 22-15 PCI Table Utility ... 22-16 Overview ... 22-16 Entering Information in a PCI Table ... 22-16 Editing PCI Information ... 22-20 Coronary and Peripheral Trees ... 22-21 Overview ... 22-21 Accessing the Coronary Tree/ Peripheral Tree ... 22-21 Adding Information Before Intervention Catheterization ... 22-24 Adding Catheterization Information... 22-27 Adding Post-intervention Information ... 22-33

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Chapter 23 - Reports Overview ... 23-1 Selecting the Report Format... 23-2 Fixed Reports... 23-3 Multiple Reports ... 23-5 Creating & Printing Reports with WordPerfect ... 23-6 Creating a WordPerfect Report... 23-6 Configuring the Printer Driver ... 23-7 Exporting a WordPerfect Report ... 23-9 Multicase Export ... 23-9 DICOM... 23-9 Sending a Report by Fax... 23-9

Chapter 24 - Spreadsheet Overview ... 24-1 Spreadsheet Functions... 24-2 Accessing the Spreadsheet Window... 24-2 Menus and Functions ... 24-4 File menu... 24-4 Commit button... 24-4 Refresh button ... 24-4 Condition button... 24-4 Maximize next level buttons ... 24-4 Scroll bars... 24-5 Modifying Data ... 24-5 Committing the Changes to the Database... 24-5 Preserving Database Integrity ... 24-6

Chapter 25 - Utilities Overview ... 25-1 Diagram Site Location... 25-2 Using the Diagram Editor... 25-6 Connectivity Information ... 25-11 Using the Card File Utility ... 25-13 Using the Calculator... 25-14 Using the Calendar ... 25-15 Using the Screenshot Tool ... 25-18

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Remote Desktop Utility ... 25-20 Connecting to the Remote Desktop ... 25-20

Chapter 26 - Database Administration Overview ... 26-1 Database Maintenance Guidelines ... 26-2 Archiving (Backing-up) Patient Data ... 26-2 Database Clean-up... 26-2 Database Administration and Cleanup... 26-3 Archive and Restore... 26-4 Archiving Process... 26-5 Selecting Data for Archiving ... 26-5 Selecting the Target for the Archived Data ... 26-7 Activating the Archiving Process ... 26-9 Restore Process... 26-9 Activating the Restore Process ... 26-9

Chapter 27 - Offline System Management Overview ... 27-1 Setting up System Management... 27-1 Setting Up System Options ... 27-4 Case Type ... 27-4 Parameters ... 27-5

Chapter 28 - Troubleshooting Overview ... 28-1 Troubleshooting Power Problems ... 28-2 Troubleshooting Workstation Problems ... 28-2 Troubleshooting Vital signs Problems ... 28-3 NIBP Error Messages... 28-5

Chapter 29 - Offline System Setup Overview ... 29-1 Notes Configuration ... 29-3 Notes Editor... 29-3 Preset Notes ... 29-6

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Condition List Configuration ... 29-8 Edit Report Title Format ... 29-10 Editing Export Definitions ... 29-12 Editing the Export Library... 29-13 Editing Export File Definitions... 29-15 Editing Export Fields ... 29-16 Field Title ... 29-18 Condition... 29-18 Defining Note Sets for Export... 29-18 Defining Condition Sets for Export ... 29-19 Date and Time Setup ... 29-21 Editing User-defined Sites... 29-23

Chapter 30 - System Shutdown Overview ... 30-1 System Shutdown Options ... 30-2

Chapter 31 - Care and Maintenance Overview ... 31-1 General Cleaning Procedures ... 31-2 General Cleaning ... 31-2 Cleaning the Cathlab and Accessories ... 31-3 Sterilization ... 31-4 Disinfection... 31-4 Calibration and Preventive Maintenance ... 31-5 Vital Signs Modules... 31-5

Appendix A Accessories ECG Accessories ... A-1 Blood Pressure (BP) Accessories ... A-6 Cardiac Output (CO) Accessories... A-7 Pulse Oximetry (PO) Accessories... A-8 Non-Invasive BP (NIBP) Accessories ... A-10 EtCO2 - Microstream Sidestream Accessories ... A-13 Temperature Accessories ... A-13 EEG Accessories... A-14 xii

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FFR Accessories ... A-14

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Chapter 1 - What You Should Know Use of the Horizon XVu Before commencing patient monitoring, always perform the following routine checks: 1. Check the system for signs of any mechanical damage. 2. Check all external leads, plug-ins and accessories. 3. Check all functions of the instrument needed to monitor the patient and ensure that the system is in proper working order. Do not use the Horizon XVu for any monitoring procedure on a patient if you identify features which demonstrate impaired functioning of the system. Contact the hospital biomedical engineer, or a Mennen Medical Ltd. service engineer. Notes:For recommended Horizon XVu cleaning procedures, see General Cleaning Procedures on page 31-2. For information on Calibration and Preventive Maintenance, refer to page 5. Mennen Medical

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What You Should Know

Horizon XVu User Manual

Replacement of the CPU Battery Whenever the Horizon XVu Cathlab is disconnected from the mains power supply, the CPU battery provides the back-up power to the system set-up. In the event that the system is disconnected from the mains power supply for an accumulated period of 2 months (1440 hours) or more, or if it is only intermittently attached to the power supply, the CPU battery should be replaced.

Intended Use of the Horizon XVu The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numeric can be stored, recorded, analyzed and presented in a variety of report formats.

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Horizon XVu User Manual

What You Should Know

Label Locations & Symbol Descriptions The following provides a short description of the meaning of various labels and symbols that appear on the Horizon XVu Cathlab and identifies their location on the equipment. Symbol

Description

Location

Attention, consult accompanying Isolation Transformer documents. (Service to be performed and CFE front panel by qualified technician; consult Service (next to the slot for the Info Card). Manual before removing cover). ON (power from mains power supply)

Power switch (CFE rear panel)

OFF (power disconnected from mains power supply)

Power switch (CFE rear panel)

Type BF Applied Part

CFE front panel (next to NIBP, SpO2 and EtCO2 connectors)

Type CF Applied Part

CFE front panel (next to IBP, Temperature and CO connectors)

Defibrillation – Proof Type CF Applied Part

CFE front panel (next to ECG connector)

Earth

CFE rear panel (lower right corner)

Fuse Fuse type for 100-120V: T3.0A Fuse type for 220-240V: T1.5A AC Output 100-120V:1.0A 220-240V: 500mA

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CFE rear panel (lower right corner)

CFE rear panel (lower right corner)

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