EMS-XL User Manual Rev A Aug 2011

Conformity according to the Council Directive 93/42/EEC concerning Medical Devices as amended by 2007/47/EC Manufacturer’s Name

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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

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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 Fax: 215-675-6212

Toll Free: 800-223-2201

Publication No. DDE-965-001 Ver 1.39 Revision: Rev A August 2011 Copyright © Mennen Medical Mennen Medical Ltd. 2011. All RIGHTS RESERVED Registered trademarks are the intellectual property of their respective holders. ii

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Important Notice This document is delivered subject to the following conditions and restrictions: The EMS-XL User’s Guide 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 EMS-XL 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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EMS-XL User’s Guide Table of Contents Chapter 1 What You Should Know Intended Use of the EMS-XL System... 1-1 Using the EMS-XL System... 1-1 Replacement of the CPU Battery... 1-2 Compliance... 1-3 Label Locations & Symbol Descriptions... 1-4 General Use of Accessories... 1-5 Environmental Specifications... 1-5 Where to Find Information... 1-7

Chapter 2 Warnings and Precautions Prescription Notice... 2-1 Biocompatibility... 2-1 Radiation... 2-1 Transducer Protection... 2-2 SAFETY WARNINGS... 2-2

Explosion Hazard... 2-2 Electrical Shock Hazards... 2-3 CAUTIONS... 2-4 Safety Rating and Manufacturer Identification Label... 2-5 Warning and Compliance Labels... 2-5

Chapter 3 Introduction Overview... 3-1 Introduction to Basic System Hardware Components... 3-2 Amplifiers... 3-4 Connection Boxes... 3-5 EMS-XL Special Features... 3-6 Comprehensive Full Disclosure... 3-6 Computerized Integrated Stimulator... 3-6 Continuous Case Log... 3-6 Reports... 3-6 Additional Features and Functions... 3-6 Offline Utilities... 3-7 EMS-XL Review Station - Complementary Product (Optional)... 3-7 System Specifications... 3-7

Chapter 4 Getting Started Starting the EMS-XL Application... 4-1 Keyboard Shortcut Keys... 4-3 ... 4-4 Run Time Monitor... 4-5 Traces Display... 4-12 Review Screen... 4-15 Upper Panel Controls... 4-18 Parameter Setup and Command Menus... 4-24 Left Panel Controls... 4-31

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Printing... 4-34 Exiting the EMS-XL Application... 4-35

Chapter 5 Setting Up Monitoring Building a Configuration... 5-2 Setting Up Traces Display... 5-2 Channel Select - Run Time Screen... 5-7 Channel Select - Review Screen... 5-11 Setting Up Intra-cardiac ECG Channels... 5-13 Channel Settings... 5-14 Saving and Loading a Configuration... 5-17 Setting Up Tachycardia Detection... 5-21 Setting Up the Holter Display Mode... 5-22 Setting Up the Stimulator Auto Snapshot... 5-26 Setting Up the Repeat Auto Snapshot... 5-27 Setting Up Ablation... 5-28

Chapter 6 Performing the EP Study EP Study Overview... 6-1 Registering a Patient... 6-2 Setting Up a Procedure... 6-6 Loading the System Setup for the Study... 6-6 Using the Stimulator... 6-15 Marking an Event... 6-28 Sinus Node Recovery Time - SNRT... 6-42 Procedure Documentation... 6-48 Printing... 6-51 Working with Templates... 6-56 Ending the EP Study... 6-60 Saving and Storing the EP Study... 6-60 Editing the EMS-XL Report... 6-60

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Ending a Case... 6-64 Saving Part of a Case... 6-64

Chapter 7 Case Playback Overview... 7-1 Run Time Screen in Playback... 7-1 Review Screen in Playback... 7-2

Chapter 8 Care and Maintenance General Care and Maintenance... 8-1 General Cleaning Procedures... 8-1 Calibration and Preventive Maintenance... 8-5

Chapter 9 Offline Utilities Overview... 9-1 Configuration Setup Utility... 9-1 Archive Utility... 9-5 Storing Patient Data... 9-5 Restoring Patient Data... 9-9 Locating Archived Case Studies... 9-12 Configuring a Target... 9-14

Index

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Chapter 1

What You Should Know Intended Use of the EMS-XL System The EMS-XL is a computerized Cardiac Electrophysiological Measurement System, designed for conducting regular or experimental electrophysiology (EP) studies. The EMS-XL System is intended to be used for performing computerized Cardiac Electrophysiological and Ablation procedures. The EMS-XL is intended for sale as a system for performing Cardiac EP clinical studies.

Using the EMS-XL System 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

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Do not use the EMS-XL System 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 EMS-XL System cleaning procedures, see General Cleaning Procedures on page 8-1. For information on Calibration and Preventive Maintenance on page 8-5.

Replacement of the CPU Battery Whenever the EMS-XL System 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.

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Compliance The EMS-XL System is designed to comply with (amongst others) the following international safety requirements for medical electrical equipment:

IEC 60601-1 IEC 60601-1-2 IEC 60601-2-27 AAMI (voluntary performance standards): ES1 EC-11 The European Directive of 93/42/EEC classifies the EMSXL as a Class IIb device. The system is designed to have special protection against electric shocks and is defibrillator-proof. The ECG application is classified as Type CF equipment for direct cardiac application. The EMS-XL provides protection against the effects of defibrillation and electrosurgery. If the correct electrodes are used and applied in accordance with the manufacturer’s instructions, the screen display will recover within 10 seconds of defibrillation. Type CF equipment is designed to have special protection against electric shocks (particularly regarding leakage current) and is defibrillator-proof. For descriptions and locations of the symbols used on the modules of the EMS-XL System, see Label Locations & Symbol Descriptions on page 1-4.

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Label Locations & Symbol Descriptions The following provides a short description of the meaning of various labels and symbols that appear on the EMS-XL System and identifies their location on the equipment. Symbol

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Description

Location

Attention, consult accompanying documents. (Service to be performed by qualified technician; consult Service Manual before removing cover).

Isolation Transformer and front and rear panels on Amplifier

ON (power from mains power supply)

Power switch (Isolation Transformer front panel)

OFF (power disconnected from mains power supply)

Power switch (Isolation Transformer front panel)

Defibrillation – Proof Type CF Applied Part

Amplifier - front panel (next to all ECG-related connectors)

Earth

Isolation Transformer (rear panel)

AC Output 220-240V: 10A

Isolation Transformer (rear panel)

CE Approval by Notified Body

Manufacturer Identification Label (Isolation Transformer - rear panel)

Date of Manufacture

Manufacturer Identification Label (Isolation Transformer - rear panel)

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General Use of Accessories • Use only Mennen Medical-approved accessories with the EMS-XL System. This includes - but is not limited to - those accessories approved for use with the Vital Signs Modules: ECG and IBP.

• Do not use a damaged accessory. Always refer to the instructions for use included with each accessory.

• A disposable (single patient) accessory should not be sterilized or cleaned for re-use.

• Use care when installing accessories such as adapters and cables. Do not use force. Do not cause tension in cables when connecting them to the vital signs modules.

Environmental Specifications Operation Mode of Operation

Continuous use during EP study.

Humidity

10%-93%, non condensing

Temperature

5°C to 35°C (41°F-95°F)

Environmental Conditions for Transport and Storage Temperature

-15°C to68°C (5°F-158°F)

Relative Humidity

10%-93%, non condensing

Atmospheric Pressure

700hPa to 1060hPa

For easy reference, a table showing the Environmental Conditions and Situations to be Avoided is provided on the next page.

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Table 1-1 Environmental Conditions and Situations to be Avoided Do not operate EMS-XL System equipment in these environmental conditions. Always adhere to the safety instructions.

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Locations where sudden impact or vibration may occur.

Avoid damp locations. Do not operate the equipment with wet hands.

Locations exposed to chemicals or explosive gases.

Locations with large temperature fluctuations (Operational range: 5-35oC; humidity 1093%)

Do not allow dust or metal debris to penetrate the monitors.

Locations where: • moisture level may increase considerably • room is inadequately ventilated

Do not plug in the mains power cable until all installation procedures are completed. Damage can be caused to the equipment!

Locations exposed to direct sunlight.

Do not pull directly on the mains power cable. Always hold the plug when pulling the cable out of the wall socket.

Locations near electrical heating apparatus.

Do not dis-assemble the equipment! This should be done by authorized personnel only, otherwise Mennen Medical Ltd. will not be obligated to provide technical service.

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Where to Find Information This guide contains the following additional chapters: Chapter 2 - Warnings and Precautions: includes detailed warnings and precautions you should adhere to. Chapter 3 - Introduction: describes the main features and the hardware of the EMS-XL system. Chapter 4 - Getting Started: describes the Run Time and Review screens and provides a short description of their funcutionalities. In addition it describes logging in and out of the application. Chapter 5 - Setting Up Monitoring: describes how you can setup the run-time display as well as other parameters that can constitute a Configuration which you can save choose to load for an EP study. Chapter 6 - Performing the EP Study: describes the steps involved in performing an EP study and how to perform them. Chapter 7 - Case Playback: describes the Case Playback function which enables off-line review of a closed EP Study. Chapter 8 - Care and Maintenance: describes the routine care and maintenance procedures and provides recommendations for the frequency with which they should be performed. Chapter 9 - Offline Utilities: describes the available offline utilities: Configuration Setup Utilitiy and Archive Utility.

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Chapter 2

Warnings and Precautions Prescription Notice Federal United States law restricts the sale and use of this instrument to qualified medical personnel only. In addition, the user should be properly trained in the use of the system. The instructions for use presented in this guide should in no way supersede established medical protocol concerning patient care.

Biocompatibility All materials used in the patient cables and applied parts have been tested for biocompatibility by the OEM manufacturer(s) and are in compliance with the applicable standards on biocompatibility. The following information contains general warnings and cautions for the user before initial use of the system. Specific warnings and cautions pertaining to the operation of part of the system or to an individual module, appear in the relevant section of the manual.

Radiation Radio frequency (RF) generates an electromagnetic field. The intensity of the radiated field, at any point in space, is directly proportional to the source of the voltage, and inversely proportional to the distance from the source. In the case of Ablation, the active electrode, return plate, and their cables act as transmitting antennas.

Electromagnetic fields radiate perpendicular to their associated cables. Therefore, susceptibility of the ECG cable to this RF is maximum when the ECG cable is parallel to the Ablation cable. Separating or placing cables perpendicular to one another will minimize radiation coupling effects. In summary, radiation interference can be minimized by the following:

• Using the lowest possible Ablation power setting. • Keeping ECG cables as far from Ablation cables as possible.

• Keeping ECG cables at right angles to Ablation cables.

Transducer Protection Immunity requirements of IEC Collateral Standard 606011-2 for Electromagnetic Compatibility are met with the transducers recommended for use with the unit.

SAFETY WARNINGS A WARNING INDICATES A SITUATION IN WHICH THE USER OR THE PATIENT MAY BE IN DANGER OF INJURY OR DEATH.

Note:

This symbol is also used to signify a potential risk of permanent loss of data.

Explosion Hazard The equipment is not suitable for use in the presence of flammable anesthetic mixture with air or with Oxygen or Nitrous Oxide.

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Electrical Shock Hazards To eliminate the risk of electrical shock, always adhere to the precautions shown below.

• Do not touch the patient, bed or instrument during defibrillation.

• Before cleaning the monitor, switch the monitor OFF and disconnect it from the power supply and electrical outlet. After cleaning, or if liquid has accidentally entered the interior of the monitor, make sure that every part of the monitor is dry before reconnecting it the power supply. See Chapter 8 - Care and Maintenance for more information on cleaning the monitor.

• Access to any internal part of the EMS-XL System and/ or the performance of any service procedures should only be carried out by a qualified technician, fully trained in the operation of the system. For continued protection against fire hazard, fuses should be replaced only with those of the same type and rating. Disconnect the power supply before servicing.

Risk of Permanent Loss of Data To eliminate the risk of permanent loss of data, always adhere to the procedure instructions provided in this manual.

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CAUTIONS A CAUTION INDICATES A SITUATION IN WHICH THE UNIT, OR DEVICES CONNECTED TO IT, MAY BE DAMAGED OR MALFUNCTION.

• The EMS-XL System is designed to conform to Electromagnetic Compatibility (EMC) standard IEC 60601-l-2 and will operate accurately in conjunction with other medical equipment which also meets this requirement. To avoid interference problems affecting the Monitor, do not use Monitor in the presence of equipment which does not conform to these specifications. Note:

The term "Monitor" refers to both the EMS-XL RT Monitor (Run Time) and the EMS-XL Review Screen.

• Do not apply pressurized air to any outlet, or tubing connected to the monitor. Pressure may destroy sensitive elements.

• Do not store the system outside the specified temperature range (-20ºC to +65ºC [-4ºF to +149ºF]).

• Leave space for circulation of air to prevent the system from overheating.

• Do not subject critical components of the system to excessive heat, bending or magnetic fields.

• To prevent any liquid from entering the casing of the display screen, do not tilt the display more than 45 degrees backwards, or 15 degrees forwards, and ensure that the display screen is not exposed to knocking and bumping.

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