Micropace Cardiac Stimulators EPS320B-BT User Instruction Manual Compact Ver 0.6 Stim sw ver 3.21

USER INSTRUCTION MANUAL

Table of Contents 1 INTRODUCTION & ESSENTIAL PRESCRIBING INFORMATION ... 1 1.1 DEVICE DESCRIPTION... 1 1.1.1 Description of Stimulator... 1 1.1.2 Accompanying Documentation ... 1 1.1.3 Intended Use... 1 1.1.4 Indications for Use ... 1 1.1.5 Operating Environment ... 1 1.1.6 Contraindications ... 2 1.2 COMPATIBLE EQUIPMENT ... 2 1.3 IMPORTANT PATIENT SAFETY WARNINGS ... 2 1.3.1 General Warning... 2 1.3.2 Warnings Specific to the Micropace Stimulator ... 3 1.3.3 Warnings Related to the use of Micropace Stimulator with RF Ablation Equipment... 3 1.4 GENERAL PRECAUTIONS IN HANDLING STIMULATOR ... 4 2 DEVICE RATINGS, CLASSIFICATION AND CERTIFICATION... 6 3 COPYRIGHT, WARRANTY AND DISCLAIMER NOTICE... 7 4 EXPLANATION OF SYMBOLS... 8 5 EPS320 FAMILY OF CARDIAC STIMULATORS ... 12 5.1 DESCRIPTION OF STIMULATOR FAMILY ... 12 6 EPS320B/BT CONFIGURATION ... 13 6.1 DESCRIPTION OF SYSTEM ... 13 6.2 SYSTEM COMPONENTS ... 13 6.3 EPS320B/BT OPTIONAL ACCESSORIES ... 16 7 STIMCOR™ CONFIGURATION... 17 7.1 DESCRIPTION OF SYSTEM ... 17 7.2 HOW SUPPLIED ... 17 7.3 SYSTEM COMPONENTS ... 18 7.4 STIMCOR™ OPTIONAL ACCESSORIES... 18 8 STIMLAB™ CONFIGURATION ... 19 8.1 DESCRIPTION OF SYSTEM ... 19 8.2 HOW SUPPLIED ... 19 8.3 SYSTEM COMPONENTS ... 20 8.4 STIMLAB™ OPTIONAL ACCESSORIES ... 21 9 INSTALLATION ... 21 10 USING THE MICROPACE CARDIAC STIMULATORS ... 22 10.1 CONNECTING THE STIMULUS CONNECTION BOX ... 22 10.2 SWITCHING ON THE SYSTEM ... 22 10.3 USING THE COMPUTER ... 22 10.4 SETTING UP THE COMPUTER ... 23 10.5 INDICATING LOCATION OF SGU ... 23 11 USING THE KEYBOARD AND THE TOUCH DISPLAY ... 24 11.1.1 Numeric Keypad ... 26 11.2 USING THE STIMLAB™ BEDSIDE CONTROLLER FEATURES ... 26 11.2.1 Input Device Control ... 26 11.2.2 Local/Remote Indicator: ... 27 12 USING THE STIMULATOR SOFTWARE ... 28 12.1 HELP FUNCTION ... 28 12.2 TRAINING VIDEOS ... 28 12.3 HELP SEARCH... 28 12.4 THE MAIN STIMULATOR SCREEN ... 28 12.5 PACING PARAMETERS ... 29 12.6 BASIC PACING ... 29

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12.7 USING THE STIMULATOR SOFTWARE PROTOCOLS ... 30 12.8 PACING PROTOCOLS ... 31 12.8.1 Protocol Selection & Renaming ... 31 12.8.2 Pace Protocols ... 31 12.8.3 Threshold Protocol... 31 12.8.4 Nodal_ERP Protocol ... 32 12.8.5 Multi_Sx Protocol ... 32 12.8.6 Wenckebach Protocol ... 32 12.8.7 RSynced_Sx Protocol ... 32 12.8.8 SNRT* Protocol... 33 12.8.9 Burst_Pace Protocol ... 33 12.8.10 AV Atrio-ventricular Delayed Protocol ... 33 12.8.11 Overdrive Pace and ATP Protocols ... 33 12.8.12 Specialised Protocols... 34 12.9 SOFTWARE CONFIGURATION. ... 35 12.10 SOUND CONFIGURATION ... 35 12.11 SAFETY FEATURES... 36 12.12 SOFTWARE ERROR MESSAGES ... 36 12.13 ADDITIONAL SOFTWARE MESSAGES ... 38 12.13.1 Advisory Messages... 38 12.13.2 Text Messages... 40 12.14 CONFIGURING THE PROGRAM - THE CONFIG MENU ... 41 13 THE EPS320 STIMULUS GENERATOR UNIT ... 43 13.1 EPS320 STIMULUS GENERATOR UNIT LAYOUT ... 43 13.2 EPS320 STIMULATOR CONNECTIONS ... 44 13.3 HARDWARE ERROR MESSAGES ON THE EPS320 STIMULUS GENERATOR UNIT ... 45 14 TROUBLESHOOTING... 47 15 MAINTENANCE... 48 15.1 BATTERIES ... 48 15.2 MAINTENANCE AND CALIBRATION ... 48 15.3 CLEANING INSTRUCTIONS ... 48 15.4 SERVICEABLE LIFE AND DISPOSAL ... 48

Tables TABLE 1 EXPLANATION OF SYMBOLS ... 9 TABLE 2 EXPLANATION OF SYMBOLS – SPECIFIC TO THE SGU... 11 TABLE 3 LIST OF AVAILABLE ACCESSORIES FOR THE EPS320B/BT CARDIAC STIMULATOR. ... 16 TABLE 4 LIST OF AVAILABLE OPTIONS FOR THE STIMLAB™ CARDIAC STIMULATOR SYSTEM. ... 21 TABLE 5 COMPUTER FRONT PANEL EXPLANATIONS ... 22 TABLE 6 TOUCH BUTTONS, TOUCH ZONES AND THEIR FUNCTIONS ... 25 TABLE 7 ADVISORY MESSAGES AND SUGGESTED ACTIONS... 40 TABLE 8 CONFIGURATION MENU PAGE ... 42 TABLE 9 TABULATED ERROR MESSAGES ... 46

Figures FIGURE 1: EPS320B/T, STIMCOR™ AND STIMLAB™... 12 FIGURE 2 EPS320BT SYSTEM COMPONENTS ... 13 FIGURE 3 EPS320BT QUICK INSTALLATION GUIDE ... 15 FIGURE 4 STIMCOR™ SYSTEM COMPONENTS ... 17 FIGURE 5 STIMCOR QUICK INSTALLATION GUIDE... 18 FIGURE 6 STIMLAB™ SYSTEM COMPONENTS ... 19 FIGURE 7 STIMLAB™. QUICK INSTALLATION GUIDE ... 20 FIGURE 8 COMPUTER FRONT PANEL FOR EPS320B/BT (LEFT) AND STIMLAB / STIMCOR (RIGHT) ... 22 FIGURE 9 KEYBOARD LAYOUT ... 24

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FIGURE 10 TOUCH SCREEN ... 24 FIGURE 11 HELP MENU ... 28 FIGURE 12 STIMULATOR USER INTERFACE SCREEN SET TO PACE PROTOCOL... 29 FIGURE 13 STIMULATION PATTERNS IN BASIC PACING PROTOCOLS. ... 30 FIGURE 14 PROTOCOL TOOLBOX... 31 FIGURE 15 THE EPS320 STIMULUS GENERATOR UNIT FRONT PANEL ... 43 FIGURE 16 CONNECTORS ON REAR PANEL OF STIMULUS GENERATOR UNIT... 44

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Glossary and Terms Term

Explanation

Drive Train ECG

Electrocardiogram

EP

Electrophysiology

IECG

Intra-cardiac Electrocardiogram

LCD

Liquid Crystal Display

LED

Light Emitting Diode

P/QRS

P wave or QRS; also signifies any IECG waveform.

PC

Personal Computer

RA

Right Atrium

RV

Right Ventricle

RF

Radiofrequency, e.g. RF Ablation

RR

R-R interval on ECG or peak-to-peak interval on IECG.

S1

Basic stimulation interval.

SGU SM-Box SNRT StimLink™

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Also called S1; the 6-8 regular pacing stimuli before any extra-stimuli is applied.

Micropace Stimulus Generator Unit Stimulus Multiplexer Box – converts EPS320 two stimulus output channels to four channels. Sinus Node Recovery Times Communication cable for connection to EP Recording Equipment

Sx

The name for and the coupling interval of one or more extra-stimuli added after Drive Train called S2, S3…S7.

GUI

Graphical User Interface

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CARDIAC STIMULATOR

1 INTRODUCTION & ESSENTIAL PRESCRIBING INFORMATION 1.1

Device Description

1.1.1

Description of Stimulator

Micropace cardiac stimulator systems are all based on the EPS320 cardiac stimulator, a diagnostic external programmable cardiac stimulator. The description of each system is described in its own section below.

1.1.2

Accompanying Documentation

 User Instruction Manual (Instructions for Use), this document.  Technical Description, which includes installation instructions and advanced usage information

(English-only, included in full English UIM MP3395).  Accessories Unit Contents and Instructions for Use Leaflet  Service Manual is available on request

It is strongly recommended that the Operator reads the User Instruction Manual document in its entirety and is familiar with its contents before using the Stimulator on patients.

1.1.3

Intended Use

The Micropace Cardiac Stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of initiation and termination of tachyarrhythmias, refractory measurements and measurements of electrical conduction.

1.1.4

Indications for Use

The Stimulator system is an electrical stimulus generator for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

1.1.5

Operating Environment

The stimulator is intended for use in air conditioned hospital cardiac electrophysiology laboratories equipped for advanced cardiac resuscitation, by technicians trained in diagnostic cardiac stimulation under constant supervision by a cardiologist. Stimulator parts Remote Station MP3168 and connection boxes MP3086 and MP3014 may be used in the patient environment, but must be protected from ingress of fluids. The required installation and electromagnetic environment is described in the Technical Manual. Device is not intended for use with flammable gasses of liquids, no part of it is sterile or sterilizable and device is not protected from ingress of fluids. Warning: Do not stack EPS320 components or use them directly adjacent with other equipment. If adjacent or stacked use is necessary, verify normal operation in the configuration per the system verification instructions in this IFU.

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1.1.6

Contraindications

Do not use the Stimulator system for life support in patients with life-threatening bradycardia; use instead temporary external pacemaker.

1.2

Compatible Equipment

The primary function of the Micropace Cardiac Stimulator is the generation of constant current rectangular stimulation pulses with amplitudes of 0.1mA to 25mA, duration of 0.5ms to 10ms and with a maximum voltage of ± 27V. Third party switching equipment with the following special characteristics must be used to carry the stimulus pulses to the intracardiac electrodes without significant distortion:  Series resistance: < 100 Ohms at up to ± 25mA  Shunt resistance: > 100,000 Ohms at up to ± 27V  Frequency bandwidth: DC to 300 Hz  Interference RF energy sources: < 350Vpp at 400 kHz to 600 kHz, or 150W into a 300 Ohm load Micropace Stimulator is intended for use with the following equipment; Diagnostic and Ablation pacing electrode catheters  Currently available legally marketed electrophysiological diagnostic electrode catheters,

including those manufactured by Cordis Biosense Webster, Daig, CR Bard, Medtronic and EPT. EP Recording equipment TM

 Computerized EP Recording systems manufactured by Bard Electrophysiology (LabSystem TM

TM

Duo and LS Pro ) and GE/Prucka (CardioLab 4000, 7000) have been tested for use with the EPS320 Stimulator.

1.3

Important Patient Safety Warnings

1.3.1

General Warning

Warning: Stimulator must be used only under supervision by a cardiologist.  To avoid death or injury to patient from arrhythmias, the Stimulator may be used on humans

only under the direct supervision by a physician familiar with electrophysiology in an appropriate hospital facility.  The supervising physician must verify all Stimulator settings immediately prior to

commencement of pacing. Warning: Installation and use only by qualified personnel.  Only qualified personnel, such as representatives of Micropace Pty Ltd, its authorized

distributor or hospital-appointed biomedical engineers, may carry out installation of the Stimulator system and its connection to other equipment.  In order to reduce operator errors, installation, configuration and customer training should be

performed in a manner, which allows optimal use of the Stimulator by the user. Warning: Stimulator is not a life support device – operator must have available backup temporary external pacemaker.  To avoid injury to patient from bradycardia, operator must have available a backup temporary

external pacemaker.

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Warning: Stimulator must use isolated mains supply only.  To avoid electrocution hazards, all parts of the Stimulator, including the computer, monitor and

Stimulus Generator Unit must all be connected to the Mains Isolation Transformer and never directly to a mains power outlet. Warning: To avoid electrocution hazards, connect Stimulator system only to legally marketed, mains-isolated electrical equipment.  Connect Stimulator only to parts specified by Micropace as compatible or to equipment

certified to IEC 60601-1.  Do not connect equipment other than that specified by Micropace to the multiple socket outlets

on the Micropace supplied Isolation Transformer.  If this equipment is modified, appropriate inspection and testing, including IEC 60601-1:2005,

must be conducted to ensure continued safe use of the equipment.  Avoid connecting equipment parts to patient by touching simultaneously conductive part of this

or other equipment and the patient. Warning: Use Stimulator only in ventilated areas and away from flammable gasses.  To avoid risk of explosion, the Stimulator should only be used in a ventilated area as gasses

may be released during charging of backup battery, and should not be used in rooms with flammable anesthesia.

1.3.2

Warnings Specific to the Micropace Stimulator

Warning: Monitor function of Stimulator and patient’s vital signs continuously.  The Micropace Stimulator may fail to stimulate or unintentionally stimulate the patient through

software, hardware or human error. To avoid injury to patient from arrhythmias, monitor the function of Stimulator and patient’s vital signs continuously while Stimulator is connected to the patient.  In case of repeated recurrence of unexplained life-threatening arrhythmias despite

cardioversion/defibrillation during the use of the Stimulator, disconnect the Stimulator from the patient by unplugging the green Pace Output plug on the front panel in case it has an occult malfunction causing recurrent micro-electrocution or recurrent DC current stimulation. Warning: Measurements by Stimulator are for information only.  Measurements displayed by Stimulator, including the Impedance measurement, RR interval

and SNRT measurement are for facilitation of use of Stimulator. The user should use third party legally marketed measurement devices independent of the Stimulator to measure these parameters for the purpose of clinical diagnoses. Warning: When using the optional Four Channel Stimulus Multiplexer Box (SM-Box)  Product is not suitable for sterilization and must be protected from ingress of fluids  In order to prevent inadvertent or ineffective pacing, the user should always verify the actual

channel being paced using independent EP Recording Equipment.

1.3.3 Warnings Related to the use of Micropace Stimulator with RF Ablation Equipment Warning: Use Stimulator only with RF-filtered stimulus connection. (Micropace parts: MP3014, MP3086).

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 Use only supplied Stimulus Connection Box (MP3014) or optional Stimulus Multiplexer Box

(MP3086) components to connect Stimulator’s stimulus output to patient circuits.  The MP3014 and MP3086 components are over voltage protected by gas arrestors for

differential voltages > 350VAC. Exposing these components to unfiltered RF ablation energies exceeding this limit (e.g. by direct connection to unfiltered RF Ablation energies > 150W or ablating into > 300 Ohm loads may cause reduction of RF energy available for ablation and overheating and a fire hazard within these components. Warning: Do not stimulate via ablation electrode during delivery of RF Ablation energy.  To avoid possibility of unintended arrhythmia induction, do not stimulate myocardium via the

ablation electrode during application of RF energy. Efficacy and potential for adverse effects of stimulation of heated myocardium in the process of ablation have not been established.

1.4

General Precautions in Handling Stimulator

Caution: Installation, Transport, and Storage.  To ensure reliable operation of the Stimulator, install it in a well-ventilated place away from

dust, excessive heat or humidity, direct sunlight and splashing liquids.  To ensure operator may see important error messages displayed during operation, install with

the front panel of the Stimulus Generator Unit visible to the Operator.  To avoid damage to the Stimulator, avoid exposure to chemical gases, excessive vibration,

impact, temperatures above 60 Deg. Celsius or ambient air pressures equivalent to above 10000m altitude during transport and handling.  To ensure that backup battery remains fully charged, store system between uses with the

Stimulus Generator Unit connected to mains power supply, switched on at the rear panel switch.  Assembly and modification of this Medical System during the actual service life requires

evaluation to the requirements of IEC 60601-1:2005. Caution: Precautions prior to use.  When turning on the SGU, ensure all LEDs illuminate during the Power On Self Test and no

error messages are displayed, else refer to Troubleshooting section below.  Ensure that all cables are properly installed and secured.  Ensure that the mains power supply is isolated and that attached equipment is also electrically

isolated and does not pose an electrical hazard.  If the Stimulator has been unused or may have been disconnected from mains power supply

for more than 1 month, charge backup battery by leaving connected to the mains supply in Standby Mode overnight.  Do not use the Stimulator if any component appears damaged, computer appears to start up

abnormally, or error messages appear on the computer screen or Stimulator front panel. If in doubt, contact the Distributor or Micropace directly.  Ensure that the Operator is trained thoroughly on how to switch the Stimulator to Backup

Manual mode or Emergency Fixed Rate Pacing modes.  To prevent custom software malfunction, do not install other software.

Caution: Precautions during use.

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 Observe the Stimulator and patients at all times for abnormal function and rectify any problem

promptly or disconnect the patient from the Stimulator (by unplugging the green plug from the green PACE OUTPUT socket on the front panel).  Do not use the Stimulator and disconnect it from the patient if it repeatedly switches to Backup

Manual mode and displays error messages on the front panel. Contact your Micropace Distributor.  Use of excessive stimulation currents may induce fibrillation and produce misleading results in

ventricular stimulation studies.

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2 DEVICE RATINGS, CLASSIFICATION AND CERTIFICATION CE Mark Compliance The Micropace Cardiac Stimulator, is compliant with the following EEC directives:  89/336/EEC & 92/31/EEC (EMC Directives)  93/42/EEC & 2007/47/EEC (Medical Device Directive)

Issuing Notified Body: SGS.

 93/68/EEC (CE Marking Directive)

Compliance Testing was carried out and coordinated by the following certified bodies:  EMC Technologies, Castle Hill, Australia  TCA - Testing and Certification Australia, Chatswood, Australia

The Micropace Cardiac Stimulator classification:  TGA, Rule 4.3 Classification

Class IIb  Medical Devices Directives (93/42/EEC, 2007/47/EEC & 93/68/EEC), Rule 10 classification:

Class IIb medical device  IEC60601-1 electrical device classification:

Class II (mains-isolated by approved external isolation transformer), IPX0, Type CF  FDA Medical Device Level of Concern

Level II  Health Canada Medical Device Classification, Rule 10(2)

Class III

The Micropace Cardiac Stimulator system Power rating:  220-240VAC 50-60Hz, 0.7A max / 110-120VAC 60Hz, 1.4A max

Identification of technical standards with which compliance is claimed  ISO 13485 Quality management systems - Medical devices - System requirements for

regulatory purposes  IEC60601-1:2005 Medical Equipment – Part 1: General requirements for safety.  IEC60601-1-2:2007 Medical Equipment – Part 1: General requirements for safety. Collateral

Standard: Electromagnetic compatibility – Requirements and tests

Environmental Conditions  Operating T° Range

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+5ºC to +35ºC (30% to 80% RH)

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3 COPYRIGHT, WARRANTY AND DISCLAIMER NOTICE Copyright Notice Copyright © 1994-2012 by Micropace Pty Ltd. 7/186 - 188 Canterbury Road, Canterbury NSW 2193, Australia All rights reserved, Printed in Australia

Trademarks Datalight and ROM-DOS are registered trademarks of Datalight, Inc. Copyright 1989-2008 Datalight, Inc., All Rights Reserved.

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4 EXPLANATION OF SYMBOLS Symbol

Name

Location

Read User Instruction Manual

Read User Instruction Manual prior to use.

On product label

Manufactu red on

Manufactured on date: YYYY-MM

On medical device product label

Type CF Defibrillato r Proof

Patient Outputs

Warning

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Meaning

Type CF defibrillator protected equipment (Protected against intra-cardiac voltages during external defibrillation)

Stimulus outputs connect to patient box or SM Box here.

Cardiac pacing output. Read Important Patient Safety Warnings and General Precautions in Handling Stimulator section at the front of this document.

On Stimulus Generator Unit, MP3008: 1. Pace Output Socket. 2. Emergency Fixed Rate Pacing output socket

As above

As above

Attention

Electrocution Hazard,ensure that Isolation Transformer has Mains Cord Retaining Bracket MP3181 installed at all times."

Isolation Transformer

Attention

Connect only to Micropace supplied parts.

AUXILIARY PORT on MP3008

Warning

Not Suitable for direct connection to RF Ablation Power > 150W into 300 Ohms

On MP3086

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Symbol

Meaning

Name CE Marking & Notified Body Identificati on

Complies with European Medical Devices Directive (MDD).

Location

On MP3008

CE Marking

Complies with EMC and Safety Standards for distribution in Europe.

Accessories. 1 Isolation Transformer. 2 Low voltage Transformer

Equipotentiality

System central grounding terminal.

Isolation Transformer

0

Power OFF

I

Power ON

Device is switched OFF; battery is NOT charging.

POWER ON/OFF switch of MP3008

Device is switched ON and battery is charging.

POWER ON/OFF switch of MP3008

Increase / Decrease

Increase / Decrease adjacent Interval or Current parameter.

On the front of MP3008 next to Interval Current displays

Positive Output

Positive stimulus output. Defibrillator CF Protected part

On MP3014 and MP3086

Negative Output

Negative stimulus output, Defibrillator CF Protected part

On MP3014 and MP3086

FAULT

Fault Detected in Stimulus Multiplexer Box – use Emergency Bypass.

On MP3086

Emergency Bypass

Emergency Bypass output socket - pace Ch2 (Ventric), or use Emergency Pacing on the Stimulator.

On MP3086

Backup Stimulator Here

Sign indicating location of Stimulator SGU MP3008 for backup pacing.

Next to where SGU MP3008 is installed.

Table 1 Explanation of symbols

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Table 2 below lists explanations of symbols displayed only on the SGU MP3008

Symbol

Name

Meaning

Location

No light: No external power. Orange Light: Connected to Mains Power, SGU Off, Battery is not charging. Mains Power

Green Light: Connected to Mains Power and SGU on – in Manual Backup or PC Pace Control modes. Battery is charging. Green Light Flashing: Connected to Mains Power and SGU in Standby. Battery is charging.

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Battery Power

SGU is powered by Battery.

Battery Low

Battery is nearly discharged. Connect to mains power to continue use of SGU.

PC Pace Control

SGU is under control of Computer.

Backup Pace

Backup / Manual pacing controls are located here. This can be used to pace when not under control of the computer.

Pace On/Off

Press to start / stop pacing.

Backup / Standby

Press to toggle between Backup Manual Pace Control and Standby.

Pace Interval

Basic pacing interval in ms.

Current

Current amplitude of stimulus.

Pace Output

Stimulus output and indicator lights are here.

Ch1 (Atrium)

Green flash: Stimulus into Channel 1, usually located in Atrium.

Left Front Panel of Stimulus Generator Unit

Left centre Front Panel of Stimulus Generator Unit

Right centre Front Panel of Stimulus Generator Unit

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Ch2 (Ventic)

Green flash: Stimulus into Channel 2, usually located in Ventricle.

Check Lead

Stimulus current not able to be delivered because of a break in the electrical lead / circuit.

Emergenc y Fixed Pace Output

Plug green patient connection cable into this socket to immediately pace Ventricle Ch2 at 100ppm @ 5mA. Note: Ch1 Atrium is not paced.

Pace V at 100ppm @ 5mA

As above.

Pace V Ch2

Green flash: Stimulus on Channel 2, usually located in Ventricle.

Battery

Emergency Fixed Pace Output enabled and powered from a battery with adequate charge.

DC Power

Direct Current power input, voltage and current consumption as specified.

Computer Link Port

Port for connection to controller computer, use only Micropace supplied cables.

Auxiliary Port

Port for connection to Stimulus Multiplexer Box, use only Micropace supplied cables.

ECG-1 Input ECG-2 Input

High Level ECG input, 1V peak-to-peak.

Sync-1 Output

Digital 0-5V sync output for triggering recorders

Replace

Replace battery on specified date with specified batteries.

Battery

Right Front Panel of Stimulus Generator Unit

Rear panel of Stimulus Generator Unit

Battery Replacement Label on SGU

Contains Batteries

Table 2 Explanation of symbols – specific to the SGU.

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5 EPS320 FAMILY OF CARDIAC STIMULATORS

Figure 1: EPS320B/T, StimCor™ and StimLab™

5.1

Description of Stimulator Family

The EPS320 Cardiac Stimulator is a diagnostic external programmable cardiac stimulator. The Cardiac Stimulator consists of a self-contained two channel microcontroller-based Stimulus Generator Unit, MP3008,capable of generating simple regular pacing pulses by the controls on its front panel. During normal use, however, it is externally programmable by using a computer to generate complex pacing patterns. The two stimulation channels are independent isolated current pulse generators capable of generating 0.5 to 10ms pulses at 0.1 to 25mA with a maximum output voltage of 27V. The stimulus output may be used to stimulate the human heart during electrophysiological studies via any third party legally marketed transvenous intracardiac pacing catheters. These may be connected directly or via any third party legally marketed EP recording equipment intended to switch pacing pulses of above description to selected specific catheters and electrodes.

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6 EPS320B/BT CONFIGURATION 6.1

Description of system

The Micropace EPS320B/BT EP Stimulator System is a computerized Cardiac EP diagnostic stimulator system. LCD Display, MP3076 or MP3114(Touch) Computer, MP3093

Stimulus Connection Box, MP3014 (2Ch) or MP3086 (4Ch)

Isolation Transformer, e.g. MP3107

Keyboard, MP3016

Stimulus Generator Unit (SGU), MP3008

Figure 2 EPS320BT System Components

6.2

System Components

This configuration includes a Bona Computech Light System PC, a separate NEC LCD Display Screen and a 110-240VAC Mains isolation transformer with the EPS320 system. Appropriate mains cables are included for proper system installation, as per Packing list below.

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Figure 3 EPS320BT Quick Installation Guide

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