EPS320B and BT Cardiac Simulator User Instruction Manual sw ver 4.0

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USER INSTRUCTION MANUAL

Micropace Cardiac Stimulators

EPS320B/BT

StimCor™

StimLab™

ENGLISH

Page 2

Distributed by:

Boston Scientific Corporation

300 Boston Scientific Way

Marlborough, MA 01752

USA

USA Customer Service 888-272-1001

AND

GE Medical Systems Information Technologies

8200 West Tower Ave

Milwaukee, WI 53223

U.S.A

Micropace Pty Ltd.

7/186-188 Canterbury Road

Canterbury NSW 2193

Australia

Advena Ltd, Pure Offices, Plato Close,

EC

Warwick CV34 6WE UK

REP

www.micropaceEP.com/euar.html

CAUTION

US Federal Law restricts this device to sale

by or on the order of a physician.

Micropace Cardiac Stimulators

User Instruction Manual

EPS320 & StimCor™ & StimLab™ Micropace Part Order No. MP3425

Compact Version English 1.1

Valid for:

Stimulator Software version 4.0

SGU Firmware versions 4.76

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CARDIAC STIMULATOR

12.7 USING THE STIMULATOR SOFTWARE PROTOCOLS ..................................................................... 31

12.8 PACING PROTOCOLS .............................................................................................................. 32

12.8.1 Protocol Selection & Renaming ..................................................................................... 32

12.8.2 Pace Protocols ..............................................................................................................32

12.8.3 Threshold Protocol ........................................................................................................ 32

12.8.4 Nodal_ERP Protocol ..................................................................................................... 33

12.8.5 Multi_Sx Protocol ..........................................................................................................33

12.8.6 Wenckebach Protocol ...................................................................................................33

12.8.7 RSynced_Sx Protocol ...................................................................................................33

12.8.8 SNRT* Protocol ............................................................................................................. 34

12.8.9 Burst_Pace Protocol......................................................................................................34

12.8.10 AV Atrio-ventricular Delayed Protocol ............................................................................34

12.8.11 Overdrive Pace and ATP Protocols ............................................................................... 34

12.8.12 Specialised Protocols ....................................................................................................35

12.9 SOFTWARE CONFIGURATION. .................................................................................................. 37

12.10 SOUND CONFIGURATION......................................................................................................... 37

12.11 SAFETY FEATURES ................................................................................................................ 37

12.12 SOFTWARE ERROR MESSAGES ............................................................................................... 38

12.13 ADDITIONAL SOFTWARE MESSAGES......................................................................................... 39

12.13.1 Advisory Messages ....................................................................................................... 39

12.13.2 Text Messages ..............................................................................................................41

12.14 CONFIGURING THE PROGRAM - THE CONFIG MENU .................................................................. 42

13 THE EPS320 STIMULUS GENERATOR UNIT ............................................................................44

13.1 EPS320 STIMULUS GENERATOR UNIT LAYOUT ......................................................................... 44

13.2 EPS320 STIMULATOR CONNECTIONS ...................................................................................... 45

13.3 HARDWARE ERROR MESSAGES ON THE EPS320 STIMULUS GENERATOR UNIT ............................ 46

14 TROUBLESHOOTING ................................................................................................................. 48

15 MAINTENANCE .......................................................................................................................... 49

15.1 BATTERIES ............................................................................................................................ 49

15.2 MAINTENANCE AND CALIBRATION ............................................................................................ 49

15.3 CLEANING INSTRUCTIONS ....................................................................................................... 49

15.4 SERVICEABLE LIFE AND DISPOSAL ........................................................................................... 49

Tables

TABLE 1 EXPLANATION OF SYMBOLS .....................................................................................................10

TABLE 2 EXPLANATION OF SYMBOLS – SPECIFIC TO THE SGU. .................................................................12

TABLE 3 LIST OF AVAILABLE INSTALLATION ACCESSORIES FOR THE EPS320B/BT CARDIAC STIMULATOR. ...17

TABLE 4 LIST OF AVAILABLE INSTALLATION OPTIONS FOR THE STIMLAB™ CARDIAC STIMULATOR SYSTEM....22

TABLE 5 COMPUTER FRONT PANEL EXPLANATIONS ................................................................................23

TABLE 6 TOUCH BUTTONS, TOUCH ZONES AND THEIR FUNCTIONS ..............................................................27

TABLE 7 ADVISORY MESSAGES AND SUGGESTED ACTIONS. ....................................................................... 41

TABLE 8 CONFIGURATION MENU PAGE ..................................................................................................43

TABLE 9 TABULATED ERROR MESSAGES ..................................................................................................47

Figures

FIGURE 1: EPS320B/T, STIMCOR™ AND STIMLAB™ ............................................................................. 13

FIGURE 2 EPS320BT SYSTEM COMPONENTS ....................................................................................... 14

FIGURE 3 EPS320BT QUICK INSTALLATION GUIDE................................................................................16

FIGURE 4 STIMCOR™ SYSTEM COMPONENTS .......................................................................................18

FIGURE 5 STIMCOR QUICK INSTALLATION GUIDE ................................................................................... 19

FIGURE 6 STIMLAB™ SYSTEM COMPONENTS ........................................................................................ 20

FIGURE 7 STIMLAB™. QUICK INSTALLATION GUIDE .................................................................................21

FIGURE 8 COMPUTER FRONT PANEL FOR EPS320B/BT (LEFT) AND STIMLAB / STIMCOR (RIGHT) ................23

FIGURE 9 KEYBOARD LAYOUT ..............................................................................................................25

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USER INSTRUCTION MANUAL

FIGURE 10 TOUCH SCREEN ................................................................................................................. 25

FIGURE 11 HELP MENU ........................................................................................................................29

FIGURE 12 STIMULATOR USER INTERFACE SCREEN SET TO PACE PROTOCOL. ..........................................30

FIGURE 13 STIMULATION PATTERNS IN BASIC PACING PROTOCOLS............................................................ 31

FIGURE 14 PROTOCOL TOOLBOX ..........................................................................................................32

FIGURE 15 FOR URGENT PACING ..........................................................................................................37

FIGURE 15 THE EPS320 STIMULUS GENERATOR UNIT FRONT PANEL .......................................................44

FIGURE 16 CONNECTORS ON REAR PANEL OF SGU (REFERENCE ONLY)....................................................45

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CARDIAC STIMULATOR

Glossary and Terms

Term

Drive Train

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

EP

Electrophysiology

LCD

Liquid Crystal Display

P/QRS

P wave or QRS; also signifies any IECG waveform.

RA

Right Atrium

ECG

IECG

LED

PC

RV

RF

RR

Electrocardiogram

Intra-cardiac Electrocardiogram

Light Emitting Diode

Personal Computer

Right Ventricle

Radiofrequency, e.g. RF Ablation

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

S1

Basic stimulation interval.

SM-Box

Stimulus Multiplexer Box – converts EPS320 two stimulus output channels to

four channels.

SGU

SNRT

Micropace Stimulus Generator Unit

Sinus Node Recovery Times

StimLink™

Communication cable for connection to EP Recording Equipment

GUI

Graphical User Interface

Sx

iv

Explanation

The name for and the coupling interval of one or more extra-stimuli added after

Drive Train called S2, S3…S7.

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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

1.1.4

Indications for Use

1.1.5

Operating Environment

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.

The Stimulator system is an electrical stimulus generator for diagnostic cardiac stimulation during

electrophysiological testing of the human heart.

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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USER INSTRUCTION MANUAL

1.1.6

Contraindications

1.2

Compatible Equipment

Do not use the Stimulator system for life support in patients with life-threatening bradycardia; use

instead temporary external pacemaker.

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



Computerized EP Recording systems manufactured by Bard Electrophysiology (LabSystem TM

DuoTM and LS ProTM) 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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CARDIAC STIMULATOR

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.



1.3.2

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.

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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USER INSTRUCTION MANUAL





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.



1.4

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.

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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CARDIAC STIMULATOR







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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USER INSTRUCTION MANUAL

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)



93/68/EEC (CE Marking Directive)



93/42/EEC & 2007/47/EEC (Medical Device Directive)

Issuing Notified

Body: BSI group.

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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CARDIAC STIMULATOR

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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USER INSTRUCTION MANUAL

4 EXPLANATION OF SYMBOLS

Symbol

Location

Read User

Instruction

Manual

Read User Instruction Manual prior to use.

On product label.

Contents

Contents.

On shipping label.

Component

of

This is a component of a system.

On product label.

Manufacture

d on

Manufactured on date: YYYY-MM.

On medical device

product label.

Manufacture

d by

Legal Manufacturer

On medical device

product label.

Type CF

Defibrillator

Proof

Patient

Outputs

Warning

Attention

Page 8 of 49

Meaning

Name

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.

Electrocution Hazard,ensure that Isolation

Transformer has Mains Cord Retaining

Bracket MP3181 installed at all times."

On Stimulus

Generator Unit,

MP3008:

1. Pace Output

Socket.

2. Emergency Fixed

Rate Pacing output

socket .

As above.

As above.

Commented [M1]: Moved here from below

Isolation

Transformer.

Commented [M2]: Actually it is B&W the Baaske

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CARDIAC STIMULATOR

Symbol

Name

Meaning

Location

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 and

MP3014.

Complies with European Medical Devices

Directive (MDD).

On MP3008.

CE Marking

& Notified

Body

Identification

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 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.

Emergen-cy

Bypass

Emergency Bypass output socket - pace

Ch2 (Ventric), or use Emergency Pacing

on the Stimulator.

On MP3086.

Sign indicating location of Stimulator SGU

MP3008 for backup pacing.

Next to where SGU

MP3008 is installed.

Backup

Stimulator

Here

ENGLISH

Device is switched OFF; battery is NOT

charging.

POWER ON/OFF

switch of MP3008.

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USER INSTRUCTION MANUAL

Table 1 Explanation of symbols

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CARDIAC STIMULATOR

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

Symbol

Name

Meaning

Location

No light: No external power.

Mains

Power

Orange Light: Connected to Mains Power,

SGU Off, Battery is not charging.

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.

ENGLISH

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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USER INSTRUCTION MANUAL

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

Pace V at

100ppm

@ 5mA

Plug green patient connection cable into this

socket to immediately pace Ventricle Ch2 at

100ppm @ 5mA. Note: Ch1 Atrium is not

paced.

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

Contains Batteries

Right Front Panel

of Stimulus

Generator Unit

Rear panel of

Stimulus

Generator Unit

Battery

Replacement

Label on SGU

Table 2 Explanation of symbols – specific to the SGU.

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CARDIAC STIMULATOR

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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USER INSTRUCTION MANUAL

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 Generator Unit

(SGU), MP3008

Stimulus

Connection Box,

MP3014 (2Ch) or

MP3086 (4Ch)

Isolation

Transformer,

e.g. MP3107

Keyboard,

MP3016

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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CARDIAC STIMULATOR

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USER INSTRUCTION MANUAL

Figure 3 EPS320BT Quick Installation Guide

Page 16 of 49

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CARDIAC STIMULATOR

6.3

EPS320B/BT Optional Installation Accessories

Part

Number

Name

Description

MP3114

MP3113 (kit)

Touch Screen Kit

ELO Entuitive Touch LCD Screen

MP3086

MP3091 (kit)

Four Channel Multiplexer Kit

MP3096 (kit)

StimLinkTM Kit for

communication with EP

Recorder.

Alternative PC-controlled Stimulus Connection Box

with four Stimulus Channel Outputs 1-4

MP3070-XX

XX = 08

XX = 13

XX = 17

MP3090

MP3084-12

MP3084-25

Extension Stim Cable Kit –

For Stimulus Connection Box

in variants: 8M, 13M & 17M

Extension Stimulus

Multiplexer cable, 15m

Extension Serial RS232

Cable, (incl. RF suppression)

– 12m or 25m

Opto-isolated outgoing RS232 communication channel

for connection with EP Recorder with corresponding

Software receiver.

Low capacitance extension stimulus connection cable.

Extended control cable for four channel stimulus

multiplexer – MP3086.

Standard extension RS232 connection cable for

connection between SGU and PC.

Table 3 List of available Installation Accessories for the EPS320B/BT Cardiac Stimulator.

ENGLISH

Page 17 of 49

Page 24

USER INSTRUCTION MANUAL

7 STIMCOR™ CONFIGURATION

7.1 Description of system

The Micropace StimCor™ EP Stimulator System is a computerized Cardiac EP diagnostic stimulator

system with a new integrated hardware to support “Cockpit” laboratories and a remote monitor.

7.2

How Supplied

Main Components of the StimCor™ system comprise of the EPS320 Stimulus Generator Unit (SGU),

the Computer Cabinet and the Local Controller.

Touch Screen,

MP3114

Stimulus

Generator

Unit, MP3008

StimCor

Computer

Cabinet, MP3346

Keypad, MP3393

or keyboard,

MP3016

Figure 4 StimCor™ System Components

Page 18 of 49

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Page 25

CARDIAC STIMULATOR

7.3

System Components

Figure 5 StimCor Quick Installation Guide

7.4

StimCor™ Optional Installation Accessories

Same as EPS320B/BT.

ENGLISH

Page 19 of 49