MicroPace

Cardiac Stimulators

EPS320 Cardiac Stimulator Service Manual ver 1.4

Service Manual

55 Pages

File Type: PDF

File Size: 1MB

File Name: eps320_cardiac_stimulator_service_manual_ver_1-4.pdf

Available for download

Page 1

0120

EPS320 Cardiac Stimulator

SERVICE MANUAL

Version 1.4

CAUTION

Federal (U.S.A) law restricts this device to sale,

distribution and use by or on order of a physician.

Applies to Firmware V4.68

Page 2

EPS320 Service Manual

CONTENTS

INTRODUCTION

1.1

1.2

1.3

1.4

PURPOSE

SCOPE

Page 3

10.4SGU PROBLEMS

11 COMPUTER SETUP & TROUBLESHOOTING

11.1COMPUTER HARDWARE SETUP

11.2CMOS SETUP

11.3PC OPERATING SYSTEM

11.4SOFTWARE INSTALLATION

12 SOFTWARE TROUBLESHOOTING

12.1SOFTWARE ERROR MESSAGES

12.2ERRORS RECORDED IN STIM.LOG

12.3HARDWARE-RELATED W ARNING MESSAGES ON THE COMPUTER DISPLAY

13 SUB-ASSEMBLY REPLACEMENT

14 TESTING AND RE-INSTALLATION OF REPAIRED EPS320 SYSTEM

15 EPS320 SPARE PARTS LIST

ERROR! BOOKMARK NOT DEFINED.

16 SERVICE RECORD

FIGURES

Figure 1 EPS Stimulator System........................................................................................................ 18

Figure 2 EPS320 Stimulator main components.................................................................................. 20

Figure 3 Typical EPS320 installation, with the Bard Duo EP Recording System. ................................ 26

Figure 4 External ECG sensing schematic......................................................................................... 28

Figure 5 Simpler set up for Catheter-tip ECG sensing........................................................................ 28

Figure 6 Auxillary Interface ................................................................................................................ 32

Figure 7 Patient Connector................................................................................................................ 32

Figure 8 Emergency Pace Connector ................................................................................................ 32

Figure 9 EPS320 System Schematic Layout...................................................................................... 33

Figure 10 SGU off PCB component connections................................................................................ 34

Figure 11 SGU Subsystem Physical Components Layout .................................................................. 35

TABLES

Table 1 Suggested connections for external ECG sensing. ................................................................ 27

Table 2 Accessing the catheter-tip ECG sensing ............................................................................... 28

Table 3 Intracardiac ECG Input Specifications ................................................................................... 29

Table 4 High Level ECG Input Specifications..................................................................................... 30

Table 5 Sync In Specifications........................................................................................................... 30

Table 6 Intracardiac ECG Input Specifications ................................................................................... 30

Table 7 Intracardiac Pace Output Specifications................................................................................ 31

Table 8 Sync Out Specifications ........................................................................................................ 31

Table 9 Emergency Pace Output Specifications................................................................................. 31

Table 10 Tabulated SGU Error messages ......................................................................................... 41

Table 11 SGU Error Code Number interpretation............................................................................... 42

Table 12 Table of File-related errors, recorded in the 'stim.log'........................................................... 48

Table 13 Table of warning and advisory messages............................................................................ 49

Table 14 EPS320 Spare parts list ...................................................................................................... 53

Table 15 EPS320 Test jig Spare parts list.......................................................................................... 54

Page 4

EPS320 Service Manual

1 INTRODUCTION

1.1 Purpose

This document is intended to enable the servicing of the EPS320 Cardiac Stimulator system by

Micropace service staff and by Distributor Service Department technicians suitable trained by

Micropace.

1.2 Scope

This manual covers the covers the servicing by sub-assembly replacement only of all EPS320

components including the SGU, PC and software and connecting cables. Issues of device

interaction between the EPS320 and connected equipment are also covered. Outside of the scope

of this document are the repair of the accessory computer, computer display, power supplies and

component level repair of the EPS320 printed circuit boards.

1.3 Related documents

Inputs:

TestJigManual.doc

EPS320-SGUAcceptanceProtocol.doc

Outputs:

q Nil

1.4 Definitions, Acronyms, and Abbreviations

The following abbreviations are applicable to this document.

SYMBOL

SGU:

ECG:

IECG:

RF:

JP:

TP:

EMC

EMI

POST

Moniputer

LED

µP

EXPLANATION

Stimulus Generator Unit

Electrocardiogram

Intracardiac Electrocardiogram

Radio Frequency

Header or a connector

Test point

Electromagnetic compatibility. This will refer to emissions of

electromagnetic waves and the effect of these on the environment. It also

refers to the effects of electromagnetic waves on the equipment

Electromagnetic Interference

Personal computer, IBM compatible

Power On Self Test

Refers to a combined computer monitor/CPU

Light emitting diodes and seven segment displays when referring to display

information

Microprocessor, in this manual refers specifically to the PIC16C77

microcontroller, by Microchip

Page 5

Stimulus Generator Box controls and terms:

SGU or Stim Box

Backup mode

PC mode

Standby mode

'Pace Output' socket

'Emergency Output' socket

Switches:

'Power' switch

'Backup Enable' switch

'Pace On/Off' switch

= Stimulus Generator Unit

= 'Backup Manual Pace Control' mode, whereby SGU operates

independently of the PC as a simple pacemaker

= 'PC Pace Control' mode, whereby SGU opertation is

controlled by the Custom PC Software

= Low power SGU operational mode; Mains Power flashes

Green colour

= 'Pace Output' green coloured socket on SGU front membrane

= 'Emergency Fixed Pace Output' red coloured socket on SGU

front membrane providing backup pacing at 100bpm

independent of SGU or PC Software.

= SGU Power On/Off switch located at rear of SGU

= Blue membrane push button switch on front of SGU; invokes

alternatively Backup mode and Standby mode

= Red membrane push button switch on front of SGU; starts &

stops pacing in the Backup mode

Numeric Indicators on SGU front panel

'Pace Interval' display

= Backup Manual Pace Mode Pacing interval display,

adjustable by adjacent up and down push button keys

'Current' display

= Backup Manual Pace Mode Pacing current display, adjustable

by adjacent up and down push button keys

LED Indicators on SGU front panel

'Mains Power'

= Constant Green: Mains power connected and SGU Power

switch On and unit in Backup or PC Control mode; flashing

Green: Mains power connected and SGU Power switched On

and in unit in Standby state; Orange: Mains power connected

and SGU Power switch Off. Backup battery trickle charges

with any flashing or steady Green

'Battery Power'

= SGU power switch On but unit disconnected from mains

power and using battery power

'Battery Low'

= SGU internal backup 12V battery near depletion

'Atrium Pace' LED

= Stimulus issued on Atrial channel

'Ventricle Pace' LED

= Stimulus issued on Ventricular channel

'Atrium Check Lead' LED

= High impedance (>4Kohm) detected on channel

'Ventricle Check Lead' LED = High impedance (>4Kohm) detected on channel

'QRS' LED

= QRS complex (peak) detected on programmed ECG input

channel. Inactive when Software QRS detection selected in

software.

'Emergency Pace V' LED

= Stimulus issued on Emergency Pace channel;

'Emergency Battery OK' LED = Emergency Pace is engaged and 9V Lithium Battery has

adequate charge

Page 6

EPS320 Service Manual

2 DOCUMENT OVERVIEW

2.1 Document Contents

This document aims to provide the service technician with the resources to troubleshoot, repair,

obtain further help and and report on problems associated with the EPS320 Cardiac Stimulator

installation.

For technicians not familiar with electrophysiology, the section Background Information within the

Principles of Operation chapter gives an overview of the topic.

This manual contains the following:

(i)

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

(viii)

(ix)

(x)

Safety, Warning and Precautions

Overview of the Stimulator System

Description of the principle of operations

Device Specification

Device Installation Requirements

Descriptions of the system components and interconnections

Troubleshooting guide

Testing and Re-installing Repair

Available spare parts list

Reporting Forms

2.2 Software License And Warranty

Refer to user instruction manual for the terms of software license and warranty.

Page 7

2.3 Service Policy

Micropace recommends servicing of the EPS320 by the various stakeholders according to the

following schema:

Site

User / Hospital

biomedical

Engineering

Distributor

Service Dept.

Micropace

Service Dept.

Recommended scope of repair / Service

1. Replacement of apparently faulty accessories,

such as power supplies, signal cables, isolation

transformer, LCD Display Screen.

2. Replacement of fuses in Isolation transformer

with Micropace supplied fused only.

3. Replacement of batteries internal to the SGU,

namely the 12V lead acid backup battery

(MP3109) and the 9V Lithium PP3 format battery

(MP3110), when SGU POST indicates faulty

battery. Use Micropace supplied batteries only.

4. Upgrade of product firmware by replacement

of EEPROM/ Microcontroller on SGU main PCB.

5. Upgrade of product software by installation of

software from FDD or by replacement of

Compact Flash Memory Card in PC.

1. As above, plus:

2. Repair of faulty PC by a Micropace-approved

and identified Computer service center and

subsequent reloading of software.

1. Repair of SGU internal subassemblies

including PCB’s, PCB header cables and

connectors or chassis components by

replacement.

2. Calibration of SGU current delivery system.

As above, plus

Repair of cables and connector subassemblies or

their replacement.

Repair of PCB’s through through-hole or SMT

component replacement or PCB repair.

Verification of repair

1. System functions OK.

2. System functions;

only supplied fuses

used.

3. POST passes OK;

only supplied batteries

used.

4. POST passes OK

5. POST passes OK and

software launches OK.

As above

Software tests own

checksum and essential

PC resources.

Verification with te.exe

test jig/test software.

As above.

Acceptance testing at

Micropace.

Performance of the full

EPS320-SGUAcceptanceProtocol.doc

There are no user serviceable parts inside the Stimulus Generation Box.

It is recommended that hospital service personnel contact the distributor with details of any faults

prior to attempted repairs to obtain recommendations for repair procedures. It is also

recommended that on-site repair be limited to repair of any off-PCB faults and visual inspection of

PCB. Apparently faulty PCB's should be tested by replacement of either the main PC board or

display PC board; defective PC boards should be returned to the manufacturer for repair.

Page 8

EPS320 Service Manual

3 SAFETY, WARNINGS AND PRECAUTIONS

Brief Device Description

Intended Use

The Micropace EPS320 Cardiac Stimulator is used to stimulate the heart via intracardiac

electrodes during electrophysiological cardiac studies. The stimulator system is a diagnostic tool

intended for provocative electrical stimulation of the heart for the purpose of measurement of

cardiac conduction properties and induction and diagnosis of arrhythmias. Note that the system is

not a life support device and is not intended to qualify as a life support device in respect to its

functionality, construction or reliability.

Description of system

The EPS320 Cardiac Stimulator by Micropace Pty Ltd. is a diagnostic external programmable

cardiac stimulator. The Stimulator consists of a self-contained two channel microcontroller-based

Stimulus Generator Unit independently capable of generating simple regular pacing pulses, but

under normal use externally interactively programmable by the user for complex pacing patterns

via a serial data link, using a custom software program implemented on a standard personal

computer. The two stimulation channels are independent isolated constant 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 directly or via any third party legally marketed EP recording equipment intended to switch

pacing pulses of above description without distortion to selected specific catheters and electrodes.

The Stimulus Generator Unit is mains-powered via a DC power supply and has an internal tricklecharged backup battery in case of power failure. Its outputs are defibrillator and RF energy

protected and it features external ECG input ports as well as catheter-tip ECG sensing for

triggering of pacing events and three trigger output channels for synchronization with other

equipment. The system is powered from the mains via a medical grade isolation transformer.

The EPS320 software allows interactive programming of all aspects of the pacing stimulus: the

current amplitude, pulse width, delivery to channel 1 or 2 or both, and all stimulus parameters

including drive train number, timing and up to 6 extra-stimuli. The stimulator has an intuitive user

interface, with all commonly used stimulus and pacing protocol parameters located on fixed menus

on the one screen instantly adjustable via hotkeys including during actual pacing. All standard EP

stimulation protocols are available pre-programmed but may be reconfigured and automated

according to user requirements.

Accompanying Documentation

A reference package, comprising of a manual and a leaflet, is provided with the EPS 320 Cardiac

Stimulator. Included in the package are:

q User Instruction Manual

q Accessories Unit Contents and Instructions for Use Leaflet

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.

One further document is available on request, contact your distributor for copies of this document:

Software Reference Manual

This Service Manual applies to PC Software ver. 3.19.59 and SGU Firmware ver. 4.68.

Page 9

Compatible Equipment

The EPS320 Stimulator’s primary function is the generation of constant current predominantly

rectangular stimulation pulses with amplitudes of 0.1 to 25mA, duration of 0.5 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

Higher series resistance reduces maximal attainable pulse current amplitude; lower shunt

resistance reduces delivered current in all ranges; reduced frequency bandwidth may alter efficacy

of stimulation at any current level and higher RF energy exposure may activate over-voltage safety

elements, reducing RF energy delivery and overheating within the EPS320 system’s Stimulus

Connection Box.

Subject to these requirements, the EPS320 Stimulator is intended for use with the following

equipment; the user should contact Micropace Pty Ltd for compatibility information prior to use of

other equipment:

Diagnostic pacing electrode catheters

q Currently available legally marketed electrophysiological diagnostic electrode catheters,

including those manufactured by CR Bard, Cordis Biosense Webster, Daig, Medtronic and

EPT.

Ablation electrode catheters

q The EPS320 is tested for use with a number of legally marketed RF ablation catheters. Contact

Micropace Pty Ltd for further information (Refer also to “Warnings and Precautions” section

below).

EP Recording equipment

Computerised EP Recording systems manufactured by Bard Electrophysiology (LabSystemTM

Duo ) and GE/Prucka (CardioLab 4000) have been tested for use with the EPS320

Stimulator.

RF Ablation Equipment

q RF ablation equipment manufactured by EPT (EPT1000XP) and Medtronic (Atakar RF

Generator) have been tested for use with the EPS320 Stimulator.

Page 10

EPS320 Service Manual

Warnings and Precautions

General Warnings

Warning: Stimulator must be used only under supervision by a cardiologist.

The Micropace EPS320 Cardiac Stimulator is used in procedures, during which

intentional or unintentional induction of potentially dangerous cardiac arrhythmias is

likely to occur. The Stimulator must only be used by appropriately qualified and

experienced personnel, in appropriate facilities and in conjunction with adequate safety

equipment.

Specifically, the EPS320 Stimulator System may be used on humans only by or under

the direct supervision at all times by a physician familiar with the operation of this

Stimulator.

Warning: Installation only by qualified personnel.

Only qualified personnel, such as representatives of Micropace, its authorized

distributor or hospital-appointed biomedical engineers with guidance from Micropace,

may carry out installation or modifications of the EPS320 Stimulator and its connection

to other equipment. Incorrect installation may create electrocution hazards or impair

performance of the Stimulator.

Warning: The Stimulator must only use isolated mains power supply.

To avoid electrocution hazards, the EPS320 Stimulus Generator Unit power supply,

computer power supply, and monitor power lead must all be connected to a mains

isolation transformer and never directly to a mains power outlet, (i.e. wall outlet).

To avoid electrocution hazards, do not plug cables or leads directly into mains power

outlet.

Warning: Connect Stimulator system only to legally marketed, mains-isolated electrical

equipment

To avoid electrocution hazards and system malfunction, the Stimulator outputs, RS232

communication port, Auxiliary port and ECG and Sync ports may be connected to other

equipment provided the other equipment is also isolated from the mains power supply,

and complies with IEC601-1, IEC601-2 and IEC601-1-1 standards and is legally

marketed in the country of use and CE marked for installations in the EU countries.

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.

Page 11

Warnings Specific to the EPS320 Stimulator

Warning: Stimulator is not a life support device and may fail to pace – To avoid injury to

patient from bradycardia, use only with immediately available backup temporary external

pacemaker.

The EPS320 Stimulator System is a diagnostic tool for provocative electrophysiological

testing of the human heart. The Stimulator System is not intended, designed or fit for the

purpose of life support. Two levels of backup pacing are provided in case of failure of

normal functioning of the Stimulator and are for use in non-life-threatening bradycardia or

until temporary external pacing is established in case of life-threatening bradycardia or

asystole.

A backup temporary external pacemaker must be immediately available for use in case of

occurrence of life-threatening bradycardia and should preferably be connected directly to

an intracardiac electrical catheter located in a ventricle, bypassing any switching apparatus

in case of failure or inappropriate settings of such switching apparatus.

Warning: Stimulator may not always function as expected – To avoid injury to patient from

arrhythmias, monitor function of Stimulator and patient’s vital signs continuously while

Stimulator is connected.

The EPS320 Stimulator software is warranted to operate substantially according to

specification however it is not guaranteed to do so at all times, in all possible

circumstances and in an uninterrupted manner, nor to be error-free. The Stimulator could

potentially fail to stimulate or unintentionally stimulate the patient; to avoid injury to the

patient, the Stimulator and the patient must be observed for abnormal function of

Stimulator at all times while the Stimulator is connected to the patient.

In case of recurrent or persistent unexplained life-threatening ventricular tachycardia or

ventricular fibrillation occurring despite cardioversion/defibrillation during the use of the

Stimulator, disconnect the patient from the Stimulator and any attached third party

switching equipment in case of occult malfunction in any of the equipment is causing microelectrocution or DC current stimulation and repeat cardioversion/defibrillation. It is

recommended to disconnect patient at the intra-cardiac electrode catheter connectors; the

Stimulator itself may be disconnected instantly by unplugging the green Pace Output plug

on the front panel.

Warning: Measurements by stimulator are for information only.

Measurements displayed by stimulator, including the Impedance measurement 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.

Warnings Related to the use of EPS320 Stimulator with RF Ablation

Equipment

Warning: Use Stimulator only with Stimulus Connection Box (Micropace Parts MP3014 or

MP3065)

Use only supplied Stimulus Connection Box (Micropace Parts MP3014) or alternative

optional In-line RF Filter (MP3065) components to connect Stimulator output to patient

circuits. These components contain RF suppression filters to prevent large RF energies

from RF Ablation equipment not equipped with RF filters from reaching the Stimulator

output circuits. Use of other, including custom made connectors may bypass RF filtering

and potentially lead to repeated alarms and shutdowns of the Stimulator and possible

induction of unintended life-threatening arrhythmias during delivery of RF ablation energy.

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.

Page 12

EPS320 Service Manual

General Precautions in Handling the EPS320 Stimulator

Caution: Installation, Transport and Storage.

To ensure reliable operation of the Stimulator, install away from dust, excessive heat or

humidity, direct sunlight and splashing liquids and in a well-ventilated place.

To ensure that operator may see important error messages displayed during operation,

install the Stimulus Generator Unit with the front panel visible to the operator.

To avoid damage to the Stimulator, avoid exposure to chemical gases, excessive vibration,

impact, temperatures above 60 ºC or ambient air pressures less than 500 hPa during

transport and handling.

To ensure that backup battery remains fully charged, store Stimulator between uses with

the Stimulus Generator Unit connected to isolated mains power supply, switched on at the

rear panel switch (Mains Power green Led should blink) and in the Standby Mode .

Caution: Precautions prior to use.

Ensure that all cables are free from defects, are properly installed and secured.

Ensure isolation of the mains power supply to the Stimulator and that no newly attached

equipment is compromising the electrical safety of the installation.

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 and check that Emergency Backup Fixed Pacing and the

stimulator functions correctly.

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 and Emergency Fixed Rate Pacing modes, and knows how to bypass any

third party switching apparatus to maintain pacing capability in case of failure of that

apparatus.

To prevent EPS320 software malfunction, do not attempt to install drivers, utilities or

software into the EPS320 PC other than that supplied by Micropace. The EPS320 software

will not execute if Terminate and Stay Resident (TSR) programs are detected by the

software.

Caution: Precautions during use.

Observe the Stimulator and patient at all times for abnormal function and rectify any

problem promptly or disconnect the patient from the Stimulator (by unplugging the green

Pace Output plug on the front panel).

Do not use the Stimulator and disconnect it from the patient if it repeatedly switches to

Backup Manual mode or repeatedly displays error messages on the front panel. Contact

your Micropace Distributor.

Use of excessive stimulation currents increases potential for induction of fibrillation, which

may be harmful to the patient and may be prognostically non-specific in ventricular

stimulation studies.

To ensure reliable pacing capture, the user must establish pacing current thresholds for

electrode catheters, including RF ablation catheters, prior to diagnostic stimulation studies

and set pacing current accordingly. Pacing thresholds, impedance and sensing

characteristics may differ amongst various diagnostic and RF Ablation electrode catheters

due to differing electrode geometries and associated electrical pathways.

To reduce chance of accidentally inducing ventricular fibrillation, ensure reliable ECG

sensing and use Synch-to-QRS function to avoid stimulating in the vulnerable diastolic

period where appropriate.

Caution: The Stimulus Generator Unit should be charging its backup battery while not in

use.

Page 13

The EPS320 Stimulator should be connected to external power; its Power switched on at

the rear panel switch and in the Standby Mode while not in use to ensure that backup

battery remains fully charged.

The Stimulator should be maintained according to “Maintenance” section of this manual.

Adverse Events

Observed Adverse Events

The EPS320 produces standard cardiac stimulation outputs similar to other existing programmable

cardiac stimulators in use for the past 30 years. The standard pulse output characteristics are well

defined in standard Electrophysiology texts and the application, safety and clinical efficacy of this

group of devices is well established in the medical field (2,3). and in one recent review by McLaughlin

et al (4).

Report of adverse events related to EPS320 arises from the following clinical experience with the

product subject to product vigilance (device exposure estimated by adopting an estimate of 14

patients per stimulator per month of use, each patient exposed for an estimated mean time of 2.5

hours)

Clinical use of the device in its evolving form since January 1998, evaluated in October 1999 by a

survey of 6 clinicians using 6 Stimulators with an accrued clinical experience with the product on

more than 1600 patients

A prospective field trial of safety and efficacy of the EPS320 performed in May to July 1999

concurrently at 4 hospitals in Sydney, involving 6 Stimulators / cardiologist users and a

total of 23 patients.

Clinical use of the EPS320 in Australia and Southeast Asia from July 1999 to October

2001, involving 22 Stimulators and an estimated 7400 patients.

Clinical use of the EPS320 in EC countries from January 2001 to October 2001, consisting

of 17 Stimulators accumulating clinical exposure to an estimated 2400 patients.

The EPS320 Stimulator has thus been used on an estimated total of 10,000 patients,

approximately half using the current firmware version, leading to an estimated device exposure of

25,000 hours.

No deaths or injuries related to the use of the EPS320 Stimulator have been reported during the

device exposure.

Two adverse events were reported, both due to device interaction with an RF Ablation Generator.

They were non-sustained Ventricular arrhythmias arising when operators simultaneously paced

and delivered RF ablation energy through the same ablation electrode; the EPS320 Stimulator

detected the interaction and shut down in both cases. Device interaction has been eliminated in the

field by the issue of a Safety Alert warning against this application and the addition of RF filters to

Stimulator’s Stimulus Connection Box to isolate Stimulator from RF signals.

Page 14

EPS320 Service Manual

Potential Adverse Events

Following is a list of potential adverse events which could be directly associated with diagnostic

cardiac stimulation using the EPS320 during electrophysiological studies (in alphabetical order):

Bradycardia or asystole

Should a patient develop bradycardia or asystole during the use of the Stimulator,

failure to promptly backup pace the patient may lead to hypotensive injury within

seconds to minutes. Such arrhythmia may typically occur (i) in patients with atrioventricular conduction defects, (ii) during placement of intra-cardiac electrode

catheters, (iii) after cardioversion/defibrillation or (iv) during RF ablation.

The Stimulator may fail to normally deliver stimuli due to (i) power failure or power

interruption, (ii) failure of PC, (iii) loss of communication between PC and Stimulus

Generator Unit (SGU), e.g. due to lead disconnection or (iv) failure of SGU itself due to

spontaneous fault or damage from external events such as defibrillation of RF ablation

energies.

To avoid patient injury, the user may use the battery powered Backup Manual Pace

mode in case of power failure, failure of PC or the communication link, and the

Emergency Fixed Pacing mode in case of failure of normal operation of the SGU. The

EPS320 Stimulator is not a life-support device; these functions are for use in non-lifethreatening bradycardia or until external temporary pacing is established in case of

asystole. Refer to “The EPS320 Stimulus Generator Unit” section below for instructions

on the use of these features.

DC voltages greater than 5000V or RF voltages greater than 350V pp applied to

Stimulator outputs may cause circuit failure; the Stimulator issues a range of alarms in

case of failure of output circuits – see Section “Hardware Error Messages on the

Stimulus Generator Unit.”

Explosion or fire

Explosion could arise from accumulation and ignition of explosive gasses vented from

charging of the backup battery within the Stimulator. Use Stimulator only in well

ventilated areas.

Explosion could also arise from electrical sparks within the Stimulator igniting explosive

anaesthetic gasses in the operating room. Do not use Stimulator in the presence of

volatile anaesthetic gasses.

Continuous RF voltages greater than 350V pp applied to Stimulator outputs in

contravention of labeling may cause overheating of the Stimulus Connection Box and

possibly cause a fire hazard. Similar hazards would probably be present in other

equipment with over-voltage protection. Special care will be required should RF

generators capable of delivering such voltages (corresponding to in excess of 150W

into 300 Ohm load) become available.

Myocardial injury

Excessive current flows through intra-cardiac electrodes, such as due to failure of

Stimulator output circuit causing excessive stimulation currents and inadvertent

shunting of defibrillation or RF ablation energies through a malfunctioning Stimulator

or equipment attached to its outputs could theoretically cause localized myocardial

damage at the pacing electrode.

In order to minimize risk of myocardial injury, connect EPS320 Stimulator stimulation

outputs only to legally marketed medical equipment compliant with IEC60601-1 and

IEC60601-1-1, and if error messages appear on the SGU, consult the section

“Hardware Error Messages on the Stimulus Generator Unit.” prior to using the

Stimulator again.

Operator electrocution

The EPS320 Stimulator auxiliary signal input/output ports and RS232 communications

port are optically isolated from patient circuits, but connect directly to Stimulator signal

ground plane, in accordance with IEC60601-1. Connection of these ports to equipment

Page 15

without appropriate mains isolation or protective grounding may cause electrocution of

the operator by mains-derived AC current in case of malfunction in the connected

equipment.

In order to minimize risk of electrocution to the operator, connect EPS320 Stimulator

input/output ports only to legally marketed medical equipment, isolated from mains

power and compliant with IEC60601-1 and IEC60601-1-1.

Ventricular tachycardia or fibrillation

The EPS320 Stimulator may be used to intentionally induce ventricular or atrial

arrhythmias including ventricular tachycardia and fibrillation. Causes of inadvertent

induction of such arrhythmias includes operator error, Stimulator malfunction and

device interactions:

(i) Myocardial stimulation with DC current.

Myocardial stimulation with DC current is likely to cause arrhythmias, including

intractable ventricular fibrillation (if operator is unaware of the fault and does not

remove the source from the patient, ventricular fibrillation may repeatedly recur

after defibrillation, possibly leading to patient death). DC current flow in the

stimulation circuit loop, may potentially be caused by Stimulator output circuit

failure, failure in other third party equipment inserted in the stimulation circuit loop

or device interaction between interconnected equipment. Should the EPS320

detect such a condition a DC-ERROR alarm is issued, (_,d,c,_,E,r,r )displayed on

SGU front panel and DC-ERROR alarm message on the computer), followed by a

safe state shut down of the Stimulator. Refer to section “Hardware Error Messages

on the Stimulus Generator Unit” below for instructions in this case. Regardless of

Stimulator alarm state, recurrent unexplained ventricular fibrillation should prompt

user to immediately disconnect the patient from the stimulation circuit, preferably at

the intracardiac electrode catheter connectors.

(ii) Intended cardiac stimulation in the vulnerable diastolic cardiac period

User should ensure that ECG sensing by the Stimulator is reliable and always use

the Synch-to-QRS function to avoid stimulating in the vulnerable diastolic period,

where appropriate. External amplified ECG signal is the recommended source of

ECG, however, where external ECG source is not available or unreliable, the

EPS320 may be configured to sense intra-cardiac ECG from either of the

stimulation output channels.

(iii) Inappropriately rapid cardiac stimulation

Cardiac stimulation at rapid intervals, typically less than 300 ms, may cause

undesirable arrhythmias including ventricular fibrillation. Inadvertent rapid

stimulation, may occur either through user error, inappropriate Stimulator software

safety parameter configuration or Stimulator hardware or software malfunction.

The Stimulator’s SGU monitors for unprogrammed rapid stimulation and if

detected, issues a Rate Error alarm, followed by a shut down safety state. Monitor

the Stimulator function, patient’s ECG and observe the patient continuously for

unexpected behaviour whenever patient is connected to the Stimulator; disconnect

the patient from the Stimulator and do not use if abnormal stimulation is observed.

(iv) Unprogrammed isolated stimulation pulses

Unintended cardiac stimulation with isolated stimulation pulses may cause

undesirable arrhythmias including ventricular fibrillation. Isolated stimulation pulses

may potentially occur due to Stimulator hardware or software malfunction. The

Stimulator’s SGU monitor detects unprogrammed stimulus pulses occurring within

300 ms of another stimulus pulse and issues a Rate Error alarm, followed by a

shut down safety state. Monitor the Stimulator function, patient’s ECG and observe

the patient continuously for unexpected behaviour whenever patient is connected

to the Stimulator; disconnect the patient from the Stimulator and do not use if

abnormal stimulation is observed.

(v) Mains derived AC current microshock

Page 16

EPS320 Service Manual

Mains derived AC leakage currents to ground may cause patient microshock

leading to arrhythmias, including intractable ventricular fibrillation. AC leakage

currents may potentially arise from a malfunction in the EPS320 Stimulator or

connected third party equipment if the mains power supply is not isolated in all

interconnected equipment. Ensure that the EPS320 Stimulator system, including

the PC and all connected third party equipment is connected only to isolated mains

power supply.

Adverse events which may be directly associated with diagnostic cardiac stimulation during

electrophysiological studies (in alphabetical order):

Arrhythmias

Death

Temporary chest pain

Adverse events may occur arising from use of third party equipment attached to the EPS320

Stimulator during EP studies. Refer to User Instructions for such third party equipment for

warnings, precautions and lists of adverse events.

Page 17

4 OVERVIEW OF STIMULATOR SYSTEM

4.1 General

The Micropace EPS320 is a programmable external cardiac pacemaker used in

electrophysiological studies. The device features two independent fully programmable and isolated

constant current stimulator channels used to pace the heart temporarily via transvenous

intracardiac electrodes.

The EPS320 system consists of a manufactured instrument case containing the Stimulus

Generator Unit (SGU) connected to and controlled by a Personal Computer (PC) via a serial

RS232 interface. A Stimulus Box connected to the SGU output is used to interface the stimulus

output to third party transvenous pacing electrodes and to filter out any unwanted electrical

interference. The transvenous electrodes are not part of the EPS320; they are a disposable

medical product.

Normal operation of the EPS320 SGU is under control of software running on the attached PC

which sends specific real-time commands to generate pacing pulses and control the associated

functions (see the software description for more details). In case of software or communication

failure, the SGU can operate independently in the Manual Backup mode, capable of providing

constant pacing at a rate and pulse current displayed on and programmable from the SGU's front

panel. A secondary backup facility is available, the Emergency Fixed Backup mode, which is a

completely separate analogue circuit pacemaker, powered by a ultra-long life battery, capable of

providing a fixed pacing train at 500 ms, 5mA and 2ms pulse width.

The two isolated outputs will deliver pulse widths from 0.5ms to 10ms, adjusted in 1ms steps. The

current amplitude can be adjusted from 0.1mA to 25mA in steps of 0.1mA. The maximum available

output voltage is 26V, so the maximum output pulse current will be less than 25mA for load

impedance greater than 1kΩ.

4.2 Hardware Overview

The EPS320 stimulator system:

•

A computer with power supply (CPU and separate Display as shown or all-in-one PC)

Stimulus Generator Unit (SGU)

Mains Isolation Transformer

15VDC power supply unit

Patient Connection Box

Auxiliary cables for connection to an EPS recording system

Various power cables as shown

Page 18

EPS320 Service Manual

Figure 1 EPS Stimulator System

Page 19

5 PRINCIPLES OF OPERATION

5.1 Background Information

The EPS 320 cardiac stimulator is a 2 channel constant current stimulator designed for delivery of

complex sequence of cardiac pacing stimuli for the purpose of clinical electrophysiological testing

of the human heart. Pacing stimuli are delivered to the heart by a third party transvenous pacing

electrode. The stimulator is a class 2B medical device according to MDD classification and class III

medical device according to FDA classification.

The stimulus parameters and timing sequences are programmed by the operator on the computer

which issues commands to the microprocessor controlled Stimulus Generation Unit at the

appropriate time. Stimulus protocols include simple constant rate stimulation, decremental

stimulation with ever decreasing inter-stimulus interval, single extra stimulus consisting of a drive

train of eight (8) constant interval stimuli followed by one (1) extra stimulus with progressively

decreasing coupling interval. More than one (1) extra stimuli may be called upon to be delivered

with or without synchronization with the cardiac intrinsic rhythm. In the VT induction protocol up to

six (6) independently timed extra stimuli are given at close coupling intervals to determine if the

heart can be provoked into abnormal ventricular arrhythmias. Potentially dangerous rhythms are

routinely induced in patients during these studies and external DC cardioversion or defibrillation is

frequently performed. Despite the frequent such rhythms and the frequent severe ill health of

patients undergoing the test, electrophysiological studies performed by trained personnel are

remarkably safe with expected death rates of approximately one (1) in 5000 studies.

What is an Electrophysiological Study?

Electrophysiological studies are diagnostic tests performed to investigate patients with complaints

of palpitations, fainting or resuscitated from sudden death. The information obtained from these

studies aids in clinical decisions regarding therapy, which may include drug, radio-frequency

ablation or implantation of an implantable defibrillator.

What is a Pacing Stimulus?

The heart may be electrically stimulated to contract by an electrical pulse if the current-duration

product exceeds the pacing threshold for that part. Pacing threshold may vary due to presence of

heart disease, drug therapy and depend heavily on the site of the stimulation within the heart.

Stimuli less than 0.03ms and less than 0.1mA generally do not produce cardiac depolarization

(myocardial capture). The usual pacing pulse parameters in the EPS laboratory are 2ms in

duration and applied from a constant current source at 0.1-5.0mA. Normal satisfactory pacing

threshold is less than 1.0mA for the ventricle and less than 1.5mA for the atrium. Current

amplitudes of up to 20mA may be required for patients with severe heart disease or in emergency

situations. Pacing impedance varies from 300-100 Ω and thus the constant current source must be

able to supply up to 20 volts to deliver 20mA into 1kΩ resistance. The EPS 320 delivers up to

25mA. Certain specialized applications such as transoesophageal stimulation require wider pulse

width.

Cardiac capture depends on pulse strength-duration product and thus is not sensitive to the shape

of the waveform, which should be approximately square with little effect from ringing, damping or

noise. Whereas chronic pacing arguably benefits from a biphasic pacing pulse, the application of

a small reverse polarity between pacing spikes prevent myocardial polarization, this is not an issue

in short term pacing involved in EPS studies and thus the pulse may be entirely positive. The

pacing electrode tip should be negative with respect to the reference electrode. Pacing during EPS

studies is usually bipolar. The current amplitude has modest accuracy requirements - stimulation is

usually performed in steps of 0.1mA up to 1mA, steps of 0.2mA up to 5mA and in 1mA steps up to

25mA.

Page 20

EPS320 Service Manual

Stimulation rates are typically 230ms to 700ms but may on occasion be as rapid as 100ms. Pacing

duration is typically from 1 second up to 1 minute. Extra stimulus coupling intervals vary typically

from 300 to 100ms but may be as short as 50ms.

5.2 System Functional Description

The EPS320 Stimulator is made up of two main components described below and illustrated in

Figure 2:

1. Desktop IBM compatible Computer (PC):

This computer executes a DOS

program with a windows-like graphical

user interface using the keyboard as

the only user input. The software

generates each stimulus by sending a

serial command to the Stimulus

Generation Unit to initiate a stimulus

pulse. Stimulus parameters may be

altered any time between stimuli by

other specific serial commands. Since

the PC software programs each

stimulus one at a time, its parameters

and its timing may be altered by the

user at any time prior to the actual

occurrence of the stimulus pulse,

affording the user the desired control

over stimulation at all times, as one

would have with most hardware

stimulators.

Monitor

Stimulus

Output:

Atrium &

Ventricle

Channels

COM1

EPS320

STIMULUS

GENERATOR

UNIT (SGU)

Computer

Emergency

Pace

Output

Auxiliary

Port

ECG1 In

15 VDC

Sync1 Out

Power Supply

110-240VAC-15V

Front Panel Display/ Keys

Figure 2 EPS320 Stimulator main components

2. Stimulus Generation Unit (SGU):

The Stimulus Generation Unit contains a PIC16C77 µP and two optically isolated digitally

programmable constant current generators. Channel 0 is labeled and intended for pacing the

atrium and Channel 1 the ventricle, although they are electrically identically. The µP firmware

normally operates in one of two user modes:

(i)

(ii)

(iii)

In the Manual Backup mode, the Stimulus Generation Unit operates independently of the

PC, and is capable of generating regular pacing stimuli (always 2ms wide pulses into both

channels) at amplitudes and intervals adjustable by buttons

And displayed by 7-segment LED displays on the front panel. This mode is intended for

backup use only in the rare instance of the failure of the PC or its software at a time when

the patient urgently requires pacing.

In the PC Control mode, the Stimulus Generation Unit communicates with the PC via a

19,200-baud asynchronous serial link. Transmission takes place in three 8 bit word

'command strings', the 1 word the ‘frame’, 2 word ‘command’ and 3 word ‘data’. The

PC transmits to the Stimulus Generation Unit a watchdog command string every 47ms and

at other times any command strings produced by software logic or operator actions. The

Stimulus Generation Unit transmits to the PC a command string every 2ms with every

second transmission containing either an embedded 8 bit ECG data or status report word.

The Stimulus Generation Unit returns four words containing measured stimulus data after

executing each stimulus command from the PC. In case of communications failure, the PC

computer is able to reset the Stimulus Generation Unit microprocessor by raising the DTR

line in the RS232 port, which is wired to the microprocessor master reset.

Page 21

The isolated current generators consists of an 8 bit D to A converter with 0.1% voltage references

programming an operational amplifier capable of a 27V output swing and configured as a constant

current generator. Output current is DC coupled to the patient with multiple safeguards against

delivery of constant DC current. An 8 channel 8 bit A to D converter monitors output current and

voltage in addition to amplified ECG from catheter tip with 4 programmable gains. An analogue

peak detector also generates QRS-detected pulses. Digital converters communicate with the

microprocessor via optocoupled serial links using the SPI (serial peripheral interface) protocol. A

relay in the output circuit can shunt the output with a 1kΩ resistor for testing and self-calibration

which occurs on every power-up. The isolated channels are powered by a 2 watt 5kV isolated DC

to DC converter (Newport) which can be turned off by either a microprocessor command in the

case of a detected fault in the isolated channel or by a watchdog timer in the case of a

microprocessor failure.

In the case of communication failure with the PC, the microprocessor automatically changes to

Backup Manual mode and engages the front panel 7 segment LED displays and push buttons

enabling operator to program pacing current and interval. A second emergency backup channel is

provided in case of failure of microprocessor within the Stimulus Generation Unit. This is an

entirely independent circuit consisting of a 9V lithium manganese battery, an analogue multivibrator circuit and a fixed current source circuit for production of pacing stimuli. An extremely low

power monitoring circuit detects the connection of a load resistance to the output of this channel

and turns power on to the pacing circuit providing immediate fixed rate and current pacing at a

fixed 100 pulses per minute, 5mA amplitude and pulse a width of 2ms. Expected battery life is

equal to its shelf life of 10 years. The computer monitors approximate condition of this battery via

optocouplers.

The Stimulus Generation Unit hardware consists of one (1) main board and one (1) display board

located behind the front panel. The PCB’s are two layer, surface-mount and through-hole

component populated boards containing approximately 650 components. The Stimulus Generation

Unit is powered by an external 14.5VDC to 15.0VDC (at 750mA) power supply unit (PSU). This is

used to trickle charge the backup battery and supply three 5V regulated power networks (the latter

two may be switched off during stand-by mode):

(i)

(ii)

(iii)

Microcontroller power,

General circuit power

DC to DC converter power.

Electromagnetic emissions and susceptibility (EMC) compliance is achieved by use of surface

mount components (SMD), good PCB layout using separate grounds for digital, analogue and I/O

circuits with star grounding points, slow microprocessor speed of 8MHz, inductors and capacitors

on all interfaces and shielding of external cables. Note that the enclosure is not

electromagnetically sealed as this was found not to be required.

Page 22

EPS320 Service Manual

6 EPS320 Specifications:

vii. Protocol Automation

i. Computer

CPU:

VIA-Eden ESP 566 MHz or similar

Weight: 4.2 kg, with monitor and keyboard

Dimension:

234x48x175 mm, 15” Monitor, 101

Keyboard

Hard Disk:

64Mb CompactFlash Card

Power Source:

100-240VAC to 12V DC 5.0A PSU

(via isolation transformer)

O/S Software:

Non-windows custom RTOS

ii. Stimulus Generator Unit

Main power source: 100-240VAC to 15 VDC 2 A PSU

Backup power:

12V 2.1 Ah sealed lead acid

Emergency power: 9V LiMnO2i PP3, 10y life

Weight: 5.3 kg including batteries, PSU

Dimensions:

31.5cm x 34.0 cm x 9.5cm

Power Consumption: 800 mA peak during operation

40 mA in standby mode

Operating Time:

Indefinite with mains connected

Two(2) hours on backup battery

iii. Pacing Channels

Isolated Channels(3): (i) Atrial and (ii) Ventricular via green

Redel 4 pin socket

(iii) Emergency Fixed Pace Output to Ventricle,

via red Redel 4 pin socket

Power Source:

Internal DC-DC converters

Circuit Isolation:

Compliant with AS3200 /IEC601,

5kV, common, differential modes

iv. Computer Controlled Stimulus Pulses

Current: 0.1 to 25 mA

Current Steps:

0.1 mA

Accuracy: ± 2% or ± 0.2 mA, which ever is greater

Pulse Duration:

0.5 ms, 1-10 ms in steps of 1ms

Accuracy: ± 0.15 ms

Load Impedance:

700 Ω max, for max current

Max Output Voltage: 27V

v. Inter-stimulus Intervals

S1 Range:

180 - 9990 ms(Pace)

30 - 9990 ms (Burst Pace)

Stability: Quartz computer clock,

± 30 parts per million @ 25 C

Extra-Stimuli:

6 max, S2-S7, independent

Coupling interval:

30 - 9990 ms,

Accuracy ± 1 ms or 0.1% whichever is greater

vi. Pre-programmed Protocols

♦

Stimulation Threshold ♦ Wenckebach Periods

Anterograde/Retrograde ♦ Programmed V Stimulation

SN Recovery Times

♦ Burst Pacing (to 30ms)

SN Conduction Times ♦ Auto-decremental Pacing

His-coincident extras

♦ AV sequential Pacing

Overdrive Pacing

♦ Combined AV drive-train

AICD-type ATP

♦ AF/VF induction

EPS320 Device Specifications Ver 2.4, 4.8.04

♦

Auto decrement / increment: S1, S2-S7,stim current

SNRT S1 intervals and RT calculation

Auto pace and sense - site selection in protocols

His-coincident extra-stimulus timing calculation

ATP S1 calculation from % of TCL

Trigger output on sensed ectopic beats

All automation subject to instant operator adjustment

viii. Backup Manually Controlled Stimulation

Power Source:

12V 2.1Ah sealed lead acid

battery

Pulse Current:

0.1 to 25mA

Accuracy: ± 2%, or ± 0.2mA which ever is greater

Pulse Duration:

2ms, fixed

Pulse Interval:

100 - 1400ms, accuracy:+1%

ix. ECG Sense/Trigger

High level external Two inputs:

Connector:

Input Ranges:

Maximum Input:

Frequency Range:

Pacing catheter tip Two channels:

Input ranges:

Frequency Range:

Either Source Threshold:

Lockout Period:

Pace Sync Delay:

Sampling- display:

(i) Ext_ECG1, (ii) Ext_ECG2,

6.5mm Phone socket

1V and 2V

2V AC pk - pk

1 to 250 Hz, typical

(i) Atrial, (ii) Ventricular

2mV to 36mV, 4 gains

30 to 250 Hz, typical

Adaptive software peak detect

50 - 1000ms in software

50 - 5000ms in software

500Hz, 8 bit

x. Auxiliary Sync Inputs/Outputs

Sync1 Output:

6.5 mm Phone socket

Timing: On any drive train pulse, on halt of pacing,

on extra in R-synced S2

Pulse: +5V CMOS level, 50 ms duration

Sync2 & 3 Output:

Used for internal functions

Sync1 & 2 Input:

Used for internal functions

xi Emergency Backup Pacing

Power Source:

9V Lithium Manganese PP3

battery, 10 years life

Pacing Pulse:

5mA +1.0 mA, 2ms + 0.5ms, 100

bpm

Pace output:

Separate red Redel 4 pin socket

Control: Pacing activated by connection of a load

<1MΩ, i.e. insertion of plug

connected to patient

xii Certification

MDD Device Class:

IEC60601-1

EMC compliance

CE Marking

US Regulations

Class IIb

certified

510(k) Accepted

Notes: 1. Specifications may change without notice

2. Computer specifications will vary according to

availability

Page 23

7 DESCRIPTION OF SYSTEM COMPONENTS

The EPS320 is always powered through an isolation transformer normally connects to a patient

through an external third party EP Recording System, such as the Bard Duo TM via stimulus (and

possibly trigger) output connectors and External ECG input cables.

7.1 System Configuration Options

There are four EPS320 Configurations, according to the computer used and mains power supply:

Configuration

Description

EPS320

First international configuration. Contains a Leo Aries III Model LS523

Moniputer 15" Pentium 75MHz All-in-one PC, for 220-240 VAC mains

supply.

EPS320N

Contains NEC Powermate 2000, Intel Celeron 433 MHz all-in-one PC,

with 15 inch Active TFT LCD Screen, for 110-120VAC mains supply.

EPS320H-US

Contains HP eVectra Intel Pentium III/733MHz Mini PC and NEC MultiSync LCD1530V (or LCD1540V) active TFT LCD display screen for 110120VAC mains supply

EPS320H-EU

As for EPS320H-US, but for 220-240VAC mains supply.

EPS320B-EU

Bona Light PC, NEC Multi-Sync LCD 1560V, 220-240VAC mains supply

EPS320B-US

Bona Light PC, NEC Multi-Sync LCD 1560V, 110-120VAC mains supply

Page 24

EPS320 Service Manual

EPS320B-US STIMULATOR & PC CARTON

Item

Torema Transformer Isolation, 110-120 VAC, 300VA

Keyboard with key labels Ver2.2 for Software 3.19

Accessories Box:

Isolated Mains Power Lead, IEC 3 to 2 Pin- US

Style

Stimulus Connection Box with RF Filter

Serial Boost Cable, Serial RS232

Isolation Transformer Power Lead, according to customer

country

Isolated Mains Power Lead IEC 3 to 3 Pin – US Style

Signal Cable, with Phone Plugs

Hipower Switched Mode 15.0 VDC 1 A Power Supply for

SGU

Accessories Booklet

Installation Kit:

Phone Plug – RCA socket adapter

RCA Plug – BNC socket adapter

Test LED, Yellow/Red

Fuses, 4A Semi-delay HBC M205

Cable tie

Cable tie adhesive anchor

Stimulus Generator Unit

Bona Light PC Computer

Power Supply for Bona Light PC

Documentation:

User Instruction Manual

Installation Procedure Booklet

Manufacturer’s Test Certificate

MS DOS6.22 Operating System Software License

Summary of Hotkeys

Part No.

MP3001US

MP3016

MP3055

MP3066US

Qty

MP3014

MP3033A

MP3059_

MP3030US

MP3034

MP3074

MP3064US

MP3063US

MP3056

MP3057

MP3058

MP3068US

MP3039

MP3061

MP3008

MP3093

MP3099

MP3036US

MP3069

MP3067

Part No.

LCD51V

MP3030US

Qty

NEC LCD Sceen Carton

Item

LCD Display (Micropace Part No. MP3076)

Video Signal Cable (Part of Micropace No. MP3076)

NEC LCD Screen Instruction Manual

Isolated Mains Power Lead, (IEC 3 to 3 pin) US Style

Page 25

7.2 Power Requirements

The PC must be powered from mains power via a mains-isolation transformer (Part No. MP3001 or

MP3001US) supplied with the system.

The Stimulus Generation Box is powered from a low voltage power supply, 14.5VDC for EU

(MP3002) or 15.0VDC (MP3074) for the US markets, rated at 750mA or higher. These power

supplies are double insulated and are to be powered only from the isolation transformer.

The Stimulus Generation Unit contains a backup sealed lead acid gel maintenance free 12 volt

2.1Ah battery in case of failure of mains power supply. The battery is float charged to 14.1V and

has an expected life span of five years. The battery is charged at all times when the MAINS

POWER light is lit green (unit on) or is flashing green (unit on Standby). It is NOT being charged

when the MAINS POWER light is glowing yellow (External Power available, SGU power

switched off) or not lit (no external power).

The EPS320 Cardiac stimulator system Power ratings are as follows:

Item

EU Low Voltage Transformer

Part no. MP3002

Mains Isolation Transformer

Part no. MP3001

US Low Voltage Transformer

Part no MP3074

US Mains Isolation

Transformer

Part no. MP3001US

Input Volts

220-240VAC

Output Volts

14.5@ 0.75A

Output VA

11 VA

220-240VAC

400VA

90-264 VAC

15V @ 2.4A

36 VA

100-120VAC

400VA

Item

Stimulus Generation Unit

Part no. MP3008

Computer + Monitor

Input Volts

14.5-18VDC, 750 mA

110-240VAC

The Emergency Fixed Rate Pacing channel is powered from a 9V Lithium/Manganese Dioxide

1200mAh PP3 style battery. This battery has a 10 year shelf life and will power the emergency

circuit for a minimum of two hours of continuous operation if pacing was commenced with green

battery OK LED lit.

Note that if the SGU has external power disconnected, while switched on or in the backup mode

(green Power LED blinking), a short beep is emitted by the SGU every few seconds to alert staff to

switch unit off completely. This is helpful particularly in laboratories where equipment is on a trolley

and gets disconnected and stored between EPS cases.

7.3 System Interconnection

The EPS320 is always powered through an isolation transformer normally normally connects to a

patient through an external third party EP Recording System, such as the Bard Duo TM via stimulus

(and possibly trigger) output connectors and Ext ECG input cables. Figure 3 shows a typical

installation of the stimulator.

Please refer to the full Installation Procedure supplied in the Distributor Handbook,

InstallProcedure.doc for details of installation.

MicroPace

Cardiac Stimulators

EPS320 Cardiac Stimulator Service Manual ver 1.4

Available for download in the BioClinical Services library

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