eps320b_and_bt_cardiac_stimulator_user_instruction_.pdf
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USER INSTRUCTION MANUAL
Micropace Cardiac Stimulators
EPS320B/BT
StimCor™
StimLab™
ENGLISH
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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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USER INSTRUCTION MANUAL
Table of Contents
1 INTRODUCTION & ESSENTIAL PRESCRIBING INFORMATION .................................................1
1.1 DEVICE DESCRIPTION............................................................................................................... 1
1.1.1 Description of Stimulator .................................................................................................1
1.1.2 Accompanying Documentation ........................................................................................1
1.1.3 Intended Use...................................................................................................................1
1.1.4 Indications for Use ..........................................................................................................1
1.1.5 Operating Environment....................................................................................................1
1.1.6 Contraindications ............................................................................................................2
1.2 COMPATIBLE EQUIPMENT ......................................................................................................... 2
1.3 IMPORTANT PATIENT SAFETY WARNINGS ................................................................................... 2
1.3.1 General Warning .............................................................................................................2
1.3.2 Warnings Specific to the Micropace Stimulator ................................................................3
1.3.3 Warnings Related to the use of Micropace Stimulator with RF Ablation Equipment ..........3
1.4 GENERAL PRECAUTIONS IN HANDLING STIMULATOR .................................................................... 4
2 DEVICE RATINGS, CLASSIFICATION AND CERTIFICATION .....................................................6
3 COPYRIGHT, WARRANTY AND DISCLAIMER NOTICE ..............................................................7
4 EXPLANATION OF SYMBOLS .....................................................................................................8
5 EPS320 FAMILY OF CARDIAC STIMULATORS.........................................................................13
5.1 DESCRIPTION OF STIMULATOR FAMILY ..................................................................................... 13
6 EPS320B/BT CONFIGURATION .................................................................................................14
6.1 DESCRIPTION OF SYSTEM ....................................................................................................... 14
6.2 SYSTEM COMPONENTS........................................................................................................... 14
6.3 EPS320B/BT OPTIONAL INSTALLATION ACCESSORIES .............................................................. 17
7 STIMCOR™ CONFIGURATION ..................................................................................................18
7.1 DESCRIPTION OF SYSTEM ....................................................................................................... 18
7.2 HOW SUPPLIED ..................................................................................................................... 18
7.3 SYSTEM COMPONENTS........................................................................................................... 19
7.4 STIMCOR™ OPTIONAL INSTALLATION ACCESSORIES ................................................................. 19
8 STIMLAB™ CONFIGURATION ...................................................................................................20
8.1 DESCRIPTION OF SYSTEM ....................................................................................................... 20
8.2 HOW SUPPLIED ..................................................................................................................... 20
8.3 SYSTEM COMPONENTS........................................................................................................... 21
8.4 STIMLAB™ OPTIONAL INSTALLATION ACCESSORIES .................................................................. 22
9 INSTALLATION...........................................................................................................................22
10 USING THE MICROPACE CARDIAC STIMULATORS ................................................................23
10.1 CONNECTING THE STIMULUS CONNECTION BOX ........................................................................ 23
10.2 SWITCHING ON THE SYSTEM .................................................................................................... 23
10.3 USING THE COMPUTER ........................................................................................................... 23
10.4 SETTING UP THE COMPUTER ................................................................................................... 24
10.5 INDICATING LOCATION OF SGU ............................................................................................... 24
11 USING THE KEYBOARD AND THE TOUCH DISPLAY ..............................................................25
11.1.1 Numeric Keypad ............................................................................................................27
11.2 USING THE STIMLAB™ BEDSIDE CONTROLLER FEATURES ......................................................... 28
11.2.1 Input Device Control ......................................................................................................28
11.2.2 Local/Remote Indicator:.................................................................................................28
12 USING THE STIMULATOR SOFTWARE..................................................................................... 29
12.1 HELP FUNCTION .................................................................................................................... 29
12.2 TRAINING VIDEOS .................................................................................................................. 29
12.3 HELP SEARCH ....................................................................................................................... 29
12.4 THE MAIN STIMULATOR SCREEN ............................................................................................. 29
12.5 PACING PARAMETERS ............................................................................................................ 29
12.6 BASIC PACING ....................................................................................................................... 30
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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
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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
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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.
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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
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CARDIAC STIMULATOR
7.3
System Components
Figure 5 StimCor Quick Installation Guide
7.4
StimCor™ Optional Installation Accessories
Same as EPS320B/BT.
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