EPS320B/BT StimCor and StimLab User Instruction and Technical Manual

Distributed by:

GE Medical Systems Information Technologies 8200 West Tower Ave Milwaukee, WI 53223 U.S.A

Advena Ltd, Pure Offices, Plato EC REP Close, Warwick CV34 6WE UK 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. MP3395 Global Version English 1.7 Valid for: Stimulator Software version 3.21 SGU Firmware versions 4.76

Distributed in Japan by:

Medicon Inc. 2-5-8 Hiranocho, Chuo-ku, Osaka 541-0046, JAPAN Phone: +81-(6)-6203-6541 Fax: +81-(6)-6203-6448

Note for Japanese Market: Japanese configuration of EPS320B-J is shipped with a Isolation transformer approved for the Japan Market Part MP3001JUS, instead of the MP3107 Isolation Transformer. The Japanese reader should substitute MP3001JUS for every reference to MP3107 in this manual.

Micropace Cardiac Stimulators User Instruction Manual EPS320 & StimCor™ & StimLab™ Micropace Part Order No. MP3395 Global Version English 1.7 Valid for: Stimulator Software version 3.21 SGU Firmware versions 4.76

Distributed by: Boston Scientific Corporation One Boston Scientific Place, Natick, MA – 01760-1537 USA USA Customer Service 888-272-1001

AND

GE Medical Systems Information Technologies 8200 West Tower Ave Milwaukee, WI 53223 U.S.A

Advena Ltd, Pure Offices, Plato EC REP Close, Warwick CV34 6WE UK 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. MP3395 Global Version English 1.7 Valid for: Stimulator Software version 3.21 SGU Firmware versions 4.76

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...1 1.2 COMPATIBLE EQUIPMENT ...2 1.3 IMPORTANT PATIENT SAFETY W ARNINGS ...2 1.3.1 General Warning ...2 1.3.2 Warnings Specific to the Micropace Stimulator...4 1.3.3 Warnings Related to the use of Micropace Stimulator with RF Ablation Equipment ...4 1.4 GENERAL PRECAUTIONS IN HANDLING STIMULATOR ...5 1.5 ADVERSE EVENTS ...7 1.5.1 Observed Adverse Events...7 1.5.2 Potential Adverse Events ...8 1.6 SUMMARY OF EPS320 STIMULATOR FIELD TRIAL ...10 1.7 INDIVIDUALIZATION OF TREATMENT & PATIENT COUNSELING INFORMATION ...11 1.8 REFERENCES ...11 2 DEVICE RATINGS, CLASSIFICATION AND CERTIFICATION ...12 3 COPYRIGHT, WARRANTY AND DISCLAIMER NOTICE ...13 4 EXPLANATION OF SYMBOLS ...14 5 EPS320 FAMILY OF CARDIAC STIMULATORS ...18 5.1 DESCRIPTION OF SYSTEM...18 6 EPS320B/BT CONFIGURATION ...19 6.1 DESCRIPTION OF SYSTEM...19 6.2 PACKING LIST...19 6.3 EPS320B/BT INSTALLATION ...20 6.3.1 Unpack containers...20 6.3.2 Connect System Components...20 6.4 EPS320B/BT OPTIONAL ACCESSORIES ...24 7 STIMCOR™ CONFIGURATION ...25 7.1 DESCRIPTION OF SYSTEM...25 7.2 HOW SUPPLIED ...25 7.3 PACKING LIST...25 7.4 STIMCOR™ INSTALLATION...26 7.4.1 Installation of cables ...26 7.5 STIMCOR™ OPTIONAL ACCESSORIES ...27 8 STIMLAB™ CONFIGURATION...28 8.1 DESCRIPTION OF SYSTEM...28 8.2 HOW SUPPLIED ...28 8.3 PACKING LIST...29 8.4 STIMLAB™ INSTALLATION ...29 8.4.1 Technical Description ...29 8.4.2 Installation of cables ...30 8.5 STIMLAB™ OPTIONAL ACCESSORIES ...31 8.6 USING THE STIMLAB™ BEDSIDE CONTROLLER FEATURES ...33 8.6.1 Input Device Control ...33 8.6.2 Local/Remote Indicator:...34 8.6.3 Touch Screen Availability Indication...34 8.6.4 Always Active keys ...34 9 USING THE MICROPACE CARDIAC STIMULATORS ...35

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9.1 9.2 9.3 9.4

CONNECTING THE STIMULUS CONNECTION BOX ...35 SWITCHING ON THE SYSTEM ...35 USING THE COMPUTER ...36 SETTING UP THE COMPUTER...36

10 VERIFYING THE SYSTEM ...38 10.1 TRAIN CUSTOMER ...38 10.2 MAKE RECORD ...39 10.3 MICROPACE INSTALLATION CHECKLIST ...40 11 USING THE KEYBOARD AND THE TOUCH DISPLAY ...41 11.1.1 Numeric Keypad & Mouse control...43 12 USING THE STIMULATOR SOFTWARE ...44 12.1 HELP FUNCTION ...44 12.2 TRAINING VIDEOS ...44 12.3 HELP SEARCH ...45 12.4 THE MAIN STIMULATOR SCREEN ...45 12.5 PACING PARAMETERS...45 12.6 BASIC PACING ...46 12.7 OVERVIEW OF THE STIMULATOR SOFTWARE ...47 12.8 STIMULATION PARAMETERS ...50 12.8.1 Current...50 12.8.2 Duration ...50 12.8.3 Train...50 12.8.4 Decrement ...51 12.8.5 Sync-to ...51 12.8.6 Pace Mode ...51 12.8.7 S1 Parameter ...52 12.8.8 S2-S7 Parameter...52 12.8.9 Pause Parameter...53 12.8.10 Pace Site ...54 12.8.11 ECG Sense Site ...55 12.8.12 QRS Detect Menu ...56 12.9 PACE STATUS ...56 12.9.1 Sense Site ...56 12.9.2 RR Measurement ...56 12.9.3 Impedance measurement...56 12.9.4 ECG Display Bar ...56 12.10 PACING PROTOCOLS ...57 12.10.1 Protocol Selection & Renaming...57 12.10.2 Pace Protocols ...58 12.10.3 Threshold Protocol ...58 12.10.4 Nodal_ERP Protocol...58 12.10.5 Multi_Sx Protocol...58 12.10.6 Wenckebach Protocol...59 12.10.7 RSynced_Sx Protocol...59 12.10.8 SNRT* Protocol ...59 12.10.9 Burst_Pace Protocol...59 12.10.10 AV Atrio-ventricular Delayed Protocol...60 12.10.11 Overdrive Pace and ATP Protocols ...60 12.10.12 Specialised Protocols...61 12.10.13 Trigger Sync output interfaces ...62 12.10.14 Saving Storing Stimulator Defaults ...62 12.10.15 Parameter persistence...62 12.11 SOFTWARE CONFIGURATION. ...63 12.12 SOUND CONFIGURATION ...63 12.13 SAFETY FEATURES ...64 12.14 SOFTWARE ERROR MESSAGES ...65 12.15 ADDITIONAL SOFTWARE MESSAGE ...66 12.15.1 Advisory Message ...66 12.15.2 Text Messages ...68

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Glossary and Terms Term

Explanation

Drive Train ECG

Electrocardiogram

EP

Electrophysiology

IECG

Intra-cardiac Electrocardiogram

LCD

Liquid Crystal Display

LED

Light Emitting Diode

P/QRS

P wave or QRS; also signifies any IECG waveform.

PC

Personal Computer

RA

Right Atrium

RV

Right Ventricle

RF

Radiofrequency, e.g. RF Ablation

RR

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

S1

Basic stimulation interval.

SGU SM-Box SNRT StimLink™

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

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

Sx

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

GUI

Graphical User Interface

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CARDIAC STIMULATOR

1 INTRODUCTION & ESSENTIAL PRESCRIBING INFORMATION 1.1

Device Description

1.1.1

Description of Stimulator

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

1.1.2

Accompanying Documentation

A reference package, comprising of a manual and a leaflet, is provided with the Cardiac Stimulator; a service manual is available on request. Included in the package are: q

User Instruction Manual / Technical Description (this document)

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.

1.1.3

Intended Use

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

1.1.4

Indications for Use

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

1.1.5

Operating Environment

The stimulator is intended for use in air conditioned hospital cardiac electrophysiology laboratories equipped for advanced cardiac resuscitation, by technicians trained in diagnostic cardiac stimulation under constant supervision by a cardiologist. Stimulator parts Remote Station MP3168 and connection boxes MP3086 and MP3014 may be used in the patient environment, but must be protected from ingress of fluids. Device is not intended for use with flammable gasses or 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 manual.Contraindications

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

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1.2

Compatible Equipment

The primary function of the Micropace Cardiac Stimulator is the generation of constant current rectangular stimulation pulses with amplitudes of 0.1mA to 25mA, duration of 0.5ms to 10ms and with a maximum voltage of ± 27V. Third party switching equipment with the following special characteristics must be used to carry the stimulus pulses to the intracardiac electrodes without significant distortion: q Series resistance: < 100 Ohms at up to ± 25mA q Shunt resistance: > 100,000 Ohms at up to ± 27V q Frequency bandwidth: DC to 300 Hz q 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 stimulator system’s Stimulus Connection Box. Subject to these requirements, the Micropace 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 Cordis Biosense Webster, Daig, CR Bard, Medtronic and EPT.

Ablation electrode catheters q

The EPS320 Cardiac Stimulator 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 q

TM

Computerized EP Recording systems manufactured by Bard Electrophysiology (LabSystem TM TM Duo and LS Pro ) and GE/Prucka (CardioLab 4000, 7000) have been tested for use with the EPS320 Stimulator.

RF Ablation Equipment q

1.3

RF ablation equipment manufactured by EPT (EPT1000XP) and Medtronic (Atakar RF Generator) have been tested for use with the EPS320 Stimulator.

Important Patient Safety Warnings

Throughout this document, a Warning is intended to indicate a potential hazard or unsafe practice which, if not avoided, could result in death or serious personal injury, while a Caution conveys a potential hazard or unsafe practice which, if not avoided, could result in minor personal injury or product/property damage.

1.3.1

General Warning

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

Cardiac Diagnostic Stimulators are used in medical procedures, during which intentional or unintentional life-threatening cardiac arrhythmias are likely to occur. 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 and the operation of this Stimulator, in an appropriate hospital facility.

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q

The supervising physician must verify all Stimulator settings immediately prior to commencement of pacing, with particular attention to any adaptively calculated S1 pacing interval settings, and in the case of StimLab™, in case settings were altered using the alternate controller.

Warning: Installation and use only by qualified personnel. q

In order to prevent electrocution hazards or impaired performance of the Stimulator from incorrect installation, 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.

q

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. q

To avoid injury to patient from bradycardia, operator must have available a backup temporary external pacemaker. The 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 for bradycardia are provided in case of failure of normal functioning of the Stimulator and are for use in non-lifethreatening bradycardia; in case of life-threatening bradycardia, pacing with a temporary external pacemaker must be established immediately.

q

A backup temporary external pacemaker must be immediately available for use in case of the occurrence of a life-threatening bradycardia. It 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 must use isolated mains supply only. q

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.

q

For StimLab™ and StimCor™, in order to comply with IEC60601-1 and avoid possibility of patient / operator shock from accidental connection of Stimulator computer parts directly to mains power, ensure that Isolation Transformer has Mains Cord Retaining Bracket MP3181 installed.

q

For StimLab™, in order to avoid electrocution hazards or loss of normal device function, ensure that the StimLab™ Bedside Remote Controller Station touch screen has its DC Power Plug Cover securely attached by screws, preventing accidental disconnection of its DC power plug and preventing insertion of a mains lead plug; this part must only use low voltage DC power input and must never be connected to mains power.

q

Provided above isolated mains supply warnings are complied with, the complete StimLab™, StimCor™ or EPS320 system may be located within the patient environment.

Warning: To avoid electrocution hazards, connect Stimulator system only to legally marketed, mains-isolated electrical equipment.

3

q

To avoid electrocution hazards, the Stimulator system may be connected to parts specified by Micropace as compatible or to other equipment provided the other equipment is also isolated from the mains. It must comply with electrical safety requirements of IEC60601-1 standard or equivalent, is legally marketed in the country and is CE marked for installations in the EU countries.

q

Do not connect equipment other than that specified by Micropace to the multiple socket outlets on the Micropace supplied Isolation Transformer.

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USER INSTRUCTION MANUAL

q

If this Stimulator System is modified, reconfigured or has other equipment connected to it or to its isolation transformer, the hospital or the Responsible Organisation must perform appropriate inspection and testing, including to EN60601-1:2005.

q

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. q

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. q

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.

q

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. q

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) q

Product is not suitable for sterilization and must be protected from ingress of fluids

q

In order to prevent inadvertent or ineffective pacing, the user should always verify the actual channel being paced using independent EP Recording Equipment. If unexpected results are observed or the SM-Box FAULT indicator lights, do not use the SM-Box; if urgent pacing is required, use the Emergency Bypass output socket and pace Ch2 (Ventric), or use Emergency Pacing on the Stimulator.

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). q

Use only supplied Stimulus Connection Box (MP3014) or optional Stimulus Multiplexer Box (MP3086) components to connect Stimulator’s stimulus 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 lifethreatening arrhythmias during delivery of RF ablation energy.

q

The MP3014 and MP3086 components are over voltage protected by gas arrestors for differential voltages > 350VAC. Exposing these components to unfiltered RF ablation energies

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CARDIAC STIMULATOR

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. q

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. q

To ensure reliable operation of the Stimulator, install the Stimulator away from dust, excessive heat or humidity, direct sunlight and splashing liquids and in a well-ventilated place.

q

To ensure that operator may see important error messages displayed during operation, install with the front panel of the Stimulus Generator Unit visible to the Operator, as important error messages may be displayed during operation.

q

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.

q

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 (green MAINS POWER LED should blink) and in Standby Mode to ensure that backup battery remains fully charged. The computer should be switched off.

q

Assembly and modifications of this Medical System during the actual service life require evaluation to the requirements of EN60601-1:2005.

Caution: Precautions prior to use.

5

q

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.

q

Ensure that all cables are properly installed and secured.

q

Ensure that the mains power supply is isolated and that attached equipment is also electrically isolated and does not pose an electrical hazard.

q

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 Fixed Rate Pacing and the Stimulator generally functions correctly.

q

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.

q

Ensure that the Operator is trained thoroughly on how to switch the Stimulator to Backup Manual mode or Emergency Fixed Rate Pacing modes.

q

To prevent custom software malfunction, do not install other software.

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USER INSTRUCTION MANUAL

Caution: Precautions during use. q

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).

q

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.

q

To ensure reliable stimulus capture, set stimulation current according to capture threshold whenever changing stimulation site or catheter. Two times threshold is usually used.

q

Use of excessive stimulation currents may induce fibrillation and produce misleading results in ventricular stimulation studies.

q

To reduce chance of accidentally inducing ventricular fibrillation, ensure reliable ECG sensing from correct source and use SYNC_TO function to avoid stimulating in the vulnerable diastolic period where appropriate.

q

When using ECG-synchronous stimulation, to improve efficacy and prevent unwanted induction of arrhythmias, ensure that the ECG signal and detection of PQRS are satisfactory before and during pacing.

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

The Micropace 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.

q

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

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1.5

Adverse Events1

The StimLab™ / ESP320 produce standard cardiac stimulation outputs similar to other existing programmable cardiac stimulators in use for the past 30 years; there are no known adverse effects from short term diagnostic use of such stimulation when applied correctly. Following is a list of potential adverse events from Stimulator device malfunction or human error (in alphabetical order): q

Arrhythmia

q

Death

q

Explosion or fire

q

Myocardial injury

q

Operator electrocution

Refer to above Warnings and Precautions.

1.5.1

Observed Adverse Events

Micropace stimulators produce 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 and in one recent review by McLaughlin et al [“Review of seven cardiac electrophysiology stimulators”, by N.B.McLaughlin, C.J.Griffiths, R.W.F.Cambell et al in Physiol.Meas.,14 (1993) 57-69]. Report of adverse events related to EPS320 Micropace Stimulator 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) q

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

q

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.

q

Clinical use of the EPS320 in Australia and Southeast Asia from July 1999 to October 2001, involving 22 Stimulators and an estimated 7400 patients.

q

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.

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Sections 1.5 – 1.8 for US Market only

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1.5.2

Potential Adverse Events

Following is a list of potential adverse events which could be directly associated with diagnostic cardiac stimulation using the stimulator during electrophysiological studies (in alphabetical order): Bradycardia or asystole q

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 atrio-ventricular conduction defects, (ii) during placement of intra-cardiac electrode catheters, (iii) after cardioversion/defibrillation or (iv) during RF ablation.

q

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.

q

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 Micropace Stimulator is not a life-support device; these functions are for use in non-life-threatening 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.

q

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 q

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.

q

Explosion could also arise from electrical sparks within the Stimulator igniting explosive anesthetic gasses in the operating room. Do not use Stimulator in the presence of volatile anesthetic gasses.

q

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 q

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.

q

In order to minimize risk of myocardial injury, connect EPS320 Stimulator stimulation outputs only to legally marketed medical equipment compliant with IEC60601-1 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 q

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 IEC 601-1. Connection of these ports to equipment without

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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. q

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.

Ventricular tachycardia or fibrillation q

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. Stimulation of myocardium 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 Stimulator 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 SYNC-TO function set to PQRS 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 Stimulator 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 behavior whenever patient is connected to the Stimulator; disconnect the patient from the Stimulator and do not use if abnormal stimulation is observed. (iv) Un-programmed 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 behavior 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. 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 Stimulator, including the PC and all connected third party equipment is connected only to isolated mains power supply.

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USER INSTRUCTION MANUAL

1.6

Summary of EPS320 Stimulator field trial

Introduction: The core of the Micropace cardiac stimulator systems, the EPS320 Cardiac Stimulator, were validated earlier in the clinical setting in conjunction with other equipment while operated by a sample of end users and subjected to typical sources of potential interference, such as Radio Frequency (RF) ablation energies and DC cardioversion. Validation end points were the absence of adverse events during the procedure, demonstration of adequate pacing in all protocols for the duration of typical Electrophysiological (EP) study and RF ablation procedure without interruption, adequate sensing of QRS, subjective scoring of fitness for purpose by user and freedom from error states. Patients studied: 23 clinically indicated EP studies with or without RF ablations in 23 patients in routine clinical settings. A total of 6 operators used the EPS320 Cardiac Stimulator in 4 different hospitals. Methods: The protocol consisted of the collection of data on Stimulator clinical performance by a trained observer during routine clinically indicated EP studies by cardiologists. Sequential patients were chosen and no change to the routine clinical management of patients was made. Device performance was assessed qualitatively with defined pass criteria for each case study and defined criteria for overall device pass or fail for each application. Results: Data was collected from 23 EP studies, consisting of 10 cases of RF ablation of supraventricular tachycardia(SVT), 4 studies of ventricular tachycardia (VT) , 3 syncope studies and 6 other study types. The Stimulator was used during delivery of RF ablation energies in 14 of the cases and during DC cardioversion of patient on 6 occasions in 4 patients. Results are shown in Table 1 below. No hazardous events or stimulator failures were observed; Stimulator functioned as per specification at all times in all cases. Conclusions: The EPS320 Cardiac Stimulator: q

Performs within acceptable safety parameters at all times.

q

Performs substantially to the system requirements set out for the device and appears to satisfy Electrophysiologist’s clinical requirements.

PARAMETER Nominal Protocol Stimulator performance (all must pass) All programmed pacing stimuli are delivered (all = pass) Adequate capture achieved (all expected = pass) Adequate sensing: 4:>90%, 3:70-90%, 2:50–70%, 1: <50% (>70%=Pass) Upper and lower limits of variables satisfactory for clinical purpose? (Ask clinician) Did Sync-to-QRS function correctly- pacing started on all first (detected) QRS? Performance during tachycardia (all must pass) Adequate sensing4:>90%, 3:70-90%, 2:50–70%, 1:<50% ( >70%=Pass) Performance during RF ablation (all must pass) No Stimulator Error during ablation Operator able to recover Stimulator from error Performance during defibrillation (all must pass) Number of defibrillations during study; Record of any malfunction (no., none = pass) Failure modes(all must pass) Did error codes appear on Stimulator Unit? (No=Pass) Loss of communication between PC and Unit occurred? (No=Pass).

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TOTAL/ MAX 74/105 -

PASS 23/23 23/23 23/23 22/22 23/23 8/8

53/85

18/18

14/141 -

14/14 -

6 0

6/6

0 0

23/23 23/23

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PARAMETER If communication lost, was it re-established easily? (Yes=Pass) Record of any computer freeze or unexpected behavior as well as any display anomalies, (None = pass). Test of Backup Manual stimulation(all must pass) Did Interval and Current adjustments work and pacing stimuli work? (Yes= pass) Did all stimuli capture patient; (all = pass) Emergency fixed pace operation worked (all stimuli issued) User performance Score (5=very good, 4=good, 3=adequate, 2=poor, 1unsatisfactory) User-friendliness of computer user interface (self-evident menus/operation) Ergonomic (speed, ease, minimum number of steps) of operation. Overall Safety of operation. Reliability of operation, lack of breakdowns, delays. Fit for purpose of EPS Stimulation (essential features) Comprehensiveness of features within system (all desired features) Flexibility of use (adaptability to non-standard/new uses)

TOTAL/ MAX 0 0

PASS 23/23 23/23

6 6 6

6/6 6/6 6/6

71/80 70/80 72/80 75/80 75/80 73/80 60/70

16/16 16/16 16/16 16/16 16/16 16/16 13/13

Table 1 Results for individual measured parameters Notes for Table 1 above. 1

During one study, the Stimulator entered Fail Safe operation mode due to a false alarm without causing hazard to the patient after the pacing electrode inadvertently directly contacted the RF Ablation electrode during application of RF energy (the Stimulator alarm was subsequently modified, validated and appropriately labelled as per current labelling).

1.7 Individualization of treatment & Patient Counseling Information q

Pacing threshold in each chamber studied should be established prior to the EP study and stimulation current should be set at twice the pacing threshold or 1mA, whichever is greater. Pacing thresholds may differ with different catheter positions and presence of myocardial scarring.

q

Adequate ECG / IECG signal should be derived from the patient to enable stimulation triggering. External amplified IECG signals should be the first choice but catheter-tip IECG may be used otherwise. Output level of the IECG source or Micropace Stimulator input gain should be adjusted to obtain optimal IECG / ECG.

q

To our knowledge, the StimLab™ requires no specific counseling in addition to standard patient consent by the clinician for the overall EP Study or RF Ablation procedure during which it is to be used.

1.8

References

(1) AHA Medical/Scientific Statement: ACC/AHA Guidelines for Clinical Intracardiac Electrophysiological and Catheter Ablation Procedures. Circulation. 1995;92:673-691 (2) Adams, D.E: Setting Up the Laboratory for Ablation. Catheter Ablation of Arrhythmias. D. Zipes ed. Futura Publishing Company, Inc., Armonk, New York. 1994: 89-90. (3) Josephson, ME: Clinical Cardiac Electrophysiology: Techniques and interpretations. 2nd Edition. Lee & Febiger, Pennsylvania, 1993:pp10,67. (4) McLaughlin, NB Griffiths CJ, Campbell RWF and Murray A. Review of Seven cardiac Electrophysiology stimulators. Physiol.Meas. 14 (1993) 57-69.

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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: q

89/336/EEC & 92/31/EEC (EMC Directives)

q

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

q

93/68/EEC (CE Marking Directive)

Issuing Notified Body – SGS.

Compliance Testing was carried out and coordinated by the following Certified Bodies: q

EMC Technologies, Castle Hill, Australia

q

TCA - Testing and Certification Australia, Chatswood, Australia

The Micropace Cardiac Stimulator classification: q

TGA, Rule 4.3 Classification Class IIb

q

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

q

IEC60601-1 electrical device classification: Class II (mains-isolated by approved external isolation transformer), IPX0, Type CF

q

FDA Medical Device Level of Concern Level II

q

Health Canada Medical Device Classification, Rule 10(2) Class III

The Micropace Cardiac Stimulator system Power rating: q

220-240VAC 50-60Hz, 0.7A max

q

110-120VAC 60Hz, 1.4A max

Identification of technical standards with which compliance is claimed q

ISO 13485 Quality management systems - Medical devices - System requirements for regulatory purposes

q

IEC60601-1:2005 Medical Equipment – Part 1: General requirements for safety.

q

IEC60601-1-2 Medical Equipment – Part 1: General requirements for safety. Collateral Standard: Electromagnetic compatibility – Requirements and tests

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

Trademarks Datalight and ROM-DOS are registered trademarks of Datalight, Inc. Copyright 1989-2012 Datalight, Inc., All Rights Reserved. The cardiac stimulator system is protected under applicable copyright laws. Purchase and use of this System is subject to the following agreements:

License Agreement You may: (i) use this program on only one computer at a time; (ii) make a copy solely for the purpose of backup. You may not: (i) distribute copies of this program or documentation to others; (ii) rent, lease or grant sublicenses to the program to others without prior consent from Micropace Pty Ltd. Your license to use this program will terminate automatically if you fail to comply with the terms of this Agreement. A full copy of the license agreement can be found in the software.

Limited Warranty Micropace warrants that, for a period of one year from the date of installation of the Product, the Custom Hardware will under usual use be free from defects in materials and workmanship. The Software will, when properly used in accordance with this license, operate in accordance with its applicable specifications published by Micropace, be free of material defects and be fit for the purpose intended by Micropace. Micropace shall have no obligation to make repairs to, or replace, Products which are damaged by normal wear and tear, or which result from (i) catastrophe, fault or negligence of a person other than Micropace, (ii) improper or unauthorised repair, or (iii) causes external to the Products, including, but not limited to, power surges, extreme environmental conditions outside of specifications or mishandling, such as spillage of liquids within the Products. All claims for warranty services must be directed to your authorised Micropace distributor. Except for the above express limited warranties, and subject to law, Micropace makes, and you receive, no warranties, express, implied, statutory, or in any communication with you; and Micropace specifically disclaims any other warranty including the implied warranty of merchantability or fitness for a particular purpose. Micropace does not warrant any of the third party hardware or that the operation of the product will be completely free from minor software or hardware inconsistencies. The Stimulator must only be used by appropriately qualified and experienced personnel, in appropriate facilities and in conjunction with appropriate safety equipment as described in section “Important patient safety warnings” above. Micropace accepts no responsibility for any consequences arising out of the use of the Stimulator outside of these restrictions. The Operator should verify for him / herself that each function of the Stimulator performs to the Operator’s expectation prior to use of the Stimulator on patients.

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