EPS320 Cardiac Stimulator User Instruction Manual sw ver 3.20

USER INSTRUCTION MANUAL

Table of Contents 1 INTRODUCTION & ESSENTIAL PRESCRIBING INFORMATION...1 1.1 DEVICE DESCRIPTION ...1 1.1.1 Description of system ...1 1.1.2 Accompanying Documentation...1 1.1.3 Intended Use ...2 1.1.4 Indications for Use...2 1.1.5 Contraindications ...2 1.2 COMPATIBLE EQUIPMENT ...2 1.3 IMPORTANT PATIENT SAFETY W ARNINGS ...3 1.3.1 General Warning ...3 1.3.2 Warnings Specific to the EPS320 Stimulator ...4 1.3.3 Warnings Related to the use of EPS320 Stimulator with RF Ablation Equipment...4 1.4 GENERAL PRECAUTIONS IN HANDLING STIMULATOR ...5 1.5 ADVERSE EVENTS ...6 1.5.1 Observed Adverse Events...6 1.5.2 Potential Adverse Events ...7 1.6 SUMMARY OF EPS320 STIMULATOR FIELD TRIAL ...9 1.7 INDIVIDUALIZATION OF TREATMENT & PATIENT COUNSELLING INFORMATION ...10 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 CONFIGURATION ...18 6 INSTALLATION...19 6.1 UNPACK CONTAINERS ...19 6.2 CONNECT SYSTEM COMPONENTS ...19 7 STIMULATOR OPTIONS ...22 8 USING THE EPS320 CARDIAC STIMULATOR...23 8.1 SWITCHING ON THE SYSTEM ...23 8.2 USING THE COMPUTER ...23 8.3 USING THE KEYBOARD AND THE OPTIONAL TOUCH DISPLAY ...24 8.4 USING THE STIMULATOR SOFTWARE...27 8.4.1 Help Function ...27 8.4.2 The Main Stimulator Screen...27 8.4.3 Pacing Parameters ...27 8.4.4 Basic Pacing...27 8.4.5 Overview of Using the Stimulator Software...29 8.5 STIMULATION PARAMETERS ...32 8.5.1 Current...32 8.5.2 Duration ...32 8.5.3 Train...32 8.5.4 Decrement ...33 8.5.5 Sync-to...33 8.5.6 Pace Mode ...33 8.5.7 S1 Parameter ...34 8.5.8 S2-S7 Parameter ...34 8.5.9 Pause Parameter...35 8.5.10 Pace Site ...36 8.5.11 ECG Sense Site ...37 8.5.12 QRS Detect Menu ...38 8.6 PACE STATUS ...38 8.6.1 Sense Site ...38 8.6.2 RR Measurement ...38 8.6.3 Impedance measurement...38

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8.6.4 ECG Display Bar ...38 8.7 PACING PROTOCOLS ...39 8.7.1 Pace Protocols ...39 8.7.2 Threshold Protocol ...39 8.7.3 Nodal_ERP Protocol...39 8.7.4 Multi_Sx Protocol...39 8.7.5 Wenckebach Protocol...40 8.7.6 RSynced_Sx Protocol...40 8.7.7 SNRT* Protocol ...40 8.7.8 Burst_Pace Protocol...40 8.7.9 AV Atrio-ventricular Delayed Protocol ...41 8.7.10 Overdrive Pace and ATP Protocols...41 8.7.11 Specialised Protocols ...42 8.7.12 Trigger Sync output interfaces ...43 8.7.13 Saving Storing Stimulator Defaults...43 8.8 SOFTWARE CONFIGURATION. ...43 8.9 SAFETY FEATURES ...44 8.10 SOFTWARE ERROR MESSAGES ...45 8.11 ADDITIONAL SOFTWARE MESSAGE ...46 8.11.1 Advisory Message ...46 8.11.2 Text Messages ...48 8.12 CONFIGURING THE PROGRAM - THE CONFIG MENU ...49 8.13 SUMMARY OF HOT KEYS...51 9 THE EPS320 STIMULUS GENERATOR UNIT...52 9.1 STIMULUS GENERATOR UNIT LAYOUT ...52 9.2 STIMULATOR CONNECTIONS...54 9.3 HARDWARE ERROR MESSAGES ON THE STIMULUS GENERATOR UNIT. ...55 9.4 TROUBLESHOOTING ...58 9.5 USING THE OPTIONAL FOUR CHANNEL STIMULUS MULTIPLEXER BOX ...60 9.5.1 Stimulus Multiplexer box (SM-Box) features ...60 9.5.2 Software Support...61 10 MAINTENANCE ...62 10.1 BATTERIES ...62 10.2 MAINTENANCE AND CALIBRATION ...62 10.3 CLEANING INSTRUCTIONS ...63 10.4 SERVICEABLE LIFE AND DISPOSAL ...63 11 EPS320 SPECIFICATIONS ...64 12 EPS320 SYSTEM OPTIONAL ACCESSORIES ...65 12.1 OPTIONAL UPGRADE KITS ...65 12.2 OPTIONAL ACCESSORIES ...65 13 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS..66 13.1 CABLE LENGTHS...66 13.2 EMI / EMC SPECIFICATIONS...67

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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™ Sx

iv

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 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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USER INSTRUCTION MANUAL

1 INTRODUCTION & ESSENTIAL PRESCRIBING INFORMATION 1.1

Device Description

1.1.1

Description of system

The EPS320 Cardiac Stimulator by Micropace Pty Ltd. is a diagnostic external programmable cardiac stimulator. The Cardiac Stimulator consists of a self-contained two channel microcontroller-based Stimulus Generator Unit capable of generating simple regular pacing pulses by the controls on its front panel. During normal use, however, it is externally programmable by the user 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. 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 one trigger output channel 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. The EPS320 system may be enhanced with a number of optional kits, including: (i) Stimulus Multiplexer Box (SM-Box) which converts the two stimulus output channels to four output channels by automatic reprogramming and switching of stimulus generator outputs, (ii) Touch Screen Kit, which adds a touch screen interface to keyboard control of the stimulator, and (iii) StimLink™ Kit, which offers integration with certain EP recording equipment.

1.1.2

Accompanying Documentation

A reference package, comprising of a manual and a leaflet, is provided with the EPS320 Cardiac Stimulator; a service manual is available on request. 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.

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1.1.3

Intended Use

The EP320 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 EPS320 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

1.1.5

Contraindications

Do not use the EPS320 system for life support in patients with life-threatening bradycardia; use instead temporary external pacemaker.

1.2

Compatible Equipment

The primary function of the EPS320 Cardiac Stimulator 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: 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 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 Cordis Biosense Webster, Daig, CR Bard, 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 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

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

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USER INSTRUCTION MANUAL

1.3

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.

q

The supervising physician must verify all Stimulator settings prior to commencement of pacing, with particular attention to any adaptively calculated S1 pacing interval settings.

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 authorised distributor or hospital-appointed biomedical engineers, may carry out installation of the EPS320 Stimulator and its connection to other equipment.

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 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 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 outlet.

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

To avoid electrocution hazards, the stimulator system may be connected 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.

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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 EPS320 Stimulator

Warning: Monitor function of Stimulator and patient’s vital signs continuously. q

The EPS320 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 EPS320 Stimulator with RF Ablation Equipment

Warning: Use Stimulator only with RF-filtered stimulus connection. (Micropace parts: MP3014, MP3086 or MP3065).

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q

Use only supplied Stimulus Connection Box (MP3014), optional Stimulus Multiplexer Box (MP3086) or optional In-line RF Filter Box (MP3065) 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 life-threatening arrhythmias during delivery of RF ablation energy.

q

The MP3014, MP3086 and MP3065 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.

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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.

Caution: Precautions prior to use. 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 EPS320 software malfunction, do not install other software.

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.

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q

To reduce chance of accidentally inducing ventricular fibrillation, ensure reliable ECG sensing and use SYNC_TO 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. q

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.

q

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

1.5

Adverse Events1

The EPS320 produces 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

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 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 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 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. 1

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Sections 1.5 – 1.8 for US Market only

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USER INSTRUCTION MANUAL

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.

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 EPS320 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 EPS320 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 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.

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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 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 and IEC60601-1-1.

Ventricular tachycardia or fibrillation q

8

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 DCERROR 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 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 un-programmed 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)

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 un-programmed 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

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USER INSTRUCTION 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.

1.6

Summary of EPS320 Stimulator field trial

Introduction: The Stimulator indications were validated 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.

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EPS320 CARDIAC STIMULATOR

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). If communication lost, was it re-established easily? (Yes=Pass) Record of any computer freeze or unexpected behaviour 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 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 0 0

23/23 23/23 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: 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 Counselling Information

10

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 EPS320 input gain should be adjusted to obtain optimal IECG / ECG.

q

To our knowledge, the EPS320 Stimulator 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.

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USER INSTRUCTION MANUAL

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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EPS320 CARDIAC STIMULATOR

2 DEVICE RATINGS, CLASSIFICATION AND CERTIFICATION CE Mark Compliance The EPS320 Cardiac stimulator system, is compliant with the following EEC directives: q

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

q

73/23/EEC (Low Voltage Directive)

q

93/42/EEC (Medical Device Directive)

q

93/68/EEC (CE Marking Directive)

0120

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 EPS320 Cardiac stimulator classification: q

TGA, Rule 4.3 Classification Class IIb

q

Medical Devices Directives (93/42/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 EPS320 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

12

q

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

q

IEC60601-1 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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USER INSTRUCTION MANUAL

3 COPYRIGHT, WARRANTY AND DISCLAIMER NOTICE Copyright Notice Copyright © 1994-2005 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 1989-2004 Datalight, Inc., All Rights Reserved. The EPS320 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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EPS320 CARDIAC STIMULATOR

4 EXPLANATION OF SYMBOLS Explanation of symbols. Table 2 below lists explanations of symbols displayed on various parts of the Stimulator system.

Symbol

!

Name

Attention

Meaning

Explosion Hazard. Not for use in the presence of flammable gasses such as some anaesthetic mixtures. Do not expose to liquids. No user-serviceable parts inside. Refer Service to qualified service personnel.

!

Attention

In order to avoid patient electrocution, connect only to Micropace supplied power supply unit (PSU), which must be connected only to transformer isolated mains power outlet.

!

Attention

Connect only to Micropace supplied parts.

Attention

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

CF Defibrillator

Type CF defibrillator protected equipment.

CE Marking & Notified Body Identificati on

This item is in compliance with the requirements of the European Union EMC, Low Voltage and MD directives and is labelled in accordance with the requirements of these directives.

CE Marking

The commercially available Isolation transformer and Low voltage transformer supplied with each system fully comply with EMC and Safety Standards

Equipoten -tiality

System central grounding terminal.

!

0120

14

Location

Next to POWER ON/OFF switch on rear panel of Stimulus Generator Unit Next to POWER INPUT on rear panel of Stimulus Generator Unit Next to AUXILIARY PORT on rear panel of Stimulus Generator Unit 1. Pace Output Socket. 2. Emergency Fixed Rate Pacing output socket. Front of Stimulus Generator Unit: 1. Pace Output Socket. 2. Emergency Fixed Rate Pacing output socket. 1. Side of Stimulus Generator Unit. 1 Isolation Transformer. 2 Low voltage Transformer Next to the earthing terminal on Isolation Transformer

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USER INSTRUCTION MANUAL

Symbol

Meaning

Location

Device is switched OFF; battery is NOT charging. Note that the MAINS light glows yellow to indicate that power is available to the device.

Next to POWER switch on rear panel of Stimulus Generator Unit

Name

0

Power OFF

I

Power ON

Device is switched ON and battery is charging.

Increase / Decrease

Increase / Decrease adjacent Interval or Current parameter.

Positive Output

Negative Output

Positive stimulus output. Defibrillator CF Protected part

Negative stimulus output, Defibrillator CF Protected part

Next to POWER switch on rear panel of Stimulus Generator Unit On the front of Stimulus Generator Unit next to Interval Current displays Stimulus Connection Box or on optional Stimulus Multiplexer Box Stimulus Connection Box or on optional Stimulus Multiplexer Box

FAULT

Fault Detected in Stimulus Multiplexer Box – use Emergency Bypass.

On optional Stimulus Multiplexer Box

Emergenc y Bypass

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

On optional Stimulus Multiplexer Box

Warning

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

On optional Stimulus Multiplexer Box

Table 2 Explanation of symbols

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15

EPS320 CARDIAC STIMULATOR

Table 3 below lists explanations of symbols displayed only on the EPS320B_EU European version of the SGU.

Symbol

Name

Meaning

Location

No light: No external power to SGU. Orange Light: Connected to Mains Power, but SGU switched off at Power Switch at rear. Battery is not charging. Mains Power

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

16

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. Use keyboard or touch screen, if fitted, to control pacing.

Pace On/Off

Press to toggle 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.

Ch1 (Atrium)

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

Ch2 (Ventic)

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

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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