EPS320 Cardiac Stimulator User Instruction Manual sw ver 3.19

Distributed by: Electrophysiology Division C.R. Bard Inc. 55 Technology Drive Lowell. MA 01851

EU Authorized Representative: Bard Limited UK Valleybridge Road Clacton, Essex C015 4AF England Ph: 011-44-1255-222200

CAUTION US Federal Law restricts this device to sale by or on the order of a physician.

This EPS320 Cardiac Stimulator User Instruction Manual Micropace Part Order No. MP3036 Version US4.22 Valid for: EPS320 Software version 3.19 SGU Firmware version 4.68

USER INSTRUCTION MANUAL

Table of Contents 1

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 ... 1 1.1.4 Indications for Use ... 1 1.1.5 Contraindications ... 1 1.2 COMPATIBLE EQUIPMENT ... 2 1.3 WARNINGS AND PRECAUTIONS ... 3 1.3.1 General Warnings ... 3 1.3.2 Warnings Specific to the EPS320 Stimulator ... 3 1.3.3 Warnings Related to the use of EPS320 Stimulator with RF Ablation Equipment ... 4 1.3.4 General Precautions in Handling the EPS320 Stimulator ... 4 1.4 ADVERSE EVENTS ... 6 1.4.1 Observed Adverse Events ... 6 1.4.2 Potential Adverse Events... 6 1.5 SUMMARY OF EPS320 STIMULATOR FIELD TRIAL ... 9 1.6 INDIVIDUALIZATION OF TREATMENT & PATIENT COUNSELING INFORMATION ... 10 1.7 CONFORMANCE TO STANDARDS ... 11 1.7.1 Statement of relevant regulations ... 11 1.7.2 Identification of technical standards with which compliance is claimed... 11 1.8 REFERENCES ... 11

2

DEVICE RATINGS, CLASSIFICATION AND CERTIFICATION ... 12 2.1.1 2.1.2 2.1.3 2.1.4

3

CE Mark Compliance ... 12 Compliance Testing was carried out and coordinated by the following Certified Bodies:... 12 The EPS320 Cardiac stimulator classification: ... 12 The EPS320 Cardiac stimulator system Power rating: ... 12

COPYRIGHT, WARRANTY AND DISCLAIMER NOTICE ... 13 3.1.1 3.1.2 3.1.3 3.1.4

Copyright Notice ... 13 Trademarks... 13 License Agreement ... 13 Limited Warranty... 13

4

EXPLANATION OF SYMBOLS ... 14

5

HOW SUPPLIED ... 15

6

INSTALLATION ... 16 6.1 6.2

7

UNPACK CONTAINERS... 16 CONNECT SYSTEM COMPONENTS ... 16

USING THE EPS320 CARDIAC STIMULATOR ... 19 7.1 SWITCHING ON THE SYSTEM ... 19 7.2 USING THE STIMULATOR SOFTWARE ... 19 7.2.1 Help Function... 19 7.2.2 The Main Stimulator Screen ... 19 7.2.3 Pacing Parameters ... 19 7.2.4 Basic Pacing ... 19 7.2.5 Overview of Using the Stimulator Software... 21 7.3 STIMULATION PARAMETERS ... 22 7.3.1 Current... 22 7.3.2 Duration ... 22 7.3.3 Train... 23 7.3.4 Decrement ... 23 7.3.5 Sync-to... 24 7.3.6 Pace Mode... 24 7.3.7 S1 Parameter... 24 7.3.8 S2-S6 Parameter ... 25 7.3.9 Pause Parameter... 25 7.3.10 Pace Site ... 26

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EPS320 CARDIAC STIMULATOR

7.3.11 ECG Sense Site... 27 7.3.12 QRS Detect Menu... 27 7.4 PACE STATUS ... 28 7.4.1 Sense Site ... 28 7.4.2 RR Measurement... 28 7.4.3 Impedance measurement ... 28 7.4.4 ECG Display Bar... 28 7.5 PACING PROTOCOLS ... 29 7.5.1 Pace Protocols... 29 7.5.2 Threshold Protocol... 29 7.5.3 Nodal_ERP Protocol ... 29 7.5.4 Multi_Sx Protocol... 29 7.5.5 Wenckebach Protocol ... 30 7.5.6 RSynced_Sx Protocol ... 30 7.5.7 SNRT* Protocol... 30 7.5.8 Burst_Pace Protocol ... 30 7.5.9 AV Delayed Protocol... 31 7.5.10 Overdrive Pace and ATP Protocols ... 31 7.5.11 Specialized Protocols... 31 7.5.12 Sync Trigger output interfaces ... 33 7.5.13 Saving Stimulator Defaults... 33 7.6 SOFTWARE CONFIGURATION. ... 33 7.7 SAFETY FEATURES ... 34 7.8 ERROR MESSAGES ... 35 7.8.1 Advisory Signs ... 35 7.8.2 Text Messages ... 37 7.8.3 The 'SAFE MODE' ... 37 7.8.4 Run time - timing error ... 37 7.8.5 Program warnings on exit ... 38 7.9 CONFIGURING THE PROGRAM - THE CONFIG MENU: ... 38 8

THE EPS320 STIMULUS GENERATOR BOX... 41 8.1 STIMULUS GENERATOR BOX LAYOUT ... 41 Four power indicator lights on the extreme left: ... 41 Backup Manual Pace Control: ... 41 Pace Output:... 42 Emergency Fixed Pace Output: ... 42 Information Displayed During Normal Operation: ... 42 8.2 STIMULATOR CONNECTIONS: ... 43 Power On/Off ... 43 Power Input... 43 Computer Port ... 43 ECG1 input & ECG2 inputs ... 43 Sync Output... 44 Auxiliary Port... 44 8.3 HARDWARE ERROR MESSAGES ON THE STIMULUS GENERATOR BOX... 44 8.4 TROUBLESHOOTING ... 45 Micropace Stimulator software does not start on turning on the computer. ... 45 Pacing is not capturing and no stimulus artifact is seen. ... 45 Patient is not capturing but a stimulus artifact is visible. ... 46 Regular pacing produces irregular stimulus symbols on the screen. ... 46 The Generator does not pace, 'dC Err' appears on Stimulus Generator Box. ... 46 No Triggering of attached EP recording system's display screen. ... 46

9

MAINTENANCE ... 47 9.1 9.2 9.3 9.4

BATTERIES ... 47 MAINTENANCE AND CALIBRATION ... 47 CLEANING INSTRUCTIONS ... 48 SERVICEABLE LIFE AND DISPOSAL ... 48

10

SPECIFICATIONS: ... 49

11

EPS320 SYSTEM OPTIONAL ACCESSORIES ... 50

12

EPS320 SYSTEM SPARE PARTS ... 51

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USER INSTRUCTION MANUAL

1 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 Stimulator consists of a self-contained two channel microcontroller-based Stimulus Generator Unit independently capable of generating simple regular pacing pulses, but under normal use externally interactively programmable by the user for complex pacing patterns via a serial data link, using a custom software program implemented on a standard personal computer. The two stimulation channels are independent isolated constant current pulse generators capable of generating 0.5 to 10ms pulses at 0.1 to 25mA with a maximum output voltage of 27V. The stimulus output may be used to stimulate the human heart during electrophysiological studies via any third party legally marketed transvenous intracardiac pacing catheters directly or via any third party legally marketed EP recording equipment intended to switch pacing pulses of above description without distortion to selected specific catheters and electrodes. The Stimulus Generator Unit is mains-powered via a DC power supply and has an internal trickle-charged backup battery in case of power failure. Its outputs are defibrillator and RF energy protected and it features external ECG input ports as well as catheter-tip ECG sensing for triggering of pacing events and three trigger output channels for synchronization with other equipment. The system is powered from the mains via a medical grade isolation transformer. The EPS320 software allows interactive programming of all aspects of the pacing stimulus: the current amplitude, pulse width, delivery to channel 1 or 2 or both, and all stimulus parameters including drive train number, timing and up to 6 extra-stimuli. The stimulator has an intuitive user interface, with all commonly used stimulus and pacing protocol parameters located on fixed menus on the one screen instantly adjustable via hotkeys including during actual pacing. All standard EP stimulation protocols are available pre-programmed but may be reconfigured and automated according to user requirements.

1.1.2

Accompanying Documentation

A reference package, comprising of a manual and a leaflet, is provided with the EPS 320 Cardiac Stimulator. Included in the package are: q q

User Instruction Manual 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 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 temporary pacemaker equipment instead.

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EPS320 CARDIAC STIMULATOR

1.2

Compatible Equipment

The EPS320 Stimulator’s primary function is the generation of constant current predominantly rectangular stimulation pulses with amplitudes of 0.1 to 25mA, duration of 0.5 to 10ms and with a maximum voltage of +/27V. Third party switching equipment with the following special characteristics must be used to carry the stimulus pulses to the intracardiac electrodes without significant distortion: q q q q

Series resistance: < 100 Ohms at up to +/- 25mA Shunt resistance: > 100,000 Ohms at up to +/- 27V Frequency bandwidth: DC to 300 Hz Interference RF energy sources: < 350Vpp at 400 kHz to 600 kHz, or 150W into a 300 Ohm load

Higher series resistance reduces maximal attainable pulse current amplitude; lower shunt resistance reduces delivered current in all ranges; reduced frequency bandwidth may alter efficacy of stimulation at any current level and higher RF energy exposure may activate over voltage safety elements, reducing RF energy delivery and overheating within the EPS320 system’s Stimulus Connection Box. Subject to these requirements, the EPS320 Stimulator is intended for use with the following equipment; the user should contact Micropace Pty Ltd for compatibility information prior to use of other equipment: Diagnostic pacing electrode catheters q Currently available legally marketed electrophysiological diagnostic electrode catheters, including those manufactured by Cordis Biosense Webster, Daig, CR Bard, Medtronic and EPT. Ablation electrode catheters 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).

q

EP Recording equipment TM TM q Computerized EP Recording systems manufactured by Bard Electrophysiology (LabSystem Duo and TM Pro ) and GE/Prucka (CardioLab 4000) have been tested for use with the EPS320 Stimulator. RF Ablation Equipment q RF ablation equipment manufactured by EPT (EPT1000XP) and Medtronic (Atakar RF Generator) have been tested for use with the EPS320 Stimulator.

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USER INSTRUCTION MANUAL

1.3

Warnings and Precautions

1.3.1

General Warnings

Warning: Stimulator must be used only under supervision by a cardiologist. q The Micropace EPS320 Cardiac Stimulator is used in procedures, during which intentional or

unintentional induction of potentially dangerous cardiac arrhythmias is likely to occur. The Stimulator must only be used by appropriately qualified and experienced personnel, in appropriate facilities and in conjunction with adequate safety equipment. q Specifically, the EPS320 Cardiac Stimulator may be used on humans only by or under the direct

supervision at all times by a physician familiar with the operation of this Stimulator. q The supervising physician must verify all Stimulator settings prior to commencement of pacing, with

particular attention to adaptively calculated S1 pacing interval settings in the Burst Pace, Overdrive Pace, and ATP protocols, and S2 intervals in Rsynced_Sx and X_Rsynced_Sx protocols.

Warning: Installation only by qualified personnel. q Only qualified personnel, such as representatives of Micropace, its authorized distributor or hospital-

appointed biomedical engineers with guidance from Micropace, may carry out installation or modifications of the EPS320 Stimulator and its connection to other equipment. Incorrect installation may create electrocution hazards or impair performance of the Stimulator.

Warning: The Stimulator must only use isolated mains power supply. q To avoid electrocution hazards, the EPS320 Stimulus Generator Unit power supply, computer power

supply, and monitor power lead must all be connected to a mains isolation transformer and never directly to a mains power outlet, (i.e. wall outlet). q To avoid electrocution hazards, do not plug cables or leads directly into mains power outlet.

Warning: Connect Stimulator system only to legally marketed, mains-isolated electrical equipment q To avoid electrocution hazards and system malfunction, the Stimulator outputs, RS232

communication port, Auxiliary port and ECG and Sync ports may be connected to other equipment provided the other equipment is also isolated from the mains power supply, and complies with IEC60601-1, IEC60601-2 and IEC60601-1-1 standards and is legally marketed in the country of use and CE marked for installations in the EU countries.

Warning: Use Stimulator only in ventilated areas and away from flammable gasses. q 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.

1.3.2

Warnings Specific to the EPS320 Stimulator

Warning: Stimulator is not a life support device and may fail to pace – To avoid injury to patient from bradycardia, use only with immediately available backup temporary external pacemaker. q The EPS320 Stimulator System is a diagnostic tool for provocative electrophysiological testing of

the human heart. The Stimulator System is not intended, designed or fit for the purpose of life support. Two levels of backup pacing are provided in case of failure of normal functioning of the Stimulator and are for use in non-life-threatening bradycardia or until temporary external pacing is established in case of life-threatening bradycardia or asystole.

3

EPS320 CARDIAC STIMULATOR

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

occurrence of life-threatening bradycardia and should preferably be connected directly to an intracardiac electrical catheter located in a ventricle, bypassing any switching apparatus in case of failure or inappropriate settings of such switching apparatus.

Warning: Stimulator may not always function as expected – To avoid injury to patient from arrhythmias, monitor function of Stimulator and patient’s vital signs continuously while Stimulator is connected. q The EPS320 Stimulator software is warranted to operate according to specifications however it may

not do so at all times, in all possible circumstances and in an uninterrupted manner. The Stimulator could potentially fail to stimulate or unintentionally stimulate the patient; to avoid injury to the patient, the Stimulator and the patient must be observed for abnormal function of Stimulator at all times while the Stimulator is connected to the patient. q In case of recurrent or persistent unexplained life-threatening ventricular tachycardia or ventricular

fibrillation occurring despite cardioversion/defibrillation during the use of the Stimulator, disconnect the patient from the Stimulator and any attached third party switching equipment in case of occult malfunction in any of the equipment is causing micro-electrocution or DC current stimulation and repeat cardioversion/defibrillation. It is recommended to disconnect patient at the intra-cardiac electrode catheter connectors; the Stimulator itself may be disconnected instantly by unplugging the green Pace Output plug on the front panel.

Warning: Measurements by stimulator are for information only. q Measurements displayed by stimulator, including the Impedance measurement and SNRT

measurement are for facilitation of use of stimulator. The user should use third party legally marketed measurement devices independent of the Stimulator to measure these parameters for the purpose of clinical diagnoses.

1.3.3

Warnings Related to the use of EPS320 Stimulator with RF Ablation Equipment

Warning: Use Stimulator only with Stimulus Connection Box (Micropace Parts MP3014 or MP3065) q Use only supplied Stimulus Connection Box (Micropace Parts MP3014) or alternative optional In-line

RF Filter (MP3065) components to connect Stimulator output to patient circuits. These components contain RF suppression filters to prevent large RF energies from RF Ablation equipment not equipped with RF filters from reaching the Stimulator output circuits. Use of other, including custom made connectors may bypass RF filtering and potentially lead to repeated alarms and shutdowns of the Stimulator and possible induction of unintended life-threatening arrhythmias during delivery of RF ablation energy. q The MP3014 (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 the components.

Warning: Do not stimulate via ablation electrode during delivery of RF Ablation energy. q 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.

1.3.4

General Precautions in Handling the EPS320 Stimulator

Caution: Installation, Transport and Storage. q To ensure reliable operation of the Stimulator, install away from dust, excessive heat or humidity,

direct sunlight and splashing liquids and in a well-ventilated place. q To ensure that operator may see important error messages displayed during operation, install the

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

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USER INSTRUCTION MANUAL

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

temperatures above 60 ºC or ambient air pressures less than 500 hPa during transport and handling. q To ensure that backup battery remains fully charged, store Stimulator between uses with the

Stimulus Generator Unit connected to isolated mains power supply, switched on at the rear panel switch (Mains Power green Led should blink) and in the Standby Mode .

Caution: Precautions prior to use. q Ensure that all cables are free from defects, are properly installed and secured. q Ensure isolation of the mains power supply to the Stimulator and that no newly attached equipment

is compromising the electrical safety of the installation. 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 Backup Fixed Pacing and the stimulator 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 and Emergency Fixed Rate Pacing modes, and knows how to bypass any third party switching apparatus to maintain pacing capability in case of failure of that apparatus. q To prevent EPS320 software malfunction, do not attempt to install drivers, utilities or software into

the EPS320 PC other than that supplied by Micropace. The EPS320 software will not execute if Terminate and Stay Resident (TSR) programs are detected by the software.

Caution: Precautions during use. q Observe the Stimulator and patient at all times for abnormal function and rectify any problem

promptly or disconnect the patient from the Stimulator (by unplugging the green Pace Output plug on the front panel). q Do not use the Stimulator and disconnect it from the patient if it repeatedly switches to Backup

Manual mode or repeatedly displays error messages on the front panel. Contact your Micropace Distributor. q Use of excessive stimulation currents increases potential for induction of fibrillation, which may be

harmful to the patient and may be prognostically non-specific in ventricular stimulation studies. q To ensure reliable pacing capture, the user must establish pacing current thresholds for electrode

catheters, including RF ablation catheters, prior to diagnostic stimulation studies and set pacing current accordingly. Pacing thresholds, impedance and sensing characteristics may differ amongst various diagnostic and RF Ablation electrode catheters due to differing electrode geometries and associated electrical pathways. q To reduce chance of accidentally inducing ventricular fibrillation, ensure reliable ECG sensing and

use Synch-to-QRS function to avoid stimulating in the vulnerable diastolic period where appropriate.

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

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EPS320 CARDIAC STIMULATOR

1.4

Adverse Events

1.4.1

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

1.4.2

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

6

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.

USER INSTRUCTION MANUAL

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.

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

The EPS320 Stimulator may be used to intentionally induce ventricular or atrial arrhythmias including ventricular tachycardia and fibrillation. Causes of inadvertent induction of such arrhythmias includes operator error, Stimulator malfunction and device interactions: (i) Myocardial stimulation with DC current. Myocardial stimulation with DC current is likely to cause arrhythmias, including intractable ventricular fibrillation (if operator is unaware of the fault and does not remove the source from the patient, ventricular fibrillation may repeatedly recur after defibrillation, possibly leading to patient death). DC current flow in the stimulation circuit loop, may potentially be caused by Stimulator output circuit failure, failure in other third party equipment inserted in the stimulation circuit loop or device interaction between interconnected equipment. Should the EPS320 detect such a condition a DC-ERROR alarm is issued, ( _,d,c,_,E,r,r displayed on SGU front panel and DC-ERROR alarm message on the computer), followed by a safe state shut down of the Stimulator. Refer to section “Hardware Error Messages on the Stimulus Generator Unit” below for instructions in this case. Regardless of Stimulator alarm state, recurrent unexplained ventricular fibrillation should prompt user to immediately disconnect the patient from the stimulation circuit, preferably at the intracardiac electrode catheter connectors. (ii) Intended cardiac stimulation in the vulnerable diastolic cardiac period User should ensure that ECG sensing by the Stimulator is reliable and always use the Synchto-QRS function to avoid stimulating in the vulnerable diastolic period, where appropriate. External amplified ECG signal is the recommended source of ECG, however, where external ECG source is not available or unreliable, the EPS320 may be configured to sense intra-cardiac ECG from either of the stimulation output channels.

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EPS320 CARDIAC STIMULATOR

(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 EPS320 Stimulator system, including the PC and all connected third party equipment is connected only to isolated mains power supply.

Adverse events which may be directly associated with diagnostic cardiac stimulation during electrophysiological studies (in alphabetical order): q q q

Arrhythmias Death Temporary chest pain

Adverse events may occur arising from use of third party equipment attached to the EPS320 Stimulator during EP studies. Refer to User Instructions for such third party equipment for warnings, precautions and lists of adverse events.

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USER INSTRUCTION MANUAL

1.5

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 box? (No=Pass) Loss of communication between PC and box 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).

1.6

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 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.

10

USER INSTRUCTION MANUAL

1.7

Conformance to Standards

1.7.1

Statement of relevant regulations

COMPLIED REGULATION

TITLE

73/23/EEC

Electrical Equipment designed for use within certain voltage limits directive (LVD)

89/336/EEC, 92/31/EEC

Electromagnetic compatibility directive (EMC)

93/42/EEC

Medical Device directive (MDD)

93/68/EEC

CE Marking directive (CE)

1.7.2

Identification of technical standards with which compliance is claimed

COMPLIED STANDARDS

TITLE

ISO 13485

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

IEC60601-1

Medical Equipment – Part 1: General requirements for safety.

IEC60601-1-2

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

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.

11

EPS320 CARDIAC STIMULATOR

2 DEVICE RATINGS, CLASSIFICATION AND CERTIFICATION 2.1.1

CE Mark Compliance

The EPS320 Cardiac stimulator system, comprising of the Stimulus Generator Unit, Isolation Transformer, Low Voltage Transformer, Computer and associated software and cables, with the exception of the Stimulus Connection Box, is compliant with the following EEC directives: q

89/336/EEC (EMC Directive)

q

73/23/EEC (Low Voltage Directive)

q

93/42/EEC (Medical Device Directive)

q

93/68/EEC (Council Directive)

0120

2.1.2

2.1.3

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

q

QAS - Quality Assurance Services, Chatswood, Australia

The EPS320 Cardiac stimulator classification: q

Medical Devices Directives (93/42/EEC & 93/48/EEC), Rule 10 classification: Class IIb medical device

q

FDA Medical Device Level of Concern Level II

q

EN60601/ IEC60601-1 electrical device classification: Class I (mains-isolated by approved external isolation transformer), not protected against ingress of water, Type CF defibrillator proof

2.1.4

12

The EPS320 Cardiac stimulator system Power rating: q

220-240VAC 50Hz, 0.7A max, ( with MP3001EU Isolation Transformer) OR

q

110-120VAC 60Hz, 1.4A max, ( with MP3001USA Isolation Transformer)

USER INSTRUCTION MANUAL

3 COPYRIGHT, WARRANTY AND DISCLAIMER NOTICE 3.1.1

Copyright Notice

Copyright © 1994-2003 by Micropace Pty Ltd. 571 Canterbury Road, Campsie NSW 2194, Australia All rights reserved, Printed in Australia

3.1.2

Trademarks

MS-DOS and Windows are registered trademarks of Microsoft, Inc. The EPS320 Cardiac Stimulator System is protected under applicable copyright laws. Purchase and use of this System is subject to the following agreements:

3.1.3

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.

3.1.4

Limited Warranty

Micropace Pty Ltd. warrants the EPS320 Cardiac Stimulator system to be free of defects of workmanship or material for a period of one year from the date of delivery. The warranty covers transport costs, parts and labor for any fault in the Stimulator, provided it arose during correct use of the device and, in the reasonable judgment of Micropace, the fault is a result of defective manufacturing workmanship of materials. Where possible, the Stimulator will be repaired or replaced on site. Micropace limits its liability under this warranty to the costs of repair, replacement or refund, as Micropace may elect; under no circumstance will Micropace be liable for incidental damages arising from the loss of use of the Stimulator including the loss of revenue. This warranty will be void if repairs or alterations to the Stimulator are made by any persons other than Micropace employees unless with a written consent from Micropace. Micropace warrants the EPS320 Software to be substantially correct, however it does not warrant its operation to be fault-free and uninterrupted under all circumstances. The user should verify for him/herself that each function of the Stimulator performs to the user’s expectation prior to use of the Stimulator on patients. The Micropace EPS320 Cardiac Stimulator is used in procedures, during which intentional or unintentional induction of potentially dangerous cardiac arrhythmias is likely to occur. The Stimulator must only be used by appropriately qualified and experienced personnel, in appropriate facilities and in conjunction with 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.

13

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

Location

Meaning

CF Defibrillator

1. Pace Output Socket. 2. Emergency Fixed Rate Pacing output socket

Type CF defibrillator protected equipment

Attention

1. Pace Output Socket. 2. Emergency Fixed Rate Pacing output socket

CE Marking

0120 & Notified

Body Identification

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.

1 Isolation Transformer. 2 Low voltage Transformer

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

Equipotentiality

Next to the earthing terminal on Isolation Transformer

System central grounding terminal

0

Power OFF

Next to POWER switch on rear of Stimulus Generator Unit

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

I

Power ON

Next to POWER switch on rear of Stimulus Generator Unit

Device is switched ON and battery is charging

CE Marking

Table 2 Explanation of symbols

14

1. Side of Stimulus Generator Unit

Read User Instructions Manual prior to use

USER INSTRUCTION MANUAL

5 HOW SUPPLIED EPS320 Configuration EPS320B-US The EPS320 Cardiac Stimulator System is supplied in two separate cartons. This configuration includes a Bona Computech Light System PC, a separate NEC LCD Display Screen and a 110-120VAC isolation transformer with the EPS320 system. Appropriate mains cables are included for proper system installation, as per Packing list and connection diagram below.

EPS320B-US STIMULATOR & PC CARTON Item Torema Transformer Isolation, 110-120 VAC, 300VA Keyboard with key labels Ver2.2 for Software 3.19 Accessories Box: Isolated Mains Power Lead, IEC 3 to 2 Pin- US Style Stimulus Connection Box with RF Filter Serial Boost Cable, Serial RS232 Isolation Transformer Power Lead, according to customer country Isolated Mains Power Lead IEC 3 to 3 Pin – US Style Signal Cable, with Phone Plugs Hipower Switched Mode 15.0 VDC 1 A Power Supply for SGU Accessories Booklet Installation Kit: Phone Plug – RCA socket adapter RCA Plug – BNC socket adapter Test LED, Yellow/Red Fuses, 4A Semi-delay HBC M205 Cable tie Cable tie adhesive anchor Stimulus Generator Unit Bona Light PC Computer Power Supply for Bona Light PC Documentation: User Instruction Manual Installation Procedure Booklet Manufacturer’s Test Certificate MS DOS6.22 Operating System Software License Summary of Hotkeys

Part No. MP3001US MP3016 MP3055 MP3066US MP3014 MP3033A MP3059_ MP3030US MP3034 MP3074 MP3064US MP3063US MP3056 MP3057 MP3058 MP3068US MP3039 MP3061 MP3008 MP3093 MP3099 MP3036US MP3069 MP3067 -

Qty 1 1 1 1 1 1 1 1 2 1 1 1 2 2 1 4 4 1 1 1 1

Part No. LCD51V -

Qty 1 1 1 1

1 1 1 1 1

NEC LCD Sceen Carton Item LCD Display (Micropace Part No. MP3076) Video Signal Cable (Part of Micropace No. MP3076) NEC LCD Screen Instruction Manual Isolated Mains Power Lead, (IEC 3 to 3 pin) US Style

MP3030US

15

EPS320 CARDIAC STIMULATOR

6 INSTALLATION 6.1

Unpack containers

Remove components from EPS320 Stimulus Box and and LCD Display and inspect for missing or damaged items. Verify the contents of the cartons against the enclosed packing lists. Most configurations contain the following items: q q q q q q q

6.2

Computer and LCD flat screen and their accessories EPS320 Stimulus Generator Unit (SGU) Mains isolation transformer (220-240VAC, 400VA or 120VAC, 400VA) 14.5VDC or 15.0VDC low voltage power supply transformer for the SGU RS232 serial boost communication cable Stimulus Connection Box with cable ECG input signal cables for connection to your EP recording system.

Connect System Components

Read this manual completely before assembling the system, particularly sections Essential Prescribers Information above. Connect the system components as shown in Figure 1 below. Connect mains power to the PC and monitor via the IEC Power Distribution Board, MP3079 and the mains isolation transformer provided, part No. MP3001US (for 110-120VAC mains voltage). For patient safety, neither the computer nor the monitor must ever be connected directly to the mains power supply. Connect the SGU Power supply, part No. MP3074 to the blue Power connector on the rear of the Stimulus Generator Box and connect its mains lead to the isolation transformer, MP3001US, output. Connect the COMPUTER LINK PORT on the rear panel of the Stimulus Generator Box to the serial port COM1 of the computer via cable MP3033A provided.

16