Micropace OPLab User Instruction Manual Ver 1.4 Firmware ver 4.73

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 Intended Use ...1 1.1.3 Indications for Use...1 1.1.4 Contraindications ...1 1.1.5 Compatible Equipment ...2 1.2 IMPORTANT PATIENT SAFETY WARNINGS ...3 1.2.1 General Warning ...3 1.2.2 Warnings Specific to the ORLab™ Cardiac Stimulator ...4 1.2.3 Warnings Related to the use of ORLab™ Stimulator with RF Ablation Equipment ..5 1.3 GENERAL PRECAUTIONS IN HANDLING STIMULATOR ...5 1.4 ADVERSE EVENTS ...7 1.4.1 Observed Adverse Events ...7 1.5 POTENTIAL ADVERSE EVENTS ...8 1.6 SUMMARY OF ORLAB’S EPS320 STIMULUS GENERATOR UNIT FIELD TRIAL ...10 1.7 INDIVIDUALIZATION OF TREATMENT & PATIENT COUNSELING INFORMATION ...11 1.8 REFERENCES ...12 2. DEVICE RATINGS, CLASSIFICATION AND CERTIFICATION ...13 3. COPYRIGHT, WARRANTY AND DISCLAIMER NOTICE ...14 4. EXPLANATION OF SYMBOLS ...15 5. INSTALLATION INSTRUCTIONS...21 5.1 TECHNICAL DESCRIPTION...21 5.2 WHO MAY INSTALL THE ORLAB™ ...22 5.3 HOW ORLAB™ SUPPLIED ...22 5.4 STIMULATOR OPTIONS ...23 5.5 CONNECT SYSTEM COMPONENTS ...24 6. VERIFYING THE SYSTEM...27 6.1 TRAIN CUSTOMER ...28 6.2 MICROPACE ORLAB™ INSTALLATION CHECKSHEET...29 7. USING THE ORLAB™ CARDIAC STIMULATOR ...31 7.1 SWITCHING ON AND OFF THE SYSTEM ...31 7.2 USING THE COMPUTER ...31 7.3 USING THE TOUCH DISPLAY ...32 8. USING THE ORLAB™ SOFTWARE...34 8.1 SCREEN PAGE LAYOUT ...34 8.2 STARTING A NEW STUDY ...34 8.3 ORLAB™ HELP FACILITY ...35 8.4 MAIN STUDY PAGE - SENSE PACE PROTOCOL ...36 8.4.1 Controls include: ...36 8.4.2 Conduction Block Determination...37 8.4.3 Pacing threshold measurement ...38 8.4.4 Synchronizing start of pacing to PQRS...38 8.4.5 Contact Test ...38 8.4.6 Peak Detection / QRS detection ...39 8.4.7 Peak to peak interval / RR Display ...39 8.4.8 Amplitude Measurement & Display ...39 8.4.9 Ablation State labels: “Pre” and “Post”...40 8.5 BURST STIMULATION PROTOCOL ...41 8.5.1 Controls include: ...41 8.5.2 Burst Stim Button Safety Delay Tone...42 8.6 EMERGENCY PACE ...43 8.7 REVIEWING ECG’S ...44 8.7.1 Calipers ...45

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8.7.2 Saving ECG Data ...45 8.7.3 Loading Stored ECG Data ...45 8.8 PRINTING ECG’S ...46 8.9 CONFIGURING ORLAB™ PROTOCOLS ...48 8.9.1 Setup available for Sense Pace Protocol...48 8.9.2 Setup Page for Burst Stim Protocol ...52 8.10 SERVICE SET UP ON ENTRY SCREEN – ADMINISTRATION PAGE ...53 8.11 KEYBOARD AND NUMERIC KEYPAD...55 9. THE EPS320 STIMULUS GENERATOR UNIT ...56 9.1 STIMULUS GENERATOR UNIT LAYOUT ...56 9.2 STIMULATOR CONNECTIONS ...58 9.3 HARDWARE ERROR MESSAGES ON THE STIMULUS GENERATOR UNIT...60 10. TROUBLESHOOTING ...62 11. MAINTENANCE ...64 11.1 BATTERIES...64 11.2 MAINTENANCE AND CALIBRATION ...64 11.3 CLEANING INSTRUCTIONS...65 11.4 SERVICEABLE LIFE AND DISPOSAL ...66 12. ORLAB™ SPECIFICATIONS ...67 13. MANUFACTURER’S GUIDANCE AND DECLARATION–ELECTROMAGNETIC EMISSIONS 68 13.1 CABLE LENGTHS ...68 13.2 EMI / EMC SPECIFICATIONS ...69

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Glossary and Terms Term

Explanation

Drive Train

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

ECG

Electrocardiogram

EP

Electrophysiology

IECG 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

Micropace Stimulus Generator Unit

SNRT

Sinus Node Recovery Times

StimLink™ Sx

iv

Intra-cardiac Electrocardiogram

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.

ppm

Pulses per minute

bpm

Beats per minute

GUI

Graphical User Interface

/min

Events per minute

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USER INSTRUCTION MANUAL

1. INTRODUCTION & ESSENTIAL PRESCRIBING INFORMATION 1.1 Device Description 1.1.1 Description of system The ORLab™ is a programmable diagnostic cardiac stimulator with electrocardiogram display tailored for use as a diagnostic tool during surgical and RF ablation procedures for the treatment of arrhythmias in cardiothoracic theaters and hospital electrophysiological laboratories. No part of the ORLab or its accessories is intended to contact the patient, instead, pacing stimuli are delivered, and ECG signal recorded, via third party products, which may include transvenous endocardial electrode catheters or epicardial mapping and ablation wands. The ORLab™ device belongs to the Micropace EPS320 product family (Models EPS320B, StimLab™ and ORLab™), which are all based on the EPS320 stimulus generator unit (SGU). The EPS320 SGU is a two channel, mains and battery powered microprocessor-based cardiac stimulator, manually controllable from its front panel. In normal use, however, it is controlled by a separate computer using a variety of user interfaces and computer accessories according to the product model. The ORLab™ model uses a single touch-activated graphical user interface (GUI) to control, display and record results of diagnostic stimulation with the option of printing of selected ECG signals to a laser printer. The ORLab™ computer interface is optimized for the subset of electrophysiological procedures performed in cardiothoracic operating rooms, which require greater ECG display functionality but simpler stimulation protocols than do the procedures typically performed in the EP laboratory. Three ECG channels are displayed, one surface ECG channel derived from a third party ECG monitor and two intra-cardiac channels from the two pacing channels of the ORLab’s EPS320 SGU. ECG data is continuously recorded in a circular 80s buffer and may be captured for review, measured and printed to an external laser printer along with user text comments. ORLab’s two main stimulation protocols include Pace-Sense protocol, suitable for physiological pacing within the range of 30 to 350 ppm, as well as determination of pacing threshold. The second protocol, Burst Stim allows burst overdrive stimulation of arrhythmias and induction of fibrillation with pacing rates from 100 to 1800 ppm. Stimulation protocols with extra-stimuli, incremental or decremental pacing and repetitive stimulation are also available from a background menu.

1.1.2 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.

1.1.3 Indications for Use The ORLab™ Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

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

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1.1.5 Compatible Equipment The primary function of the ORLab™ 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: 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 maximum attainable pulse current amplitude; lower shunt resistance reduces delivery of 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 ORLab™ system’s Stimulus Connection Box. Subject to these requirements, the ORLab™ 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: RF Ablation generators and ablation electrode catheters The ORLab is tested for use with Atricure range of intra-operative RF Ablation products, including the Isolator ® System, consisting of the following products: Isolator® System Isolator® pen, 19cm AtriCure® Source Switch Accessory ® AtriCure Ablation and Sensing Unit

Product Code MAX1 / MAX3 ASB1 / ASB3 ASU2 / ASU3

ORLab’s EPS320 Stimulus Generator Unit is compatible with a number of other commercially available RF generators and ablation catheters – contact Micropace Pty Ltd to for further information. (Refer also to “Warnings and Precautions” section below). EP Recording equipment TM

Computerized EP Recording systems manufactured by Bard Electrophysiology (LabSystem DuoTM and LS ProTM) and GE/Prucka (CardioLab 4000, 7000) have been tested for use with the EPS320 Stimulus Generator Unit and are compatible with ORLab™. Diagnostic pacing electrode catheters ORLab’s EPS320 Stimulus Generator Unit is compatible with most currently available legally marketed electrophysiological diagnostic electrode catheters, including those manufactured by Cordis Biosense Webster, Daig, CR Bard, Medtronic and EPT. External ECG Monitor ORLab requires an amplified surface ECG signal from an external source and is compatible with the ECG output of third party Patient Monitors such as the Phillips IntelliView Patient Monitor series and others having: 6.5mm Phone Socket with ECG signal on center pin Signal amplitude ±1V peak to peak full scale with source impedance < 3kOhms Amplification 20 to 1000

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1.2 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.

1.2.1 General Warning Warning: Stimulator must be used only under supervision by a cardiologist or surgeon. 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 by or under the direct supervision by a physician or surgeon familiar with electrophysiology and the operation of this Stimulator, and in an appropriate hospital facility. The supervising physician or surgeon 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. In order to prevent electrocution hazards or impaired performance of the Stimulator from incorrect installation, only qualified personnel, such as representatives of Micropace Pty Ltd, its authorized distributor or hospital-appointed biomedical engineers, may carry out installation of the ORLab™ Stimulator and its connection to other equipment. In order to reduce operator errors, the installation, configuration and customer training should be performed in a manner, which allows optimal use of the stimulator by the user. Warning: Stimulator is not a life support device – operator must have available backup temporary external pacemaker. To avoid injury to patient from bradycardia, operator must have available a backup temporary external pacemaker. The ORLab™ 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-life-threatening bradycardia; in case of life-threatening bradycardia, pacing with a temporary external pacemaker must be established immediately. 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 power supply only. To avoid electrocution hazards, all parts of the Stimulator system, including the computer, monitor, laser printer and the Stimulus Generator Unit must all be connected to the Mains Isolation Transformer and never directly to a mains outlet. To avoid electrocution hazards and prevent overloading the transformer, do not connect any other equipment to the supplied Mains isolation transformer. To avoid electrocution hazards due to mains cords bypassing the isolation transformer in the future, ensure that mains cords are retained in the isolation transformer outlets with the supplied screw-on Transformer Cord Retention Bracket and that power supply units next to the transformer are secure and access to be prevented by a screw-on cover supplied with the cart.

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Warning: Connect Stimulator system only to legally marketed, mains-isolated electrical equipment. 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 UL/IEC60601-1 or IEC60601-1-1 standards or equivalent as applicable, is legally marketed in the country and is CE marked for installations in the EU countries. Ensure that total earth leakage current of ORLab™ and any interconnected equipment under normal conditions does not exceed 500µA (300µA in USA). Warning: Use Stimulator only in ventilated areas and away from flammable gasses. To avoid risk of explosion, the Stimulator should only be used in a ventilated area as gasses may be released during charging of backup battery, and should not be used in rooms with flammable anesthesia.

1.2.2 Warnings Specific to the ORLab™ Cardiac Stimulator Warning: ORLab™ is not an ECG Monitor or Heart Rate meter and has no alarms – always monitor patient’s vital signs with other equipment intended for such monitoring. The ORLab™ is a clinical diagnostic tool with only intermittent indirect access to patient electrocardiograms; it is not an ECG Monitor or Heart Rate meter for monitoring vital sign nor is it a life support device. When using the ORLab™, do not rely on the “Rate (/min)” displayed on the ORLab™ to represent patient’s heart rate, as it may be set to count events other than QRS’s. Always monitor the patient’s ECG and Heart Rate with a separate approved ECG monitor / vital signs monitor. Warning: ORLab™ may cause unexpected effects – always monitor patient’s vital signs with other equipment intended for vital signs monitoring. The ORLab™ Stimulator may fail to stimulate or unintentionally stimulate the patient through software, hardware or human error. To avoid injury to patient from arrhythmias, monitor the function of Stimulator and patient’s vital signs continuously while Stimulator is connected to the patient. In case of repeated recurrence of unexplained life-threatening arrhythmias despite cardioversion/defibrillation during the use of the Stimulator, disconnect the Stimulator from the patient by unplugging the green Pace Output plug on the front panel in case it has an occult malfunction causing recurrent micro-electrocution or recurrent DC current stimulation. Warning: Patients with permanent or temporary pacemakers - ORLab™ ECG display and Rate measurement may be incorrect in the presence of pacing spikes. ORLab™ has no pacemaker spike detection or suppression. Pacemaker spikes may or may not be displayed and may or may not be counted in Rate measurement. Warning: Burst Stimulation may induce Ventricular Fibrillation In order to prevent inadvertent induction of ventricular fibrillation, when applying Burst Stimulation, ensure stimulation electrode is not in contact with ventricular myocardium. In particular when pacing inferior parts of left or right atria, verify that no second ventricular electrogram is present in the atrial recordings prior to stimulation.

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1.2.3 Warnings Related to the use of ORLab™ Stimulator with RF Ablation Equipment Warning: Use Stimulator only with RF-filtered stimulus connection. (Micropace parts: MP3014). Use only supplied Stimulus Connection Box (MP3014), to connect Stimulator’s stimulus output to patient circuits. The component 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. The MP3014 component is 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 MP3014 component. Warning: Do not stimulate via ablation electrode during delivery of RF Ablation energy. To avoid possibility of unintended arrhythmia induction, do not stimulate myocardium via the ablation electrode during application of RF energy. Efficacy and potential for adverse effects of stimulation of heated myocardium in the process of ablation have not been established.

1.3 General Precautions in Handling Stimulator Caution: Installation, Transport and Storage. 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. To ensure that operator may readily 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. 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 10,000m altitude during transport and handling. To ensure that backup battery remains fully charged, store system between uses with the Stimulus Generator Unit connected to mains power supply, switched on at the rear panel switch (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. Ensure that all cables are properly installed and secured. Ensure that the mains power supply is isolated and that attached equipment is also electrically isolated and does not pose an electrical hazard. If the stimulator has been unused or may have been disconnected from mains power supply for more than 1 month, charge backup battery by leaving connected to the mains supply in Standby Mode overnight and check that Emergency Fixed Rate Pacing and the stimulator generally functions correctly.

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Do not use the stimulator if any component appears damaged, computer appears to start up abnormally, or error messages appear on the computer screen or Stimulator front panel. If in doubt, contact the Distributor or Micropace directly. Ensure that the Operator is trained thoroughly on how to switch the Stimulator to Backup Manual mode or Emergency Fixed Rate Pacing modes. To prevent ORLab™ software malfunction, do not install other software. Caution: Precautions during use. The entire EPS320-ORLab™ may be used in the Patient Environment. Observe the stimulator and patients at all times for abnormal function and rectify any problem promptly or disconnect the patient from the stimulator (by unplugging the green plug from the green PACE OUTPUT socket on the front panel). Do not use the Stimulator and disconnect it from the patient if it repeatedly switches to Backup Manual mode and displays error messages on the front panel. Contact your Micropace Distributor. To ensure reliable stimulus capture, set stimulation current according to capture threshold whenever changing stimulation site or catheter. Two times threshold is usually used. Use of excessive stimulation currents may induce fibrillation and produce misleading results in ventricular stimulation studies. To reduce chance of accidentally inducing ventricular fibrillation, ensure reliable ECG sensing and use QRS SYNC function to avoid stimulating in the vulnerable diastolic period where appropriate. Line isolation monitor transients may resemble actual cardiac waveforms and thus make Rate measurements incorrect. Such transients may be minimized by proper grounding of ORLab™ and following directions for the connection of ORLab™ to other equipment. ORLab™ indicates inoperative state in one of two ways: (i) Error message or ‘freeze’ of or loss of display on computer screen followed 7 seconds later with Stimulus Generator Unit (SGU) adopting Backup Manual mode, displaying ‘600’ and ‘5.0’ on its front display. You may now operate the SGU by the buttons on its front panel to urgently pace the patient if required. You may also power off and on the computer. (ii) Error message on front of Stimulus Generator Unit, in which case, if you need urgent pacing, you may move green Stimulus Output plug to the Emergency Fixed Rate Output which will pace Chan 2 (Ventricle) only. ORLab™ is not a life support device, connect patient to a temporary pacemaker box as soon as possible. ORLab™ should be serviced before further use. Caution: Precautions between uses. The ORLab™ Stimulator should be connected to external power; its Power switched to the On position at the rear panel switch and in the Standby Mode while not in use to ensure that backup battery remains fully charged. The Stimulator should be maintained according to “Maintenance” section of this manual.

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1.4 Adverse Events1 The ORLab™ 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): Arrhythmia Death Explosion or fire Myocardial injury Operator electrocution Refer to above Warnings and Precautions.

1.4.1 Observed Adverse Events The ORLab™ 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 A prospective field trial of safety and efficacy of the EPS320 performed in May to July 1999 concurrently at 4 hospitals in Sydney, involving 6 Stimulators / cardiologist users and a total of 23 patients. Clinical use of the EPS320 in Australia and Southeast Asia from July 1999 to October 2001, involving 22 Stimulators and an estimated 7400 patients. Clinical use of the EPS320 in EC countries from January 2001 to October 2001, consisting of 17 Stimulators accumulating clinical exposure to an estimated 2400 patients. The EPS320 Stimulator has thus been used on an estimated total of 10,000 patients, approximately half using the current firmware version, leading to an estimated device exposure of 25,000 hours. No deaths or injuries related to the use of the EPS320 Stimulator have been reported during the device exposure. Two adverse events were reported, both due to device interaction with an RF Ablation Generator. They were non-sustained Ventricular arrhythmias arising when operators simultaneously paced and delivered RF ablation energy through the same ablation electrode; the EPS320 Stimulator detected the interaction and shut down in both cases. Device interaction has been eliminated in the field by the issue of a Safety Alert warning against this application and the addition of RF filters to Stimulator’s Stimulus Connection Box to isolate Stimulator from RF signals.

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Sections 1.4 – 1.8 for US Market only

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1.5 Potential Adverse Events Following is a list of potential adverse events which could be directly associated with diagnostic cardiac stimulation using the ORLab™ during electrophysiological studies (alphabetical order): Bradycardia or asystole Should a patient develop bradycardia or asystole during the use of the Stimulator, failure to promptly backup pace the patient may lead to hypotensive injury within seconds to minutes. Such arrhythmia may typically occur (i) in patients with atrio-ventricular conduction defects, (ii) during placement of intra-cardiac electrode catheters, (iii) after cardioversion/defibrillation or (iv) during RF ablation. The Stimulator may fail to normally deliver stimuli due to (i) power failure or power interruption, (ii) failure of PC, (iii) loss of communication between PC and Stimulus Generator Unit (SGU), e.g. due to lead disconnection or (iv) failure of SGU itself due to spontaneous fault or damage from external events such as defibrillation of RF ablation energies. To avoid patient injury, the user may use the battery powered Backup Manual Pace mode in case of power failure, failure of PC or the communication link, and the Emergency Fixed Pacing mode in case of failure of normal operation of the SGU. The ORLab™ 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. DC voltages greater than 5000V or RF voltages greater than 350V pp applied to Stimulator outputs may cause circuit failure; the Stimulator issues a range of alarms in case of failure of output circuits – see Section “Hardware Error Messages on the Stimulus Generator Unit” Explosion or fire Explosion could arise from accumulation and ignition of explosive gasses vented from charging of the backup battery within the Stimulator. Use Stimulator only in well-ventilated areas. Explosion could also arise from electrical sparks within the Stimulator igniting explosive anesthetic gasses in the operating room. Do not use Stimulator in the presence of volatile anesthetic gasses. Continuous RF voltages greater than 350V pp applied to Stimulator outputs in contravention of labeling may cause overheating of the Stimulus Connection Box and possibly cause a fire hazard. Similar hazards would probably be present in other equipment with over voltage protection. Special care will be required should RF generators capable of delivering such voltages (corresponding to in excess of 150W into 300 Ohm load) become available. Myocardial injury Excessive current flows through intra-cardiac electrodes, such as due to failure of Stimulator output circuit causing excessive stimulation currents and inadvertent shunting of defibrillation or RF ablation energies through a malfunctioning Stimulator or equipment attached to its outputs could theoretically cause localized myocardial damage at the pacing electrode. In order to minimize risk of myocardial injury, connect ORLab™ Stimulator stimulation outputs only to legally marketed medical equipment compliant with UL/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 The ORLab™ 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 UL/IEC60601-1. 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. In order to minimize risk of electrocution to the operator, connect ORLab™ Stimulator input/output ports only to legally marketed medical equipment, isolated from mains power and compliant with UL/IEC60601-1 and IEC60601-1-1. Ventricular tachycardia or fibrillation The ORLab™ 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 ORLab™ 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 QRS Sync 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 ORLab™ 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 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 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 behavior whenever patient is connected to the Stimulator; disconnect the patient from the Stimulator and do not use if abnormal stimulation is observed.

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(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 ORLab™ Stimulator or connected third party equipment if the mains power supply is not isolated in all interconnected equipment. Ensure that the ORLab™ Stimulator system, including the PC and all connected third party equipment is connected only to isolated mains power supply.

1.6 Summary of ORLab’s EPS320 Stimulus Generator Unit field trial Introduction: EPS320 Stimulus Generator Unit used in the ORLab’s configured system was validated in the clinical setting by a field trial of a related configuration, model EPS320B Cardiac Stimulator, using the same generator unit and similar computer interface architecture, and by subsequent field clinical experience with this generator unit from 800 products placed into the market since 2001. The ORLab’s integration of this generator unit with a new computer graphical interface and a printer was verified by laboratory testing to perform according to specifications and validated by one user expert in the field of clinical electrophysiology. The field validation trial of the earlier EPS320B stimulator was performed by a sample of end-users while 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.

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Conclusions: The EPS320 Cardiac Stimulator: Performs within acceptable safety parameters at all times. Performs substantially to the system requirements set out for the device and appears to satisfy Electrophysiologist’s clinical requirements. PARAMETER Nominal Protocol Stimulator performance (all must pass) All programmed pacing stimuli are delivered (all = pass) Adequate capture achieved (all expected = pass) Adequate sensing: 4:>90%, 3:70-90%, 2:50–70%, 1: <50% (>70%=Pass) Upper and lower limits of variables satisfactory for clinical purpose? (Ask clinician) Did Sync-to-QRS function correctly- pacing started on all first (detected) QRS? Performance during tachycardia (all must pass) Adequate sensing4:>90%, 3:70-90%, 2:50–70%, 1:<50% ( >70%=Pass) Performance during RF ablation (all must pass) No Stimulator Error during ablation Operator able to recover stimulator from error Performance during defibrillation (all must pass) Number of defibrillations during study; Record of any malfunction (no., none = pass) Failure modes (all must pass) Did error codes appear on stimulator Unit? (No=Pass) Loss of communication between PC and Unit occurred? (No=Pass). If communication lost, was it re-established easily? (Yes=Pass) Record of any computer freeze or unexpected behavior as well as any display anomalies, (None = pass). Test of Backup Manual stimulation (all must pass) Did Interval and Current adjustments work and pacing stimuli work? (Yes= pass) Did all stimuli capture patient; (all = pass) Emergency fixed pace operation worked (all stimuli issued) User performance Score (5=very good, 4=good, 3=adequate, 2=poor, 1unsatisfactory) User-friendliness of computer user interface (self-evident menus/operation) Ergonomic (speed, ease, minimum number of steps) of operation. Overall Safety of operation. Reliability of operation, lack of breakdowns, delays. Fit for purpose of EPS Stimulation (essential features) Comprehensiveness of features within system (all desired features) Flexibility of use (adaptability to non-standard/new uses)

TOTAL/ MAX 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 Counseling Information Pacing threshold in each chamber studied should be established prior to stimulation and stimulation current should generally 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.

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ORLab™ CARDIAC STIMULATOR

To our knowledge, the ORLab™ 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.

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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2. DEVICE RATINGS, CLASSIFICATION AND CERTIFICATION CE Mark Compliance The ORLab™ Cardiac stimulator system, is compliant with the following EEC directives: 89/336/EEC & 92/31/EEC (EMC Directives) 73/23/EEC (Low Voltage Directive) 93/42/EEC (Medical Device Directive) 93/68/EEC (CE Marking Directive) Issuing Notified Body – SGS.

Compliance Testing was carried out and coordinated by the following Certified Bodies: EMC Technologies, Castle Hill, Australia TCA - Testing and Certification Australia, Chatswood, Australia

The ORLAB™ Cardiac stimulator classification: TGA, Rule 4.3 Classification Class IIb Medical Devices Directives (93/42/EEC & 93/68/EEC), Rule 10 classification: Class IIb medical device IEC60601-1 electrical device classification: Class II (mains-isolated by approved external isolation transformer), IPX0, Type CF FDA Medical Device Level of Concern Level II Health Canada Medical Device Classification, Rule 10(2) Class III

The ORLab™ Cardiac stimulator system Power rating: 220-240VAC 50-60Hz, 4.1A max (while printing), 1.5A (not printing) 110-120VAC 60Hz, 8.6A max (while printing), 2.2A (not printing)

Identification of technical standards with which compliance is claimed: ISO 13485:2003 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 ANSI/AAMI EC13:2002 Cardiac monitors, heart rate meters, and alarms (relevant clauses only). ANSI/AAMI/IEC 62304:2006 Medical Device Software – Software Life Cycle Processes.

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3. COPYRIGHT, WARRANTY AND DISCLAIMER NOTICE Copyright and Trademark Notice Copyright © 1994-2008 by Micropace Pty Ltd. 7/186-188 Canterbury Road, Canterbury NSW 2193, Australia All rights reserved, Printed in Australia Datalight and ROM-DOS are registered trademarks of Datalight, Inc. Copyright 1989-2007 Datalight, Inc., All Rights Reserved. The ORLab™ 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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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 anesthetic mixtures. Do not expose to liquids. No user-serviceable parts inside. Refer Service to qualified service personnel.

! ! !

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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 labeled 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.

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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ORLab™ CARDIAC STIMULATOR

Symbol

Meaning

Name

Location

0

Power OFF

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

Device is switched ON and battery is charging.

Increase / Decrease

Increase / Decrease adjacent Interval or Current parameter.

Positive Output

Positive stimulus output. Defibrillator CF Protected part

On Stimulus Connection Box

Negative Output

Negative stimulus output, Defibrillator CF Protected part

On Stimulus Connection Box

Warning

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

On Stimulus Connection Box

Next to POWER switch on rear panel of Stimulus Generator Unit Next to POWER switch on rear panel of Stimulus Generator Unit On the front of Stimulus Generator Unit next to Interval Current displays

Table 2 Explanation of symbols

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