EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM

K071348 · Mennen Medical , Ltd. · DQK · Sep 7, 2007 · Cardiovascular

Device Facts

• Record ID: K071348
• Device Name: EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM
• Applicant: Mennen Medical , Ltd.
• Product Code: DQK · Cardiovascular
• Decision Date: Sep 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

EMS-XL is indicated to acquire, filter, digitize, amplify, display and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals and pressure recordings. Physiological parameters such as the diastolic, systolic and mean blood pressure, heart rate and cycle length are derived from the signal data, displayed and recorded. The system allows the user to monitor, display and record the signal data. The system allows the user to monitor the acquisition data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. The system may display and record data received from other medical devices typically used during these procedures, such as Ablation RF generators. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

Device Story

The EMS-XL is a software-driven cardiac electrophysiology system used in clinical labs by physicians. It acquires, digitizes, and amplifies 12-lead surface ECG, blood pressure, and 18-50 channel intracardiac ECG signals via a patient connection box. An integrated, computer-controlled stimulator provides diagnostic pacing protocols (e.g., SNRT, overdrive, Wenckebach). The system features two displays: one for real-time waveform monitoring and one for non-real-time review, analysis, and report generation. It interfaces with ablation RF generators to display procedure parameters. Data is stored for archival and review. The system assists clinicians in diagnosing tachy-arrhythmias and conduction pathway issues by providing tools like on-screen calipers, event marking, and template comparison. It benefits patients by enabling precise electrophysiological mapping and diagnostic stimulation during cardiac procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technical specification comparisons, compliance with electrical safety standards (IEC 60601-1, EMC), and performance characteristics relative to predicate devices.

Technological Characteristics

System includes multichannel amplifier, stimulator, and computer. Inputs: 12-lead ECG, 2 pressure channels, 18/50 intracardiac channels. Connectivity: Ethernet, TCP/IP. Software: Windows-based, MS Word for reporting. Safety: Class CF, 5kV isolation, isolation transformer. Dimensions: 32/64 channel amplifier configurations. Sterilization: N/A (non-patient contacting).

Indications for Use

Indicated for patients undergoing electrophysiological studies and related procedures in an electrophysiological laboratory. Used for acquisition, display, and recording of ECG, intracardiac signals, and blood pressure. Includes diagnostic cardiac stimulation. Prescription use only.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Cardiolab EP system (K993414)
• Micropace model EPS 320 (K011826)

Reference Devices

• Carto XP System (referenced for comparison)

Submission Summary (Full Text)

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K07/348

Image /page/0/Picture/2 description: The image shows the logo for "mennen medical". The logo consists of a black circle with a white "m" inside it on the left. To the right of the circle, the word "mennen" is written in black, and below it, the word "medical" is written in gray.

SEP - 7 2007

Date: July 30, 2007

#### Topic: 510K Summery EMS-XL Cardiac Electrophysiology system

#### Establishment Name, Registration Number and Address:

| Name: | Mennen Medical Ltd. |
|----------------------|-----------------------------------------|
| Registration Number: | 9611022 |
| Operator Number: | 9069173 |
| Address: | 4 Hayarden Street, Yavne, 81228, Israel |
| Postal Address: | PO Box 102,<br>Rehovot, 76100, Israel |
| Tel: | [phone] |
| Fax: | [phone] |
| Contact person: | Micha Oestereich, Regulatory Affairs |

The following information is being submitted in conformance with [807.92(a)(2)].

| 1. Device Name: | EMS-XL - Cardiac Electrophysiology System |
|----------------------------|----------------------------------------------------------|
| 2. Classification Name: | Programmable Diagnostic Computer |
| 3. Trade/Proprietary Name: | EMS-XL Cardiac Electrophysiology System |
| 4. Common/Usual Name | Cardiac Electrophysiology system |
| 5. Classification Number: | 870.1425 computer, diagnostic, programmable |
| | 870.1750 External programmable pacemaker pulse generator |
| 6. FDA Classification | Class II |
| 7. Product Code | DQK |

#### 8. Predicated Devices:

Substantial Equivalence is claimed to the following devices:

- K993414 (4 July 2000) Cardiolab EP system. Prucka Engineering, Inc -
- K011826 (24 Jan 2002) -- Micropace model EPS 320. Micropace Pty Ltd. -

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#### Device description

The EMS-XL Cardiac Electrophysiology System consists of a software driven, multichannel amplifier and stimulator that are connected to a computer.

Input signals include 12 lead surfaces ECG, two Blood pressure channels and 18 or 50 channel intra-cardiac ECG.

The signals are digitized and sent to the computer for analysis, display and storage.

Signals are displayed with sweep speeds of 25 to 300mm/sec in either predefined or customized configurations.

The system consists of a computer, Front end amplifiers with integrated stimulator.

Two display screens, one used for Real Time signal display and the other for Non real Time display for analysis and review and playback of stored signals.

A Laser printer is used to print surface and intra-cardiac ECG and a CD or DVD is used for archive of signals.

The two display screens are used to show the signals. The real time display, RT, shows the real time signal waveforms. Each waveform channel is color-coded for easy identification. The non real time display, NRT, serves as a Review monitor allowing the manipulation and processing of data, including caliper measurements, event marking, snapshot storage and final report processing.

The stimulator is computer controlled and provides basic stimulation rate plus up to 4 stimulations delayed after the basic stimuli. Stimulation can be either synchronized to the cardiac electrical activity or non synchronized. Pacing protocols with automatic increment and decrement functions provides refractory period measurements.

A variety of stimulation sequences can be created and stored for future use.

The EMS-XL can be used for all types of electrophysiological procedures, including His bundle recording, Sinus Node Recovery Time - SNRT, Overdrive, Wenckebach, and tachy-arrhythmias. An interface to ablation generators provide Ablation Start and End information with data on the ablation parameters.

Each waveform is color-coded for easy identification.

The review monitor allows the manipulation and processing of data, including caliper measurements, event marking, snapshot storage and final report processing.

Special display options support the signal analysis

This includes Trigger mode and template comparison. Event marking. Holter mode: quick. minute-by-minute scrolls and jumps to event, On screen calipers: both real-time and review screen with auto measurement , Auto Tachycardia detection. Free text labeling, and Customized reports in Word™.

The input to the amplifiers is via a patient connection box, to which the intra-cardiac catheter electrodes (not manufactured and not supplied by Mennen Medical) are connected.

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#### Indication for use:

EMS-XL is indicated to acquire, filter, digitize, amplify, display and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals and pressure recordings. Physiological parameters such as the diastolic, systolic and mean blood pressure, heart rate and cycle length are derived from the signal data, displayed and recorded.

The system allows the user to monitor, display and record the signal data.

The system allows the user to monitor the acquisition data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. The system may display and record data received from other medical devices typically used during these procedures, such as Ablation RF generators. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

#### The intended use

The EMS-XL is a computerized Electrophysiological Measurement System, designed for conducting regular or experimental electrophysiology (EP) studies.

The EMS-XL System is intended to be used for performing computerized Electrophysiological and Ablation procedures.

The EMS-XL is intended for sale as a system for performing EP clinical studies Prescription Use under the supervision of a physician

### Control and Integration

The EMS-XL integrated stimulator allows complete control of all stimulator functions at all times, featuring programmable pacing protocols with automatic increment and decrement functions, comprising all basic modes. Furthermore, the system includes online Holter and Event windows that allow for simple and immediate tracking of ectopic events. Fully editable final reports are generated in a Microsoft Word™ format, easily integrating measured intervals and procedure notes, to improve efficiency and productivity while saving valuable staff time.

#### Additional Features

- · Trigger mode and template comparison
- · Customized reports in MS WordTM
- · Auto Tachycardia detection: Jump to event
- · SNRT Protocol
- · Automatic snapshot after pacing
- · Event marking
- · Holter mode: Quick, minute-by-minute scrolls and jumps to event
- · On screen calipers: Both real-time and review screens with auto measurement

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- · Export snapshots as image file for a PowerPoint presentation
- · Multiple interfaces to Ablation RF generators for display of ablation parameters and ablation stop/start events
- · Total case full disclosure archiving on hard drive
- · Easily upgradeable software

## Product Highlights

- · Built-in integrated stimulator:
- · Total full disclosure: Guaranties data integrity and long term archiving
- · Off-line review station: Review, analysis and printing of entire case from remote location (optional)

#### Product Comparison to predicated devices

The EMX-XL system combined signal amplification, display and recording features with stimulation capabilities.

We thus have two predicated devices:

- Cardiolab EP system. Prucka Engineering, Inc K993414 (4 July 2000) | for the signal amplification, display and recording
- Micropace model EPS 320. Micropace Pty Ltd. K011826 (24 Jan 2002) --for the stimulation specification and features.

The following are the comparison tables:

- Amplifier Spec comparison .
- Comparison of Systems .
- Stimulator Spec Comparison .

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| Manufacturer | Predicated - GE Pruka | Mennen Medical | Effect<br>on<br>safety | Effect on<br>Intended use |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------|---------------------------|
| System | CardioLab II Plus<br>Amplifier | EMS-XL amplifier | | |
| Item | Description | Description | | |
| Physical Specifications | | | | |
| 64/32 channel HxWxD | 9.5x 14.0x 14.0 in | 32 = 4.5x 11.5x 8 in x<br>64 = 9.0x 11.5x 8 in x | No | No |
| 128/96 channel HxWxD | 14.0 x 14.0 x 14.0 in | Not used | N/A | N/A<br>Note 1 |
| Environmental Specifications | | | | |
| Temperature Operating | 0°C to +35°C | Same | | |
| Transport/Storage: | -15°C to + 50°C | -30°C to + 65°C | No | No |
| Humidity Operating: | < 95% relative at 35°C non-<br>condensing | 30% - 75% non<br>condensing | No | No |
| Humidity<br>Transport/Storage: | < 95% relative at 35°C non-<br>condensing | 5% - 95% non<br>condensing | No | No |
| rower Specifications: | | | | |
| Power Requirements | 100-240 V AC; 50-60 Hz | Same | | Same |
| Power Input (64/32<br>channel) | 0.0-0.5 Amps Class I, Type<br>CF Continuous operation | + 5 V , 0.0 - 0.2 A<br>+ 12 V, 0.0 - 0.3 A<br>- 12 V , 0.0 - 0.3 A | No | No |
| Power Input (128/96<br>channel) | 0.5-0.75 Amps Class I,<br>Type CF Continuous<br>operation | Not used | N/A | N/A<br>Note 1 |
| Design | | | | |
| Sampling and Hold | Each channel sampled prior<br>to acquisition. | Same | | Same |
| Sampling Rate | 1K, 2K and 4K | 1KHz | No | No<br>Note 2 |
| CMMR | 100 dB min | Same | | Same |
| | | Typical 20 MΩ | No | No |
| Input Impedance | > 1 Billion Ohms | Above the 2.5 MOhm<br>required by the<br>ANSI/AAMI EC11 par<br>3.2.9 | | Per standard |
| akage Current | | | | |
| Patient Source: | < 10 uA | Same - Per ISO 60601- | | Same |
| ...anufacturer | Predicated – GE Pruka | Mennen Medical | Effect on safety | Effect on Intended use |
| System | CardioLab II Plus<br>Amplifier | EMS-XL amplifier | | |
| Item | Description | Description | | |
| | | 1 | | |
| Patient Sink: | < 10 uA | Same – Per ISO 60601-1 | | Same |
| Patient Sink (measured at<br>patient leads under single<br>fault conditions): | < 50 uA | Same – Per ISO 60601-1 | | Same |
| Chassis Leakage: | < 100 uA | Same – Per ISO 60601-1 | | Same |
| ECG Input | | | | |
| Outputs | 12 lead ECG produced | Same | | Same |
| High Pass Filter | 0.05 Hz, 0.5 Hz, 5 Hz | 0.05, 0.2, 40, 80 Hz | No | No<br>Note 3 |
| Low Pass Filter | 100 Hz | Same | | Same |
| RF Filtering | All inputs | Same | | Same |
| ain | 50-10,000 in 8 settings | Between 0 and 255 mm/mVolt – Continuous | No | Note 4 |
| Saturation Recovery | Less than 1 sec. | Same | | Same |
| Notch Filter | Power line (50/60 Hz) | Same | | Same |
| | No data | +/- 5 mVolt<br>AAMI EC11 par 3.2.3 | | Per standard |
| Dynamic range | | | | |
| | No data | +/- 300 mVolt<br>AAMI EC11 par 3.2.3 | | Per standard |
| Baseline correction | | | | |
| Input / Output | | | | |
| Inputs 32 channels | 32 intracardiac inputs, 4<br>pressure inputs, 10 ECG<br>inputs | 36 intracardiac inputs<br>(18 channels), 2<br>pressure inputs, 10 ECG<br>inputs (12 channels) | No | No<br>Note 5 |
| Inputs 64 channels | 96 intracardiac inputs, 4<br>pressure inputs, 10 ECG<br>inputs | 100 intracardiac inputs,<br>(50 channels), 2<br>pressure inputs, 10 ECG<br>inputs (12 channels) | No | No<br>Note 5 |
| Inputs 96 channels | 160 intracardiac inputs, 4<br>pressure inputs 10 ECG<br>inputs | Not used | No | No<br>Note 1 |
| Inputs 128 channels | 224 intracardiac inputs, 4 | Not used | No | No |
| ...anufacturer | Predicated - GE Pruka | Mennen Medical | Effect<br>on<br>safety | Effect on<br>Intended use |
| System | CardioLab II Plus<br>Amplifier | EMS-XL amplifier | | |
| Item | Description<br>pressure inputs, 10 ECG<br>inputs | Description | | Note 1 |
| Outputs | 16 channels/Block. Up to<br>112 channels. 32 channel:<br>Block A 64 channel: Blocks<br>A-C 96 channel: Blocks A-E<br>128 channel: Blocks A-G | No outputs | No | No<br>Note 1 |
| Switching | Any input can be switched<br>to any output within a Block. | Each channel can be<br>either Bipolar or Unipolar<br>with Manual switching | No | No<br>Note 6 |
| High Pass Filter | DC, 0.05 Hz, 0.5 Hz, 5.0 Hz,<br>30 Hz, 100 Hz | 0.05, 0.2, 40, 80 Hz | No | No<br>Note 7 |
| Low Pass Filter | 500 Hz, 2,000 Hz | 500 Hz | No | No<br>Note 8 |
| RF Filtering | All inputs | Same | | Same |
| Gain | 50-10,000 in 8 settings | Between 0 and 255<br>mm/mVolt - Continuous | No | No<br>Note 4 |
| Saturation Recovery | Less than 1 sec. | Same | | Same |
| Notch Filter | Power line (50/60 Hz) | Same | | Same |
| Dynamic range | No data | +/- 5 mVolt<br>AAMI EC11 par 3.2.3 | | Per standard |
| Baseline correction | No data | +/- 300 m Volt<br>AAMI EC11 par 3.2.3 | | Per standard |
| Pressure Inputs | | | | |
| Inputs | Compatible with all standard<br>external pressure<br>transducers. 5uV/V/mmHg | Same | | Same |
| Input Impedance | > 1 Billion Ohms | Typical 20 MΩ<br>Above the 2.5 MOhm<br>required by the ANSI/AAMI<br>EC11 par 3.2.9 | No | No<br>Per standard |
| Outputs | Up to 4 pressure channels | 2 pressure channels | No | No<br>Note 4 |
| Low Pass Filter | 6 Hz, 25 Hz, 100 Hz, 400<br>Hz | DC to 12 Hz<br>(DC to 40 Hz optional).<br>IEC 60601-2-34 Standard<br>par. 51.103 requests at<br>least DC to 10 Hz. | No | No<br>Per standard |
| Excitation Voltage | 5V DC | 10 V DC (+5 to -5V). | No | Note 9 |
| ...anufacturer | Predicated – GE Pruka | Mennen Medical | Effect<br>on<br>safety | Effect on<br>Intended use |
| System | CardioLab II Plus<br>Amplifier | EMS-XL amplifier | | |
| Item | Description | Description | | |
| Output Impedance | < 0.050 Ohms | Same | | Same |
| Range | -400mm Hg to +400 mmHg | Same | | Same |

# Amplifier Technical Specifications comparison

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# Stimulator Specification comparison

| Manufacturer | Micropace Pty. Ltd.<br>Austria | Mennen Medical Ltd.<br>Israel | Effect<br>on<br>safety | Effect on<br>Performance |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------|---------------------------|
| | Predicated device | | | |
| Subject/Parameter | EPS320 | (integrated in) EMS-<br>XL | | |
| JA Concurrence | Yes K011826 | Pending | | |
| Isolated Stimulus<br>channels | 2 | 2 | | |
| Pulse Amplitude | | | | |
| Range | 0.1 to 25 mA into 800 Ω<br>load | 0.1 to 25 mA into 1500<br>Ω load | No | Note 10 |
| Increment | 0.1 mA up to 1 mA<br>Amplitude | 0.1 mA within whole<br>range | No | No |
| Accuracy | +/- 2% or +/- 0.2 mA<br>(whichever is larger) | Same | | Same |
| Pulse duration | | | | |
| Range | 0.5 to 10 msec | 0.1 to 9.9 msec | No | No |
| Increment | 0.5 - 10 msec, increment<br>of 1-10 msec | 0.1 msec | No | No, smaller<br>increments |
| Accuracy | +/- 0.15 msec | Same | | same |
| Inter-stimulus Interval (ISI) | | | | |
| Range | 180 msec to 9990 msec +/-<br>1msec or 0.1% (whichever<br>is greater) | Same | | Same |
| Manufacturer | Micropace Pty. Ltd.<br>Austria<br>Predicated device | Mennen Medical Ltd.<br>Israel | Effect<br>on<br>safety | Effect on<br>Performance |
| Subject/Parameter | EPS320 | (integrated in) EMS-<br>XL | | |
| Range (Burst) | 30 - 9900 msec +/- 1msec<br>or 0.1% (whichever is<br>greater) | Same | | Same |
| Increment | 1 msec | 10 msec | No | Note 11 |
| Sequential Delay (AV) | | | | |
| Range | 10-1000+/- 1 msec<br>(maximum ISI - 50 msec) | 11 - 250 msec | No | Note 12 |
| Increment | 1 msec | same | | |
| Programmed<br>Protocols | Threshold | Threshold panel key | No | No |
| | SNRT | SNRT panel key | | |
| | Burst | Vent. Burst key | | |
| | Overdrive | Atrial Burst key | | |
| | | Vent. Overdrive key | | |
| | | Atrial Overdrive key | | |
| | Multi- Sx | Same | | |
| Programmed<br>Protocols | Pace | Same | No | No |
| | Wenkebach | User defined protocol | | |
| | Nodal ERP / RSync_S2 | User defined protocol | | |
| Programmable<br>Protocol Key | 5 | Same | | |
| Number of Extra-<br>stimuli | 6(S2-S7) | 4(S2-S5) | No | Note 13 |
| Sensing (ECG synchronization) | | | | |
| Automatic or Manual<br>trigger setting -<br>sensitivity | External: 50 – 2000 mV<br>Internal: Pacing catheter<br>tip | Internal from any<br>surface or intra-cardiac<br>channel | No | No |
| Automatic or Manual<br>trigger setting -<br>Trigger lockup<br>(refractory time) | 5 - 5000 msec | Same | | Same |
| Automatic or Manual<br>gger setting - ECG<br>delay | 5 - 5000 msec | Same | | Same |
| Manufacturer | Micropace Pty. Ltd.<br>Austria<br>Predicated device | Mennen Medical Ltd.<br>Israel | Effect<br>on<br>safety | Effect on<br>Performance |
| Subject/Parameter | EPS320 | (integrated in) EMS-<br>XL | | |
| Additional Outputs | Stimulus channel A:Sync 3<br>Input marker<br>Stimulus channel A:Sync 3<br>Input marker<br>Programmable Auxiliary /<br>Paper advance: Sync 1<br>Input marker<br>ECG trigger marker: Sync<br>1, Sync 2 . | No | No | Note 14 |
| Power Source | Mains 220/110 to 14.5<br>VDC, 750 mA low voltage<br>power supply.<br>Backup Power: battery | Integrated with<br>Amplifier<br>+ 5 V , 0.0-0.2 A<br>+ 12 V, 0.0-0.3 A<br>- 12 V , 0.0 - 0.3 A | Yes | Note 15 |
| Simulation module | | N/A | | |
| Dimension | 3.0x12.9x14.0 inch | N/A | | |
| Weight | 18.7 lbs. | N/A | | |
| Control terminal | | | | |
| Isolation<br>Transformer | | Yes | | Note 15 |
| Environment | | Stimulator integrated<br>with amplifier | | |
| Operating<br>Temperature | +10 to +40 Celsius | 0°C to +35°C | No | No, Note 15 |
| Storage Temperature | -20 to +60 Celsius | -30°C to + 65°C | No | No, Note 15 |
| Operating Relative<br>humidity | 20% to 90% non-<br>condensing | 30% - 75% non<br>condensing | No | No, Note 15 |
| Storage Relative<br>humidity | 20% to 90% non-<br>condensing | 5% - 95% non condensing | No | No, Note 15 |
| Operating altitude | 0 to 4572 meter | - 400 to 3050 meter | No | No |
| Storage Altitude | 0 to 7620 meter | - 400 to 5000 meter | No | No |
| Controller | Embedded micro-<br>controller | Integrated into the<br>Amplifier and computer | No | No, Note 15 |
| *Manufacturer | Micropace Pty. Ltd.<br>Austria<br>Predicated device | Mennen Medical Ltd.<br>Israel | Effect<br>on<br>safety | Effect on<br>Performance |
| Subject/Parameter | EPS320 | (integrated in) EMS-XL<br>control | | |
| User Interface | PC windows-style<br>graphical display | Same on the EMS-XL<br>display | No | Note 15 |
| Power supply | Class II | See EMS-XL computer | No | Note 15 |
| Isolation transformer | Toroidal 1 : 1 medical<br>grade, 110-240 VAC, 100<br>VA max | See EMS-XL computer | No | Note 15 |
| 0/S Software: | Custom RTOS / Datalight<br>ROM-DOS | See EMS-XL computer | No | Note 15 |
| Backup power | 12V 2.1 Ah sealed lead<br>acid | See Note A. | No | Note A |
| Emergency power: | 9V LiMn02i PP3, 10y life | See Note A. | No | Note A |
| Operating time | Two (2) hours on backup<br>battery | See Note A. | No | Note A |
| Pacing Channels | | | | |
| Isolated Channels(3) | (i) Atrial and<br>(ii) Ventricular via green<br>Redel 4 pin socket<br>(iii) Emergency Fixed<br>Pace Output to Ventricle,<br>via red Redel 4 pin socket | Same function with<br>different connectors | No | Same |
| Power Source: | Internal DC-DC converters | See Note A. | No | No, Note A |
| Circuit Isolation: | Compliant with IEC601-1,<br>Class CF, 5kV, common &<br>differential mode | Compliant with<br>IEC60601-1, Class CF,<br>5kV, common &<br>differential mode | No | No |
| Computer Controlled Stimulus Pulses | | | | |
| Current: | 0.1 to 25 mA into 800 Ω<br>load | 0.1 - 25.5 mA, into<br>1500 Ω load 40V | No | Note 10 |
| Current Steps: | 0.1 mA | 0.1 mA | | Same |
| "Manufacturer | Micropace Pty. Ltd.<br>Austria<br>Predicated device | Mennen Medical Ltd.<br>Israel<br>(integrated in) EMS-XL | Effect on<br>safety | Effect on<br>Performance |
| Subject/Parameter | EPS320 | | | |
| Accuracy: | +/- 2% or +/- 0.2 mA, which ever is greater | +/- 0.1 mA | | |
| Pulse Duration: | 0.5 ms, 1-10 ms in steps of 0.1ms | Pulse width 0.1 – 9.9 mSec steps of 0.1 mS | No | No |
| Accuracy: | +/- 0.15 ms | +/- 0.1 mA | | Same |
| Load Impedance: | 200-1000 Ω, $<$ 700 Ω for max current | 1500 Ω | No | Note 10 |
| Max Output Voltage | 27V | 40 V | No | Note 10 |
| Inter-stimulus Intervals | | | | |
| S1 Range: | 180 - 9990 ms (Pace)<br>30 - 9990 ms (Burst Pace) | Same | | Same |
| ability: | Quartz computer clock,<br>+/- 30 parts per million @ 25° C | Same | | |
| Extra-Stimuli: | 6 max, S2-S7, independent | 4 max, S2-S5, independent | No | Note 13 |
| Coupling interval: | 30 - 9990 ms | Same | | Same |
| Accuracy | +/- 1 ms or 0.1 % whichever is greater | +/- 10 ms | No | Note 11 |
| Protocol Automation | | | | |
| Auto decrement / increment: | Yes | Same | | Same |
| | SNRT S1 intervals and RT calculation | Same | | Same |
| | Auto pace and sense - | Same | | Same |
| | His-coincident extra-stimulus timing calculation | Caliper with labels | No | Same function |
| | ATP S1 calculation from % of TCL | No | Yes | Note 16 |
| | Trigger output on sensed ectopic beats | No | Yes | Note 16 |
| Manufacturer | Micropace Pty. Ltd.<br>Austria<br>Predicated device | Mennen Medical Ltd.<br>Israel | Effect on<br>safety | Effect on<br>Performance |
| Subject/Parameter | EPS320 | (integrated in) EMS-<br>XL | | |
| | Stop On Tachycardia | No | Yes | Note 16 |
| | All automation subject to<br>instant operator<br>adjustment | Same | No | Same |
| Backup Manually<br>Controlled<br>Stimulation | | No backup stimulator<br>Use external backup<br>stimulator | Yes | Note 17 |
| Emergency Backup<br>Pacing | | No backup stimulator.<br>Use external backup<br>stimulator | Yes | Note 17 |

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