WorkMate Claris System Instructions for Use Sw Ver v.1.0.1 July 2015

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General

General Symbol

Description

Symbol

Description

Type CF applied part

Caution

Defibrillation-proof type CF applied part

Warning

Notified body CE Mark Defibrillator-proof type BF applied part EC

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

Do not reuse

Fragile

REP

Authorized representative in the European community Consult Instructions for Use On (power: connection from the mains)

Off (power: disconnection from the mains)

Keep dry Alternating Current Date of Manufacture Fuse Manufacturer Phone Use by date Facsimile Lot number Do Not Use If Package Is Damaged Catalog number Finish Goods Number Serial number

Separate collection of waste at end of life as required by European Directives. Dispose of in accordance with the applicable country regulation.

Temperature Limitation

Relative Humidity

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General

General Symbol

Description

Do not connect to the Patient

Symbol

Description Electrocardiogram Cable System

Package Contains 1 Items

Non Sterile

Intertek Safety Agency Certification Mark

This Way Up

Compatible with St. Jude Medical™ Electrophysiology Products

Potential Equalization Conductor (symbol is located on the terminal itself

TUV Safety Agency Certification Mark

Review Software

2 Port KVM Switch Amplifier

Includes: Bed Bracket Assembly

Ready for Transport

2 Port DVI Monitor Splitter

Bed Rail Kit Software Version Cable Kit. 10 m Integration Engine

Software Upgrade Kit

Cable Kit, 15 m Cable Kit, 30 m

Cable, Coax, 1 ft Follow instructions for use

RecordConnect Invasive Blood Pressure (IBP) Cable SDU Cable GSU Cable

Cable, Fiber Crossover 10m Cable, Fiber, 10m Cable, Fiber, 30m Cable, Serial, 3 ft Cardiac Stimulator

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General Symbol

General Description Cardiac Stimulator Cable Display Plus Amplifier DisplayPort Adapter

Symbol

Description Monitor Mount Rotational Stop Monitor Stand Kit Monitor

DMS59 to Dual DVI

Power Conditioner 1440 VA

ECG Cable Set, Radiolucent

Power Conditioner 1500 VA

ECG Cable Set, Radiopaque

Power Conditioner 500 VA

ECG International Cable Assy

Power Conditioner 600 VA

ECG Leadset ECG Radiotranslucent Leadset

Power Cord Power Kit, 110 Power Kit, 220

Equipotential Cable Power Strip 4 Ferrite, 18mm Power Strip 6 Ferrite, 9.85mm For Use With Generic Stimulator Cable

Power Strip 8 Power Supply Adapter Power Supply

HDMI Adapter Power Supply, 12V IFU, Software v.1.0 Printer Mouse Review Module - 10 License Keyboard Stimulator, 4 Channel Media Conv, DB9 Female System - Display Plus Media Conv, DB9 Male Touch Screen Stand Monitor 23” USB2DVI USB Framegrabber Monitor Cable Kit

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General Amplifier Symbol

Description Symbol

Description

DVI Cable S-Video to VGA Signal Converter Unit

Right Leg Connection

Software Upgrade

Stimulator connection

Software Installation

Catheter Interface Module cable connection for catheter inputs 1-56; RecordConnect Catheter Inputs 1-56

Refer to instruction manual/booklet

Catheter Interface Module cable connection for catheter inputs 57-120; RecordConnect Catheter Inputs 57-120 WorkMate™ Claris™ System Display Workstation Symbol

Description

RF Generator connection

Stimulator connection

Software Version

Amplifier Network Connection

Analog cable input connection

Analog cable output connection

Pace Detection cable connection

Synchronization Output cable connection

ECG or Record Connect ECG Cable Connector

DATA Network Connection

Display Workstation

Hospital Network Connection RF Filter

Indicates connector location

Fiber Optic Cable

Internal Blood Pressure

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Catheter Interface Modules (CI Module) Symbol

Description 56 Pin Catheter Interface Module 64 Pin Catheter Interface Module Reference socket connector

Amplifier

WorkMate™ Claris™ RecordConnect Symbol

Description RecordConnect

ECG cable connector

WorkMate™ Scribe™ Module Symbol

Description Display Workstation

Module

Amplifier Network Connection

DATA Network Connection

PHYSIO Connection Dual Monitor Mount

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WorkMate™ ImageSync™ Module Symbol

Description Module

WorkMate™ Unity™ Review Module Symbol

Description HL7 Module Review Module - Single License Review Module - Site License Review Module DICOM Module

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Table 1.Definitions, Acronyms, and Abbreviations ATM

Activation Timing Map

DPST

Double Pole Single Throw

EP

Electrophysiology

DWS

Display Workstation

OS

Operating System

CI Module

Catheter Input Module

TSM

Philips Touch Screen Module

A/D

Analog to Digital Converter

D/A

Digital to Analog Converter

Select

To click the left mouse button once while the mouse pointer is pointing to a selectable item.

FFT

Fast Fourier Transform

RF

Radiofrequency

CMRR

Common Mode Rejection Ratio

CathMap

Catheter map

LAT

Local Activation Time

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Introduction

The WorkMate™ Claris™ System is a fully computerized system for capturing and measuring physiological data in the clinical electrophysiology (EP) laboratory. It provides digital signal acquisition and display of those electrical signals on high resolution monitors. An EP system is used to monitor and analyze surface ECGs and intracardiac signals. Catheters are guided into the heart and intracardiac electrical signals are acquired from the electrodes on the indwelling catheters from various heart locations. These signals are then used to measure cardiac electrical activity via a catheter to the heart. A cardiac stimulator is used to send an electrical pulse via a catheter to the heart. These electrical pulses are called pacing protocols. Pacing protocols, for example, may be performed in order to reproduce any life threatening arrhythmias under the safest possible conditions for the patient. Treatment of an arrhythmia may then be initiated with ablation therapy, drug therapy, or placement of cardiac devices that will control the heart's rhythm. The system is also intended for recording electrocardiograms from multiple sites during clinical assessment of electrophysiological interventions. The WorkMate™ Claris™ System provides online measurements of intra-channel intervals, and presents these measurements on the display monitor. Retrieval and display are provided without interruption of the multi-channel acquisition process. A DVD disk drive is available for archival storage of digitized data. Menu-driven software is incorporated for patient signal analysis and data. The WorkMate™ Claris™ System has an integrated patient database system for rapid access to all patient records. Unique features of the system include: ■

Online interval measurement

■

Four-channel integrated stimulator

■

A choice of scrolling or wiper-mode display during Real Time signal acquisition

■

A comprehensive database with a query function

■

User configurable report template

Indications for Use The WorkMate™ Claris™ System is indicated for use during clinical electrophysiology procedures.

Contraindications There are no known contraindications to the use of the WorkMate™ Claris™ System.

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System Description The WorkMate™ Claris™ System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies. The system contains a fully automated software waveform detector (trigger), which performs on-line recognition of cardiac activation on pre-selected leads. Temporal interval measurements are computed on a beat-by-beat basis on multiple channels and dynamically posted on the Real Time display. Intervals are calculated between waveforms from the same source on a specific channel (intra-channel measurements) and from multisource signals across two or more channels (inter-channel measurements). All trigger locations with notes or annotations, as well as interval measurements, are stored concurrently with the digitized signals. The following intervals and measurement are presented on the display monitor as they occur: ■

Atrial-to-atrial (A-A)

■

Ventricular-to-Ventricular (V-V)

■

Surface QRS-to-QRS (R-R)

■

Ventricular-to-Atrial (V-A)

■

Pacing Stimulus (Stim)

■

Pressure (Pres)

Continuous capture of the digitized signals can be invoked for any portion of the study protocol, or for the entire study. Retrieval of earlier passages of the current study, or an earlier study of the same patient, can be enabled on a secondary monitor without interruption of the Real Time display. Review by protocol or by time of event can be performed by use of user interface buttons and hot keys. Editing of computer-generated trigger markers can be done under operator control in the Review mode. Archival storage of edited patient records is provided on various archive media.

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Figure 1 is a picture of the WorkMate™ Claris™ System cart and its components. 1. Remote Monitors (Review and Real Time) 2. Amplifier (120 channel pictured) 3. EP-4™ Cardiac Stimulator 4. Printer 5. Isolation Transformer 6. WorkMate™ Claris™ Display Workstation (DWS) 7. Keyboard 8. EP-4™ Touch Screen 9. Real Time Monitors

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1 8

7

5 3 2

4

5

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Figure 1. The WorkMate™ Claris™ Cart and Components WARNING: The cart pictured in Figure 1 is mounted on wheels and is mobile. During operation it is important to set the front wheel locks to prevent unexpected movement. Failure to do so could result in possible damage to the equipment and/or disruption of desired operation. NOTE: The cart in Figure 1 is mounted on wheels and is mobile. During transport it is important to retract monitors so they are centered above cart (Figure 2 and Figure 3).

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Figure 2. Safe transport position

Figure 3. Unsafe-Tip Hazard Figure 4 is a block diagram of most EP recording systems in use today. The cardiac signals are monitored by viewing a Real Time monitor, and are analyzed by viewing and measuring these signals on the Review monitor. The cardiac signals are captured and conditioned with a Amplifier, and then stored by the computer. The stimulator sends electrical impulses to indwelling catheters through the Amplifier. The computer then sends the signals to the monitors and stores these signals for future retrieval. Significant events and user notes are also stored for each EP procedure. EP summary reports and electrograms can be printed as desired.

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Figure 4. Basic EP Lab Connection WARNING: The components in the WorkMate™ Claris™ System must be supplied power from an isolation transformer for use in the Patient Environment to reduce leakage currents to safe levels.The amplifier and the EP-4™ Cardiac Stimulator may be plugged directly into the mains power.

System Components The WorkMate™ Claris™ System includes the following features and components:

ClearWave™ Technology The ClearWave™ Technology's 32-bit processing and increased sample rate allows increased dynamic range of signals. This dynamic range increase allows greater resolution of signals, providing dramatic clarity. It also retains all the flexibility and control offered with the unipolar signal capture. ClearWave™ Technology provides the highest signal resolution available for an EP Recording System. View complex, smaller, fractioned signals more clearly via the Increased Amplitude Resolution and Sample Rate. The ActiveNotch™ System cleanly filters line noise without compromising critical electrograms. The time from a pacing pulse to the recovery of the signal is important in pacing/mapping situations. ClearWave™ Technology also dramatically reduces this post pacing interval.

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WorkMate™ Scribe™ Module The WorkMate™ Scribe™ Module product is an optional integrated monitoring and review station for the WorkMate™ Claris™ System that allows a separate user to review and edit current patient study data stored on the WorkMate™ Claris™ System and monitor patient data from the WorkMate™ Claris™ System during the patient study. Most of this Instructions for Use (IFU) covers functions and features that are common to both the WorkMate™ Claris™ System and WorkMate™ Scribe™ Module. Refer to Chapter 10 for the instructions for use of the WorkMate™ Scribe™ Module.

EnSite™ Derexi™ Module The EnSite™ Derexi™ Module product is a software extension to the WorkMate™ Claris™ System Mapping Window and an electronic interconnection between the WorkMate™ Claris™ System computer and the EnSite™ Velocity™ System. EnSite™ Derexi™ Module synchronizes the Mapping Window signals and the procedure log to the EnSite™ Velocity™ stored map points. NOTE: The WorkMate™ Claris™ System is not compatible with the EnSite™ System prior to the EnSite™ Velocity™ System.

Refer to Chapter 11 in this IFU for information on the functions and features of the Mapping Window. Refer to Chapter 12 for information on the EnSite™ Derexi™ Module.

WorkMate™ ImageSync™ Module The WorkMate™ ImageSync™ Module is a supplementary component to the WorkMate™ Claris™ System, which connects to other systems and records images or movies into the WorkMate™ Claris™ System database, case, and patient record. Image systems (video sources) are logged in the procedure log. This module identifies and retrieves images side by side with the signals with this module. Refer to Chapter 4 on page 72 for information on the functions and features of the Imaging Window.

Patient Connections The patient is connected to the WorkMate™ Claris™ System through a surface ECG cable, catheters, and pressure transducer(s). These are plugged into the WorkMate™ Claris™ Amplifier and the CI Module. These inputs are electrically isolated from earth ground. The pacing outputs of the stimulator are electrically isolated and are plugged into the Amplifier.

Non-isolated Connections WARNING: The stimulator back panel connectors and Amplifier back panel BNC connectors are NOT isolated. Never connect them directly to a patient. Always plug external devices into an isolation transformer.

Non-isolated analog signals from other devices may be displayed using the non-isolated channels on the backside of the Amplifier NOTE: Special attention must be given to proper grounding and electrical safety. Even small chassis leakage currents passing through

the heart can induce fibrillation. Never connect non-isolated inputs or outputs directly to a patient. A functioning defibrillator should always be available. NOTE: Special attention must be given to all equipment connected to the patient. All equipment capable introducing a DC voltage level offset or introducing 50/60 cycle noise should be plugged into and share a common earth ground circuit. These devices include other recording systems, stimulators, defibrillators, and RF generators.

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Graphical User Interface The WorkMate™ Claris™ System consists of two, independent high resolution screens as well as a keyboard and a mouse for control of data acquisition, storage, and retrieval of electrophysiological signals. The main monitor is dedicated to Real Time visualization of signals. Signals that can be accommodated are typically surface ECG, intracardiac signals, stimulation markers, and output of blood pressure transducers. Automated wave form recognition and interval measurement are available for any of the electrocardiographic signals. The page number is also displayed. The secondary monitor is used as a menu-driven Review console for display and retrieval of data from either the current study or a previous study contained in the patient database. The presentation of menus provides for selection and control of system features. These features may be either mouse or keyboard activated and include such options as: ■

Catheter or lead identification

■

Choice of location, size, and color of the signal display

■

Selection of signals to be automatically analyzed

■

Entry of customized study protocols

■

Enabling or disabling permanent storage of signals

■

Measurement storage with the case study

The Review monitor serves as the display medium for previously recorded data. In the Review monitor, any portion of the recorded file can be accessed by event marker, time of event, or by scrolling through in a continuous or page-by-page mode. Other options available in the Review monitor are ■

Holter window,

■

Post acquisition filtering,

■

Automatic analysis

Warnings, Cautions, and Disclaimers The detection algorithms used by the WorkMate™ Claris™ System contain a sophisticated software trigger for electrocardiograms. The accuracy of trigger placement and interval measurement cannot be guaranteed, particularly in the case of poor signal quality. Therefore, verification of trigger locations and associated measurements is required on the part of the user before full confidence can be placed in reports produced by automated analysis. The equipment is intended for use by qualified medical personnel and only after they have been trained in the proper use of this equipment. This system should be used by or under the supervision of physicians thoroughly trained in techniques of intracardiac electrophysiology. The IFU is recyclable. Dispose of all packaging materials as appropriate. St. Jude Medical, Inc. does NOT assume responsibility for damage to the equipment caused by improper ventilation, improper or faulty power, or improper monitor booms. For continued safety, it is necessary that the instructions listed in this IFU are followed. It is important that instructions in this IFU in no way supersede established medical procedures concerning patient care. Federal law restricts this device to sale by or on the order of a physician.

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The following is a list of warnings and cautions that appear in this IFU or that may appear as labeling on the WorkMate™ Claris™ System or WorkMate™ Scribe™ Module: WARNING: The WorkMate™ Claris™ System components are not suitable for use within Oxygen Rich Environments or in the presence of flammable gases, including flammable anesthetic mixtures with air or with oxygen or with nitrous oxide. WARNING: The WorkMate™ Claris™ System should not be used adjacent to or stacked with other equipment.

The Amplifier has been tested in a stacked or adjacent configuration with the EP-4™ Cardiac Stimulator, and this is the only stacked or adjacent use that is permitted. WARNING: The use of the WorkMate™ Claris™ System accessories, transducers and cables, with any other Medical Electrical equipment or Medical Electrical system, may result in increased emissions or decreased immunity of that equipment or system. WARNING: Installing un-approved software or operating system on the WorkMate™ Scribe™ Module or WorkMate™ Claris™ hard drive may severely affect system performance and device safety. WARNING: Service by Qualified Personnel Only. WARNING: Do not utilize or add any extension cords with the system. The isolation transformer supplied with the system and any multiple socket outlet used on the system must not be positioned on or near the floor. These multiple socket outlets shall not be placed on the floor. WARNING: Do not handle power line connections while in contact with the patient. WARNING: The rate, cycle length, ECG, and pressure displays are not to be used as the primary/sole patient monitor during an

Electrophysiology study. These subsystems contain no alarms for indicating inoperative conditions. WARNING: Prior to using the WorkMate™ Claris™ or WorkMate™ Scribe™ Module system, read any and all supplied instructions and Technical Bulletins that describe known system limitations. WARNING: Consult the IFU for the optional Smiths Medical Advisor™ Vital Signs Monitor for all operating instructions, warnings and cautions specific to that device. WARNING: Prior to using the WorkMate™ Claris™ System, WorkMate™ Scribe™ Module, or the Derexi™ Module, be sure all system components are safely secured to the cart or other operating surface where the system installed. Falling components can cause injury to the operator or patient. WARNING: Do not allow liquid to enter the case or submerge any part of the WorkMate™ Claris™ System, WorkMate™ Scribe™ Module, or any accessories used with the system. Fluid spilled in the WorkMate™ Claris™ System, WorkMate™ Scribe™ Module, or accessory electronic components could cause the unit to malfunction or present a hazard that could result in patient or operator injury. Unplug the AC power cord from this equipment before cleaning or disinfecting. If any liquid enters the case of any item while the system is in use, unplug the power cable immediately. Only use dry hands when unplugging the power cable. Remove the unit from service and contact St. Jude Medical, Inc. CAUTION: DO NOT touch any connector to avoid electric shock. WARNING: If the connectors are forcefully connected the pins in the connector can be bent or broken. If this happens the cable must be destroyed to prevent its use. WARNING: The cart is mounted on wheels and is mobile. During operation it is important to set the front wheel locks to prevent unexpected movement. Failure to do so could result in possible damage to the equipment and/or disruption of desired operation. WARNING: Exit the system via the menu-driven selections for shutdown before turning the power OFF. Simply turning off the system or a power failure while running the system could cause loss of data. WARNING: This product is not intended as a life sustaining device. Rescue equipment must be available at all times during the EP procedure.

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WARNING: The Maximum Total Output Power of the main cart isolation transformer and the multi-socket power strips is limited to 1440 VA. The Maximum Total Output Power of the bedside cart isolation transformer and its multi-socket power strips is limited to 500 VA. Do not connect additional equipment to power strips supplied with the transformer. Failure to do so could result in system failure or damage. WARNING: Do not modify or make any additional connections to the WorkMate™ Claris™ System, other than those described in this manual. WARNING: Do not connect items of the WorkMate™ Claris™ System that are required to be plugged into an isolation transformer directly to a wall supply power outlet. Plugging these items directly into the power outlet supply can cause excessive patient leakage currents. WARNING: The multi-socket power strips supplied with the system should only be connected to the isolation transformer supplied with the system. WARNING: The system may serve for clinical use only after it has been fully tested and approved according to standard St. Jude Medical procedures. WARNING: The WorkMate™ Claris™ System and its peripherals/accessories comply with IEC 60601-1-2 for EMI/EMC. However, since it processes and displays low level patient signals, other radiating devices may interfere. WARNING: When connecting the WorkMate™ Claris™ System or components to any other device or system, verify proper

operation before clinical use. WARNING: Accessory equipment connected to the analog and digital interfaces must comply with the respective IEC standards (IEC 60950 for data-processing equipment and IEC 60601-1 for medical equipment). Additional equipment connected to the signal input or output connections comprise a medical system and therefore, must comply with the requirements of IEC 60601-1-1 or Clause 16 of IEC 60601-1 3rd Edition. WARNING: Interconnecting cables are subject to abuse if laid on the floor. Precautions must be taken to dress cabling to prevent

damage. WARNING: Use only St. Jude Medical approved accessories, cables and peripherals. Use of non-approved accessories can degrade

the system performance and compliance to safety, emissions and immunity standards. CAUTION: This device and accessories should be recycled according to local and national laws after useful life. WARNING: To avoid electrical safety hazard, check grounding reliability periodically. WARNING: The WorkMate™ Claris™ System must be installed and set up by authorized St. Jude Medical personnel only. WARNING: Service must be provided by qualified St. Jude Medical (SJM) Personnel only. SJM shall be released from all obligations under its warranty if repairs or modifications are made to the Product by persons other than SJM's service personnel. WARNING: Do not connect Multiple Socket-Outlets (MSO’s) or extension cords to the system. WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. WARNING: The potential equalization conductor can be connected to that of other equipment when necessary, to make sure that all these devices are connected to the potential equalization bus bar of the electrical installation. WARNING: The Stimulus Accessory cable connectors numbered 1 through 4 (including 4-dot symbols) must be connected to the EP4™ Cardiac Stimulator connectors labeled with the same 4-dot symbols, to prevent incorrect output of the stimulus signals. WARNING: Only defibrillation-proof stimulators shall be connected to the amplifier when using the generic stimulator cable. WARNING: The stimulator back panel connectors and Amplifier back panel BNC connectors are NOT isolated. Never connect them directly to a patient. Always plug external devices into an isolation transformer.

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CAUTION: The power cord for each isolation transformer in the WorkMate™ Claris™ System is the main disconnect for the patient environment area equipment and the non-patient environment equipment. To disconnect the mains power, unplug the power cord to each isolation transformer. The system components should be positioned such that access to the power cord connection is unobstructed.

Power Off the WorkMate™ Claris™ System Exit the software to the main menu using the user interface navigation techniques presented in the following steps. 1. Power off all EP-4™ Cardiac Stimulator stim channels and the power switch on the front of the unit. 2. Power off the Amplifier, using the rocker switch on the front of the unit 3. On the WorkMate™ Claris™ System click [Exit]. 4. Answer prompt. 5. If studies are available for archive, initiate the archive sequence (optional). If the system is configured to prompt archiving upon

case exit, a DVD must be inserted into the DVD drive prior to exiting. If not, the system will not recognize the DVD. 6. Select [Shutdown] on the WorkMate™ Claris™ System. If prompted to shutdown the EP-4™ Touch Screen, click [Yes]. The

WorkMate™ Claris™ System DWS and the EP-4™ Touch Screen will power off automatically. If you are not prompted to shut down the EP-4™ Touch Screen, select [Shutdown] on the EP-4™ Touch Screen and it will power down automatically. WARNING: Exit the system via the menu-driven selections for shutdown before turning the power OFF. Advanced buffering techniques are used for both the database and Real Time acquisition. Simply turning off the system or a power failure while running the system could cause loss of data.

IEC 60601-1 Classifications Amplifier Classifications: ■

Protection against electric shock: Class I

■

Applied Parts Classification: CF

■

Ingress Classification: IPX1

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Method of Sterilization: Non-sterile

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Not classified for use in an Oxygen Rich Environment

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Mode of Operation: Continuous Operation