Spacelabs Healthcare Pathfinder SL User manual

Pathnder SL v1.9
98000
Ambulatory ECG Analysis System
OPERATIONS MANUAL
070-2567-03 Rev. A | www.spacelabshealthcare.com

Consult Documents
YOU MUST READ THE ACCOMPANYING DOCUMENTS
(NOTE: Further instances of this symbol within this manual may be represented
in black and white)
WARNING
Acons or circumstances that may result in personal injury or death.
(NOTE: Further instances of this symbol within this manual may be represented
in black and white)

070-2567-03 Rev. A
iii
©2018 Spacelabs Healthcare Ltd
All rights reserved. Contents of this publicaon may not be reproduced in any form without the
wrien permission of Spacelabs Healthcare. Products of Spacelabs Healthcare are covered by
U.S. and foreign patents and/or pending patents. Specicaons and price change privileges are
reserved.
Spacelabs Healthcare considers itself responsible for the eects on safety, reliability and perfor-
mance of the equipment only if:
• Assembly operaons, re-adjustments, modicaons or repairs are carried out by per-
sons authorized by Spacelabs Healthcare, and
• The electrical installaon of the relevant room complies with the requirements of the
standard in force, and
• The equipment is used in accordance with the operaons manual.
Spacelabs Healthcare will make available, on request, such circuit diagrams, component part lists,
descripons, calibraon instrucons or other informaon which will assist appropriately quali-
ed technical personnel to repair those parts of the equipment which are classied by Spacelabs
Healthcare as eld repairable.
Spacelabs Healthcare is commied to providing comprehensive customer support beginning with
your inial inquiry through purchase, training, and service for the life of your Spacelabs Health-
care equipment.
CORPORATE OFFICES
Spacelabs Healthcare Inc
35301 SE Center St,
Snoqualmie, WA 98065.
USA
Tel: [phone]
Fax: [phone]
Spacelabs Healthcare Ltd
Unit B, Foxholes Centre,
John Tate Road, Herord.
SG13 7DT. UK
Tel: [phone]
Fax: [phone]
Brands and product names are trademarks of their respecve owners.
Cauon:
US Federal law restricts the devices documented herein to sale by, or on the
order of, a physician.
CE marked in accordance with the Medical Device Direcve, 93/42/EEC.
This manual was developed to provide key concepts about safety precauons.
Warnings: Alert the user to potenal serious outcomes (death, injury, or serious adverse
events) to the paent or user.
Cauons: or precauons alert the reader to exercise special care necessary for the safe
and eecve use of the device. They may include acons to be taken to avoid
eects on paents or users that may not be potenally life threatening or
result in serious injury, but about which the user should be aware. Cauons
may also alert the user to adverse eects on the device of use or misuse and
the care necessary to avoid such eects.
Note: A Note provides useful informaon about a funcon, or a procedure.

Pathnder SL v1.9 Operaons Manual
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070-2567-03 Rev. A
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1. Introducon
1.1 Intended Use 1-1
1.2 Safety and Regulatory Informaon 1-1
1.2.1 General 1-2
1.2.2 Precauons for Use 1-2
1.2.3 FCC Compliance and Advisory Noce 1-2
1.3 Cleaning and Maintenance 1-3
1.4 Pathnder SL Compability 1-3
1.4.1 System Requirements 1-3
1.5 Manuals 1-4
1.6 Disclaimer 1-4
1.7 Installaon Informaon 1-4
1.8 Working with Pathnder SL 1-4
1.8.1 Sing Properly 1-5
1.8.2 Arranging the Equipment 1-5
1.9 UDI Idener 1-5
2. Pathnder SL - System
2.1 The Time Bar 2-2
2.2 Pathnder SL Screens 2-2
2.3 7-Day Holter Analysis 2-3
2.4 Tool Bar 2-4
2.4.1 ECG Scan Toolbar 2-4
2.4.2 Setups Cog-Wheel 2-4
3. System Set Up
3.1 Display 3-1
3.2 Secondary Display 3-2
3.3 Context Menus 3-3
3.4 Other controls and buons 3-3
3.5 Tool ps 3-3
3.6 Event Markers 3-3
TABLE OF CONTENTS

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3.7 Beat Labels 3-3
3.8 Saving Sengs 3-4
3.9 Analysis Opons Acvated: Dongle Reader 3-6
4. Arrhythmia Analysis
4.1 Arrhythmia Detecon Algorithm 4-1
4.2 Analysis Sengs 4-1
4.3 Saving Analysis Sengs 4-3
4.4 Event Order 4-3
4.5 Event Severity 4-3
4.6 Analysis Menu 4-5
4.7 Thresholds 4-6
4.8 Insert a Trigger / Beat 4-7
4.9 Enable / Disable Channels 4-7
5. Pathnder SL Workow
5.1 Triage the recording 5-1
5.2 Scan the Recording 5-3
5.3 Full Disclosure ECG Scan 5-3
5.4 Superimposion/AVSEP Scan 5-3
5.4.1 Arrythmiagraph Markers 5-4
5.5 Starng ECG Scan 5-4
5.5.1 New Form 5-5
5.5.2 An Event 5-5
5.5.3 Reclassifying Individual Beats 5-6
5.6 Create An Event 5-6
5.7 Create New Event Types / Event Labels 5-6
5.8 Prinng ECG 5-7
5.9 Periodic Strips 5-7
6. Mouse/Keyboard/Hot Keys
6.1 Mouse and Keyboard 6-1
6.1.1 Dragging ECG Events 6-2
6.2 Keyboard 6-2
6.3 Beat classicaon keyboard shortcuts 6-3
7. Morphology
8. 12-Lead Holter
8.1 View all 12 Leads 8-1
8.2 Scan on 12 Leads 8-1

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8.2.1 Calipers/Measurements 8-2
8.3 Detailed 12-Lead Review 8-2
8.3.1 Display Menu 8-2
8.3.2 Display Markers 8-3
8.3.3 Making Measurements with Markers 8-3
8.3.4 Marker Flags 8-3
8.3.5 Moving marker ags with the mouse 8-3
8.3.6 Making measurements with Calipers 8-4
8.3.7 Markers, Caliper and keyboard shortcuts 8-4
9. Event Eding
9.1 Event Review Screens 9-2
9.2 Filtered Event List 9-2
9.3 Event Summary Table 9-3
9.4 Mul-Event Screen 9-3
9.5 Edit Paent Details / Diary Events 9-4
9.5.1 Paent Events 9-4
9.6 Atrial Fibrillaon (AF) 9-4
9.6.1 Manual Creaon of AF Events 9-5
9.6.2 Eding AF 9-5
9.6.3 Mark Enre Recording as AF 9-5
10. Report Creaon and Data Export
10.1 Report Comments 10-2
10.2 Preview/Store Report 10-2
10.2.1 Preview 10-2
10.2.2 Store 10-2
10.2.3 AutoStore 10-3
10.2.4 Report Sengs 10-3
10.2.5 Create a Default Report Format 10-4
10.3 Exporng Data 10-4
11. Pacing
11.1 Pacing Screen 11-1
11.2 Pacing Graphs 11-2
11.2.1 Paced Beat Annotaon 11-2
11.3 Pacing Histograms 11-2
11.3.1 RR Intervals 11-3
11.3.2 Pace-spike to Pace-spike Intervals 11-3
11.3.3 Trigger to Pace-spike Intervals 11-3

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11.4 Scaer Plots 11-3
11.5 Combined 11-4
11.6 Summary Table 11-4
11.7 Paced Event Table 11-4
11.7.1 Create a Paced Event 11-4
11.8 Pacing Report 11-4
12. Graphs
13. Trend Table
14. HRV Analysis
14.1 Display HRV 14-1
14.2 Denions 14-2
14.3 HRV Criteria 14-2
14.4 HRV Graphs 14-3
15. Advanced HRV
15.1 Advanced HRV Opon Overview 15-1
15.2 What is HRV Analysis? 15-1
15.3 Accessing HRV 15-2
15.4 Time Domain Analysis: 15-2
15.5 Frequency Analysis 15-2
15.6 Viewing On-screen Epoch Reports 15-3
15.7 HRV Screens 15-4
15.8 Summary Stascs Screen 15-4
15.9 Mul-Epoch Analysis of HRV Screen 15-5
15.9.1 To use the Mul-Epoch Analysis of HRV screen 15-5
15.9.2 Scaer Plot (NN) Screen 15-5
15.10 NN Interval Histogram Screen 15-7
15.10.1 To use the NN Interval Histogram screen: 15-7
15.11 RR Intervals Screen 15-8
15.12 Frequency 3D Screen 15-8
15.12.1 To use the Frequency 3D screen: 15-9
15.13 HRV Terms and calculaons 15-9
15.14 Heart Rate Calculaon 15-9
16. Sleep Apnea
16.1 Indicaons and Intended Use 16-1
16.2 Warning 16-1
16.3 Precauons 16-2

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16.4 Review the ECG Quality and QRS Detecon. 16-2
16.5 Arfact Signicant Misdetecon in Sleep-Time Periods 16-2
16.6 Set the Sleep Periods 16-2
16.7 Analysis Results 16-3
16.7.1 Sleep Period Apnea Classicaon : 16-3
17. QT Analysis
17.1 What is QT Analysis? 17-1
17.2 Before you Begin 17-2
17.3 QT Analysis 17-2
17.3.1 QT Graphs 17-2
17.3.2 QT Markers 17-2
17.3.3 QT Trend Table 17-2
18. Advanced QT Analysis
18.1 QT Opon Overview 18-1
18.2 Retrospecve QT analysis 18-2
18.3 Prospecve QT Analysis 18-3
18.4 QT Histogram 18-5
18.5 QTc Histogram 18-5
18.6 Trends 18-6
18.7 Scaer Plot 18-7
18.8 QT Strips 18-7
18.9 Summary Report 18-8
18.10 Hourly Reports 18-8
18.11 Analysis Opons 18-9
18.12 QT Detecon Criteria 18-9
18.13 QT Rejecon Criteria 18-10
18.14 User Proles 18-10
18.15 Review Opons 18-11
18.16 Report Opons 18-12
18.17 To Print the QT Report 18-12
19. ST Analysis
19.1 The ST Screen 19-1
19.2 ST Acon Replay Display 19-2
19.3 ST Analysis Sengs 19-3
19.3.1 Measurement Point Osets 19-3
19.3.2 ST Event Thresholds 19-3
19.3.3 ST Beat Exclusions 19-3
19.3.4 ST Datum 19-3
19.3.5 Pre/Post Event Times 19-4

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19.4 ST Graphs 19-4
19.5 ST Event Table 19-4
19.6 Not ST Buon 19-5
19.7 12-Lead ST 19-5
19.8 ST Reports 19-5
20. Signs and Symbols

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1. Introducon
1.1 Intended Use
The Spacelabs Pathnder SL Holter Analyzer is intended to be used to analyze recordings of
ambulatory electrocardiograms made on compable Holter recorders. It is capable of detecng
certain abnormal arrhythmias, and allows the operator to view and edit the ECG and the analysis
results, and construct a report for physician use.
The Spacelabs Pathnder SL Holter Analyzer is intended for use on adult paents only as a
screening device to determine the need for clinical diagnosis and evaluaon by polysomnography
based on the paent’s score. The EGG recording may be obtained at any locaon specied by
a physician including home, hospital or clinic. Subjects screened for sleep apnea should have
periods of sleep of at least 4 hours duraon during which the EGG is predominantly sinus rhythm
in nature.
1.2 Safety and Regulatory Informaon
This product is in conformity with the essenal requirements and provisions of Council
Direcve 93/42/EEC concerning medical devices.
US Federal law restricts the devices documented herein to sale by, or on the order of,
a physician.
Consult Documents
THIS SYMBOL MEANS YOU MUST READ THE ACCOMPANYING DOCUMENTS
This product must be sent to separate collecon facilies for recovery and recycling.

Pathnder SL v1.9 Operaons Manual
1-2
1.2.1 General
The soware has been designed to be installed on a hardware system that complies with the
internaonal safety standard EN 60950/IEC 950, which is designated as class 1 and staonary
equipment.
This equipment must be earthed (grounded).
This equipment is designed for internal use only.
The equipment should be installed near to a socket outlet that is readily accessible. Do not use
mulple portable sockets.
Do not aempt to remove any enclosures. There are no user serviceable parts inside.
Use only the connecng cables supplied.
Do not operate the equipment if any of the cables are damaged.
Switch o and unplug the equipment if it is not going to be used for a few days.
1.2.2 Precauons for Use
The equipment should only be used with the external enclosures ed.
Do not expose the equipment to sudden extremes in temperature, direct sunlight or other heat
sources.
Do not spill any liquids onto the equipment. If you do, turn the equipment o and contact the
Service Department.
Do not drop the equipment or subject it to excessive bumping or jarring.
Do not obstruct, cover or poke objects into the equipment.
1.2.3 FCC Compliance and Advisory Noce
This equipment generates, uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instrucons, may cause harmful interference to radio
communicaons.
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protecon
against harmful interference in a residenal installaon. However, there is no guarantee that
immunity to interference to radio or television recepon, which can oen be determined by
turning the equipment o and on. If radio or television interference is suspected, the user is
encouraged to try and correct the interference by one of the following measures:
• Reorient or relocate the receiving antenna
• Increase the separaon between the equipment and the receiver
• Connect to an outlet on a circuit dierent from that to which the receiver is connected
• Consult the dealer or an experienced radio/television technician for help.

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1.3 Cleaning and Maintenance
Note:
There are no user serviceable parts inside the Analyzer. The operator must not aempt
to dismantle the Analyzer. Aempng to do so may result in damage to the Analyzer or
personal injury. Refer any problems to qualied service personnel.
Periodically check that the venlaon grilles in the PC tower are free of dust. Refer to the PC
manufacturer’s instrucons for cleaning and maintenance advice.
Clean the monitor screen using a so cloth moistened with nonabrasive screen cleaning solvent.
Polish the screen to remove smears. Do not use rough paper towels or uy cloths.
Peripheral System Units : Consult the manufacturer’s operang manuals for further informaon
on instrucons for use. Clean the laser printer by following the instrucons in the printer’s
operator guide.
System Test Procedure: System tesng should be entrusted to a trained service engineer. Please
contact your supplier if you require the system checkout procedure.
The supporng PC should be regularly serviced, maintained and backed up to support recovery
or restores.
1.4 Pathnder SL Compability
Compable with:
• Sennel Cardiology Informaon Management System V9.x, V10.0.x, V10.5.0
• Lifecard CF, Lifecard 12, Evo and Aria Holter Recorders
Operang Systems
The analyzer is compable with:
Windows 7 (32 bit & 64 bit)
Windows 8.1 (64 bit)
Windows 10 (64 bit)
The PC specicaon should meet or exceed the minimum recommended specicaon for the
operang system.
1.4.1 System Requirements
The following is the minimum recommended PC Specicaon.
Processor: Intel i3, or i7 (lower specicaons are only acceptable for tesng or
training purposes)
RAM: 8Gb
Opcal Drive: CD-RW or DVD-RW/RAM
USB Ports: 3 available
Minimum Disk Space: 500 Gbyte free disk. (Plus sucient for data storage of recordings).
Audio
Display Resoluon Recommended 1920 x 1080 (lower resoluons may cause image
cropping)

Pathnder SL v1.9 Operaons Manual
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1.5 Manuals
Customers using Pathnder SL should also refer to specic product user manuals for detailed
operang instrucons and safety informaon. Customers should ensure that they are using the
latest revision of the manual.
1.6 Disclaimer
Every eort has been taken to ensure the accuracy of this manual but Spacelabs Healthcare
cannot accept liability for consequences caused by errors or omissions. You are advised to check
with Spacelabs Healthcare on any point on which you are unsure or need conrmaon.
Note:
All images within this manual are intended for illustraon purposes only and may dier
slightly from the actual product.
1.7 Installaon Informaon
The installaon CD should be safely stored for re-use
This equipment should only be installed by Spacelabs Healthcare or qualied service personnel.
If being installed on hardware not provided by Spacelabs Healthcare or complex networks users
should seek appropriate qualied advice before installing the soware.
This equipment must be earthed (grounded).
The equipment should be installed in an area that is well venlated, clean, dry and where
the ambient temperature is between 10˚C to 32.5˚C, relave humidity is 30% to 75% (non-
condensing) and an atmospheric pressure is 700-1060 hPa.
This equipment is designed for indoor use only.
The equipment should be installed near to a socket outlet that is readily accessible.
Ensure that any furniture is suitable to support the weight of the equipment.
Locate the equipment away from strong magnec elds and electrical interference.
The equipment should be installed on a hard level surface, allowing enough space for air to
circulate when in use.
The equipment should be located in such a way that it does not present a hazard or interfere
with other equipment.
Ensure that cords and cables are routed sensibly so that they cannot be snagged or tripped over.
They should not be tugged or twisted or used to li the equipment.
1.8 Working with Pathnder SL
Pathnder SL should only be operated by an appropriately skilled or trained person. The operator
should be trained in electrocardiography. A qualied medical praconer should make the
diagnosis.

070-2567-03 Rev. A
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Working with the Holter system may require:
• Close visual working with the display
• Frequent eye movement
• Sing sll for long periods of me
• Typing or mouse use for long periods of me
• Unaccustomed posture
This secon is to help advise against the these possible causes of discomfort. Follow the
instrucons to help you work more comfortably.
1.8.1 Sing Properly
If possible, use an adjustable chair that gives
support to your lower back. It should adjusted
so that the operator can sit with a straight back,
upper legs horizontal and feet at on the oor.
The back rest should be adjusted to support the
hollow of the back.
The shoulder and upper arm should make a right
angle with the forearm and hands. If the chair
needs to be raised to achieve correct posture, a
foot stool should be used to ensure the feet are
supported.
1.8.2 Arranging the Equipment
Ensure that the operang environment is free from interrupons to prevent operator error during
analysis.
Glare and reecons from lights and windows should be minimised by adjusng the lt and
swivel of the display. Cleaning the display regularly will help minimize reecons. Adjusng the
brightness and contrast of the controls will also help.
Posion the keyboard in from the front of the desk. Use a light touch on the keys when typing and
where available use a keyboard arm rest to support forearms.
Posion the mouse where it can be easily reached, normally just to the side of the keyboard.
Ensure there is plenty space in the area surrounding the mouse so you can make unimpeded
movements. Use the mouse mat to prevent mouse slipping and where available a mouse mat
with a forearm support / rest.
1.9 UDI Idener
The Pathnder SL v1.9 UDI (Unique Device Idencaon) idener can be found by clicking on
‘Help’ from within the Pathnder SL soware followed by ‘About Pathnder SL’.

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2. Pathnder SL - System
Full Disclosure is the rst screen displayed, the icons and menu opons remain the same
throughout analysis.
The top of the screen can be split into several secons:
Title Bar: The bar across the very top of the screen shows the paent’s name and ID.
Main Menu: Click on these text tles to open operaonal menus. These are Analysis, Report,
View, Sengs, Paent Details, Setups, and Help.
Screen Selector Icons: Click on these to move within the dierent display screens and analysis

Pathnder SL v1.9 Operaons Manual
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modules. The icons across the screen are grouped according to their funcon and ordered le
to right with arrows moving you forward. Users can follow this workow to move through the
recording using the opmum Pathnder SL workow.
2.1 The Time Bar
The blue me bar runs across the top of the screen.
This will display the full recording (up to 7-days). Depending on the recording duraon markers
will indicate hourly references.
The me bar displays blue to indicate how much of the ECG has been analysed, yellow to show
how much has been loaded. Grey is outside the analysis.
Click on any point on the me bar to move the yellow marker arrows and display the associated
ECG. Use the drop down menu to the le to move to a specic day. Enter in a me in the
selected format to move to a specic me in the selected day.
2.2 Pathnder SL Screens
There are many dierent screens provided by Pathnder SL, each with their own purposes.
Switching between screens is simple as the me being displayed is consistent on all screens that
support any idea of a “current me”
Screen Selector
Icon
Description
Full disclosure
This display is designed to show the maximum amount of ECG at one me in
up to 12 channels.
Event Trend
This display graphically illustrates the me order and frequency of
arrhythmia events
ECG Scan
This display contains a super-imposion scanning view of the ECG in Full
Disclosure or Super Imposion, with a simultaneous Arrythmiagraph to
provide local context.
Event Editing
This display is split into two secons: the top secon always shows ECG while
the boom secon shows one of a large number of opons, each useful
for idenfying dierent areas of interest you may wish to invesgate, for
example; a heart rate graph; an RR interval histogram; event tables etc.
Multievent
This display is useful to speed up eding when there are many events of the
same type occurring, as on this display, several events can be edited at once.
Morphology
This display shows the dierent QRS morphologies that the analyser
detected, you can reclassify; merge and/or split these morphologies.

070-2567-03 Rev. A
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Screen Selector
Icon
Description
Graphs
The Heart rate, ventricular beats per minute and paced beats per minute
graphs.
Report Summary
An editable screen showing data that will be on the front page of the nal
report
Trend Table
An editable hourly tabular data of events during the recording
Pacing
Graphs and tabular data showing paced beat intervals
Apnea
Displays an Esmated Apnea/Hypopnea score with corresponding ECG
ST
ST data analysis and graphs
QT
Stascal QT data
HRV
Stascal Heart Rate Variability data and graphs
Advanced HRV
Time Domain data and spectral (frequency) HRV analysis
Advanced QT
Beat to Beat QT analysis and reporng
12-Lead
Displays 12-Lead ECG with a rhythm strip
2.3 7-Day Holter Analysis
A useful feature in Pathnder SL is the ability to download and display up to 7-day’s Lifecard CF
Holter ECG connuously, over 1 analysis. One seven day report is compiled showing all data for
the recording on the summary page. This provides a valuable over-view of the enre recording.
Use the Event Trend screen to view 7-day’s of events.

Pathnder SL v1.9 Operaons Manual
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2.4 Tool Bar
Within the Full Disclosure screen and ECG scan screens the Tool Bar of icons is displayed. These
include:
Icon Function
Play ECG.
Stop ECG.
Speed of Flowing ECG.
Channel displayed.
Use the magnifying icons to zoom in and out of the ECG.
Use the up and down arrow icons to page through the ECG.
Select the Back or Forward buons (found on the Time Bar) to navigate
me cursor posions.
Print a page direct. This will not be included in the nal report but is
useful for immediate print out review.
Print scaling will be dependent on the display Zoom sengs and the
number of channels displayed.
This icon will turn on / o beat annotaon - including the beat trigger
arrow.
2.4.1 ECG Scan Toolbar
Icon Funcon
Play ECG
Stop ECG
Speed of Flowing ECG
Channel displayed
2.4.2 Setups Cog-Wheel
Icon Funcon
Provides access to sengs for that feature.