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
iv
This page is intenonally blank

070-2567-03 Rev. A
v
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

Pathnder SL v1.9 Operaons Manual
vi
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

070-2567-03 Rev. A
vii
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

Pathnder SL v1.9 Operaons Manual
viii
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

070-2567-03 Rev. A
ix
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

Pathnder SL v1.9 Operaons Manual
x
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