Sentinel v11.5 Users Manual Rev C March 2022

Consult Documents THIS SYMBOL MEANS YOU MUST READ THE ACCOMPANYING DOCUMENTS (Note: Further instances of this symbol may be represented in black & white)

WARNING Actions or circumstances that may result in personal injury or death. (Note: Further instances of this symbol may be represented in black & white)

WARNING In the event of a serious incident, notify Spacelabs and the competent authority of the EU Member State.

©2022 Spacelabs Healthcare Ltd. All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of Spacelabs Healthcare. Products of Spacelabs Healthcare are covered by U.S. and foreign patents and/or pending patents. Specifications and price change privileges are reserved. Spacelabs Healthcare considers itself responsible for the effects on safety, reliability and performance of the equipment only if: • assembly operations, re-adjustments, modifications or repairs are carried out by persons authorized by Spacelabs Healthcare, and • the electrical installation of the relevant room complies with the requirements of the standard in force, and • the equipment is used in accordance with the operations manual. Spacelabs Healthcare will make available, on request, such circuit diagrams, component part lists, descriptions, calibration instructions or other information which will assist appropriately qualified technical personnel to repair those parts of the equipment which are classified by Spacelabs Healthcare as field repairable. Spacelabs Healthcare is committed to providing comprehensive customer support beginning with your initial inquiry through purchase, training, and service for the life of your Spacelabs Healthcare equipment.

CORPORATE OFFICES Manufactured for: Spacelabs Healthcare Inc 35301 SE Center Street Snoqualmie, WA 98065 USA

Spacelabs Healthcare Ltd. Unit B, Foxholes Centre, John Tate Road Hertford. SG13 7DT UK Tel: +44 1992 507700 Fax: +44 1992 501213

Tel: +1 425 396 3300 Fax: +1 425 396 3301

EC REP

MediMark® Europe, 11 rue E. Zola, 38100 Grenoble. France

Brands and product names are trademarks of their respective owners.

Safety-related information is indicated in the following manner in this manual:

WARNING

or

WARNING

CAUTION

Note

-

Actions or circumstances that may result in personal injury or death.

-

Actions or circumstances that could damage the equipment, produce naccurate data, or invalidate a procedure.

-

Useful information to a product feature, function, or procedure.

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Table of Contents 1

Introduction 1.1

What’s in this Manual?

1-1

1.2

Sentinel Overview

1-2

1.3

Disclaimer

1-3

1.4

Compatible Software/Products

1-3

2

Safety and Regulatory 2.1

Precautions

2.2 2.3

2-1

Cautions

2-2

Warnings

2-2

2.4

Intended Use

2-3

2.5

Spare parts

2-3

2.6

Working with Sentinel

2-3

2.6.1 2.6.2

Sitting Properly Arranging the Equipment

2-4 2-4

2.7

UDI Identifier

2-4

2.8

Decommissioning

2-4

3

Set-Up 3.1 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5

3.2 3.2.1 3.2.2 3.2.3 3.2.4

3.3 3.3.1 3.3.2 3.3.3

3.4

Sentinel Home Screen Actions Panel Function Bar Test Icons Footer Useful Navigation Information

Initial Setup System Administrator User Users with Administrator permission Creating Facilities / Organizations Create Staff Members

Logging In Single Sign On (Windows Authentication) Logging In (Sentinel Authentication) Logging Off

Further Information

3-1 3-2 3-2 3-3 3-4 3-4

3-4 3-5 3-5 3-6 3-6

3-7 3-7 3-8 3-8

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4

Patient Centric Workflow 4.1

Add / Edit / Delete Patient

4-1

Add New Patient Edit Existing Patient Delete a Patient Add Case for a Patient

4-2 4-2 4-2 4-3

4.2

View all Tests for one Patient

4-3

4.3

View Cases for one Patient

4-3

4.4

Acquiring ECG, Configuring Recorders, and Downloading Recordings from the Patients Screen 4-4

4.1.1 4.1.2 4.1.3 4.1.4

4.4.1 4.4.2 4.4.3 4.4.4

4.5

Ambulatory Blood Pressure: Ambulatory ECG 12-Lead ECG Stress ECG

Other actions

4.5.1 4.5.2 4.5.3

Create Order Import Report Audit for Selected Patient

4-5 4-5 4-6 4-6

4.6

Reviewing Tests

4-6

4.7

Review a Report

4-7

4.8

Complete Test

4-7

4.9

Import/Export

4-7

5

Search for Tests 5.1

Tests

5.1.1 5.1.2 5.1.3 5.1.4 5.1.5

6

Search for a test Edit patient details Change patient / Identify Edit test details Mark tests as complete

5-1 5-1 5-2 5-2 5-3 5-4

Cases, Orders and Reports 6.1 6.1.1 6.1.2 6.1.3 6.1.4 6.1.5

6.2 6.2.1 6.2.2

6.3

Cases Create New Case Search by Case Number Assign Case to Patient Cases created by 3rd party applications and GDT Add Case Number to new patient tests

Orders Manually create an order Orders created by 3rd party applications and GDT

Reports

6-1 6-1 6-2 6-2 6-3 6-3

6-3 6-4 6-4

6-4

6.3.1

Review Report

6-4

6.3.2

Delete Reports

6-5

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4-4 4-4 4-5 4-5

6.3.3 6.3.4 6.3.5 6.3.6

7

Audit for report Automated Export / Print reports Review 12 / 15 / 18-Lead Test Edit Patient

6-5 6-5 6-6 6-6

Send and Receive / Import and Export, Recordings and Reports. 7.1

Send and Receive data (RDT)

7.1.1 7.1.2 7.1.3 7.1.4

7.2

7-1 7-1 7-2 7-2

Sentinel Importer

7.2.1 7.2.2 7.2.3 7.2.4 7.2.5 7.2.6

7.3

7-3

Import Files to Module Sentinel Importer active screen Import a File/Folder Import report - From Patients Screen Clear search and start new Supported Import / Export Formats

7-3 7-4 7-4 7-4 7-4 7-5

Export

7.3.1

7.4

7-6

Export from All Modules

7-6

DICOM / FDA XML

7.4.1

7.5 7.5.1 7.5.2

8

7-1

Return completed report to originating Sentinel site Send completed report to a new Sentinel site Export the full test (including analyzed data and report) Send to Facility Progress

7-7

DICOM

7-7

Bulk Archive/Delete

7-8

Bulk Archive: Bulk Delete:

7-8 7-8

ABP Module 8.1 8.1.1 8.1.2

8.2 8.2.1

8.3 8.3.1 8.3.2

8.4 8.4.1 8.4.2 8.4.3 8.4.4 8.4.5 8.4.6 8.4.7 8.4.8

Configure ABP recording

8-1

Select patient Configuring the ABP recorder

8-1 8-2

Fit the Recorder to the Patient

8-4

Start the recording

8-4

Download ABP Recording

8-4

Download Recording if programmed by Sentinel Download recording if programmed using Independent Initialization (OnTrak only)

8-4 8-5

Review Test Data

8-6

Findings Patient Test Recording Medications Indications Signatures Confirm

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8.4.9 8.4.10 8.4.11 8.4.12 8.4.13 8.4.14 8.4.15 8.4.16 8.4.17 8.4.18 8.4.19

8.5

Protocols

8.5.1 8.5.2

8.6

9

Decline Save Cancel Print Settings Graphs Tables Callipers Summary Exit the ABP Review Import / Export Data: Protocols Statistics

Additional ABP Settings

8-11 8-11 8-12

8-12

Ambulatory ECG Module 9.1 9.1.1 9.1.2

9.2 9.2.1 9.2.2 9.2.3

9.3 9.3.1 9.3.2 9.3.3

9.4

Configure Ambulatory ECG recorder

9-2

Associating Eclipse MINI Patient Hook up and Recording Start

9-3 9-4

Download a recording into Sentinel

9-4

Downloading from Eclipse MINI where recording periods are invalid Programmed recorders Unprogrammed Recorders

9.5

9-6

Medications Indications Diary events

9-6 9-7 9-7

Start a new analysis with Pathfinder SL: Analyze stored Ambulatory ECG / Resume Ambulatory ECG Analysis

Ambulatory ECG Analysis with Lifescreen PRO

9.5.1

9-4 9-4 9-5

Edit test details

Ambulatory ECG Analysis with Pathfinder SL

9.4.1 9.4.2

Start a new analysis with Lifescreen PRO:

9-7 9-7 9-7

9-7 9-7

9.6

Review Reports

9-8

9.7

Complete Test

9-8

10

Resting ECG Module

10.1 10.1.1 10.1.2 10.1.3 10.1.4

Start a New Test Acquire ECG using CD12USB Screen Settings Start The Test Stop Test

10-1 10-1 10-2 10-3 10-4

10.2

Exit the Test

10-4

10.3

Emergency Resting ECG

10-4

10.4

Order and 3rd Party Carts

10-5

10.4.1 Orders and CardioExpress Sentinel v11.5 Operations Manual

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8-8 8-8 8-8 8-8 8-9 8-10 8-10 8-10 8-11 8-11 8-11

10-5

10.4.2

10.5

ECG From 3rd Party Carts

Identify ECG in Sentinel

10.5.1 10.5.2

Identify patient Manually associate to a patient

10-5

10-5 10-5 10-6

10.6

Review the ECG

10-6

10.7

Review a report

10-8

10.8

Batch (bulk) review of resting ECG tests

10-8

10.9

Additional Features

10-9

11

Rhythm ECG Module

11.1

Start a New Test

11.1.1 11.1.2 11.1.3

Acquire ECG using CD12USB Configure Start Recording

11-1 11-1 11-2 11-2

11.2

Stop the recording and enter Comments

11-4

11.3

Immediate Review

11-4

11.4

Exit the Test

11-5

11.4.1

11.5

Identify ECG in Sentinel

11.5.1 11.5.2

11.6

Identify patient Manually associate to a patient

Review the ECG

11.6.1 11.6.2 11.6.3 11.6.4 11.6.5

12

Save and Exit Acquire / Immediate review screen

Making measurements with Callipers Making measurements with Markers Interpretations and Findings Rhythm Review Print

11-5

11-5 11-5 11-6

11-6 11-8 11-8 11-9 11-10 11-10

ECG Stress Test Module

12.1

Recording a Stress Test with CD12USB

12-2

12.2

Configure the parameters to display

12-2

12.3

Start the test

12-3

12.3.1 12.3.2 12.3.3 12.3.4 12.3.5 12.3.6

Modify the ECG recording parameters (optional) Reference Stage - Save the Reference ECG Proceed to the next stage Preload stage (optional) Load stage - start the exercise ECG Recovery Stage - Monitor the Recovery ECG

12-3 12-4 12-4 12-5 12-5 12-6

12.4

End the test

12-7

12.5

Manual Control of the Treadmill or Bicycle

12-7

12.5.1 12.5.2

12.6

Manual adjustment within a protocol Manual Control of the Threshold and Target Values

ST Median Display

12-7 12-7

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12.7

Reviewing a Saved Recording

12.7.1 12.7.2 12.7.3 12.7.4 12.7.5 12.7.6 12.7.7 12.7.8 12.7.9 12.7.10 12.7.11 12.7.12 12.7.13

12.8 12.8.1 12.8.2

Select the recording Review the Rhythm ECG Marking and Saving new 12-Lead strips Deleting the 12-Lead Rhythm Review 12-Lead ECGs (Strip List) Review Stress Graphs Review the Results Table Review the Stage Comments Edit BP Review the Representative Cycles Review the Medians Review the Mean Complexes Stress Test ‘Hot keys’

12-10 12-10 12-11 12-11 12-11 12-11 12-11 12-11 12-11 12-11 12-13 12-13 12-14

Edit test details

12-15

Medications Indications

12-15 12-15

12.9

Import report

12-16

12.10

Review the Report

12-16

12.11

Complete Test

12-16

13

Cardioline Cubestress

13.1

Cardioline Configuration

13-1

13.2

Acquiring ECG via Cardioline Cubestress

13-1

13.2.1 13.2.2 13.2.3

13.3 13.3.1

14

Stress End of the Cubestress test PDF report Export: Report Review in Sentinel:

13-1 13-2 13-2

Cardioline Touch ECG - Resting ECG

13-2

Reviewing the Resting ECG

13-2

Ergospirometry Module

14.1

Select patient

14-1

14.2

Create an order

14-2

14.3

Acquire data

14-2

14.3.1

From the Ergospirometry Tests screen

14-2

14.4

Import report

14-3

14.5

Edit Test Details

14-3

14.6

Review Report

14-3

15

Spirometry Module

15.1 15.1.1 15.1.2

15.2

Acquire data Acquire data from patient screen Acquire data from Spirometry test screen

Review Report

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12-10

15-1 15-1 15-1

15-2

15.3

16

Complete Test

15-2

Echo Module

16.1

Create a new patient

16-1

16.2

Create an Order:

16-2

16.3

Edit Test Details

16-2

16.4

Import report

16-2

16.4.1

Import report - From Patients Screen

16-2

16.5

Review Report

16-2

16.6

Complete Test

16-3

17

Plethysmography Module

17.1

Acquire Data

17.1.1

From the Plethysmography Tests Module

17-1 17-1

17.2

Review Report

17-2

17.3

Complete Test

17-2

18

System Administration

19

EN 60601-1:2006/A1:2013 Compliance

Appendix 1 - Signs and Symbols

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1

Introduction

This user manual describes the operation of the Sentinel v11.5 product from Spacelabs Healthcare. Sentinel is a Cardiology Information Management System utilizing a Windows-based software solution designed to provide an electronic, paper-free, environment for noninvasive Diagnostic Cardiology. Designed with the latest programming technology, Sentinel allows for ease of installation and ease of use. Sentinel uses a Central Data Management system (SQL Server) database and features security against unauthorized access to the clinical data. Fully networkable, and scalable, solutions are provided from single practice to multi regional hospitals. Sentinel contains technology licensed from the University of Glasgow to provide 12-Lead ECG interpretation.

1.1

What’s in this Manual?

The user manual is divided into sections, as follows: •

Introduction The introduction describes how to use this manual and provides an overview of the features of Sentinel including the benefits these provide to users, patients and administrators.

•

Safety and Regulatory Describes the standards in use and the intended use of the product.

•

Workflows: Sentinel 11.5 supports two standard workflows: 1.

2.

Patient Centric Workflow: Users who wish to search for a patient and configure recorders, edit test details and launch tests from one work screen follow the steps described in the Patient Centric section. Module Manuals: Customers who use primarily one test module (example Blood pressure or Ambulatory ECG) may find using the Module Manuals 070-2930-00 Rev. C

1-1

quicker. The Module Manuals provide step by step instructions of how to perform the specific tests using Sentinel In both cases, users must read and follow the instructions in Section 3 on Mandatory settings before entering any patient or test data. • Appendix 1 Shows the symbols and their definitions used on Spacelabs Healthcare products. •

Admin Detailed instructions regarding user management and preferences, together with licence management and remote data transfer configuration. Refer to the Sentinel 11.5 Administrators Manual.

1.2

Sentinel Overview

What is Sentinel? Sentinel is a Cardiology Information Management System which can store Ambulatory ECG, Resting and Rhythm ECG, ABP, Stress, Echo, Ergospirometry, Spirometry, and Plethysmography data with analyses and reports, together with the corresponding patient information. Sentinel can be used as a single stand-alone installation, or as part of a multi-user network. Sentinel may be used for recording and reviewing of ECG of adults and pediatrics in a clinical environment inside and outside of hospitals. It is also capable of interfacing with other systems and products via its HL7, DICOM, DataMedFT and GDT capabilities. Sentinel also provides the ability to review reports via web access.

Sentinel Security Sentinel 11.5 introduces more security permissions, improvements to the security of server-side Sentinel windows services and support for TLS 1.2. In a client - server installation Sentinel stores all clinical related data on the server. If the optional off-line workstation option is installed and used, Sentinel will store test data locally. This locally stored data can be exported and import to a server as you like. Access to Sentinel can only be performed by authenticated users. The software provides authentication of users using either Windows Authentication or Sentinels own unique username and password on commencement of a work session. Sentinel also employs additional security measures such as an audit trail and user lockouts . The audit trail in Sentinel enables the administrator to view actions performed by user or per patient. All activities are logged and can be viewed from one screen. Sentinel’s design contributes to your facility’s HIPAA compliance.

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1.3

Disclaimer

Every effort 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 confirmation. Note:

Images and screen shots used within this manual are for illustration purposes only and may differ with individual Sentinel configurations

1.4

Compatible Software/Products

Ensure you have the latest version of product software (such as Pathfinder SL and Lifescreen PRO) are installed. Check with your local representative for more information. Supported mobile browsers are iOS 13.4.1 Safari browser and Android 10 native browser (No additional configuration is required to use these browsers). Sentinel supports the following interfaces: HL7, DICOM, CD12USB, OnTrak, 90217, 90207, CardioExpress, Lifecard CF, Lifecard 12, Evo, Datamed FT (Ver. 2 & Ver. 3), xDT (slave and master), Eclipse PRO and Eclipse MINI. SERVER and DATA FARM supported SQL Server versions are: SQL Server 2016, 2017 and 2019 Standard and Enterprise. WORKSTATION SQL Server version is SQL Server Express 2014 SP3.

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2

Safety and Regulatory

2.1

Precautions 1.

Always read the instruction manuals for the individual products before using them. 2. If other computer programs are installed on the same computer as Sentinel, there may be incompatible interactions. Spacelabs Healthcare is not responsible for such interactions. It is strongly recommended that Sentinel be installed on a dedicated computer and only used in conjunction with supported Sentinelcompatible products from Spacelabs Healthcare. 3. Do not change, download or update the operating system of these computers without first consulting Spacelabs Healthcare. 4. Ensure that the PC running Sentinel complies with the electrical safety requirements of your country. 5. In the US, Sentinel must be used only with devices cleared by the Food and Drug Administration (FDA). 6. Use only the operating systems indicated in this document. 7. Operators should be aware that additional security precautions should be taken when PDF's are viewed on a mobile device. If the mobile device is being used in a public area, unauthorized personnel may be able to see the patient’s PHI. The use of mobile devices generally means using a wireless network. These networks should be encrypted, or password protected, to prevent data snooping. 8. It is important to keep the batteries in mobile devices charged, so that the devices are ready to use when desired. Mobile devices are easy to damage by dropping. Spacelabs recommends that a protective cover is used for all mobile devices. 9. It is recommended that Sentinel SERVER and DATA FARM installations occur only on dedicated PC or VMs which are not being used for any other purpose other than running Sentinel. This will avoid interaction between Sentinel and other applications which may have unintended effects. 10. Sentinel should only be used on supported operating systems: Windows 7 SP1 Pro, Ultimate and Enterprise (64 Bit), Windows 10 Pro and Enterprise (64 Bit), Windows Server 2012 R2, Windows Server 2016 (64 Bit) or Windows Server 2019 (64 Bit). 070-2930-00 Rev. C

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11. No two devices supplying PHI for tests of the same modality should be directly connected to a Sentinel client PC simultaneously. This is to avoid confusion over the identity of the patient for whom imported data is to be supplied. 12. Minimum Display Resolution:

2.2

Workstation

-

1600 x 1200 (if only configure and download then minimum can be 1024 x 960)

Client

-

1024 x 768

Cautions • • • • •

2.3

Federal (USA) Law restricts this device for sale by or on the order of a medical practitioner licensed by the law of the State in which they practice, to use or prescribe the use of the device. Spacelabs Healthcare recommends disposing of packing material in a responsible manner by recycling such material where possible. Customization can prevent Sentinel from starting up if performed incorrectly. Customer workflows should be tested after performing customization. It is recommended to use multiple ways to identify a recording (e.g. label, configuring, wave file). Sentinel stored Protected Health Information (PHI). Care must be taken during installation and configuration to consider the security of the data Sentinel will hold. This includes making full use of the security features of Sentinel such as user accounts, passwords and roles. It also includes managing the security of the PC on which Sentinel is to be used, especially the PC on which SERVER, DATA FARM, WORKSTATION and CLIENT 3 installations are performed. This may include but is not limited to Firewalls, Windows User accounts, and anti-virus software.

Warnings 1. 2.

3. 4. 5. 6.

Devices used by third party applications connected to Sentinel by a GDT interface may expose the patient to a mechanical force, i.e. Starting a treadmill. No two of the same devices should be connected to Sentinel at the same time, (Example: 2 evo's), to ensure that there is no ambiguity to which device Sentinel communicates with. This is also to prevent users ascribing diary events or comments to the incorrect patient. Sentinel should be used by trained qualified health care professionals only, not by patients The recorders are only for use on one patient at a time. Resting, Rhythm or Stress recorders are not for home use nor are they therapeutic devices. Operators should use multiple ways to identify a recording (where available), such as configuring the recorder or media in Sentinel, making a voice recording

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and writing on the appropriate label. These measures must conform to the customer’s security policy.

2.4

Intended Use

The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and to manage patient and facility information. The Sentinel Cardiology Information Management System provides download and storage of data from supported Ambulatory ECG recorders and feeds this data to separate and optional Ambu latory ECG analyzers. The completed reports are stored back in Sentinel. The Sentinel Cardiology Information Management System facilitates presenting, analyzing, reviewing cardiovascular information, including automatic interpretation of 12-Lead ECG and stores the finished reports. The automatic interpretation of 12-Lead ECG is not suitable for neonates. Sentinel supports importing reports, patient records and orders from external systems using interfaces such as HL7, DICOM, GDT and SCI-Store. The Sentinel Cardiology Information Management System is intended to be used by a trained user and as an aid to a medical professional in hospital or primary care environment. The Sentinel Cardiology Information Management System is not intended for patient monitoring.

2.5

Spare parts

Spare recorders, ABP monitors, cables and/or cardiographs for use with Sentinel are available from Spacelabs Healthcare.

2.6

Working with Sentinel

Working with Sentinel may require: • Close visual working with the display • Frequent eye movement • Sitting still for long periods of time • Typing or mouse use for long periods of time • Unaccustomed posture This section is to help advise against the possible causes of discomfort. Follow the instructions to help you work more comfortably.

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2.6.1

Sitting Properly

If possible, use an adjustable chair that gives support to your lower back. It should be adjusted so that the operator can sit with a straight back, upper legs horizontal and feet flat on the floor. 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.

2.6.2

Arranging the Equipment

Glare and reflections from lights and windows should be minimized by adjusting the tilt and swivel of the display. Cleaning the display regularly will help minimize reflections. Adjusting the brightness and contrast of the controls will also help. Position the keyboard in from the front of the desk. Use a light touch on the keys when typing and where available use a keyboard wrist rest to support forearms. Position 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.

2.7

UDI Identifier

The Sentinel UDI (Unique Device Identification) identifier will be shown when clicking the ‘About’ icon in Sentinel’s Admin module.

2.8

Decommissioning

This section deals with the Decommissioning, Disposal, or Re-purposing of Spacelabs Sentinel Cardiology Information System Spacelabs’ Sentinel Cardiology Information System is a PC based system that uses a hard drive to store sensitive personal health information. If re-purposing, disposing of, or decommissioning the System, the data on the hard drive must be erased or destroyed to ensure non retrieval of such information. Recommended methods include: • • •

Clearing - Using software or hardware products to overwrite the hard drive Purging - Degaussing the hard drive through exposure to a strong magnetic field to disrupt the magnetically encoded information Destroying - Complete destruction of the hard drive using methods such as shredding, melting, and incineration

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