Itamar Medical CloudPAT Operation Manual

Itamar Medical Ltd.

CloudPAT

™

Web Software Operation Manual

Itamar Medical REF: OM2200000

!

Caution: Federal (U.S.) law restricts this device to sale by, or on the order of a physician.

Copyright



2011-2012 by Itamar Medical Ltd.

Software Version: 1.0

CloudPAT Page 1 Operation Manual

Itamar Medical Ltd.

This manual and the information contained herein are confidential and are the sole property of

Itamar Medical Ltd. Only Itamar Medical Ltd. or its licensees have the right to use this information. Any unauthorized use, disclosure or reproduction is a direct violation of Itamar Medical’s proprietary rights.

DISCLAIMER

Itamar Medical Ltd. shall not be held responsible in any manner for any bodily injury and/or property damage arising from operation or use of this product other than that which adheres strictly to the instructions and safety precautions contained herein and in all supplements hereto and according to the terms of the warranty provided in the License

Agreement in Appendix F. Screen layouts are subject to change from time to time without notification and without being altered in this Web software operation manual as long as the intent of the content has not been altered significantly.

This product and/or method of use, is covered by one or more of the following US patents: 6319205, 6322515, 6461305, 6488633, 6916289, 6939304, 7374540, as well as any pending US patent applications and corresponding patents and/or applications filed in other countries.

Itamar Medical Ltd.

9 Halamish St., P.O.Box 3579

Caesarea 38900, Israel

Tel + 972 4 617 7000

Fax + 972 4 627 5598 www.itamar-medical.com

[email protected]

ISO 9001:2008 and ISO 13485:2003 certified

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Table of Contents

........................................................................................................................................ 1

1.

Introduction to CloudPAT ................................................................................. 6

1.1.

Intended Use of WatchPAT ......................................................................... 6

1.2.

zzzPAT S/W – Definition ............................................................................ 6

1.3.

CloudPAT S/W – Definition ....................................................................... 6

1.4.

Overview ..................................................................................................... 7

1.5.

Terminology ................................................................................................ 8

1.6.

Minimum requirements ............................................................................... 8

2.

Setting CloudPAT Access.................................................................................. 8

2.1

Obtaining an account ................................................................................... 8

2.2

Accessing CloudPAT .................................................................................. 9

2.3

Setting [Initial] Password ............................................................................ 9

2.4

Resetting Password .................................................................................... 10

2.5

Profile Settings & Support ......................................................................... 10

3.

Using CloudPAT as a User .............................................................................. 12

3.1.

Main Access Screen (Home “Lobby”) ...................................................... 12

3.2.

Creating a New Study ................................................................................ 12

3.2.1.

Preparing WatchPAT for a New Study .................................................. 13

3.2.1.1.

Initializing WatchPAT ....................................................................... 15

3.2.1.2.

First Time Initialization ...................................................................... 15

3.2.1.3.

Initialization Process Protection ......................................................... 15

3.3.

Uploading a Study ..................................................................................... 16

3.3.1.

Normal Mode ......................................................................................... 16

3.3.2.

Manual Mode ......................................................................................... 19

3.4.

Viewing Reports ........................................................................................ 20

3.5.

Managing Patient Information ................................................................... 21

4.

Using CloudPAT as a Specialist ...................................................................... 23

4.1.

Main Access Screen ................................................................................... 23

4.2.

Studies ....................................................................................................... 24

4.2.1.

Reviewing a Study ................................................................................. 24

4.2.2.

Viewing a Completed Study .................................................................. 27

4.3.

Templates................................................................................................... 27

4.3.1.

Managing Templates .............................................................................. 28

5.

Troubleshooting ............................................................................................... 30

6.

Appendix A: Initializing WatchPAT via CloudPAT Guide ............................ 32

7.

Appendix B: Uploading study from WatchPAT to CloudPAT Guide ............ 35

8.

Appendix C: Uploading study from zzzPAT to CloudPAT Guide .................. 38

9.

Appendix D: Interpretation and editing of events by the Specialist Guide ..... 43

10.

Appendix E: CloudPAT Assistant “cheat sheets" ......................................... 49

11.

Appendix F: License Agreement................................................................... 55

12.

Appendix G: Regulatory Representative...................................................... 61

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Table of Figures

Figure 1: Sign In screen ................................................................................................. 9

Figure 2: Set Password screen ....................................................................................... 9

Figure 3: Reset Password screens ................................................................................ 10

Figure 4: Functions available from all screens ............................................................ 10

Figure 5: Profile Settings ............................................................................................. 11

Figure 6: Support screen .............................................................................................. 11

Figure 7: Home (Lobby) screen ................................................................................... 12

Figure 8: Create New Study selection ......................................................................... 13

Figure 9: Patient data entry screen ............................................................................... 14

Figure 10: More Detail screen for patient data (optional) ........................................... 14

Figure 11: Initialize Device screen .............................................................................. 14

Figure 12: Message to download the PC-resident program ......................................... 15

Figure 13: Protection from accidentally overwriting previous sleep study ................. 16

Figure 14: WatchPAT's Micro USB port ..................................................................... 16

Figure 15: Upload Study Selection .............................................................................. 17

Figure 16: Upload Study Dialog box ........................................................................... 17

Figure 17: Select Specialist Dialog box ....................................................................... 17

Figure 18: Patient sleep study upload in progress ....................................................... 18

Figure 19: Upload complete screen ............................................................................. 18

Figure 20: Upload failed screen ................................................................................... 19

Figure 21: Manual Upload ........................................................................................... 19

Figure 22: Successful upload screen ............................................................................ 19

Figure 23: Viewing Sleep Study Reports..................................................................... 20

Figure 24: Report Details for reviewing sleep study reports ....................................... 21

Figure 25: Search for Patients screen ........................................................................... 22

Figure 26: Search for Patients screen ........................................................................... 22

Figure 27: Manage Patient Details screen ................................................................... 23

Figure 28: Specialist’s Home screen............................................................................ 24

Figure 29: Study selection screen ................................................................................ 24

Figure 30: Review a new study .................................................................................... 25

Figure 31: First page of sleep report ............................................................................ 26

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Revision Table

Revision

Date

0

1

August 2011 Preliminary

November 2012 1 st

Release

Description Chapter Pages

All

All

All

All

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1. Introduction to CloudPAT

1.1. Intended Use of WatchPAT

WatchPAT is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WatchPAT device is used as a diagnostic aid for the detection of sleep-related breathing disorders, and sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep and Deep Sleep).

The device generates a peripheral arterial tonometry ("PAT") Respiratory

Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI") and PAT sleep staging identification ("PSTAGES"). The device’s "PSTAGES" provides supplemental information to its PRDI/PAHI. The device’s "PSTAGES" is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

WatchPAT is not indicated for children less than 17 years old.

1.2. zzzPAT S/W

– Definition

zzzPAT is an analysis software package used with the WatchPAT device to aid in diagnosis of sleep related breathing disorders and detects REM, Light

Sleep, Deep Sleep and Wake stages. The zzzPAT S/W displays the signals recorded by the WatchPAT device, automatically identifies breathing disordered events and REM, Light Sleep, Deep Sleep stages, and generates a comprehensive report for the physician.

1.3. CloudPAT S/W

– Definition

CloudPAT is a HIPAA-compliant (PL104-191) web-based application supporting the sleep apnea lifecycle from diagnosis through interpretation. It offers individual physicians or large organizations the ability to control the process of sleep disorder management seamlessly and electronically in a turnkey fashion.

In its basic implementation, CloudPAT is a parallel adjunct to the local zzzPAT sleep analysis software sold separately with WatchPAT. CloudPAT uses zzzPAT’s analyzing software modules that are responsible for the identification of the breathing disordered events and REM, Light Sleep and

Deep Sleep stages.

CloudPAT offers simple preparation and uploading of WatchPAT sleep studies that can be sent transparently for interpretation by a local Boardcertified specialist or from a national network of telemedicine Board-certified specialists. After interpretation the sleep study results will be attached to the patient’s record. The regular, comprehensive WatchPAT sleep study report is available for printing, export, and analysis. All data is securely stored and backed up on the Web.

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1.4. Overview

Obstructive sleep apnea syndrome (OSAS) is considered a major public health problem. The prevalence of the syndrome is estimated at 2% to 5% in the adult population. It is characterized by recurrent events of complete or partial obstruction of the upper airways during sleep, often leading to hypoxemia, and/or arousals associated with sympathetic nervous system activation. The diagnosis and assessment of the sleep apnea patient is based on the

Respiratory Disturbance Index (RDI), the number of Apneas, Hypopneas and

Respiratory Effort Related Arousals (RERA) per hour of sleep and/or apneahypopnea index (AHI), along with sleep architecture. The common consequences of this sleep disruption are daytime sleepiness, poor daytime performance and increased vulnerability to accidents. Cardiovascular complications such as systemic/pulmonary hypertension, ischemic heart disease and arrhythmias are the major sequel of OSAS in the adult population.

The WatchPAT device is worn on the wrist and utilizes a plethysmographic based finger–mounted probe, to measure the PAT (Peripheral Arterial Tone) signal. The PAT signal is a measurement of the pulsatile volume changes in the fingertip arteries which reflects the relative state of the arterial vasomotor activity, and thus indirectly the level of sympathetic activation. Peripheral arterial vasoconstriction, which mirrors sympathetic activation, is shown as attenuation in the PAT signal amplitude. The PAT signal is recorded continuously and stored on a micro-SD card along with pulse rate (derived from the PAT signal), data from a built in pulse-oximeter (the sensor is mounted on an adjacent finger) and an actigraph (embedded in the device).

Following the sleep study, in an offline procedure, the recordings are uploaded to a web server and analyzed using the proprietary CloudPAT software.

CloudPAT uses the same algorithms as zzzPAT. The study data can be downloaded to a local PC in case the whole night data needs to be viewed and the automatically detected events need to be revised manually using the zzzPAT software.

This manual provides the information necessary for routine use of CloudPAT software.

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1.5. Terminology

CloudPAT supports various types of users and entities.

o Office – a practice including one or more referring physicians, as well as technicians and administrative staff. o Doctor – the primary physician administering the sleep test. o User – typically a Provider such as a technician or a nurse, but might also be a physician. This is the most common type of user using CloudPAT functions such as Creating a new study, Uploading a study and Viewing reports (see

Section 3).

o Specialist – a Board-certified physician performing the sleep study analysis, interpretation and diagnosis. This is another type of user using CloudPAT functions: Reviewing studies and Managing templates for diagnosis and

recommendations (see Section 4).

o Patient – the person who undergoes the sleep study.

1.6. Minimum requirements

An internet connection using a PC workstation with Microsoft XP SP2 and above, running at a minimum upload speed of 1 Mbps and Internet Explorer version 7.0 or

higher is required.

2. Setting CloudPAT Access

2.1

Obtaining an account

Usage of CloudPAT is intended for WatchPAT customers’ only (using Watch-

PAT200 devices). A secure and individual login account must be assigned by the trusted Itamar administrator.

To obtain a Username and Password, contact Itamar Medical or send an email to [email protected]. After a vetting process, you will get an email invitation nd containing your assigned Username followed by a 2 email with the initial password.

Note

Be sure to change the initial password upon sign in.

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2.2

Accessing CloudPAT

All subsequent access to CloudPAT will be via the Sign-in icon located on the home screen of www.Itamar-Medical.com

or directly at https:\\cloudpat.precisemd.com

Access to CloudPAT starts with the Sign In screen where Username and Password are

entered (see Figure 1).

Figure 1: Sign In screen

2.3

Setting [Initial] Password

Upon initial account setup, you will be prompted to enter an initial temporary password. Upon first time signing in CloudPAT you will be prompted to pick a new

password (see Figure 2).

Figure 2: Set Password screen

For identification purposes you will be prompted to fill in an answer to a secret question.

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Note

All asterisk (*) tagged fields are mandatory and should

be filled (see Figure 2).

2.4

Resetting Password

In the event you forgot your password, simply click on “Forgot your password?” link

on Sign In screen (see Figure 1) and you will get the following sequence where you

press “Continue” after each stage. Follow the instructions on each screen (see Figure

3).

Figure 3: Reset Password screens

2.5

Profile Settings & Support

Users may set their preferences by selecting the “Settings” option from the top of any

screen at any time (see Figure 4). The only mandatory fields are the Last name and

Email address (see Figure 5). In addition, you must select a secret question and

provide an answer to that question for the purpose of resetting your password. A new temporary password will be sent to your email address.

Please contact administration support by pressing Support from any screen if any difficulties arise. The Support screen contains the up to date phone numbers (see

Figure 6).

Figure 4: Functions available from all screens

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Figure 5: Profile Settings

Figure 6: Support screen

Note that the contact numbers shown above are subject to change.

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3. Using CloudPAT as a User

3.1. Main Access Screen (Home

“Lobby”)

Here are the main actions that can be selected from this screen:

1. Create New Study – prepares & initializes WatchPAT for a new sleep study.

2. Upload Study – uploads sleep study files from WatchPAT to the

CloudPAT web server and subsequent redirection (e.g., Board-certified interpretation by a Specialist) according to pre-determined instructions.

3. View Reports – enables the User to see which sleep studies have been analyzed and for which diagnosed sleep reports exist. The User may optionally elect to receive an email notification that a sleep study has been interpreted and diagnosed.

4. Manage Patients – enables the User to see which sleep studies have been performed on patients, alter the patient’s information or generate a followup sleep study for an existing patient.

Figure 7: Home (Lobby) screen

3.2. Creating a New Study

In order to prepare WatchPAT for a new study select “Create New Study” from the

Home screen (see Figure 8).

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Figure 8: Create New Study selection

3.2.1. Preparing WatchPAT for a New Study

The following steps are involved in preparing for a new study:

1. Fill the mandatory Patient ID in the Patient fields as in Figure 9.

Note

If the User is associated with only one Office then this

Office will be automatically filled.

2. Insert any additional information if needed, the rest of the fields are optional. You may insert additional information after the study is saved to

WatchPAT if necessary (see Section 3.5).

Note that you will be prompted to select a Specialist while uploading the

study (see Section 3.3.1 3.2.1) if the "Sent to Specialist" field is left empty

and you have more than one Specialists to choose from.

3. More Details (optional): Figure 10 shows the ability to add More Details,

Diseases, and/or Medications in the respective drop down lists. From this screen you may require a bracelet to be used as Positive Chain of

Custody in Occupational Testing (e.g., truck drivers. See WatchPAT user

manual for further details).

4. Once the study definition is completed, press “Save and Initialize Device”

(see Figure 9).

5. The system will prompt you to verify that the WatchPAT device is connected to the computer and then you should continue by selecting

”Proceed with initialization” (see Figure 11).

6.

Note

The first time you run the initialization process, a one-time

PC-resident program will be downloaded (see

Section 3.2.1.2).

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7. A pop-up application will open and manage the initialization of the device.

See section 3.2.1.3 for error handling in different cases.

8. The system will prompt you once the initialization process is completed.

Figure 9: Patient data entry screen

Figure 10: More Detail screen for patient data (optional)

CloudPAT

Figure 11: Initialize Device screen

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3.2.1.1. Initializing WatchPAT

Pressing the “Save and Initialize Device” button saves the patient information in the system and initializes the device. Alternatively, you can choose to prepare patient information without initializing the device by clicking the “Save” button shown in

Figure 9. This action will save the patient information in the system for later use. You

will be able to return later on to this patient from the “Manage Patients” screen and quickly initialize the device by clicking the “Save and Initialize Device”.

3.2.1.2. First Time Initialization

The first time you run the Initialization process, a small one-time PC-resident

program will be downloaded from CloudPAT (see Figure 12). If your system asks you

for permission to run this application, please enable to process, it is required for the successful connection to the WatchPAT device.

Figure 12: Message to download the PC-resident program

3.2.1.3. Initialization Process Protection

Data entry protection: Once the system saves the patient details (after pressing

“Save” or “Save and Initialize”) the system checks the values of the entered fields.

Relevant fields will be highlighted in red if not all mandatory fields have values, or if there are illegal/out of range values in any of the fields. Correct the errors and proceed.

Overwrite protection: If a previous study was found on the WatchPAT device that

was not uploaded to CloudPAT, it will not permit you to overwrite but will prompt by

saying “Previous study found” (see Figure 13) and that you should upload the study

before proceeding. This behavior prevents you from accidental overwriting a study that was not uploaded.

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Figure 13: Protection from accidentally overwriting previous sleep study

3.3. Uploading a Study

3.3.1. Normal Mode

When a patient returns WatchPAT after a night study, simply connect WatchPAT's

Micro USB port (see Figure 14) to any USB port on the PC by using WatchPAT's

communication cable and select “Upload Study” from the Home Screen (see Figure

15).

Figure 14: WatchPAT's Micro USB port

Note

In order to expose WatchPAT's Micro USB port:

1. Disconnect the Oximetry module by disconnecting the

Oximetry module connector.

2. Gently slide the WP200 out of the wrist strap until a click is heard and the Micro USB port is exposed.

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Figure 15: Upload Study Selection

Proceed by selecting the “Proceed with upload” button (see Figure 16).

Figure 16: Upload Study Dialog box

A small PC-resident program will be downloaded the first time remote access is

requested from CloudPAT (see Figure 12) and select “Run”. During the upload

process you will see a screen informing that upload is in progress.

If more than one Specialist is defined for the current Office and no Specialist was previously designated (while creating the new study), you will be prompted to select a

Specialist at this time (see Figure 17) from a list of Specialists which were defined for

your office.

CloudPAT

Figure 17: Select Specialist Dialog box

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While uploading the following dialog (see Figure 18) will be displayed.

Figure 18: Patient sleep study upload in progress

Note

Depending on your connection speed to upload and the size of the study data file, the upload time will vary between 2 and 5 minutes.

If upload is successful you will receive the message: “Upload Complete: Study uploaded successfully. The analyzed data file will be ready shortly under Reports.

Data has been sent to be reviewed by [Specialist’s name]” (see Figure 19).

Figure 19: Upload complete screen

If an error is reported, you will need to try again (see Figure 20).

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Figure 20: Upload failed screen

3.3.2. Manual Mode

In the rare event that a “manual” upload is needed (such as when an internet outage occurred and sleep study was uploaded locally using zzzPAT), select “Switch to

Manual Upload” in which case the following files: patient.dat, sleep.dat and log.dat (if it exists) should be concatenated into a single .ZIP file and uploaded this way. You may press “Browse” for the “Combined zzp file” (ZIP) file location and press “Next”

(see Figure 21).

See Appendix C: Uploading study from zzzPAT to CloudPAT Guide.

Figure 21: Manual Upload

In both modes at the end of a successful upload you will see the following screen:

CloudPAT

Figure 22: Successful upload screen

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3.4. Viewing Reports

After a patient sleep study has been sent to your Specialist for reviewing and Boardcertified interpretation, you will receive an email notification that your patient sleep study report is available. Alternatively, you may poll the system by pressing “View

Reports” from the main screen which will display the newest studies as well as a list

of previously viewed sleep study reports (see Figure 23).

You have the option to review subsets of your patient studies by selecting Yes/No for the different options (Sent to Specialist, Report Ready or Report Viewed), or by entering a specific Patient ID, name, etc.

Note

Click on the CSV icon (see Figure 23) if you want to obtain

an Excel file containing the "List of Reports".

Figure 23: Viewing Sleep Study Reports

After selecting a Patient ID, you will be brought to the following screen (see Figure

24) from which you can review the Board-Certified sleep study report.

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Figure 24: Report Details for reviewing sleep study reports

Simply click on the “Analysis File” link for a details report complete with comments and diagnosis from the Specialist and/or click the Excel File link to download an equivalent file in Excel format. Depending on the default setting for your institution, an unofficial and un-reviewed version of the sleep report may be available right after uploading your patient study.

Note

Contact Itamar Medical support for other file type options of report availability.

3.5. Managing Patient Information

You may use this function in order to manage patient information or see all studies that have been recorded for a particular patient.

You may browse or edit patient details by pressing “View Reports” from the main

screen which will display the Search for Patients screen (see Figure 25). You may

press on the Search button in order to see all patients or you may search by Patient ID, name, etc.

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Figure 25: Search for Patients screen

After selecting Search, you will be brought to the following screen (see Figure 26)

from which you can select the specific Patient to manage.

Figure 26: Search for Patients screen

Note

Click on the CSV icon (see Figure 26) if you want to obtain

an Excel file containing the "List of Patients".

After selecting a Patient ID, you will be brought to the following screen (see

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Figure 30) from which you can edit the Patient details.

Here are the main actions that can be selected from this screen:

1. Save – saves your changes to the Patient record.

2. Save and Initialize Device – loads WatchPAT with the current patient information while saving your changes (if any) to the Patient record.

The bottom of the screen lists all studies for the specific patient and you may select the Study Date link in order to view the corresponding Report Details screen (see

Figure 24).

Figure 27: Manage Patient Details screen

4. Using CloudPAT as a Specialist

4.1. Main Access Screen

When you sign in CloudPAT as a Specialist you will be presented with the

Specialist’s Home screen (see Figure 28).

Here are the main actions that can be selected from this screen:

3. Review studies – reviews new or displays completed studies.

4. Manage templates – defines new or edits existing templates used for

Clinical diagnosis and recommendations while reviewing studies.

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Figure 28: Specialist’s Home screen

4.2. Studies

4.2.1. Reviewing a Study

After a patient sleep study has been sent for interpretation, you will receive an email notification that a sleep study is waiting for your interpretation. Alternatively, you may poll this site by pressing on the “New” tab from the main screen which will

display the new studies screen (see Figure 29). You may also select the “Completed”

tab for viewing completed sleep study reports. You have the option to review subsets

of your studies by selecting a particular Office, Patient name, etc. (see Figure 29).

Note

Click on the CSV icon (see Figure 29) if you want to obtain

an Excel file containing the "Results".

CloudPAT

Figure 29: Study selection screen

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After selecting a Patient ID while on the “New” studies tab, you will be brought to the

following screen (see Figure 30) from which you can review the new sleep study.

Figure 30: Review a new study

Here are the main actions that can be selected from this screen:

1. Analysis File link - you can Click on the Analysis File link in order to see the two page report that was produced automatically by CloudPAT.

According to the Respiratory indices, various statistics and sleep stages you will be able to make your interpretation and fill in the Diagnosis and

Recommendations sections (see Figure 30).

2. Preview report - after you fill in the Diagnosis and Recommendations sections you can click the “Preview report” button in order to see the first

page of the final report with your interpretation included (see Figure 31,

sections “Summary & Diagnosis” and “Recommendations”). You may use the Diagnosis and Recommendations templates if you wish to insert an already defined paragraph in the corresponding section.

3. Download to zzzPAT - if you wish to see more details on the study’s signals you can use the “Download to zzzPAT” function in order to download a copy of this study to your local computer. Once the study files are downloaded, you can use the “Import Packed study” zzzPAT’s function (see zzzPAT’s OM) in order to open the study, view the signals and edit the Respiratory events or sleep stages if needed.

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4. Load Manual Events and Reanalyze - in case you used the “Download to zzzPAT” function and manually edited the Respiratory events or sleep stages you will be required to save the new events file (see zzzPAT’s OM) and then point to this file when clicking on the “Load Manual Events and

Reanalyze” button (see Figure 30). This action will re-analyze the study

using your input and will generate an updated sleep report. You may review the new report by clicking on the Analysis File link.

5. Save and Lock Report - finally when you are satisfied with your interpretation select the “Save and Lock Report” button. At this point the study report will be automatically digitally signed with your name, tagged as completed and be available for the Physician’s review.

6. Save – saves your input without locking the report.

Note

Once a report is Locked no more changes can be added. Use the “Save” button if you are not sure if you are done with this study. If a report is accidently locked contact Itamar Medical in order to unlock it.

CloudPAT

Figure 31: First page of sleep report

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4.2.2. Viewing a Completed Study

After selecting a Patient ID while on the “Completed” studies tab, you will be brought

to the following screen (see Figure 32) from which you can view the old sleep study.

Here are the main actions that can be selected from this screen:

1. Analysis File link - you can Click on the Analysis File link in order to see the two page report that was produced automatically by CloudPAT.

2. View report - you can click on the “View report” button in order to see the three page final report (with your interpretation included).

Figure 32: View a completed study

4.3. Templates

Templates are predefined paragraphs ready for use while reviewing a study and entering the Clinical diagnosis or Recommendations sections. For example, you may define a diagnosis template for Severe Sleep Apnea and a different one for Mild Sleep

Apnea.

You may have a number of predefined templates for Clinical diagnoses or

Recommendations and which can be used with a click of a button in order to facilitate the Reviewing process.

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Note

Click on the CSV icon (see Figure 33) if you want to obtain

an Excel file containing the "Templates".

Selecting the Templates tab will open up the Template Search screen (see Figure 33).

Figure 33: Search a template screen

4.3.1. Managing Templates

Clicking on the “New” button will open up a new template for editing (see Figure 34).

Figure 34: New Template screen

You need to fill all three fields (Name, Type and Text) in order to define the new template.

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Clicking on an existing template name (see Figure 33) will open up the Template

screen for editing (see Figure 35).

Here are the main actions that can be selected from this screen:

1. Save & New – Saves the template and creates a duplicate copy.

2. Delete – Deletes the template.

3. List – Returns to the list of templates.

4. Save - Saves the template.

Figure 35: Existing Template screen

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5. Troubleshooting

Trouble Possible Cause

New Study screen

Creating a You took too new study timed out long in replying to a message that there is another study resident on

WatchPAT.

Previous

Study found

There is a sleep study still on

WatchPAT that has not been uploaded from the device.

Solution

Re-run the initialization process a little quicker. If the problem persists it could be an internet connectivity problem so contact Support.

Press Exit and upload this old study.

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Error Message

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Could not access device.

The PC does not recognize

WatchPAT.

Make sure

WatchPAT is connected to the

PC via the USB.

Select Retry.

Trouble Possible Cause

Upload Study screen

Failed to

Send.

The station may not have

Internet access.

Failed to

Send.

Could not access device.

The Itamar

Upload service is temporarily unavailable.

The PC does not recognize

WatchPAT.

Solution

Save the data

(using "Save" option) and send it later.

Save the data

(using "Save" option) and send it later.

Make sure

WatchPAT is connected to the

PC via the USB.

Select Retry.

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Error Message

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6. Appendix A: Initializing WatchPAT via CloudPAT Guide

This guide will give you step-by-step instructions on how to initialize a WatchPAT device using CloudPAT.

1. Go to https:\\cloudpat.precisemd.com

and the following screen should appear:

2. Enter the Username and Password that was emailed to you and click "Sign In".

3. Clicking on the "Create New Study" from the main screen will start the process of device initialization using CloudPAT.

4. Thereafter, the following screen will open up. The only mandatory field is

“Patient ID”

, but you may put as much patient information as you like, including date of birth, gender, etc. Make sure to select a specialist in the "Sent to

Specialist" field, otherwise you will be prompted to select a specialist while uploading (in case you have several specialists to choose from).

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Itamar Medical Ltd.

Just as with zzzPAT, the only mandatory field is

Patient ID – there is other information to fill out, but it can be done after the study is uploaded if necessary.

5. Clicking the button next to either “More Details”, “Diseases”, or

“Medications” allows even more patient details to be entered.

Selection of the interpreting physician can be selected during initialization or while the study is been uploaded.

6. After the

“Patient ID”

(mandatory) and any of the other patient details you want to enter are completed, you will now select

“Save and Initialize Device”

in the upper right portion of the CloudPAT screen

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Itamar Medical Ltd.

7. The following screen will appear. Click on

“Proceed with initialization”

8. The following screen will then appear and initialization is complete.

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Itamar Medical Ltd.

7. Appendix B: Uploading study from WatchPAT to CloudPAT

Guide

This guide will give you step-by-step instructions on how to upload a study directly from the WatchPAT device to CloudPAT.

1. Go to https:\\cloudpat.precisemd.com

and the following screen should appear:

2. Enter the Username and Password that was emailed to you and click

“Sign In”

3. Clicking on the "Upload Study" from the main screen will start the process of uploading a study from the WatchPAT device to CloudPAT.

4. Thereafter, the following screen will open up. We will select “ Proceed with upload

” when uploading directly from the device.

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Itamar Medical Ltd.

5. Depending on your connection speed to upload and the size of the study data file, the upload time will vary between 2 and 5 minutes. If an error is reported, you will need to try again.

6. The study will automatically attach itself to the associated patient if the device was initialized via CloudPAT.

7. Now, the study must be assigned to a sleep specialist. Then, click

“Next”

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Itamar Medical Ltd.

8. The following screen will appear and the process is complete

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Itamar Medical Ltd.

8. Appendix C: Uploading study from zzzPAT to CloudPAT

Guide

This guide will give you step-by-step instructions on how to upload a study from zzzPAT to CloudPAT. This process will be utilized when you do not have an internet connection and you loaded the study to zzzPAT from the WatchPAT device.

1. Open zzzPAT (default Login and Password: “111” for both entries)

2. Select “ Export/Delete

” under “

Tools

”

3. Highlight the study that you want to export to CloudPAT and select

“Export for

Interpretation”

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Itamar Medical Ltd.

4. You will now be asked to save this file to your hard drive. Generally, I choose a folder called “CloudPAT” that I create prior to this step. After selecting the folder to save the exported file, click “ OK

”.

5. Now go to https:\\cloudpat.precisemd.com

and the following screen should appear:

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Itamar Medical Ltd.

6. Enter the Username and Password that was emailed to you and click "Sign In" .

7. Uploading a .zzp exported for interpretation study using CloudPAT is performed by following these steps:

8. Select

“Upload Study” from Home screen.

9. Thereafter, the following screen will open up. Select

“Switch to Manual Upload”.

10. Now you need to find the file that was exported out of zzzPAT by selecting

“Browse”.

11. The file will end in .zzp. Select the file that you want to upload and select

“Open”

.

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12. Select

“Next”

.

13. Depending on your connection speed to upload and the size of the study data file, the upload time will vary between 2 and 5 minutes. If an error is reported, you will need to try again.

14. Now, the study must be assigned to a sleep specialist. Then, click

“Next”

.

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15. The following screen will appear and the process is complete.

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Itamar Medical Ltd.

9. Appendix D: Interpretation and editing of events by the

Specialist Guide

This guide will give you step-by-step instructions on how to view, download to zzzPAT, edit events, upload to CloudPAT, and generally interpret a study using

CloudPAT.

1. Go to https:\\cloudpat.precisemd.com

and the following screen should appear:

2. Enter the Username and Password that was emailed to you and click

“Sign In”

.

3. After logging in to CloudPAT, the following screen will appear. Note (circled in red) at the top left corner to options “Studies” and “Templates”. Choose

“Studies”

.

Beneath “Studies”, there are two options “New” and “Completed”. a. "Completed" Studies are studies that have been interpreted b. "New" Studies are studies that have been uploaded to CloudPAT and are in the queue awaiting interpretation. These studies can be sorted by clicking “Patient_ID”, “Patient”, “Office”, “Current Doctor”,

“Study Date”, or “Waiting (days)”. See below:

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Itamar Medical Ltd.

4. Once you have sorted, searched, and identified the study to interpret, the next step is to open the file by clicking on the

“Patient ID” name.

5. The next steps for the interpreting specialist is to

“Preview Report”

(1st page of report that is the dictated impression and recommendations from the custom template and is blank until selections are made),

“Download to zzzPAT”

(to review the raw data), and

“Save and Lock Report”

(completed review and interpretation of raw data).

6. To view the auto analyzed 2 page report that the technician uploaded, double click the

“Analysis File”

.

7. This will open a new window in Internet Explorer to a 2 page pdf document. At the bottom of the new page, you can scroll to view both pages of the sleep report:

8. To download the raw data for review, follow these steps:

a. Click on

“Download to zzzPAT” b. At the bottom of the webpage, you will see a new box open. Click on

“Save” and a new box will open then click on

“Save as”

: c. From here you will need to save the file to your hard drive. I do this by creating a new folder in “Documents” called “CloudPAT” so that I can find the zzp file for import into zzzPAT in subsequent steps.

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Itamar Medical Ltd.

d. We are now ready to open zzzPAT to review the raw data.

9. To review the raw data open zzzPAT software and put in the Login and Password

“111” for both entries (default values).

10. Select “Import Packed studies” under “Tools”

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Itamar Medical Ltd.

11. The following box will open and we need to highlight the zzp file to import and select “Open”.

.

12. A new box will now open and the imported study will now be loaded and analyzed.

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13. The study is now available to be reviewed and manually edited by the interpreting physician.

14. If changes are made, the study will need to be uploaded to CloudPAT by following the steps below:

e.

Add and/or Delete events per your training

f.

Go to

File

and select

“Export Manual Events…”

c. A new box will open and we will now save the changes to our

CloudPAT folder and select

“OK” d. The manually edited changes now need to be uploaded to CloudPAT.

To do so follow these remaining steps: i. Click on

“Browse”

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Itamar Medical Ltd.

ii. Find the saved file, highlight it, and click

“Open”

iii. Now click

“Save”

iv. The manually edited study is now saved to CloudPAT and is ready for interpretation using the customizable template system:

15. Preview the new report. Enter your Diagnosis and Recommendations and click on

“Save and Lock Report” to complete the process and alert the provider that the study is complete.

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10. Appendix E: CloudPAT

Assistant “cheat sheets"

You may print the following pages for a quick reference to frequent tasks.

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Create a New Study (Initialization) via CloudPAT

t

Step

Action(s)

Do you have…?

1. PC workstation w/internet access?

2. Internet Explorer 7.0 or higher?

3. Username & Password?

4. Minimum upload speed of 1 Mbps

Comment

Problems or Questions?

Select Support or

Call: +1-888-748-2627

1. 1

.

Enter

CloudPAT via the Web

Log in to: www.cloudpat.precisemd.com



Enter your Username & Password



Select Sign In

2.

Create

(initialize) new Sleep

Study using

CloudPAT



Select

“Create New Study”



Slide WatchPAT out of its “cradle” to reveal the USB connection.



Connect WatchPAT to any USB port.

4.

OPTIONAL

Chain of

Custody

Bracelet



Only one (1) patient field is mandatory:

“Patient ID”



Select your Board-certified interpreter under “Send to Specialist.”



If no Specialist was selected for study interpretation, you will be prompted to select one when eventually uploading a study.



Select

“Save & Initialize Device” OR



For more patient detail entry, select

“More Details” opening another screen



Select the box “Bracelet Study” for occupational testing using a Chain of

Custody bracelet.



Select

“Save & Initialize Device”



Select:

“Proceed with initialization”



1st time usage: a small PC-resident program

will be downloaded. Select: “Run”

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Upload Sleep Study from WatchPAT to CloudPAT

Step

Action(s)

Do you have…?

1. PC workstation w/internet access?

2. Internet Explorer 7.0 or higher?

3. Username & Password?

4. Minimum upload speed of 1 Mbps

Comment

Problems or Questions?

Select Support or

Call: +1-888-748-2627

1. 1

Enter

.

CloudPAT via the Web

Log in to: www.cloudpat.precisemd.com



Enter your Username & Password



Select Sign In

2.

Upload a

Sleep Study-

WatchPAT to CloudPAT

3.

Connect

WatchPAT to USB port



Select

“Upload Study”



Slide WatchPAT out of its “cradle” to reveal the USB connection.



Connect WatchPAT to any USB port.

Select

: “Proceed with upload”



1 st

time usage: a small PC-resident program will be downloaded.

Select: Run



If no Specialist was pre-selected for Study interpretation, you will be prompted to select one after the study has uploaded.

Depending on your connection speed, upload time will vary between two (2) and five (5) minutes. If an error is reported, you will need to try again.

“Upload Complete”: Study uploaded successfully. Data has now been sent for analysis to your Specialist (and after you have now been prompted to select a

Specialist).

“Upload Failed”: try again or call Support

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Manual Upload from zzzPAT to CloudPAT

(Rarely needed. e.g. if an internet outage occurred and sleep study was saved locally on zzzPAT)

Step

Action(s) Comment

1. Start zzzPAT

Open zzzPAT

(default Login and

Password: “111” for both entries)

Select

“Export/Delete” under “Tools”

3.

Find a patient via ID number

Highlight the patient that you want to export to CloudPAT and select

“Export for

Interpretation

”



Browse for a Folder you created prior to this step (suggestion: name it “CloudPAT”).



After selecting that Folder, Save the exported file by selecting

“OK”



The file will end in .zzp.



Log into CloudPAT like a regular study, www.cloudpat.precisemd.com



Enter your Username and Password



Select Sign In

Select

“Upload Study”

Select

“Switch to Manual Upload”

Find the file: select

“Browse”

7.

Proceed as in normal

Upload

The file extension is .zzp.

Select

“Open” for the file you want to upload.

Proceed as in Step 3 for a regular Upload

Sleep Study

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Specialist: Board-certified physician review of raw sleep study data

Download study for scoring & interpretation

Step Action(s) Comment

Do you have…?

1. PC workstation w/internet access

2. Internet Explorer 7.0 or higher?

3. Username & Password?

4. zzzPAT familiarity & installed

Problems or Questions?

Select Support or

Call: +1-888-748-2627

2.

Enter

CloudPAT via the Web

Log in to: www.cloudpat.precisemd.com



Enter your Username & Password



Select Sign In

3.

4.

View autoanalyzed suggestions

5.

Select patient study

Analyze & save Sleep

Study raw data

You may



Analyze a study (“Studies”) or



Create custom forms (“Templates”).

Select the patient you want to analyze.

Various Sort options are available at the bottom



To view the auto analyzed, 2-page report that the Provider uploaded, select

“Analysis File.”



To view patient information, select

"Preview Report"

To download the raw data for review:



Select

“Download to zzzPAT”



Browse for a Folder you created prior to this step (suggestion: name it

“CloudPAT”)



If/when scoring results are satisfactory, diagnosis, and recommendations have been entered, select

“Save and Lock

Report

.”



You are done.

6. Start zzzPAT

Open zzzPAT

(default Login and Password: “111” for both entries)

7.

Manual

Study

Upload



Select

“Import Packed studies” under

“Tools”



Get to “Select Packed Studies to Import”



Go to your previous CloudPAT Folder



Highlight the .zzp file to Import



Select

“Open”



Edit/Score as usual with zzzPAT

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Specialist: Board-certified physician review of raw sleep study data

Score, Interpret, Upload Changes, Save & Lock Report

Step Action(s) Comment

1.

Manually edit and score the sleep study



Add and/or Delete Events per your training



The changes now need to be saved on your local disk.

2.

3.

4.

Save Event changes on local disk

Upload

Event changes to

CloudPAT

Save Event changes on

CloudPAT

5.

Lock report; notify

Provider



Select “File”



Select “Export Manual Events…”



A new box will open;



Save the changes to your local

CloudPAT Folder



Select

“OK”



The manually edited changes now need to be uploaded back to CloudPAT.



Select

“Browse”



Find the saved file, highlight it, select

“Open”



Select

“Save” from the CloudPAT toolbar.



Your manually edited study is now saved on CloudPAT, ready for diagnosis using your customizable template system



Preview the new report.



Enter your Diagnosis and

Recommendations



Select

“Save and Lock Report” to complete the process



Provider will be alerted automatically that the study is complete.

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11. Appendix F: License Agreement

License To User From Itamar

IMPORTANT - PLEASE READ THIS LICENSE AGREEMENT CAREFULLY

BEFORE INSTALLING OR OTHERWISE USING THE LICENSED SOFTWARE

(AS DEFINED BELOW) OR THE PRODUCT WITH WHICH YOU RECEIVED

THIS LICENSE AGREEMENT. THIS LICENSE AGREEMENT APPLIES TO (a)

ALL LICENSED SOFTWARE, (b) ALL LICENSED PRODUCTS (AS DEFINED

BELOW), AND (c) ALL THIRD PARTY PRODUCTS INTO WHICH A LICENSED

PRODUCT OR LICENSED SOFTWARE IS INCORPORATED. SHOULD YOU

HAVE ANY QUESTIONS CONCERNING THIS LICENSE AGREEMENT, PLEASE

CONTACT THE VENDOR FROM WHICH YOU PURCHASED THE LICENSED

SOFTWARE, LICENSED PRODUCT, OR PRODUCT INTO WHICH A LICENSED

PRODUCT OR LICENSED SOFTWARE IS INCORPORATED. YOU MAY ALSO

CONTACT ITAMAR AT THE ADDRESS PROVIDED AT THE END OF THIS

LICENSE AGREEMENT.

This License Agreement is a legal agreement between you (as an individual, company, organization or other entity) and Itamar Medical Ltd. (“Itamar”). By installing, copying, or otherwise using the Licensed Software, and/or by using the Licensed Product or third party product into which a Licensed Product or Licensed Software is incorporated

(“Third Party Product”), you agree to be bound by the terms of this License Agreement with respect to the Licensed Software and Licensed Products. If you do not agree to the terms of this License Agreement, including, without limitation, the Restrictions on Use as provided in Section 2 do not install, use or copy the Licensed Software or use the

Licensed Product or the Third Party Product.

The Licensed Software and the Licensed Products are protected by US patent laws, trade secret laws, copyright laws, and international treaty provisions as well as other intellectual property laws and treaties. Therefore, you must treat the Licensed Software and the Licensed Products like any other copyrighted and protected material or product.

All title to the Licensed Software and all intellectual property rights in and to the

Licensed Software and the Licensed Products shall remain with Itamar.

1.

DEFINITIONS

1.1. “Licensed Product(s)” means the Watch-PAT200, the PAT Probe,

Integrated Snore & Body position sensor, Tamper-proof Patient Identification

Bracelet and the corresponding components of any Third Party Product with which this License Agreement was received. Some Licensed Products are stand-alone products and some Licensed Products are incorporated as components within Third Party Products, in each case sold or otherwise made available, by Itamar and/or third parties. If you have received this License

Agreement with a Third Party Product, this License Agreement applies only to the Licensed Product incorporated as a component within such Third

Party Product.

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1.2. “Licensed Software,” means the zzzPAT software, CloudPAT software, and the associated media and accompanying materials provided to you with such software. Some Licensed Software is a stand-alone product and some

Licensed Software is incorporated as a component within a Licensed Product, in each case sold or otherwise made available, by Itamar and/or third parties.

If you have received this License Agreement with a Licensed Product, which incorporates the Licensed Software as a component within such Licensed

Product, this License Agreement applies to the Licensed Software.

2. GRANT OF LICENSE AND RESTRICTIONS ON USE

2

.1 Itamar hereby grants you a non-exclusive right to use the Licensed Software, solely for its intended use in sleep medicine (with the term "sleep medicine" including

Cheyne-Stokes respiration as well as research in sleep medicine and Cheyne-Stokes respiration) (i) with the Licensed Product(s) and (ii) in accordance with the provisions of this License Agreement and the instructions provided in the documentation accompanying the Licensed Software and the Licensed Product You may make one copy of the Licensed Software solely for backup or archival purposes, or transfer the

Licensed Software to a single hard disk, provided you keep the original solely for backup or archival purposes. However, you may not cause any Licensed Software, which is not designed for use on a server, to execute or be loaded into the active memory or media of more than one computer at any one time.

2.2 Any use of the Licensed Software and/or Licensed Product other than as set forth in

Section 2.1 above is strictly forbidden. Without derogating from the generality of the above, you may not:



Distribute, reproduce, copy, assign, rent, lease, or otherwise transfer the rights granted to you under this License Agreement to any third party except explicitly as set forth in this License Agreement;



Reverse engineer, recompile, or disassemble, as applicable, the Licensed

Software or the Licensed Product, except as expressly permitted by applicable law; or



Modify in any manner the Licensed Software and/or the Licensed Product unless obtaining the prior written consent of Itamar.

3. TRADEMARKS

Cardio-PAT™, Sleep-PAT™ and all trademarks and logos, which appear on or in connection with the Licensed Software and/or the Licensed Products, as may be amended from time to time, are, unless stated otherwise, trademarks of Itamar. No right, license, or interest to such trademarks are generated or granted hereunder other than the limited right to use provided herein, and you agree that no such right, license, or interest shall be asserted by you with respect to such trademarks. You may not remove or destroy any copyright, trademark, logo or other proprietary marking or legend placed on or contained in the Licensed Software or a Licensed Product.

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4. LIMITED WARRANTIES AND DISCLAIMERS

a. Against

Infringement. Itamar hereby warrants to you that it has the right to grant you the license to use the Licensed Software and/or the Licensed Product and to enter into this License Agreement and that neither the Licensed Software nor the Licensed

Product(s) infringes the intellectual property rights of any third party. b. As to Licensed Product. Itamar warrants that the Licensed Product, with which this

License Agreement was delivered, will be free from defects in design, materials and workmanship for a period of one year from the date of delivery of the Licensed Product to you. If the Licensed Product contains a defect in design, materials or workmanship and such Licensed Product is returned to Itamar within one (1) year of delivery of the

Licensed Product to you, Itamar will repair or replace the Licensed Product, or issue a credit for the purchase price of the Licensed Product, with the choice to repair, replace or credit being within the sole discretion of Itamar. The foregoing repair, replacement or credit remedy will be your sole remedy for breach of the warranty set forth in this

Section 4(b). c. As to Licensed Software. Itamar warrants that for a period of ninety (90) days from the date of delivery of the Licensed Software to you, the Licensed Software will, under normal use, be free from defects in materials and workmanship and will perform substantially as it is intended to perform. If during such ninety (90) day period, the

Licensed Software has a defect in materials or workmanship or does not perform substantially as it is intended to perform, Itamar shall (a) attempt to correct or assist you around errors with efforts which Itamar believes suitable to the problem, (b) replace the

Licensed Software with a functionally equivalent software, or (c) issue a credit for the purchase price of the Licensed Software, with the choice to correct or assist, replace or credit being within the sole discretion of Itamar. The foregoing correct or assist, replacement or credit remedy will be your sole remedy for breach of the warranty set forth in this Section 4(c). d. Limitation of Warranties. The warranties contained in Sections 4(b) and 4(c) above do not cover damage to the Licensed Products or the Licensed Software caused by accident, misuse, abuse, negligence, failure to install in accordance with Itamar’s installation instructions, failure to operate under conditions of normal use and in accordance with the terms of the documentation accompanying the Licensed Product and/or the Licensed Software, failure to maintain in accordance with applicable documentation accompanying the Licensed Product and/or the Licensed Software, alteration or any defects not related to materials or workmanship, or in the case of

Licensed Products, design, materials or workmanship. This warranty does not cover damage which may occur in shipment. This warranty does not apply to Licensed

Products and/or Licensed Software not purchased new. This warranty does not apply to any Licensed Product or any individual parts of a Licensed Product which have been repaired or altered by anyone other than Itamar or a person or entity authorized by

Itamar to repair Licensed Products.

While every reasonable effort has been made to ensure that you will receive Licensed

Software that you can use, Itamar does not warrant that the functions of the Licensed

Software will meet your requirements or that the operation of the Licensed Software will be uninterrupted or error free. Itamar is not responsible for problems caused by changes in the operating characteristics of the hardware or operating system software

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Itamar Medical Ltd.

you are using, nor for any problems in the interaction of the Licensed Software with non-Itamar software.

ITAMAR HEREBY DISCLAIMS, WITH RESPECT TO THE LICENSED

PRODUCTS AND THE LICENSED SOFTWARE, ALL OTHER WARRANTIES

AND CONDITIONS, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT

LIMITED TO, ANY WARRANTIES OR CONDITIONS OF OR RELATED TO

MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY

OR COMPLETENESS OF INFORMATION, LACK OF NEGLIGENCE AND

CORRESPONDENCE TO DESCRIPTION.

5. LIMITATION OF LIABILITY

(A) TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW,

EXCEPT FOR DAMAGES ARISING UNDER SECTION 4(A) ABOVE, IN NO

EVENT SHALL ITAMAR BE LIABLE TO YOU FOR DAMAGES IN EXCESS OF

THE PURCHASE PRICE YOU PAID FOR THE LICENSED SOFTWARE, THE

LICENSED PRODUCT OR THE APPLICABLE THIRD PARTY PRODUCT. THE

FOREGOING LIMITATION SHALL BE APPLICABLE REGARDLESS OF

WHETHER THE ACTION GIVING RISE TO SUCH DAMAGES IS IN TORT,

CONTRACT, STRICT PRODUCTS LIABILITY, OR OTHERWISE.

(B) IN NO EVENT SHALL ITAMAR BE LIABLE FOR ANY SPECIAL,

INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVER

ARISING OUT OF OR IN ANY WAY RELATED TO THE USE OF OR INABILITY

TO USE THE LICENSED SOFTWARE AND/OR THE LICENSED PRODUCT

AND/OR THE THIRD PARTY PRODUCT, OR THE PROVISION OF OR FAILURE

TO PROVIDE SUPPORT SERVICES BY ITAMAR, EVEN IF ITAMAR HAS BEEN

ADVISED OF THE POSSIBILITY OF SUCH CONSEQUENTIAL DAMAGES. THE

FOREGOING DISCLAIMER OF CONSEQUENTIAL DAMAGES SHALL BE

APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE TO

SUCH DAMAGES IS IN TORT, CONTRACT, STRICT PRODUCTS LIABILITY,

OR OTHERWISE.

(C) IN ORDER TO BE ENTITLED TO INDEMNIFICATION HEREUNDER IN

CONNECTION WITH AN INFRINGEMENT CLAIM, YOU MUST (i) NOTIFY

ITAMAR IN WRITING PROMPTLY UPON BECOMING AWARE OF AN

INFRINGEMENT CLAIM OR THE POSSIBILITY THEREOF, (ii) GRANT

ITAMAR SOLE CONTROL OF THE SETTLEMENT, COMPROMISE,

NEGOTIATION AND DEFENSE OF ANY SUCH ACTION, AND (iii) PROVIDE

ITAMAR WITH ALL INFORMATION RELATED TO THE ACTION THAT IS

REASONABLY REQUESTED BY ITAMAR. NOTWITHSTANDING THE

FOREGOING, ITAMAR SHALL HAVE NO INDEMNIFICATION OBLIGATIONS

WITH RESPECT TO ANY INFRINGEMENT CLAIM TO THE EXTENT ARISING

FROM YOUR USE OF THE LICENSED PRODUCT AND/OR LICENSED

SOFTWARE IN CONJUNCTION WITH OTHER HARDWARE OR SOFTWARE

WHERE USE WITH SUCH OTHER HARDWARE OR SOFTWARE GAVE RISE

TO THE INFRINGEMENT CLAIM.

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6. TERMINATION

Without prejudice to any other rights or remedies, Itamar may terminate this License

Agreement immediately if you fail to comply with any of its terms and conditions. In the event of such termination, you must, within ten (10) business days of receiving notice of termination from Itamar, cease all use of the Licensed Software and destroy all copies thereof, and cease all use of the Licensed Product (including Licensed

Product incorporated within Third Party Product).

7. TRANSFERABILITY

You may only transfer or assign the rights and obligations hereunder together with the

Licensed Software and/or the Licensed Product or Third Party Product as a whole, without retaining any rights or, subject to Sections 2 and 3 above, any obligations arising after the date of such transfer or assignment, or retaining any installed or uninstalled copy of the Licensed Software, the Licensed Product or the Third Party

Product. Any attempt by you to rent, lease, sublicense, assign or transfer any of the rights, duties or obligations hereunder in any other way is forbidden and shall be null and void.

8. SEVERABILITY

Should any term or provision of this License Agreement be declared void or unenforceable by any court of competent jurisdiction in any country or countries, such declaration shall have no effect on the remainder of this License Agreement in such country or countries, or on this License Agreement in other countries.

9. NO WAIVER

The failure of either party to enforce any rights granted to it hereunder or to take action against the other party in the event of any breach hereunder shall not be deemed a waiver by that party as to subsequent enforcement actions in the event of future breaches.

10. GOVERNING LAW AND JURISDICTION

This License Agreement is governed by the laws of the State of New York, excluding its conflict of laws principles. The United Nations Convention on Contracts for the

International Sale of Goods shall not apply to any of the transactions contemplated by this License Agreement.

11. ENTIRE UNDERSTANDING

This License Agreement represents the complete and exclusive understanding between you and Itamar concerning the license by Itamar to you of Licensed Software and

Licensed Products and supersedes all prior agreements and representations between the parties with respect to the subject matter hereof, unless specifically stated otherwise in a

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writing signed by Itamar and you. This License Agreement may not be amended other than by a written agreement specifically intended for this purpose and signed by Itamar and you.

Note: Should you have any questions concerning this License Agreement, or if you desire to contact Itamar for any reason, please write to: Itamar Medical Ltd., 9

Halamish St., P.O.Box 3579, Caesarea, 38900, Israel, Facsimile: +972-4-627 5598, or visit Itamar’s web site at www.itamar-medical.com.

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12. Appendix G: Regulatory Representative

Itamar Medical’s authorized regulatory representative is:

MEDES Ltd.

P.O.Box 231

5 Beaumont Gate, Shenley Hill,

Radlett, Herts WD7 7AR.

England

Tel: +423-663-169205

Tel / Fax: +44 1923859810

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