Itamar Medical 200 U, 200 WatchPAT, CloudPAT, zzzPAT Operation Manual
Below you will find brief information for WatchPAT 200 U, WatchPAT 200. The WatchPAT is a non-invasive home care device used to diagnose sleep-related breathing disorders.
Advertisement
Advertisement
Itamar Medical Ltd.
CloudPAT
™
Web Software Operation Manual
Itamar Medical REF
OM2200000
WatchPAT
TM is a trademark of Itamar Medical, Ltd.
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner
Copyright
2011-2017 by Itamar Medical Ltd. Software Version: 2.0
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 Ind. Park, 3088900, Israel
Tel + 972 4 617 7000
Fax + 972 4 627 5598 www.itamar-medical.com
EN ISO 13485:2012 and ISO 13485:2003 / CMDCAS
CloudPAT Page 2 Operation Manual
Itamar Medical Ltd.
Table of Contents
........................................................................................................................................ 1
1.
Introduction to CloudPAT ................................................................................. 7
1.1.
Intended Use of WatchPAT™ device ......................................................... 7
1.1.1
WP200U in US ........................................................................................ 7
1.1.2
WP200 / WP200U in ROW ..................................................................... 7
1.2.
zzzPAT S/W – Definition ............................................................................ 7
1.3.
CloudPAT S/W – Definition ....................................................................... 8
1.4.
Overview ..................................................................................................... 8
1.5.
Terminology .............................................................................................. 10
1.6.
Minimum requirements ............................................................................. 10
2.
Setting CloudPAT Access................................................................................ 10
2.1
Obtaining an account ................................................................................. 10
2.2
Accessing CloudPAT ................................................................................ 11
2.3
Setting [Initial] Password .......................................................................... 11
2.4
Changing password.................................................................................... 13
2.5
Resetting Password .................................................................................... 14
2.6
Profile Settings & Support ......................................................................... 15
3.
Using CloudPAT as a User .............................................................................. 17
3.1.
Main Access Screen (Home “Lobby”) ...................................................... 17
3.2.
Create New Study and manage patients .................................................... 18
3.2.1.
Preparing for a New Study ..................................................................... 20
3.2.2.
First Time Installation ............................................................................ 25
3.2.3.
Initialization Process Protection ............................................................ 29
3.3.
Uploading a Study ..................................................................................... 31
3.3.1.
Normal upload Mode ............................................................................. 31
3.3.2.
Manual Mode ......................................................................................... 34
3.4.
Managing studies and Viewing Reports .................................................... 35
3.4.1.
Searching studies and reports................................................................. 35
3.4.2.
Study management ................................................................................. 36
3.4.2.1.
Understanding the Study screen ......................................................... 36
3.4.2.2.
Attaching files to a study .................................................................... 37
3.4.2.3.
Changing Interpreting Physician and viewing assignment history .... 38
3.4.2.4.
View analysis file ............................................................................... 38
3.4.2.5.
Request for a script ............................................................................. 39
3.4.2.6.
Changes of Study Parameters ............................................................. 39
3.4.3.
Viewing reports ...................................................................................... 40
3.5.
Manage lists ............................................................................................... 42
3.5.1.
Medications ............................................................................................ 42
3.5.2.
Diseases.................................................................................................. 44
4.
Using CloudPAT as an Interpreting Physician ................................................ 47
4.1.
Main Access Screen ................................................................................... 47
4.2.
Studies ....................................................................................................... 48
4.2.1.
Reviewing a Study ................................................................................. 49
4.2.2.
Viewing a Completed Study .................................................................. 55
4.3.
Manage Templates & NPIs ........................................................................ 55
4.3.1.
Templates ............................................................................................... 56
CloudPAT Page 3 Operation Manual
Itamar Medical Ltd.
4.3.2.
NPIs........................................................................................................ 57
4.4.
Signature .................................................................................................... 59
5.
Troubleshooting ............................................................................................... 60
6.
Appendix A: Exporting a study from zzzPAT into CloudPAT ....................... 65
7.
Appendix B: Interpretation and editing of events by the Interpreting Physician
Guide ........................................................................................................................ 67
8.
Appendix C: CloudPAT Assistant “cheat sheets" ........................................... 72
9.
Appendix D: License Agreement..................................................................... 81
10.
Appendix E: Regulatory Representative ...................................................... 87
Table of Figures
Figure 1: Sign In screen ............................................................................................... 11
Figure 2: Set Password screen ..................................................................................... 12
Figure 3: Change Password Screen .............................................................................. 13
Figure 4: Reset Password screens ................................................................................ 15
Figure 5: Functions available from all screens ............................................................ 15
Figure 6: Profile Settings ............................................................................................. 16
Figure 7: Support screen .............................................................................................. 16
Figure 8: Home (Lobby) screen ................................................................................... 18
Figure 9: Contact Us screen ......................................................................................... 18
Figure 10: Create New Study selection ....................................................................... 19
Figure 11: Search for Patients screen ........................................................................... 19
Figure 12: Search for Patients screen ........................................................................... 20
Figure 13: Patient data entry screen ............................................................................. 21
Figure 14: More Detail screen for patient data (optional) ........................................... 23
Figure 15: Initialize Device screen .............................................................................. 25
Figure 16: the browser will prompt you to download the installer .............................. 25
Figure 17: Failing to work with PC App ..................................................................... 26
Figure 18: installation process ..................................................................................... 26
Figure 19: download and run on Firefox ..................................................................... 27
Figure 20: download and run on Chrome .................................................................... 28
Figure 21: Select the Itamar application (right – FireFox, left: Chrome) ................... 29
Figure 22: Protection from accidentally overwriting previous sleep study ................. 30
Figure 23: Upload Study Selection .............................................................................. 31
Figure 24: Upload Study Dialog box ........................................................................... 31
Figure 25: Patient sleep study upload in progress ....................................................... 32
Figure 26: Successful upload screen ............................................................................ 32
Figure 28: Upload complete screen ............................................................................. 34
Figure 29: Upload failed screen ................................................................................... 34
Figure 30: Manual Upload ........................................................................................... 35
Figure 31: Viewing Sleep Study Reports..................................................................... 36
Figure 32: Study screen ............................................................................................... 37
Figure 33: Deleting attached files. ............................................................................... 38
Figure 34: Rerun Analysis Message ............................................................................ 40
CloudPAT Page 4 Operation Manual
Itamar Medical Ltd.
Figure 35: Report Details for reviewing sleep study reports ....................................... 41
Figure 36: Manage Lists screen ................................................................................... 42
Figure 37: Search for medication screen ..................................................................... 43
Figure 38: Medication Details screen .......................................................................... 43
Figure 39: New Medication screen .............................................................................. 44
Figure 40: Search for diseases screen .......................................................................... 45
Figure 41: Disease Details screen ................................................................................ 45
Figure 42: New Disease screen .................................................................................... 46
Figure 43: Interpreting Physician’s Home screen ........................................................ 47
Figure 44: Contact Us screen ....................................................................................... 48
Figure 45: Study selection screen ................................................................................ 49
Figure 46: Review a new study .................................................................................... 50
Figure 47: Attach files to a report ................................................................................ 52
Figure 48: First page of sleep report ............................................................................ 54
Figure 49: View a completed study ............................................................................. 55
Figure 50: Templates & NPIs screen ........................................................................... 56
Figure 51: Search a template screen ............................................................................ 56
Figure 52: New Template screen ................................................................................. 57
Figure 53: Existing Template screen ........................................................................... 57
Figure 54: Search NPI screen ...................................................................................... 58
Figure 55: Existing NPI screen .................................................................................... 58
Figure 56: New NPI screen .......................................................................................... 59
CloudPAT Page 5 Operation Manual
Itamar Medical Ltd.
Edition Table
Edition
0
1
2
3
Date
August 2011 Preliminary
November 2012 1 st
Release
March 2014
April 2015
Description
Update software version
Updating Itamar Medical address
Updating ISO symbols
Updating authorized regulatory representative address
Update software version
4
5
July 2015
July 2017
Chapter
All
All
All
All
Update CloudPAT S/W – Definition 1.3
Version 2.0:
Update company logo, Rx caution
Update company standards
-
-
Update screen to fit the new design
New installation process
Updated intended use (Central+)
All
3.2.2
1.1
Pages
All
All
All
All
7
1
2
All
25
7
CloudPAT Page 6 Operation Manual
Itamar Medical Ltd.
1. Introduction to CloudPAT
1.1. Intended Use of WatchPAT
™ device
1.1.1 WP200U in US
The WatchPAT™200U (WP200U) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The
WP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep,
Deep Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance
Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP200U's PSTAGES and snoring level and body position provide supplemental information to its
PRDI/PAHI/PAHIc. The WP200U's PSTAGES and snoring level and body position are 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.
PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.
1.1.2 WP200 / WP200U in ROW
WatchPAT™ device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WatchPAT™ device is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep,Deep Sleep and
Wake), snoring level and body position. The device generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-
Hypopnea index ("PAHI"),PAT sleep staging identification ("PSTAGES") and optional snoring level and body position discrete states from an external integrated snoring and body position (SBP) sensor. The device’s "PSTAGES" and SBP provide supplemental information to its PRDI/PAHI. The device’s
"PSTAGES" and SBP are 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.
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.
CloudPAT Page 7 Operation Manual
Itamar Medical Ltd.
1.3. CloudPAT S/W
– Definition
CloudPAT is a HIPAA-compliant (PL104-191) web-based cloud application used for providing management system for sleep studies. 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™ device.
CloudPAT uses zzzPAT’s analyzing software modules (part of WP Interface package) that are responsible for the identification of the breathing disordered events and Sleep stages.
CloudPAT offers simple preparation and uploading of WatchPAT™ sleep studies that can be sent transparently for interpretation by a local Interpreting
Physician or from a national network of telemedicine to a Board-certified
Interpreting Physicians. 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 actions performed in the CloudPAT described above are performed from a secure website. Each user will have his own permissions and restrictions that enable to see only her/his sleep patients. All data is securely stored and backed up on the Web.
1.4. Overview
Sleep apnea is considered a major public health problem. The prevalence of the syndrome is estimated at 2% to 5% in the adult population. Obstructive
Sleep apnea is characterized by recurrent events of complete or partial obstruction of the upper airways during sleep with the presence of breathing effort, while Central Sleep apnea is characterized by no respiratory effort.
Both conditions often lead to hypoxemia, and/or arousals associated with sympathetic nervous system activation. The diagnosis and assessment of the sleep apnea patient is usually based on apnea-hypopnea index (AHI – the number of Apneas, and Hypopneas per hour of sleep) and / or the Respiratory
Disturbance Index (RDI) which is AHI plus Respiratory Effort Related
Arousals (RERA), 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 sleep apnea 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 device’s memory along with pulse rate (derived from the PAT signal), together with either data from oximetry channels
CloudPAT Page 8 Operation Manual
Itamar Medical Ltd.
integrated into the uPAT probe (WP200U), or from a built-in pulse-oximetry sensor (WP200) and an actigraph (embedded in the device). Snoring and Body
Position signals are generated from the SBP/RESBP integrated sensor
(optional). The RESBP (Respiratory Effort Snoring and Body Position) sensor records the subject’s chest movement signal in addition to the snoring and body position signals that are included with the SBP sensor. 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 zzzPAT’s analysis . 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.
This manual provides the information necessary for routine use of CloudPAT software.
CloudPAT Page 9 Operation Manual
Itamar Medical Ltd.
1.5. Terminology
CloudPAT supports various types of users and entities.
o Office – a practice responsible to dispensing the tests. Office can include one or more referring physicians, as well as technicians and administrative staff. o Referring Physician – the primary physician or dentist prescribing 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, Viewing reports and
Managing Patient Information (see Section 3).
o Interpreting Physician– a physician (typically Board-certified) performing the sleep study analysis, interpretation, diagnosis and recommendations. This is another type of user using CloudPAT functions: Reviewing and interpreting studies and Managing templates for diagnosis and recommendations (see
o Patient – the person who undergoes the sleep study.
1.6. Minimum requirements
An internet connection using a PC workstation with Microsoft Win7 and above, running at a minimum upload speed of 1 Mbps and supported browser (Internet
Explorer version 11 or higher, Edge, Chrome or Firefox) is required.
2. Setting CloudPAT Access
2.1
Obtaining an account
Usage of CloudPAT is intended for WatchPAT™ customers only (using Watch-
PAT200/200U devices). A secure and individual login account must be assigned by
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 containing your assigned Username followed by a 2 nd
email with the initial password.
Note
Be sure to change the initial password upon sign in.
Be sure to select Secret Question and provide an answer, so you will be able to generate a new password in case you will forget your password.
CloudPAT Page 10 Operation Manual
Itamar Medical Ltd.
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, according to the server location at:
Server location
United state
Direct link https://cloudpat.precisemd.com
European union
United Kingdom https://cloudpateu.precisemd.com
https://cloudpatuk.precisemd.com
Access to CloudPAT starts with the Sign In screen where Username and Password
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). The minimum password length is eight characters, that must
contain characters from three of the following four categories: English uppercase characters (A through Z), English lowercase characters (a through z), digits (0 through
9), Non-alphabetic characters (for example !, $, #, %).
CloudPAT Page 11 Operation Manual
Itamar Medical Ltd.
Figure 2: Set Password screen
For identification purposes you will be prompted to fill in an answer to a secret question.
You must select a secret question and provide an answer to it. This answer will be used for authentication in case you forget your password and need to reset it (in such case a new temporary password will be sent to your email address).
Note
All asterisk (*) tagged fields are mandatory and should
CloudPAT Page 12 Operation Manual
Itamar Medical Ltd.
2.4
Changing password
When an office is defined, there’s an option to determine the period of time (in days) that the password is valid before it expires. After that the system will require the user
to change his password by the same rules mentioned in section 2.3 (see Figure 3).
Figure 3: Change Password Screen
CloudPAT Page 13 Operation Manual
Itamar Medical Ltd.
2.5
Resetting Password
In the event you forget 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
In the event you forget your username, first try this: “first-name.last-name” and if it doesn’t work contact customer support (i.e. john.smith).
CloudPAT Page 14 Operation Manual
Itamar Medical Ltd.
Figure 4: Reset Password screens
2.6
Profile Settings & Support
Users may set their preferences by selecting the “Settings” option from the top of any
screen at any time (see Figure 5). Last name and Email address are mandatory fields
(see Figure 6). The secret question you have chosen and your answer will be
displayed here as well. You may change the secret question at any time if you want.
The “Notifications” check-box is for receiving emails notification:
User will get notification when a report for a study that has been uploaded is ready.
Interpreting Physician will get notification when there is a new study awaiting interpretation.
For administration support and help with any problems you experience with
CloudPAT, please contact us by clicking the “Contact Us” link from any window.
This link creates an e-mail sent to Itamar-Medical CloudPAT Support. Use the form
shown in Figure 9 to send us a message with your problem description.
Please contact customer support by pressing “Support” from any screen if any difficulties arise. The Support screen contains the up to date phone numbers (see
Figure 5: Functions available from all screens
CloudPAT Page 15 Operation Manual
Itamar Medical Ltd.
Figure 6: Profile Settings
Figure 7: Support screen
Note that the contact numbers shown above are subject to change. Always use the updated numbers.
CloudPAT Page 16 Operation Manual
Itamar Medical Ltd.
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 (see Figure 8):
1. Create New Study – prepares a new patient & initializes WatchPAT™ device for a new sleep study.
2. Upload Study – uploads sleep study files from WatchPAT™ device to the
CloudPAT web server and subsequent redirection (e.g., interpretation by an Interpreting Physician) 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. 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.
5. Manage Lists – allows the user to manage the following lists:
Medications – enables the User to search for existing medications from global and office level lists and add new ones.
Diseases – enables the User to search for existing diseases from global and office level lists and add new ones.
6. Contact – for help with any problems you experience with CloudPAT, please contact us by clicking the “Contact Us” link from any window. This link creates an e-mail sent to Itamar-Medical CloudPAT Support. Use the
form shown in Figure 9 to send us a message with your problem
description. The e-mail sent to us will include information about the web page the user viewed when he pressed “contact us”. This will help us locate and understand the problem.
Note
Make sure to specify the correct name and e-mail address so Itamar support will be able to return to you if needed. If you already logged-in your name and e-mail will be taken form the system
CloudPAT Page 17 Operation Manual
Itamar Medical Ltd.
Figure 8: Home (Lobby) screen
Figure 9: Contact Us screen
3.2. Create New Study and manage patients
In order to prepare WatchPAT™ device for a new study select “Create New Study”
from the Home screen (see Figure 10). This will create a new patient record and open
the patient screen (see Figure 13).
CloudPAT Page 18 Operation Manual
Itamar Medical Ltd.
Figure 10: Create New Study selection
You may browse or edit existing patient details by pressing “Patients” from the main
screen which will display the Search for Patients screen (see Figure 11). Click
“Search” to see a list of all patients (see Figure 12). You can enter filters (patient ID,
name, office, etc.) to limit the search results.
Figure 11: Search for Patients screen
CloudPAT Page 19 Operation Manual
Itamar Medical Ltd.
Figure 12: Search for Patients screen
Selecting a Patient ID, will display the patient’s details screen (see Figure 13).
3.2.1. Preparing 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 13.
Note
Patient ID cannot be changed once a device was initiated.
Note
Users that are associated with more than one office will have to choose an office as well.
CloudPAT Page 20 Operation Manual
Itamar Medical Ltd.
Figure 13: Patient data entry screen
2. It is recommended you save the patient record at this stage, by pressing the
‘save’ button on the top (see Figure 13). You can save the patient record at
any stage and return to it later from the “Patients” screen.
Note
Once the system saves the patient details the system checks the values of the entered fields.
Erroneous fields and empty mandatory fields will be highlighted in red. Correct the errors and proceed.
3. Insert additional information as needed, the rest of the fields are optional, but filling the patient name is recommended for easier patient management.
You may insert additional information after the study is saved to the device if necessary, this information will be updated in the report as long as the report has not been signed yet.
4. More Details (optional): Figure 14 shows the ability to add More Details
as the following:
Patient demographics.
Contact details.
Sync Clock – select this option if the WatchPAT
device clock needs to be set.
Bracelet Study (available only if office setting permits) - from this screen you may require a Tamper proof Bracelet to be used as
CloudPAT Page 21 Operation Manual
Itamar Medical Ltd.
Positive Chain of Custody in Occupational Testing (e.g., truck drivers. See WatchPAT™ user manual for further details).
Pacemaker (available only if office setting permits) – select this option if the patient has an implantable pacemaker. The CloudPAT will automatically detect segments where the PAT pulses seem to be paced i.e. very low pulse rate variations (near to stable) and exclude these segments from the analysis.
Note
Some types of pacemakers are excluding the use of the
WatchPAT device. See the exclusion criteria section of the device operating manual for more details.
If the office setting permits Multiple Nights Study: in order to run up to 3 nights recording with the same WP200 device, select the number of nights needed. There are two options for Multi Nights study: o Two nights when no charging is needed between the nights
(maximum length of study is approximately 8 hours) o Three nights when charging is necessary between the nights
(maximum length of study is approximately 10 hours)
Note
Changing the number of night in a multiple night study might require longer initiation of the device.
Note
The "Enable Tamper-Proof Testing" and "Enable Multiple
Nights" options are available only when the WP200 internal S/W is version 2.2182 and higher.
5. Diseases, and/or Medications can be added in the respective drop down lists or as free text.
Note
Free text entered to lists will automatically be added to the office’s list. You can add/update and remove items from
the office lists – see section 3.5 for more details
.
6. You will be able to let the patient fill a STOP BANG questionnaire: click on “Initiate Patient Questionnaire” in Patient Details page, to receive an individual code, which will be valid for 20 minutes only.
CloudPAT Page 22 Operation Manual
Itamar Medical Ltd.
Note
Once the patient starts the questionnaire, he/she has 20 minutes to complete it. If they don’t complete it in that time, a new code will need to be generated from within the
Patient Details screen.
Click the STOP-BANG link shown on the CloudPAT Sign In screen (see
Figure 1), and after inserting the code, the patient will be able to start the
questionnaire.
Note
If the patient will use the same computer as you, make sure to logout from the system, close the browser and reopen a browser before handing the computer to the patient, to ensure data safety.
The questionnaire will be viewable in the patient screen form after patient submitted the questionnaire. The last questionnaire of the patient will also be viewable by the Interpreting Physicians the study will be sent to.
Note
Patient filled information will update any empty fields in the patient record, but will not update fields that already had data in them.
If you want to update the patient record based on the newly entered information you will need to do it manually.
Figure 14: More Detail screen for patient data (optional)
7. Once the study definition is completed, press “Save and Initialize Device”
CloudPAT Page 23 Operation Manual
Itamar Medical Ltd.
8. 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 15).
Note
The first time you run the initialization process, a one-time
PC-App will be downloaded (see Section 3.2.2).
9. A pop-up application will open and manage the initialization of the device.
See section 0 for error handling in different cases.
Note
Make sure to connect the device, perform a device test and guide the patient before handing out the WatchPAT™ device. Refer to the WatchPAT™ operation manual for more details.
10. The system will prompt you once the initialization process is completed.
Then you will be asked to select an Interpreting Physician for this study.
You will be able to change the Interpreting Physician during the upload process and later on, once the study is uploaded from the study page. As long as there is no Interpreting Physician (leaving this field empty) the report is not sent for interpretation and final report cannot be generated.
It is recommended to review the study and correct all the patient and study information that needs update before sending it to Interpreting Physician.
Note
There are few patient details that might change the
analysis. See section 3.4.2.6 for more details.
Note
The office can update the patient’s details as long as the report wasn’t electronically signed. Once the report is electronically signed, the modified patient data will not be included in the report.
To prevent double work for the Interpreting Physician and the need to open signed report, it is recommended to not assign the study until all patient and study fields are updated correctly.
CloudPAT Page 24 Operation Manual
Itamar Medical Ltd.
Note
If the office defined Interpreting Physician as Medicare
Physician Interpreting, it will be indicated next to his name while selecting Interpreting Physician from the list.
Figure 15: Initialize Device screen
3.2.2. First Time Installation
The first time you run the Initialization process or upload form the WP device, a small one-time PC-App will be downloaded from CloudPAT.
Your browser might only prompt you for the installation after a failed attempt to
initialize device / upload (see Figure 16), or might prompt you before, but still fail and
prompt you again one time afterwards (see Figure 17) - both are normal, depending
on the browser and its setting. You should download the PC-App and run its
installation - follow your browser instructions (see Figure 18). Figure 19 and Figure
20 depict the download and run processes in Firefox and Chrome respectively.
Once it is installed – approve the use of the application as default (see Figure 21).
CloudPAT
Figure 16: the browser will prompt you to download the installer
Page 25 Operation Manual
Itamar Medical Ltd.
Figure 17: Failing to work with PC App
CloudPAT
Figure 18: installation process
Page 26 Operation Manual
Itamar Medical Ltd.
CloudPAT
Figure 19: download and run on Firefox
Page 27 Operation Manual
Itamar Medical Ltd.
Figure 20: download and run on Chrome
CloudPAT Page 28 Operation Manual
Itamar Medical Ltd.
Figure 21: Select the Itamar application
(right – FireFox, left: Chrome)
3.2.3. Initialization Process Protection
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 that data but will
prompt by saying “Previous study found” (see Figure 22) and that you should upload
the study before proceeding. This behavior prevents you from accidental overwriting a study that was not uploaded.
CloudPAT Page 29 Operation Manual
Itamar Medical Ltd.
Figure 22: Protection from accidentally overwriting previous sleep study
CloudPAT Page 30 Operation Manual
Itamar Medical Ltd.
3.3. Uploading a Study
This section covers uploading a study from the device and manual upload of study
(for zzzPAT users).
3.3.1. Normal upload Mode
When a patient returns WatchPAT™ device after a night study, simply connect
WatchPAT™'s mini USB port to any USB port on the PC by using WatchPAT™'s
communication cable and select “Upload Study” from the Home Screen (see Figure
Figure 23: Upload Study Selection
Proceed by selecting the “Proceed with upload” button (see Figure 24).
Figure 24: Upload Study Dialog box
A small PC-App will be downloaded the first time remote access is requested from
CloudPAT (see Error! Reference source not found.) and select “Run”. During the pload process you will see a screen informing that upload is in progress.
CloudPAT Page 31 Operation Manual
Itamar Medical Ltd.
Note
When a multi-night study is loaded all the night recordings are loaded automatically.
While uploading, the following dialog (see Figure 25) will be displayed.
Figure 25: Patient sleep study upload in progress
Note
Depending on your connection speed to upload, the number of nights included in the study and the type of device, the upload time will vary between 2 and 15 minutes.
Figure 26: Successful upload screen
If upload is successful you will be asked to approve or change the Interpreting
Physician selection (see Figure 27) from a list of Interpreting Physicians which were
defined for your office.
CloudPAT Page 32 Operation Manual
Itamar Medical Ltd.
Figure 27: Select Interpreting Physician Dialog box
Note
Users connected to two or more offices might be asked to select an office for the upload.
At the end of the upload process you will receive the message: “Upload Complete:
Study uploaded successfully. The analyzed data file will be ready shortly under View
Reports”. If the data was assigned to be sent to an Interpreting Physician the message will also include “Data has been sent to be reviewed by [Interpreting Physician’s
Note
If at the end of the upload process you get an ‘Upload
Error’ message,
Make sure you either store the saved file until your internet connection is restore and upload again, or upload again form the device before you re-initiate it.
CloudPAT Page 33 Operation Manual
Itamar Medical Ltd.
Figure 28: Upload complete screen
If an error is reported, you will need to try again (see Figure 29).
Figure 29: Upload failed screen
Once you upload a study you can choose to add documents to it, see section 3.4.2.2
for more details. These documents will be available for the Interpreting Physician to review when preparing the report. Once the Interpreting Physician locks the report, the Office is no longer able to attach further documents to the patient record.
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 if existing also log.dat, sleep1.dat and sleep2.dat (for multi night studies) 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 30).
See Appendix A: Exporting a study from zzzPAT to CloudPAT Guide for more
information about how to export a study from zzzPAT,
CloudPAT Page 34 Operation Manual
Itamar Medical Ltd.
Figure 30: Manual Upload
The rest of the upload process is the same as for the regular upload (selecting
Interpreting Physician and onward).
3.4. Managing studies and Viewing Reports
3.4.1. Searching studies and reports
Clicking the “View Reports” gets the user to a search screen that enables viewing all
or a subset of the studies and reports available to the current user (see Figure 31).
Filtering by patient name and ID, Office, Referring Physician, study and load dates and the study / report status (study sent to Interpreting Physician, report ready, report viewed) are available.
The patient ID in the search result is a link to the study record.
CloudPAT Page 35 Operation Manual
Itamar Medical Ltd.
Figure 31: Viewing Sleep Study Reports
Search results can be exported to a CSV format.
3.4.2. Study management
Once a study is uploaded and until the Interpreting Physician locks the report, there are several tasks that a user can do.
3.4.2.1. Understanding the Study screen
Figure 32 shows the study screen on unlocked study (no report yet).
This screen presents information about the study – patient information (the patient name is a link to the patient record and any information modified in the patient record will be reflected in the report until the report is locked), study date, assigned
Interpreting Physician, Minimum % of Desaturation for AHI/RDI calculation, analysis status, report status and errors or warnings returned from the analysis. You can indicate to the Interpreting Physician that a script is required for this study and attach files for the Interpreting Physicians review.
Information can be also found about the assignment history.
If the office settings allows you can see the Analysis File under “Files”.
Most of the fields are not editable. The next few sections present what can be done in this screen.
CloudPAT Page 36 Operation Manual
Itamar Medical Ltd.
Note
To prevent double work for the Interpreting Physician and the need to open signed reports, it is recommended to not assign the study until all patient and study fields are updated correctly and all the relevant files are attached.
Figure 32: Study screen
3.4.2.2. Attaching files to a study
Once a study is uploaded, and as long as the report is not locked, the user can choose to add documents to it. These documents will be available for the Interpreting
Physician review when preparing the report.
CloudPAT Page 37 Operation Manual
Itamar Medical Ltd.
To attach a file – enter a description and select the file to be uploaded using the
Browse button. To add additional files click the
icon at the top of the list and a new line will be added to the table.
Note
The maximal size of all attached files is limited to 20MB.
The user can also remove attached files by marking them for deletion (see Figure 33).
Figure 33: Deleting attached files.
Save the study by pressing the “Save” button on the top of the screen to complete uploading the attached file and to remove deleted files.
3.4.2.3. Changing Interpreting Physician and viewing assignment history
The user can assign a non assigned study to any of the Interpreting Physicians connected to the office.
The user can view Assignment History to see how long a study is waiting for an
Interpreting Physician in an Interpreting Physician queue. Based on that information the user can also change the assignment between the different Interpreting Physicians connected to the office.
Notification of a new study will be sent to the Interpreting Physician only in the first assignment of the study, in all later assignments the study will simply appear in the new Interpreting Physician queue and disappear from the old Interpreting Physician queue.
Note
It is up to the user to verify the old and new Interpreting
Physician are notified about the change, and to check there will be no surplus charges for the interpretation of this study as 2 Interpreting Physicians have seen it.
3.4.2.4. View analysis file
Some offices have settings that allow their users view the analysis file (pages 2 and 3 of the report) before the report is ready. This setting is usually given to sleep labs
CloudPAT Page 38 Operation Manual
Itamar Medical Ltd.
using the CloudPAT where the expertise needed to understand the results are part of the office skill sets.
Users of such offices can click the analysis file link to open pages 2 and 3 of the report immediately after uploading the study.
When a multi-night study is uploaded, all the reports of the night studies results will appear in one analysis file one after another, with a summery page in the end.
3.4.2.5. Request for a script
In case Interpreting Physician should add a script to the report, check the “Request
Script” box. Save the study by pressing the “Save” button on top of the screen to complete sending the request to the Interpreting Physician.
The Interpreting Physician will get a reminder to add a script upon locking the report.
3.4.2.6. Changes of Study Parameters
The user can change patient information and some study parameters as long as the report is not close. Some of the parameters will require running the analysis again:
AHI index – according to 3% or 4% desaturations.
Gender
Date of Birth
Pacemaker – this option is shown only if the feature is enabled.
After making changes to these parameters (whether in the patient screen or in the study screen), the user should rerun the analysis to get the new correct results (see
Figure 34). A reminder about the need to rerun the analysis will appear on the top of
the page together with an option to rerun the analysis. Once reanalyze a notification will be sent to the Interpreting Physician.
CloudPAT Page 39 Operation Manual
Itamar Medical Ltd.
Figure 34: Rerun Analysis Message
3.4.3. Viewing reports
After a patient sleep study has been sent to your Interpreting Physician for review and interpretation, and the Interpreting Physician has reviewed and finalized the report, the user who uploaded the study 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).
After selecting a Patient ID from the list of reports, you will be brought to the report
screen (see Figure 35) from which you can review the signed sleep study report and
the attached files.
CloudPAT Page 40 Operation Manual
Itamar Medical Ltd.
Figure 35: Report Details for reviewing sleep study reports
Simply click on the “Result File” link for a details report complete with comments and diagnosis from the Interpreting Physician. PDF file attachments added by the
Interpreting Physician will be appended at the end of the report. Other attachments
(non PDF) will only be viewable by downloading them (clicking on the link to the file).
CloudPAT Page 41 Operation Manual
Itamar Medical Ltd.
In case of multi-night study, the analysis of each night will appear one after another in the report, followed by a summery page at the end.
Note
Contact Itamar Medical support for other file type options of report availability.
3.5. Manage lists
This section explains how to manage the office’s lists of medications and diseases.
The user can add items to the list and edit or delete them. Selecting the “Manage
Lists” tab will open up a search screen in which the user can choose between
medications and diseases (see Figure 36).
Notice that each list contains both the office list and a global list for the whole system.
Items in the global list cannot be changed.
Figure 36: Manage Lists screen
3.5.1. Medications
Under “Manage Lists” choose “Medications”. Click on the “Search” button to see the
list of all medications (see Figure 37). You can enter filters (medication name, office,
include items from the global list) to limit the search results. Clicking on an existing medication name will display the medication’s details screen, in which you can delete
or edit details and save the changes (see Figure 38).
Note
Click on the CSV icon if you want to obtain an Excel file containing a tabular presentation of the search results.
CloudPAT Page 42 Operation Manual
Itamar Medical Ltd.
Figure 37: Search for medication screen
Figure 38: Medication Details screen
On “New” tab you can add a new medication to the list. If you are connected as user to more than one office, you will be asked to select the office for which the medication will be added. Do not forget to click save after you add or change an item
CloudPAT Page 43 Operation Manual
Itamar Medical Ltd.
Figure 39: New Medication screen
3.5.2. Diseases
Under “Manage Lists” choose “Diseases”. Click on the “Search” button to see
the list of all diseases (see Figure 40). You can enter filters (disease name, office,
include items from the global list) to limit the search results. Clicking on an existing disease name will display the disease details screen, in which you can delete or edit
details and save the changes (see Figure 41).
Note
Click on the CSV icon if you want to obtain an Excel file containing a tabular presentation of the search results.
CloudPAT Page 44 Operation Manual
Itamar Medical Ltd.
Figure 40: Search for diseases screen
Figure 41: Disease Details screen
On “New” tab you can add a new disease to the list. If you are connected as user to more than one office, you will be asked to select the office for which the disease will
be added. Do not forget to click save after you add or change an item (see Figure 42).
CloudPAT Page 45 Operation Manual
Itamar Medical Ltd.
Figure 42: New Disease screen
CloudPAT Page 46 Operation Manual
Itamar Medical Ltd.
4. Using CloudPAT as an Interpreting Physician
4.1. Main Access Screen
When you sign in CloudPAT as an Interpreting Physician you will be presented with
the Interpreting Physician’s Home screen (see Figure 43).
Here are the main actions that can be selected from this screen:
1. Review studies – reviews new or displays completed studies.
2. Manage templates and NPIs – defines new or edits existing NPIs and templates used for Clinical diagnosis and recommendations while reviewing studies.
3. Contact – for help with any problems you experience with CloudPAT, please contact us by clicking the “contact” link from any window. This link
leads to Itamar-Medical CloudPAT Support. Use the form shown in Figure
44 to send us a message with your problem description.
Figure 43: Interpreting Physician’s Home screen
CloudPAT Page 47 Operation Manual
Itamar Medical Ltd.
Figure 44: Contact Us screen
4.2. Studies
After a patient sleep study has been sent for interpretation, you will receive an email notification that a sleep study is awaiting interpretation. Alternatively, you may poll this by pressing on the “New” tab from the main screen which will display the new
studies screen (see Figure 45) which includes all unlocked studies waiting for you.
You may also select the “Completed” tab for viewing completed (signed) sleep study reports. You have the option to review subsets of your studies by selecting a particular
Office, Patient name, etc. (see Figure 45).
Note
Click on the CSV icon if you want to obtain an Excel file containing a tabular presentation of the search results.
CloudPAT Page 48 Operation Manual
Itamar Medical Ltd.
Figure 45: Study selection screen
4.2.1. Reviewing a Study
When you are in “New” studies tab, selecting a study you want to review (clicking on
the Patient ID link), will display the following screen (see Figure 46) from which you
can review the new sleep study.
CloudPAT Page 49 Operation Manual
Itamar Medical Ltd.
Figure 46: 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 (or more in case of a multi night study) 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
2. View Questionnaire – if the patient filled a STOP BANG questionnaire, you will be able to view the results by clicking the “View Questionnaire” button.
CloudPAT Page 50 Operation Manual
Itamar Medical Ltd.
3. Office Details – by clicking the “Office Details” button, you can see the following details of the office that sent the sleep study: Name, Address,
City, State, Zip Code, Country, Phone and Minimum % Desaturation for
AHI/RDI calculation.
4. Preview report - You can click the “Preview report” button in order to see the first page of the final report. This page will present to you patient
information as well as your interpretation as it was last saved (see Figure
5. Download to zzzPAT - if you wish to see more details on the study’s signals or to review and edit the events, you can use the “Download to zzzPAT” function in order to download a copy of this study to your local computer.
Note
On first use configure the zzzPAT to allow interpretation for CloudPAT studies: go to: “Setup” “General Settings” ”General Options”, then check the “Enable Packed Studies Import” checkbox and go to “Setup” ”User Settings” ”Options”, then check the “Enable Manual Scoring” and the “Enable
Export Manual Events” checkboxes.
Once the study files are downloaded, you can use the “Import Packed study” zzzPAT’s function in order to open the study, view the signals and edit the Respiratory events or sleep stages if needed (see zzzPAT’s OM).
Note
You should make sure that the zzzPAT has the same AHI calculation method (3% or 4%) setting as the study:
In the Analysis File look for the “pRDI/pAHI are
calculated using oxi desaturations ≥ “ number
In the zzzPAT look at “Setup””General
Settings””Analysis/ Statistics Parameters”.
6. Errors/Warnings – in case of errors or warnings returned from the analysis, a message will appear in the Errors/Warnings box.
7. 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 manual events file (in zzzPAT press “File” “Export Manual Events…”) and add the manual event file to CloudPAT by selecting it on the “Manual Events Files” table (see
Figure 46). 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.
CloudPAT Page 51 Operation Manual
Itamar Medical Ltd.
Note
Make sure to upload the correct manual event file. The filename will be comprised of
ID_[patient ID]_
SD_[stusy Date & time]_ events_analysis_user.zpt other file will generate an error during the post upload analysis and will not change the analysis file
Note
In case of a multi night study – you can upload a manual event file for each of the nights. The system will know to link the files correctly.
8. View files attached by the office – if the office attached file to the study, you can view them by clicking on the file name in the attached file by office section.
9. Enter interpretation - Diagnosis and Recommendations by typing in the information in the relevant sections.
You may use the Diagnosis and Recommendations templates if you wish to insert an already predefined paragraph in the corresponding section (See
10. NPI – you can add the NPI to the report. If you have more than one NPI, select the right NPI number that matches the office details.
11. Add attachments like prescription or any other files to the report. If you add PDF files they will be added to the report itself. Any other files will be available to download in the office.
To attach files enter a description and select the file to be uploaded using the Browse button. To add additional files click the
icon at the top of the list a new line will be added to the table.
The user can also remove attached files by marking them for deletion (see
CloudPAT
Figure 47: Attach files to a report
Save the study by pressing the “save” button on the top of the screen to complete uploading the file and to remove deleted files.
Page 52 Operation Manual
Itamar Medical Ltd.
Note
The maximal size of all attached file is limited to 20MB
12. Save – saves your input without locking the report.
13. 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.
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 Page 53 Operation Manual
Itamar Medical Ltd.
Figure 48: First page of sleep report
14. Notifications – you may receive notifications which will be displayed on the screen in the following cases:
If a script was requested by the office, a “Study requires a script” notification will be displayed on the screen. Also, a reminder will appear before locking the report.
If the office changed one of the following analysis parameters:
Minimum % Desaturation for AHI/RDI calculation, Pacemaker,
Gender, Date of Birth, a rerun of the analysis is required to update the analysis result. In case rerun was not initiated by the office, a notification that rerun is required will be displayed on the screen and
“Rerun Analysis” button will appear. You won’t be able to lock the report before rerun the analysis.
CloudPAT Page 54 Operation Manual
Itamar Medical Ltd.
Note
Manual events file are based on a specific analysis. Verify the manual events you are loading are based on the same parameters as the current study parameters.
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 49) 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
(without your interpretation).
2. View report - you can click on the “View report” button in order to see the full final report (with your interpretation included).
Figure 49: View a completed study
4.3. Manage Templates & NPIs
This section explains how to manage the lists of templates and NPIs each Interpreting
Physician has. Selecting the “Templates & NPIs” tab will open up a search screen in
which you can choose between templates and NPIs (see Figure 50).
CloudPAT Page 55 Operation Manual
Itamar Medical Ltd.
Figure 50: Templates & NPIs screen
4.3.1. 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 and for
Recommendations which can be used with a click of a button in order to facilitate the
Reviewing process.
Using a template will fill the relevant section (diagnosis or recommendation) in the report. After choosing a template you may edit the text.
Selecting the Templates tab will open up the Template Search screen (see Figure 51).
Figure 51: Search a template screen
Note
Click on the CSV icon if you want to obtain an Excel file containing a tabular presentation of the search results.
Clicking on the “New” button will open up a new template for editing (see Figure 52).
CloudPAT Page 56 Operation Manual
Itamar Medical Ltd.
Figure 52: New Template screen
You need to fill all three fields (Name, Type and Text) in order to define the new template.
Clicking on an existing template name (see Figure 51) will open up the Template
screen for editing (see Figure 53).
Here are the main actions that can be selected from this screen:
1. Save & New – Saves the template and creates a duplicate template.
2. Delete – Deletes the template.
3. List – Returns to the list of templates.
4. Save - Saves the template.
Figure 53: Existing Template screen
4.3.2. NPIs
You can manage a list of NPI to later be used in the report. Under “Templates &
NPIs” choose “NPIs”.
Click on “Search” to see the list of all NPIs currently in the system (see Figure 54).
You can also enter text in the NPI field to limit the search results. Clicking on an
CloudPAT Page 57 Operation Manual
Itamar Medical Ltd.
existing NPI will display the NPI’s details screen, in which you can edit the NPI
number and save the changes (see Figure 55).
Clicking on the “New” button can be used to add a new NPI to the list. Make sure you
save your changes (see Figure 56).
Note
Click on the CSV icon if you want to obtain an Excel file containing a tabular presentation of the search results.
Figure 54: Search NPI screen
CloudPAT
Figure 55: Existing NPI screen
Page 58 Operation Manual
Itamar Medical Ltd.
Figure 56: New NPI screen
4.4. Signature
Interpreting Physicians can send Itamar Medical their signature sample as a graphical file. In this way, the Interpreting Physician’s signature will be added to the report automatically. The file of the signature should be bmp or jpg file, size 384 pixels in width and 186 pixels in height. Contact Itamar-Medical support for more details.
CloudPAT Page 59 Operation Manual
Itamar Medical Ltd.
5. Troubleshooting
Note
Make sure you are using Chrome, Firefox, Edge or Internet
Explorer 11 or above as your browser.
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™ device.
Solution
Re-run the initialization process a little quicker. If the problem persists it could be an internet connectivity problem so contact
Support.
Error Message
CloudPAT Page 60 Operation Manual
Itamar Medical Ltd.
Previous
Study found
There is a sleep study still on
WatchPAT™ device that has not been uploaded from the device.
Press Exit and upload this old study.
Error - unexpected
Could not access device.
The PC App didn’t start on time. The problem might be that it is not installed or that the browser is waiting for your approval to use it.
The PC does not recognize
WatchPAT™ device.
Select the application as default.
Make sure WatchPAT™ device is connected to the PC via the USB.
Select Retry.
Upload Study screen
CloudPAT Page 61 Operation Manual
Itamar Medical Ltd.
Failed to
Send.
Failed to
Send.
Failed to analyze a
CloudPAT study. The error appears in the Report
Details screen, and an email notification is sent to the user.
The station may not have
Internet access.
The Itamar
Upload service is temporarily unavailable.
Mismatch between
Patient.dat and
Sleep.dat files.
Check your internet connection
Repeat the upload process
Save the study using zzzPAT
Collect the data from the device manually by copying all the files on the device and zipping them. Use manual upload at a later stage to upload the data in to the
CloudPAT.
If you use this option contact
Itamar-Medical support to reset the device.
Contact Itamar-Medical support for help.
CloudPAT Page 62 Operation Manual
Itamar Medical Ltd.
Could not access device.
The PC does not recognize
WatchPAT™ device.
Make sure WatchPAT™ device is connected to the PC via the USB.
Select Retry.
Error – access denied
There are remaining files from previous upload or initializations
Remove all files form
C:\Users\ username \AppData\Loca l\RPAT\OUT
And form
C:\Users\ username \AppData\Loca l\RPAT\IN
And try again
Error - unexpected
The PC App didn’t start on time. The problem might be that it is not installed or that the browser is waiting for your approval
Select the application as default.
CloudPAT Page 63 Operation Manual
Itamar Medical Ltd.
Upload error to use it.
Internet connection was lost during upload of the study, site is done
The files from the device are temporary stored on your computer. Follow the link in the message to their location.
Copy the files to a secure location and once communication with the site is restore – manually upload them to the CloudPAT.
Make sure to permanently delete the files after uploading them, as they might contain patient information.
Attach files to a study or a report
Trying to attach a very large file(s)
File attachment is limited to
20MB per study or report.
Reduce file size
STOP BANG
Session has The been completed.
Cannot questionnaire has been submitted restart.
Expired code.
STOP BANG
Code is valid for 20 minutes.
Find the completed questionnaire in the patient record.
If needed – generate a new questionnaire from the patient record.
Generate a new STOP BANG
Code from the patient record.
CloudPAT Page 64 Operation Manual
Itamar Medical Ltd.
6. Appendix A: Exporting a study from zzzPAT into CloudPAT
Note
This guide gives 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.
If you do have internet connection it is recommended not to switch between the CloudPAT and the zzzPAT
Note
Multi night studies uploaded to zzzPAT will be exported night by night, if you wish to join them into one study please contact
Itamar Medical support for more information.
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”
4. You will now be asked to save this file to your hard drive. It is recommended to choose a folder called “CloudPAT” that I create prior to this step. After selecting the folder to save the exported file, click “ OK
”.
Now go to the CloudPAT site (for US https://cloudpat.precisemd.com
, for EU https://cloudpateu.precisemd.com
and for UK https://cloudpatuk.precisemd.com
) and login using your username and password.
5. Select
“Upload Study” from Home screen.
CloudPAT Page 65 Operation Manual
Itamar Medical Ltd.
6. Thereafter, the following screen will open up. Select
“Switch to Manual Upload”.
7. Now you need to find the file that was exported out of zzzPAT by selecting
“Browse”.
8. The exported file from the zzzPAT will end in .zzp. Select the file that you want to upload and select
“Open”
. Then click the next button.
9. 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.
10. Assign the study to an Interpreting Physician. Then, click
“Next”
.
11. The following screen will appear and the process is complete.
CloudPAT Page 66 Operation Manual
Itamar Medical Ltd.
7. Appendix B: Interpretation and editing of events by the
Interpreting Physician Guide
Note
This guide gives instructions on how to download a study from the CloudPAT to zzzPAT for review and manual editing, and how to upload the changes back to the CloudPAT.
This Guide is directed to Interpreting Physicians, already familiar with the zzzPAT and it is replacing the zzzPAT operation manual.
Go to CloudPAT site ( for US https://cloudpat.precisemd.com
, for EU https://cloudpateu.precisemd.com
and for UK https://cloudpatuk.precisemd.com
) and login using your user name and password.
1. From the new study screen select the study you want to view in zzzPAT. Click on the patient ID to move to the report screen.
2. Once you have reviewed the study (see section 3.5 above) using
“Preview Report”
, the analysis file and the attachments added by the office, you can decide to import the study into your zzzPAT software. Click
“Download to zzzPAT”
3. 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”:
4. Save the file to a predefined location on your hard drive. We recommend creating a folder called CloudPAT for such file exchange.
CloudPAT Page 67 Operation Manual
Itamar Medical Ltd.
5. To review the raw data open zzzPAT software and login (default Login and
Password: “111” for both entries)
6. Select “Import Packed studies” under “Tools”
CloudPAT Page 68 Operation Manual
Itamar Medical Ltd.
7. In the dialog box that opens, select the file you have just saved in the CloudPAT and click “Open”.
8. A new box will now open and the imported study will now be loaded and analyzed.
9. The study is now available to be reviewed and manually edited by the interpreting physician.
Note
When importing multi night study into zzzPAT, each night will create a different zzzPAT study. Each of the night should be reviewed and edited separately.
Once the interpretation process is done
If changes were made in the study, the study will need to be uploaded to CloudPAT by following the steps below.
10. Save the study in the zzzPAT.
11. Go to
File
and select
“Export Manual Events…”
CloudPAT Page 69 Operation Manual
Itamar Medical Ltd.
12. Select a file location – again we recommend using a predefine location. Press ok.
The manually edited changes now need to be uploaded to CloudPAT. Go to CloudPAT site (for US https://cloudpat.precisemd.com
, for EU https://cloudpateu.precisemd.com
and for UK https://cloudpatuk.precisemd.com
) and login using your user name and password. Locate the study you were working on and enter the report screen like before.
13. Click the
“Choose File”
button near the manual events files box.
14. Find the saved file. The file name will consist from the patient id and the study date
& time in the following structure:
ID_[patient ID]_SD_[study Date & time]_events_analysis_user.zpt
Select the file and click “Open”.
15. Save the report.
The manually edited study is now saved to CloudPAT:
16. You can check that the analysis file was updated with your manual events.
17. Fill the Diagnosis and Recommendation fields and add attachments as needed.
CloudPAT Page 70 Operation Manual
Itamar Medical Ltd.
18. “Save and Lock Report” to complete the process and alert the provider that the study is complete.
Note
In a multi night study, a manual events file might be created for each of the nights. Upload all of them into the cloudPAT.
Add files by pressing the
icon.
CloudPAT Page 71 Operation Manual
Itamar Medical Ltd.
8. Appendix C: CloudPAT
Assistant “cheat sheets"
t
You may print the following pages for a quick reference to frequent tasks.
Create a New Study (Initialization) via CloudPAT
Step
Action(s) Comment
1. 1
.
Enter
CloudPAT via the Web
Do you have…?
1. PC workstation w/internet access?
2. Username & Password?
3. Minimum upload speed of 1 Mbps
Log in to CloudPAT :
US - https://cloudpat.precisemd.com
EU - https://cloudpateu.precisemd.com
UK - https://cloudpatuk.precisemd.com
Enter your Username & Password
Select
“Sign In”
Problems or Questions?
Select Support or
Call: +1-888-748-2627
2.
Create
(initialize) new Sleep
Study using
CloudPAT
Select
“Create New Study”
Slide WatchPAT
™ device out of its
“cradle” to reveal the USB connection.
Connect WatchPAT
™ device to any USB port.
OPTIONAL
4.
Chain of
Custody
Bracelet
Only the
“Patient ID” and office are mandatory.
We recommend you fill the patient name to ease searching for the study.
Select
“Save & Initialize Device”
For more patient detail entry, select
“More Details” section
Select the box “Bracelet Study” for occupational testing using a Chain of
Custody bracelet.
For multi night study select the number of nights
Select
“Save & Initialize Device”
Select:
“Proceed with initialization”
1st time usage: a small PC-App will be downloaded. Select: “Run”
CloudPAT Page 72 Operation Manual
t
Itamar Medical Ltd.
Step
Action(s)
6.
Select
Interpreting
Physician
Select the Interpreting Physician (or leave empty at this point)
Select
“Save”
Comment
Reinsert the WatchPAT
“cradle”
™
device into its
Complete a device test
Instruct the patient about the use of the device.
Step
1. 1
Enter
.
CloudPAT via the Web
Upload Sleep Study from WatchPAT
™ to CloudPAT
Action(s)
Do you have…?
1. Computer running Win7 or higher with internet access?
2. Username & Password?
3. Minimum upload speed of 1 Mbps
Log in to CloudPAT :
US - https://cloudpat.precisemd.com
EU - https://cloudpateu.precisemd.com
UK - https://cloudpatuk.precisemd.com
Enter your Username & Password
Select Sign In
Comment
Problems or Questions?
Select Support or
Call: +1-888-748-2627
2.
Upload a
Sleep Study-
WatchPAT™ device to
CloudPAT
Select
“Upload Study”
Slide WatchPAT
™ device out of its
“cradle” to reveal the USB connection.
Connect WatchPAT
™ device to a USB port.
3.
Connect
WatchPAT™ device to
USB port
Select
: “Proceed with upload”
1
st
time usage: a small PC-App will be downloaded. Select: Run
You will be prompted to select an
Interpreting Physician after the study has uploaded.
CloudPAT Page 73 Operation Manual
Itamar Medical Ltd.
Step
Action(s) Comment
Depending on your connection speed, the device type and the number of night (in a multi night study) upload time will vary between two (2) and fifteen (15) minutes. If an error is reported, you will need to try again.
5.
6.
Select
Interpreting
Physician
OPTIONAL
Attach Files
(up to 20MB) and update study details
“Upload Complete”: Study uploaded successfully. Now you can select the
Interpreting Physician that will interpret the study (can be done later on form the study page). Select: Next
“Upload Failed”: try again or call Support
Select
“View Reports”
Select the Study for which you want to attach files by clicking on the
“Patient
ID
” link.
Go to the
“Attached Files” section at the bottom of the “Report Details” screen and “Browse” to the file and add “Description”.
Add additional files by clicking on the + sign on the right.
Select the box under the x to delete a file.
Update study parameters if needed and Assign to Interpreting Physician if needed.
Select
“Save” to save your changes.
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”
CloudPAT Page 74 Operation Manual
Itamar Medical Ltd.
Step
Action(s)
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 in to CloudPAT :
US - https://cloudpat.precisemd.com
EU - https://cloudpateu.precisemd.com
UK - https://cloudpatuk.precisemd.com
a regular study
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
Comment
CloudPAT Page 75 Operation Manual
Itamar Medical Ltd.
Interpreting Physician: Physician review of raw sleep study data
part -1
Step Action(s) Comment
2.
Enter
CloudPAT via the Web
Do you have…?
1. Computer running Win7 or higher with internet access?
2. Username & Password?
3. zzzPAT familiarity & installed
Log in to CloudPAT :
US - https://cloudpat.precisemd.com
EU - https://cloudpateu.precisemd.com
UK - https://cloudpatuk.precisemd.com
Enter your Username & Password
Select
“Sign In”
Problems or Questions?
Select Support or
Call: +1-888-748-2627
3.
Select patient study
You may
Analyze a study (“Studies”) or
Create custom forms (“Templates”) or
NPI number (“NPIs”)
Select the patient you want to analyze.
Various Sort options are available at the bottom
4.
View autoanalyzed suggestions
5.
Analyze & save Sleep
Study raw data
To view the auto analyzed, 2-page report that the Provider uploaded,
select
“Analysis File”
To view patient information, select
"Preview Report"
Open attachments if exist
If analysis is satisfactory, skip to step 12
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”)
6. Start zzzPAT
Open zzzPAT
(default Login and Password: “111” for both entries)
CloudPAT Page 76 Operation Manual
7.
Itamar Medical Ltd.
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
CloudPAT Page 77 Operation Manual
Itamar Medical Ltd.
Interpreting Physician: Physician review of raw sleep study data
part 2
Step Action(s) Comment
8.
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.
9.
10.
11.
Save Event changes on local disk
Upload
Event changes to
CloudPAT
Save Event changes on
CloudPAT
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
13.
Lock report; notify
Provider
Preview the new report.
Enter Diagnosis and Recommendations.
Open files attached by the office (if any) by clicking on the file link.
Add prescriptions or additional information as PDF attachments o Go to the
“Attached Files” section at the bottom of the screen and
“Browse” to the file and add
“Description”. o Add additional files by clicking on the + sign on the right. o Select the box under the x to delete a file.
Select
“Save” to save your changes.
Select
“Save and Lock Report” to complete the process
Provider will be alerted automatically that the study is complete.
DONE
CloudPAT Page 78 Operation Manual
Itamar Medical Ltd.
Step
Fill a STOP BANG questionnaire
Action(s)
1.
Enter
CloudPAT via the Web
Log in to CloudPAT :
US - https://cloudpat.precisemd.com
EU - https://cloudpateu.precisemd.com
UK - https://cloudpatuk.precisemd.com
Enter your Username & Password
Select Sign In
Comment
Select
Patient either through “Manage
Patients
” or through “Create New Study”
Select
“Initiate Patient Questionnaire”
3. Get code
4. Use code
You will receive an individual code, which will be valid for 20 minutes only
The code starts with the Patient’s ID and is part of the 2 line message displayed on the screen
Copy the code. You will need it to start the questionnaire
On the laptop or tablet given to the patient, Go to:
US - https://cloudpat.precisemd.com/sb.aspx
EU - https://cloudpateu.precisemd.com/sb.aspx
UK - https://cloudpatuk.precisemd.com/sb.aspx
Enter code in “Code” field
Select
“Start Session”
Let the patient fill in the questionnaire.
Note: Once the patient starts filling in the questionnaire, they have 20 minutes to complete it. If they don’t complete it during that time, a new code must be generated from within the Patient Details screen.
CloudPAT Page 79 Operation Manual
Itamar Medical Ltd.
6. Submit
Select the “Submit” button once the patient has filled in the questionnaire
The Patient details will be automatically updated with the new information (except if the fields were already filled previously)
Filled questionnaires can be viewed from the “Questionnaires” section of the Patient details screen.
CloudPAT Page 80 Operation Manual
Itamar Medical Ltd.
9. Appendix D: 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.
CloudPAT Page 81 Operation Manual
Itamar Medical Ltd.
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.
CloudPAT Page 82 Operation Manual
Itamar Medical Ltd.
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
CloudPAT Page 83 Operation Manual
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.
CloudPAT Page 84 Operation Manual
Itamar Medical Ltd.
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
CloudPAT Page 85 Operation Manual
Itamar Medical Ltd.
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 Ind. Park
, 3088900, Israel, Facsimile:
+972-4-627 5598, or visit Itamar’s web site at www.itamar-medical.com.
CloudPAT Page 86 Operation Manual
Itamar Medical Ltd.
10. Appendix E: Regulatory Representative
Itamar Medical’s authorized regulatory representative is:
MEDES Ltd.
5 Beaumont Gate, Shenley Hill,
Radlett, Hertfordshire WD7 7AR.
England
Tel: +44 20 8123 8056
Tel / Fax: +44 1923859810
CloudPAT Page 87 Operation Manual
Download
Public link updated
The public link to your chat has been updated. You may view and manage your chat links after registration here.
Document public link
Advertisement
Key features
Non-invasive
Home care
Sleep disorder detection
Sleep staging
Snoring level
Body position
Comprehensive report
Frequently asked questions
WatchPAT™ is a non-invasive home care device for patients suspected of having sleep-related breathing disorders. It is a diagnostic tool that detects sleep-related breathing disorders, sleep stages, snoring levels, and body position. The device generates a Peripheral Arterial Tonometry (PAT) Respiratory Disturbance Index (PRDI), Apnea-Hypopnea index (PAHI), and a comprehensive report for the physician.
WatchPAT™ is designed to help diagnose sleep-related breathing disorders like sleep apnea. It monitors a patient's sleep patterns and respiratory activity, providing valuable data for healthcare professionals to make informed decisions about diagnosis and treatment.
WatchPAT™ uses a finger-mounted probe that measures the PAT (Peripheral Arterial Tone) signal. The PAT signal is a measure of pulsatile volume changes in fingertip arteries, reflecting the arterial vasomotor activity, which is linked to sympathetic activation. It records the PAT signal, pulse rate, and data from oximetry channels or a built-in pulse-oximetry sensor, along with an actigraph. The data is then analyzed to identify breathing disorders, sleep stages, snoring levels, and body position.
The device is worn on the wrist during sleep. After the study, the data is uploaded to a web server and analyzed using the CloudPAT software. The results are then presented in a comprehensive report for the physician.
