Table of Contents
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Table of Contents
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Summary of Contents for Wesper Lab
- Page 1 User Manual Wesper Lab User Manual Document No. UMNAG001 Page 1 of 32...
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Page 2: Table Of Contents
5.3.3. Patch Connection Loss ................13 5.3.4. Patch Low-Battery Indication ..............14 Using Wesper ....................15 6.1. First-time Use: Install the Wesper App .............15 6.2. Check Patches Before Starting a Session ............15 6.2.1. Apply Adhesive Layer to Patches ..............15 6.3. Begin a new WESPER Session ................17 6.4. - Page 3 7.2. Authorized Pulse Oximeters ................27 7.3. Smartphone ......................27 Label and Symbols ..................28 8.1. Wesper Lab Patches ..................28 8.1.1. Device Label ....................28 8.1.2. Symbols on the Wesper Lab Patches ............28 Troubleshooting ..................... 29 Document No. UMNAG001 Page 3 of 32...
- Page 4 User Manual Manufacturer Wesper Inc. 234 5 Ave, New York, New York 10001 Tel: (516) 654-4166 E-mail: Info@WESPER.co Web Site: http://www.WESPER.co Document No. UMNAG001 Page 4 of 32...
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Page 5: Introduction
User Manual 1. Introduction Use of This Manual This manual covers the operation and maintenance of Wesper Lab. The user of this device should be fully familiar with the contents of this manual before using the device. PLEASE RETAIN THIS USER MANUAL FOR FUTURE REFERENCE. -
Page 6: Safety
User Manual 2. Safety 2.1. Types of Warnings, Cautions and Notes Three types of special messages appear in this User Manual: Warning: A warning indicates precautions to avoid the possibility of personal injury or death. Caution: A caution indicates a condition that may lead to damage to equipment, or a lower quality of treatment. -
Page 7: General Warnings And Cautions
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Wesper Lab Patches, including cables specified by WESPER. Otherwise, the performance of this equipment could be negatively impacted. - Page 8 Use of accessories, transducers, and cables other than those specified or provided by WESPER could result in increased electromagnetic emissions or decreased electromagnetic immunity of Wesper Lab Patches and result in improper operation. Do not use the Patches if outside the appropriate temperature range, as specified in Section 7.1.1 Environmental and Storage Conditions.
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Page 9: Conditions For Use
4. Conditions for Use 4.1. Indications for Use The Wesper Lab is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. Wesper Lab records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. -
Page 10: System Overview
The data is then forwarded to the WESPER Cloud for use by the care provider. Wesper Lab is simple to use. An adhesive layer is used to attach the Patches to the patient’s skin, and the App is configured to record data in a few simple steps. -
Page 11: Device Description
WESPER smartphone App. 5.3.1.1. The Wesper Lab Patches The Wesper Lab Patches are two thin Patches that are attached to the patient's stomach and right side of the rib cage with adhesive before the patient goes to sleep. -
Page 12: Essential Performance
User Manual 5.3.1.1.1. Essential Performance Essential performance of the Wesper Lab Patches is defined as a functioning patch being able to both collect accurate physiological data, and successfully deliver this data to the Wesper mobile application. Accuracy and data delivery may be affected as a result of exposure to electromagnetic disturbances that are outside of the environments listed in the indications for use (Section 7.1). -
Page 13: The Pulse Oximeter
A pulse oximeter is a small device that measures blood oxygen saturation and heart rate, typically at the finger or ear lobe. When used as part of the Wesper system, the data produced by the pulse oximeter is transmitted to the Cloud and can be analyzed, along with the data from the Patches, by Wesper’s... -
Page 14: Patch Low-Battery Indication
5.3.4. Patch Low-Battery Indication When the user connects a Wesper Patch to the mobile App (see Section 6 Using Wesper), the system automatically runs an internal test to determine if the Patch has sufficient battery capacity to sustain a full night’s session. Should the battery level be insufficient, the mobile App will notify the user with a warning screen (see section 6.7.2 Patch Low Battery Indication). -
Page 15: Using Wesper
6.1. First-time Use: Install the Wesper App If it is not installed already, install the Wesper App. Open the Apple App Store and search for “Wesper” in the search bar. Install the Wesper App by tapping on the download icon next to the app icon. - Page 16 User Manual Use both hands to lower the adhesive onto the Patch, taking care to ensure that the adhesive cutout lines up well with the Patch bottom layer, and that the Patch’s sensor window is not obstructed with adhesive. Press the adhesive into the patch, removing any air bubbles in between the adhesive and the bottom layer of the patch.
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Page 17: Begin A New Wesper Session
6.3. 6.3. Begin a new WESPER Session Open the WESPER App on the iPhone. On the main screen, tap the “Get Started” icon to begin a new session. A new screen should appear; tap the “Activate your Kit” button to continue with the session. -
Page 18: Turn On Patch 1 (Pairing)
6.4.2. Apply Patch 1 to Ribcage Caution: Only apply Wesper Lab Patches to intact skin. Once paired, remove the adhesive liner and attach the Patch to the right side of your ribcage in the position and orientation shown on the app. -
Page 19: Turn On Patch 2 (Pairing)
User Manual 6.4.3. Turn on Patch 2 (Pairing) When directed by the app, press and hold the button on the Patch for three seconds. The light on the Patch will cycle between green, blue, and, red before settling on solid green, to indicate that the Patch is powered on and connected. 6.4.4. -
Page 20: Connect And Activate Your Pulse Oximeter
Caution: Use only authorized pulse oximeters, a list of which can be found at www.Wesper.co/oximeter. Caution: Read the pulse oximeter’s IFU before using with Wesper Lab When prompted by the WESPER App to connect the authorized pulse oximeter, follow the instructions provided with the pulse oximeter to connect it to the app. -
Page 21: Patch Low Battery Indication
If this occurs, the Patches will be disabled, and the user will require a replacement set of Patches for recording on a future night. Contact Wesper Support at support@wesper.co for further instructions regarding kit usage. -
Page 22: Wait For Wesper Data To Upload
User Manual 6.9. Wait for Wesper Data to Upload After the session ends, any data remaining on the patches will be transferred to the cloud. Keep the patches close to your mobile device while this process completes. Document No. UMNAG001... -
Page 23: Remove The Patches And Adhesive
6.11. Disconnect Your Pulse Oximeter Following the completion of the test, remove your pulse oximeter from your finger and disconnect it from the WESPER App. Store the device as indicated in its user manual. 6.12. Access Output Data (Healthcare Providers Only) Healthcare providers with access to Wesper Lab output data should see Appendix A –... -
Page 24: General Specifications
User Manual 7. General Specifications 7.1. Wesper Lab Patches The Wesper Lab patches are intended for use in the home or clinical healthcare environment. The patient and any healthcare professional involved in the use of Wesper Lab should assure that the following conditions are met with regards to storage and usage. -
Page 25: Electromagnetic Compatibility
Range of transmission powers -4 to +20dBm Nominal transmission power +0dBm 7.1.4. Shelf Life Wesper Lab Patches can be stored indefinitely under the storage conditions described in Section 7.1.1 Environmental and Storage Conditions. Document No. UMNAG001 Page 25 of 32... -
Page 26: Single Use
User Manual 7.1.5. Single Use Wesper Lab Patches are meant to be used over the course of a single night’s sleep. After the patient ends the test, the patches cannot be used to run another diagnostic test. Contact Wesper Support at support@wesper.co... -
Page 27: Authorized Pulse Oximeters
7.2. 7.2. Authorized Pulse Oximeters A list of approved pulse oximeters can be found at www.Wesper.co/oximeter. 7.3. Smartphone The WESPER App is compatible with iPhone 7 or newer running iOS 15 or higher. Document No. UMNAG001 Page 27 of 32... -
Page 28: Label And Symbols
8.1. Wesper Lab Patches 8.1.1. Device Label 8.1.2. Symbols on the Wesper Lab Patches The following symbols may appear on the Wesper Lab Patches. Do not expose this device to moisture Prescription Only This device is in compliance with FCC regulations Document No. -
Page 29: Troubleshooting
User Manual 9. Troubleshooting If you encounter issues with the Wesper Lab patches or the app, please visit www.Wesper.co/support for more information. Document No. UMNAG001 Page 29 of 32... - Page 30 User Manual Appendix A: Wesper Lab Output Specification Wesper Lab data is provided as a set of two files which contain all information necessary to parse and view the patient’s sleep data. These files are: 1. CSV (Comma-separated values) file, containing all numerical data 2.
- Page 31 User Manual Below is an example snapshot of the CSV file from a sample study from the beginning and middle (ellipsis were introduced for brevity, they do not appear in the original file): In this snapshot, it’s shown that: • The time resolution is 100ms •...
- Page 32 User Manual <TatchStudy> <ScoredEvents> <ScoredEvent> <Name>Artifact</Name> <Input>THX </Input> <Start>0.1</Start> <Duration>30221.5</Duration> <Family>Signal</Family> </ScoredEvent> </ScoredEvents> </TatchStudy> Under TatchStudy->ScoredEvents, there will be a collection of <ScoredEvent> tags. Under each one, there will be the following four tags: Tag Name Contents Notes Name Type of event For artifacts, this tag will always have the contents “Artifact”...
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