Wesper Lab User manual
User Manual
Document No. UMNAG001 Page 1 of 32
Wesper Lab
User Manual
User Manual
Document No. UMNAG001 Page 2 of 32
Contents:
1. Introduction.....................................................................................................5
2. Safety...............................................................................................................6
2.1. Types of Warnings, Cautions and Notes .............................................................6
3. General Warnings and Cautions .......................................................................7
3.1. Warnings ............................................................................................................7
3.2. Cautions..............................................................................................................7
4. Conditions for Use............................................................................................9
4.1. Indications for Use ..............................................................................................9
4.2. Contraindications................................................................................................9
5. System Overview ...........................................................................................10
5.1. Why WESPER? ..................................................................................................10
5.2. WESPER in Brief ................................................................................................10
5.3. Device Description ............................................................................................11
5.3.1. Main Components.....................................................................................11
5.3.1.1. The Wesper Lab Patches ...............................................................11
5.3.1.1.1. Essential Performance ....................................................................12
5.3.1.2. The WESPER App ...........................................................................12
5.3.1.3. The Pulse Oximeter .......................................................................13
5.3.2. Data Capture –Automatic and Continuous ..............................................13
5.3.3. Patch Connection Loss ..............................................................................13
5.3.4. Patch Low-Battery Indication....................................................................14
6. 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. Activate and Apply the Patches ........................................................................17
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6.4.1. Turn on Patch 1 (Pairing)...........................................................................18
6.4.2. Apply Patch 1 to Ribcage...........................................................................18
6.4.3. Turn on Patch 2 (Pairing)...........................................................................19
6.4.4. Apply Patch 2 to Stomach .........................................................................19
6.5. Connect and Activate Your Pulse Oximeter ......................................................20
6.6. Sweet Dreams...................................................................................................20
6.7. Warning Messages ...........................................................................................20
6.7.1. Phone Not Connected to Charger .............................................................20
6.7.2. Patch Low Battery Indication ....................................................................21
6.8. End the Test ......................................................................................................21
6.9. Wait for Wesper Data to Upload ......................................................................22
6.10. Remove the Patches and Adhesive .................................................................23
6.11. Disconnect Your Pulse Oximeter .....................................................................23
6.12. Access Output Data (Healthcare Providers Only) ...........................................23
7. General Specifications....................................................................................24
7.1. Wesper Lab Patches..........................................................................................24
7.1.1. Environmental and Storage Conditions.....................................................24
7.1.2. Electromagnetic Compatibility..................................................................25
7.1.3. Radio Specification ....................................................................................25
7.1.4. Shelf Life....................................................................................................25
7.1.5. Single Use ..................................................................................................26
7.1.6. Water Ingress Protection ..........................................................................26
7.1.7. Disposal .....................................................................................................26
7.2. Authorized Pulse Oximeters..............................................................................27
7.3. Smartphone ......................................................................................................27
8. 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
9. Troubleshooting.............................................................................................29
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Manufacturer
Wesper Inc.
234 5th Ave, New York, New York 10001
Tel: (516) 654-4166
E-mail: [email protected]
Web Site: http://www.WESPER.co
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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.
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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.
Note: A note provides other important information.
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3. General Warnings and Cautions
3.1. Warnings
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.
3.2. Cautions
Do not expose the Patches to direct heat or flammable products.
Do not immerse or expose the Patches to water or other liquids.
The Patches are intended for use on adult patients.
Do not use the Patches if they show any sign of damage.
Replace the device if it is not working properly.
Use of the Patches in any way other than that described in this manual is
prohibited.
Do not fully immerse the Patches into alcohol or solvents.
Do not allow the Patches to get wet.
Expired or damaged Patches are to be discarded according to electronic
waste disposal regulations in your region.
Use of Wesper Lab Patches adjacent to or stacked with other monitoring
equipment should be avoided as the presence of other equipment could
result in improper operation. If such use is necessary, the Wesper Lab
Patches and the other equipment should be observed to verify that they
are operating normally.
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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.
Do not use the Patches if the casing is damaged.
Do not use the Patches if the lights on the Patch do not light up during
initial pairing.
Do not use the Patches if the lights on the Patch do not change color
during initial pairing.
Do not use the Patches if there is no measurement indication.
Use only authorized pulse oximeters, a list of which can be found at
www.Wesper.co/oximeter.
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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. The displayed data assists in the identification of sleep apnea by
trained personnel. Wesper Lab is intended to be used for adult sleep studies
at home or clinical environment. The device does not monitor or diagnose the
patient and does not issue any alarms.
4.2. Contraindications
Use of this device is contraindicated for pediatric patients, including infants
and neonates.
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5. System Overview
5.1. Why WESPER?
Wesper Lab is a digital recording device designed to collect sleep data in adult
patients as prescribed by a healthcare professional.
Wesper Lab uses a set of comfortable adhesive Patches to record physiological
parameters during sleep. The kit is coupled with a compatible pulse oximeter
to collect information about pulse rate and oxygen desaturations. This
information is wirelessly transmitted and stored using the Wesper mobile
application. 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. The collected data is delivered to the patient’s healthcare provider who
can analyze the information as they normally would for any physiological
recording device.
5.2. WESPER in Brief
Wesper Lab uses an FDA-cleared pulse oximeter and a proprietary set of
flexible, thin, wireless, and wearable adhesive Patches designed to record
sleep disorder data in adult patients.
The Patches consist of a battery-powered physiological recording system
encapsulated in layers of fabric (top layer), silicone (bottom layer), and
medical-grade skin adhesive. The adhesive is safe for adult patient use. It is
strong enough to keep the Patches affixed to the body throughout a single
night.
The Patches collect multiple physiological parameters related to sleep quality,
including sleep position and respiratory effort. The pulse oximeter records
oxygen saturation levels and pulse rate. Data from the Patches and the pulse
oximeter is transmitted via low-energy Bluetooth (BLE) throughout the night
to a companion mobile application installed on the patient’s personal mobile
device. The data is then uploaded to a secure cloud-based server after the
recording has ended.
Clinicians can access this data for interpretation and use it as additional
information to support diagnoses of sleep apnea.
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This document explains the use of the Wesper Lab and its associated
smartphone App.
5.3. Device Description
5.3.1. Main Components
Wesper Lab consists of three components: the Patches, an FDA-cleared pulse
oximeter, and the 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.
The Patches reliably and continuously record the patient's physiological data,
including sleep position, respiratory effort, and other data relevant to sleep
quality.
This data is automatically stored in the Patches’ electronic memory and is also
continuously transmitted to the WESPER App when the smartphone is nearby.
Data is then transmitted from the smartphone to the Cloud, where it can be
analyzed by WESPER’s data analysis software.
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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). If issues are experienced, move the
Wesper Lab patches away from the source of any electromagnetic
disturbances.
5.3.1.2. The WESPER App
The WESPER App is used with the Patches; it automatically collects and
forwards physiological information from the Patches.
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5.3.1.3. 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
software. Please consult www.Wesper.co/oximeter for a list of authorized
oximeters that work with the system.
5.3.2. Data Capture –Automatic and Continuous
While the patient is sleeping, the Patches
continuously record and transmit physiological data
to their personal mobile device. The data is
automatically uploaded from the phone to the
Wesper Cloud, where it is analyzed and then
delivered to the patient’s healthcare provider for
scoring and interpretation.
5.3.3. Patch Connection Loss
Warning: The Wesper Lab Patches should be used no closer than 30 cm
(12 inches) to any equipment in the intended use environment which
emits EM radiation. Otherwise, degradation of the performance of the
patches could occur.
If Bluetooth connection loss occurs during recording, for example, due to EM
disturbances, the patches will continue to record data and will automatically
send data accumulated during a connection loss when the connection is re-
established.
If the connection loss lasts for a large portion of the night, the patient may
need to wait a few minutes in the morning while Wesper sends all recorded
data to the Cloud to ensure the integrity of the sleep study. At this point, the
patient may remove the Patches, but it’s important they’re kept close to the
patient’s mobile device to ensure successful completion of the study.
A progress bar on the App shows when the data has been successfully
delivered.
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If any connection loss persists at completion of the test, data may be lost, and
a new study must be initiated on a future night. If connection loss becomes a
persistent issue, the patient may consider moving potential sources of
disturbances, or may make alternative sleeping arrangements.
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). If this occurs,
for further instructions regarding kit usage.
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6. 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.
6.2. Check Patches Before Starting a Session
6.2.1. Apply Adhesive Layer to Patches
Before starting the Wesper test, adhesive will need to be applied to the
patches.
Place the patch onto a flat surface with its glass sensor window facing up.
Remove the thin plastic film from one side of a new adhesive cutout and stick
this side onto the exposed bottom layer of the patch.
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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.
Repeat this process for the other patch.
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6.3. Begin a new WESPER Session
6.3.
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.
Scan the QR code included with your Wesper kit. Press “Connect Patches” to
proceed setting up the session.
6.4. Activate and Apply the Patches
Caution: Do not allow the Patches to get wet.
Caution: The Patches must be applied in the following order: right side of
the rib cage (diaphragm), then the stomach.
Ensure that the patient’s chest and abdomen are clean and dry before pressing
“Continue” to set up both patches.
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6.4.1. Turn on Patch 1 (Pairing)
When directed by the app, press and hold the button on the first 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.
Caution: Do not use a Patch if the lights on the Patch do not light up or
change color during initial 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.
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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. Apply Patch 2 to Stomach
Peel off the adhesive liner from the Patch and attach it to your stomach in the
position and orientation shown in the App.
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6.5. 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.
6.6. Sweet Dreams
A final set of screens finishes the session setup. Ensure that your patches are
in the correct position, then begin the session.
Note: Make sure that your phone is connected to its charger and is near
you before going to sleep.
6.7. Warning Messages
6.7.1. Phone Not Connected to Charger
If the phone is not charging, a warning message appears at the top of the
screen:
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