Wesper Lab Manuale utente

User Manual

Document No. UMNAG001 Page 1 of 32

Wesper Lab

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

User Manual

Document No. UMNAG001 Page 3 of 32

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

User Manual

Document No. UMNAG001 Page 4 of 32

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

User Manual

Document No. UMNAG001 Page 5 of 32

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.

User Manual

Document No. UMNAG001 Page 6 of 32

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.

User Manual

Document No. UMNAG001 Page 7 of 32

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.

User Manual

Document No. UMNAG001 Page 8 of 32

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.

User Manual

Document No. UMNAG001 Page 9 of 32

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.

User Manual

Document No. UMNAG001 Page 10 of 32

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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