Beddr SleepTuner User manual

Brand: Beddr

Model: SleepTuner

Type: User manual

These instructions provide the necessary information for proper operation of the Beddr SleepTuner.

INTENDED USE

The Beddr SleepTuner™ System is intended to help maintain and encourage a general state of health and/or healthy sleep. SleepTuner is for users who are interested

in understanding their functional oxygen saturation of arterial hemoglobin (SpO2), heart rate and sleeping position overnight. It is indicated for adult users or children

under the supervision of an adult and can be used for spot-checking, collection, and recording of data in home environments.

INTENDED POPULATION

The Beddr SleepTuner is indicated for adult users or children under the supervision of an adult and can be used for spot-checking, collection, and recording of data in

home environments.

CAUTIONS

The Beddr SleepTuner is not intended to diagnose any medical condition.

Do not use the SleepTuner during Magnetic Resonance Imaging (MRI) or in an MRI environment.

Avoid looking directly at the LED Sensor Array.

Use only the Power Adapter and Charging Cable provided with the SleepTuner to recharge the battery.

Use of the SleepTuner adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the

SleepTuner and the other equipment should be observed to verify that they are operating normally.

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 SleepTuner System. Otherwise, degradation of the performance of the SleepTuner System could result.

Do not use the SleepTuner if it appears or is suspected to be damaged.

Do not repair, open or modify the SleepTuner.

Do not use the SleepTuner if the internal parts have been exposed to liquids.

Do not use the SleepTuner while charging.

Do not use the Sleep Tuner if forehead skin shows irritation or damage.

Keep SleepTuner out of reach of pets and children.

Separation from power is only assured by unplugging the Power Adapter from the wall outlet. Ensure a clear path to the wall outlet is maintained while charging.

Use of the SleepTuner with active implantable medical devices, such as cardiac pacemakers and ICDs, has not been evaluated and is therefore not recommended.

The SleepTuner user should be familiar with basic smartphone application navigation and Bluetooth connectivity requirements. Keep the operating system of your

smartphone up to date to enhance security.

Avoid exposure of the SleepTuner System to known sources of EMI (electromagnetic interferences) such as magnetic resonance imaging (MRI) systems, diathermy,

lithotripsy, electrocautery, RFID (radio frequency identification), and electromagnetic security system such as metal detectors. Note the presence of RFID devices may

not be obvious. If such interference is suspected reorient equipment if possible, to maximize distances. If required, reboot device by holding the Sensor button down

for ten minutes.

NOTES

Do not immerse in fluid or run fluid over the SleepTuner.

TIPS

When using the SleepTuner with a smart device (smartphone, tablet computer), keep both devices within the recommended range of each other. Moving outside of

this range may cause a loss of connection with the smart device.

The Power Adapter is two-pronged and does not require a grounded outlet.

The SleepTuner has a Lithium-ion battery which may be restricted for certain types of travel.

The SleepTuner is not provided sterile.

SleepTuner performance may be affected if used outside the operating ranges specified.

Avoid the following to optimize measurements:

• Improper SleepTuner placement or alignment

• Externally applied skin products such as make-up or skin lotion applied to the sensor location

• Excessive motion

The following health conditions may reduce the accuracy of the measurements:

• Low arterial perfusion

• Motion conditions

• Improper sensor placement or alignment

• Externally applied skin products such as make-up or skin lotion applied to the Sensor location’

• Elevated levels of COHb and MetHb

• Intravascular dyes (i.e. methylene blue, indocyanine green)

• Elevated bilirubin levels

• Severe anemia

• Venous congestion or pulsation

Use a new Adhesive for each new test. Do not re-use Adhesives. Re-use of Adhesives may result in degraded sensor performance and user experience.

PRODUCT OVERVIEW

Product Description: The SleepTuner is a wellness oximeter, a non-invasive overnight recording device that measures and displays functional oxygen saturation of

arterial hemoglobin (SpO2), stopped breathing events per hour, Heart Rate (HR), sleeping position and movement. The system is comprised of a small light weight

sensor designed for overnight wearable use, a charging cable, power adapter, smartphone application, and a data analysis server. The sensor is worn overnight on the

forehead, attached by a medical grade, biocompatible adhesive patch. It captures oximetry and pulse rate data. These data are processed by software on the server.

Data are presented to the user in the smartphone application.

Oxygen Saturation

(SpO2)

The amount of oxyhemoglobin expressed as a percentage of

the hemoglobin that is available to transport oxygen.

Stopped Breathing

Events per Hour

Number of times per hour that the device detects a stopped

breathing event.

Heart Rate

Heart rate, measured in beats per minute (BPM), is based

on optical detection of peripheral flow pulse

Sleeping Position

Sleeping position is based upon measurements derived

from a 3-axis accelerometer. The SleepTuner is able to track

if you are on your side, back, front or upright.

The SleepTuner works in conjunction with an application that runs on a smartphone and uses BLE (Bluetooth Low Energy) for communication between the Sensor and

the smartphone. As the mobile application is updated, new information may be presented to the user.

Theory of Operation: The SleepTuner shines light of different wavelengths into tissue and analyzes the differences in intensity of the returned light. The light

absorbance in the tissue changes depending on the concentration of oxygenated hemoglobin in the blood. A set of formulas are used to derive the measured SpO2

(functional oxygen saturation of arterial hemoglobin) from that returned light.

Sensor Configuration: The SleepTuner sensor is composed of Light Emitting Diode (LED) emitters that send different wavelengths of light into tissue and detectors

that receive and measure those returned wavelengths.

System Requirements: The SleepTuner runs on iPhone 6 smartphone and newer and requires iOS 11.3 or newer and Bluetooth 4.0 or newer.

Package Contents:

SleepTuner (Part Number SA01116)

12 Adhesives (Part Number SA01113)

Case (Part Number PC01109)

Charging Cable (Part Number PC01114)

Power Adapter (Part Number PC01115)

Quick Start Guide (Part Number LB01112)

USING THE SLEEPTUNER

Use of the SleepTuner System requires the SleepTuner application which runs on iPhone 6 smartphones and newer and requires iOS 11.3 or newer. Keep the

operating system of your smartphone up to date to enhance security and performance. The Beddr SleepTuner does not yet support Android smartphones.

Setup

Fully charge your SleepTuner Sensor prior to use.

Download the SleepTuner application from the iOS Apple Store.

After downloading and opening the Application, create an account by tapping “Sign Up” and entering an email and creating a password. You must accept the Terms of

Use and Privacy Policies to proceed.

Follow instructions in the Application to pair the Sensor with Smartphone.

Follow instructions in the Application to begin using the SleepTuner.

Once a recording is complete, your results will be available for display.

Note: it is not required that you keep the smartphone application open, or smartphone connected during recording. The smartphone application is only required to

begin and end a recording.

Troubleshooting

Forgot Password: Press the “Forgot Password” button on the Sign in page to have a password reset email sent to the account’s registered email address.

Reset Password: If you need to reset your password, go to “Settings” and then “Accounts and Passwords” on the smartphone application to request an email allowing

a password reset.

Bluetooth Connection: If you receive the “Bluetooth not found. Make sure Bluetooth is enabled” message ensure Bluetooth is turned on in your phone’s settings.

Recording Upload Failed: If you receive the “Recording failed to upload” message, ensure you have a good network connectivity on your smartphone (E.g. move your

phone’s location), then press “Try Again” to upload the data.

Firmware Update Required: If you receive “Firmware update required Tap Here” message, press “Update” to install new firmware.

CLEANING THE SLEEPTUNER

Confirm that the SleepTuner is off, disconnected from power and not applied to the forehead. Wipe the Sensor and outer surfaces using a lint-free cloth lightly

dampened with water. Do not use any cleaning solution.

SERVICE AND MAINTENANCE

Only Beddr-authorized personnel can service the SleepTuner. Do not attempt to service the SleepTuner.

The expected service life of the SleepTuner is 1 year.

For additional help, visit the support section of the Beddr mobile application, our website at www.beddrsleep.com/support or email [email protected].

DISPOSAL

The SleepTuner is electronic equipment. Please use your local return and collection system for electrical and electronic equipment waste. Improper disposal may

have harmful effects on the environment and on public health. Recycle wherever possible.

TECHNICAL SPECIFICATIONS

Clinical Data

Measurement Range

Measured Accuracy (A

rms

)

90% to 100%

1.5%

80% to 90%

2.2%

70% to 80%

2.8%

70% to 100%

2.2%

Graphical Plot of Measured Data Points

Performance Specifications

Functional Oxygen Saturation (SpO2)

Resolution

Measurement Range

Accuracy (A

rms

)

70% to 100%

£3.5%

Heart Rate

Resolution

Range

Accuracy (A

rms

)

1 bpm

30 bpm to 240 bpm

5bpm

Display Ranges

SpO2

0%-100%

Heart Rate

30 bpm to 240bpm

Sleeping Position

back, side, face, sitting

Battery

Specs

3.7V, 50mAH, Lithium-ion

Life

Approximately 20 hours of operation

Physical Characteristics

Dimensions

33.7mm x 24.5mm x 9.5mm

Weight

5.3 grams

Charger Electrical Specifications

Input

100-240V

Output

50-60Hz; (output) 5V, 1.2A

Environment

Item

Description

Operating Temperature Range

-5C to 40C

Operating Humidity Range

15% to 90%

Storage/Transport

Temperature Range

-25°C to 70°C

Storage/Transport Humidity

Range

0% to 90%

Operating / Transportation /

Storage Atmospheric Pressure

70 to 106 kPa

Ingress Protection

(SleepTuner)

IP22 - Protected from touch by fingers and objects greater than 12.5

millimeters. Protected from water spray less than 15 degrees from vertical.

Ingress Protection (Power

Adaptor)

IP21 - Protected from touch by fingers and objects greater than 50

millimeters. Protected from water spray less than 15 degrees from vertical.

The SleepTuner has been verified by an independent test institute for compliance with the EN / IEC 60601-1 standard.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The SleepTuner is intended for use in the electromagnetic environment specified below. The user of the SleepTuner should assure that it is used in such an

environment.

Emissions Test

Compliance

RF emissions CISPR 11

Group 1

The EQUIPMENT uses RF energy only for its internal function. Therefore, its RF emissions are very

low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

The EQUIPMENT is suitable for use in all establishments, including domestic establishments and

those directly connected to the public low-voltage power supply network that supplies buildings

used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Class A

Voltage Fluctuations/Flicker emissions

Complies

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The SleepTuner is intended for use in the electromagnetic environment specified below. The user of the SleepTuner should assure that it is used in such an

environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

±8 kV contact

±15 kV air

±8 kV contact

±15 kV air

Floors should be wood, concrete or

ceramic tile. If floors are covered with

synthetic material, the relative humidity

should be at least 30 %.

Electrical fast

transient/burst

IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines

±2 kV for power supply lines

±1 kV for input/output lines

Mains power quality should be that of a

typical commercial or hospital

environment.

Surge

IEC 61000-4-5

±1 kV differential mode

±2 kV common mode

±1 kV differential mode

±2 kV common mode

Mains power quality should be that of a

typical commercial or hospital environment.

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines

IEC 61000-4-11

Voltage Dips 30% reduction,

25/30 periods At 0°

Voltage Dips 30% reduction,

25/30 periods At 0°

Mains power quality should be that of a

typical commercial or hospital environment. If the user of the

SleepTuner requires continued operation during power mains

interruptions, it is recommended that the SleepTuner be

powered from an uninterruptible power supply or a battery.

Voltage Dips > 95% reduction, 0.5

period At 0°, 45°, 90°, 135°, 180°,

225°, 270° and 315°

Voltage Dips > 95% reduction, 0.5

period At 0°, 45°, 90°, 135°, 180°,

225°, 270° and 315°

Voltage Dips > 95% reduction, 1

period At 0°

Voltage Dips > 95% reduction, 1

period At 0°

Voltage Interruptions > 95%

reduction, 250/300 periods

Voltage Interruptions > 95%

reduction, 250/300 periods

(50/60 Hz)

magnetic field

IEC 61000-4-8

30 A/m

Power frequency magnetic fields

should be at levels characteristic of a

typical location in a typical commercial

or hospital environment.

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

(6 Vrms in ISM and amateur radio

Bands within 150kHz – 80MHz)

10 V/m

80 MHz to 2.7 GHz

3 Vrms

10 V/m

Portable and mobile RF communications equipment should be

used no closer to any part of the SleepTuner, including cables,

than the recommended separation distance calculated from the

equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.2ÖP

d = 1.2ÖP 80 MHz to 800 MHz

d = 2.3ÖP 800 MHz to 2.7 GHz

where P is the maximum output power rating of the transmitter

in watts (W) according to the transmitter manufacturer and d is

the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an

electromagnetic site survey

, should be less than the compliance

level in each frequency range.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio

broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an

electromagnetic site survey should be considered. If the measured field strength in the location in which the SleepTuner is used exceeds the applicable RF

compliance level above, the EQUIPMENT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be

necessary, such as reorienting or relocating the SleepTuner.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the SleepTuner

The SleepTuner is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the SleepTuner can help

prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the

SleepTuner as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output

power of transmitter (W)

Separation distance according to frequency of transmitter (m)

150 kHz to 80 MHz, d = 1.2ÖP

80 MHz to 800 MHz, d = 1.2ÖP

800 MHz to 2.7 GHz, d = 2.3ÖP

0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation

applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter

manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Immunity to RF Wireless Communications Equipment

Test Frequency

(MHz)

Band a)

(MHz)

Service a)

Modulation b)

Maximum

Power (W)

Distance

(m)

IMMUNITYTEST

LEVEL (V/m)

385

380 –390

TETRA 400

Pulse modulation b) 18 Hz

1.8

0.3

450

430 – 470

GMRS 460,

FRS 460

FM c) ± 5 kHz deviation 1 kHz

sine

0.3

710

704 – 787

LTE Band 13, 17

Pulse modulation b) 217 Hz

0.2

0.3

745

780

810

800 – 960

GSM 800/900, TETRA 800,

iDEN 820, CDMA 850, LTE Band 5

Pulse modulation b) 18 Hz

0.3

870

930

1720

1700 – 1990

GSM 1800; CDMA 1900; GSM 1900;

DECT; LTE Band 1, 3, 4, 25; UMTS

Pulse modulation b) 217 Hz

0.3

1845

1970

2450

2400 - 2570

Bluetooth, WLAN, 802.11 b/g/n, RFID

2450, LTE Band 7

Pulse modulation b) 217 Hz

0.3

5240

5100 –5800

WLAN 802.11

a/n

Pulse modulation b) 217 Hz

0.2

0.3

5500

5785

a) For some services, only the uplink frequencies are included.

b) The carrier shall be modulated using a 50 % duty cycle square wave signal.

c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst

case.

LIMITED WARRANTY

Hancock Medical, Inc. warrants to the original purchaser (“Customer”) that hardware provided with the product will be free from material defects under normal

intended use for one year from the original purchase date. Hancock Medical’s sole obligation under this warranty shall be, in its sole discretion, to replace or repair

the defective product, or refund the purchase price. All items returned to Hancock Medical become the property of Hancock Medical. Replacements are warranted

for the longer of 90 days or the original warranty period. Customer must contact Hancock Medical within the warranty period to obtain a warranty service

authorization. Dated proof of original purchase will be required. Hancock Medical is not responsible for items received without warranty service authorization.

Customer bears the risk of loss during shipment. HANCOCK MEDICAL, INC. MAKES NO OTHER WARRANTIES WITH RESPECT TO ANY HARDWARE, SOFTWARE, OR

SERVICE, WHETHER EXPRESS OR IMPLIED, AND ALL IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO THOSE FOR MERCHANTABILITY, FITNESS FOR A

PARTICULAR PURPOSE AND NON-INFRINGEMENT ARE DISCLAIMED. This limited warranty is void if defects are caused by misuse, neglect; by unauthorized attempts

to open, repair, or modify the product; or by accident, fire, lightning, or other hazards.

FCC

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device

must accept any interference received, including interference that may cause undesired operation. Change or modification not expressly approved by the party responsible for

compliance could void the user’s authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant

to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses

and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However,

there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be

determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the

receiving antenna, Increase the separation between the equipment and receiver, Connect the equipment into an outlet on a circuit different from that to which the receiver is

connected, Consult the dealer or an experienced radio/TV technician for help.

LICENSE

This product contains software, the use of which licensed by Hancock Medical Inc. to customer for the customer’s personal use only, as further provided at

www.beddrsleep.com/license which is hereby incorporated herein by reference. Modification, reverse engineering, reverse compiling, or disassembly of the software

is expressly prohibited, except to the extent authorized by applicable law.

SYMBOLS

The following symbols appear on the product, product packaging or this User Manual:

SYMBOL DEFINITION

Device Manufacturer

Manufacturer’s Device Catalogue Number

Type BF Applied Part

Do not dispose the device together with unsorted municipal waste

Non-Sterile

Temperature Limitation

Humidity Limitation

Not for Continuous Monitoring (No Alarm for SpO2)

Reusable

Use-by Date

Federal Communications Commission (FCC) Licensing

Manufacturing Information

Manufactured For & Distributed By:

Hancock Medical, Inc.

897 Independence Ave

Suite 3A

Mountain View, CA 94043 USA

https://www.beddrsleep.com

TRADEMARK

Inc. iOS is a trademark or registered trademark of Cisco in the U.S. and other countries and is used under license. iPhone, iPad, iPad Air and iPad Pro are trademarks of

Apple Inc., registered in the U.S. and other countries. iPad mini is a trademark of Apple Inc.

LB 01019 Rev H JAN/2020