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
)
1%
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
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
a
, should be less than the compliance
level in each frequency range.
b
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.
a
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.
b
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
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
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
27
450
430 – 470
GMRS 460,
FRS 460
FM c) ± 5 kHz deviation 1 kHz
sine
2
0.3
28
710
704 – 787
LTE Band 13, 17
Pulse modulation b) 217 Hz
0.2
0.3
9
745
780
810
800 – 960
GSM 800/900, TETRA 800,
iDEN 820, CDMA 850, LTE Band 5
Pulse modulation b) 18 Hz
2
0.3
28
870
930
1720
1700 – 1990
GSM 1800; CDMA 1900; GSM 1900;
DECT; LTE Band 1, 3, 4, 25; UMTS
Pulse modulation b) 217 Hz
2
0.3
28
1845
1970
2450
2400 - 2570
Bluetooth, WLAN, 802.11 b/g/n, RFID
2450, LTE Band 7
Pulse modulation b) 217 Hz
2
0.3
28
5240
5100 –5800
WLAN 802.11
a/n
Pulse modulation b) 217 Hz
0.2
0.3
9
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
© 2018 Hancock Medical Inc. All rights reserved. Beddr, SleepTuner, and “Breathe more. Sleep beddr.” are registered trademarks or trademarks of Hancock Medical
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
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