BresoTEC URU User manual
User Guide for User Recording Unit (URU)
DOC-00015
Rev.00
BresoTec
Inc. | 555 Richmond St. W, Unit 407
Toronto,
ON, M5V 3B1 Canada
www.bresotec.com
The User Recording Unit (URU) is designed to be used as part of the Patch system. The URU is a wearable
sensor intended to record biological signals from the user during sleep.
Cautions and Warnings for URU
Read the entire manual before using the URU.
When using consumables and accessories, please read the manufacturer’s information supplied with
the products.
It is important to inspect the condition of the URU. If there are any visible defects, the URU should
not be used.
It is recommended to initiate recording on the URU immediately before going to sleep.
Do not submerge the URU in liquid.
Do not modify the URU.
Excessive noise may affect the quality of the recording. When using the URU, the patient should
sleep in a quiet environment to minimize the impact of the ambient noise.
Wireless communication devices might have an impact on the system. Do not place too close to the
patch.
Small parts may be a choking hazard to children.
The healthcare professional is responsible for explaining to the patient the functions of the URU and
how to operate it safely with the help of the patient User Guide.
URU LED Light Indicators
Light Description
Solid
Green
URU will start recording
Flashing Green URU recording in progress
Solid Red
URU in error state
Charging URU
1. Plug the data collection unit (DCU) into a wall outlet.
URU
LED
Light
Indicator
User Guide for User Recording Unit (URU)
DOC-00015
Rev.00
BresoTec
Inc. | 555 Richmond St. W, Unit 407
Toronto,
ON, M5V 3B1 Canada
www.bresotec.com
2. Insert the URU to the charging dock in DCU.
3. The URU should be charged for approximately 2 hours.
4. The URU should be charged the day you wish to conduct the home sleep test.
Directions for Use
Note: The URU must be fully charged prior to usage. See charging instruction for URU.
1. Attach the URU on the neck.
2. Turn on the URU by pressing the button. The green LED light will turn on solid.
3. Once all components are connected, LED light on URU will flash green and eventually turn off within a
minute.
4. Go to sleep.
Cleaning and maintenance
1. Wipe all outer surfaces of URU using antiseptic isopropyl alcohol wipe.
2. Leave the components to dry.
FCC Regulatory Statements
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.
(2) This device must accept any interference received, including interference that may cause
undesired operation.
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the Federal Communication Commission (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 causes 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 doing 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.
User Guide for User Recording Unit (URU)
DOC-00015
Rev.00
BresoTec
Inc. | 555 Richmond St. W, Unit 407
Toronto,
ON, M5V 3B1 Canada
www.bresotec.com
NOTE: THE GRANTEE IS NOT RESPONSIBLE FOR ANY CHANGES OR MODIFICATIONS
NOT EXPRESSLY APPROVED BY THE PARTY RESPONSIBLE FOR COMPLIANCE. SUCH
MODIFICATIONS COULD VOID THE USER’S AUTHORITY TO OPERATE THE
EQUIPMENT.
RF Exposure Warning
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment. In order to avoid the possibility of exceeding the FCC radio frequency exposure
limits, human proximity to the antenna must not be co-located or operating in conjunction with
any other antenna or transmitter.
ISED Regulatory Statements
This device complies with ISED Canada license-exempt RSS standard(s). Operation is subject
to the following two conditions: (1) this device may not cause interference, and (2) this device
must accept any interference, including interference that may cause undesired operation of the
device.
Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio
exempts de licence. L’exploitation est autorisée aux deux conditions suivantes : (1) l’appareil
ne doit pas produire de brouillage; (2) l’appareil doit accepter tout brouillage radioélectrique
subi, même si le brouillage est susceptible d’en compromettre le fonctionnement.
CAN ICES-3 (B)/NMB-3(B)
RF Exposure Information
This equipment complies with ISED RSS-102 radiation exposure limits set forth for an
uncontrolled environment. This transmitter must not be co-located or operating in conjunction
with any other Ω.
Storage/Environmental/ transport conditions
Environmental operating
conditions
Temperature
+5
°
C
to
+40
°
C
Relative Humidity 15% - 93%, non-
condensing
Atmospheric
Pressure
700
-
1060
hPa
Altitude
Up
to
4000
meters
Temperature
-
40
°
C
to
+70
°
C
User Guide for User Recording Unit (URU)
DOC-00015
Rev.00
BresoTec
Inc. | 555 Richmond St. W, Unit 407
Toronto,
ON, M5V 3B1 Canada
www.bresotec.com
Environmental conditions
of transportation and
storage before first use
Relative Humidity 10% - 100%, including
condensation
Atmospheric
Pressure
50
-
106
kPa
Environmental conditions
of transportation and
storage between uses
Temperature -25°C without relative
humidity control; and
+70°C at a relative
humidity up to 93%, non-
condensing
Safety and EMC Compliance
1. IEC 60601-1:2005+AMD1:2012 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
2. IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -
Requirements and tests
3. IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral standard: Usability
4. IEC 60601-1-11:2015: Medical electrical equipment - Part 1-11: General requirements
for basic safety and essential performance - Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare environment
5. IEC 62366-1:2015: Medical devices -- Part 1: Application of usability engineering to
medical devices
6. IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid
electrolytes -Safety requirements for portable sealed secondary lithium cells, and for batteries
made from them, for use in portable applications - Part 2: Lithium systems
7. ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and
testing within a risk management process
8. ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro
cytotoxicity
9. ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for
irritation and skin sensitization
User Guide for User Recording Unit (URU)
DOC-00015
Rev.00
BresoTec
Inc. | 555 Richmond St. W, Unit 407
Toronto,
ON, M5V 3B1 Canada
www.bresotec.com
Symbols
Medical Prescription required
Operating instructions
Consult operating instructions
Caution,
Consult accompanying documents
Follow instructions for use
General warning sign
Type BF applied part
Manufacturer information
WEEE
Catalogue number
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
Fragile, handle with care
User Guide for User Recording Unit (URU)
DOC-00015
Rev.00
BresoTec
Inc. | 555 Richmond St. W, Unit 407
Toronto,
ON, M5V 3B1 Canada
www.bresotec.com
Degree of protection against harmful ingress of water or particulate matter,
where N1 defines the degree of protection against harmful ingress of
particulate matter and N2 the degree of protection against harmful ingress
of water
Medical device
Non-ionizing electromagnetic radiation. Equipment includes RF
transmitters.
Interference may occur in the vicinity of equipment marked with this symbol.
User Guide for User Recording Unit (URU)
DOC-00015
Rev.00
BresoTec
Inc. | 555 Richmond St. W, Unit 407
Toronto,
ON, M5V 3B1 Canada
www.bresotec.com
Manufacturer’s info
Manufacturer name: BresoTEC Inc.
Manufacturer address: Unit 407, 555 Richmond Street West, Toronto, Ontario M5V 3B1, Canada.
Manufacturer website: www.bresotec.com
Contact information:
+1.844.276.3239
Technical Specification
Function
and
Features
URU
Recording time per session 8 hours maximum
Sample Resolution
(Sound/snoring)
8000 Hz, 24 bits
Sample Resolution
(Neck/Chest Movement)
100 Hz, 12 bits x 3 axis
Power
Requirements
Power Source
URU Lithium-ion rechargeable battery, 3.7V, 170mAh,
0.6Wh
IEC62133-2:2017 Certified
Battery Life
URU (continuous and repeated
uses)
17 hours (new and fully charged battery)
URU (idle, not in use) > 6 months (new and fully charged battery)
Physical
Specification
URU
Dimension 17.4mm x 38.7mm x 35.5mm
(H x W x D)
Weight 17 grams
Transmitter
URU
WLAN compliance 802.11 b/g/n
Antenna Type Internal, 2.4GHz Chip Antenna
Operating Frequency 2.4 GHz
Band Width 20 MHz
Operation WLAN Station
Modulation 1 DSSS, 6 OFDM, 54 OFDM
FCC ID
2AYNV
-
BTSM1URU
IC
26577
-
BTSM1URU
Expected
Service
Life
URU 50 Recordings (8 hours per recording)
