VivaLNK VV330 User manual

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INSTRUCTIONS FOR USE
SDK 01
Medical Wearable Platform
LBL 75-06-78 Rev AA

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What’s Included 1
Intended Use & Precautions 2
Instructions for Use 5
Charging, Storage & Maintenance 10
Troubleshooting 11
Certification & Disclaimer 12
Electromagnetic Compatibility (EMC) Tables 14
Technical Specifications 17
Definition of Symbols 19
Contents
Wireless Technology
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What’s Included
1
ECG Recorder(the Patch) ontinuous ECG Recorder
x1
Charging Case
x1
Adhesives
x8
USB Charging Cable
x1

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Intended Use and Precautions
Intended Use
Precautions
Medical Wearable Platform SDK-01 is intended to record, store and transfer electrocardiogram (ECG) and accelerometer
data. The platform has the capability to provide Heart Rate, Respiratory Rate and R-R Interval using the ECG rhythm. The ECG recorder patch is an
ambulatory, continuous recording patch, intended for at-home or hospital, by clinicians or health professionals who intend to monitor their patient's
physiological and health conditions for an extended period of time. The device is not intended for patients under 18 years old and it is meant for a
single patient use
This Instructions for Use is only limited to the use of the hardware and the Software Development Kit (SDK). It does not include any information about
the mobile application or user interfacing device as that is outside the scope of the system.
5.
6.Do not use the patch with a cardiac pacemaker, defibrillators,
or other implanted electronic devices.
1.Any form of modification to this device is forbidden.
2.Do not use this device if it cannot stay in contact with the
skin and do not use on wounded or irritated skin.
3.This device is non-sterile.
4.The Continuous ECG Recorder is to be worn on chest.
2
Do not submerge the Patch in water. Patch may be removed
and be reapplied after showering or bathing

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Intended Use and Precautions
b) storage outside the manufacturer’s stated temperature and
humidity range; c) mechanical shock (for example,being dropped)
14.Please contact customer service at [e-mail] if
you have any questions.
15. For best results, the Patch must be used with the provided
16. No servicing/maintainance required while the device is in use.
17.Not for use in an oxygen rich enviroment.
18.Before every use, check the device. Do not use the device if it
is damaged. The continuous use of a damaged unit maycause
improper results.
19.If the device is not charging or the device is not working,
please contact the authorized maintenance personnel.
20.Be careful to potential allergic reactions to Silicone and
Hydrogel that are primary materials of the patch and adhesive.
21.The device should be used only with the components
recommended for use by the manufacturer.
7.Do not wear or use the patch during a magnetic resonance
imaging (MRI), or electro-cautery procedures. The Patch
is MR Unsafe.
8.Exposure of the wireless communications features of the
device,or its accessories,may be interfered with by other
devices that operate on the same frequencies.
9. Excessive body tissue, hair, or dry skin may affect the signal
quality.
10.Do not excessively bend or twist the Patch
11. In case of skin discomfort,remove the Patch immediately.
12.User may only charge the patch via USB cable with the
provided charger.No user serviceable part is provided for
this product.
13.The performance of the device may be degraded if one or
more of the following occur: a) operation outside the
manufacturer’s stated temperature and humidity range;
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adhesives.

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Intended Use and Precautions
22.When not in use, store the device in a dry room and protect it
against extreme moisture, heat, lint, dust and direct sunlight.
23.Never place any heavy objects on the storage case.
24. The device is not intended for measuring and/or analyzing ST
segments.
25. The device does not analyze the ECG tracing or detect the
presence of any arrhythmias. It is simply a Patch.
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26. In case of interference from other RF emitters in the vicinity,
follow Troubleshooting steps listed below.
1. Device pairing: ensure LOT#/SN returned to the SDK from the Patch
matches with the LOT#/SN printed on back of the patch. Do not
connect the SDK to any unknow devices.
2. All the Patch data is encrypted for security purposes.
The SDK needs a decryption key to encrypt the patch data..
3. The Patch will not connect or transfer data to any devices that does
not use VivaLNK provided SDK package. The bluetooth protocol of
the Patch and SDK is proprietary to VivaLNK and cannot be intercepted
by other unknown devices.
4. Do not attempt to connect any unknown devices to the Patch.
CYBERSECURITY:
27. When the Patch battery is fully discharged,charge the patch
first then reconnect to the SDK via Bluetooth before re-attaching
to the body to get Clock Synchronization.

1. Place the patch in the 2. Fully charge the patch before use 3. Once charged, see
instructions for “Applying
the Patch”
charger to recharge
Align the two dots on the patch with
the two pins on the charger to
properly charge the patch.
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Instructions for Use - Charging the Patch
5
Indicates Fully Charged
Indicates Charging
Note: For the charger base, just
clean with a dry cloth

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Instructions for Use - Applying the Patch
6
1. Prepare Skin
Ideally, clean the left, upper
middle chest area with an
alcohol swab. Shave area if
needed.Let dry completely.
2. Peel adhesive starting
with tab #1
3. Place the patch on
the adhesive
Be sure to press patch firmly
onto the adhesive.
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Instructions for Use - Applying the Patch
7
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4. Peel adhesive using
tab #2
Tab #2 is located on the
bottom side of the patch.
5. Place the Recorder around the middle
of upper left chest area at a roughly inclined
angle as shown below
Press the patch firmly on
chest and around outer layer
of the adhesive.Make sure
the heart symbol on the
patch is upright.

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Instructions for Use - Removing and Cleaning the Patch
8
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1. Remove the patch from
chest by pulling from the
yellow tab of the
adhesive
Start at the yellow tab of the
transparent film to peel off the
patch.
Use the red tab to peel the adhesive
from the patch. Do not reuse
this adhesive.
2. Remove the adhesive from
the patch itself by peeling
from the edge
3. Clean the patch with
warm water
Rub off any residue with your
fingers,wait for patch to dry
completely.Do not submerge.

Instructions for Use - Tips before Showering
Note: While the patch is water resistant,
avoid excessive exposure to water as it can
affect the adhesive and sensors.
1.Avoid prolonged or hot showers
2.Avoid soap or rubbing around the patch
3.Dry patch by dabbing with towel
4.If the patch dislodges after a shower, or you
notice a problem with the sensor signals, see
instructions for “Removing and Cleaning the Patch”.
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Charging, Storage & Maintenance
Patch Storage & Charging Charger Indicators
Adhesives
RED
GREEN
OFF
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•When the Patch is placed inside the charger, green light
indicates the patch is fully charged.
•When the Patch is not placed in charger,or the charger is
not plugged in via USB cable.
•When the Patch is placed inside the charger,red light
indicates the patch is charging.
•The light should stay on when charging.
It is recommended to store the Patch inside the
charging case when not in use for better.
Charging can start when the USB cable is
connected to a USB power source.
Each Patch comes with 8 medical grade,
disposable adhesives.Adhesives can be used
up to 72 hours, but some users may want to
change adhesives more often depending on skin
type and comfortability. Additional adhesives can
be purchased separately as needed.

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Troubleshooting
1.This device might be damaged.
2.This device might not be worn correctly.
3.The operation temperature is too high or too low.
4.Improper or no skin preparation.
5.Incorrect attachment of adhesive.
1.Bluetooth turned off in the SDK-installed device.
2.Out of connection range.
3.Interference from other RF emitters, such as RFID,
metal detectors, medical equipments etc, in the
vicinity
Unusual Data
No data or
intermittent data
received by SDK
1.Enable Bluetooth.
2.Move the Patch close to the SDK-installed deviceo
3. Move far away from any electronic equipment or
change rooms or move to an open space.
4.Check if the Patch is activated.
5.Restart the SDK- installed device.
6.The Patch battery is low and charge it.
Possible Causes
Symptom Solutions
1.Contact your device provider.
2.Recheck device’s location or contact with skin.
3.Use this device under instructed operation
temperature.
4.Prepare the skin before application.
5.Follow the instructions to attach the adhesive.
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No BLE signal or data
transmission latency

Certification & Disclaimer
Notes:
This device 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 according 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 device does cause harmful
interference to radio or television reception, the user is encouraged to try to correct the interference by one or more of the following measures:
1.Increase the separation between the Patch and the devicer r
2.Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected.
3.Consult an experienced radio / TV technician for help.
4.Reorient or relocate the receiving antenna.
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.
Changes or modification not expressly approved by your device
provider could void the user’s authority to operate the equipment.
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Certification & Disclaimer
For private households: Information on Disposal for Users of
WEEE
Disposing of this product correctly will help save valuable
resources and prevent any potential negative effects on human
health and the environment,which could otherwise arise from
inappropriate waste handling.Please contact your local authority
for further details of your nearest designated collection point.
Penalties may be applicable for incorrect disposal of this waste,in
accordance with your national legislation.
This symbol on the product(s) and / or accompanying
documents means that used electrical and electronic equipment
(WEEE) should not be mixed with general household waste.For
proper treatment,recovery and recycling,please take this
product(s) to designated collection points where it will be
accepted free of charge.
Alternatively,in some countries,you may be able to return your
products to your local retailer upon purchase of an equivalent new
product.
Battery Removal
2.All batteries / accumulators should be disposed separately from
the municipal waste stream via designated collection facilities
appointed by the government or the local authorities.The correct
disposal of your old batteries/accumulators will help to prevent
potential negative consequences for the environment, animal, and
human health.
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The Patch contains a lithium battery.Refer to proper disposal instructions
below:
1.To remove the battery, cut the Patch. The battery is located in
the center of the patch.

Electromagnetic Compatibility (EMC) Tables Table 1
Continuous ECG Recorder used in aircraft shall meet the RF EMISSIONS requirements of ISO 7137. The conducted RF EMISSIONS
test is also applicable to Continuous ECG Recorder stored in charger connected to aircraft power.ISO 7137 is identical to RTCA
DO-160C:1989 and EUROCAE ED- 14C:1989.The latest editions are RTCA DO-160G: 2010 and EUROCAE ED-14G: 2011.
Therefore, use of Section 21 (and category M) of a more recent edition,e.g.[39] or [40],should be considered.
In other intended modes or in EM ENVIRONMENTS of transportation,applicable standards shall apply.
Examples of standards that might be applicable include CISPR 25 and ISO 7637-2.
Conducted and
radiated RF EMISSION
Phenomenon
Emission Test Levels
IEC 60601 Test Level
Professional Healthcare Facility Environment
(E.g. physician offices, dental offices, clinics etc.)
Home Healthcare Environment
(E.g. restaurants, cafes, shops, etc.)
IEC 60601 Test Level
CISPR 11 CISPR 11
a)
b)
a) b)
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Electromagnetic Compatibility (EMC) Tables Table 2
This test level assumes a minimum distance between the Continuous ECG Recorder and power source with magnetic field of at
least 15 cm.If the RISK ANALYSIS shows that the Continuous ECG Recorder will be used closer than 15 cm to power source with
magnetic field,the IMMUNITY TEST LEVEL shall be adjusted as appropriate for the minimum expected distance.
Immunity Test Levels
Phenomenon and
Basic EMC standard
or test method
Electrostatic discharge
IEC 61000-4-2 ± 8 kV contact
± 2 kV , ± 4 kV, ±8 kV, 15 kV air
30 A/m
50Hz or 60Hz
Radiated RF EM fields
IEC 61000-4-3
Rated power frequency
magnetic fields
IEC 61000-4-8
3 V/m
80 MHz - 2.7 GHz
8% AM at 1kHz
10 V/m
80 MHz - 2.7 GHz
8% AM at 1kHz
Professional Healthcare Facility Environment
(E.g. physician offices, dental offices, clinics etc.)
Home Healthcare Environment
(E.g. restaurants, cafes, shops, etc.)
c)
c)
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Wireless Technology
VivaLNK Continues ECG Recorder uses Bluetooth Low Energy (LE) wireless technology (IEEE 802.15.1, managed by
Bluetooth Special Interest Group now) to transfer data between the ECG Recorder and the SDK, including ECG, RRI, HR, ACC data, and
device information, which complies with the BLE 4.0 and above.
Security Measures:
Low-power Bluetooth wireless communication between patch firmware and SDK, in line with Bluetooth 4.0+ low-power Bluetooth protocol,
works in the 2.4GHZ ISM radio frequency band, and belongs to general information technology equipment. Through security mechanism in
wireless Bluetooth communication protocol stack ensured by Bluetooth Special Interest Group, both patch firmware and SDK in APP are required
to execute these secure controls during data/information exchange. Additionally, AES128 encryption algorithm is added to encrypte the data in
the air during BLE transmission.
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Technical Specifications ECG Recorder
Product Name: ECG Recorder
Catalog/Model: VV330/VV-330
Patch Size: 90mm x 28mm
Patch Thickness: 7.9 mm
Patch Weight: 7.5 g
Patch Battery: 95 mAh,rechargeable
Duration of continuous patch use: 3 Days
Product Shelf Life: 1 Year
Product Service Life: 2 Years
Heart Rate Detection Range: 40 BPM - 300 BPM
Operating Conditions:
Temperature Range: 50° F - 113° F (10° C - 45° C)
Humidity Range: 10% - 95%
Pressure Range: 70 - 106 kPa
Storage Conditions:
Temperature Range: 50° F - 122° F (10° C - 50° C)
Humidity Range: 10% - 95%
Pressure Range: 70 - 106 kPa
This device complies with Part 15 of the FCC Rules.
Accelerometer Range: ± -4g in x,y,z
Patch Water Resistance: IP25(splash proof but should not be immersed in water)
Charger Water Resistance: IP21(protected against condensation or dripping water
falling vertically)
Charger Power Source: VV330 Charging Base (micro-USB)
Note: 24 hours of data storage on the patch during no wireless transmission.
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Technical Specifications
Product Name:
Catalog/Model: VV330/VV-330
Patch Size: 90mm x 28mm
Patch Thickness: 7.9 mm
Patch Weight: 7.5 g
Patch Battery: 95 mAh,rechargeable
Duration of continuous patch use: 3 Days
Heart Rate Detection Range: 40 BPM - 300 BPM
Operating Conditions:
Temperature Range: 50° F - 113° F (10° C - 45° C)
Humidity Range: 10% - 95%
Pressure Range: 70 - 106 kPa
Storage Conditions:
Temperature Range: 50° F - 122° F (10° C - 50° C)
Humidity Range: 10% - 95%
Pressure Range: 70 - 106 kPa
This device complies with Part 15 of the FCC Rules.
Accelerometer Range: ± -4g in x,y,z
Patch Water Resistance: IP25(splash proof but should not be immersed in water)
Charger Water Resistance: IP21(protected against condensation or dripping water
falling vertically)
Charger Power Source: VV330 Charging Base (micro-USB)
(After adhesive bag is open,use within one month.
Otherwise,the water evaporation of the adhesive tape
may affect performance.)
Respiration Rate Detection Range: 5 BrPM - 25 BrPM
Respiration Rate Accuracy: +/- 4 BrPM