Vital Connect VCI-VP1 WIRELESS HEALTH MONITOR User Manual IFU 02 Instructions for use Draft Dec 7

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Document ID	2838488
Application ID	PV/uCkuHiOyGV8+etLq8Rw==
Document Description	IFU-02,Instructions for use, Draft Dec 7
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	86.17kB (1077096 bits)
Date Submitted	2015-12-10 00:00:00
Date Available	2016-06-07 00:00:00
Creation Date	2015-12-07 13:47:29
Document Lastmod	2015-12-07 13:47:29
Document Title	IFU-02,Instructions for use, Draft Dec 7
Document Author:	Azin Sahabi

VITAL CONNECTTM PLATFORM
INSTRUCTIONS FOR USE, VITALPATCH
IFU-02, Draft, December 4, 2015
Page 1 of 14
Device Description
The Vital Connect Platform is a wireless physiological monitoring system. The Vital Connect Platform
was developed with an Application Programming Interface intended to allow development of user
interface applications enabling healthcare professionals to access collected vital information. The
platform consists of:
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Vital Connect Sensor (includes adhesive Patch and Sensor Module)
Relay Software Library
Server Software Library (Optional)
The Vital Connect Sensor is a battery-operated adhesive patch with integrated sensors and wireless
transceiver, worn on the torso to record heart rate, electrocardiography (ECG), heart rate variability,
R-R interval, respiratory rate, skin temperature, fall detection, activity (including step count) and
posture (body position relative to gravity including fall detection). The Vital Connect Sensor
continuously gathers physiological data from the person being monitored and then transmits
encrypted data via bi-directional communication to the relay device when in range of the relay. The
encrypted wireless data provided by the Sensor may be downloaded from the relay device for storage,
or integrated into a Third-Party Relay Application via the APIs of the Relay Software Library. In
addition, the wireless data may be transferred to the Vital Connect Secure Server where they are
stored for analysis with the deployment of the server.
During normal operation, data are collected on the Vital Connect Sensor and transmitted to the Relay
immediately. A continuous connection is needed between the Sensor and the Relay in order to
facilitate continuous data transmission. The continuous wireless transmission of the data occurs with
a delay or latency of seconds between continuous data collection and transmission. Data can be
stored and downloaded from the Relay. Data can continue to be transferred to the Vital Connect
Server with a server connection.
Authorized healthcare professionals can configure the system parameters via the API to generate
notification of changes in measured data. With the connection to the Secure Server, a notification is
triggered when configured physiologic data parameters are exceeded. Notification can be transmitted
to a generic display device (i.e. smartphone, tablet, PC or monitor).
The Vital Connect Patch is available in two different adhesive configurations: Active (Hydrocolloid
adhesive) and Gentle (Silicone adhesive). Silicone adhesives provide lower skin stress during removal
than hydrocolloid. However, in high humidity or perspiration conditions silicone adhesives can cause
mild irritation and have reduced adhesion.
IFU-02, Draft, December 4, 2015
Page 2 of 14
Indications for Use
The Vital Connect Platform is a wireless remote monitoring system intended for use by healthcare
professionals for continuous collection of physiological data in home and healthcare settings. This can
include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin
temperature, activity (including step count), and posture (body position relative to gravity including
fall). Data are transmitted wirelessly from the Vital Connect Sensor for storage and analysis. The Vital
Connect Platform can include the ability to notify healthcare professionals when physiological data fall
outside selected parameters.
The device is intended for use on general care patients who are 18 years of age or older as a general
patient monitor, to provide physiological information. The data from the Vital Connect Platform are
intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not
intended for use on critical care patients.
Contraindications:


The device is not intended for use on users who have implanted defibrillators or
pacemakers.
The device is not intended as a stand-alone diagnostic monitor, but the data may be
applicable for use in diagnosis.
Warnings:
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Depending on wireless connectivity, a temporary interruption of data transmission is
possible, which may impact continuous or real-time monitoring. Data will be stored on
the VitalConnect Sensor module for transfer once connectivity is reestablished.
The nature of silicone or hydrocolloid adhesives may cause adverse skin reactions.
Healthcare providers should advise patients to seek medical attention if a severe adverse
event or allergic reaction occur and/or persist beyond 2-3 days.
Histories of skin irritations should be considered before placing the patch on a patient.
Do not place device on broken skin.
This device is not intended to replace appropriate medical supervision and safe
practices.
Clinical validation has not been performed on patients who are pregnant or
breastfeeding.
Do not use this device during an MRI scan or in a location where it will be exposed to
strong electromagnetic forces.
Precautions:

For data to be sent to a healthcare professional for review.
o The battery must have adequate power for data transmission. Notification will
indicate that the battery power is low.
o The patch must be attached to the patient. Notification will indicate if the patch
is off the body or not properly attached.
IFU-02, Draft, December 4, 2015
Page 3 of 14

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





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o The patient must remain in range of their relay (i.e. smartphone, PC, tablet, body
worn cellular modem or wall mount device). Notification will indicate that the
sensor has disconnected from the relay.
o The relay must remain charged and functional for data transmission. Wireless
connectivity must be active for transmission of data from the relay to the server.
Healthcare providers must be aware if uninterrupted continuous data monitoring is
necessary for patient safety, treatment in home setting may not be appropriate. If
considered medically necessary, additional measures may be taken to ensure
appropriate care and monitoring is provided to meet the clinical need.
If connected to other devices/system through the same user interface (i.e. mobile
phone), while connected to the Vital Connect System via a Bluetooth connection, please
note that performance of either or both Bluetooth connected devices/system could
potentially be affected.
Similar devices may cause signal interference during data transmission. If you experience
this affect, steer clear of interfering devices.
Do not use the device if the package has been opened, or appears used, damaged, or
expired.
Do not wear device over excessive body hair in the torso area. Excessive body hair
should be removed several hours before application.
Do not use the Silicone adhesive device when showering or bathing.
Hydrocolloid adhesive device will adhere in moist environments. It will not be damaged
while showering. Minimize exposure directly under the shower head, excessive contact
with soap, or scrubbing. Gently dry device after showering. Submersing the device or
using in a sauna is not recommended. If submersion occurs the duration must be less
than 5 minutes and less than 18 inches in depth.
If discomfort or irritation occurs in patient, device should be removed. If using a Silicone
adhesive device, you may transfer it to another recommended torso location. Wear only
one device at a time.
If you experience mild soreness or redness after removing the device, do not apply a
new device in the same location. Choose another recommended location.
Incorrect handling, excessive force, or dropping the device may cause malfunction or
permanent damage.
Keep the device away from children and pets. The device may be a choking hazard, and
may be harmful if swallowed.
If any component of your Vital Connect System fails to operate after attempting all
suggested troubleshooting methods, contact your healthcare provider immediately.
Clinical validation performed in elderly population, including elderly subjects (Age 59 to
86) with a BMI (Body Mass Index) range of 13.5-59.5 kg/m2.
Dispose Vital Connect Patch per local laws, care facility laws or hospital laws.
Storage and Handling



Storage temperature range: 0 – 40o C
Storage relative humidity range: 10 – 95% RH
Ensure your hands are clean and dry before handling the patch and sensor module. Gloves are
recommended for healthcare professionals when handling the re-usable module.
IFU-02, Draft, December 4, 2015
Page 4 of 14
System Interoperability
The Vital Connect platform is developed with an Application Programming Interface (API) intended to
allow development of user interface applications enabling healthcare professionals to access collected
vital information. Please contact Vital Connect, Inc. to obtain implementation information, including
the Vital Connect Platform Integration Manual – Developer Guide.
VitalPatch Operational Instructions
VitalPatch Overview
Top
view
Bottom view
Skin Preparation and Application
1. Remove from pouch
Tear open the pouch and remove the VitalPatch
carefully to avoid pressing the Power Button.
Retain the pouch or the adhesive backing with
the device Bluetooth ID #. You will need this
information to connect to your software
application after the patch is applied.
2. Prepare skin
Select a location for patch placement within the
oval region (adjust placement away from nipple
and armpit):
1) Upper chest at a 45 degree angle
2) Center of the chest on the sternum
3) Below chest on the rib cage.
For men, shave chest hair where the patch will
be applied. Use isopropyl alcohol to clean skin
and allow site to dry.
IFU-02, Draft, December 4, 2015
Page 5 of 14
3. Power on
Locate and press the Power Button. Look for a
green light illuminating temporarily to confirm
the device is powered on.
4. Apply to Left Chest
Follow the battery orientation indicated in step 2 for proper patch placement. Remove the
adhesive backings from the patch and apply to your prepared skin. Press down on both ends of
the patch to ensure it is well adhered to your skin. Avoid exercise for at least 30 minutes after
patch application.
Connect
Important: Refer to your software application provider’s user manual for more instructions on
how to connect to the VitalPatch. A connection is required to establish a start time in the data
file. After connecting, walk approximately 30 steps to automatically calibrate posture. For
calibrating your VitalPatch manually, refer to your software application provider’s user manual.
Removal and Re-application
A. Gentle VitalPatch
Grip one end of the patch and pull away from skin. Place the patch adhesive side up on a clean
and dry surface away from reach of children, pets, direct sunlight, and AC/fans, etc. Remove the
patch prior to showers and baths.
Gentle VitalPatch can be reapplied up to 3 times during the intended use of the device.
Reapply used patch on clean and dry skin.
B. Active VitalPatch
Use of an adhesive tape remover is recommended. Gently sweep the remover pad under the
patch and pull away from skin.
Active VitalPatch cannot be reapplied.
For application of a new patch, it is recommended to use a different location within the oval
application area.
Disposal
Please observe local laws for disposal of battery- operated electronic products.
IFU-02, Draft, December 4, 2015
Page 6 of 14
It is recommended that healthcare providers advise users to replace a patch after


72 hours of continuous monitoring of all Vital Connect Platform measurements or,
96 hours of continuous monitoring of all Vital Connect Platform measurements except ECG (ECG
monitoring is turned off).
Troubleshooting
Basic troubleshooting includes the following:
Make sure that the “Vital Connect Patch Operational Instruction” have been followed.
If the Patch is lifting from the skin surface, press down firmly on the areas of the Patch that
lifted to reattach it to the skin. If the problem persists, use a new patch.
For other issues, attempt the following:
o Restart the application and reconnect to the Vital Connect Sensor. Or if that does not
resolve the issue, then
o Turn off Bluetooth. Turn back on Bluetooth. Start the application and reconnect to the
Vital Connect Sensor. Or if that does not resolve the issue, then
o Power down the relay. Turn back on the relay. Start the application and reconnect to
the Vital Connect Sensor.
Issues that need troubleshooting may relate to the user interface application developed by mobile
healthcare professionals to use with the Vital Connect Platform. For example, messages such as
“Communication not established”, “Communication lost”, “Battery low”, “Bad Battery”, may be
generated as part of the functionalities of the user interfacing. Please refer to their instructions
for use for additional troubleshooting guidance. For additional information regarding the proper
use of the Vital Connect Platform and mobile service provider user interface, please contact the
prescribing physician, caregiver, or healthcare providers.
Vital Connect Contact Information
Vital Connect Inc.
900 East Hamilton Ave. Suite 500
Campbell, CA 95008
USA
Phone: 408 (963) 4600
www.vitalconnect.com
European Authorized Representative
Emergo Europe
Molenstraat 15
2513 BH The Hague
The Netherlands
Phone: (31) (0) 70 345-8570
Fax: (31) (0) 70 346-7299
IFU-02, Draft, December 4, 2015
Page 7 of 14
Product Specifications
Measurements
Specifications
ECG Dynamic Range
Heart Rate (stationary and
ambulatory)
Respiration Rate
-10mV to +10mV
30 – 200 Beats per Minute (<±5 or 10% Beats per Minute,
whichever is greater)
• 10-30 Breaths per Minute with a mean absolute error of less than
3 Breaths per Minute, validated by clinical studies
• 4-42 Breaths per Minute with a mean absolute error of less than
1.5 Breaths per Minute, validated by simulation studies
150C – 500C (≤± 0.30C )
Fall or No Fall (> 90% Sensitivity and >98% Specificity)
< 5% Absolute Error Compared to Manual Count
Step count is reset to 0 after step count 65535 is reached.
Lying down, Upright, Walking, Running, or Leaning (>70% Accuracy
Compared to Visual)
Skin Temperature
Fall Detection
Step Count
Posture Detection
System Specifications
Communications
Bluetooth (BT4.1)
Radio Modulation
Radio Frequency
Transmit power
Security
Battery
Battery Type
Battery Voltage
Battery Life
Max. 10 Meters (30 Feet Line of Sight)
FSK (Frequency Shift Keying)
2.4 – 2.5GHz
≤10dbm
AES-CCM 128 Bit Encryption (Advanced Encryption Standard-CCM
mode)
Zinc Air
DC 1.4V
72 Hours with all measurements
96 hours with ECG monitoring turned off
Operating Conditions
Ambient Temperature
Humidity
Altitude
Barometric Pressure
IFU-02, Draft, December 4, 2015
10 – 40 o C
10 – 95% RH
<3000 m
70 kPa to 102 kPa
Page 8 of 14
Electromagnetic Emission Declaration
Vital Connect Sensor is intended for use in the electromagnetic environment specified below.
The end user of the Vital Connect Sensor should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment
RF emissions CISPR 11
Group 1
Vital Connect Sensor 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
Vital Connect Sensor is suitable for use in all
establishments, including domestic establishments
and those directly connected to the public lowvoltage power supply network that supplies buildings
used for domestic purposes.
FCC Compliance
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FCC ID:SPO-VCI-VP1
This Vital Connect Platform 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 (FCC Title 47, Subpart A, Part 15.19(3)).
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment (FCC Title 47,
Subpart A, Part 15.21)
Note: 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 (FCC Title 47, Subpart B, Part 15.105(b)):
 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.
IFU-02, Draft, December 4, 2015
Page 9 of 14
Canada License-exempt
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IC ID:11013A-VCIVP1
This device complies with Industry 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 present appareil est conforme aux CNR d'Industrie Canada applicables aux appareils
radio exempts de licence. L'exploitation est autorisee aux deux conditions suivantes : (1)
l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter
tout brouillage radioelectrique subi, meme si le brouillage est susceptible d'en
compromettre le fonctionnement.
Guidance and declaration – electromagnetic immunity
(For ME equipment ME system that are not life-supporting)
Vital Connect Sensor is intended for use in the electromagnetic environment specified below.
The end user of the Vital Connect Platform (including Vital Connect Sensor) should assure that
it is used in such an environment.
Immunity
IEC 60601 Compliance
Electromagnetic environment- guidance
test
test level
level
Radiated RF
3 V/m
IEC 61000-43
80 MHz to
2.5 GHz
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of the Vital Connect Platform than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
𝑑 = 1.17√𝑃 80 MHz to 800 MHz
𝑑 = 2.33√𝑃 800MHz to 2.5 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 meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya
should be less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of
equipment marked with the following symbol:
IFU-02, Draft, December 4, 2015
Page 10 of 14
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 Vital Connect Platform is used exceeds the applicable RF compliance level above, the
Vital Connect Platform should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the Vital Connect
Platform.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and declaration – electromagnetic immunity
(For ME equipment ME system that are not life-supporting)
Vital Connect Sensor is intended for use in the electromagnetic environment specified below. The
end user of the Vital Connect Platform (including Vital Connect Sensor) should assure that it is used
in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment- guidance
Electrostatic
discharge (ESD)
Âą 6 kV contact
Âą 6 kV contact
Âą 8 kV air
Âą 8 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 %.
3 A/m
3 A/m
IEC 61000-4-2
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
IFU-02, Draft, December 4, 2015
Page 11 of 14
Recommended separation distance between portable and mobile RF communications equipment and
Vital Connect Platform
(For ME equipment ME system that are not life-supporting)
Vital Connect Sensor is intended for use in the electromagnetic environment in which radiated RF
disturbances are controlled. The end user of the Vital Connect Platform (including Vital Connect Sensor)
can help prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the Vital Connect Platform Sensor as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
Separation distance according to frequency of transmitter
80 kHz to 800 MHz
800 MHz to 2.5 GHz
𝑑 = 1.17√𝑃
𝑑 = 2.33√𝑃
0.01
0.17
0.23
0.1
0.37
0.74
1.17
2.33
10
3.69
7.38
100
11.67
23.33
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
General symbols
Symbol
IP24
IP27
Title
Protected against splashing water
Protected against submerging in water (up to 1 meter for 30 minutes)
Re-use is not allowed
IFU-02, Draft, December 4, 2015
Page 12 of 14
Symbol
Title
Read usage instructions
Properly dispose of EEE (Electrical and Electronic Equipment)
Non-ionizing radiation
Defibrillation proof type CF applied part
MR Unsafe
Underwriters Laboratories
MEDICAL — PATIENT MONITORING EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005), "Medical Electrical Equipment - Part 1:
General Requirements for Basic Safety and Essential Performance;
CAN/CSA-C22.2 No. 60601-1:08; ANSI/AAMI/IEC 60601-2-25,
"Medical Electrical Equipment - Part 2-25: Particular Requirements for the
Basic Safety and Essential Performance of Electrocardiographs" E358758
CE Marking conformity
0843
Manufacturer
Caution, consult documents
Not to be used in case package is damaged
Prescription only
Authorized Representative in the European Community
IFU-02, Draft, December 4, 2015
Page 13 of 14
Symbol
Title
Catalogue number
Batch code
Use by date
Temperature limits (Storage)
Humidity limits (Storage)
IFU-02, Draft, December 4, 2015
Page 14 of 14

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