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User Manual | Users Manual | 1.61 MiB | January 14 2021 / July 13 2021 | delayed release | ||
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External Photos | External Photos | 1.13 MiB | January 14 2021 / July 13 2021 | delayed release | ||
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Label | ID Label/Location Info | 141.95 KiB | January 14 2021 | |||
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1 | Block Diagram | Block Diagram | January 14 2021 | confidential | ||||
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MPE Report | RF Exposure Info | 298.00 KiB | January 14 2021 | |||
1 | Operational Description | Operational Description | January 14 2021 | confidential | ||||
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Power of Attorney Letter | Cover Letter(s) | 123.39 KiB | January 14 2021 | |||
1 | Schematic | Schematics | January 14 2021 | confidential | ||||
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Test Report | Test Report | 1.73 MiB | January 14 2021 | |||
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Test Setup Photo | Test Setup Photos | 921.24 KiB | January 14 2021 / July 13 2021 | delayed release |
1 | User Manual | Users Manual | 1.61 MiB | January 14 2021 / July 13 2021 | delayed release |
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CONFIDENTIAL
1
ETROG®Care PLATFORM
INSTRUCTIONS FOR USE
MULTIVS ES008 A
Wireless Wearable Health monitor
Patch and Chest Belt.
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
Device Description
CONFIDENTIAL
2
The ETROG® Care Platform is a wireless physiological monitoring system. The Platform
was developed with an Application Programming Interface intended to allow
development of user interface applications enabling health care professionals to access
collected vital information. The platform consists of:
• Wearable Biosensor – MULTIVS ES008A
• Adhesive patch
• Chest Belt
• Gateway Software
• Server Software
MULTIVS ES008A is an integrated Bio-Sensors and wireless transceiver, rechargeable
battery-operated device that can be worn on the body torso via adhesive patch or chest
belt, Enabling recording of heart rate, electrocardiography (ECG), Photoplethysmogram
(PPG), Pulse Wave Transit time (PWTT), Changes in Blood Pressure, heart rate
variability(HRV) , R-R interval, respiratory rate, skin temperature, activity (including step
count) and posture (body position relative to gravity).
MULTIVS ES008A operates at spot or continues measurements mode to gather
physiological data from the person being monitored and transmit the data via encrypted
bi-directional communication to the gateway (smart phone / mobile device) when in
range of the Gateway that in turn will transmit the data to the server platform storage for
real-time monitoring and or future analysis.
Collected data by MULTIVS ES008A device is transmitted to the gateway immediately.
A continuous connection is needed between the sensor device and the gateway in order
to facilitate continuous data transmission. The wireless transmission of the data occurs
continuously with a delay or latency of 100 millisecond between continuous data
collection and transmission. Gateway data will be uploaded immediately after receiving
full measurement data to secure platform server. Authorized healthcare professionals
can configure the system parameters via the secure server platform to generate
notifications and alerts based on changes in measured data. The secure server platform
will trigger a notification when configured physiologic data parameters are exceeded.
In the event that MULTIVS ES008A device is NOT in range to communicate with
gateway, the measurement data will be stored in local device memory and will be
transmitted when communication is reestablished.
The gateway will pair automatically with device once in range.
The MULTIVS ES008A can operate as standalone device and collect measurement
data per pre-scheduled program, this data will be sent to gateway once it comes into
range – automatically.
In addition, the healthcare professionals can configure the type, mode (spot or
continues), Duration and Interval of measurements done by the sensor device.
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document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
Indications for Use
CONFIDENTIAL
3
MULTIVS ES008A is an integrated Bio-Sensors and wireless transceiver, rechargeable
battery-operated device that can be worn on the body torso via adhesive patch or chest
belt, Enabling recording of heart rate, electrocardiography (ECG), Photoplethysmogram
(PPG), Pulse Wave Transit time (PWTT), Changes in Blood Pressure, heart rate
variability (HRV) , R-R interval, respiratory rate, skin temperature, activity (including
step count) and posture (body position relative to gravity). MULTIVS ES008A operates
at spot or continues measurements mode to gather physiological data from the person
being monitored and transmit the data via encrypted bi-directional communication to
the gateway (smart phone / mobile device) when in range of the gateway that in turn
will transmit the data to the server platform storage for real-time monitoring or future
analysis. The ETROG®Care platform can be configured by authorized persons to notify
healthcare professionals when physiologic data falls outside selected parameters.
The ETROG® Care Platform MULTIVS ES008A is intended for use on adult patients
who are 18 years of age and above.
The ETROG®Care platform is not intended for use on critical care in-patients or as a
diagnostic or alarm device
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
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CONFIDENTIAL
4
10/29/20 1:52:12 PM – IFU
Contraindications:
Warnings:
The device is not intended for use on patients who have implanted defibrillator or
pacemaker.
The device is not intended as a stand-alone diagnostic monitor, but the data can
be used to diagnose health status.
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 sensor device or gateway for transfer once connectivity is
reestablished.
The nature of hydro-gel silicone or hydrocolloid adhesives may cause adverse
skin reactions. Healthcare providers should advise patients to seek medical
attention if either of the following occurs:
• Allergic reaction that persisting beyond 24 Hours
Relative contraindications:
the patch on a patient.
• Histories of skin allergic reactions irritations should be considered before placing
• Do not place device on broken skin.
• This device is not intended to replace appropriate medical supervision and safe
• Clinical validation has not been performed on patients who are pregnant or
practices.
breastfeeding.
Warnings:
practices.
• This device is not intended to replace appropriate medical supervision and safe
• Do not use this device during an MRI scan or in a location where it will be
exposed to strong electromagnetic forces.
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
CONFIDENTIAL
5
Precautions:
• For data to be sent to a healthcare professional for review: The device battery must have
adequate power for data transmission. Red flashing LED on device will indicate that the battery
power is low. Low power device notification will be passed to gateway and server too.
• The patch must be attached to the patient. Notification will indicate if the patch is off
the body or not properly attached.
• The patient must remain in range of their gateway (i.e. smartphone, PC, tablet, body
worn cellular modem or wall mount device). Notification will indicate that the sensor
has disconnected from the gateway.
• The gateway must remain charged and functional for data transmission. Wireless
connectivity must be active for transmission of data from the gateway 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 there
is a clinical need, additional measures may be taken to ensure appropriate care.
• Data collected by MULTIVS ES008A for patients experiencing cardiac arrhythmia may
indicate slightly elevated respiratory rate values, compared to visual observation, for the
duration of the active arrhythmic episode.
• The gateway device must operate and connected ONLY to MULTIVS ES008A during
active monitoring. please note that performance of either or both Bluetooth connected
devices/system could potentially be affected if gateway is used for other purpose.
• 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 patch when showering or bathing.
•
•
if discomfort or irritation occurs to the patient, device should be removed.
If the patient experience mild soreness or redness after removing the patch, a new
patch should not be placed in the same location.
Incorrect handling, excessive force, or dropping the device may cause malfunction or
permanent damage.
•
• The device must be kept away from children and pets. The device may be a choking
•
hazard, and may be harmful if swallowed.
If any component of the MULTIVS ES008A ETROG®Care Platform fails to operate after
attempting all suggested troubleshooting methods, the patient should contact his
healthcare provider as soon as possible..
• Clinical validation performed in mixed age population, including elderly subjects (Age 59
to 86) with a BMI (Body Mass Index) range of 13.5-59.5 kg/m2.
• Dispose of MULTIVS ES008A per local laws, care facility laws or hospital laws for
routine/non- hazardous electronic waste.
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
Storage and Handling
CONFIDENTIAL
6
• Storage temperature range: 0 – 40o C
• Storage relative humidity range: 10 – 95% RH
• The patient hands must be clean and dry before handling MULTIVS ES008A. Gloves are
recommended for healthcare professionals when handling the Device.
System Interoperability
The ETROG® Care Platform is a wireless physiological monitoring system. The Platform was
developed with an Application Programming Interface intended to allow development of user
interface applications enabling health care professionals to access collected vital information.
Please contact ETROG SYSTEMS LTD., to obtain implementation information.
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
CONFIDENTIAL
7
10/29/20 1:52:12 PM – IFU
MULTIVS ES008A Operating Instructions
MULTIVS ES008A Overview
Top View - Device
Bottom View - Device
Top View - Device with Patch
Bottom View - Device with Patch
Charger Cabel
Device Charging
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
CONFIDENTIAL
8
Preparation and Application
Note: Please fully charge the device before start of use.
MULTIVS ES008 Patch
1.
patch.
2.
free from hair and skin is intact.
3.
and allow site to fully dry.
4.
Remove the adhesive backing from the patch and apply to prepared skin. Press down on
patch ends to ensure it is well adhered to skin. Note: keep the adhesive backing in a clean place
for later use.
Select the location for patch placement on body as per the diagram below. ensure it is
Use isopropyl alcohol to clean the skin area where the patch is intended to be placed
Take device and attach to patch via magnetic connectors. Retain the adhesive backing of
Right
Regul
arft
Left
Reg
ularf
t
Upper Left position
Regularft
Mid position
Regularft
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
ES-Chest Belt
CONFIDENTIAL
9
1. Take device and attach to chest belt via magnetic connectors.
2. Use isopropyl alcohol to clean the skin area where the belt is intended to
be placed and allow site to fully dry.
3. Strap the belt around chest as per the diagram below and adjust size. the
feel should be firm yet comfortable.
Right
Regul
arft
Left
Reg
ularf
t
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
CONFIDENTIAL
10
Please refer to the Gateway application’s user manual for more instructions on how to
connect to the MULTIVS ES008A. During first time connection a calibration and data
measurement control test will be done – to ensure proper placement and compatibility.
10/29/20 1:52:12 PM – IFU
Connect to Gateway
Removal and Re-application
ES-Patch
Grip the Device and gently pull away from patch magnets. Place Device in original box
or soft material. Keep away from reach of children, pets, direct sunlight, and AC/fans.
Grip one end of the patch and peal gently away from skin. Place the patch adhesive
side on the original adhesive backings away from reach of children, pets, direct sunlight,
and AC/fans. Remove the patch prior to showers and baths.
The patch can be re-applied. Re-apply used patch follow instruction above.
ES-Chest Belt
Open belt hook and place in a dry clean area. Keep away from reach of children, pets,
direct sunlight, and AC/fans.
The chest belt can be re-used. follow instruction above.
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
CONFIDENTIAL
11
Charging
Place device on provided cradle or connect to charging cable as per diagram.
The charging connector is magnetic and will align automatically to the right position.
Connect the USB plug to available charger. (not provided).
Led indicator
During charging the Device led indication will flash slowly RED and will be steady GREEN when
device is fully charged.
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
CONFIDENTIAL
12
Disposal
Disposal of a battery into fire or a hot oven, or mechanically crushing or cutting of a battery can
result in an explosion.
Leaving a battery in an extremely high temperature surrounding environment that can result in
an explosion or the leakage of flammable liquid or gas.
A battery subjected to extremely low air pressure may result in an explosion or leakage of
flammable liquid or gas.
Please observe local laws for disposal of battery-operated electronic products.
Additional notes:
It is recommended that continues wearing of patch on single position will be for up to 48
hours at a time. Allow 4 hours of rest to skin before re-applying on same position.
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
CONFIDENTIAL
13
Troubleshooting
Device Not Charging -
No led light -
Connectivity -
Make sure all magnets contacts are connected
Belt – clean electrode area
For additional information regarding the proper use of the MULTIVS ES008A Platform
please contact the prescribing physician, caregiver, or healthcare provider.
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
CONFIDENTIAL
14
ETROG SYSTEMS Contact Information:
HQ
ETROG SYSTEMS LTD.
7/9 Derech HaDarom Road, Kiryat Gat , ISRAEL
Phone: +972 86665042
eMail: info@etrogsystems.com
Web: www.etrogsystems.com
USA
ETROG Systems Ltd.
750 Chestnut Ridge Rd.
Chestnut Ridge, NY 10977
Phone: +1 347 434 9204
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
CONFIDENTIAL
15
Product Specifications:
Measurements
ECG Dynamic Range
Heart Rate (at rest and or physical
activity)
Specifications
-10mV to +10mV
30 – 200 Beats per Minute (<±5 or 10% Beats
per Minute, whichever is greater)
Photoplethysmogram (PPG)
RED, Infra RED, Green
Respiration Rate (RR)
6 – 30 BPM
Step Count
Skin Temperature
150C – 470C (≤± 0.300C )
Re-set after upload to server / every 24 HRs.
Upright, Lying down, Lying Right, Lying Left,
Posture Detection (relative to gravity)
Lying front, Upside-down, Moving.
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this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
CONFIDENTIAL
16
10/29/20 1:52:12 PM – IFU
System Specifications
Communications
Bluetooth (BT4.2)
Radio Modulation
Radio Frequency
Transmit power
Security
Battery
Battery Type
Battery Voltage
Battery Life
Operating Conditions
Ambient Temperature
Humidity
Altitude
Barometric Pressure
Max. 10 Meters (30 Feet Line of Sight)
GFSK
2.402 – 2.48 GHz
≤0dBm
AES-CCM 128 Bit Encryption (Advanced
Encryption Standard-CCM mode)
Polymer Li-Ion
DC 3.7 V (0.45W)
300 Charge cycles
10–400 C
10 – 95% RH
<3000 m
70 kPa to 102 kPa
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
CONFIDENTIAL
17
Electromagnetic Emission Declaration
MULTIVS ES008A is intended for use in the electromagnetic environment specified
below. The end user of ES008A should assure that it is used in such an environment.
Emission test
Compliance Electromagnetic environment
RF emissions CISPR
11
Group 1
RF emissions CISPR
11
Class B
ES008A 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.
ES008A 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.
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
CONFIDENTIAL
18
10/29/20 1:52:12 PM – IFU
FCC Compliance
•FCC ID: 2ATHK-ES008A
•
The MULTIVS ES008A 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)):
o Reorient or relocate the receiving antenna.
o
o Connect the equipment into an outlet on a circuit different from that to which
Increase the separation between the equipment and receiver.
the receiver is connected.
o Consult the dealer or an experienced radio/TV technician for help.
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
CONFIDENTIAL
19
Canada License-exempt
•IC ID:
• 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.
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this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
CONFIDENTIAL
20
Guidance and declaration – electromagnetic immunity (For ME equipment ME system
that are not life-supporting)
MULTIVS ES008A is intended for use in the electromagnetic environment specified
below. The end user of the MULTIVS ES008A Platform should assure that it is used in
such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment- guidance
Radiated RF
10 V/m
IEC 61000-4- 3
80 MHz to
2.5 GHz
10 V/m
Portable and mobile RF communications
equipment should be used no closer to any part of
the MULTIVS ES008A 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:
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this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
CONFIDENTIAL
21
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
MULTIVS ES008A Platform is used exceeds the applicable RF compliance level above,
the MULTIVS ES008A 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 MULTIVS ES008A Platform.
b 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)
MULTIVS ES008A is intended for use in the electromagnetic environment specified
below. The end user of the MULTIVS ES008A Platform should assure that it is used in
such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV
contact ±
15 kV air
± 8 kV contact
± 15 kV air
30 A/m
30 A/m
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Electromagnetic environment- guidance
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
CONFIDENTIAL
22
Recommended separation distance between portable and mobile RF communications
equipment and MULTIVS ES008A Platform
(For ME equipment ME system that are not life-supporting)
MULTIVS ES008A is intended for use in the electromagnetic environment in which
radiated RF disturbances are controlled. The end user of the MULTIVS ES008A
Platform can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters)
and MULTIVS ES008A 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
80 MHz to 800 MHz
𝑑 = 1.17√𝑃
800 MHz to 2.5 GHz
𝑑 = 2.33√𝑃
0.23
0.74
2.33
7.38
23.33
0.17
0.37
1.17
3.69
11.67
0.01
0.1
1
10
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.
ES008A complies with the applicable requirements and relevant provisions of the Radio
Equipment Directive 2014/53/EU (RED).
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
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
General symbols
Symbol
IP24
IP67
CONFIDENTIAL
23
Title
Protected against splashing water
Protected against submerging in water (up to 1 meter for 30 minutes)
Re-use is not allowed
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
CONFIDENTIAL
24
10/29/20 1:52:12 PM – IFU
Symbol
Title
Read usage instructions
Non-ionizing radiation
Defibrillation proof type CF applied part
MR Unsafe
Underwriters Laboratories
Properly dispose of EEE (Electrical and Electronic Equipment)
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
0843
CE Marking conformity
Manufacturer
Caution, consult documents
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
10/29/20 1:52:12 PM – IFU
CONFIDENTIAL
25
Not to be used in case package is damaged
Prescription only
Authorized Representative in the European Community
Symbol
Title
Catalogue number
Batch code
Use by date
Temperature limits (Storage)
Humidity limits (Storage)
Contents (Numeral represents quantity of units inside)
This document may contain information that is confidential or attorney-client privileged and may constitute inside information. The contents of
this document are intended only for the recipient(s) listed above. If you are not the intended recipient, you are directed not to read, disclose,
distribute or otherwise use this document. If you have received this document in error, please notify the sender immediately and delete the
document. Delivery of this document is not intended to waive any applicable privileges ©2020 ETROG SYSTEMS LTD.
1 | Label | ID Label/Location Info | 141.95 KiB | January 14 2021 |
G O R T E 8 0 0
S E
. D T L S M E T S Y S G O R T E
e m a n y n a p m o C r o t i n o M h t l a e H e l b a r a e W s s e l e r i W
e m a n e c i v e D A 8 0 0 S E
l e d o M A 8 0 0 S E
K H T A 2
D I C C F i a n h C n i e d a M
1 | Applicant Declaration Letter | Cover Letter(s) | 118.51 KiB | January 14 2021 |
a) b) c) d) e) f) g) SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Declaration Applicant Legal Business Name ETROG SYSTEMS LTD. Address Grantee Code FCC ID Contact Email Contact Phone 124 Hertzel street,Jerusalem,Israel 2ATHK 2ATHK-ES008A Info@etrogsystems.com
+9722 5022304 Authorized Contact Name Eyal D. Vardi I, the undersigned, certify that I am an authorized signatory for the Applicant and therefore declare;
in accordance with 47CFR2.911(d), all of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief. in accepting a Grant of Equipment Authorization issued by a TCB, under the authority of the FCC, as a result of the representations made in this application, the Applicant is responsible for:
labeling the equipment with the exact FCC ID as specified in this application,
(1)
(2) compliance statement labeling pursuant to the applicable rules,
(3) compliance of the equipment with the applicable technical rules, if the Applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCCs technical requirements. in accordance with 47 CFR 2.909 and KDB394321, the Applicant has read, understood and agrees to accept that they are the responsible party and agree to abide by their responsibilities as specified under 47 CFR 2.909 and KDB394321. in accordance with ISO17065, FCC KDB641163, FCC KDB610077, KDB394321 and RSP-100, the Applicant has read, understood, accepts and agrees to abide by the post market surveillance requirements.
(1)
(2)
(3) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing. the Applicant shall make provisions to always have a production sample available upon request by SGS, FCC and/or ISED. the Applicant shall, upon request by SGS, at the Applicants expense, provide a production sample of the requested product to SGS, FCC and/or ISED as instructed. The sample shall include all support devices, cables, software, accessories or other hardware or software required for evaluation, review, certification and audit surveillance of products certified by SGS. neither the Applicant nor any party to the application is subject to a denial of Federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862 because of a conviction for possession or distribution of a controlled substance. See 47CFR 1.2002(b) for the definition of a party for these purposes. the Applicant has read, understood, accepts and agrees to abide by the SGS North America, Inc.(TCB) terms and conditions. Link to CFRs: https://www.fcc.gov/wireless/bureau-divisions/technologies-systems-and-innovation-division/rules-regulations-title-47 Link to KDBs: https://apps.fcc.gov/oetcf/kdb/index.cfm Link to RSP-100: https://www.ic.gc.ca/eic/site/smt-gst.nsf/eng/sf01130.html Applicant Signature:
Date:2020-10-26 Print Name:
Eyal D. Vardi Chief Technology Officer Title:
*NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database Applicant Declaration Rev:0.0
1 | Confidentiality letter | Cover Letter(s) | 143.29 KiB | January 14 2021 |
ETROG SYSTEMS LTD. TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Confidentiality Request regarding application for FCC ID: 2ATHK-ES008A Regarding:
LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commissions rules, the applicant hereby request confidential treatment of the documents listed below, associated with the certification application referenced above. Schematic(s) Block Diagrams Operational Descriptions The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. SHORT TERM CONFIDENTIALITY Additionally, the applicant requests the following documents be held confidential until the device is marketed or 180 days from the grant date, whichever is less. If the device is marketed within 180 days of the Grant Date, the applicant will notify the TCB per FCC KDB 726920 D01 Confidentiality Request Procedures. External Photos Internal Photos Test Setup Photos User manual(s) Sincerely, Print Name: Eyal D. Vardi Title: Chief Technology Officer Signature:
On behalf of Company: ETROG SYSTEMS LTD. Telephone: +9722 5022304 E-mail: Info@etrogsystems.com
1 | Power of Attorney Letter | Cover Letter(s) | 123.39 KiB | January 14 2021 |
ETROG SYSTEMS LTD. Date: 2020-10-26 TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: 2ATHK-ES008A To whom it may concern:
We, the undersigned, hereby authorize SGS-CSTC Standards Technical Services Co., Ltd. (SGS) Shenzhen Branch and Keny Xu in SGS-CSTC Standards Technical Services Co., Ltd. (SGS) Shenzhen Branch to act on our behalf in all manners relating to application for equipment authorization with respect to the FCC ID above, including signing of all documents relating to these matters. Any and all acts carried out by the agent on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Where our agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by SGS North America, Inc., still resides with ETROG SYSTEMS LTD. This authorization is valid until further written notice from the applicant. Print Name: Eyal D. Vardi Title: Chief Technology Officer Signature:
On behalf of Company: ETROG SYSTEMS LTD. Telephone: +9722 5022304 E-mail: Info@etrogsystems.com
1 | Test Setup Photo | Test Setup Photos | 921.24 KiB | January 14 2021 / July 13 2021 | delayed release |
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2021-01-14 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2021-01-14
|
||||
1 | Applicant's complete, legal business name |
ETROG SYSTEMS LTD.
|
||||
1 | FCC Registration Number (FRN) |
0028506483
|
||||
1 | Physical Address |
124 Hertzel street
|
||||
1 |
Jerusalem, N/A
|
|||||
1 |
Israel
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
U******@SGS.COM
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2ATHK
|
||||
1 | Equipment Product Code |
ES008A
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
E******** V********
|
||||
1 | Title |
Chief Technology Officer
|
||||
1 | Telephone Number |
+9722********
|
||||
1 | Fax Number |
+9722********
|
||||
1 |
I******@etrogsystems.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd.
|
||||
1 | Name |
k**** X******
|
||||
1 | Physical Address |
No.1 Workshop, M-10, Middle Section
|
||||
1 |
Shenzhen, 518057
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
86-75********
|
||||
1 | Fax Number |
86-75********
|
||||
1 |
k******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 07/13/2021 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Wireless Wearable Health Monitor | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output Power listed is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd
|
||||
1 | Name |
K****** X********
|
||||
1 | Telephone Number |
+86 (********
|
||||
1 |
K******@sgs.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0000800 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC