Etrog systems Multivs es008 a User manual

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ETROG®Care PLATFORM

INSTRUCTIONS FOR USE

MULTIVS ES008 A

Wireless Wearable Health monitor

Patch and Chest Belt.

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Device Description

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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Indications for Use

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

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Contraindications:

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.

Warnings:

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:

•Histories of skin allergic reactions 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.

Warnings:

•This device is not intended to replace appropriate medical supervision and safe

practices.

•Do not use this device during an MRI scan or in a location where it will be

exposed to strong electromagnetic forces.

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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.

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Storage and Handling

• 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.

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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

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Preparation and Application

Note: Please fully charge the device before start of use.

MULTIVS ES008 Patch

1. Take device and attach to patch via magnetic connectors. Retain the adhesive backing of

patch.

2. Select the location for patch placement on body as per the diagram below. ensure it is

free from hair and skin is intact.

3. Use isopropyl alcohol to clean the skin area where the patch is intended to be placed

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.

Right

Regul

arft

Upper Left position

Regularft

Mid position

Regularft

Left

Reg

ularf

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ES-Chest Belt

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.

Left

Reg

ularf

Right

Regul

arft

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Connect to Gateway

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.

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.

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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.

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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.

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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.

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ETROG SYSTEMS Contact Information:

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

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Product Specifications:

Measurements

Specifications

ECG Dynamic Range

-10mV to +10mV

Heart Rate (at rest and or physical

activity)

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

Skin Temperature

150C – 470C (≤± 0.300C )

Step Count

Re-set after upload to server / every 24 HRs.

Posture Detection (relative to gravity)

Upright, Lying down, Lying Right, Lying Left,

Lying front, Upside-down, Moving.

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System Specifications

Communications

Bluetooth (BT4.2)

Max. 10 Meters (30 Feet Line of Sight)

Radio Modulation

GFSK

Radio Frequency

2.402 – 2.48 GHz

Transmit power

≤0dBm

Security

AES-CCM 128 Bit Encryption (Advanced

Encryption Standard-CCM mode)

Battery

Battery Type

Polymer Li-Ion

Battery Voltage

DC 3.7 V (0.45W)

Battery Life

300 Charge cycles

Operating Conditions

Ambient Temperature

10–400 C

Humidity

10 – 95% RH

Altitude

<3000 m

Barometric Pressure

70 kPa to 102 kPa

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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

Group 1

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.

RF emissions CISPR

Class B

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.

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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 Increase the separation between the equipment and receiver.

o Connect the equipment into an outlet on a circuit different from that to which

the receiver is connected.

o Consult the dealer or an experienced radio/TV technician for help.

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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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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

IEC 61000-4- 3

10 V/m

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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