Samsung Electronics Co SPATCH3 Wearable Health Monitoring System User Manual
Samsung Electronics Co Ltd Wearable Health Monitoring System
User Manual
Samsung Confidential
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USER MANUAL
Wearable Health Monitoring System
(MODEL : S-PATCH3)
Document No. : S-UM-01 (Rev. 0.2)
Samsung Electronics Co., Ltd.
1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, South Korea
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Revision History
Revision
Number
Issue Date
Contents of revision
Rev.0.0
2016.12.28
Established by Manufacturer’s User Manual Policy
Rev.0.1
2017.1.5
5.1 Label Update
Rev.0.2
2017.2.9
5.1 Label Update
Rev.0.2
2017.2.9
4.2.1 Spec Update
서식 있음: 양쪽
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Contents
1. Product Introduction .................................................................................................................................... 5
1.1 Introducing S-PATCH3 ......................................................................................................................... 5
1.2 Indication for Use .................................................................................................................................... 5
2. Cautions ............................................................................................................................................................. 5
2.1 General ........................................................................................................................................................ 5
2.2 Safety ............................................................................................................................................................ 5
2.3 Contra-Indication .................................................................................................................................... 6
2.4 Usage and Storage Conditions ............................................................................................................. 7
2.4.1 Conditions for Usage ........................................................................................................................ 7
2.4.2 Conditions for Storage ...................................................................................................................... 7
2.4.3 Cleaning Condition ........................................................................................................................... 7
3. Components and Installation of S-PATCH3 .......................................................................................... 8
3.1 Main Device Components ..................................................................................................................... 8
3.2 Accessory Components .......................................................................................................................... 9
3.3 Display viewer ........................................................................................................................................ 10
3.4 How to Install S-PATCH3 .................................................................................................................. 18
3.4.1 Installing S-PATCH ....................................................................................................................... 18
3.5 Precautions .............................................................................................................................................. 18
4. Using and Operating S-PATCH3 ............................................................................................................ 20
4.1 How to Use S-PATCH3 ....................................................................................................................... 20
4.2 Specifications .......................................................................................................................................... 25
4.2.1 S-PATCH3 Specifications ............................................................................................................ 25
4.3 Error Message and Alarm ................................................................................................................. 26
4.3.1 Device Disconnection .................................................................................................................... 26
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4.3.2 Abnormal signal detect .................................................................................................................. 26
4.3.3 Low Battery mode .......................................................................................................................... 27
4.3.4 Low Remaining Storage ................................................................................................................ 28
5. Labels and Packaging ................................................................................................................................. 30
5.1 Labels ........................................................................................................................................................ 30
5.1.1 Label for Packaging ....................................................................................................................... 30
5.1.2 Label for module ............................................................................................................................. 30
5.2 Packaging................................................................................................................................................. 31
5.2.1 Package List ..................................................................................................................................... 31
5.2.2 Package Units .................................................................................................................................. 32
6. Information on EMC ................................................................................................................................... 33
6.1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ........................ 33
6.2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ........................ 33
6.3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ........................ 34
6.4 Recommended separation distances between portable and mobile RF communications
equipment and the EUT .................................................................................................................................. 35
6.5 Immunity and Compliance Level .................................................................................................... 36
6.6 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ........................ 37
7. FCC Compliance Statement ..................................................................................................................... 38
8. Product Life time and Warranty ............................................................................................................ 38
8.1 Product Life time .................................................................................................................................. 38
8.2 Product Warranty ................................................................................................................................ 38
9. Company Introduction ............................................................................................................................... 39
9.1 Company Name and Address ........................................................................................................... 39
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1. Product Introduction
1.1 Introducing S-PATCH3
This product is intended to measure, transfer and record electrocardiogram signal. The viewer on
mobile device may display ECG wave form, Heart Rate, Respiration Rate, Heart Rate Variability and
other information. The product consists of S-PATCH3 body signal sensing module, ECG electrodes
and mobile app viewer to monitor the signals.
• Product Type– Ambulatory electrocardiographic systems
• Name– S-PATCH3 Wearable Health Monitoring System
• Serial Number– SP3-1612-0041
• Manufacturer–SAMSUNG ELECTRONICS Co., Ltd.
1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, 18448 Korea
1.2 Indication for Use
The S-PATCH3 Wearable Health Monitoring System is intended to record, transfer and store single
channel electrocardiogram signals. The S-PATCH3 signal sensing module transmits data through
wireless communication to mobile device. The product is not intended for pediatric use.
The S-PATCH3 wearable health monitoring system monitors and displays:
• Heart Rate
• ECG signal
• Heart Rate Variability
• Respiration Rate
2. Cautions
2.1 General
1) DO NOT store in extremely hot, cold, humid, or wet conditions.
2) Since this product is a medical device, instructions are required to properly dispose
of it. Contact the deputy or manufacturer for such instructions. Improper disposing of
this device can lead to legal consequences.
3) Contact the manufacturer if the product functions abnormally, problematically, or not
at all. Any attempt to repair without the manufacturer’s guide is not recommended.
4) Reuse of the electrodes is prohibited in any circumstances due to the infection.
5) Use of electrodes sticker may cause a skin irritation or reaction.
6) DO NOT expose to strong electromagnetic fields.
7) Too much body hair may cause an unsuccessful recording.
8) DO NOT use to diagnose heart related conditions.
9) No warranty for any data or information that is collected erroneously by the device,
or misuse or malfunction as a result of abuse, accidents, alteration, misuse, neglect,
or failure to maintain the products as instructed.
2.2 Safety
1) Before treatment, the doctor must explain cautions to the patient.
2) Operate the product in the correct order as described in this manual.
3) Use this device under doctor’s prescription.
4) Beware of the polarity of the Coin battery when exchange and insert the battery.
5) DO NOT use during magnetic resonance imaging (MRI) or external defibrillation
procedures.
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6) DO NOT drop or bump with excessive force.
7) DO keep components out of reach of children.
8) DO NOT swallow the device or wind the cable around the neck.
2.3 Contra-Indication
1) Patients with artificial cardiac pacemaker, cardioverter defibrillator, or other implantable
electric devices.
2) Pregnant or breast-feeding mothers
3) A current sign or medical history of skin cancer, rash, skin disorder, keloid, and/or any
injury.
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2.4 Usage and Storage Conditions
2.4.1 Conditions for Usage
1) Temperature: 0℃-45℃(32℉ to 113℉)
2) Relative humidity: 10%-95%(non-condensing)
3) Atmospheric pressure: 700hPa-1060hPa
2.4.2 Conditions for Storage
1) Temperature: −20℃-70℃(-4℉ to 158℉)
2) Relative humidity: 10%-95%( non-condensing)
3) Atmospheric pressure: 400hPa-1500hPa
4) Keep the device in the case when it doesn't use.
2.4.3 Cleaning Condition
1) Clean the device with soft, dry cloth
2) Equipment failure may occur due to dust and debris during long-term use of the
equipment.
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3. Components and Installation of S-PATCH3
3.1 Main Device Components
<S-PATCH3>
Label
Name
Description
1
Main Body1
Coin battery inset module
2
Main Body2
Main PCB module
3
Connect Cable
Cable between two main bodies
4
Power Button
Power On/Off button
5
LED
LED Lamp to indicate the states
6
Electrode connect hole
Holes for ECG electrodes connecting
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3.2 Accessory Components
<Electrode>
<Battery>
Label
Name
Description
1
Electrode
Multi-purpose monitoring electrodes with sticky gel
feature (high performance adhesive and foam backing)
Note: Use the FDA registered Electrode.
2
Battery
Power supply for S-PATCH3. DC 3V Coin Battery.
The Applied Parts are main device and electrode
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3.3 Display viewer
1) Main Display of S-PATCH3 App
서식 있음: 글꼴: (영어) 바탕, (한글)
바탕, 11 pt
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A. STATUS Bar
A.1. Elapsed Time: The elapsed time from the first signal receiving time
A.2. Device ID: Connected S-PATCH Device’s ID
A.3. BLE Connection Indicator: Bluetooth Low Energy Connection State
A.4. Device Battery Indicator: Remained battery state of the connected device
In the case of the ratio is lower than 25%, “Battery is too low” Notification will appear.
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In the case of the ratio is lower than 10%, “Change Device’s Battery!” Notification will
appear.
B. ECG View
Double Tapping on ECG View will toggle MONITORING and PAUSE mode.
In PAUSE mode, it’s enabled that Scrolling by swipe gesture on ECG Graph. Scaling
(magnification ratio changing 50 ~ 150%, by 10%) by zooming gestures is able for both
modes.
B.1. Measured ECG Signal: Measured ECG signals
B.2. ECG Paper Scale: Scale of ECG Paper. It’s same as actual size in case of the
magnification ratio is 100%
B.3. Heart Rate: Current Measured Heart Rate and Maximum/Minimum HR
B.4. Respiratory Rate: Measured Respiratory Rate. The unit of the respiratory rate is BrPM
(Breath per minute). Actual range of the respiratory rate is from 9 BrPM to 30 BrPM. The
resolution is 0.96 BrPM.
** During measure the Respiratory Rate, minimize move.
B.5. PAUSE Indicator: PAUSE mode indicator. Even in PAUSE mode, received signal will
be stored.
B.6. Left-side Time: The elapsed time of the left-side signal
B.7. Right-side Time: The elapsed time of the right-side signal
B.8. Magnification Ratio: The magnification ratio of the ECG signal and ECG Paper. It’s
invisible in case of the ratio is 100%
C. Heart Rate Trend View: Heart rate trend graph for 1 Hour.
D. Menu Button: It’s translucent. Touching the button makes it opaque and show menu buttons.
Nothing selected until 3 seconds then it backs to translucent and menu buttons will be
disappeared.
D.1. Change Device: Device Select View will appear
D.2. Set MARK: add User event mark
D.3. Show/Hide STATUS Bar: show/hide STATUS Bar
서식 있음: 글꼴: (영어) Times New
Roman, (한글) 바탕체
서식 있음: 글꼴: (영어) Times New
Roman, (한글) 바탕체
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D.4. ECG View’s Background:
BLACK: black background, green signal
PAPER: ECG Paper background, black signal
D.5. Import from file: read signal data from stored file. S-PATCH format(*.sp) and MIT
BIH format(.hea/.dat, 16 format - only for exported by this app) can be loaded.
If there is no folder stored signal files, check your system options like below. In case of
Android OS, Internal Storage would be hidden.
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D.6. Export to file: Received Signal data automatically stored to device’s storage as
formatted .sp (S-PATCH format). This button makes MIT BIH format file. The file name is
automatically generated by based on the Device Number and the first connection time.
D.7. Show HRV View: shows HRV information view
D.8. Show/Hide HR Trend View: show/hide HR Trend View
HR Trend View shows HR trend and minimum/maximum HR for 1 Hour.
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E. HRV View: shows HRV information
E.1. Time Domain HRV
E.1.1. AVNN: mean of all the intervals in ms
E.1.2. SDNN: standard deviation all RRIs over the complete test duration in ms
E.1.3. SDANN: standard deviation of the 5 min means in ms
E.1.4. ASDNN: mean of the 5 min standard deviation in ms
E.1.5. NN50: the number of RRI difference of successive RRIs greater than 50ms
E.1.6. PNN50: NN50 as a percentage of all allowed RRIs
E.1.7. RMSSD: root mean square of successive differences in ms
E.1.8. TINN: triangular index interval is the baseline width of the distribution measured as
a base of a triangle approximating the RRI distribution
E.2. Frequency Domain HRV
E.2.1. VLF: very low frequency power (0.00333 Hz to 0.040 Hz)
E.2.2. LF: low frequency power (0.040 Hz to 0.150 Hz)
E.2.3. HF: high frequency power (0.150 Hz to 0.400 Hz)
** During measure the HRV, minimize move.
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F. Device Select View: scanning S-PATCH devices nearby and show IDs.
F.1. Devices: Scanned S-PATCH devices are shown. One of them is selected then
connection will be tried. The number in bracket after S-PATCH name is the
Device ID. RSSI is Received signal strength indication in a wireless environment,
in arbitrary units. It could be used to calculate distance of the S-PATCH and the
host device.
F.2. Nothing available: This will disconnect connected device and stay without any
connection
F.3. Cancel: This will back without any changes
F.4. App version: This shows App’s version
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G. Signal Viewer
G.1. File Name: Loaded File Name
G.2. Total Time Range: Stored total signal’s range
G.3. Left-side time of signal: Signal Viewer’s left side time
G.4. Right-side time of signal: Signal Viewer’s right side time
G.5. Near Signal Navigation: This shows signals of larger range than Signal Viewer. Swipe
gesture will scroll the time range.
G.6. Small Time Range Navigation: This supports specific time selection in small time
range by touch. If total time range is too small, this will disappear.
G.7. Total Time Range Navigation: This supports the selection of the Small Time Range
Navigation’s range on the total time range.
H. Viewer Menu Button
“BACK” button supports return of previous window as like as Android Device’s Cancel
button.
Other buttons are same as S-PATCH real-time signal display state.
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The app shows as Landscape orientation as following as device’s orientation.
3.4 How to Install S-PATCH3
3.4.1 Installing S-PATCH
1) Download the S-PATCH App from Google Play Store (Android KitKat or later). The
device must support Bluetooth Low Energy.
2) Install the downloaded file on user’s mobile device.
3) Insert battery to main body 1 of S-PATCH3.
4) Connect Electrodes to electrode connect hole in each side of S-PATCH3.
3.5 Precautions
1) The electrodes and coin battery are disposable. Please observe local laws for disposal of
electrodes and coin battery.
2) Please ensure user’s hands are clean and dry when handle the S-PATCH3
3) The body hair possibly causes contact problem which results a fault detection of
physiological data.
4) After using the device, wipe dust and other foreign substances using a dry cloth.
5) This product must not be disposed of with your other household waste. Instead, it is
your responsibility to dispose of your waste equipment by handing it over to a
designated collection point for the recycling of waste electrical and electronic
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equipment. The separate collection and recycling of your waste equipment at the
time of disposal will help to conserve natural resources and ensure that it is recycled
in a manner that protects human health and the environment. For more information
about where you can drop off your waste equipment for recycling, please contact
your local city office, your household waste disposal service or the shop where you
purchased the product.
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4. Using and Operating S-PATCH3
4.1 How to Use S-PATCH3
1) After connect the electrodes with S-PATCH3, peel the plastic on the backside of the
electrodes.
2) Attach the S-PATCH3 on recommended position as drawn.
3) Push the power button longer than 3 seconds.
4) Confirm that the LED is ON and OFF 3 times.
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< ON > < OFF >
5) Put the Bluetooth mode to “ON” mode of user’s mobile device.
6) Please execute S-PATCH App.
7) Please touch the Menu Button located right bottom side like as below.
8) Menu Buttons will appear then touch “DEVICE” button
Buttons will disappear if there is no selection for 3 seconds.
9) Connectable S-PATCH Devices will be added to the list.
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If the app has not yet proper permission to access the host device’s BLE, permission
requesting messages will be shown like below.
S-PATCH app uses BLE and storage of the host device. And BLE needs Location
Permission, so, BLE, Location and Storage permissions are requested. If it’s denied one
of them, the app could not receive and store signal data.
10) Select the device to be connected.
11) After pairing S-PATCH device, top-right side’s connection indicator will be updated,
and ECG Signals will be shown as following as BLE transmission.
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Received signal data is automatically stored to the host device’s storage as file under
/SPATCH folder. The file and folder name is generated by S-PATCH device number and
connection time.
Above example means S-PATCH (3105) device’s signals are received since 2015 year
January 1st day PM 1:30:47. Same name’s folder has detail data.
Algorithm Result (Heart rate, Respiratory Rate and Heart rate variability) will be updated
after valid signals are received for required time range for each algorithm.
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12) Select “N/A” to finish recording on Device Selection
13) To load a stored signal, select “IMPORT” button through Menu-Button and choose
the file. Then it will be loaded like below.
Bottom navigation and swiping on signal graphs are able to move on the showing time.
And HR, RR and HRV values are updated as following as the time.
If the S-PATCH device is connected, received signal will be stored in background.
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“BACK” button of Menu Buttons will back.
14) To finish S-PATCH app, push “BACK” button of Android device.
To prevent unintended finish, below message is shown.
If “BACK” button is pressed again during 1 second, one more confirmation is required.
“YES” will terminate the app. “NO” will not.
In case of using iOS, just push “HOME” button.
4.2 Specifications
4.2.1 S-PATCH3 Specifications
Classification
Name
Description
Performance
Type
CF-Type
Channel
Single channel
Circuitry
Communication with
Mobile device
Bluetooth
DC Offset Tolerance
+/- 300mV
ADC Resolution
12 bits
ADC Sampling Rate
1000 Samples/Second
Input Impedance
>100 MΩ
Power
Requirements
Power Supply
DC 3V , Coin Battery ( CR2032 )
Battery Life
>48 Hr.
Software
F/W version
V1.00
CPU
S1SBP6A (Cortex-M4F microprocessor)
BLE
Dialog DA14583(ARM Cortex-M0)
App(Android)
Kitkat(API19) or later
Physical
Characteristics
Weight (Exc. Battery)
6g
Dimension(Main Body1,2)
38*27*5 (mm), 38*27*3 (mm)[W*D*H]
Dimension(Connect Cable)
110 ± 5 (mm)
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4.3 Error Message and Alarm
4.3.1 Device Disconnection
If the BLE is disconnected on receiving signal, BLE connection indicator is updated.
And notification will appear with alarm or vibration as user’s setting.
(Mute setting woulddoes not make any alarm sound and vibration)
4.3.2 Abnormal signal detect
In case of algorithm detects invalid signal, assume LEAD OFF state and show below.
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And alarm like below. All algorithms are not available.
After valid signal is detected, it’s changed to LEAD ON state and algorithms are restarted.
4.3.3 Low Battery mode
Battery state is updated on top-right of the STATUS bar.
Battery Icon’s meaning is like below.
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In the case of the ratio is lower than 25%, “Battery is too low” Notification will appear.
In the case of the ratio is lower than 10%, “Change Device’s Battery!” Notification will appear.
4.3.4 Low Remaining Storage
If the remaining storage is under 10MB, caution will appear.
Then make some more remaining storage. If not, signal would be lost.
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4.4 Maintenance
For cleaning, gently wipe with a soft dry cloth after using the S-PATCH 3. Please attempt to keep
S-PATCH3 dust free. S-PATCH is waterproof. But it should be kept dry. This device does not have
serviceable components.
Do not disassemble, crush, puncture, short external contacts or circuits, dispose of in fire or water.
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5. Labels and Packaging
5.1 Labels
5.1.1 Label for Packaging
5.1.2 Label for module
Front- side 2 Labels
Rear-side 2 Labels
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- Descriptions on the visual symbols of the label
Label
Symbol
Description
1
The serial number that identifies the object.
2
Date of manufacture
3
Manufacturer
4
Caution / Warning
5
Instruction for User Manual
6
Type of applied part
7
Prescription only
8
WEEE Mark
9
Temperature limitation
5.2 Packaging
5.2.1 Package List
Classifications
Components
Quantity
Main Box
S-PATCH3 module
1
Electrodes
4
Battery
1
Manual
1
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5.2.2 Package Units
1) S-PATCH3 module
Main module.
2) Electrodes
4 Electrodes are in the 1 plastic bag.
3) Battery
1 Coin Cell battery is shipped at package.
4) Manual
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6. Information on EMC
6.1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
- The EUT is intended for use in the electromagnetic environment specified below. The
customer or the user of the EUT should assure that it is used in such an environment.
Immunity test
Compliance
Electromagnetic environment - Guidance
RF Emissions
CISPR 11
Group 1
The EUT 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
The EUT is suitable for use in ail establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations /
Flicker emissions
IEC 61000-3-3
Complies
6.2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
- The EUT is intended for use in the electromagnetic environment specified below. The
customer or the user of the EUT should assure that it is used in such an environment.
Immunity test
IEC 60601
Test level
Compliance level
Electromagnetic environment -
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6kV Contact
±8kV air
±6kV Contact
±8kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power
supply lines
± 1kV for
input/output lines
±2kV for power
supply lines
± 1kV for
input/output lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1kV differential
mode
±2kV common
mode
±1kV differential
mode
±2kV common
mode
Mains power quality should be
that of a typical commercial or
hospital environment.
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Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% Uт
(>95% dip in Uт)
for 0.5cycle
40% Uт
(60% dip in Uт )
for 5 cycle
70% Uт
(30% dip in Uт)
for 25 cycle
<5% Uт
(<95% dip in Uт )
for 5 s
<5% Uт
(>95% dip in Uт)
for 0.5cycle
40% Uт
(60% dip in Uт)
for 5 cycle
70% Uт
(30% dip in Uт)
for 25 cycle
<5% Uт
(<95% dip in Uт)
for 5 s
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the EUT image intensifier
requires continued operation
during power mains interruptions,
it is recommended that the EUT
image intensifier be powered from
an uninterruptible power supply or
a battery.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
NOTE Uт is the A.C. Mains voltage prior to application of the test level.
6.3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
- The EUT is intended for use in the electromagnetic environment specified below. The
customer or the user of the EUT should assure that it is used in such an environment.
Immunity test
IEC 60601
Test level
Compliance
level
Electromagnetic environment - Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to
80MHz
3 V/m
80 MHz to
2.5GHz
3 Vrms
150 kHz to
80MHz
3 V/m
80MHz to
2.5GHz
Portable and mobile RF communications
equipment should be used no closer to any
part of the EUT, including cables, than the
recommended separation distance calculated
from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
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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 deter-mined by an electromagnetic site
survey, a
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 :
NOTE 1) At 80MHz and 800MHz, 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 the EUT is used exceeds the applicable RF compliance level above, the EUT should
be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the EUT.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m.
6.4 Recommended separation distances between portable and mobile RF communications
equipment and the EUT
- There is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the EUT can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the EUT as recommended
below, according to the maximum output power of the communications equipment.
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Rated maximum output
power of transmitter
[W]
Separation distance according to frequency of transmitter [m]
150kHz to 80MHz
80MHz to
800MHz
800MHz to
2.5GHz
V1=3Vrms
E1=3V/m
E1=3V/m
0.01
0.116
0.1166
0.2333
0.1
0.368
0.3687
0.7378
1
1.166
1.1660
2.3333
10
3.687
3.6872
7.3785
100
11.660
11.6600
23.333
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 80MHz and 800MHz, 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.
6.5 Immunity and Compliance Level
Immunity test
IEC 60601 Test Level
Actual Immunity Level
Compliance Level
Conducted RF
IEC 61000-4-6
3Vrms
150kHz to 80MHz
3Vrms
3Vrms
Radiated RF
IEC 61000-4-3
3Vrms
80MHz to 2.5GHz
3V/m
3V/m
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6.6 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
- The EUT is intended for use in the electromagnetic environment specified below. The
customer or the user of the EUT should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment - Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to
80MHz
3 V/m
80 MHz to
2.5GHz
3 Vrms
150 kHz to
80MHz
3 V/m
80MHz to
2.5GHz
The EUT must be used only in a shielded
location with a minimum RF shielding
effectiveness and, for each cable that enters
the shielded location with a minimum RF
shielding effectiveness and, for each cable
that enters the shielded location
Field strengths outside the shielded location
from fixed RF transmitters, as determined
by an
electromagnetic site survey, should be less
than 3V/m.a
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
NOTE 2) It is essential that the actual shielding effectiveness and filter attenuation of the shielded
location be verified to assure that they meet the minimum specification.
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
outside the shielded location in which the EUT is used exceeds 3V/m, the EUT should be observed to
verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as relocating the
EUT or using a shielded location with a higher RF shielding effectiveness and filter attenuation.
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7. FCC Compliance Statement
This device complies with part 15 of the FCC rules. Operation is subject to the following two
conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may
cause undesired operation.
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 on and off, the user is encouraged to try to correct the interference by one or
more of the following measures:
● Reorient or relocate the receiving antennae
● Increase the separation between the equipment and the 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.
FCC RF Exposure Statement
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment. End users must follow the specific operating instructions for satisfying RF
exposure compliance. The antenna used for this transmitter must not transmit simultaneously
with any other antenna or transmitter, except in accordance with FCC multi-transmitter product
procedures.
FCC Caution
Any changes or modifications to the equipment not expressly approved by the party responsible
for compliance could void user’s authority to operate the equipment.
8. Product Life time and Warranty
8.1 Product Life time
- S-PATCH3 is guaranteed to last for a minimum of two years.
8.2 Product Warranty
- The warranty covers a year.
However, the conditions excluded by the warranty are as follows.
Natural aging of the product from daily usage
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Product damage due to improper storage
Product damage due to improper usage
9. Company Introduction
9.1 Company Name and Address
Company name: Samsung Electronics Co., Ltd.
Address: 1-1, Samsungjeonja-ro, Hwaseong-si, Gyeonggi-do, 18448 Korea
Tel : +(82) 31-8037-3533
e-mail: s.patch@samsung.com