Wellysis S-Patch Ex Wearable Health Monitoring System User Manual
- June 6, 2024
- Wellysis
Table of Contents
S-Patch Ex Wearable Health Monitoring System
USER MANUAL
Wearable Health Monitoring System
(MODEL: S-Patch Ex)
Document No: WS-UM-01 (Rev. 0.1) Wellysis Corp.
1111ho, 311, Gangnam-daero, Seocho-gu, Seoul, Republic of Korea
[1]
1 Product Introduction 1.1Introducing S-Patch Ex The S-Patch Ex is a light-
weight electrocardiogram (ECG) and heart rate (HR) monitoring device with
accompanying software. The S-Patch Ex operates wirelessly, and due to its
compact size it is unobtrusive during daily activity. The S-Patch Ex
continuously measures ECG and HR signals, and streams the digitized signals to
a mobile gateway device equipped with S-Patch Ex App. At the end of each ECG
recording session, patients can upload their data to a secure cloud portal via
their mobile device connection. After the data upload takes place, physicians
can access and review their patients’ ECG data remotely via the SPatch Ex Web.
The S-Patch Ex is intended to be used with direction from trained medical
professionals in accordance with the user manual. · Product Name: Wearable
health Monitoring System
· Model Name: S-Patch Ex
· Manufacturer: Wellysis Corp.
1.2Indication for Use
Intended Use
The S-Patch Ex is a wearable health monitoring system for measuring and analyzing patient electrocardiogram (ECG) waveforms and heart rate (HR). The product consists of bio-signal sensing device, mobile application and web portal of electrocardiogram analysis for physician. The S-Patch Ex is intended for use in the diagnosis of patients with suspected cardiac symptoms such as but not limited to: Abnormalities of heartbeat, abnormalities of breathing, lightheadedness, dizziness, chest pain, sweating, pre-syncope, syncope, fatigue, or anxiety. The device has not been tested specifically for pediatric use.
1.3Marks and Symbols
Labe l
Symbol
1
Description 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
[2]
8
WEEE Mark
9
Keep Dry
10
Temperature limit
11
Humidity limitation
12
Authorized European Representative address
The CE symbol indicates that this product complies
13
with the European Directive for Medical Devices 93/42/EEC as amended by 2007/47/EC as a class IIa
device.
14
Non-ionizing radiation
15
MR unsafe
1.4Target treatment group and diseases
No Contents
Description
1 Indications
Detection of cardiac arrhythmia and diagnostic evaluation of patients who may be asymptomatic or who may suffer from transient symptoms such as, but not limited to abnormalities of heartbeat, abnormalities of breathing, lightheadedness, dizziness, chest pain, sweating, pre-syncope, syncope, fatigue, or anxiety.
2
Age
Adults and adolescents at physician’s discretion
3
Weight
Not limited
1. Not recommended for use on patients with artificial cardiac
pacemaker, cardioverter defibrillator, or other implantable electric
devices.
4
Health
2. Not recommended for use with pregnant women or breastfeeding mothers
3. To be used at physician’s discretion on patients with current symptoms or
medical history of skin cancer, rash, skin disorder,
keloid, and/or any skin injury.
5 Nationality
Not limited
6 Condition
Not limited
[3]
2 Cautions 2.1 General 1) Store in climate controlled environments (parameters
specified in section 1.4) 2) Since this product is a medical device,
instructions are required to properly dispose of it. Contact the distributor
or manufacturer for such instructions 3) Contact the manufacturer if there are
any problems with product functionality. 4) Reuse of the electrodes is
prohibited in any circumstances due to the risk of infection. 5) Prolonged use
of electrodes may cause skin irritation. Discontinue use and consult your
physician if skin irritation occurs. 6) DO NOT expose the device to strong
electromagnetic fields. 7) No warranty is provided for any erroneous data
collected by the device due to misuse or malfunction as a result of abuse,
accidents, alteration, neglect, or failure to maintain the products as
instructed. 8) Contact the manufacturer if there is a change in the
performance of the device. 9) DO NOT place the device on top of excessive body
hair. Body hair should be removed prior to placement of the device. 10) This
device can be operated in at least one Member State without infringing
applicable requirements on the use of radio spectrum.
2.2 Safety 1) A healthcare professional should explain the proper use of the
device to a patient 2) Use this device under doctor’s prescription. 3) Make
sure the coin battery is inserted in the correct orientation 4) DO NOT use
during magnetic resonance imaging (MRI) or external defibrillation procedures.
5) DO NOT drop or bump with excessive force. 6) Keep components out of reach
of children. 7) 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
women or breast-feeding mothers. 3) Patients with current symptoms or medical
history of skin cancer, rash, skin disorder, keloid, and/or any injury.
2.4 Usage and Storage Conditions
2.4.1Conditions for Usage 1) Temperature: 5- 40 (41 to 104) 2) Relative
humidity: 10%-95%(non-condensing) 3) Atmospheric pressure: 700hPa-1060hPa
[4]
2.4.2Conditions for Storage 1) Temperature: -25- 70 (-13°F to 158°F) 2)
Relative humidity: 10%-95% (non-condensing) 3) Atmospheric pressure: 700hPa-
1060hPa 4) Keep the device in the case when it doesn’t use.
2.4.3Conditions for Cleaning 1) Disinfect by wiping with standard hospital
disinfectant 2) DO NOT immerse device in liquid
2.4.4Conditions for Usage and Storage of Electrode 1) Temperature: -10- 40
(14°F to 104°F)
2.5 Use of Device 1) The electrodes and coin battery are disposable. Please
observe local laws for disposal of electrodes and coin battery. 2) Remove the
battery if the device is not likely to be used for an extended period of time.
3) Please ensure hands are clean and dry when handling the S-Patch Ex 4)
Excessive body hair may cause noise in the recording. 5) Clean and disinfect
the device by wiping with standard hospital disinfectant. Do not immerse the
device in liquid. 6) This product must not be disposed of with household
waste. Please recycle with other electrical equipment.
2.6 Use of Electrodes 2.6.1 Storage 1) Store electrodes according to
manufacturer recommendations
2.6.2 Patient Preparation 1) Get the electrode ready for treatment. Wash the
target area of the body and dry out the region. If necessary, shave the area
for a better adhesion of the electrode to the skin.
2.6.3 Electrode Placement Precautions 1) Do not use the electrode in fracture
region, neck, face or region around the heart. 2) Do not use this electrode to
the patient who has a pacemaker and/or any kinds of transplantations inside
his or her body. 3) Do not use this electrode while taking a shower, bathing
or swimming. 4) Dried out electrodes should not be used 5) Electrodes should
not be reused
2.7 Warning
[5]
2.7.1 MR-unsafe! Do not expose the device to a magnetic resonance (MR) environment.
- The device may present a risk of projectile injury due to the presence of ferromagnetic materials that can be attracted by the MR magnet core.
- Thermal injury and burns may occur due to the metal components of the device that can heat during MR scanning.
- The device may generate artifacts in the MR image
2.7.2 FCC 1) 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 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: – Reorient or relocate the receiving antenna. – Increase the separation between the equipment and receiver. – Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. – Consult the dealer or an experienced radio/TV technician for help. - This device comply with part15 of FCC rules. Operation is subject to the following two conditions: – This device may not cause harmful interference. – This device & its accessories must accept any interference received, including interference that may cause undesired operation.
- This equipment may generate or use radio frequency energy. Changes or
modifications to this equipment may cause harmful interference unless the
modifications are expressly approved in the instruction manual. This user
could lose the authority to operate this equipment if an unauthorized change
or modifications is made.
3 Components and Installation of S-Patch Ex
3.1 Main Device Components
[6]
Label
Name
< Rear of S-Patch Ex > Description1
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
3.2 Accessory Components
[7]
Labe l
1
Name Electrode(single use)
Description
Model name: HR-OP42 Dimension: 43Ø Multi-purpose monitoring electrodes with
sticky gel feature (high performance adhesive and foam backing)
Material: PE foam, Ag/AgCl sensor, Nickel plated brass, Solid hydro gel
2
Battery
3
S-Patch Ex Web
Power supply for S-Patch Ex. DC 3V Coin Battery. Battery is replaceable.
The S-Patch Ex Web is a cloud-based server which stores the encrypted ECG data
3.3 Material
No.
Title
1 Exterior of Signal Detection Module
2
Connection cable
Material PVC PVC
Grade V-0 V-0
[8]
3.4 How to Install S-Patch Ex 3.4.1 Installing S-Patch Ex
- Download the S-Patch Ex App (Android 8 and above /iOS 12 and above) from SPatch Ex mobile app download link (https://play.google.com/store/apps/details?id=com.wellysis.spatchcardio.app& hl=en_US&gl=US or https://apps.apple.com/kr/app/s-patchcardio/id1496099268?l=en). The device must support Bluetooth Low Energy.
- Install the downloaded file on user’s mobile device. 3) Insert battery to
main body 1 of S-Patch Ex (Check the polarity of the battery and
insert it correctly).
First, Open the Battery cover on main body 1. Second, Insert the battery. Lastly, close the battery cover and turn it clockwise. Caution ; Do not expose the battery to extreme environmental conditions (Extremely high temperature, high pressure, high humidity and etc.)
[9]
4 Using and Operating S-Patch Ex 4.1 Turning S-Patch Ex on and Positioning it on Body 1) Push and hold the power button for 3 second.
- Confirm that the LED blinks ON 1 time and OFF for 5 seconds.
On
Off
- Make sure Bluetooth is enabled on the mobile device. 4) After connecting
the electrodes with S-Patch Ex, peel off the plastic covers from
the backside of the electrodes. 5) Attach the S-Patch Ex according to the recommended position as shown below.
[10]
4.2 S-Patch Ex ECG Test with Smart Phone 1) Connecting S-Patch Ex Device to
the App. 1-1) Start S-Patch Ex App from the mobile device. 1-2) Enter the
Organization Code as shown below to connect S-Patch Ex to the mobile device.
a. Select Region and entering Organization Code and Device S/N
[11]
b. Connecting S-Patch Ex Device Note: Contact the system administrator if the
Organization Code is unknown Note: S-Patch device number is printed on the
back of the device
1-3) Verify that User’s ECG graph, HR and HRV can be viewed on the screen.
[12]
-
Logging Symptoms 2-1) Click on ADD SYMPTOM button to log symptoms into Patient Diary.
2-2) Entering Patient Diary
(1) Click on Add new diary button to create a new Patient Diary. (2) Enter start and end date of the diary event. (3) Enter start date/time of the diary event. (4) Enter end date/time of the diary event. (5) Click on “Add symptom” button to choose a symptom from the list. (6) Click on “Select activity” button to specify what activity was being performed
when the symptom occurred. (7) Click Confirm button to save the new Patient Diary.
[13] -
Pausing and Resuming Test 3-1) Click on the “Pause Test” button in my status page to temporarily pause the test. 3-2) Click “Restart Test” to resume.
-
Completing Test Click on the “End Test” button in my status page to complete the test.
[14] -
Sending Data
For analysis of the test the ECG data needs to be sent to S-Patch Ex Web. 5-1) Click Send Data button.
4.3 Specifications
4.3.1S-Patch Ex Specifications
Classification Performance
Circuitry
Power Requirements
Hardware/ Software
Name Type Channel Communication with Mobile device DC Offset Tolerance ADC
Resolution ADC Sampling Rate
Input Impedance
Power Supply
Battery Life
F/W version CPU BLE
Description CF-Type
Single channel
Bluetooth
+/- 300mV 12 bits
256 Samples/Second >100 M
DC 3V, Coin Battery (CR2032)
100 Hr. (replaceable)
V1.5.0 S1SBP6A (Cortex-M4F microprocessor)
Nordic nRF52833(ARM Cortex-M4)
[15]
IMU Memory App(Android/iOS) Language
ICM-42605 W25M02GVZEIG ( 256MB ) 8 and above / 12 and above
English, Korean iPhone – 6, 6Plus, 6s, 6sPlus, 7, 7Plus, 8, 8Plus, XR, SE,
SE2, 11, 11Pro, 12, 12Pro
Physical Characteristics
Technical Characteristics
RF
Optimized mobile devices
Weight(Exc. Battery)
Dimension(Main Body1,2)
Dimension(Connect Cable)
Heart Rate Range
Heart Rate Accuracy
Linearity and Dynamic Range Input impedance Gain accuracy
Gain stability RF Information Max RF output
Power
Samsung Galaxy A7, A9, A9Pro, A30, A50, A21, A31, A51, A90-5G, Note9,
Note10, Note10Plus, Note20, Note20Ultra, S9, S9Plus, S10, S10Plus, S20,
S20Plus, S20Ultra
9g
306(mm), 306(mm) [Diameter* Height] 110 ± 5 (mm)
30 ~ 240bpm 30 ~ 120 ± 2bpm 120 ~ 240 ± 3bpm
± 10%
10M ± 10% ± 3% 2402 ~ 2480 HMz
– 4.57 dBm
4.4 Error Message
Error Message
Situation
The server
encountered
an error.
Please try again later. * Contact
When an error has occurred at server and the mobile request cannot be executed
email :
spatch.cardio@
wellysis.com
When no data has been recorded because
No data to
there is an error with time of gateway
send
device and the test ends as soon as it has
been started
Failed to
connect to
When mobile device cannot access server
service. Please
due to network error
check your
Solution
Contact service desk and enquire.
Reinstall App Re-try after moving to area with LTE or Wifi
connection
[16]
network status
[17]
4.5 Maintenance For cleaning, gently wipe the S-Patch Ex with medical grade
disinfectant. DO NOT immerse the SPatch Ex in liquid. The S-Patch Ex is water
resistant, but should be kept dry. This device does not have user serviceable
components. Do not disassemble, crush, puncture, short external contacts or
circuits, dispose of in fire or water.
4.6 Specification of External Device Connection The S-Patch Ex connects to an
application running on a mobile device
A. S-Patch to Application Interface 1) Main Device / Mobile App interface
Data format: Bluetooth Mobile Application: Android/iOS Application Device
status information Device information (Bringing information when connecting to
BLE) Battery information (Receiving information periodically) Data to Device
Data Channel Transmits data to the device
B. Solution Network Security 1) The Mobile Application has been tested to be
secure against all currently known threats 2) Specification of Network
Connection Communication protocol: the protocol between the main unit and the
mobile app is a BLE central (Mobile) peripheral (main unit) communications
and the communication with security requirements defined in the BLE Protocol
Stack.
C. User Responsibility for Security Connection of the S-Patch Solution to an
unsecure IT-Network could result in previously unidentified risks to patients,
operators or third parties; The responsible organization should identify,
analyze, evaluate and control these risks; Changes to the IT-Network
include: · Changes in the IT-Network configuration; · Connection of additional
items to the IT-Network; · Disconnecting items from the IT-Network; · Update
of equipment connected to the IT-Network; and · Upgrade of equipment connected
to the IT-Network.
4.7 Daily Use The S-Patch Ex is meant to be worn during normal daily
activities, as well as at night while sleeping. However, the S-Patch Ex needs
to be removed before the following activities: -Showering, bathing, or
swimming -Traveling on aircraft -Undergoing an MRI
- To finish S-Patch app, push “BACK” button of Android or iOS device. 2) If
“BACK” button is pressed again during 1 second, one more confirmation
is required. 3) Tap “YES” to terminate the app. 4) Remove the S-Patch Ex and push the power button longer than 20 seconds
to turn off the device. 5) When you are ready to put the monitor back on, attach the S-Patch Ex on
recommended position. On the mobile phone application, resume monitoring
[18]
5 Labels and Packaging 5.1 Labels 5.1.1Main Label (location: under the back of the box) (Size: 100 x 55 mm)
5.1.2Label for module (Size: 26mm)
5.2 Packaging
5.2.1Package List Classifications
Components S-Patch Ex module
Main Box
Electrodes
Quick Manual
Quantity 1 4
(4 Electrodes are in the 1 plastic bag) 1
[19]
5.2.2Package Units 1) S-Patch Ex module Main module. 2) Electrodes 4
Electrodes are in the 1 plastic bag. 3) Manual Korean or English
** If users request, the wellysis can provide the user manual in the requested
language
5. Information on EMC
5.1Guidance 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
RF Emissions CISPR 11
Class B
The S-Patch Ex 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 The S-Patch Ex is suitable for use in ail establishments, including domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes
5.2Guidance 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
±8kV Contact ±2,4,8,15 kV air
±8kV Contact ±2,4,8,15 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
[20]
5.3Guidance 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
Portable and mobile RF communications equipment should be used no closer to any part of the S-Patch Ex, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Conducted RF IEC 61000-4-6
3 V 0,15 MHz 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz
3 V 0,15 MHz 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz
Recommended separation distance
Radiated RF IEC 61000-4-3
10 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz
10 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz
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
[21]
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.
5.4Recommended 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.
Rated maximum output power of
transmitter [W] 0.01 0.1 1 10 100
Separation distance according to frequency of transmitter [m]
150kHz to 80MHz
80MHz to 800MHz
800MHz to 2.5GHz
V1=3Vrms 0.116 0.368 1.166 3.687 11.660
E1=3V/m 0.1166 0.3687 1.1660 3.6872 11.6600
E1=3V/m 0.2333 0.7378 2.3333 7.3785 23.333
[22]
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.
5.5Immunity and Compliance Level
Immunity test
IEC 60601 Test Level
Radiated RF IEC 61000-4-3
10V/m 80MHz – 2.7GHz 80 % AM at 1 kHz
Actual Immunity Level 10V/m
Compliance Level 10V/m
[23]
5.6Guidance 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 V 0,15 MHz 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz
3 V 0,15 MHz 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz
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
10 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz
10 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz
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.
[24]
6. Expected Service Life time and Warranty
6.1 Product Warranty – The product is guaranteed to be free of manufacturing
defects and has a limited
warranty for 1 year from the date of purchase.
Damage or malfunction of the device to the following conditions are excluded
from the warranty: Normal wear and tear of the product from normal daily usage
Product damage due to improper storage Product damage due to improper usage
7. Manufacturer Information
Wellysis Corp.
1111ho, 311, Gangnam-daero, Seocho-gu,
Seoul, Republic of Korea (Zip code: 06628)
Tel: +8218002830
Fax: +8225201590
Emergo Europe B.V. Address: Prinsessegracht 20, The Hague 2514 AP, Netherlands
[25]
References
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