SaluberMD CorX SMD1800 User manual

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User Manual
CorX Smartwatch
(Model: SMD1800)
FCC ID:2AT4JSMD1800
File No:CE-01-08.4
Version: 3.0
Issue Date: Apr, 2019
Revised on 19, Jul, 2019

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1CONTENTS
1 CONTENTS........................................................................................................................................................................ 2
2 INFORMATION ABOUT THIS MANUAL............................................................................................................................. 4
3 TECHNICAL FEATURES...................................................................................................................................................... 5
4 DESCRIPTION ................................................................................................................................................................... 7
5 FIRST USE ....................................................................................................................................................................... 11
6 SANITATION OF THE DEVICE.......................................................................................................................................... 12
7 LIST OF ACCESSORIES..................................................................................................................................................... 13
8 WORKING ENVIRONMENT AND STORAGE .................................................................................................................... 14
9 ORDINARY AND EXTRAORDINARY PREVENTIVE MAINTENANCE................................................................................... 18
10 ENABLE STAFF FOR THE USE OF THE DEVICE............................................................................................................... 21
11 PRECAUTIONS .............................................................................................................................................................. 22
12 CONTRAINDICATIONS .................................................................................................................................................. 23
13 ASSOCIATION WITH OTHER EQUIPMENT .................................................................................................................... 24
14 HOW TO USE................................................................................................................................................................ 25
15 TROUBLE SHOOTING.................................................................................................................................................... 40
16 ADDITIONAL INFORMATIONS ...................................................................................................................................... 42
17 RESPONSIBILITY ........................................................................................................................................................... 43
18 LABELING ..................................................................................................................................................................... 44
19 DECLARATION OF CONFORMITY.................................................................................................................................. 17
3.1 General technical features ............................................................................................................................. 5
3.2 Environmental characteristics ........................................................................................................................ 5
3.3 Technical features of the CorX........................................................................................................................ 5
4.1 Basic Structure............................................................................................................................................... 9
4.2 Watch Functions Diagram ............................................................................................................................ 10
4.3 Intended Use ............................................................................................................................................... 10
5.1 Charging the battery .................................................................................................................................... 11
8.1 Tables guide of ELECTROMAGNETIC COMPATIBILITY .................................................................................... 14
8.2 SDoC of FCC (Federal Communications Commission) .................................................................................... 17
14.1 CorX SaluberMD app registration ............................................................................................................... 25
14.2 Connecting the CorX with the SaluberMD app ............................................................................................ 26
14.3 Setting up the CorX .................................................................................................................................... 27
14.4 Taking your medical test ............................................................................................................................ 28
14.5 How to get “Wellness data” ....................................................................................................................... 30
14.6 Smartwatch functions ................................................................................................................................ 31
14.7 Using the SaluberMD app........................................................................................................................... 33

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20 SHEET MACHINE .......................................................................................................................................................... 45
21 DISCLAIMERS ............................................................................................................................................................... 46
22 TRADEMARK AND COPYRIGHT INFORMATION............................................................................................................ 47

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2INFORMATION ABOUT THIS MANUAL
This documentation supporting the use of the device, is not intended for sales; its partial or total
reproduction is forbidden without the express permission.
The information contained in this document is subject to change without notice for reasons of a technical
trade.
It ensures, however, that this manual corresponds to your device delivered. The offsets will be included in
new editions.
This manual provides information for the installation and proper use of the device and is recommended its
accurate reading.
Failure, even partial, of the recommendations contained in it may lead to malfunction and damage to the
device and void the warranty.
Writing conventions:
NOTES
NOTES HIGHLIGHT SOME IMPORTANT INFORMATION CONTAINED IN THE TEXT.
CAUTIONS
CAUTIONS MESSAGES APPEAR BEFORE SOME OPERATIONS AND IF THEY ARE NOT OBSERVED, MAY CAUSE
DAMAGE THE DEVICE AND /OR ITS ACCESSORIES.
WARNINGS
WARNING MESSAGES INDICATES OPERATION OR SITUATIONS THAT MAY CAUSE RISK SITUATION FOR THE
OPERATOR OR THE PATIENT IF THEY ARE UNKNOWN OR NOT DONE PROPERLY.

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3TECHNICAL FEATURES
The CorX Smartwatch(Model: SMD1800, Hearinafter shortened as CorX) are conform to the general rules on electrical
safety of Electrical Appliances for medical use EN 60601-1, and also to detailed and collateral use applicable.
The manufacturer reserves the right to make product changes without notice according to the evolution of technology
and standards.
3.1 General technical features
Power source (battery charger):
5V DC output
Battery type
Rechargeable lithium-polymer battery 180 mAh
Safety class:
II / BF
IP protection degree
IP 67
Condition of use
Spot checking
Device not suitable for use in the presence of a mixture of flammable anesthetic with oxygen or nitrous oxide.
Expected Service Life: The expected service life is 2 years.
The mating cycle of USB cable is 1000 cycles.
3.2 Environmental characteristics
Operating temperature
+5 °C to +40 °C.
Storage temperature
-10 °C to +60 °C.
Operating and Storage Atmospheric Pressure
70 to 106 kPa
Relative humidity (non-condensing)
15% ~ 95%, without condensation
3.3 Technical features of the CorX
Technical specifications of the CorX
Physical
Weight
58 g
Dimensions
Dia 43 x 13.68 mm
Display
1.2” color active matrix TFT
Bluetooth
BLE 4.2
Sending duration
Real time
ECG
Lead type
Integrated ECG electrodes
Measurement mode
Episode
Sampling rate
250Hz
Sampling accuracy
24 bit
Display gain
10 mm/mV, 5 mm/mV
Sweep speed
25 mm/s
Bandwidth
0.5 to 40 Hz
HR measurement range
30 to 250 bpm
Accuracy
+/-2 bpm

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SpO2
SpO2 range
70% to 100%
SpO2 accuracy (Arms)
80-100%: +/-2%, 70-79%: +/-3%
PR range
30 to 250 bpm
PR accuracy
+/-2 bpm
Wavelength / Power
660nm & 880nm / 6.5 mV & 9.5 mV
Technical specifications of the battery charger cable:
Weight
17g
Dimensions (charging head)
18.45x9x6.6 mm
Cable length
1 m

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4DESCRIPTION
CorX – The CorX is a class IIa medical device that satisfies the electrical safety requirements required by
international standards.
The CorX is designed to perform exams with one derivation ECG, with a particularly fast procedure, which
uses a graphical interface controllable tablet or smartphone.
This procedure records and collects all the information from while performs the data entry with personal
data of the patient.
The CorX is a lightweight, portable health monitor for use in the home by lay-users. Instead of a customary
box type unit, the CorX has been design as a wearable device in the form of a watch that can be used as a
normal smartwatch (including social media notification, email notification, message notification) for
measuring, displaying, reviewing and storing of multiple physiological parameters including ECG, heart rate,
pulse oxygen saturation (SpO2), pulse rate, and monitor the physical activity by a pedometer and motion
sensor. The proposed device, CorX, used is for spot checking of ECG, HR, SpO2, and PR in adult patients.
This device is not intended to substitute for a hospital diagnostic ECG device or hospital pulse oxygen
saturation.
The device is intended to be used in a home setting that is worn on the wrist as a watch that connects to an
“app” on a smartdevice that can provide further functionality. The CorX is a watch that can display multiple
physiological parameters including:
•ECG recording including QRS detection, VEB detection, and heart rate
•Functional pulse oxygen saturation (SpO2) by percent of saturation including pulse rate
Sensors and electrodes are contained in the housing of the watch that converts the information to
electronic signals that are processed by the software to display different parameters. Measurement and
recording of these parameters are stored in the watch that can be synced with the “app” on a smartdevice
such as the user’s phone. Information can then be reviewed as recorded by the watch and may also be
transmitted through a “portal” for accessing information over the internet. This information can be viewed
by a healthcare professional to see current or historical health information for a patient allowing more
interaction to occur with the healthcare professional and patient.
Functionality of the device is integrated firmware and PCB contained in a housing that is slightly larger than
a conventional watch with an adjustable band. The Saluber CorX is made from flexible plastic material that
are common in other household and wearable products to provide comfort and flexibility to the user, e.g.
similar to a Fitbit™ or Garmin® wearable device. A rechargeable lithium battery is contained in the device
that can be charged through a standard USB 2.0/3.0 port. The smartwatch must not be charged while
being worn; when the smartwatch is charging it goes into a particular state that is not available for use.
The charge for continuous use is over many hours compared to intermittent use can be maintained for
many days as the power consumption depends on use of physiological parameter monitoring.
The device does not contain alarms and is not to be used in emergency situations. Notifications and user
programmable settings can be made which are indicated for personal health information. The device is not
intended to be life-supporting or life-sustaining. The device is reusable by the patient and is non-sterile.

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WARNINGS
The diagnosis of lower myocardial infarction without the use of precordial leads could cause false positives.
•The use of this device / system is not substitute for over methods of diagnosis.
•Do not change any medication or treatment without consulting your doctor. This device cannot
detect a heart attack. If you are not feeling well, need consulting your doctor.
•The Telemedicine diagnosis may not be appropriate for certain diseases.
•The system is considered to be aimed at supporting actions "low level" as the cardiological
screening, secure disposal, home monitoring.
•Do not use the device in a magnetic resonance (MR) environment.
•This device is not defibrillation proof.
•Do not allow the electrodes of the device to come into contact with other conductive parts
(including earth).
•Do not store or use the device in the following locations: locations in which the device is exposed to
direct sunlight, high temperatures or levels of moisture, or heavy contamination, heavy dust;
locations near to sources of water or fire; or locations that are subject to strong electromagnetic
influences.

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4.1 Basic Structure
CorX Smartwatch(Model: SMD 1800) is mainly comprised of LCD Display, Watch, Watch Strap,
Rechargeable Lthium Battery and CorX SaluberMD app.
Note:
-Swipe left / right to navigate different page features.
-Short tap / long tap on touch screen to select / confirm.
Wrist HR sensor
EKG back electrodes
SpO2 / HR
sensor
Crown
Watch Strap
Front view
Rear view
Side electrode
(housing case)
Crown / Home
button.
Press to return to
Home screen.
SpO2 / HR sensor
Charger
Port
LCD Display
Watch Strap
Stainless Steel
Case

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4.2 Watch Functions Diagram
4.3 Intended Use
The CorX is intended to be used for measuring, displaying, reviewing, and storing of ECG and oxygen
saturation and pulse rate in a home or personal setting. The device is intended for adult use only. The
physiological data is wirelessly transmitted to a remote server that can be reviewed by a healthcare
practitioner.

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5FIRST USE
Check for signs of damage on the packaging, if they were not, remove the device from the case holding it
firmly to void the risk of an accidental impact.
WARNINGS
If there are obvious signs of damage on the packaging NOT USE THE DEVICE and contact Customer Service
of Saluber MD.
Do not dispose of the anti-collision packaging, as it could be reused during a possible transport and / or in
case of inactivity of the device.
Please refer to the "How to Use" before turning on the device and:
•Check the parts and accessories, as listed in Section 7;
•Ensure that the power supply network respects the standards shown in this manual;
•Make sure that the electrical system is made in compliance with applicable standards;
•Place the appliance stably and safely;
•Do not use the device in potentially explosive environments (ex. the presence of anesthetic gases)
or in environments with high humidity (see table Technical Features);
•Use the device at a safe distance (at least 3 meters) to shortwave or microwave devices, in order to
avoid interaction.
WARNINGS
Please remember to read carefully this manual and the contraindications contained in paragraph 12.
CAUTIONS
Before using the device for the first time, you must charge the battery. Refer to steps RECHARGE THE
BATTERIES.
5.1 Charging the battery
1. Plug the small end of the USB cable into the charging port of your device.
2. Plug the large end of the USB cable into a USB charging port.
3. Charge the device completely.
WARNINGS
Do not place the small end of the USB cable on any metal surfaces when its large end is plugging into a USB
charging port. Otherwise this may damage your charger or device.

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6SANITATION OF THE DEVICE
The device must be sanitized / disinfected periodically (see table maintenance).
•Unplug the charger;
•Do not use compressed air or nebulized products; a possible infiltration of any fluid may
compromise the device;
•Don’t try to open the device and remove the material penetrated in case of accidental infiltration
of liquids or extraneous materials inside the casing, but please contact the technical service and not
use the device;
•Cleaning should be carried out using a not abrasive cloth with not corrosive sanitizers, rubbing
without excessive force.
CAUTIONS
Sanitize / disinfect the device with non-alcoholic products.

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7LIST OF ACCESSORIES
Battery charging cable
P/N
DESCRIPTION
J5301-0025-01-AA
CorX Charging Cable
WARNINGS
The use of not original accessories may be a source of serious risks for PATIENT OR OPERATOR.
CAUTIONS
The use of not original accessories may damage the DEVICE.
Keep away from metal contact when the USB is plugging on any devices to prevent short circuit
NOTE
The use of not original accessories will void any form of WARRANTY Product.

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8WORKING ENVIRONMENT AND STORAGE
The device cannot be used in environments that aren’t conform to the specifications given in paragraph
ENVIRONMENTAL CHARACTERISTICS (3.2)
In accordance with CEI EN 60601-1-11 sections 1.1 and 3.2 can be used:
•PROFESSIONAL HEALTHCARE STRUCTURES (hospitals, medical offices, surgical
centers, dental clinics, birth centers, health care facilities, health care facilities
for multiple treatment and emergency, medical services);
•HOME HEALTH ASSISTANCE (home / place in which a patient lives or other
places where there are patients).
WARNINGS
PREVIOUS POINT LIMITATION: THE DEVICE CANNOT BE USED IN MOTION (EN 60601-1-11 Point 3.6)
8.1 Tables guide of ELECTROMAGNETIC COMPATIBILITY
In accordance with CEI EN 60601-1-2, section 6.8.3.201 (letter "a" and "b") provides information on various aspects of
electromagnetic compatibility and in particular the methods of carrying out the type tests carried out and the characteristics
required for the environment in wichthe device can be used.
Electromagnetic Emissions
The device is intended for use in the electromagnetic environment specified below.
WARNINGS
The user must ensure that it is used in that specific environment.
Failure to observe may generate risk situations.
Emissions Test
Conformity
Electromagnetic Environment - Guidance
CEI EN 55011
Emissions RF
compliant
(group 1)
The device 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.
CEI EN 55011
Emissions RF
compliant
(class B)
The device is suitable for use in all rooms including domestic
establishments and those directly connected to a power grid at
low voltage which supplies buildings used for domestic
purposes.
CEI EN 61000-3-2
Harmonic Emissions
compliant
(class A)
CEI EN 61000-3-3
Emissions ofvoltage
fluctuations/flicker
compliant
This first table (rif.201 of the standard cited above) realizes the aspects related to the emissions of the device, and all the possible
noise or interference generated by the device that could disturb other electronic equipment more or less close.

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Electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below.
WARNINGS
The user must ensure that it is used in that specific environment.
Failure to observe may generate risk situations.
Immunity Test
Test Level
IEC 60601
Conformity Electromagnetic Environment - Guidance
CEI EN 61000-4-2
Electrostatic discharge
(ESD)
+6 kV in contact compliant Floors should be made of wood, concrete or
ceramic. If the floors are covered with
synthetic material, the relative humidity
should be at least 30%.
+8 kV in air compliant
CEI EN 61000-4-4
Electric fast
transient/Burst
+2 kV for the power
line compliant
The quality of the network voltage should be
that of a typical commercial or hospital
environment.
CEI EN 61000-4-5
Extra Voltages
+1 kV in differential
mode compliant The quality of the network voltage should be
that of a typical commercial or hospital
environment.
(applies to the step of charging the batteries)
+2 kV in common
mode compliant
CEI EN 61000-4-11
Voltage dips, short
interruptions and voltage
variations on power
supply input lines.
0% Ut (dip
100%)
for 0,5 cycles;
N.A.
Device powered only by battery
40% Ut (dip
60%)
for 5 cycles
N.A.
70% Ut (dip
30%)
for 25 cycles
N.A.
0% Ut (dip
100%)
for 5 seconds
N.A.
CEI EN 61000-4-8
Magnetic field with
network frequency
(50 Hz)
3 A/m compliant
The magnetic fields should have levels
characteristic of a typical location in a typical
commercial or hospital
Note: Ut is the network voltage before the application of the test level.
The second table (rif.202 of the standard cited above) concerns the various tests of immunity to interference, highlighting the type
and levels of the test, in addition to reporting important observations and recommendations for the user. The immunity is the
ability of a device to not be disturbed by electromagnetic disturbances in the environment of use, whether they are transmitted by
cable (ducts) than in air (radiated).

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Electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below.
WARNINGS
The user must ensure that it is used in that specific environment.
Failure to observe may generate risk situations.
Immunity Test
Test Level
IEC 60601
Conformity Electromagnetic Environment - Guidance
CEI EN 61000-4-6
RF conduct
3 Veff
from 150 KHz to 80
MHz
compliant
(3 V)
(applies to the
step of charging
the batteries)
Communications equipment to portable and mobile RF should
not be used closer to any part of the device, including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
Pd 2,1=
Pd 2,1=
(from 80 MHz to 800 MHz)
Pd 3,2=
(from 800 MHz to 2,5 GHz)
where P is the maximum rated output of the transmitter in
watts (W) according to the transmitter manufacturer anddis the
recommended separation distance in meters (m).Field strengths
from fixed RF transmitters, as determined by an electromagnetic
survey of the site, may be less than the compliance level in each
frequency range b.Interference may occur near of equipment
marked with the following symbol:
CEI EN 61000-4-3
RF radiated
3 V/m
From 80 MHz to
2,5 GHz
compliant
(3 V/m)
Note:
(1) At 80 MHz and 800 MHzapplies the higer range frequency.
(2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a) The intensity field from fixed trasmitterssuch as base stations for telephones radio (cellular and cordless) and land
mobile radios, amateur radio, AM and FM radio transmitters and TV transmitters can not be predicted theoretically
with accuracy.To assess the electromagnetic environment due to fixed R
F transmitters, you should consider an
electromagnetic study of the site. If the measured field strength in the place where the device is used exceeds the
applicable RF compliance level above, should be placed under observation normal operation of the devi
ce. If
abnormal performance is observed additional measures may be necessary such as reorienting or device location.
b) The field strength in the frequency range from 150 kHz to 80 MHz should be less than 3 V / m.
Thev previous table (rif.204 of standard cited) and one below (rif.206) concern the noise generated by RF transmitters (ex mobile
phones) and indicate the minimum distance to be maintained between an RF transmitter and the device, as well as how to calculate
this distance.Obviously, these directions are valid for any device generating significant RF power, such as equipment for diathermy
(Radar and Marconitherapy, that is at 2.5 GHz and 27 MHz also produce several hundreds of watts).If it is true that these
apparatuses are not constructed to radiate with Antenna in space, it is true that even if the coupling with the patient was optimal
(99%), the remaining part would still dispersed in air, and 1% to 500W is equal to 5W. This power at 27 MHz leads to calculate a
minimum distance of about 2.7 meters. These considerations lead to the conclusion that the use of rails for Marconi and / or
radar therapy is not compatible with the use of the device.

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Recommended separation distances between portable and mobile communications equipment and the device.
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are under control.The user
can help prevent electromagnetic interference by maintaining a minimum distance between communication devices portable
and mobile RF (transmitters) and the device as recommended below, in relation to the maximum output power of the
communications equipment.
Specified maximum output
power of the transmitter W
Separation distance to the transmitter frequency (m)
from 150 KHz to 80 MHz
Pd 2,1=
from 80 MHz to 800 MHz
Pd 2,1=
from 800 MHz to 2,5 GHz
Pd 3,2=
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,20
1,20
2,30
10
3,80
3,80
7,30
100
12
12
23
For transmitters specified for a maximum output power output is not shown above, the separation distance recom-date d in
meters (m) can be calculated using the equation applicable to the frequency of the transmitter, where P is the maximum power
rating of 'output of the transmitter in watts (W) according to the transmitter manufacturer.
Note:
At 80 MHz and 800 MHz frequency range applies is the higher.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by the a
bsorption and reflection from
structures, objects and people.
8.2 SDoC of FCC (Federal Communications Commission)
Trade Name
Model
Responsible party
Declaration of Conformity
: CorX Smartwatch
: SMD 1800
: SaluberMD LLC.
Address : 209 Capitol Street, Charleston WV 25301,USA
Telephone Number
:1-416-573-2307

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9ORDINARY AND EXTRAORDINARY PREVENTIVE MAINTENANCE
CLEAN AND CARE
•Regularly clean your strap and wrist—especially after working out or sweating. Rinse the strap with
water. Do NOT use hand soap, body soap, dish soap, hand sanitizers, cleaning wipes or household
cleaners, which could get trapped beneath the band and irritate skin. Instead use a soap-free
cleanser to clean the wristband. Always dry the band well before putting it back on.
•For tough spots, stains or buildup on your strap, scrub with a wet, soft-bristled toothbrush.
•Prolonged rubbing and pressure may irritate the skin, so give your wrist a break by removing the
strap for an hour after extended wear.
Other Tips
•If you have eczema, allergies or asthma, you may be more likely to experience a skin irritation or
allergy from this device.
•Whether you have the conditions above or not, if you start to experience redness or skin irritation
on your wrist, remove your device. If symptoms persist longer than 2-3 days of not using your
device, contact a dermatologist.
•If you sweat for more than two hours while wearing your device, be sure to wash your strap and
your wrist using the directions above to avoid skin irritation.
PREVENTIVE MAINTENANCE: to ensure the correct operation and safety of the user and the operator, you
must subject the device to some checks and periodic inspections.
Therefore it is important to check the device by authorized staff with maximum intervals of 12 months or if
in case of any malfunction.
BATTERY REPLACEMENT:
WARNINGS
The battery must / may be replaced after 300 charge cycles or after 24 months use.
To replace the CorX battery contact the technical support Saluber MD.
ORDINARY MAINTENANCE: the operator must check the wear of patient electrodes through the time, and
promptly replace them (by authorized dealer), if there is a need.
WARNINGS
In case of evident abnormalities, do not use the device.
EXTRAORDINARY MAINTENANCE: the extraordinary maintenance must be realized by internal staff of
Saluber MD or qualified personnel, trained and authorized by Saluber MD. The manufacturer is committed

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to providing circuit diagrams, parts lists and anything else necessary to calibration and repairs the device,
only to a qualified and authorized personnel in those activities.
WARNINGS
All interventions must be recorded in Table sheet machine in order to ensure the maximum safety of the
device.
WARNINGS
This device is not intended for use by people (including children) with restricted physical, sensory or mental
skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a person who has
responsibility for their safety or they receive instructions from this person on how to use the device.
WARNINGS
Please placed out of children’s and pets reach to prevent device damage.
NOTE
The following table contains the summary of the maintenance operations
TYPE ACTION AUTHORITY FREQUENCY
Preventive
Visual inspection of the integrity of
the charging cable (if there is
deterioration contact the technical
support service)
Operator Weekly
Preventive Cleaning the inside, verification of
functionality, review and calibration
Authorized
laboratory Annually
Preventive
Instrumental tests of currents
leakage and electrical safety
Authorized
laboratory Annually
Preventive Batteries replacemement Authorized
laboratory
At 300 charge
cycles or after 24
months use
Ordinary Cleaning of sensor lens Operator Each use
Ordinary Visual inspection of the integrity of
patient electrodes and sensor lens Operator Each use
Extraordinary
Disposing accessories and / or
obsolete device in accordance with
local regulations
Operator When necessary
WARNINGS
Tampering with the device by the user and the failure of the maintenance table above involve the
termination of the guarantee.

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WARNINGS
In order to ensure the safety of the patient and / or operator the legislation provides instrumental tests of
currents leakage and electrical safety.