WeHeal TS200 User manual

TS200
Version: 2019_v1.0 We Heal Biotechnology Co.
We Heal Smart TENS
& Body Analyzer

Contents
Table of Contents
1.1 Device information
1.2 Intended use
1.2.1 Transcutaneous nerve stimulation
1.2.2 Electrical muscle stimulation
1.2.3 Impedance plethysmograph
1.2.4 Galvanic skin response
1.3 Contraindications
1.4 Precautions
1.5 Device summary description
1.6 Signs and symbols
1.7 Replacement parts and accessories
1.7.1 Electrodes
1.7.2 Connection cable
1.7.3 Other accessories
1.8 Contact information
2.1 Buttons
2.2 Display
2.3 Device appearance
2.4 Initial notes on use
2.5 Starting applications
2.6 Cleaning, storage and disposal
3.1 TENS/EMS current parameter
1.Product Specifications
2.General instructions
3.Functions
1
1
2
2
2
2
2
3
4
4
5
6
6
6
6
6
7
7
7
8
8
9
9
10
10

Contents
Table of Contents
3.2 TENS/EMS auto (programmed) mode
3.3 TENS/EMS manual mode
3.4 Body analyzer
3.5 Alarms and problem solutions
3.6.1 Blue light
3.6.2 Orange light
3.6.3 Green light
3.6.4 Reset the machine
4.Warranty and service
5.Electromagnetic compatibility information
6.Federal Communications Commission
(FCC) Statement
11
12
12
13
14
14
14
14
15
16
21

1
.1
D
ev
icei
n
form
at
i
o
n
Trade name
Model
Output waveform
Pulse length/ frequency
Output voltage/ current
Power specification
Treatment time
Intensity
Bluetooth
Operating conditions
Storage/ Transport conditions
Use range atmospheric
pressure/ altitude limit
Galvanic skin response
BIA (bioelectrical
impedance analysis)
Software version
WeHeal smart transcutaneous electrical nerve stimulation & body analyzer.
TS200
Monophasic or biphasic rectangular pulse
40 – 800 μs / 1 – 200 Hz
Max. 50 V / 90 mA (500 ohm)
DC 5V 0.5A Lithium-ion battery (2100 mAh)
Adjustable from 1 to 60 minutes
Adjustable from 1 to 50
BLE 4.0
10°C – 40°C (50°F – 104°F) at a relative humidity of 30 – 85%
5°C –40°C (41 °F – 104 °F) at a relative humidity of 10% – 85 %
700 – 1060 hPa / 3000 m
Measuring the skin resistance at 100Hz
Operating at 50 KHz or 100 KHz
MCU v3.4/ BLE v2.9
This device complies with standards IEC 60601-2-10 , ANSI/AAMI NS4:2013 , IEC 60601-1-6 , ISO 14971 , IEC 62304 , IEC 60601-1-6 , IEC
60601-1-11 , IEC 60601-1-8 , EN 301489-1 , EN 301489-17 , EN 300328 , EN/IEC 60601-1 and EN/ IEC 60601-1-2 , and is subject to special
precautionary measures with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere
with this unit.
The serial number is located on the device. We reserve the right to make changes to improve and develop the product. More details can be requested
from the stated Customer Services address on the device.
Note: If the device is not used according to the instructions specified, perfect functionality cannot be guaranteed!
1.
P
r
o
d
u
c
t
Speci
fi
c
a
t
io
ns
-1-

1
.2
I
n
t
ende
d
u
s
e
TENS- transcutaneous
nerve stimulation
EMS- electrical muscle
stimulation
Impedance
plethysmograph
Galvanic skin response
symptomatic relief of neuro-muscular pain, chronic intractable
pain, and post traumatic and post-surgical pain.
measurement of skin resistance. The device is not intended for
use in any diagnosis.
Improvement and facilitation of muscle performance, relaxation
of muscle spasm, increasing local blood circulation, prevention
or retardation of disuse atrophy, and maintaining or increase
range of motion.
Use bioelectrical impedance analysis (BIA) technology to
determine and estimate body composition, including body fat,
body water percentage, body muscle mass, bone mass, and
visceral fat rating.
1.
P
r
o
d
u
c
t
Speci
fi
c
a
t
io
ns
-2-

1
.3
Co
nt
r
ai
ndi
cat
i
ons
Do not use this device if you have a cardiac pacemaker, known cardiac arrhythmias
or heart disorders, the implanted defibrillator, or other implanted metallic or
electronic device. Do not place the stimulation electrodes on the front ribcage
near to the heart. Such use could cause electric shock, ventricular fibrillation,
and induce cardiac arrest or death.
Do not use this device if you have high temperature (> 38℃), seizure disorder,
on the injured or irritated skin, or if you are pregnant.
Do not use this device in humid environments (e.g. in the bathroom), when
bathing or showering, or after consuming alcohol.
Do not use by children or people with restricted physical, sensory (e.g. reduced
sensitivity to pain) or mental skills or a lack of experience and/or lack of
knowledge, unless they are supervised by a person who is responsible for their
safety or are instructed by such a person in how to use the device. Keep the
device away from children.
Do not place the electrodes on the neck/carotid artery area, genital area,
skeletal skull structure, or around the eyes, mouth, throat or larynx. The
stimulation should not be applied across or through the head or the heart.
Do not use the device if the device is damaged. Do not drop or disassemble the
device.
Do not attempt to open and/ or repair the device yourself. Failure to
comply will result in voiding of the warranty. The manufacturer is not liable for
damage resulting from improper or careless use. Contact your retailer or the
customer services if the device is damaged.
The device is not a substitute for medical consultation and treatment. Consult your
doctor first if you are experiencing any pain or are suffering from a chronic illness such
as cancer, diabetes, high blood pressure, and blood coagulation/thrombo-embolic
diseases. To avoid damage to health, we strongly advise against using the We Heal
Smart TENS & body analyzer in the following situations:
1.
P
r
o
d
u
c
t
Speci
fi
c
a
t
io
ns
-3-

1
.4
P
rec
au
t
io
ns
Do not expose the device to direct sunlight or high temperatures.
The WeHeal smart TENS & body analyzer is a combination of TENS/EMS unit, galvanic skin response
unit, and impedance plethysmograph unit. It is powered by rechargeable lithium-ion battery which is
permanently built into the main unit. This device can work independently or receive remote control
signals through Bluetooth module. The correspondent App for Android oriOS system can remote
control the functions of this device.
The TENS/EMS unit delivers nerve or muscle stimulation by applying an electrical current to electrodes,
which are attached on the patient's skin. The output waveform, pulse length/frequency, treatment time,
and intensity are adjustable according to the intended treatment of patient. The stimulator has 2 output
channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4
electrodes simultaneously.
The galvanic skin response and impedance plethysmograph units measure skin resistance and estimate
body composition by bioelectrical impedance analysis (BIA) technology with a low, safe, electrical
current.
Keep the device away from sources of heat and do not use it close (approx. 1 m) to
shortwave or mobile phones, as doing so can result in unpleasant current peaks.
Do not use the device more than 1 hour, which could result in electrical burns.
Do not modify electrodes (e.g. by cutting or change it's shape). This may
increase the current intensity, which is potentially hazardous, an effective
current intensity beyond 2 mA/cm² requires increased awareness.
Ensure that no metallic objects or high-frequency surgical devices are in contact
with the electrodes during stimulation, which could result in electrical burns.
The treatment effect can be affected by the physical, mental and medical
conditions of the user.
1.
P
r
o
d
u
c
t
Speci
fi
c
a
t
io
ns
1
.
5
De
v
i
c
es
u
m
m
a
r
y
d
escript
io
n
-4-

1
.6
Signs a
n
d
sy
m
b
ols
IP22
SN
Do not use this product if you have implanted pacemaker installed
Protected against ingress of solid foreign objects greater than 12.5 mm
in diameter. Protected against drops of water falling at up to 15° from vertical
Serial number
Read the instructions before use
Electrodes as the applied part, type BF
Manufacturer
Class II symbol
Disposal in accordance with the Waste Electrical and
Electronic Equipment EC Directive – WEEE
1.
P
r
o
d
u
c
t
Speci
fi
c
a
t
io
ns
-5-

1.
8
Co
n
t
act inform
ation
1.7.1Electrodes:
Adhesive electrodes (small) Ø35mm x 2sets (4pcs); adhesive electrodes
(Big) 97x47mm x 1set (4pcs).
1.7.2Connection cable : The black head of the connection cable is the negative
pole of the wire, and the white head is the positive pole of the wire.
1.7.3Other accessories :USB charging cord x 1; soft shell package x 1.
1.7.4Recommended adaptor：
At distances below 5 cm, the unit primarily stimulates surface structures intensively.
Greater distances (>15 cm) between electrodes mean a larger tissue volume is
stimulated, but less intensively. Consequently, you must increase the impulse intensity.
To ensure that the adhesive electrodes remain adhesive for as long as possible, clean
them carefully with a damp, lint-free cloth or clean the underside of the electrodes
under lukewarm, running water and pat dry with a lint-free cloth.
Clean the skin prior to any application; do not use skincare lotions or oils prior to treatment.
Electrodes item numbers: GMP 001357
Replace the electrodes if they still do not adhere securely after cleaning the electrodes. You
can obtain the replacement electrodes directly from customer services.
Address: 9F., No. 205, Minsheng 2nd Rd., Chyan Jin Dist.,
Kaohsiung City 801, Taiwan (R.O.C.)
Phone: [phone]
Website: www.weheal.com
Email: ser[email protected]
Manufacturer: We Heal Biotechnology Co.
1.
P
r
o
d
u
c
t
Speci
fi
c
a
t
io
ns
1
.
7
R
ep
l
a
cemen
t
par
t
sa
n
d
acces
s
o
r
ie
s
-6-

ON/OFF button：Press 1 sec to turn on and 3 secs to turn off
ENTER button：START/PAUSE button
BACK button
Shift button : switch the display of treatment setting
Setting button ：choose left or right, increasing or decreasing
the frequency, impulse width, and working time
2
.1
But
ton
s
2
.2
Disp
la
y
MODE
1
3
4
65
7 8 9
2
1. Electrode positioning indicator
2. Impulse waveform
3. Number display
4.
Display for impedance and resistance (KΩ),
frequency (Hz), pulse width (%) and timer
5. Impulse intensity
6. Battery level display
7. Auto (programmed) mode
8. Manual mode
9. Body analyzer
2.
G
en
e
r
a
l
i
n
st
r
u
c
ti
ons
-7-

2
.3
D
ev
ice
a
p
pearance
2
.4
I
n
i
tia
l
n
o
t
es
on
use
Connect the connection cables with the electrodes.
Guide the connection cable plugs into the socket on the top of the device.
Do not pull, twist or make sharp bends in the cables.
If the battery level is low, charge this device with the USB charging cord and
the corresponding adaptors
Do not charge the device on the place where it is difficult to disconnect the
device!
(HPU15-102-P88D101, Input Voltage:100 - 240 Vac, 47–63 Hz, 0.2–0.4A; Output
Voltage: 5Vdc/2.4A (max), 12W. Make sure the voltage of the power source is
correct before connecting the equipment to the power outlet.
When this device is charging, the blue light is on and this device cannot be
used for any applications. When charging is finished, unplug the charging
cord and adaptor to disconnect the device from Mains supply.
Dimensions: 121 x 60 x 28 mm
Weight: 134.2g
Color: Black or pink
The socket for the
connection cables.
The socket for the
USB charging cord.
warning light
2.
G
en
e
r
a
l
i
n
st
r
u
c
ti
ons
-8-

2
.5
Starti
n
g
appl
icat
ion
s
Cleaning the device
Please turn off the device while cleaning the device. Clean the device after use
with a soft, slightly damp cloth. If it is very dirty, you can also moisten the cloth
with a mild soapy solution. Ensure that no water enters the device. Do not use
any chemical or abrasive cleaning agents.
Storage
Do not make sharp bends in the connection cables and electrodes. Disconnect
the connection cables from the electrodes. Reapply the electrodes to the carrier
foil after use. Store the device and accessories in a cool, well-ventilated space.
Never place any heavy objects on the device.
Disposal
For environmental reasons, do not dispose of the device in the household
waste at the end of its useful life. Dispose of the unit at a suitable local collection
or recycling point. Dispose of the device in accordance with EC Directive – WEEE
(Waste Electrical and Electronic Equipment). If you have any questions, please contact
the local authorities responsible for waste disposal.
Step 1 Pressure the ON/OFF button to switch on the device.
Step 2 Use the >/< button to navigate through the / /
modes and press the ENTER button to confirm your selection.
2.
G
en
e
r
a
l
i
n
st
r
u
c
ti
ons
2
.6
Cl
e
an
i
n
g
,s
t
o
rage
a
n
d
d
is
p
o
sa
l
-9-

3
.1
T
E
NS/EMSc
u
rrent
p
ar
am
et
er
Impulse
shape
Impulse
frequency
Impulse
width
Impulse
intensity
3.
F
u
n
ct
i
o
ns
monophasic pulse
biphasic pulse
t
t
Time
lmpulse intensity
time
period
t
Pulse width
t
t
It distinguishes between monophasic and
biphasic pulse currents. In monophasic
pulse currents, the current flows in one
direction and in biphasic pulse currents
the electrical impulse alternates its
direction. The device provides both
monophasic and biphasic rectangular
wave.
IThe frequency indicates the number of
individual impulses each second and is
given in Hz (Hertz). It can be calculated by
determining the cyclic value for the time
period.
This indicates the duration of an individual
impulse in microseconds.
Pulse width
Intensity levels indicates the output voltage/
current of the stimulus. The setting used should be
effective but should never cause an unpleasant
sensation, such as pain, at the site of application.
While a gentle tingling indicates sufficient
stimulation energy levels, any setting that causes
pain should be avoided. During longer applications
it may be necessary to make readjustments due to
the adjustment processes over time at the site of
application.
-10-

No.
1
2
3
No.
4
5
6
7
8
9
10
11
12
13
14
15
Mode
TENS
EMS
MASSAGE
Mode
TENS
TENS
TENS
TENS
EMS
EMS
MASSAGE
TENS
TENS
MASSAGE
TENS
TENS
Area of application, indications
Pain relief in shoulder, back and ankle
Strengthening abdomen and back muscles
Tapping massage
Area of application, indications
Chronic pain in low back
Pain in back, buttock, thigh
Pain relief
Pain relief
Shaping the muscle
Tightening the muscle
Tapping massage
Pain relief
Pain relief
Relaxing massage
Pain relief
Pain relief
Step 1 The digital EMS/TENS unit features a total of 15 programs. Use the >/< setting buttons to
select the program number you want and press the ENTER button to confirm your selection.
Step 2 You can set the impulse intensity of both channels in all programs.
Program table:
3
.2
T
E
NS/EMS
a
uto
(p
r
o
gr
a
m
m
ed
)
m
od
e
You can apply the program on the discomfort position except the contraindicated area (section 1.4).
3.
F
u
n
ct
i
o
ns
-11-

Program No.
1
2
3
Indications
Measure skin conductance (galvanic response)
Estimate body fat, body water percentage by bioelectrical
impedance analysis
Estimate body muscle mass, bone mass, and visceral fat
rating by bioelectrical impedance analysis
Step 1 Place the electrodes on the desired area for treatment. Choose the waveform.
Step 2 Set the impulse frequency between 1 to 200 Hz.
Step 3 Set the impulse width between 1%-20% (40-800 μs).
Step 4 Set the timer. Adjust the impulse intensity.
3
.3
T
E
NS/EMS
ma
n
u
al
m
o
de
3
.
4
Body
a
nalyze
r(gal
v
a
nicsk
i
n
r
e
spo
n
s
e
an
d
B
I
A
)
3.
F
u
n
ct
i
o
ns
-12-

3
.5
Po
s
i
ti
on
ingo
fe
l
e
ctro
d
es
3.
F
u
n
ct
i
o
ns
ch1
ch2
-13-

3
.6
A
ppinstruc
ti
o
n
3.
F
u
n
ct
i
o
ns
3.6.1 Blue light It represents that this device is charging.
3.6.4 Reset the machine
If the device is not work, press > and simultaneously
for 5 secs, the device will return to default status.
Contact customer service if you cannot reset the
machine.
3.6.3 Green light It represents the device is in connection with correspondent
Apps.
3.6.2 Orange light It represents that at least one of the electrodes are not adhered
to the body. Please adhere the electrodes to the body.
Visit www.weheal.com for further additional
information and instruction.
-14-

In case of a claim under the warranty please contact your local dealer
or the local representation. In case of returning the unit please add a
copy of your receipt and a short report of the defect.
The following warranty terms shall apply:
The warranty period for this product is 3 years warranty period from date
of purchase. In case of a warranty claim, the date of purchase has to be
proven by means of the sales receipt or invoice.
This product does not need regular verification. Repairs (complete unit or
parts of the unit) do not extend the warranty period.
Local dealer/ retailer
Purchase Date: / /
4.
W
a
rr
a
n
t
y
an
d
s
e
rv
i
ce
The warranty shall not be valid for damages because of the following
reasons:
(1) improper use, e.g. not follow the user instructions
(2) repairs or tampering by the customer or unauthorized third parties
(3) transport from the manufacturer to the consumer or during transport
to the service center.
(4) The warranty shall not be valid for accessories which are subject
to normal wear and tear
(5) Liability for direct or indirect consequential losses caused by the unit
are excluded even if the damage to the unit is accepted as a warranty
claim.
-15-

Table 1. Guidance and manufacturer’s declaration – electromagnetic emissions
The TS200 is intended for use in the electromagnetic environment
specified below. The customer or the user of the TS200 should assure
that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Compliance
Group 1
Class B
Class A
Not applicable
5
.
E
l
e
c
t
ro
m
agn
et
i
c
c
o
mp
a
ti
b
ilit
y
i
n
f
o
r
m
a
t
i
o
n
The TS200 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 TS200 is suitable for use in all
establishments,including domestic
establishments
and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.
Electromagnetic environment – guidance
-16-

Table 2. Guidance and manufacturer’s declaration – electromagnetic immunity
The TS200 is intended for use in the electromagnetic environment specified below.
The customer or the user of the TS200 should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Power frequency
(50, 60 Hz) magnetic
field
IEC 61000-4-8
IEC 60601 test level
5
.
E
l
e
c
t
ro
m
agn
et
i
c
c
o
mp
a
ti
b
ilit
y
i
n
f
o
r
m
a
t
i
o
n
Voltage Dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Compliance level Electromagnetic environment – guidance
Contact:±8 kV
Air:±2 kV,±4 kV,±8 kV,
±15 kV
+ 2kV for power supply
lines
+ 1kV for input/output
lines
+ 0.5kV, +1kV line(s)
to line(s)
30 A/m
50 Hz or 60 Hz 30 A/m 50 Hz or 60 Hz
Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Voltage interruptions:
0 % UT; 250/300 cycle
Voltage dips:
Not applicable
Not applicable
Not applicable
Voltage interruptions:
Not applicable
Contact:±8 kV
Air:±2 kV,±4 kV,
±8 kV,±15 kV
NOTE
U
T is the a.c. mains voltage prior to application of the test level.
The TS200 power frequency magnetic
fields should be at levels characteristic
of a typical location in a typical home
healthcare environment.
Mains power quality should
be that of a typical home
healthcare environment.
Mains power quality should
be that of a typical home
healthcare environment.
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should
be at least 30%
Mains power quality should be
that of a typical home healthcare
environment. If the user of the
TS200 requires continued operation
during power mains interruptions,
it is recommended that the TS200
be powered from an uninterruptible
power supply or a battery.
-17-