Kinetik TD3 Wellbeing Dual Channel TENS Machine

Product's Documents

Below are documents related to this product, you can read online or download:
TD3 photo

User Guide

This is the main product document for model TD3.

The file format is pdf, 27 pages, you can download this manual here .

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TD3 Series
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Content
Support
Introduction
Indications for Use
Safety Warning
Contraindications
Warnings
Precautions
Adverse Reactions
Product Specifications
Parts & Setup
How to Use
Recommended Use Positions
Cleaning and Maintenance
Technical Information
Troubleshooting
Environmental Condition for Transport and Storage
Symbols interpretation
Safety Test Standards
EMC and FCC statement
Contact Information
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9 - 10
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Support
Our manual should provide you with all the information you need to set up and use this product.
If you have a question, have a look at our Troubleshooting page!
For further assistance, why not contact our Customer Care team directly? We’re here to help!
Our Customer Care team are available from 9am-5pm, Monday to Friday (excluding bank holidays).
We promise to respond to all queries and will ensure to resolve any issue you may be having.
You can reach us by…
Phone:
+44 1483 937969
Live Chat:
Simply visit www.kinetikwellbeing.com and send us a message.
Email:
Post:
Kinetik Medical Devices Limited
Unit 3, Perrywood Business Park, Honeycrock Lane,
Salfords, Redhill. RH1 5DZ
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Introduction
Kinetik TENS Pain Reliever delivers electric impulses to tired and sore muscles. These different
frequencies of impulses covering Transcutaneous Electrical Nerve Stimulation mimic the action
potential coming from the central nervous system to trigger contraction of the muscle. It may be
helpful in relieving aches and pains in various parts of the body such as the waist, shoulders, joints,
hands and feet.
Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
Safety Warning
Contraindications
Do not use this device on patients who have a cardiac pacemaker, implanted defibrillator, or other
implanted metallic or electronic device, because this may cause electric shock, burns, electrical
interference, or death.
Do not use this device on patients whose pain syndromes are undiagnosed.
Warnings
Do not apply stimulation over the patient’s neck because this could cause severe muscle spasms
resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood
pressure.
Do not apply stimulation across the patient’s chest, because the introduction of electrical current
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into the chest may cause rhythm disturbances to the patient’s heart, which could be lethal.
Do not apply stimulation over, or in proximity to, cancerous lesions.
Do not apply stimulation when the patient is in the bath or shower.
If you have one of the following conditions, please consult with your physician before purchasing or
using this device.
• Acute disease
• Malignant tumor
• Infective disease
• Pregnant
• Heart disease
• High fever
Abnormal blood pressure
Lack of skin sensation or an abnormal skin condition,
Any condition requiring the active supervision of a physician.
Precautions
Do not use this device while driving.
Do not use this device while sleeping.
Do not use this device in high humidity areas such as a bathroom.
Keep the device away from wet, high temperature and direct-sunlight place.
Keep this device out of reach of children.
Stop using this device at once if you feel pain, discomfort, dizziness or nausea and consult your
physician.
Do not attempt to move the electrode pads while the device is operating.
Do not use the device around the heart, on the head, mouth, pudendum or blemished skin areas.
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Do not apply stimulation of this device in the following conditions:
(1) across the chest because the introduction of electrical current into the chest may cause rhythm
disturbances to the heart, which could be lethal;
(2) over painful areas. Please consult with your physician before using this device if you have painful
areas;
(3) over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions
(e.g., phlebitis, thrombophlebitis, varicose veins). Apply stimulation only to normal, intact, clean,
healthy skin;
(4) in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms). The
electronic stimulator may not operate properly when the electrical stimulation device is in use;
(5) while operating machinery, or during any activity in which electrical stimulation can put you at risk
of injury;
(6) on children.
Be aware of the following.
(1) To consult with your physician before using this device. The stimulation from the device may:
i. cause lethal rhythm disturbances to the heart in susceptible individuals.
ii. disrupt the healing process after a recent surgical procedure.
(2) That the device is not effective for pain of central origin, including headache.
(3) That the device is not a substitute for pain medications and other pain management therapies.
(4) That the device has no curative value.
(5) That the device is a symptomatic treatment and, as such, suppresses the sensation of pain that
would otherwise serve as a protective mechanism.
(6) That the long-term effects of electrical stimulation are unknown.
(7) That the user may experience skin irritation, burns or hypersensitivity due to the electrical
stimulation or electrical conductive medium (gel).
(8) If the user has suspected or diagnosed epilepsy, the user should follow precautions recommend-
ed by his or her physician.
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(9) To use caution if the user has a tendency to bleed internally, such as following an injury or fracture.
(10) Use caution if stimulation is applied over the menstruating uterus.
(11) Use caution if stimulation is applied over areas of skin that lack normal sensation;
(12) Stop using the device if the device does not provide pain relief.
(13) Use this device only with the leads, electrodes, and accessories that the manufacturer
recommends.
(14) Do not share the use of the electrode pads with others.
(15) Do not use the device while it’s charging.
(16) The device contains a lithium battery. If overheating of the device occurs while charging, stop the
charging or operation immediately and report to Kinetik Wellbeing.
(17) Dispose of the battery-containing device according to the local, state, or federal laws.
The long-term effects of electrical stimulation are unknown.
Since the effects of stimulation of the brain are unknown, stimulation should not be applied across
the head, and electrodes should not be placed on opposite sides of the head.
The safety of electrical stimulation during pregnancy has not been established.
Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation
or electrical conductive medium (gel).
Patients with suspected or diagnosed heart disease should follow precautions recommended by
their physicians.
Patients with suspected or diagnosed epilepsy should follow precautions recommended by their
physicians.
Use caution if stimulation is applied over the menstruating or pregnant uterus.
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Adverse Reactions
Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the
skin;
Patients may experience headache and other painful sensations during or following the application
of electrical stimulation near the eyes and to the head and face.
Patients should stop using the device and should consult with their physicians if they experience
adverse reactions from the device.
Accessories included in the package.
Kinetik TD3 Tens Machine
4 x Gel Pads
2 x Output Cables
• Micro USB Charger
• Instruction Manual
Quick Start Guide
Product Specifications
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Parts & Setup
Unpack the product, take the product and accessories out, charge device and then connect the
electrode pad into the device. Then simply turn-on and select mode/intensity as desired.
ON/OFF
USB port
Battery Indicator
LCD Display
Countdown Timer
Intensity Indicator
Decrease Intensity
Mode Selection
B Channel
Timer
A Channel
Output A channel Output B channel
Pause/Play
(a lock symbol will be shown
on screen when paused)
Increase Intensity
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How to Use
The Kinetik Wellbeing TD3 TENS Machine needs to be charged for up to 8 hours before the first
use.
Connect a pair of electrode pads to one output cable – this is done by snapping them on. If
required, connect the other pair of electrode pads to the remaining output cable.
Insert the output cables in use into the TD3
Attach electrode pads to the treatment area, such as shoulders or legs.
Turn the device on – the device will automatically start at Mode 1
To change the mode, press the M button until desired.
Gradually increase the intensity as needed by pressing the + button; to decrease the intensity
press the – button.
When pressing the
▌▌
button, the device will pause treatment – this will be indicated by a lock
symbol on the screen.
When pressing T, one of the six-time options can be selected.
When pressing the B button once, the device will switch from the control of channel A (left) to
channel B – you can independently increase/decrease intensity of the channels.
Recommended practice:
Suggested duration for each skin area is 20 mins/2 times per day. Consult with your physician for
longer and more frequent uses.
Start from the lowest intensity and gradually adjust the intensity to a comfortable level – from a
scale of 1 to 20.
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Good skin care is important for the comfortable use of this device. Be sure that the treatment
area is clean of dirt and body lotion.
Keeping the electrode pads in their plastic storage bags after use will extend lifespan. The
electrode is disposable and should be replaced when it loses the adhesiveness. To purchase
additional electrodes, please contact Kinetik Wellbeing.
Product Programs
Program name
Mode 1
Mode 2
Mode 3
Mode 4
Mode 5
Mode 6
Mode 7
Mode 8
Mode 9
Mode 10
Mode 11
Mode 12
Time min.
10,20,30,40,50,60
10,20,30,40,50,60
10,20,30,40,50,60
10,20,30,40,50,60
10,20,30,40,50,60
10,20,30,40,50,60
10,20,30,40,50,60
10,20,30,40,50,60
10,20,30,40,50,60
10,20,30,40,50,60
10,20,30,40,50,60
10,20,30,40,50,60
Frequency (Hz)
68.9
12.5-55.5
1.2
68.9
100
12.5-55.5,1.2,55.5,1.2,55.5,1.2
20
55.5
55.5
100
68.9
68.9
Pulse Width (µs)
100
100
100
100
100
100
100
100
100
100
100
100
Remarks
Feels like a Massage
Feels like Acupuncture
Feels like Beating
Feels like Scraping
Feels like Cupping
Feels like a Thai massage
Feels like a Shiatsu massage
Feels like an Elbow massage
Feels Relaxing
Feels like a Foot massage
Feels like Tapping
Feels like a Swedish massage
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Recommended Use Positions
Cleaning and maintenance
Please use a slightly wettened cloth or natural detergent to clean the device first, and then use a
dry cloth to wipe again.
The electrode pads that come with the device are disposable and should be replaced after they
lose their adhesiveness – please contact Kinetik Wellbeing for replacements. We recommend that
users avoid the sticky side of the pads from touch.
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Technical Information
Note: Not intended to be sterilized.
Not for use in an OXYGEN RICH ENVIRONMENT
Modes
Typical operation
time of Battery
Behaviour of equipment
while the rechargeable
internal electrical power
source is charging:
Typical service
life of Battery
Output intensity
Output Voltage
Pulse duration
Power supply Powered by internal 3.7V li-ion battery
Biphasic rectangular wave pulse
100us (Microseconds)
1-100Hz (Hz=vibration per second)
Max. 70Vpp ±20%(at 500ohm load)
10 min, 20 min, 30 min, 40 min,
50 min, 60 min
No use (in storage): 1 year
In use: 30 uses
0 to 20 levels, adjustable
12 auto modes
To use both channels together at level 10,
the battery can be used 570 mins after fully
charged. If to use at level 20, the battery can
be used for 180 mins after fully charged.
The battery icon on the right corner will flash
during charging and will be still with full
capacity after fully charged.
300 times of recharging
Automatic shutoff
Degree of protection against electric shock
Type of protection against electric shock
Grade of waterproof
Product life
Lifetime for electrode pad
Mode of operation
Software version
The time required for equipment to warm from
the minimum storage temperature between
uses until it is ready for intended use
The time required for me equipment to cool
from the maximum storage temperature
between uses until it is ready for intended use
Adapter for charging
After 20 minutes without use
Type BF applied part
Internally powered equipment
IP22
1 year
Continuous operation
A0
30 minutes
15 minutes
Please use output DC5V
and output current 0.3-2.0A
adapter for charging
Treatment time
Pulse frequency
Waveform and wave shape
Model/type
TD3
Weight
40g
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Troubleshooting
If your device is not operating properly, please check below for common problems and suggested
solutions. If the recommended action does not solve the problem, please contact Kinetik Wellbeing.
Problem Possible Cause Solution
One pad feels stronger than the other
The intensity feels very weak
The skin turns red or the skin feels
irritated
This is normal. Different area of your body
will react differently
Nothing needs to be done. Make sure the
pads are moist and making good contact.
Pads are not attached to the body firmly
The adhesive surface of the pads is dirty or dry
Wash adhesive surface of pads gently with
your fingertips for about 3 seconds under
slow running water
Reduce the application time or reduce the
intensity
Replace electrode pad
The therapy time is too long, or the intensity is
set too high
The electrode pad surface is worm out
Attach both pads firmly to the skin
The transparent films are still stuck to the pads
Peel off film on the adhesive surface of pads
The pads stack together or overlap Do not stack pads together or overlap pads
The cord is not properly connected to the unit
Connect cord correctly into the jack
The intensity setting is low Increase the intensity level
The battery capacity is low Charge the battery
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Troubleshooting
Problem Possible Cause Solution
No power source; no display on LCD
Power cuts off during use
It is difficult to attach the pad to the
skin
Adhesive surface of pad is not sticky
The battery capacity is depleted Charge the battery
The battery is weak
Pads have deteriorated Contact the vendor for replacements.
Replace the pad.Were the pads stored under high temperature,
high humidity, or direct sunshine?
Charge the battery
The cord is broken Replace the cord
Have you removed the transparent film from
the pad?
Peel off film on the adhesive surface of pads
Was the pad applied immediately after washing? Dry the pad
Is the adhesive surface of the pad damaged? Replace the pad
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Environmental condition for normal working,
transport and storage
- Normal working ambient temperature: 5~40°C
- Normal working ambient humidity: 15~90%
- Store and transport ambient temperature: -25 ~70°C
- Store and transport ambient humidity: 0~90%
- Atmospheric pressure: (70~106)kPa
Symbols interpretation
Fragile, handle with care Type BF applied part
Keep the product in the dry place
Away from water and rain
This way up
Product package should be recycled
Unrecyclable
Date of manufacture
Serial number
Read the instructions (actual symbol colours
are white on a blue background).
Manufacturer
Symbol for "AUTHORISED REPRESENTATIVE
IN THE EUROPEAN COMMUNITY"
CE marking, Certificate issued by TUV Rheinland
IP code of the device
Restriction of Hazardous Substances
0197
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Safety Test Standards
Medical Devices Directive 93/42/EEC
IEC 60601-1:2005+A1:2012/EN 60601-1:2006 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
• IEC60601-1-22014/EN60601-1-22014 Medical electrical equipment - Part 1-2: General require-
ments for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-2-10:2012/EN 60601-2-10:2000+A1:2001 Medical electrical equipment - Part 2-10:
Particular requirements for the safety of nerve and muscle stimulators
IEC60601-1-11:2015. Medical electrical equipment -- Part 1-11: General requirements for basic
safety and essential performance -- Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment.
EN ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling
and information to be supplied -- Part 1: General requirements
EN 1041 Information supplied by the manufacturer with medical devices
IEC/60601-1-6/ EN 60601-1-6 Medical electrical equipment – Part1-6: General requirements for
basic safety and essential performance – Collateral standard: Usability
IEC 60601-1-11/ EN 60601-1-11 Medical electrical equipment – Part 1-11: General requirements for
basic safety and essential performance – Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in home healthcare environment
IEC 62304/ EN 62304 Medical device software - Software life-cycle processes
IEC 62366/ EN 62366 Medical devices – Application of usability engineering to medical devices
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process
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Electromagnetic Compatibility and FCC Compliance Statement
1) This product needs special precautions regarding electromagnetic compatibility (EMC) and needs
to be installed and put into service according to the EMC information provided, and this unit can
be affected by portable and mobile radio frequency (RF) communications equipment.
2) Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This
may result in incorrect operation of the unit.
3) Caution: This unit has been thoroughly tested and inspected to assure proper performance and
operation!
4) Caution: This machine should not be used adjacent to or stacked with other equipment and that
if adjacent or stacked use is necessary, this machine should be observed to verify normal
operation in the configuration in which it will be used
EMC and FCC statement
The device is intended for use in the electromagnetic environment specified below. The customer of
the user of the device should assure that it is used in such an environment.
RF emissions
CISPR 11
Group 1
The device use 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.
Emission test Compliance Electromagnetic environment – guidance
Guidance and manufacture’s declaration – electromagnetic emission
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EMC and FCC statement
The device is intended for use in the electromagnetic environment specified below. The customer of
the user of the device should assure that it is used in such an environment.
RF emission
CISPR 11
Class B
The device 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.
Emission test Compliance Electromagnetic environment – guidance
Guidance and manufacture’s declaration – electromagnetic emission
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
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EMC and FCC statement
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that it is used in such an environment.
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile.
If floor are covered with synthetic material,
the relative humidity should be at least 30%.
±2 kV for
power supply lines
±1 kV for
input /output lines
±2kV for
power supply lines
Mains power quality should be that of a typical
commercial or hospital environment.
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
±1 kV differential
mode
Mains power quality should be that of a typical
commercial or hospital environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Guidance and manufacture’s declaration – electromagnetic immunity
Electrical fast
transient /burst
IEC 61000-4-4
Surge
IEC 61000-4-5
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EMC and FCC statement
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that it is used in such an environment.
<5% UT
(>95% dip in U
T)
for 0.5 cycle
40% U
T
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in U
T)
for 5 sec
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in U
T)
for 5 sec
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the device requires continued operation
during power mains interruptions, it is
recommended that the device be powered from
an uninterruptible power supply or a battery.
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.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Guidance and manufacture’s declaration – electromagnetic immunity
Power frequency
(50Hz /60Hz)
magnetic field
IEC 61000-4-8
NOTE U
T is the a.c. mains voltage prior to application of the test level.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
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EMC and FCC statement
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that it is used in such an environment.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
Portable and mobile RF communications
equipment should be used no 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
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Guidance and manufacture’s declaration – electromagnetic immunity
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EMC and FCC statement
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that it is used in such an environment.
NOTE 1 At 80 MHz and 800 MHz, 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.
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
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 metres (m).
Field strengths from fixed RF transmitters, as
determined 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:
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Guidance and manufacture’s declaration – electromagnetic immunity
80 MHz to 800 MHz
800 MHz to 2,5 GHz
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EMC and FCC statement
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 device is used exceeds the applicable RF compliance level above,
the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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EMC and FCC statement
The device is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the device can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the device as recommended below, according to the maximum
output power of the communications equipment.
NOTE 1 At 80 MHz and 800 MHz, 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.
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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.
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
150 KHz to 80 MHz
Separation distance according to frequency of transmitter
(m)Rated maximum output
power of transmitter
(W)
Recommended separation distances between
portable and mobile RF communications equipment and the device.
80 MHz to 800 MHz 800 MHz to 2.5 GHz
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EMC and FCC statement
The subject device 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.
The product generates, uses, and can radiate radio frequency energy and, if not installed and used
accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that the interference will not occur in a particular installation. If the
product does cause harmful interference to radio or television reception, which can be determined
by turning the product on or off, the user is encouraged to try to correct the interference by one or
more of the following measures:
a) Reorient or relocate the receiving antenna;
b) Increase the separation between the product and the receiver;
c) Consult the dealer or an experienced radio / TV technician for help.
d) Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
Changes or modifications to this product not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
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Contact Information
Manufacturer
EC Authorized Representative
TD3 IB UK 20190425
Share Info Consultant Service LLC Repräsentanzbüro
Heerdter Lohweg 83, 40549 Düsseldorf
Harvard Medical Devices Ltd. HK
Unit 1002, 10th Floor, Railway Plaza,
39 Chatham Road South, Tsimshatsui,
Kowloon, Hong Kong.
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For support… Visit our website: www.kinetikwellbeing.com / Email: [email protected] / Call: +44 1483 937969

Specifications

Indexed Terms: Dual-Channel

Kinetik TD3 Questions and Answers