Nu-Tek UT1032 User manual

INSTRUCTION MANUAL
UT1032
Portable Ultrasound Device
www.nutekmedical.com

This manual is valid for the UT1032
This user manual is published by Shenzhen Dongdixin Technology Co., Ltd.
Shenzhen Dongdixin Technology Co., Ltd. reserves the right to improve and
amend it at any time without prior notice.
Amendments will however be published in a new edition of this manual.
All Rights Reserved.
UT1032 Rev. V2.2 © 2020

7. PACKAGE CONTENTS
1. FORWARD
2. INTENDED USE
3. EXPLANATION OF ULTRASONIC STIMULATOR EFFECT
4. CONTRAINDICATIONS
5. PRECAUTIONS
6. CAUTIONS
8. PARTS OF THE DEVICE
9. SPECIAL FEATURES
10. STEPS TO CONNECT THE ADAPTOR
11. INSTRUCTIONS FOR USE
12. LOAD DETECTION SYSTEM CAUTION
13. MAINTENANCE
14. STORAGE CONDITIONS
15. TROUBLESHOOTING
16. UNIT SPECIFICATIONS
17. GLOSSARY OF SYMBOLS
18. DISPOSAL
4
4
4
5
5
6
8
8
9
10
12
12
13
13
14
15
15
TABLE OF CONTENTS
19. ELECTROMAGNETIC COMPATIBILITY (EMC) 16
7
20. LIMITED WARRANTY 21

4
The UT1032 is a portable ultrasound device that generates deep ultrasonic
waves within body tissues for the treatment of selected medical conditions
such as pain relief, muscle spasms, and joint contractures, but not
recommended for the treatment of malignancies. Keep out of reach of
children.
INTENDED USE
The UT1032 is an ultrasonic therapeutic device that generates pulsed high
frequency sound waves (1MHz) that are transferred to a specic body area via a
sound head probe. The pulsed sound waves travel deep into the tissue to
generate vasodilation, which helps increase blood
Therapeutic ultrasound is found to help relieve pain and reduce muscle
spasms and is one of the most frequently used therapies by physicians and
physical therapists. Most patients will feel nothing at all during treatment,
while some patients may feel slight warmth.
EXPLANATION OF ULTRASONIC STIMULATOR EFFECT
This manual contains general information on the operation, precautionary
practices, and maintenance information of the UT1032.
read the manual thoroughly
1. Keep yourself informed of the contraindications.
2. The device may not be used in close proximity (i.e. less than 2 meters) to
shortwave equipment.
3. The device may not be used in so-called “wet rooms” (hydrotherapy
rooms).
The manufacturer cannot be held responsible for the results of using this
apparatus for any purposes other than those described in these operating
instructions.
FORWARD
and become familiar with it before operating the device. In particular,
pay attention to:

1. All the ultrasound parts are assembled and tested under strict process
controls.
2. To ensure quality, the device has been designed with a single chip
microprocessor.
3. Precious alloy round‐headed probe creates a smooth surface on the skin.
4. The device has an attractive exterior and was ergonomically designed so
5. Single-button control, microcomputer makes the device easy to use.
6. Designed with three output intensities and three treatment time
selections to meet a wide range of therapy requirements.
7. The device has a head warming feature that pre-heats the sound head
applicator for increased patient comfort.
5
1. Do not use over or near bone growth centers until bone growth is
complete.
2. Do not use over a healing fracture.
3. Do not use over the eyes.
4. Do not use on patients with implanted neurostimulation systems because
tissue damage can occur at the location of the implanted electrodes
resulting in severe injury or death. This can also damage the system
components.
5. Do not use to treat malignancies, nor in the region where malignant
tumors are present.
6. Do not use on patients with demand type cardiac pacemakers.
7. Do not use on someone who is pregnant.
8. Do not use over ischemic tissues in patients with vascular disease where
the blood supply would be unable to follow the increase in metabolic
demand and may result in tissue necrosis (tissue death).
9. Do not use over the carotid sinus nerves or arteries, laryngeal or
pharyngeal muscles.
CONTRAINDICATIONS
1. Do not use on patients with hemorrhagic diatheses (excessive bleeding
disorders).
2. Do not use over an area of the spinal cord following a laminectomy, i.e.,
when major covering tissues have been removed.
3. Do not use over areas that are under anesthesia.
4. Avoid bony prominences.
5. When using ultrasound, keep the sound head moving while maintaining
contact with the skin.
6. If treatment becomes uncomfortable, stop treatment and contact your
physician.
7. Do not immerse the portable ultrasound in water or other solvent.
8. Do not use over metallic implants, especially prostheses with a
cement-matrix.
PRECAUTIONS

6
1. Always use this device under the directions of a physician.
2. Patients with the following diseases, symptoms or conditions should
not use the device:
● During pregnancy or menstrual cycle.
● Acute disease, heart disease, tubercle disease, facial neuralgia (sharp
facial pain), pernicious tumor, hemophilia, high fever, abnormal blood
CAUTIONS
9. The device should be used only with adapter recommended for use by the
manufacturer.
10. Do not modify this equipment without authorization of the manufacturer.
11. Do not service and maintain the device while it is in use.
12. The device must only be served ,repaired and opened by individuals at
authorized sales centers.
13. Do not use the device if it is damaged. The continuous use of a damaged
device may cause injury, improper results, or serious danger.
14. Do not store the device at an extremes temperature (below -10°C or over
50°C) or extremes humidity (below 20%RH or over 93%RH). Failing to do
so may aect the performance of the device.
15. Store the device in the dry, clean place. Keep the device away from pet
and pests.
16. Do not expose the product to any chemical solvent, water lint, dust, direct
sunshine or high temperature.
17. Keep unit out of the reach of young children. The wire can cause
strangulation.
18. Keep the device out of the reach of children to avoid inhalation or
swallowing of small parts.
19. Do not operate the device when connected to any other medical device.
20. Do not operate this device in an environment where other devices used
intentionally radiate electromagnetic energy in an unshielded manner.
21. Please check the cables regularly. If the cables are damaged, please stop
using it.

7
pressure, or under any unhealthy conditions.
● On patients with sensitive physical conditions, ringworm, dermatitis,
and any infectious disease.
●
infants/small children, mentally disabled individuals, individuals under
● Product should not be applied on the following areas: any wounds, the
mouth, neuralgia (sharp painful) spots, surgical areas, sunburned skin,
sensitive skin and over skin implants made of metal, plastic or silicone
materials.
● Do not use with other electronic equipment, such as ECG machine etc.,
even if this device conforms to the EMC requirements.
3. DO NOT use on the thoracic region if you have a pacemaker.
4. DO NOT use on areas where malignant tumors are present.
5. DO NOT use on the areas of blood inhibited tissue, because there is not
enough blood supplied to the area to meet the metabolic demand, and
this could result in tissue necrosis (tissue death).
6. DO NOT use the device on persons with bleeding issues/disorders.
7. DO NOT use on areas under anesthesia.
WARNING
●Use of controls or adjustments to performance of procedures other
ultrasonic energy.
Part Quantity
UT1032
Adapter
User manual
Ultrasound gel
1
1
1
1
PACKAGE CONTENTS

8
1. All the ultrasound parts are assembled and tested under strict process
controls.
2. To ensure quality, the device has been designed with a single chip
microprocessor.
3. Precious alloy round‐headed probe creates a smooth surface on the skin.
4. The device has an attractive exterior and was ergonomically designed so
5. Single-button control, microcomputer makes the device easy to use.
6. Designed with three output intensities and three treatment time
selections to meet a wide range of therapy requirements.
7. The device has a head warming feature that pre-heats the sound head
applicator for increased patient comfort.
SPECIAL FEATURES
PARTS OF THE DEVICE
(1) TIME INDICATOR LIGHT
(2) TIME BUTTON
(3) POWER INDICATOR LIGHT
(4) INTENSITY INDICATOR LIGHT
(5) MODE BUTTON
(6) POWER SWITCH
(7) ULTRASOUND HEAD

9
●
●
●
UT1032 requires the following steps for proper setup:
1. Ultrasound transmission gel is required when treating a patient with the
UT1032 portable ultrasound device.
2. The AC/DC adapter is required to power the device. No battery is used.
3. Join the male connector of the AC/DC adapter to the female connector of
adapter into a wall outlet to power the unit. The UT1032 is now ready for
treatment.
4. Follow the “INSTRUCTIONS FOR USE” section of this manual.
WARNING
The device can only be used safely with the original adapter it came
with.
DO NOT re-assemble or change the specication of the adapter.
Doing so may cause damage to the unit and/or personal injury.
Be sure to follow the specic assembly instructions stated above.
Wall Outlet
Ultrasound
Unit
AC/DC
Adapter
Secure
Connectors

10
Please read this instruction manual carefully before using the UT1032
Portable Ultrasound Unit.
1. Turning on the device and head warming feature:
Turn the device on by sliding the power switch upwards
(towards “ON”). The power indicator light will illuminate.
The device will automatically enter the preheat mode.
period.
When the preset temperature is reached or the maximum preheat time has
ended (3 minutes), all of the indicators lights will flash five times. Once
complete, the device enters standby mode. This head warming feature takes
If the warming feature is not needed, press both the “MODE” button and the
“TIME” button simultaneously. The device will go back to standby mode.
When the device is in standby mode, the modulation duty cycle is defaulted
at 5% and the (L) indicator light will be illuminated.
WARNING: During the head warming period, the following items
should be noted:
●The device will automatically exit the head warming feature if any
load is detected in the preheating process. Therefore, do not apply
the ultrasound head to the patient during the warming period.
●
and turn it back on again.
INSTRUCTIONS FOR USE
2. Apply transmission gel:
Wash the area to be treated so that it is free of oil and
dirt. Apply a generous layer of ultrasound transmission
gel on the treatment area. The gel acts as a coupling
should be two times the diameter of the sound head.

11
After completing the treatment session, the device will
power switch downwards (towards “OFF”). Unplug the
unit from its power source.
5. Place sound head on treatment area and begin
treatment:
over the skin surface of the treatment area. Apply the
sound head evenly (in time) over the treatment area
(see page 11 for Load Detection System Caution).
7. Clean the device after every use:
probe with a wet towel or soft tissue. Do not immerse
the device in water. Always store device in its
protective case at room temperature in a dry location.
3. Set ultrasound intensity:
Press the “MODE” button to select the modulation duty
cycle. The mode button has three levels, Low (L) - 5%,
Medium (M) - 50% and High (H) - 100%, each level
corresponds to a LED light indicator.
4. Set treatment time:
Press the "TIME" button to cycle through the treatment
time (5, 10 and 15 minutes), as shown by the “TIME”
indicators. When the time is chosen, the system will
start working. During working time, the user can press
the "TIME" button to adjust the treatment time.

12
1. The device has a load detection system for safety. When the treatment
head does not have good contact with the skin, the device will stop
treatment automatically, and the time indicator light will flash one time. The
device will not continue the treatment program until good contact is made.
2. The device has a temperature protection function. When the temperature
of the treating head exceeds 107°F (42°C), the treatment will automatically
stop and the time indicator light will flash two times. The device will not
continue the treatment program until the temperature is below 104°F (40°C).
LOAD DETECTION SYSTEM CAUTION:
MAINTENANCE
be cleaned with a damp cloth. Use lukewarm water and a non-abrasive liquid
household cleaner (no abrasive, no alcohol content solution). If a more sterile
cleaning is needed, use a cloth moistened with an antimicrobial cleaner.
CAUTION: Do not submerse the device in liquids. Should the unit accidentally
become submersed, contact the dealer or Authorized Service center
immediately. Do not attempt to use the device that has been submersed in
any liquid substrate until inspected and tested by a Service Technician
Cleaning of the applicator
The applicator should be regularly inspected for damage, e.g. hairline cracks,
which could allow the penetration of liquids. Clean the contact surface
immediately after each treatment. Make sure that no ultrasound gel remains
on the applicator. We further recommend cleaning the head, cable and
adapter daily, using a soft cloth damped with lukewarm water. The applicator
can be disinfected using a cloth moistened with an antimicrobial cleaner.

13
The device is manufactured through complete quality assurance system. If
your device does not seem to be operating correctly, refer to the chart
below to determine what may be wrong. Should none of these measures
correct the problem, the device should be serviced.
Problem Possible Cause Solution
POWER LED
fails to
light up
POWER LED is
performing
normally,
but no output
function occurs.
TROUBLESHOOTING
The plug of the adaptor is
not inserted into the
socket properly.
The DC plug of the
adaptor is not inserted
into the DC receptacle on
the device correctly.
Did not press the ON/OFF
button.
Insert the plug of the
adaptor into the socket
again.
Connect the adaptor
with the device again
correctly.
Press the ON/OFF
button again.
Output intensity button
setting is incorrect.
Please make sure and
set it again.
When not in use, store the device with the adapter in a dry room and protect
it against extreme moisture, heat and direct sunlight. Never place any heavy
objects on the storage case.
● Storage and transportation conditions:-20°C-55°C;
10%-93%; 700-1060hPa
STORAGE CONDITIONS

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UNIT SPECIFICATIONS
MODULATION
DUTY FACTOR
5%
50%
100%
WAVE CHARACTER
Low
Medium
High
OUTPUT POWER
0.32W ±20%
3.20W ±20%
6.40W ±20%
PROGRAM
L
M
H
Ultrasound
Probe
Ultrasound Modulation Frequency:
Max. Output Power:
Output Power:
Pulse Repetition Rate:
Modulation Duty Cycle:
Waveform:
RBN (Max):
Working Time:
Preheat Temperature:
Preheat Time:
Dimension:
Weight:
Material of Applicator:
Beam Type:
Degree of Protection against Water:
Input:
Output:
Time:
Mode:
Time Indication Lights:
Duty Cycle Indication Lights:
Item Description
1.0MHz±10%
6.4W±20% (Modulation duty cycle at100%)
L: 0.32W±20% M: 3.20W±20% H: 6.40W±20%
100Hz±10%
L (5%), M (50%), H (100%)
4.0cm²± 20%
Pulsed, Continuous
5.0
1.6W/cm2±20% (Modulation duty scycle at 100%)
L: 0.08W/cm2±20% M: 0.80W/cm2±
H:1.60W/cm2±20%
Adjustable at 5 minutes, 10 minutes, 15 minutes
Max. 35±5 degree centigrade (NOTE: Actual preheat temperature
will be inuenced by the environmental temperature and preheat time.)
Max. 3 minutes
202 mm (L) x 49 mm (W) x 70 mm (H)
193g (without adapter)
Aluminum Alloy
Collimated
IPX7 (Only for Treatment Head)
Voltage: AC 100-240V, 50/60Hz, 0.5A
Output voltage: DC 15V, Max. Currency: 1.2A
Choose working time: 5min — 10min —15min
—0min (stop)
Choose modulation duty cycle: 5% —50% — 100%
5, 10, 15 minutes
Low (L), Medium (M), High (H)
Power
Adapter
Indication
Lights
Buttons
Program
Lists
Operating Conditions: 5°C ~ 40°C; 30% ~ 75%RH; 800~1060hPa
Service life: 2 years; Safety class: Class II,type BF
Beam type:
Pulse duration:
collimated
0.5ms,5ms,10ms

15
IPX7
GLOSSARY OF SYMBOLS
DISPOSAL
LOT
SN
Type BF Applied Part
Class II equipment
Disposal in accordance with Directive 2012/19/EU (WEEE)
Refer to instruction manual
temporary immersion in water.
Serial number
Batch code
Consult the instructions for use for important cautionary
information such as warnings and precautions
Keep dry
Date of manufacture
The name and the address of the manufacturer
The name and the address of the Authorized EC-
representative in Europe
The device contains materials that can be
recycled and/or are noxious to the environment.
When you dispose of the unit, nd out about local
regulations concerning waste management.
Complies with the European Medical Device Directive
(93/42/EEC) and amended by directive 2007/47/EC
requirements. Notied body TÜV Rheinland (CE0197)

16
IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC
COMPATIBILITY (EMC)
With the increased number of electronic devices such as PC’s and mobile
(cellular) telephones, medical devices in use may be susceptible to
electromagnetic interference from other devices. Electromagnetic
interference may result in incorrect operation of the medical device and
create a potentially unsafe situation.
Medical devices should also not interfere with other devices. In order to
regulate the requirements for EMC (Electro Magnetic Compatibility) with the
aim to prevent unsafe product situations, the IEC60601-1-2 standard has
been implemented. This standard denes the levels of immunity to
electromagnetic interferences as well as maximum levels of electromagnetic
emissions for medical devices.
Medical devices manufactured by Shenzhen Dongdixin Technology Co., Ltd.
conform to this IEC60601-1-2 standard for both immunity and emissions.
Refer to EMC table guidance supplied in this manual regarding the EMC
environment in which the device should be used.
The device needs to be installed and put into service in accordance with the
information provided in the instruction.
Special precautions need to be observed:
Shenzhen Dongdixin may result in increased emission or decreased
immunity of the device.
• Care must be taken when operating this device adjacent to or stacked
with other equipment. Potential electromagnetic or other interference
could occur to this or other equipment. Try to minimize this interference
by not using other equipment in conjunction with it.
• The performance of the device was determined to be essential
performance. This device has been thoroughly tested according to tested
and inspected to assure proper performance and operation.
ELECTROMAGNETIC COMPATIBILITY (EMC)

17
Guidance and manufacturer’s declaration - electromagnetic emissions
Emissions test Compliance Electromagnetic environment - guidance
The UT1032 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.
The UT1032 device is suitable for use in all
establishments including domestic and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
lEC 61000-3-2
Voltage
lEC 61000-3-3
Group 1
Class B
Class A
Applicable
the user of the UT1032 shouldassure that it is used in such an environment.
UT1032

18
Guidance and manufacturer’s declaration - electromagnetic immunity
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic
environment - guidance
Floors should be wood,
are covered with synthetic
material, the relative humidity
should be at least 30%.
Electrostatic
Power
frequency
(50Hz/60Hz)
magnetic eld
IEC 61000-4-8
discharge (ESD)
lEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
the user of the UT1032 should assure that it is used in such environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power
supply lines,
±1kV for input/
output lines
±2kV for power
supply lines,
±1kV for input/
output lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1kV for line(s)
to line(s), ±2kV
for line(s) to earth
±1kV for line(s)
to line(s), ±2kV
for line(s) to earth
30 A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
30 A/m
Power frequency magnetic
elds should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
Mains power quality should be
that of a typical commerical or
hospital environment. If the
user of the device requires
continued operation during
power mains interruptions, it
is needed that hte device be
powered from an
uninterruptible power supply.
Voltage dips,
short
interruptions
and
voltage
variations
on power
supply
input lines
IEC 61000-4-11
<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 UT) for
5 seconds
<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 UT) for
5 seconds
TABLE 2
UT1032 customer or

19
Conducted RF
lEC 61000-4-6
Radiated RF
lEC 61000-4-3
10 V/m
80 MHz to
2.7 GHz
3 Vrms
150kHz to
80 MHz
10 V/m
80 MHz to
2.7 GHz
3 Vrms
150kHz to
80 MHz
Portable and mobile RF communications
equipment should be used no closer to any part
of the UT1032 device, including cables, than the
recommended seperation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended seperation distance:
d=1.2√P
d=1.2√P , 80MHz to 800MHz
d=2.3√P , 800MHz to 2.7GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and dis the
recommended separation
distance in meters (m).
determined by an electromagnetic site surveya,
should be less than the compliance level in each
frequency rangeb.
Interference may occur in
the vicinity of equipment marked
with the following symbol:
NOTE I: At 80 MHz ends 800 MHz the higher frequency range applies.
a
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
the location in which the device is used exceeds the applicable RF compliance level above, should be
observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the device.
b
i]V/m.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic
environment - guidance
Guidance and manufacturer’s declaration - electromagnetic emissions
the user of the UT1032 should assure that it is used in such an environment.
TABLE 3
UT1032
19

Recommended separation distances between portable and mobile RF communications equipment and the
device
Rated maximum output
power of transmitter W
0.01
0.1
1
10
100
0.12
0.37
1.17
3.69
11.67
0.12
0.37
1.17
3.69
11.67
0.23
0.74
2.33
7.38
23.33
Separation distance according to frequency of
transmitter m
150 kHz to
80 MHz
d=1.2√P
80 MHz to
800 MHz
d=1.2√P
800 MHz to
2.7 GHz
d=2.3√P
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 I 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
people.
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 as
recommended below, according to the maximum output power of the communications equipment.
TABLE 4
20