Dongdixin Technology LT2061 Incontinence Treatment Device User Manual SMS LT2061 MDDX 17420

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Incontinence Treatment Device
LT2061 USER MANUAL
This manual is valid for the Incontinence Treatment Device LT2061
This instruction manual is published by Shenzhen Dongdixin Co.,Ltd.
Shenzhen Dongdixin Co.,Ltd. reserves the right to improve and amend this manual at any time
without prior notice. Amendments may however be published in new editions of this manual.
All Rights Reserved. Rev. V 1.0 © 2017, 20170213
Conformity to safety standards
Shenzhen Dongdixin Co.,Ltd. declares that the device complies to the following normative documents:
IEC60601-1, IEC60601-1-2, IEC60601-2-10, IEC62366, IEC60601-1-11
ISO10993-5, ISO10993-10, ISO10993-1, ISO7010
TABLE OF CONTENTS
1. Introduction .......................................................................................................................... 5
1.1 Feature .......................................................................................................................... 5
1.2 Intended Use ................................................................................................................ 5
2. Important Safety Precautions and Warning ........................................................................... 6
2.1 Contraindications .......................................................................................................... 6
2.2 General Warnings .......................................................................................................... 6
2.3 Caution ......................................................................................................................... 8
2.4 General Precautions ..................................................................................................... 8
2.5 Installation and Usage Precautions ................................................................................ 10
3. Product overview .................................................................................................................. 11
4. Preparing for use .................................................................................................................. 12
4.1 Indicator Description ...................................................................................................... 12
4.2 Power on/off ................................................................................................................. 13
4.3 Charging ....................................................................................................................... 13
4.4 Installing and setting up the Treatment App ................................................................... 13
5. Instructions for use .............................................................................................................. 15
5.1 vaginal probe to use ....................................................................................................... 15
5.2 APP to use .................................................................................................................... 17
6. Cleaning .............................................................................................................................. 22
7. Specifications ...................................................................................................................... 23
8.Troubleshooting .................................................................................................................... 27
9.Maintenance ......................................................................................................................... 28
10.Disposal ............................................................................................................................. 29
11.Glossary of symbols ........................................................................................................... 29
12.EMC ................................................................................................................................... 31
13.Warranty ............................................................................................................................. 42
1. Introduction
Congratulations on your purchase and welcome to Dongdixin ! Read this user manual carefully before you
use the incontinence treatment device. To achieve optimal treatment success with LT2061, we recommend
that you use it according to the treatment instructions in this user manual. If you need further information or
have questions, please contact with us.
1.1 Feature
The LT2061 is a ME system. the ME EQUIPMENT is the main device（vaginal probe）, the non-ME
EQUIPMENT including the storage case and the adapter . Features are shown below:
Through the Bluetooth to achieve wireless control, and makes it convenient to use.
The main device contains electrical stimulation teat, kegel exercise and vibration massage three functions,
Not only
can be used for treatment also can bring pleasure to you.
Ergonomic design, effectively prevent the vaginal probe off and rotation, to ensure that treatment effect.
The flange part is wrapped with silicone to ensure a comfortable touch when Treatment.
The waterproof level rating of the main device reaches IP56, to ensure that convenient to clear.
Special storage case, set of charging and admission for one, improved privacy and at the same time, also
ensure that the probe is clean and sanitary.
1.2 Intended Use
This device is used for the treatment of stess, urge and mixed urinary incontinence, weakening of the pelvic
floor muscles and pain relief.
2. Important Safety Precautions and Warning
It is important that you read all the warning and precautions included in this manual because they are
intended to keep you safe, prevent injury and avoid a situation that could result in damage to the
device.
2.1 Contraindications
This stimulator must not be used in combination with the following medical devices:
Internally transplanted electronic medical devices, such as a pacemaker.
Electronic life support equipment, such as respirators.
Electronic medical devices attached to the body, such as electrocardiographs.
Using this stimulator with other electronic medical devices may cause erroneous operation of those
devices.
2.2 Warning
DO NOT USE THIS DEVICE UNDER THESE CONDITIONS:
Consult with your physician before using this device, because the device may cause lethal rhythm
disturbances in certain susceptible individuals.
Pregnant women must not be treated with this device.
People with extra-urethral incontinence (fistula, ectopic ureter) must not be treated with this device.
People with overflow incontinence due to outflow obstacle must not be treated with this device.
People with serious retention of urine in the upper urinary tract must not be treated with this device.
People with complete peripheral denervation of the pelvic floor must not be treated with this device.
Do not use this device for treatment during menstruation, vaginal or urinary tract inflammation or infection.
The vaginal probe and silicone sleeve for single patient use, in order to avoid mutual infection, do not
cross-use.
Stimulation should not take place while the user is connected to high-frequency surgical equipment, it may
cause burn injuries on the skin under the electrodes, as well as problems with the stimulator.
Do not use the stimulator in the vicinity of shortwave or microwave therapy equipment, since this may
affect the output power of the stimulator.
DO NOT USE ON THESE INDIVIDUALS
Pregnant women, because the safety of electrical stimulation during pregnancy has not been established.
Children or infants, because the device has not been evaluated for pediatric use.
Persons incapable of expressing their thoughts or intentions.
DO NOT USE THIS DEVICE DURING THESE ACTIVITIES
When in the bath or shower;
While sleeping;
While driving, operating machinery, or during any activity in which electrical stimulation can put you at risk
for injury.
2.3 Caution
The LT2061 device is intended for use by one person. Do not share with another person.
Patients with total/subtotal prolapsed uterus/vagina should be stimulated with greatest caution.
Patients with urinary tract infections must be treated and clear of infection before starting therapy with this
device. Consult your doctor.
If tissue irritation should occur, treatment should be temporarily discontinued. if problems continue,
Contact your health care provider. Hypersensitivity can occur in isolated cases. The problem usually
disappears when the LT2061 device or the silicone sleeve changed to another type.
Always turn the power off before removing or changing the location.
If the stimulator is not functioning properly or you feel discomfort, immediately stop using the device.
Do not use for any other purpose except for what it is intended for.
Dispose of the device, batteries, and components according to applicable legal regulations. Unlawful
disposal may cause environmental pollution.
The service life of the device may vary by the frequency of washing,vaginal condition, and storage state.
Be careful to strangulation due to cables and hoses, particularly due to excessive length. Keep unit out of
the reach of young children/pets. The electrode cord can cause strangulation.
The typical service life of the main device, the adaptor and the charging box is 2 years; and the silicone
sleeve is 1 years.
2.4 General precautions
Inspect the equipment prior to use.
The long-term effects of electrical stimulation are unknown.
If you have suspected or diagnosed heart disease, you should follow precautions recommended by your
physician.
If you have suspected or diagnosed epilepsy, you should follow precautions recommended by your
physician.
Use caution if you have a tendency to bleed internally, such as following an injury or fracture.
Consult with your physician prior to using the device after a recent surgical procedure, because stimulation
may disrupt the healing process.
This stimulation should not be applied over the menstruating or pregnant uterus.
After use, the part of electrode contact with human and silicone sleeve should be cleaned.
Keep unit away from young children. The unit contains small pieces that may be swallowed. Immedi
ately contact your physician.
Use this device only with the silicone sleeve, adaptor and storage case recommended by the manufactuer.
Do not maintain or service the device while the device is in use.
Do not modify this device without authorization of the manufacturer.
Do not use the device if it is damaged. The continuous use of a damaged unit may cause injury, improper
results, or serious danger.
Do not store the device to extreme temperature (below -10°C or over 50°C) (at least 30 min required of
equipment to warm from the minimum storage temperature between uses until it is ready for intended use
at least 30 min required for me equipment to cool from the maximum storage temperature between uses
until it is ready for intended use)or extreme humidity (below 0%RH or over 93%RH). Failing to do so may
affect the performance of the stimulator.
Please report to your agency if any unexpected operation or events occur.
If you have any problems with this device, such as setting up, maintaining or using, please contact
with SERVICE PERSONNEL of SDT.
changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority
to operate the equipment.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of
the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can be determined by turning
the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following
measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may
not cause harmful interference, and (2) this device must accept any interference received, including interference that may
cause undesired operation.
10
You should stop using the device and consult with your physician if you experience adverse reactions from
the device.
The materials (e.g. ABS) of expect contact with patient had passed the ISO 10993-5 and ISO10993-10
standards test, no toxicity, allergy and irritation reaction. However, based on the current science and
technology, other potential allergic reactions are unknown. If you have allergic reaction to materials, please
stop treatment immediately and consult your physician.
2.5 Installation and Usage Precautions
Before use, check and ensure the main device and all accessories are intact.
If you feel any discomfort, stop treatment immediately.
Placed the storage case away from splashing water.
Connect the main device and APP correctly and securely.
Always adjust the output intensity in the comfort level. If you feels uncomfortable, adjust the output
intensity or stop treatment.
Do not use gasoline, hot water or chemicals to clean the main device and accessories. Use a dry cloth to
clean accessories.
Vaginal Probe can be reused, but should be cleaned it after use, and single patient use only.
10
3. Product overview
Storage and
charge case
Your LT2061 is supplied with a gift box containing:
No.
Description
Main device/Vaginal probe
Storage case
Adaptor
User manual
Main device/
Vaginal probe
Charging contact
Silicone massage part
Power Key
and indicate
Charging
indicator
Stainless steel
electrode
11
Micro-USB socket
4. Product overview
4.1 Indicator Description
LT2061 have two different indicator light, one is orange / blue light on the vaginal probe, other one is
orange/green light on the charging case.
1. What’s the function of indicator light on probe?
When device is turn on and without connect Bluetooth , blue light is flash；
When device successful connect with Bluetooth, blue light keep turn on；
Orange light means with low battery, it will flash 10s then device will turn off。
2. What’s the function of indicator light on the charging case?
Still under charging mode---Orange light；
Charging completed---Green light；
When probe is not good place, green light will last for long time and orange light will flash, you should
better to replace probe in charging case and connect USB cable again.
12
4.2 Power on/off
1. Power on
Take the main device from the shortage case, turn on the main device by press Power key, blue light will
flash, device is under standby mode.
2. Power off
Device will automatic power off when there is no connecting Bluetooth within 5 minutes under standby
mode or connection after 5 minutes without treatment；
In the Power on mode，turn off the main device by Long press the power button.
When orange light is flash to indicate lower battery, device will power off after 10s.
Remark: App also can pop up a tips to remind low battery during working time
4.3 Charging
To be able to use the device, you first have to charge it. Charging the device takes approx. 3 hours at room
temperature. When the Lithium-ion battery is fully charged, it contains sufficient energy for use about four
times electrical stimulation treatment .
Note:
If the device is not fully charged when you start a treatment, the battery may run out during the treatment.
Treatment is not possible when the device is charging.
To ensure normal use, please charge before the first time use!
If the indicator light turn to orange, or the APP prompt that the batter is in empty state, please charge.
13
if the battery cannot charge the power normally or the blood pressure monitor cannot use normally,
please connect with the authorized maintenance personal.
Under the normal using, it can charge power about 300 times,and the battery is fully charged, it can
be used for about 2 hours for vibration and 4 hours for EMS.
1. Place the main device to the storage case correctly.
2. Insert the micro-USB plug of the adapter cable into the micro-USB socket of the storage case.
3. Insert the USB plug into the socket of the adapter and insert the adapter into a wall socket.
Note:
Insert the USB plug into a wall socket that is properly accessible so that the USB plug can be removed
easily. The device is only connected to the mains during charging
When charging,the indicator light of the storage case turn to orange,and it will turn to green when the
battery is in full state.
4. When charging is finished,remove the micro-USB plug from the microUSB socket of the storage case.
Note:
The USB socket may only be used for charging with the adapter supplied .Do not use this socket for any
other purpose.
If you do not use the device for a long time,please charging every 2~3 months.
14
4.4 Installing and setting up the Treatment App
Note: System requirement IOS 7.0 +;
Internet download
In the APP Store, customer can search “My pelvic” to download app;
Scan QR code
Scan the QR code on gift box or the QR code below.
5. Instructions for use
5.1 Use the Main device
1. Remove the main device from the storage case, turn on the main device by press power key, and the
indicator light turn to blue flashing. The main device is in standby mode.
Note:
If the indicator light turn to orange flashing, it means it need charge.
If you can’t turn on the main device, please try again after charging.
2. Cleaning of the device by use clean water；
3. Try to use a comfortable treatment gesture, for example, you can lay on the bed；
4. First of all, to make sure device is power on, slowly and gently insert into vaginal cavity until the flange at
the base of electrode is located between labia. Make sure no bare metal of pins is exposed ( If vaginal
environment is dry, a approved thin coating of lubricating gel is suggested, don’t use cream or lubricating
oil, because lubricating gel should be conduct electricity).
15
Insert depth，position of labia
Bare metal need to touch on
right and left sides of body.
Remark:
When customer do electrical stimulation and Kegel exercise , vaginal probe have to be in requested
position. If not, it will influence treatment result.
During vibration mode, people can hold the handle by hand.
5. Open the APP, device will connect with APP automatically.
Note:
People need to charge the vaginal probe at first use time.
The electrode probes are designed for single patient use only.
Please keep clean of vaginal probe, it should be cleaned before first use and after each use.
16
5.2 APP operation
1. Open the Blue tooth mobile device;
2. Find App named “My pelvic”, sign as below:
3. Your mobile need to be bound to device at first time before use,
please check below picture, press “select for binding”, then you
can reach main interface. You can enter to main interface directly
during next time of treatment.
4. After you successful bind your mobile phone with our device, when
device is power on, Deice can connect with your phone automatically.
When devices correct connect with APP, the sign on the top right of
interface will turn to the sign like this:
Remark: If you are fail to connect the device, please check device is power
on or not, or you can double check Blue tooth on APP is open or not.
17
5. Pelvic floor electric stimulation treat
Press“Treat”button to enter into treatment choose interface, it shows as below picture,
please select different program based on different symptom :
Remark：There are 7 pre-set programs as below:
Stress Incontinence
Urge Incontinence
Mixed Incontinence
Pain Relief
Lack of Sensitivity
Pelvic Floor Work Out
Frequency
18
Press the specific treatment procedures , enter the treatment
display interface, As shown below:
Work /Rest indicator of stimulator
The phase prompt of this program
pause button.
increase intensity
decrease intensity
output intensity
treatment time
Press start treatment. Next，press “+” or “-” to adjust the intensity
Remark：
At operating mode, you can press to pause treatment. Then，you can
press again to continue treatment，also can press “End”to end of
treatment.
If APP pop-out an error tips as “Poor contact” during working time, maybe
it caused by Vaginal dryness, we suggest to use a thin coating of lubricating
to avoid this error tips. Below picture for your reference.
19
Press the specific treatment procedures ，enter the treatment display interface,
As shown below:
Customer can adjust the intensity based on their own bearable stress, if people feels comfortable and no
pain when she contraction and relax the muscle of Pelvic floor during treatment at some intensity, she can
use this intensity to do treatment.
The output intensity of stimulation may be adjusted depending upon the individual requirement of the user.
After a long time use, user need to increase intensity to get best treatment effect.
6. Kegel Exercise
Press“Exercise”button to enter into Kegel exercise program:
Remark：There are 2 pre-set programs and 2 self- setting program.
Pre-set program as below.
1 Speed Kegel（use for fast muscle exercise）
2 Endurance Kegel（use for slow muscle exercise）
20
Press the specific treatment procedures enter into treatment display
interface,As shown below:it include the function of timer, period and
voice indicator.
Exercise time
The prompt of Kegel training
pause button
increase of Vibration strength
decrease of Vibration strength
Voice Prompt switch
Kegel exercise
guiding interface
Or user can select the self-setting program and set the
treatment parameter by themselves, they can set the
contraction /relax timeand cycle times, then press OK
button to finish setting.
User exercise interface, press “
”button to start exercise, follow
the voice or vibration intensity to contraction and relax the Pelvic muscle
(for example, vibration time to contraction pelvic and relax pelvic muscle
if there is no vibration). When user is doing contraction, it will be better
to contract urethra, anus and perineum at same time keep relax of your
ham and abdominal muscles , press “+” or “-” to adjust vibration strength.
21
Self-setting program
Remark：
When user in process of contraction, try to use pelvic muscle to against the vibration, when muscle is
weak, it will be better to decrease intensity of vibration.
When the timer is goes to ‘’0’’, treatment will be end automatically.
7. Vibration massage
Press “Massage”to enter into treatment interface.
Chose a vibration program, there are 7 pre-set mode
as below:
“Normal”,“Breeze”,“Drumbeat”,“Burst”,“Wave”,
“Ballet”and “Dodgem”.
Press “ ”button to start vibration, press “+” and“-”
button to adjust the vibration intensity .Press“ ”button
again to pause vibration.
6. Cleaning
After user finish treatment, please close the app, shutdown the device, clean the device with clean water or
mild soap water, keep the Main device and the Silicone Sleeve clean and dry, store the device in the storage
case for next treatment.
Cautions：Clean the main device and silicone sleeve by soap water and wiping them with dry cloth，do not
cleaning with boiling water or corrosive cleaning agents.
22
7. specifications
Model
LT2061
Rated input - adapter
100-240V
Rated output - adapter
5V 0.3A
frequency (Hz) - adapter
50/60Hz
Class Medical –the main device
Class IIa
Ingress of water - the main device
IP56
Battery type - the main device
3.7V /200mAh Li-ion
Size- the main device
Ф31mm*128.5mm
Weight- the main device
50g
Service life of the device
2 years
23
TENS output parameters
Frequency range
2~100Hz（±10%）
pulse width range
50~350us（±10%）
Maximum output voltage
80V
Output Intensity Level
0~80 levels
Treatment time
1~99minutes
Kegel output parameters
Contract time
1-99S
Relax time
1-99S
cycle period
1-99S
Preset programs
4（Contains 2 custom modes）
24
Massage output parameters
Output Intensity Level
1~10 levels
Preset programs
Working noise
<40dB(Measuring distance is 50cm)
Operating conditions
Temperature
Relative humidity
Atmospheric pressure
Wireless maximum
separation distance
Wireless recommended
separation distance
From +5°C to +40°C
From 15% to 90% non-condensing, but not requiring a water vapour partial
pressure greater than 50hPa.
From 700hPa to 1060hPa
10m (In the opened environment )
3m
25
Storage and transport conditions
Temperature - device
-10°C to + 5 °C, and + 5 °C to +35 °C at a relative humidity up to 90 %,
non-condensing;+ 35 °C to 50 °C at a water vapour pressure up to 50hPa
Relative humidity
from 0% to 93% non-condensing
Atmospheric pressure
from 700hPa to 1060hPa
Bluetooth features
RF Frequency
2.4GHZ-2.48GHZ
Channel Bandwidth
2 M H z (-20db)
Types of spread spectrum
FHSS
Modulation type
GFSK
Number of channel
40
Channel spacing
2 MHz
Channel frequency
0-39 Channel 2.402-2.480GHZ
Dwell time (if FHSS)
400ms
Hopping rate (if FHSS)
1600HZ
Maximum Output Powers
0dBm
26
8. Troubleshooting
Problem
LED of the main device turn to
orange flashing, and then turn
off automatically
LED of the main device turn
to orange flashing in the
workingmode
Stimulation is
uncomfortable
Possible solution
Check points
The battery is exhausted
Charging in time
low power
Battery less than 25%，
after use，charging in time
Is the intensity too high or
too low?
Adjust the output intensity
The electrode poor contact
with vaginal of subject
Use a lubricant
The placement of the
vaginal probe is not correct
Adjust the placement according to this
USER MANUAL
27
9. Maintenance
1. Maintenance and all repairs should only be carried out by an authorized agency. The manufacturer will
not be held responsible for the results of maintenance or repairs by unauthorized persons.
2. The user must not attempt any repairs to the device or any of its accessories. Please contact the retailer
for repair.
3. Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to
warranty.
4. Check the device before each use for signs of wear and/or damage. Replace wear items as required.
5. In order to ensure the safety and effectiveness of the use, please use the main device and accessories
provided by the manufacturer.
6. If you do not use the machine for a long time, to ensure lithium battery performance, please charging
every 2~3 months.
28
10. Disposal
Please dispose of the device in accordance with the directive 2012/19/EU –WEEE (Waste of
Electronic Equipment). If you have any queries, please refer to the local authorities
responsible of waste disposal.
11. Glossary of symbols
Disposal in accordance with Directive 2012/19/EU (WEEE)
Type BF Applied Part
Refer to instruction manual.
0197
Complies with MDD 93/42/EEC and amended by directive 2007/47/EC requirements.
Notified body TÜV Rheinland (CE0197)
29
IP20
Only for storage case,The first number "2": Protected against solid foreign objects of
12,5 mm Ф and greater.The second number "0 ": non water-proof.
IP56
Only for main device/probe.Protect against the effects of powerful water jets.
SN
Represent the manufacture date and Serial number.
The name and the address of the manufacturer
The name and the address of the Authorized ECrepresentative in Europe
50 C
Transportation and storage temperature from -10℃to 50℃
-10 C
93%
Transportation and storage humidity limits from 0% to 93%
0%
106.0KPa
Transportation and storage atmospheric pressure limits from 70.0 kPa to106.0 kPa
70.0KPa
30
12. Electromagnetic emissions and immunity
Electromagnetic Compatibility (EMC)
1. This product needs special precautions regarding 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 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.
Refer to further guidance below regarding the EMC environment in which the device should be used.
31
Table 1
Guidance and manufacture’s declaration – electromagnetic emission
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.
Emission test
Compliance
RF emissions
CISPR 1
Group 1
RF emission
CISPR 11
Class B
Electromagnetic environment – guidance
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.
32
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
Complies
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.
33
Table 2
Guidance and manufacture’s declaration – electromagnetic immunity
The DEVICE is intended for use in the electromagnetic environment specified below. The customer or
the user of DEVICE should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±8 kV contact
±15 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%.
Electrical fast
transient/burst
IEC 61000-4-4
±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.
34
Electromagnetic
environment - guidance
Surge
± 1 kV line(s) to
±1 kV differential
Mains power quality should be
IEC 61000-4-5
line(s)
± 2 kV line(s) to earth
mode
that of a typical commercial
or hospital environment.
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
l<5% UT
(>95% dip in UT)
for 0.5 cycle
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
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 sec
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
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.
35
Power frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
3 A/m
30 A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
36
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
Table 4
Guidance and manufacture’s declaration – electromagnetic immunity
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.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment guidance
Portable and mobile RF
communications equipment
should be used no closer to any
part of the DEVICE, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
37
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 V RMS outside
the ISM band,
6 V RMS in the
ISM and amateur
radio bands
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
38
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:
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.
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.
39
Table 5
Recommended separation distances between
portable and mobile RF communications equipment and the DEVICE .
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.
Rated maximum
output power of
transmitter(W)
transmitter
(W)
Separation distance according to frequency of transmitter (m)
150 KHz to 80 MHz
80 MHz to 800 MHz
40
800 MHz to 2.5 GHz
1
10
0.12
0.38
1.2
3.8
0.12
0.38
1.2
3.8
0.23
0.73
2.3
7.3
100
12
12
23
0.01
0.1
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.
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
babsorption and reflection from structures, objects and people.
41
13. Warranty
Shenzhen Dongdixin Technology Co., Ltd., provides a warranty to the original purchaser that this product
will provide for a period of 1 years from the date of purchase.
In advance. the liability of Shenzhen Dongdixin Technology Co., Ltd., under this limited product warranty
does not extend to any misuse or abuse such as dropping or tampering with the device or normal wear
and tear. Any evidence of tampering will nullify this warranty.
42
Name: Shenzhen Dongdixin Technology Co.,LTD.
Add: NO.3 Building XiliBaimang Xusheng Industrial
Estate,518108 Nanshan,Shenzhen China
Tel: 0086-755-27652316
E-mail: serivce@nutekmedical.com
www.nutekmedical.com
Shanghai International Holding Corp. GmbH (Europe)
Eiffestraße 80, 20537 Hamburg Germany
Tel: 0049-40-2513175 Fax: 0049-40-255726
Copyright 2017 by Shenzhen Dongdixin
Technology Co.,LTD.
Edition:V1.0

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