Kinetik Wellbeing TMB-1970 User manual

User Manual
Fully Automatic Blood Pressure Monitor
Thank you so much for selecting the Kinetik Wellbeing Fully Automatic
Blood Pressure Monitor
Please read the user manual carefully and thoroughtly so as to ensure
the safe usage of this product. Keep the manual safe for future reference
in case you have problems.
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development
District, 528437 Zhongshan, Guangdong, China
EC REP Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany Kinetik TMB-1970 UK IB 20210901
Arm Type
TMB-1970

1
TABLE OF CONTENTS
INTRODUCTION...................................................................................................................3
SUPPORT.............................................................................................................................2
General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
LCD Display Signal
Monitor Components
List
BEFORE YOU START...........................................................................................................10
Installing and Replacing the Batteries
Setting the Date and Time
About User ID
MEASUREMENT...................................................................................................................14
Tie the Cuff
Start the Measurement
DATA MANAGEMENT...........................................................................................................16
Recall the Records
Delete the Records
INFORMATION FOR USER..................................................................................................19
Tips for measurement
Maintenance
ABOUT BLOOD PRESSURE................................................................................................21
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular heartbeat detector
Why does my blood pressure fluctuate throughout the day?
Why do I get a different blood pressure at home compared to the hospital?
Is the result the same if measuring on the right arm?
TROUBLESHOOTING..........................................................................................................23
SPECIFICATIONS.................................................................................................................24
CONTACT INFORMATION....................................................................................................25
EMC GUIDANCE...................................................................................................................26

INTRODUCTION
2 3
The Kinetik Blood Pressure Monitor is a digital monitor intended for use in
measuring blood pressure and heartbeat rate with arm circumference ranging
from 22 cm to 42 cm (about 8¾˝-16½˝).
It is intended for adult indoor use only.
Measurement Principle
Thank you for selecting Kinetik arm type blood pressure monitor
(TMB-1970). The monitor features blood pressure measurement, pulse
rate measurement and the result storage. The design provides you with
two years of reliable service.
Readings taken by the TMB-1970 are equivalent to those obtained by
a trained observer using the cuff and stethoscope auscultation method.
This manual contains important safety and care information, and
provides step by step instructions for using the product.
Read the manual thoroughly before using the product.
Features:
Maximum 90 records
General Description
3rd technology: Measuring during inflation
52 mm × 58 mm Digital LCD display
Indications for Use
Contraindications
1.The device should not be used by any person who may be suspected of,
or is pregnant .
2.The device is not suitable for use on patients with implanted, electrical
devices, such as cardiac pacemakers or defibrillators.
This product uses the Oscillometric Measuring method to detect blood
pressure. Before every measurement, the unit establishes a “zero pressure”
equivalent to the atmospheric pressure. Then it starts inflating the arm cuff,
meanwhile, the unit detects pressure oscillations generated by beat-to-beat
pulsatile, which is used to determine the systolic and diastolic pressure, and
also pulse rate.
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:
[phone]
Live Chat:
Simply visit www.kinetikwellbeing.com and send us a message.
Email:
[email protected]
Post:
Kinetik Medical Devices Limited
Unit 3, Perrywood Business Park, Honeycrock Lane,
Salfords, Redhill. RH1 5DZ
Support
SUPPORT

The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
Safety Information
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “COMPLIES WITH
MDD 93/42/EEC REQUIREMENTS”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “DIRECT CURRENT”
Symbol for “ENVIRONMENT
PROTECTION - Electrical waste
products should not be disposed of
with household waste. Please
recycle where facilities exist. Check
with your local authority or retailer
for recycling advice”
Symbol for “MANUFACTURE
DATE”
Caution: These notes must be
observed to prevent any damage
to the device.
SN
Symbol for “RECYCLE”
INTRODUCTIONINTRODUCTION
4 5
CAUTION
* This device is intended for adult use in homes only.
* The device is not suitable for use on neonatal patients, pregnant women,patients with
implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats,
atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or
arterio-venous shunt or people who received a mastectomy. Please consult your doctor
prior to using the unit if you suffer from illnesses.
* The device is not suitable for measuring the blood pressure of children. Ask your doctor
before using it on older children.
* The device is not intended for patient transport outside a healthcare facility.
* The device is not intended for public use.
* This device is intended for no-invasive measuring and monitoring of arterial blood
pressure.It is not intended for use on extremities other than the arm or for functions other
than obtaining a blood pressure measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your
blood pressure.Do not begin or end medical treatment without asking a physician for
treatment advice.
* If you are taking medication,consult your physician to determine the most appropriate time
to measure your blood pressure. Never change a prescribed medication without consulting
your physician.
* Do not take any therapeutic measures on the basis of a self measurement. Never alter the
dose of a medicine prescribed by a doctor. Consult your doctor if you have any question
about your blood pressure.
* When the device is used to measure patients who have common arrhythmias such as
atrial or ventricular premature beats or atrial fibrillation, the best result may occur with
deviation. Please consult your physician about the result.
* Don't kink the connection tube during use, otherwise, the cuff pressure may continuously
increase which can prevent blood flow and result in harmful injury to the PATIENT.
* When using this device, please pay attention to the following situation which may interrupt
blood flow and influence blood circulation of the patient, thus cause harmful injury to the
patient: connection tubing kinking too frequent and consecutive multiple measurements; the
application of the cuff and its pressurisation on any arm where intravascular access or
therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a
mastectomy.
* Warning: Do not apply the cuff over a wound; otherwise it can cause further injury.
*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied
around simultaneously, because this could cause temporary loss of function of those
simultaneously-used monitoring ME equipment.
*On the rare occasion of a fault causing the cuff to remain fully inflated during measure-
ment, open the cuff immediately. Prolonged high pressure (cuff pressure ＞300mmHg or
constant pressure ＞ 15mmHg for more than 3 minutes) applied to the arm may lead to an
ecchymosis.
*Please check that operation of the device does not result in prolonged impairment of
patient blood circulation.

CAUTION
* When measurement, please avoid compression or restriction of the connection tubing.
* The device cannot be used with HF surgical equipment at the same time.
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER
was clinically investigated according to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact
the manufacturer.
* This device is contraindicated for any female who may be suspected of, or is pregnant.
Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
* Too frequent and consecutive measurements could cause disturbances in blood
circulation and injuries.
* This unit is not suitable for continuous monitoring during medical emergencies or
operations.Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and
even purple due to a lack of blood.
* When not in use, store the device in a dry room and protect it against extreme moisture,
heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.
* This device may be used only for the purpose described in this booklet. The manufacturer
cannot be held liable for damage caused by incorrect application.
*This device comprises sensitive components and must be treated with caution. Observe
the storage and operating conditions described in this booklet.
* The equipment is not AP/APG equipment and not suitable for use in the presence of a
flammable anesthetic mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator.
* The patient can measure data and change batteries under normal circumstances and
maintain the device and its accessories according to the user manual.
* To avoid measurement errors, please avoid the condition of strong electromagnetic field
radiated interference signal or electrical fast transient/burst signal.
* The blood pressure monitor, and the cuff are suitable for use within the patient
environment. If you are allergic to polyester, nylon or plastic, please don't use this device.
* During use, the patient will be in contact with the cuff. The materials of the cuff have been
tested and found to comply with requirements of ISO 10993-5:2009 and ISO
10993-10:2010. It will not cause any potential sensation or irritation reaction.
* If you experience discomfort during a measurement, such as pain in the arm or other
complaints, press the START/STOP button to release the air immediately from the cuff.
Loosen the cuff and remove it from your arm.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should
the cuff not deflate when pressure reaches 40 kPa (300 mmHg), detach the cuff from the
arm and press the START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper working condition.
Check the device, do not use the device if it is damaged in any way. The continuous use of
a damaged unit may cause injury, improper results, or serious danger.
76
INTRODUCTIONINTRODUCTION
CAUTION
* Do not wash the cuff in a washing machine or dishwasher!
* The service life of the cuff may vary by the frequency of washing, skin condition, and
storage state. The typical service life is 10000 times.
* It is recommended that the performance should be checked every 2 years and after
maintenance and repair, by retesting at least the requirements in limits of the error of the
cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT
according to the local guidelines.
* Manufacturer will make available on request circuit diagrams, component part lists,
descriptions, calibration instructions,etc., to assist to service personnel in parts repair.
* The operator shall not touch output of batteries and the patient simultaneously.
* Cleaning :Dust environment may affect the performance of the unit. Please use a soft
cloth to clean the whole unit before and after use. Don’t use any abrasive or volatile
cleaners.
* The device doesn’t need to be calibrated within two years of reliable service.
* If you have any problems with this device, such as setting up, maintaining or using,
please contact the SERVICE PERSONNEL of Kinetik Wellbeing. Don’t open or repair the
device by yourself in the event of malfunctions. The device must only be serviced, repaired
and opened by individuals at authorised sales/service centers.
* Please report to Kinetik Wellbeing if any unexpected operation or events occur.
* Keep the unit out of reach of infants, young children or pets to avoid inhalation or
swallowing of small parts. It is dangerous or even fatal.
* Be careful of strangulation due to cables and hoses, particularly due to excessive length.
* At least 30 min required for ME 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.
* This equipment needs to be installed and put into service in accordance with the
information provided in the ACCOMPANYING DOCUMENTS;
* Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, walkie-talkies can affect this
equipment and should be kept at least a distance d away from the equipment. The
distance d is calculated by the MANUFACTURER from the 80MHz to 5.8 GHz column of
Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
* Please use ACCESSORIES and detachable parts specified/ authorised by MANUFAC-
TURE. Otherwise, it may cause damage to the unit or danger to the user/patients.
* There is no luer lock connectors are used in the construction of tubing, there is a
possibility that they might be inadvertently connected to intravascular fluid systems,
allowing air to be pumped into a blood vessel.
* Please use the device under the environment which was provided in the user manual.
Otherwise, the performance and lifetime of the device will be impacted and reduced.

LCD display signal
SYMBOL DESCRIPTION
Systolic blood pressure High blood pressure
Diastolic blood pressure Low blood pressure
EXPLANATION
Memory
mmHg
Low battery Batteries are low and need to be replaced
Current Time Year/Month/Day, Hour/Minute
Pulse in beats per minute
Pulse display
Deflation symbol The cuff is deflating.
Indicate it is in the memory mode and
which group of memory it is.
Blood pressure monitor is detecting an
irregular heartbeat during measurement.
Irregular heartbeat
Blood pressure
level indicator Indicate the blood pressure level
Heartbeat Blood pressure monitor is detecting a
heartbeat during measurement.
User 1 Start measurement for User 1
Measurement Unit of the blood pressure
98
INTRODUCTION
Monitor Components
List
1.Blood Pressure Monitor
(TMB-1970)
4.User manual
2.Cuff (Type BF applied part)
( 22~42 cm)
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
3. 4× AAA batteries
CUFF
AIR HOSE
LCD DISPLAY
MEM BUTTON
START/STOP BUTTON
SET BUTTON
BATTERY COMPARTMENT
AIR CONNECTOR PLUG
INTRODUCTION

1110
BEFORE YOU START BEFORE YOU START
Setting the Date and Time
1.
2.
3.
When the monitor is off, press “SET” button shortly, it will display the date format.
Then press “SET” or “MEM” button to switch the date format.
Then press the “START/STOP” button to confirm the date format, and the year
will flash. Press the “MEM” or “SET” button to change the year. Each press will
increase the numeral by one in a cycling manner.
It is important to set the date and time before using your blood
pressure monitor for the first time, so that a correct time stamp can be
assigned to each record that is stored in the memory.
(The setting range of the year: 2021—2050, Time format: 24H / 12H)
Press and hold the “MEM” button to quickly advance the years.
Press and hold the “SET” button to quickly go backwards through the years.
Press “START/STOP” button to confirm the year, then the month will flash.
Repeat the same steps to change the month, day, time format, hour, and
minute.
CAUTION
Replace the batteries whenever the below happens
The shows.
The display is dim.
The display does not light up.
Do not use new and used batteries together.
Do not use different types of batteries together.
Do not dispose the batteries in fire. Batteries may explode or leak.
Remove batteries if the device is not likely to be used for some time.
Worn batteries are harmful to the environment. Do not dispose with daily garbage.
Remove the old batteries from the device following your local recycling guidelines.
• Open the battery cover.
• Install the batteries as indicated in
the battery compartment.
• Replace the battery cover.
Installing and Replacing the Batteries
(Always select the
authorised / specified
battery: Four AAA-size
batteries).

Month Day
Time format Time format
Hour Minute
1312
BEFORE YOU START BEFORE YOU START
.4
About user ID
After confirming the minute, the LCD will display “do nE” and the monitor
will shut off after several seconds.
There is only one user ID available. The user has 90 memory
spaces, and is designed for 1 person to save measured values.

1514
MEASUREMENT MEASUREMENT
Adjust the zero point.
LCD display
Start the Measurement
2.
1. When the monitor is off, press the “START/STOP” button, the LCD
display will show shortly.
Remain still and do not talk until the full measurement is complete.
Inflating and measuring
Display and save
the measurement result
Press the “START/STOP” button to turn off the monitor, otherwise
it will turn off after about 1 minute.
3.
Tie the Cuff
1.
4.
Hold your arm with your palm facing up and tie the cuff
on your upper arm, then position the tube off-center toward
the inner side of arm in line with the little finger. Or position
the artery mark over the main artery (on the inside of your arm).
Note: Locate the main artery by pressing with 2 fingers
approximately 2 cm above the bend of your elbow on the inside
of your left arm. Identify where the pulse can be felt the strongest.
This is your main artery.
The cuff should be snug but not too tight. You should be able to
insert one finger between the cuff and your arm.
Remove all jewelry, such as watches and bracelets
from your left arm.Note: If your doctor has diagnosed
you with poor circulation in your left arm, use your right arm.
Roll or push up your sleeve to expose the skin.
Make sure your sleeve is not too tight.
2.
3.
Sit comfortably with your tested arm resting on
a flat surface. Place your elbow on a table
so that the cuff is at the same level as your heart.
Turn your palm upwards. Sit upright in a chair,
and take 5-6 deep breaths.
Rest for 5 minutes before first measurement .
Wait at least 3 minutes between measurements.
This allows your blood circulation to recover.
The patient must relax as much as possible and do not move and talk
during the measurement procedure.
For a meaningful comparison, try to measure under
similar conditions. For example, take daily measurements
at approximately the same time, on the same arm,
or as directed by a physician.
5.
6.
Take the measurement in a silent room.
The cuff should maintain at the same level as the right atrium
of the heart.
Please sit comfortably. Do not cross your legs and
keep your feet flat on the ground.
Keep your back against the backrest of the chair.
Helpful tips for Patients, especially for Patients
with Hypertension:
2~3 cm

Recall the Records
1.
2.
When the monitor is off, press the “MEM” button,
the lastest record will display.
The most recent record (1) is shown first. Each new measurement is
assigned to the first (1) record. All other records are pushed back one
digit (e.g., 2 becomes 3, and so on), and the last record (90) is dropped.
The current number
is No 2.
The corresponding
time is 8:07.
The corresponding
date is January 1st.
CAUTION
The date and time
of the record
will be shown
alternately.
Press “SET” or “MEN” button to find the record you want.
1716
DATA MANAGEMENTDATA MANAGEMENT
If you did not get the correct measurement, you can delete one
record or all records by following steps below.
Delete the Records
1.
3. If you do wish to delete this reading,
then press the "START/STOP" button
when the screen is flashing "dEL YES".
This reading will disappear and the LCD
will display "dEL donE".
Press the “MEM” button to enter the
memory mode, then press the “MEM” or
“SET” buton to find the record you want to
delete. Then hold and press “START/STOP”
button for about 3 seconds, the LCD will
display and flash “dEL yES”.
Delete one record:
2. Press the 'SET' or 'MEM' button to
toggle between deleting this reading (dEL
YES) or not (dEL no).

Delete all records:
Press the 'MEM' button to enter the memory
mode, then press and hold the 'SET' button.
The LCD will display and flash 'dEL ALL'.
1.
2. Press the 'SET' or 'MEM' button to toggle
between deleting all readings (dEL ALL) or
not (dEL no).
3. If you do wish to delete all memories, then
press the "START/STOP" button when the
screen is flashing "dEL ALL". All the readings
will disappear and the LCD will display "dEL
donE".
After step 3 the right picture will show
automatically. Press “START/STOP”
button to turn off the monitor, otherwise
it will turn off automatically after about
1 minute.
Note: If you replace the batteries, all the
records will disapear, and the LCD will display
the same as the right picture.
1918
INFORMATION FOR USERDATA MANAGEMENT
Tips for Measurement
Measurements may be inaccurate if taken in the following
circumstances.
Within 1 hour
after dinner or drinking
Within 20 minutes
after taking a bath
In a very cold environment
Immediate measurement
after tea, coffee, smoking
When talking or moving your fingers
When you need to use the toilet

Maintenance
In order to get the best performance, please follow the
instructions below.
Put in a dry place and avoid the sunshine
Avoid intense shaking
and collisions
Using wet cloths to remove dirt
Avoid touching water,
clean it with a dry cloth in case.
Avoid dusty and unstable
temperature environment
Do not attempt to clean the reusable cuff
with water and never immerse the cuff in
water.
20 21
ABOUT BLOOD PRESSURE
INFORMATION FOR USER
Only a physician can tell your normal BP range.
Please contact a physician if your measuring
result falls out of the range. Please note that only
a physician can tell whether your blood
pressure value has reached a dangerous point.
What are systolic pressure and diastolic pressure?
press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
When ventricles contract and pump blood out of the
heart, the blood pressure reaches its maximum value
in the cycle, which is called systolic pressure. When
the ventricles relax, the blood pressure reaches its
minimum value in the cycle, which is called diastolic
pressure.
What is the standard blood pressure classification?
The blood pressure classification published
by World Health Organization (WHO) and
International Society of Hypertension (ISH)
in 1999 is as follows:
Irregular Heartbeat Detector
CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart-
beat was detected during measurement. Usually this is NOT a cause for concern. However, if the
symbol appears often, we recommend you seek medical advice. Please note that the device does
not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.
CAUTION
SYS
DIA
<120
<80
120-129
80-84
130-139
85-89
140-159
90-99
160-179
100-109
≥180
≥110
Level
Blood
Pressure (mm Hg)
Optimal Normal High-normal Mild Moderate Severe
An irregular heartbeat is detected when a heartbeat rhythm varies while the device is
measuring systolic pressure and diastolic pressure. During each measurement, blood
pressure monitor will keep a record of all the pulse intervals and calculate the average
value of them. If there are two or more pulse intervals , the difference between each
interval and the average is more than the average value of ±25% , or there are four or
more pulse intervals ,the difference between each interval and the average is more
than the average value of ±15%, then the irregular heartbeat symbol will appear on the
display with the measurement result.

Why does my blood pressure
fluctuate throughout the
day?
Is the result the same
if measuring on the
right arm?
Why do I get a different
blood pressure at home
compared to the hospital?
1. Individual blood pressure varies
multiple times everyday. It is also affected
by the way you tie your cuff and your
measurement position, so please take the
measurement under the same conditions.
2.If the person takes medicine, the
pressure will vary more.
3.Wait at least 3 minutes for another
measurement.
The blood pressure is different even
throughout the day due to weather,
emotion, exercise etc, Also, there is the
“white coat” effect, which means blood
pressure usually increases in clinical
settings.
What you need to pay
attention to when you measure
your blood pressure at home:
If the cuff is tied properly.
If the cuff is too tight or too loose.
If the cuff is tied on the upper arm.
If you feel anxious.
Taking 2-3 deep breaths before
beginning will be better for measuring.
Advice: Relax yourself for 4-5
minutes until you calm down.
It is ok for both arms, but there
will be some different results for
different people. We suggest you
measure the same arm every time.
22 23
ABOUT BLOOD PRESSURE
This section includes a list of error messages and frequently
asked questions for problems you may encounter with your blood
pressure monitor. If the product is not operating as you think it
should, check here before arranging for servicing.
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
battery
Error
message
Display
will not light up.
Batteries are exhausted. Replace with new batteries
Insert the batteries
correctly
Replace with new batteries
Batteries are inserted
incorrectly.
Battery is low.
E 1 shows
E 2 shows
EExx shows on
the display.
A calibration error
occurred.
Retake the measurement.
If the problem persists,
contact the retailer or our
customer service
department for further
assistance.Refer to the
warranty for contact
information and return
instructions.
Display is dim or
show
Warning
message
out shows
Out of measurement
range
Relax for a moment.
Refasten the cuff and then
measure again. If the
problem persists, contact
your physician.
E 3 shows
Relax for a
moment and then
measure again.
E 4 shows Relax for a moment and
then measure again.
The measurement
process does not detect
the pulse signal.
Loosen the clothing on
the arm and then
measure again.
The cuff is not secure or
very tight.
Refasten the cuff and then
measure again.
The treatment of the
measurement failed.
The monitor detected
motion,talking or the
pluse is too poor
while measuring.
TROUBLESHOOTING

Battery powered mode:
6V DC 4x AAA batteries
Battery Powered Mode:
Internally Powered ME Equipment
Approx.198 g (Excluding the batteries)
Digital LCD display V.A.52 mm × 58 mm
Approx.102 mm × 107 mm × 40 mm
4× AAA batteries, user manual
A01
About 22~42 cm
Type BF applied part
WARNING: No modification of this equipment is allowed.
Power supply
Display mode
Measurement mode
Oscillographic testing mode
Measurement range
Measurement perimeter
of the upper arm
Net Weight
External dimensions
Attachment
Mode of operation Continuous operation
Degree of protection
Protection against
ingress of water
Accuracy
Normal working condition
Storage & transportation
condition
Software Version
Pressure:
5°C-40°C within ± 3 mmHg
Pulse value: ±5%
IP21, It means the device could protected
against solid foreign objects of 12.5 mm and
greater, and protect against vertically falling
water drops.
Device Classification
Rated cuff pressure:
0 mmHg~299 mmHg
Measurement pressure:
SYS: 60 mmHg~230 mmHg
DIA: 40 mmHg~130 mmHg
Pulse value: (40-199) beat/minute
Temperature: -20°C to +60°C
A relative humidity range of ≤ 93%, non-condensing,
at a water vapour pressure up to 50 hPa
A temperature range of : +5°C to +40°C
A relative humidity range of 15% to 90%,
non-condensing, but not requiring a water vapour
partial pressure greater than 50 hPa
An atmospheric pressure range of :
700 hPa to 1060 hPa
24 25
SPECIFICATIONS
Contact Information
For more information about our products, please visit www.kinetikwellbeing.com
Authorized European Representative:
Manufactured by:
Company:
Address:
Company: Medical Device Safety Service GmbH
Address: Schiffgraben 41, 30175 Hannover, Germany
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development District,
528437 Zhongshan, Guangdong, China
Guangdong Transtek Medical Electronics Co., Ltd.
CONTACT INFORMATION

26 27
EMC GUIDANCE EMC GUIDANCE
Guidance and manufacturer’s declaration – electromagnetic Immunity
Immunity Test
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15 kV air
±8 kV contact
30 A/m
50Hz/60Hz
NOTE UT is the a.c. mains voltage prior to application of the test level.
Table 2
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
30 A/m
50Hz/60Hz
Power frequency
magnetic field
IEC 61000-4-8
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
IEC 60601-1-2
Test level
±2 kV, ±4kV, ±8 kV, ±15 kV air
Conduced RF
IEC61000-4-6
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1kHz
Radiated RF
IEC61000-4-3
Not applicable Not applicable
Not applicable Not applicable
Not applicable Not applicable
Not applicable Not applicable
EMC Guidance
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
Warning: Don’t be near the active HF surgical equipment and the RF shielded room of an ME system for
magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external
antennas)should be used no closer than 30 cm (12 inches)to any part of the equipment TMB-1970, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
RF emissions
CISPR 11 Group 1
Class B
Not applicable
Compliance
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
RF emissions
CISPR 11
Emissions test
Not applicable
Technical description：
1. All necessary instructions for maintaining BASICSAFETY and ESSENTIALPERFORMANCE with regard to
electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity

28
EMC GUIDANCE
Table 3
Guidance and manufacturer’s declaration - electromagnetic Immunity
Test
Frequency
(MHz)
3850.3 27
Radiated RF
IEC61000-4-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
communica-
ti-ons
equipment)
Band
(MHz)
Service Modulation Modulation
(W)
Distance (m)IMMUNITY
TEST
LEVEL
(V/m)
380-390TETRA
400
Pulse
modulation b)
18Hz
1.8
450430-470
GMRS 460，
FRS 460
FM c) ± 5kHz
deviation 1kHz
sine
2 0.3 28
710704-787
745
780
LTE Band
13,17
Pulse
modulation b)
217Hz
0.2 0.3 9
810
870
930
800-960
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18Hz
20.3 28
1720
1845
1970
1700-
1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3,
4,25; UMTS
Pulse
modulation b)
217Hz
20.3 28
20.3 2824502400-
2570
Bluetooth,
WLAN,
802.11
b/g/n, RFID
2450, LTE
Band 7
Pulse
modulation
217 Hz
5240
5500
5785
5100-
5800
WLAN
802.11
a/n
Pulse
modulation
217 Hz
0.2 0.3 9