Transtek Medical Electronics TMB1597BN Blood Pressure Monitor User Manual
Guangdong Transtek Medical Electronics Co.,Ltd Blood Pressure Monitor
User Manual
version:1.0
User Manual
Blood Pressure Monitor TMB-1597-BN
Arm Type
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
TMB-1597-BN.
Please do read the user manual carefully and thoroughtly so as to ensure the
safe usage of this product, and keep the manual well for further reference in
case you have problems.
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Table of Contents
INTRODUCTION..................................................................................................................2
General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
LCD Display Signal
Monitor Components
List
BEFORE YOU START..........................................................................................................8
The Choice of Power Supply
Installing and Replacing the Batteries
Setting Date, Time and Measurement Unit
Select the User
Pair-up the Blood Pressure Monitor with Your Device
MEASUREMENT................................................................................................................15
Tie the Cuff
Start the Measurement
DATA MANAGEMENT........................................................................................................18
Recall the Records
Delete the Records
INFORMATION FOR USER...............................................................................................21
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE.............................................................................................23
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........................................................................................................25
SPECIFICATIONS..............................................................................................................26
AUTHORIZED COMPONENT ...........................................................................................27
CONTACT INFORMATION.................................................................................................27
COMPLIED STANDARDS LIST..........................................................................................28
FCC STATEMENT...............................................................................................................29
EMC GUIDANCE................................................................................................................30
1
CATALOGUE CATALOGUE
Safety Information
The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
Symbol for “THE OPERATION
GUIDE MUST BE READ”
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”
Features:
Maximum 60 records per each user
General Description
For indoor use only
F1
T1A/250V Φ3.6*10CCC Symbol for “Class II Equipment”
3rd technonoly: Measuring during inflation
73mm×49 mm Blue LCD display with white backlight
Indications for Use
Measurement Principle
This product uses the Oscillometric Measuring method to detect blood pressure.
Before every measurement, the unit establishes a “zero pressure” equivalent to the air
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.
The device also compares the longest and the shortest time intervals of detected
pulse waves to mean time interval then calculates standard deviation. The device will
display a warning signal with the reading to indicate the detection of irregular heartbeat
when the difference of the time intervals is over 25%.
Caution: These notes must be
observed to prevent any damage
to the device.
SN
Thank you for selecting TRANSTEK arm type blood pressure monitor
(TMB-1597-BN). 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-1597-BN 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.
The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring
blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm
( about 8¾˝-12½˝ ) or 22cm to 42cm(about 8¾˝-16½˝).
It is intended for adult indoor use only.
The Bluetooth Combination Mark
Symbol for “Including RF
transmitter”
Contraindications
This device is contraindicated for any person who is connected to a wearable or
implantable electronic device or instrument, such as a pacemaker or defibrillator.
This blood pressure monitor is not intended to be a diagnostic device.
Contact your physician if hypertensive values are indicated.
23
INTRODUCTION INTRODUCTION
CAUTION
* This device is intended for adult use only. It is not intended for use with neonatal patients, pregnant or
pre-eclamptic patients.
* 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.
* When the device was 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.
* If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not
deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the arm and press the
START/STOP button to stop inflation.
* 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.
* The operator shall not touch output of batteries /adapter and the patient simultaneously.
* To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated
interference signal or electrical fast transient/burst signal.
* The user must check that the equipment functions safely and see that it is in proper working condition
before being used.
* 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.
* Manufacturer will make available on request circuit diagrams, component parts list etc.
* 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.
* 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.
* 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 sensization or irritation reaction.
* Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE.
Otherwise, it may cause damage to the unit or danger to the user/patients.
* The device doesn’t need to be calibrated within two years of reliable service.
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local
guidelines.
CAUTION
* If you have any problems with this device, such as setting up, maintaining or using, please contact the
SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself.
* Please report to Transtek if any unexpected operation or events occur.
* Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator. The patient can measure,transmit data and change battery under
normal circumstances and maintain the device and its accessories according to the user manual.
* Adaptor is specified as a part of ME EQUIPMENT.
* The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a
position where it is difficult to disconnect from the supply mains to safely terminate operation of ME
EQUIPMENT.
* Before every use, check the device, do not use the device or an electrode if it is damaged in any way. The
continuous use of a damaged unit may cause injury, improper results, or serious danger.
* Be careful to strangulation due to cables and hoses, particularly due to excessive length.
* Keep unit out of the reach of young children / pets to avoid inhalation or swallowing of small parts. The
cord/tube can cause strangulation.
* 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.
* When not in use, store the device with the adapter 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.
* Warning: Be careful to regarding the effect of blood flow interference and resulting harmful injury to the
patient caused by continuous cuff pressure due to connection tubing.
*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 pressurization 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 samb 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.
* Please check that operation of the device does not result in prolonged impairment of patient blood
circulation.
* 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 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.
* Do not wash the cuff in a washing machine or dishwasher!
* 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).
* 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.
* 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 caculated by the MANUFACTURER from the 800
MHz to 2.5 GHz column of Table 6 of IEC 60601-1-2:2007,as appropriate.
45
INTRODUCTIONINTRODUCTION
LCD display signal
SYMBOL DESCRIPTION
Systolic blood pressure
Diastolic blood pressure
EXPLANATION
Memory
mmHg
kPa
Measurement Unit of the blood pressure
Measurement Unit of the blood pressure
Low battery Batteries are low and need to be replaced
Current Time Year/Month/Day, Hour/Minute
(1kPa=7.5mmHg)
(1mmHg=0.133kPa)
Heartbeat
User 1 Start measurement,save and transmit the
measuring results for User 1
User 2
Irregular heartbeat
Monitor Components
List
1.Blood Pressure Monitor
(TMB-1597-BN)
4.User manual
2.Cuff (Type BF applied part)
(22cm~32cm or 22cm~42cm)
3. 4×AA alkaline batteries
(Please use TRANSTEK
authorized cuff. The size
of the actual cuff please
refer to the label on the
attached cuff.)
Start measurement, save and transmit the
measuring results for User 2
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
CUFF
AIR HOSE
AIR CONNECTOR PLUG
LCD DISPLAY
DC POWER SOCKET
MEM BUTTON
START/STOP
SET BUTTON
BATTERY COMPARTMENT
5. AC Adaptor
(KH0601000UW!)
Average value The average value of blood pressure
Motion indicator Motion may result in an inaccurate
measurement
Bluetooth icon
Data storage
Indicate the Bluetooth is working
Indicate the data is waiting to be
transmitted
High blood pressure
Low blood pressure
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.
Blood pressure
level indicator Indicate the blood pressure level
Blood pressure monitor is detecting a
heartbeat during measurement.
7
6
INTRODUCTION INTRODUCTION
In order to get the best effect and protect your monitor,please use the right
battery and special power adaptor which complies with U.S. safety standard.
•.Open the battery cover.
•.Install the batteries by matching
the correct polarity, as shown.
•.Replace the battery cover.
Installing and Replacing the Batteries
CAUTION
Replace the batteries whenever the below happen
The shows
The display is dim
The display does not light up
The Choice of Power Supply
1.Battery powered mode:
6VDC 4×AA alkaline batteries
2.AC adaptor powered mode:
6V 1A
(Please only use the recommended AC
adaptor model).
Please unplug the adaptor to depart from
the using utility power.
Setting Date, Time and Measurement Unit
1.
2.
AC adaptor
It is important to set the clock before using your blood pressure
monitor, so that a time stamp can be assigned to each record that is
stored in the memory. (The setting range of the year :2016—2056;
Time format:24H)
When the monitor is off, press “ ”button,it will display the time.Then press and
hold “ ” button to enter the mode for year setting.
(Notes:
1.During the process of setting, you can press “ ” button to stop setting at
any time.
2. If there is no operation during the process of setting, it will turn off within 1
minute.)
Press “ ” button to change
the [YEAR]. Each press will
increase the numeral by one in a
cycling manner.
CAUTION
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.
The typical service life of the new and
unused batteries is 300 measurements
for the operation time is 60s.
9
8
BEFORE YOU START BEFORE YOU START
3.
4.Repeat steps 2 and 3 to set the [MONTH] and [DAY].
7.
6.Repeat steps 2 and 3 to set the [UNIT].
.Repeat steps 2 and 3 to set the [HOUR] and [MINUTE]. 5
When you get the right year, press “ ” button to set down and turn to next step.
After the unit is set,the LCD will display “done” first, then
display all the settings you have done and then turn off.
11
10
BEFORE YOU START BEFORE YOU START
Select the User
1.
2.
3.
When the monitor is off, press and hold “ ”button to enter
user setting mode. The user ID will blink.
Then press “ ” button again, select the user ID between
user 1 and user 2.
After selecting the suitable user ID, press “ ” button to
confirm. It will display User ID+ donE” and then turn off.
1.
2.
If SUCCEED, symbol +
will be shown on the LCD.
If FAIL, only bluetooth symbol “E12”
will be shown on the LCD.
3.
Pair - up the Blood Pressure Monitor with
Your Device
Before you start pairing, please download the MedM Health app from APP Store
or Google Play in your device which supports Bluetooth 4.0 technology first.
Turn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding. If
this is the first time you use “MedM Health”, please register an account first. Enter your
account and password to log in.Please enter “My Profile” to set your pernal information.
Please enter Settings infterface,click “My Devices”, select “Add the Device”.
When the monitor is OFF, press and hold the button to start pair-up.
The symbol and will display alternatively, indicating pair-up is proceeding.
After detecting the blood pressure monitor, “MedM Health” will display the product’s
information. Click and select the device which you want to bind with your mobile device.
Click “bind the device”, then click “User Profile” to select the user you want to connect
with your mobile device on the app to continute the pair-up. After binding the device, it
only can transmit the data of the bound user.
13
12
BEFORE YOU START BEFORE YOU START
Tie the cuff
1.
2.
3.
2~3cm
4.
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.
Sit comfortably with your tested arm
resting on a flat surface.
Patients with Hypertension:
The middle of the cuff should be
at the level of the right atrium of the
heart; Before starting measurement,
please sit comfortably with legs
uncrossed, feet flat on the floor, back
and arm supported.
Rest for 5 minutes before
measuring.
Wait at least 3 minutes between
measurements. This allows your
blood circulation to recover.
For a meaningful comparison, try to
measure under similar conditions.
For example, take daily
measurements at approximately the
same time, position of upper arm, or
as directed by a physician.
4.The monitor will shut off after Pair-up process is complete.
Bluetooth Module No.: AW51822
RF Frequency Range: 2402 MHz to 2480 MHz
Output Power Range: 4 dBm
Supply Voltage: 1.8V-3.6 V
Transmitting Distance: 10 meters
CAUTION
1.
2.
List of compatible devices:
For iOS devices:
The operating system must be iOS 8 or more, such as iPhone
4S, iPhone 5/5C/5S, iPhone 6/6 Plus and so on.
For Android devices:
The operating system must be 4.3 or more.
Interference may occur in the vicinity of equipment marked with the following
symbol . And TMB-1597-BN may interfering vicinity electrical equipment.
Sensitive people, including pregnant women pre-eclamptic and those who
implanted medical electronic instruments, should avoid using the unit
whenever possible.
Keep the monitor at least 20 centimeters away from the human body
(especially the head) when the data transmission is proceeding after
measurement.
To enable the data transmission function, this product should be paired to
Bluetooth end at 2.4 GHz.
How to mitigate possible interference?
The range between the device and BT end should be reasonably close, from
1 meter to 10 meters. Please ensure no obstacles between the device and
BT end so as to obtain quality connection and to lower the RF output range.
To avoid interference, other electronic devices (particularly those with
wireless transmission / Transmitter) should be kept at least 1 meter away
from the monitor.
15
14
MEASUREMENTBEFORE YOU START
1.
Adjust the zero. LCD display
Inflating and measuring.
Start the Measurement
4.
When the monitor is off, press “ ” button to turn on the monitor, and it
will finish the whole measurement.
(Take user 1 for example.)
Display and save the
measurement results. The
year, date and time will display
alternately. Press the “ ” button to power off, otherwise it will turn off
within 1 minute.
Tips:
1. There are two users in total. Each user has 60 records.
2. You can press “ ” button at any time to stop measuring
during the process of measurement.
3. If the measurement result is out of the measurement range
(SYS: 60mmHg to 230mmHg; or DIA: 40mmHg to 130mmHg;or
Pulse: 40-199 pulse/minute), the LCD will display “out”.
3.With TMB-1597-BN successfully pair-up with your mobile device, the
measurement data will be automatically transmitted to your mobile device
via Bluetooth.
(1).The symbol will disappear after successful data transmission, and
you may check your personal health data stored in your mobile device.
(2).If the data transmission fails, the symbol will remain. The pending
measurement data will be transmitted to your mobile device when next
measurement is complete.
2.This device will proceed to data transmission after measurement. The
Bluetooth symbol blinks on the LCD indicates data is transmitting.
Transmitting Complete
17
16
MEASUREMENT MEASUREMENT
Recall the Records
1.
2.
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 (60) is dropped
from the list.
The current No. is No. 1.
Seven records in total.
The corresponding
time is A.M. 7:00.
The corresponding
date is December 1 .
CAUTION
3.
st
When the monitor is off, please press “ ” button to show the average
value of the latest three records.
(Take user 1 for example.)
Press “ ” button or “ ” button to get the records you want.
The record number, date and
time of the measurement
records will display
alternately.
If you want to check another user’s records, press “ ” button to turn
off the monitor when the blood pressure monitor is in the memory
inquiry mode. Press and hold “ ” button to enter into the selecting
user ID mode, press “ ” button again to select the user ID between
user 1 and user 2, press “ ” button to confirm the user ID , then
press “ ” button to check the selected user’s measurement records.
19
18
DATA MANAGEMENT DATA MANAGEMENT
Delete the Records Tips for Measurement
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 want to discharge urine
Measurements may be inaccurate if taken in the following
circumstances.
If you did not get the correct measurement, you can delete all
results for the selected user by following steps. (Take User 1 for
example.)
Hold pressing “ ” button
about 3 seconds when the
monitor is in the memory
recall mode, the flash display
“ dEL ALL”+ User ID will show.
1. Press “ ” button to confirm
deleting and the monitor will
display “User ID+dEL dOnE”
and then turn off.
2.
Note: To exit out of delete
mode without deleting any
records, press “ ” button
before pressing " " button
to confirm any delete
commands.
If there is no record, when
you press “ ” button to
check the record, the following
display will show.
3.
21
20
DATA MANAGEMENT INFORMATION FOR USER
Maintenance
In order to get the best performance, please follow the
instructions below.
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?
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.
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.
An irregular heartbeat (IHB) is detected when a heartbeat rhythm varies while the unit is
measuring the systolic and diastolic blood pressure.During each measurement, the monitor
records the heartbeat intervals and calculates the average. If any average is larger than or
equal to 25%,the irregular heartbeat symbol appears on the display when the measurement
results appear.
The chart on the right is the
standard blood pressure
classification published by
American Heart Association
(AHA).
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.
CAUTION
AHA Home Guideline for
Upper Limit of Normal BP
SYS 135 mm Hg
DIA 85 mm Hg
Blood Pressure Category
Normal
Prehypertension
High Blood Pressure
(Hypertension) Stage 1
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Emergency care needed)
Systolic
mmHg (upper#)
Diastolic
mmHg (lower#)
less than 120
120-139
140-159
160 or higher
Higher than 180
and
or
or
or
or
less than 80
80-89
90-99
100 or higher
Higher than 110
This chart reflects blood pressure categories defined by American Heart Association.
22 23
INFORMATION FOR USER ABOUT BLOOD PRESSURE
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.
This section includes a list of error messages and frequently
asked questions for problems you may encounter with your blood
pressure monitor. If the products not operating as you think it
should, check here before arranging for servicing.
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
batteries
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.
Display is dim or
show Batteries are low.
E 01 shows
E 03 shows
E 04 shows
EExx,shows on
the display.
A calibration error
occurred. (XX can
be some digital symbol,
such as 01, 02,etc., if
this similar situation
appear, all belong to
calibration error.)
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.
The treatment of the
measurement failed.
AC adaptor is inserted
incorrectly.
Insert the AC adaptor
tightly
E 02 shows
The cuff is too tight
or too loose.
Refasten the cuff and then
measure again.
The monitor
detected motion
while measuring.
Movement can affect the
measurement.Relax for a
moment and then
measure again.
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.
Warning
message
Relax for a moment.
Refasten the cuff and then
measure again. If the
problem persists, contact
your physician.
“out ” shows Out of measurement
range
Data communication
is failed.
Check if the App/Bluetooth
is on or not,try data
transmission again.
E 12 shows
24 25
ABOUT BLOOD PRESSURE TROUBLESHOOTING
About 22cm~32cm or 22cm~42cm
Type BF applied part
WARNING: No modification of this equipment is allowed.
Power supply
Battery powered mode:
6VDC 4×AA alkaline batteries
AC adaptor powered mode: 6V 1A
(Please only use the recommended AC adaptor
model).
Display mode
Measurement mode Oscillographic testing mode
Measurement range
Measurement perimeter
of the upper arm
Weight Approx.258g(Excluding the dry cells and cuff)
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 A01
Pressure:
5℃-40℃within±3mmHg(0.4kPa)
Pulse value:±5%
Blue LCD display with white backlight
V.A.73mm×49mm
Approx.118mm×126mm×72mm
4×AA alkaline batteries,user manual
Contact Information
For more information about our products, please visit www.transtek.cn.you can get
customer service, usual problems and customer download, transtek will serve you
anytime.
Manufactured by:
Company:
Address:
Authorized Component
1.please use the TRANSTEK
authorized adapter.
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Guangdong Transtek Medical Electronics Co., Ltd.
Rated cuff pressure:
0mmHg~300mmHg(0kPa ~ 40kPa)
Measurement pressure:
SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa)
DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa)
Pulse value: (40-199)beat/minute
IP21 It means the device could protected against
solid foreign objects of 12.5mm and greater, and
protect against vertically falling water drops.
Adapter
Model：KH0601000UW
Input：AC 100-240V
50/60Hz 0.4A Max
Output：6V 1000mA
26 27
SPECIFICATIONS AUTHORIZED COMPONENT
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
Temperature:-20°C to +60°C
A relative humidity range of ≤ 93%,
non-condensing, at a water vapour pressure
up to 50hPa
Complied Standards List FCC Statement
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.
Caution: The user is cautioned that changes or modifications not
expressly approved by the party responsible for compliance could
void the user's authority to operate the equipment.
NOTE: 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.
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth
for an uncontrolled environment. This transmitter must not be
co-located or operating in conjunction with any other antenna or
transmitter.
FCC ID: OU9TMB1597BN
ISO 14971:2007 Medical devices - Application of risk
management to medical devices
EN 1041:2008 Information supplied by the manufacturer of
medical devices
IEC 60601-1-2:2014 Medical electrical equipment - Part
1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
IEC 62304:2006/AC: 2008 Medical device software -
Software life-cycle processes
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
ISO 15223-1:2012 Medical devices - Symbols to be
used with medical device labels, labelling and information
to be supplied - Part 1 General requirements
IEC 60601-1: 2005+A1：2012 Medical electrical
equipment - Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-11 Medical electrical equipment - Part
1-11: General requirements for basic safety and essential
performance - Collateral standard: Requirements for
medical electrical equipment and medical electrical systems
used in the home healthcare environment
IEC 80601-2-30:2009 Medical electrical equipment-
Part 2-30: Particular requirements for the basic safety and
essential performance of automated non-invasive
sphygmomanometers
IEC 62366 Medical devices - Application of usability
engineering to medical devices (IEC 62366:2007)
IEC 60601-1-6 Medical electrical equipment - Part 1
-6 : General requirements for basic safety and essential
performance - collateral standard : Usability
ISO 81060-2:2009 Non-invasive
sphygmomanometers - Part 2: Clinical validation of
automated measurement type
MODIFICATION: Any changes or modifications not expressly approved
by the grantee of this device could void the user’s authority to operate the
device.
28 29
COMPLIED STANDARDS LIST FCC STATEMENT
EMC Guidance
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.
Table 1 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC
EMISSIONS- for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emissions
RF emissions
CISPR 11 Group 1
Class B
Class A
Complies
Compliance
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.
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions IEC
61000-3-3
RF emissions
CISPR 11
Emissions test Electromagnetic environment - guidance
The 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 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.
Guidance and manufacturer’s declaration – electromagnetic immunity
IMMUNITY test
±6 kV contact
±8 kV air ±6 kV contact
±8 kV air
±2 kV for
power supply lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
3A/m
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
Table 2 Guidance and MANUFACTURER’s declaration – electromagnetic
IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS
IEC 60601 test level Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electromagnetic
environment - guidance
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
3A/m
Power frequency
(50Hz/60Hz)
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 IEC
61000-4-5
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
±1 kV for
input/output lines
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment.
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.
±2 kV for power
supply lines
±1 kV differential
mode
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
30 31
EMC GUIDANCE EMC GUIDANCE
Table 4 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY –
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
IMMUNITY test
3 Vrms
3 V/m
Compliance
level
IEC 60601
TEST LEVEL
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 Vrms
150 kHz to
80 MHz
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
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.
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, should be
less than the compliance level in each
frequency range.
a
b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
P
=d
P=d
80 MHz to 800 MHz
P=d 2.3
800 MHz to 2,5 GHz
1.2
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.
aField strengths from fixed transmitters, such as base stations for radio (cellular /
cordless) telephones and land mobile radios, amateur radio, AM and FM radio broad-
cast 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.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
b
1.2
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Table 6 Recommended separation distances between portable and mobile
RF communications equipment and the ME EQUIPMENT or ME SYSTEM –
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
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 (transmittters) and the
device as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter (m)
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 80MHz and 800MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
0.01
0.1
1
10
100
0.12 0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
P=d P=d 1.2 2.3 P=d
0.38
1.2
3.8
12
1.2
32 33
EMC GUIDANCE EMC GUIDANCE