Transtek Medical Electronics TMB1490-B Blood Pressure Monitor User Manual TMB 1490 BT
Guangdong Transtek Medical Electronics Co.,Ltd Blood Pressure Monitor TMB 1490 BT
TMB-1490-BT User Manual
version:1.0
User Manual
Blood Pressure Monitor TMB-1490-BT
Arm Type
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
TMB-1490-BT.
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 A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Table of Contents
CATALOGUE
INTRODUCTION..................................................................................................................2
General Description
Indications for Use
Safety Information
LCD Display Signal
Monitor Components
BEFORE YOU START..........................................................................................................6
The Choice of Power Supply
Installing and Replacing the Batteries
Measurement Principle
Setting Date, Time and Measurement Unit
Pair-up the Blood Pressure Monitor with Your Device
MEASUREMENT................................................................................................................12
Tie the Cuff
Start the Measurement
DATA MANAGEMENT........................................................................................................15
Recall the Records
Delete the Records
INFORMATION FOR USER...............................................................................................17
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE.............................................................................................19
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
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.......................................................................................................21
SPECIFICATIONS..............................................................................................................22
AUTHORIZED COMPONENT ...........................................................................................23
CONTACT INFORMATION.................................................................................................23
COMPLIED STANDARDS LIST..........................................................................................24
FCC STATEMENT...............................................................................................................25
EMC GUIDANCE................................................................................................................26
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”
Thank you for selecting TRANSTEK arm type blood pressure monitor
(TMB-1490-BT). 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-1490-BT 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 60 records per each user
General Description
For indoor use only
F1
7$9ĭ&&& Symbol for “Class II Equipment”
3rd technonoly: Measuring during inflation
(The updated technology in the world)
60.5 mm×92.5 mm Digital LCD display
INTRODUCTION INTRODUCTION
CAUTION
This device is intended for adult use only.
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/AC adaptor 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
provided inaccurate readings, the affects 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 using, the patient will 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.
The device has been evaluated clinically using manual cuff/stethoscope auscultation as the
reference. Blood pressure measurements determined with this device are equivalent to those
obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits
prescribed by the American National Standard, Manual, electronic, or automated
sphygmomanometers.”
The patient is an intended operator. The patient can measure under normal circumstances and
maintain the device and its accessories according to the user manual.
The blood pressure monitor, and the cuff are suitable for use within the patient environment. If you
are allergic to dacron or plastic, please don’t use this device.
Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small
parts is dangerous or even fata.
If 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.
The device is not suitable for public use.
The device is not intended for PATIENT transport outside a healthcare facility.
This device cannot be used with HF surgical equipment at the same time.
Be careful to strangulation due to cables and hoses, particularly due to excessive length.
The Bluetooth Combination Mark Symbol for “Including RF
transmitter”
Indications for Use
The Transtek Blood Pressure Monitor is digital monitors intended for use in
measuring blood pressure and heartbeat rate with arm circumference ranging
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It is intended for adult indoor use only.
LCD display signal
INTRODUCTION
Monitor Components
INTRODUCTION
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
(1mmHg=0.133kPa)
(1kPa=7.5mmHg)
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
EXPLANATION
Pulse per minute Beats per minute, BPM
Deflating CUFF air is exhausting of deflating
Memory The displayed measurement values
is from the 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
Irregular heartbeatArrhythmia
Grade The grade of the blood pressure
kPa
mmHg
Current Time Month/Day/Year, Hour/Minute
Pul/min
User A
Start measurement,save and transmit the
measuring results for User A
User B
Start measurement,save and transmit the
measuring results for User B
Heartbeat detection during the
measurement
Heartbeat
The average value The average value of the latest three
records
List
1.Blood Pressure Monitor
(TMB-1490-BT)
4.User manual
2.Cuff (Type BF applied part)
(22cm~32cm or 22cm~42cm)
Component list of
pressure measuring
system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
3. 4×AAA batteries
BATTERY COMPARTMENT
CUFF
AIR HOSE
AIR CONNECTOR PLUG
LCD DISPLAY
MEM BUTTON
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SET BUTTON
USER SWITCH
5. AC Adaptor
(Model: KH0601000UW)
Bluetooth icon The bluetooth icon blinks when the
bluetooth is working
In order to get the best effect and protect your monitor,please use the
the right batteries 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 cover.
Installing and Replacing the Batteries
CAUTION
Remove batteries if the device is not likely to be used for some time.
The old batteries are harmful to the environment, do not dispose with other daily trash.
Remove the old batteries from the device and follow your local recycling guidelines.
CAUTION
Replace the batteries whenever the below happen
The shows
The display dims
The display does not light up
Do not dispose of batteries in fire. Batteries may explode or leak.
AC adaptor
The Choice of Power Supply
1.Battery powered mode:
6VDC 4×AAA batteries
2.AC adaptor powered mode:
(Please only use the recommended AC
adaptor model).
Please unplug the adaptor to depart from
the using utility power.
BEFORE YOU START
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
displays a warning signal with the reading to indicate the detection of irregular heartbeat
when the difference of the time intervals is over 25%.
BEFORE YOU START
6V 1A
1: 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:
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 upper arm on the side of a mastectomy.
2. Do not apply the cuff over a wound, otherwise it can cause further injury.
3. 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.
4. Using it in case to result in prolonged impairment of the circulation of the blood of the
PATIENT.
5: Don’t kink the connection tube, otherwise, the cuff pressure may continuously increase which
can prevent blood flow and result in harmful injury to the PATIENT.
CAUTION
Setting Date, Time and Measurement Unit
BEFORE YOU STARTBEFORE YOU START
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
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 :2000—2050
time format:12 H/24H)
1.When the monitor is off,
hold pressing “SET”
for 3 seconds to enter
the mode for year
setting.
2.Press the “MEM” to
change the [YEAR].
Each press will increase
the numeral by one in a
cycling manner.
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
3.When you get the right
year, press “SET” to set
down and turn to next
step.
4.Repeat steps 2 and 3 to set
the [MONTH] and [DAY].
5.Repeat steps 2 and 3 to set the [TIME FORMAT]
between 12h and 24h.
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
BEFORE YOU START
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
6.Repeat steps 2 and 3 to set the [HOUR]
and [MINUTE].
8.After the unit is set,the LCD will display
“dOnE”first,then display all the settings you
have done and then it will turn off.
7.Repeat steps 2 and 3 to set the [UNIT].
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pair-up the Blood Pressure Monitor
with Your Device
1.Turn on Bluetooth and the app. Make sure both are ON when pair-up is
proceeding.
2.When the monitor is OFF, press
start pair-up. The bluetooth symbol
will blink, indicating pair-up is
proceeding.
If SUCCEED, symbol
will be shown on the LCD.
If FAIL, only bluetooth symbol
will be shown on the LCD.
3.The monitor will shut off after Pair-up process is
complete.
Bluetooth Module No.: AW2540MV1
RF Frequency Range: 2402 MHz to 2480 MHz
Output Power Range: -1 dBm
Supply Voltage: 2V-3.6 V
Transmitting Distance: 10 meters
and hold the START/STOP button to
BEFORE YOU START
MEASUREMENT
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.
Tie the cuff
1.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.
2.The cuff should be snug but not
too tight. You should be able to
insert one finger between the
cuff and your arm.
3.Sit comfortably with your tested
arm resting on a flat surface.
2~3cm
.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.
4
MEASUREMENT
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
1.Before you start the measurement, switch the User button to select the user
between User A and User B. Switch to right to select User A, switch to left to
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on the monitor, and it will finish the whole measurement,save and transmit the
measurement data for the desired user. (Take User A for example.)
Adjust to zero. LCD display
Inflating and measuring. Display and save the
measurement result.
Start the Measurement
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
DATA MANAGEMENT
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Recall the Records
2. Press the “MEM” or “SET” to get the record you
want.
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 2. The corresponding
time is P.M. 10:08.
The corresponding
date is January 6th.
CAUTION
The date and time
of the record
will be shown
alternately.
3. If you want to look over another user’s data, switch the User button to select
the desired user. Then you can look over its historical records.
1. When the monitor is off,
please press the “MEM”,it will display the
latest record first when the records are less than
three groups. When there are three or more than
three groups ,it will display the average value of
the latest three records first.
START
STOP
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off, otherwise it will turn off
within 1 minute.
Tips: Maximum 60 records are both for User A and User B.
2.This device will proceed
to data transmission
after measurement.
The Bluetooth symbol
blinks on the LCD
indicates data is
transmitting.
3.If the data is successfully
transmitted, the LCD will then
display “dOnE”.
If the data transmission fails, the
LCD will display “ Err ” instead.
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
MEASUREMENT
DATA MANAGEMENT
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
INFORMATION FOR USER
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
Pul/min
MEMORY
TIME /DATE
S
M
START
STOP
If you did not get the correct measurement, you can delete all
results for the selected user by following steps below.
Delete the Records
1.Hold pressing “MEM”
for 3 seconds when the
monitor is in the memory
recall mode ,the
flash display “dEL ALL” will
show.
2.Press “SET” to
confirm deleting and
the monitor will turn
off.
3.If you don’t want to delete the
records, press “START/STOP”
to escape.
4. If there is no record.
Press “MEM” button,
the right display will
show.
START
STOP
Measurements may be inaccurate if taken in the following
circumstances.
INFORMATION FOR USER
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.
ABOUT BLOOD PRESSURE
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.
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.
The chart on the right is the
standard blood pressure
classification published by
American Heart
Association (AHA).
CAUTION
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.
AHA Home Guideline for
Upper Limit of Normal BP
SYS 135 mm Hg
DIA 85 mm Hg
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 the two years of reliable service.
Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the
local guidelines.
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.
CAUTION
An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is
measuring the systolic and diastolic blood pressure.During each measurement,
this equipment records the heartbeat intervals and works out the standard deviation.
If the calculated value is larger than or equal to 15,the irregular heartbeat symbol
appears on the symbol when the measurement results are displayed.
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?
TROUBLESHOOTING
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
massage
Display will not
light up.
Display is dim
or shows
Err 1 shows
Err 3 shows
The cuff is not secure.
Err 10 or
Err 11 shows
The monitor detected
motion,talking or the
pulse is too poor while
measuring.
Relax for a
moment and then
measure again.
Err 20 shows
Err 21 shows
Relax for a moment and
then measure again.
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.
The measurement
process does not detect
the pulse signal.
Loosen the clothing on
the arm and then
measure again.
The treatment of the
measurement failed.
Batteries are exhausted. Replace with new batteries
Batteries are low. Replace with new
batteries
Batteries are inserted
incorrectly.
AC adaptor is inserted
incorrectly.
Insert the batteries
correctly
Insert the AC adaptor
tightly
The pressure of the
cuff is excess. Relax for a moment
and then measure again.
Err shows Data communication has
failed.
Check if the App/Bluetooth
is on or not,try data
transmission again.
Refasten the cuff and then
measure again.
Err 2 shows The cuff is very tight Refasten the cuff and then
measure again.
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.
About 22cm~32cm or 22cm~42cm
Type BF applied part
WARNING: No modification of this equipment is allowed.
Temperature:-20℃-60℃
Relative Humidity: 10%RH-93%RH
Atmospheric Pressure: 50kPa-106 kPa
Temperature:5ć to 40ć
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Atmospheric pressure: 86kPa to 106kPa
Power supply
Battery powered mode:
6VDC 4×AAA batteries
AC adaptor powered mode:
(Please only use the recommended AC
adaptor model).
Display mode
Measurement mode Oscillographic testing mode
Measurement range
Measurement perimeter
of the upper arm
Net Weight Approx.248g(Excluding the dry cells and cuff)
External dimensions
Attachment
Mode of operation Continuous operation
Degree of protection
Protection against
ingress of water IP21
Accuracy
Normal working condition
Storage & transportation
condition
Software Version V01
Pressure:
5ć-40ćwithin±0.4kPa(3mmHg)
pulse value:±5%
Rated cuff pressure:
0kPa - 40kPa (0mmHg~300mmHg)
Measurement pressure: 5.3kPa-30.7kPa
(40mmHg-230mmHg)
pulse value: (40-199) beat/minute
Digital LCD V.A.60.5 mm×92.5 mm
Approx.140mm×130mm×49.7mm
4×AAA 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
1please use the TRANSTEK
authorized adapter.
6V 1A
SPECIFICATIONS AUTHORIZED COMPONENT
$GDSWHU
7\SH˖KH0601000UW
,QSXW˖100~240VAC, 50/60Hz, 0.3A Max
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&RQIRUPVWR8/FHUWLILFDWH
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Guangdong Transtek Medical Electronics Co., Ltd.
FCC STATEMENTCOMPLIED STANDARDS LIST
Complied Standards List FCC Statement
Risk management
Labeling
User manual
General
Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements and
Clinical Investigation
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of risk
management to medical devices
ISO/EN 15223-1:2012 Medical devices. Symbols to be
used with medical device labels, labelling and information to
be supplied. General requirements
EN 1041: 2008 Medical equipment manufacturers to
provide information
IEC 60601-1: 2005+A1：2012 Medical electrical
equipment - Part 1: General requirements for basic safety and
essential performance
IEC/EN 60601-1-2:2007 Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential
performance - Collateral standard:Electromagnetic
compatibility - Requirements and tests
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
ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or
automated sphygmomanometers
IEC/EN 62304:2006+AC: 2008 Medical device software
- Software life cycle processes
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:OU9TMB1490-B
EMC Guidance
1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions
regarding EMC and needs to be installed and put into service
according to the EMC information provided in the ACCOMPANYING
DOCUMENTS
2. 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=3, 3m away from the equipment.
(Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME
EQUIPMENT, a typical cell phone with a maximum output power of 2
W yields d=3, 3m at an IMMUNITY LEVEL of 3V/m)
EMC GUIDANCE