Transtek Medical Electronics TMB1491-B Blood Pressure Monitor User Manual TMB 1491 BT

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Document Description	TMB-1491-BT User Manual
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Date Submitted	2015-11-09 00:00:00
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Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Arm Type
TMB-1491-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.
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
TMB-1491-BT.
Blood Pressure Monitor
User Manual
version:1.0
CATALOGUE
TROUBLESHOOTING........................................................................................................22
SPECIFICATIONS..............................................................................................................23
AUTHORIZED COMPONENT ...........................................................................................24
CONTACT INFORMATION.................................................................................................24
COMPLIED STANDARDS LIST..........................................................................................25
FCC STATEMENT...............................................................................................................26 
EMC GUIDANCE................................................................................................................27
ABOUT BLOOD PRESSURE..............................................................................................20
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?
INFORMATION FOR USER................................................................................................18
Tips for measurement
Maintenances
DATA MANAGEMENT..........................................................................................................16
Recall the Records
Delete the Records
MEASUREMENT...................................................................................................................13
Tie the Cuff
Start the Measurement
BEFORE YOU START...........................................................................................................6
The Choice of Power Supply
Installing and Replacing the Batteries
Measurement Principle
Setting Date, Time and Measurement Unit
Select the User
Pair-up the Blood Pressure Monitor with Your Device
INTRODUCTION...................................................................................................................2
General Description
Indications for Use
Safety Information
LCD Display Signal
Monitor Components
Table of Contents
CATALOGUE

F1
SN
For indoor use only
Symbol for “Class II Equipment”
7$9Ä­ &&&
Symbol for “Including RF
transmitter”
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 “TYPE BF APPLIED
PARTS”
Symbol for “MANUFACTURE
DATE”
Symbol for “DIRECT CURRENT”
Symbol for “SERIAL NUMBER”
Symbol for “MANUFACTURER”
The Bluetooth Combination Mark
Symbol for “THE OPERATION
GUIDE MUST BE READ”
The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
Safety Information
The Transtek Blood Pressure Monitor is digital monitors intended for use in
measuring blood pressure and heartbeat rate with arm circumference ranging
IURPFPWRFP DERXWôÝòÝ RUFPWRFP DERXWôÝòÝ 
It is intended for adult indoor use only.
Indications for Use
Features:
60mm×40.5 mm Digital LCD display
Maximum 60 records
3rd technonoly: Measuring during inflation
(The updated technology in the world)
Thank you for selecting TRANSTEK arm type blood pressure Monitor
(TMB-1491-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-1491-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.
General Description
INTRODUCTION
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 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.
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.
CAUTION
INTRODUCTION

SYMBOL
Beats per minute, BPM
CUFF air is exhausting of deflating
The displayed measurement values
is from the memory.
Pulse per minute
Deflating
Memory
The grade of the blood pressure
Year/Month/Day, Hour/Minute
Grade
Current Time
Bluetooth icon
User 2
User 1
Heartbeat
Irregular heartbeat
Arrhythmia
Start measurement,save and transmit the
measuring results for User 2
The bluetooth icon blinks when the
bluetooth is working
Heartbeat detection during the
measurement
Start measurement,save and transmit the
measuring results for User 1
Batteries are low and need to be replaced
Low battery
mmHg
Measurement Unit of the blood pressure
(1kPa=7.5mmHg)
Measurement Unit of the blood pressure
(1mmHg=0.133kPa)
Low pressure result
Diastolic blood pressure
kPa
High pressure result
EXPLANATION
Systolic blood pressure
DESCRIPTION
LCD display signal
INTRODUCTION
3. 4×AAA alkaline batteries
1.Blood Pressure Monitor
(TMB-1491-BT)
List
LCD DISPLAY
AIR CONNECTOR PLUG
AIR HOSE
CUFF
BATTERY COMPARTMENT
START/STOP BUTTON
SET BUTTON
MEM BUTTON
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
4.User manual
5. AC Adaptor
(Model : KH0601000UW)
2.Cuff (Type BF applied part) (22~32cm or 22~42cm)
Monitor Components
INTRODUCTION

AC adaptor
shows
Remove the old batteries from the device and follow your local recycling guidelines.
Do not dispose of batteries in fire. Batteries may explode or leak.
The old batteries are harmful to the environment, do not dispose with other daily trash.
Remove batteries if the device is not likely to be used for some time.
CAUTION
The display does not light up
The display dims
The
Replace the batteries whenever the below happen
‡ Open the battery cover.
‡ Install the batteries by matching
the correct polarity, as shown.
‡ Replace the cover.
Installing and Replacing the Batteries
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.
CAUTION
Please unplug the adaptor to depart from
the using utility power.
6V 1A
(Please only use the recommended AC
adaptor model).
2.AC adaptor powered mode:
6VDC 4×AAA alkaline batteries
1.Battery powered mode:
The Choice of Power Supply
BEFORE YOU START
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
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%.
Measurement Principle
BEFORE YOU START

2.Press the “MEM” button to
change the [YEAR].
1.When the monitor is off,
hold pressing “SET” button
for 3 seconds to enter the
mode for year setting.
Or when the monitor is off,
press “SET” button shortly,
it will display the time. Then
hold pressing “SET” button
to enter the mode for year
setting.
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 :2014—2054
time format:12H / 24H)
Setting Date, Time and Measurement Unit
BEFORE YOU START
5.Repeat steps 2 and 3 to set the [TIME FORMAT].
4.Repeat steps 2 and 3 to set
the [MONTH] and [DAY].
3.When you get the right
year, press “SET” button
to set down and turn to
next step.
BEFORE YOU START

8.After the unit is set,the LCD will display
“done” and then turn off.
7.Repeat steps 2 and 3 to set the [UNIT].
6.Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
BEFORE YOU START
3. After selecting the suitable user ID, press SET button to
confirm. Then the LCD will turn off.
2.Then press MEM button again, select the user ID between
user 1 and user 2.
1.When the monitor is off , press and hold the MEM button
to enter user setting mode. The user ID will blink.
Select the User

BEFORE YOU START

will be shown on the LCD.
If FAIL, only bluetooth symbol
Bluetooth Module No.: AW8001
RF Frequency Range: 2402 MHz to 2480 MHz
Output Power Range: 0 dBm
Supply Voltage: 1.8-3.6 V
Transmitting Distance: 10 meters
4.The monitor will shut off after Pair-up process is
complete.
If SUCCEED, symbol
will be shown on the LCD.
3.Then please select the user ID you want to connect with your
smartphone on the app to continute the pair-up.
2.When the monitor is OFF, press and hold the START/STOP button to start
pair-up. The symbol
and
will be shown on the LCD alternatively,
indicating pair-up is proceeding.
1.Turn on Bluetooth and the app. Make sure both are ON when pair-up is
proceeding.
Pair-up the Blood Pressure Monitor
with Your Device
BEFORE YOU START
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.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.
3.Sit comfortably with your tested
arm resting on a flat surface.
2.The cuff should be snug but not
too tight. You should be able to
insert one finger between the
cuff and your arm.
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.
Tie the cuff
S TA R T
S TO P
2~3cm
MEASUREMENT


Inflating and measuring.
LCD display
Adjust to zero.
START
STOP
Display and save the results.
The device will proceed to data
transmission after measurement.
The Bluetooth symbol blinks on
the LCD indicates data is transmitting.
1.When the monitor is off,
press the “START/STOP” button to turn
on the monitor, and it will finish the whole
measurement .
Start the Measurement
MEASUREMENT
2.Press the “START/STOP” button
to power off, otherwise it will turn
off within 1 minute.
If the data transmission fails,
the Bluetooth symbol blinks
all the time until it turns off.
START
STOP

If the data transmission succeeds,
the Bluetooth symbol will disappear.
MEASUREMENT

UP
The current No. is No. 4. The corresponding
date is March 20th.
The corresponding
time is P.M. 10:00.
DOWN
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.
CAUTION
The date and time
of the record
will be shown
alternately.
2. Press “MEM” button
or “SET” button to get
the record you want.
1. When the monitor is off,
please press “MEM” button
to show the average value of
the latest three records.
Recall the Records
DATA MANAGEMENT
START
STOP
3.If you don’t want to delete the
records, press “START/STOP”
button to escape.
1.Hold pressing “MEM” button
for 3 seconds when the
monitor is in the memory
recall mode ,the flash
display will show.
4. If there is no record.
the right display will
show.
2.Press “SET” button to
confirm deleting and
the monitor will turn
off.
If you did not get the correct measurement, you can delete all
results by following steps below.
Delete the Records
DATA MANAGEMENT


Immediate measurement
after tea, coffee, smoking
When talking or moving your fingers
When you want to discharge urine
Within 1 hour
after dinner or drinking
Within 20 minutes
after taking a bath
In a very cold environment
Measurements may be inaccurate if taken in the following
circumstances.
Tips for Measurement
INFORMATION FOR USER

Do not attempt to clean the reusable cuff
with water and never immerse the cuff in
water.
Avoid dusty and unstable
temperature environment
Avoid touching water,
clean it with a dry cloth in case.
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
Using wet cloths to remove dirt
Avoid intense shaking
and collisions
Put in a dry place and avoid the sunshine
In order to get the best performance, please follow the
instructions below.
Maintenance
INFORMATION FOR USER

Diastolic
blood entering
vein
relax
Systolic
blood discharging
artery
press
140-159
160 or higher
Higher than 180
High Blood Pressure
(Hypertension) Stage 1
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Emergency care needed)
or
or
Higher than 110
100 or higher
90-99
80-89
or
120-139
Prehypertension
or
less than 80
Diastolic
mmHg (lower#)
and
Systolic
mmHg (upper#)
less than 120
Normal
Blood Pressure Category
This chart reflects blood pressure categories defined by American Heart Association.
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
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.
Irregular Heartbeat Detector
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
SYS 135 mm Hg
DIA 85 mm Hg
AHA Home Guideline for
Upper Limit of Normal BP
The chart on the right is the standard blood pressure classification published by
American Heart Association (AHA).
What is the standard blood pressure classification?
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 are systolic pressure and diastolic pressure?
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.
Is the result the same
if measuring on the
right arm?
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.
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.

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.
What you need to pay
attention to when you measure
your blood pressure at home:
Why does my blood pressure
fluctuate throughout the
day?
ABOUT BLOOD PRESSURE
S TA R T
S TO P
ABOUT BLOOD PRESSURE
S TA R T
S TO P

Error
massage
Low
batteries
No power
REMEDY
The monitor detected
motion,talking or the
pluse is too poor
while measuring.
E10 or E11
shows
The treatment of the
measurement failed.
A calibration error
occurred.
EExx,shows on
the display.
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.
Relax for a moment and
then measure again.
The measurement
Loosen the clothing on the
process does not detect arm and then measure
the pulse signal.
again
E21 shows
E20 shows
Refasten the cuff and then
measure again.
The cuff is not secure.
E 3 shows
Relax for a
moment and then
measure again.
Check if the App/Bluetooth
is on or not,try data
transmission again.
Data communication
is failed.
E 1 shows
Insert the AC adaptor
tightly
AC adaptor is inserted
incorrectly.
Replace with new batteries
Insert the batteries
correctly
Batteries are inserted
incorrectly.
Batteries are exhausted. Replace with new batteries
CHECK THIS
Batteries are low.
Display is dim or
show
Display will not
light up.
PROBLEM SYMPTOM
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.
TROUBLESHOOTING
V01
IP21
Type BF applied part
Continuous operation
4×AAA alkaline batteries,user manual
Approx.110mm×110mm×41mm
Approx.180g(Excluding the dry cells)
WARNING: No modification of this equipment is allowed.
Software Version
Protection against
ingress of water
Mode of operation
Degree of protection
Attachment
External dimensions
Net Weight
About 22cm~32cm or 22cm~42cm
Temperature:-20℃-60℃
Relative Humidity: 10%RH-93%RH
Atmospheric Pressure: 50kPa-106 kPa
Storage & transportation
condition
Measurement perimeter
of the upper arm
Temperature:5ć to 40ć
5HODWLYHKXPLGLW\”5+
Atmospheric pressure: 86kPa to 106kPa
Pressure:
5ć-40ćwithin±0.4kPa(3mmHg)
pulse value:Âą5%
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
Oscillographic testing mode
Digital LCD V.A.60mm×40.5mm
Normal working condition
Accuracy
Measurement range
Measurement mode
Display mode
Power supply
Battery powered mode:
6VDC 4×AAA alkaline batteries
AC adaptor powered mode:
6V
1A
(Please only use the recommended AC
adaptor model).

SPECIFICATIONS

1000mA
Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd.
Company: Guangdong Transtek Medical Electronics Co., Ltd.
Address: Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
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.
Contact Information
2XWSXW˖6V
$GDSWHU
7\SH˖KH0601000UW
,QSXW˖100~240V~
50/60Hz, 0.4A Max
authorized adapter.
1please use the TRANSTEK
Authorized Component
AUTHORIZED COMPONENT
Software life-cycle
processes
Performance
requirements and
Clinical Investigation
Electromagnetic
compatibility
IEC/EN 62304:2006+AC: 2008 Medical device software
- Software life cycle processes
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 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 60601-1: 2005+A1：2012 Medical electrical
equipment - Part 1: General requirements for basic safety and
essential performance
EN 1041: 2008 Medical equipment manufacturers to
provide information
User manual
General
Requirements for
Safety
ISO/EN 15223-1:2012 Medical devices. Symbols to be
used with medical device labels, labelling and information to
be supplied. General requirements
ISO/EN 14971:2012 Medical devices — Application of risk
management to medical devices
Labeling
Risk management
Complied Standards List

COMPLIED STANDARDS LIST

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.
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.
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.
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.
FCC ID: OU9TMB1491-B
FCC Statement
FCC STATEMENT
(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)
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.
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
EMC Guidance

EMC GUIDANCE

---

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Keywords                        : ()
Modify Date                     : 2015:11:09 16:02:03+00:00
Create Date                     : 2015:11:09 16:02:03+00:00
Creator Tool                    : PDFCreator Version 1.2.0
Document ID                     : ce9de641-8956-11e5-0000-b744eaa44c04
Format                          : application/pdf
Title                           : TMB-1491-BT User Manual.pdf
Creator                         : ferry-al
Description                     : ()
Author                          : ferry-al
Subject                         : 

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