Transtek Medical Electronics TMB1583-B Blood Pressure Monitor User Manual bf 1256 b 20121229

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User Manual
Blood Pressure Monitor
TMB-1583-BT
Arm Type
MEM
START
STOP
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
SET
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
TMB-1583-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.
CATALOGUE
CATALOGUE
Table of Contents
INTRODUCTION...................................................................................................................2
General Description
Indications for Use
Safety Information
LCD Display Signal
Monitor Components
BEFORE YOU START...........................................................................................................8
The Choice of Power Supply
Installing and Replacing the Batteries
Measurement Principle
Setting Date, Time, Measurement Unit and Clock Mode
Select the User
Pair-up the Blood Pressure Monitor with Your Device
MEASUREMENT...................................................................................................................14
Tie the Cuff
Start the Measurement
DATA MANAGEMENT...........................................................................................................17
Recall the Records
Delete the Records
SPECIAL FUNCTION............................................................................................................19
About the Clock Mode
About the Lock Button
INFORMATION FOR USER..................................................................................................20
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE................................................................................................22
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..........................................................................................................24
SPECIFICATIONS................................................................................................................25
AUTHORIZED COMPONENT .............................................................................................26
CONTACT INFORMATION...................................................................................................26
COMPLIED STANDARDS LIST............................................................................................27
FCC STATEMENT.................................................................................................................28
EMC GUIDANCE..................................................................................................................29
INTRODUCTION
INTRODUCTION
General Description
Thank you for selecting TRANSTEK arm type blood pressure Monitor
(TMB-1583-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-1583-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:
84mm×73 mm Digital LCD display
Maximum 60 records
3rd technonoly: Measuring during inflation
(The updated technology in the world)
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
from 22 cm to 32 cm ( about 8¾˝-12½˝ ) or 22cm to 42cm(about 8¾˝-16½˝).
It is intended for adult indoor use only.
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 “DIRECT CURRENT”
Symbol for “MANUFACTURE
DATE”
F1
Symbol for “TYPE BF APPLIED
PARTS”
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”
For indoor use only
T1A/250V Φ3.6*10CCC
Symbol for “Class II Equipment”
The Bluetooth Combination Mark
Symbol for “Including RF
transmitter”
Caution: These notes must be
observed to prevent any damage
to the device.
CAUTION
The device is not suitable for measuring the blood pressure of children. Ask your
doctor before using it on older children.
The device is not suitable for use on pregnant women, patients with implanted,
electrocical devices, patients with pre-elcampsia, premature ventricular beats, atrial
fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or
arterio-venous shunt or people who received a mastectomy. Please consult your
doctor prior to using the unit if you suffer from illnesses
Do not take any therapeutic measures on the basis of a self measurement. Never alter
the dose of a medicine prescribed by a doctor. Consult your doctor if you have any
question about your blood pressure.
Please keep the unit out of reach of infants, children or pets, since inhalation or
swallowing of small parts is dangerous or even fatal.
INTRODUCTION
INTRODUCTION
CAUTION
This device is intended only for adult use in homes.
This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is
not intended for use on extremities other than arm or for functions other than obtaining a blood
pressure measurement.
If you experience discomfort during a measurement, such as pain in the arm or other complaints,
press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and
remove it from your arm.
On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open
the cuff immediately. Prolonged high pressure (cuff pressure >300mmHg or constant pressure
>15mmHg for more than 3 minutes) applied to the arm may lead to an ecchymosis.
Too frequent and consecutive measurements could cause disturbances in blood circulation and
injuries.
Do not wrap the cuff on the same arm which other monitoring ME EQUIPMENT is applied
simultaneously, because this could cause temporary loss of function of those simultaneously-used
monitoring ME EQUIPMENT.
Don’t kink the connection tube during use, otherwise, the cuff pressure may continuously increase
which can prevent blood flow and result in harmful injury to the PATIENT.
The maximum temperature that the applied part can be achieved is 42.5℃ while the environmental
temperature is 40℃.(only for wrist blood pressure monitor)
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.
This unit is not suitable for continuous monitoring during medical emergencies or operations.
This device cannot be used with HF surgical equipment at the same time.
This device is not intended for patient transports outside a healthcare facility.
To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated
interference signal or electrical fast transient/burst signal.
The operator shall not touch output of batteries/adapter and the patient simultaneously.
Manufacturer will make available on request circuit diagrams, component parts list etc.
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.Never apply the cuff over hurt skin.
Do not use the unit in case of existing polyester resp. synthetic allergies.
Be careful to strangulation due to cables and hoses, particularly due to excessive length.
Do not connect the air hose to other medical equipment, as this could cause air to be pumped into
intravascular systems or high pressure, what could lead to dangerous injuries.
Before use, make sure the device functions safely and is in proper working condition.
Please use the device under the environment which was provided in the user manual. Otherwise,
the performance and lifetime of the device will been impacted and reduced.
Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE.
Otherwise, it may cause damage to the unit or danger to the user/patients.
Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the
local guidelines.
Please do not attempt to repair the unit yourself in the event of malfunctions. Only have repairs
carried out by authorized service centers.
Please report to Manufacturer if any unexpected operation or events occur.
The device doesn’t need to be calibrated in two years of reliable service.
Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.
LCD display signal
SYMBOL
DESCRIPTION
Systolic blood pressure
EXPLANATION
High pressure result
Diastolic blood pressure
Low pressure result
Pulse per minute
Beats per minute, BPM
Average value
The average value of the latest three
records
Memory
The displayed measurement values
is from the memory.
kPa
mmHg
Measurement Unit of the blood pressure
(1kPa=7.5mmHg)
Measurement Unit of the blood pressure
(1mmHg=0.133kPa)
Low battery
Batteries are low and need to be replaced
Irregular heartbeat
Irregular heartbeat Detection
Grade
The grade of the blood pressure
Current Time
Year/Month/Day(M/D or D/M),
Hour/Minute
INTRODUCTION
INTRODUCTION
Monitor Components
SYMBOL
DESCRIPTION
EXPLANATION
Error
Error
Hour
The hour in the clock mode
Minute
The minute in the clock mode
Second
The second in the clock mode
Heartbeat
Heartbeat detection during the
measurement
User 1
Start measurement,save and transmit the
measuring results for User 1
User 2
Start measurement,save and transmit the
measuring results for User 2
Bluetooth icon
The bluetooth icon blinks when the
bluetooth is working
LCD DISPLAY
AIR HOSE
CUFF
MEM
START
STOP
SET
MEM BUTTON
START/STOP BUTTON
SET BUTTON
LOCK BUTTON
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
List
BATTERY COMPARTMENT
DC POWER SOCKET
1.Blood Pressure Monitor
(TMB-1583-BT)
(Please use TRANSTEK
authorized cuff. The size
of the actual cuff please
refer to the label on the
attached cuff.)
MEM
START
STOP
SET
3. 4×AAA alkaline batteries
AIR CONNECTOR PLUG
2.Cuff (Type BF applied part)
(22cm~32cm or 22cm~42cm)
4.User manual
5. AC Adaptor
(KH0601000UW !)
BEFORE YOU START
BEFORE YOU START
The Choice of Power Supply
Measurement Principle
1.Battery powered mode:
6VDC 4×AAA alkaline batteries
2.AC adaptor powered mode:
6V 1A
(Please only use the recommended AC
adaptor model).
MEM
START
STOP
SET
Please unplug the adaptor to depart from
the using utility power.
AC adaptor
CAUTION
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.
Installing and Replacing the Batteries
• .Open the battery cover.
• .Install the batteries by matching
the correct polarity, as shown.
• .Replace the cover.
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%.
Setting Date, Time, Measurement Unit
and Clock Mode
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)
1.When the monitor is off,
hold pressing “SET” button
for 3 seconds to enter the
mode for year setting.
Replace the batteries whenever the below happen
The
shows
The display dims
The display does not light up
CAUTION
2.Press the “MEM” button to
change the [YEAR]. Each
press will increase the
numeral by one in a
cycling manner.
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.
Do not dispose of batteries in fire. Batteries may explode or leak.
BEFORE YOU START
BEFORE YOU START
3.When you get the right
year, press “SET” button
to set down and turn to
next step to set the date
format between “M/D” or
“D/M”.
6.Repeat steps 2 and 3 to set the [UNIT].
4.Repeat steps 2 and 3 to set the [DATE FORMAT], then set the
[MONTH] and [DAY].
7.Repeat steps 2 and 3 to set the clock mode.
5 .Repeat steps 2 and 3 to set the [TIME FORMAT] between 12H or 24H,
then set the [HOUR] and [MINUTE].
8.After the clock mode is set,the LCD will display “done” and then turn off.
10
11
BEFORE YOU START
Select the User
1.When the monitor is off , press and hold the MEM button to enter user setting
mode. The user ID will blink.
BEFORE YOU START
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 and hold the START/STOP button to start pair-up.
The bluetooth symbol
will blink, indicating pair-up is proceeding.
2.Then press MEM button again, select the user ID between user 1 and user 2.
3.Then please select the user ID you want to connect with your smartphone on the app to
continute the pair-up.
If SUCCEED, symbol
will be shown on the LCD.
3. After selecting the suitable user ID, press SET button to confirm. Then the LCD
will turn off.
12
If FAIL, only bluetooth symbol
will be shown on the LCD.
4.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
13
MEASUREMENT
MEASUREMENT
Tie the cuff
Start the Measurement
1.When the monitor is off, press the “START/STOP” button to turn
on the monitor, and it will finish the whole measurement.
(Take User 1 for example.)
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.
LCD display
2.The cuff should be snug but not
too tight. You should be able to
insert one finger between the
cuff and your arm.
Adjust to zero.
2~3cm
3.Sit comfortably with your tested
arm resting on a flat surface.
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.
14
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.
Inflating and measuring.
Display and save the
measurement results.
15
MEASUREMENT
DATA MEASUREMENT
2.This device will proceed
Recall the Records
to data transmission
after measurement.
The Bluetooth symbol
blinks on the LCD
indicates data is
transmitting.
1. When the monitor is off,
please press “MEM” button
to show the average value of
the latest three records.
(Take User 1 for example.)
2. Press “MEM” button
or “SET” button to get
the record you want.
If the data transmission fails,
the LCD will display
If the data transmission succeeds,
the LCD will display
The current No. is No. 6. The corresponding
date is April 19th.
The corresponding
time is 9:37 P.M..
The order, date and time
of the record will be shown
alternately.
3.Press the “START/STOP” button
to power off, otherwise it will turn
off within 1 minute.
Tips: Maximum 60 records are both for User 1 and User 2.
16
CAUTION
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.
17
DATA MANAGEMENT
SPECIAL FUNCTION
About the Clock mode
Delete the Records
If you did not get the correct measurement, you can delete all
results by following steps below.(Take User 1 for example)
1.Hold pressing “MEM” button
for 3 seconds when the
monitor is in the memory
recall mode ,the flash
display “ User ID+ dEL ALL”
will show.
2.Press “SET” button to
confirm deleting and
the monitor will display
“dEL dOnE” and
then turn off.
If you set the clock mode on in the
setting mode, when you turn off the
blood pressure monitor, the backlight
of the LCD will turn off, the LCD will
display the current time.
When the backlight of the LCD is off,
press any buttons to light it up, the
following display will show.
About the Lock Button
The unnecessary keys’ touch will make the blood pressure monitor
turn on and waste electricity. To avoid this, you can press the Lock
button to lock the keys if necessary.
Note: To exit out of delete mode
without deleting any records,
press START/STOP button
before pressing "SET" to confirm
any delete commands.
3. If there is no record.
the following display will
show.
Hold pressing the Lock button
until the LCD displays “OFF”,
this indicates the touch keys
(such as MEM, START/STOP,
SET) have been locked.
Hold pressing the Lock button
until the LCD displays “ON” to
unlock the keys.
18
19
INFORMATION FOR USER
INFORMATION FOR USER
Tips for Measurement
Measurements may be inaccurate if taken in the following
circumstances.
Maintenance
In order to get the best performance, please follow the
instructions below.
ME
STA
RT
STO
SET
MEM
START
STOP
SET
Put in a dry place and avoid the sunshine
Within 1 hour
after dinner or drinking
Avoid touching water,
clean it with a dry cloth in case.
Immediate measurement
after tea, coffee, smoking
MEM
RT
STA P
STO
SET
MEM
START
STOP
Avoid intense shaking
and collisions
Within 20 minutes
after taking a bath
SET
Avoid dusty and unstable
temperature environment
When talking or moving your fingers
MEM
STAR
STO
SET
Using wet cloths to remove dirt
In a very cold environment
20
Do not attempt to clean the reusable cuff
with water and never immerse the cuff in
water.
When you want to discharge urine
21
ABOUT BLOOD PRESSURE
ABOUT BLOOD PRESSURE
What are systolic pressure and diastolic pressure?
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.
Systolic
Diastolic
press
relax
blood discharging
artery
blood entering
vein
What is the standard blood pressure classification?
The chart on the right is the
standard blood pressure
classification published by
American Heart Association
(AHA).
AHA Home Guideline for
Upper Limit of Normal BP
SYS
DIA
135 mm Hg
85 mm Hg
This chart reflects blood pressure categories defined by American Heart Association.
Blood Pressure Category
Normal
Systolic
mmHg (upper#)
Diastolic
mmHg (lower#)
less than 120
and
less than 80
Prehypertension
120-139
or
80-89
High Blood Pressure
(Hypertension) Stage 1
140-159
or
90-99
160 or higher
or
100 or higher
Higher than 180
or
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Emergency care needed)
Higher than 110
CAUTION
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.
Irregular Heartbeat Detector
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.
CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat 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.
22
Why does my blood pressure
fluctuate throughout the
day?
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.
Why do I get a different
blood pressure at home
compared to the hospital?
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.
Is the result the same
if measuring on the
right arm?
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.
23
TROUBLESHOOTING
SPECIFICATIONS
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
No power
Low
batteries
Display will not
light up.
Display is dim or
show
Err shows
E 1 shows
E 2 shows
Error
massage
E 3 shows
E10 or E11
shows
E20 shows
24
CHECK THIS
REMEDY
Batteries are exhausted. Replace with new batteries
Batteries are inserted
incorrectly.
Insert the batteries
correctly
AC adaptor is inserted
incorrectly.
Insert the AC adaptor
tightly
Batteries are low.
Replace with new batteries
Data communication
is failed.
Check if the App/Bluetooth
is on or not,try data
transmission again.
Refasten the cuff and then
measure again.
Refasten the cuff and then
The cuff is very tight
measure again.
The pressure of the cuff Relax for a moment and
then measure again.
is excess.
Power supply
Display mode
E21 shows
The treatment of the
measurement failed.
EExx,shows on
the display.
A calibration error
occurred.
Relax for a
moment and then
measure again.
Loosen the clothing on the
arm and then measure
again.
Relax for a moment and
then measure again.
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.
Digital LCD V.A.84mm×73mm
Measurement mode
Oscillographic testing mode
Measurement range
Rated cuff pressure:
0kPa - 40kPa (0mmHg~300mmHg)
Measurement pressure: 5.3kPa-30.7kPa
(40mmHg-230mmHg)
pulse value: (40-199) beat/minute
Accuracy
The cuff is not secure.
The monitor detected
motion,talking or the
pluse is too poor
while measuring.
The measurement
process does not detect
the pulse signal.
Battery powered mode:
6VDC 4×AAA alkaline batteries
AC adaptor powered mode:
6V
1A
(Please only use the recommended AC
adaptor model).
Pressure:
5℃-40℃within±0.4kPa(3mmHg)
pulse value:±5%
Normal working condition
Temperature:5℃ to 40℃
Relative humidity: ≤85%RH
Atmospheric pressure: 86kPa to 106kPa
Storage & transportation
condition
Temperature:-20℃-60℃
Relative Humidity: 10%RH-93%RH
Atmospheric Pressure: 50kPa-106 kPa
Measurement perimeter
of the upper arm
Net Weight
External dimensions
Attachment
About 22cm~32cm or 22cm~42cm
Approx.250g(Excluding the dry cells and cuff)
Approx.107mm×103mm×118mm
4×AAA alkaline batteries,user manual
Continuous operation
Mode of operation
Degree of protection
Type BF applied part
Protection against
ingress of water
IP21
Software Version
V01
WARNING: No modification of this equipment is allowed.
25
AUTHORIZED COMPONENT
Authorized Component
COMPLIED STANDARDS LIST
Complied Standards List
1.please use the TRANSTEK
authorized adapter.
Adapter
Type：KH0601000UW
Input：100~240V~
50/60Hz, 0.4A Max
Output：6V
Risk management
Labeling
ISO/EN 15223-1:2012 Medical devices. Symbols to
be used with medical device labels, labelling and
information to be supplied. General requirements
User manual
EN 1041: 2008 Medical equipment manufacturers to
provide information
General Requirements
for Safety
1000mA
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: 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
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
Electromagnetic
compatibility
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
Performance
requirements and
Clinical investigation
IEC 80601-2-30:2009 Medical electrical equipmentPart 2-30: Particular requirements for the basic safety
and essential performance of automated non-invasive
sphygmomanometers
ISO81060-2 Non-invasive sphygmomanometers —
Part 2: Clinical validation of automated
measurement type
Software life-cycle
processes
Usability
26
ISO/EN 14971:2012 Medical devices — Application of
risk management to medical devices
IEC/EN 62304:2006+AC: 2008 Medical device
software - Software life cycle processes
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
27
FCC STATEMENT
FCC Statement
EMC GUIDANCE
EMC Guidance
FCC ID: OU9TMB1583-B
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.
28
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.
1) This equipment needs to be installed and put into service in accordance
with the information provided in the user manual;
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)
29

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