English (Original)

2440

Recorder for Ambulatory Blood
Pressure Monitor

INSTRUCTION MANUAL
Ambulatory Blood Pressure Monitor

1WMPD4003473G

2309

2018 A&D Company, Limited. All rights reserved.
No part of this publication may be reproduced, transmitted,
transcribed, or translated into any language in any form by anymeans without the written permission of A&D Company, Limited.
The contents of this manual and the specifications for the
instrument covered by this manual are subject to change for
improvement without notice.
Other trademarks and trade names are those of their respective
owners.

Compliance
Compliance with European Directive
The device conforms to Medical Devices Directive 93/42/EEC.
This is shown by the CE mark of conformity accompanied by
the reference number of a designated authority.
The device conforms to RoHS Directive 2011/65/EU.

Compliance with the Australian EMD Framework
The device conforms to the following requirements:
EMD Emission standard for industrial, Scientific & Medical equipment
AS/NZS 2064:1997, EMD Generic Immunity standard AS/NZS 4252.
1:1994. The above is shown by the C-Tick label.

iWarning Definitions
To prevent accidents due to inappropriate handling, this productand its manual contain the following warning signs and marks.
The meanings of these warning signs and marks are as follows.

Warning Definitions
DangerAn imminently hazardous situation that will result in deathor serious injury, if not avoided.

Warning

A potentially hazardous situation that could result in deathor serious injury, if not avoided.

A potentially hazardous situation that may result in minor
Caution or moderate injury, if not avoided. It may also be used towarn against unsafe practice.

Symbol Examples
The symbol
indicates "Caution". The nature of the caution
required is described inside or near the symbol, using text or a
picture. The example indicates caution against electrical shock.
The symbol
indicates "Do not". The prohibited action is
described inside or near the symbol, using text or a picture.
The example indicates "Do not disassemble".
The symbol
indicates mandatory action. The mandatory
action is described inside or near the symbol, using text ora picture. The example indicates general mandatory action.

Other
Note

Provides information useful for the user when operating thedevice.

Precautions for each operation are described in the pages of thismanual. Read the instruction manual before using the device.
iiPrecautions for Use
In order to use the TM-2440 (the recorder for the ambulatory
blood pressure monitor) safely and correctly, read the following
precautions carefully before using the monitor. The following content
summarizes general matters affecting the safety of patients andoperators, as well as safe handling of the monitor. Precautions foreach operation are described in the pages of this manual. Readthe instruction manual before using the device.
1. Precautions When Wearing and Storing the Recorder.

DangerKeep the recorder away from areas where flammableanesthetics or flammable gases are present, high-pressure
oxygen chambers and oxygen tents. Using the recorder inthese areas may cause an explosion.
Do not use the recorder together with a magnetic resonanceimaging system (MRI).

CautionTo preserve the capabilities of the device, consider the following
environmental conditions when using and storing the recorder.
The performance of the recorder may be affected by excessive
temperature, humidity and altitude.
Avoid locations where the recorder may be splashed by water.
Avoid locations with high temperature, high humidity, direct
sunlight, dust, salt and sulfur in the air.
Avoid locations where the recorder may be tilted, vibrated,or impacted (including during transportation).
Avoid locations where chemicals are stored or gas is present.

iii

Caution
Operation conditions:Temperature: +10 °C to +40 °C,
Humidity:
30 %RH to 85 %RH (no condensation).
Transport and storage conditions:Temperature: -20 °C to +60 °C,
Humidity:
10 %RH to 95 %RH (no condensation).
2. Precautions Before Using the Recorder.

CautionConfirm that the recorder is operating safely and correctly.
When the recorder is used in conjunction with other devices,it may cause an incorrect diagnosis or safety problems.
Confirm that the devices can be connected safely.
Check for mutual interference with other medical devices.
Confirm that the recorder can be used correctly.
Use accessories, options and consumables specified by A&D.
Carefully read the instruction manuals provided with optional
items. Any cautions and warnings are not described in thismanual.
For safe and correct use of the recorder, inspect it before use.
Leave the recorder in a normal operation state for one hour ormore before use and turn it on.
Only connect dedicated peripherals to the USB connector.
Do not connect other devices.
Do not connect any cuff except for a cuff authorized by A&D
to the air socket.

iv

Note
Preparation of the Recorder
Delete the last data stored in the recorder before it is used by
the next patient.
Replace the batteries before the recorder is used by the next
patient.
DeviceUse the recorder for diagnosis and countermeasures only.
Confirm that the air hose and cuff are worn correctly. (Example: kinks
and tension in the air hose, position and direction of the cuff)
Instructions for the Patient Wearing the Device
Inform the patient how to suspend automatic blood pressure
measurement to stop the recorder if a problem occurs when alone.
Inform the patient to remove the recorder quickly when in pain or if
any problem occurs.
Take care when using around babies and infants, as there isa danger of accidental suffocation with the air hose.
3. Precautions for Batteries Used for Blood Pressure Measurement.

CautionInstall the batteries in accordance with polarity signs "+" and "-"shown on the inside of the battery cover. (Note the polarities)
Replace flat batteries with new ones at the same time.
Remove the batteries if the recorder is not going to be used for along period of time. The battery may leak and cause a malfunction.
Use two alkaline batteries (size AA) or specified re-chargeable
batteries (size AA, Ni-MH).
Push and hold the "-" spring terminal with the battery.
Slide and install the "+" terminal of the battery at the "+" terminalof the battery compartment. If the battery is installed from the "+"terminal, the battery cover may be damaged.
v

Do not touch the battery and the patient at the same time.
It may cause an electric shock.
Do not mix old batteries with new ones. Do not use batteries ofdifferent type and manufacturer. If these are used, this may
cause leakage, heat and explosion. The recorder may
malfunction.
4. Precautions During Use.

DangerDo not use the recorder while operating automobiles or othervehicles.
Example: The recorder may inhibit the motion of the body orarms when operating the vehicle. etc.

Warning
This medical device can be only operated by a doctor or a legallyauthorized person. Explain the correct usage to the patient andensure they can stop measurement when a problem occurs.
Do not use a mobile phone near the recorder (less than 30 cm).
It may cause a malfunction.

CautionStop using the recorder and suspend automatic blood pressure
measurement if the patient feels pain in their arm or themeasurement is incorrect.
Do not use the recorder in a strong magnetic or electric field.
Do not use the recorder on a patient using a heart-lung machine.

vi

Note
Instructions for Patient
If the temperature is low, battery power becomes lower and themeasurement count is reduced.
5. Precautions After Using the Recorder.

CautionProcessing work of Measurement Data
Be sure to process measurement data immediately using
a dedicated peripheral.
The Recorder
After cleaning the accessories, arrange and store them.
Clean the recorder for the next measurement.
Suspend automatic blood pressure measurement. Otherwise,pressurization for automatic measurement is started at the next
measurement start time and the cuff or other parts may be
broken by the inflation.
Remove the batteries from the recorder if it is not going to be
used for a long period of time. The batteries may leak and break
the recorder.
Avoid having a child use the recorder on their own.
Do not put the recorder in a place within reach of an infant.
Doing so may cause accidents or damage.
Hold the connector housing when connecting and removing thecable. Do not pull on the cable.

vii

Note
Precautions After Using the Recorder (TM-2440)
Be sure to process measurement data immediately using a dedicatedperipheral after finishing measurement.
Backup Lithium Rechargeable Battery
The recorder comes with a backup lithium battery. This battery
supplies power to the built-in clock when replacing AA batteries used
for blood pressure measurement. The lithium battery is charged fromthe AA batteries.
How to Extend the Life of the Backup Battery
When first using after purchase or after storing for a month or more,
replace the batteries and charge the backup battery. It is enough if
the backup battery is charged for 48 hours or more.
(The backup battery is always charged by the AA batteries.)
Replace with two new AA batteries when the battery indicator
displays.
Whenis displayed on the battery indicator, the blood pressure
measurement and data communication cannot be performed. Replacewith two new AA batteries.
Remove the batteries to prevent the recorder from liquid leakage froma battery if the recorder is not used for a month or more.

viii

6. Remedies When the Device Has an Error

Warning
Stop the operation and remove the AA batteries. If the battery
terminals are shorted, the battery may be hot.
In the event of a failure, the recorder may get hot during
measurement, please handle it with care.
Put the “Malfunction" "Do not use" notice label on the recorder.
Contact your dealer.
Stop the recorder immediately when the measurement time isabove 180 seconds and the air pressure rises above 299 mmHg.
7. Precautions for MaintenanceWarning
Confirm the correct performance and safety of the recorderwhen it has not been used for a long period of time.
To maintain correct measurement and safety, perform aninspection and maintenance before use. The user (hospital,
clinic, etc.) is responsible for the management of the medical
equipment. If the inspection and maintenance are not performed
correctly, an accident may occur.

Warning
Use a dry lint free cloth to clean the recorder.
Do not use volatile agents, such as a thinner or benzine.
Do not use a wet cloth.
Do not disassemble or modify the recorder (medical electronic
device). It may cause damage.

ix

8. Precautions and Remedies for a Malfunction Due to a Strong
Electromagnetic Field

CautionThe recorder complies with EMD-standard IEC60601-1-2: 2014
+A1: 2020. However, to prevent electromagnetic interferencewith other devices, do not use mobile phones near the recorder.
If the recorder is located near strong electromagnetic fields,
noise may affect the waveforms and malfunctions may occur.
If an unexpected malfunction occurs during use, check forelectromagnetic interference and take appropriate actions.

CautionThe following examples are general causes of malfunctions andtheir remedies.
Use of mobile phones
Radio waves may cause unexpected malfunctions.
Wireless communication devices, home networking
devices such as cordless phones and similar
communication devices can affect the recorder.
Therefore, they must be kept at a distance of at least
30 cm or more from the recorder.
If there is static electricity in the area of use (discharges fromdevices or the surrounding area)
Before using the recorder, ensure that the operator andpatient have discharged any static electricity.
Humidify the room.
9. Environmental Protection

Caution
Before disposing of the recorder, remove the lithium battery fromthe recorder.
xPrecautions For Safe Measurement
This section describes precautions for the measurement and thesensor. Notify the patient of following content and explain it tothem. Guide the patient in the correct use of the device.

Blood Pressure Measurement

Warning
Ensure the tube is not bent excessively and that air flows
properly. If a bent air hose is used, air pressure may remainin the cuff, which may stop blood flow to the arm.
Do not measure the blood pressure on an arm if the patient
has the following conditions. This may cause an accident or
aggravation of the injury.
1) An injury or disease on an arm.
2) An arm receiving an intravenous drip or blood transfusion.
3) A limb that is shunted for artificial dialysis.
4) The patient has been bedridden for a long time
(Where there is a possibility of thrombus).

CautionConfirm the condition of the patient if there aremeasurement problems. The device guesses that thecondition is worsening beyond the limit of measurement
or if the air flow ceases because the air hose is bent.
Measuring blood pressure too frequently may cause bodily
harm due to blood flow interference. Confirm that theoperation of the device does not result in prolonged
impairment on blood circulation when using the device
repeatedly.
Blood pressure measurement may not be accurate if thepatient has continuous arrhythmia, or moves excessively.
xi

Caution
Wear the cuff at the same level as heart. (If the level isdifferent, an error in the measurement value occurs.)
The recorder responds to artifact and external impact.
If there are any doubts in the measurement value,measure blood pressure by auscultation or palpation.
A measurement error may occur if the cuff is not of thecorrect arm circumference for the patient.
Do not inflate the cuff before it is wrapped around the arm of
the patient. Damage and explosion of the cuff may occur.

Note
Blood pressure measurement may cause subcutaneous bleeding.
This subcutaneous bleeding is temporary and disappears with time.
If the patient uses a heart-lung machine, blood pressure cannot bemeasured due to the absence of a heartbeat.
Blood pressure cannot be measured correctly if thick clothing is worn.
Blood pressure cannot be measured correctly if the clothing is rolled
up and the arm is squeezed.
Blood pressure cannot be measured correctly if peripheral circulation
is insufficient, the blood pressure is excessively low or if the patient has
hypothermia (blood flow is insufficient).
Blood pressure cannot be measured correctly if the patient has
frequent arrhythmia.
Blood pressure cannot be measured correctly with the incorrect cuff size.
Blood pressure cannot be measured correctly if the cuff is not worn at
the same level as the heart.
Blood pressure cannot be measured correctly if the patient is moving
or talking during measurement.
Clinical trials have not been conducted on newborn infants andpregnant women.
Consult a doctor before use if you have had a mastectomy.
xii

Cuff

Warning
Dispose of cuffs contaminated by blood to prevent infectious
disease from spreading.
Avoid storing the cuff folded or with a tightly twisted air hosefor extended periods of time. Such treatment may shorten
the life of the components.

Measurement of Pulse Rate

Warning
Do not use the displayed pulse rate for the diagnosis of anirregular heartbeat.

Note
The recorder measures the pulse rate when measuring the bloodpressure.

xiii

Packing List
CautionThe recorder is a precision instrument. Use with caution.
Excessive shock may cause failure and malfunction.

Note
The recorder is shipped using a special packing box designed toprotect it from damage during transport. When you open this box,
make sure you have everything on the packing list. If you haveany questions, contact your local dealer or the nearest A&D
dealer. We recommend keeping the special packing box.
Refer to "10 Optional Items (requiring order)" for options.
Blood pressure recorder .............................................................. 1
Accessories
Adult cuff

20 to 31 cm (7.8" to 12.2") for left arm
TM-CF302A ............. 1
Adult cuff cover ...................................................................... 2
Carry holder ...................................... AX-133025995 ......... 1
Belt ................................................... AX-00U44189 .......... 1
Clip ........................................................................................ 1
Activity record sheet (10 sheets) ....... AX-PP181-S ............ 1
USB cable ......................................... AX-KOUSB4C .......... 1
ABPM Data Manager CD ....................................................... 1
This instruction manual .......................................................... 1

xivAdult cuff for left arm
Blood pressure Recorder

Carry holder

Clip
Adult cuff cover

Belt
ABPM Data Manager CD

Activity record sheet (10 sheets)
USB cable

xv

This instruction manual[ Blank page ]xvi

Contents
Compliance ................................................................................................ iCompliance with European Directive ...................................................... iCompliance with the Australian EMD Framework.................................... i
Warning Definitions ....................................................................................ii
Precautions for Use...................................................................................iii
Precautions For Safe Measurement ..........................................................xi
Blood Pressure Measurement................................................................xi
Cuff.............................................................................................. xiii
Measurement of Pulse Rate ................................................................ xiii
Packing List.............................................................................................xiv
1.

Introduction..................................................................................... 4

2.

Features ......................................................................................... 4

3.

Abbreviations & Symbols ................................................................ 6

4.

Specifications ............................................................................... 10
4.1.
Recorder................................................................................ 10
4.2.
Dimensions............................................................................ 13

5.

Component Names....................................................................... 14
5.1.
Recorder................................................................................ 14
5.2.
Display of OLED (Organic light emitting diode) ...................... 15
5.3.
Principal Switch Operations ................................................... 16
5.3.1. A-BPM Operations ............................................................. 16
5.3.2. Other Operations................................................................ 19

6.

Blood pressure measurement Functions....................................... 20
6.1.
Automatic Blood Pressure Measurement (A-BPM) ................ 20
6.1.1. A-BPM Waiting Mode ......................................................... 211

6.1.2. Sleep Function and Interval time ........................................ 22
6.1.3. Stopping Measurement ...................................................... 22
6.2.
Measurement Result.............................................................. 23
6.2.1. Displaying Measurement Results ....................................... 23
6.2.2. Storing Measurement Results ............................................ 23
6.2.3. Outputting Measurement Results ....................................... 24
6.2.4. ID numbers......................................................................... 24
7.

Preparing the Recorder................................................................. 25
7.1.
Installing Batteries (Replacing Batteries)................................ 25
7.1.1. How to Replace Batteries ................................................... 27
7.2.
Preparing the Carry Holder .................................................... 27
7.3.
Inspection for Use.................................................................. 28
7.3.1. Battery Pre-installation Checklists ...................................... 28
7.3.2. Battery Post-installation Checklists..................................... 29

8.

Operations .................................................................................... 29
8.1.
Operation Flowchart............................................................... 29
8.2.
Initial Settings ........................................................................ 31
8.2.1. Factory Settings ................................................................. 31
8.2.2. The Clock and the Monitor Function of Measurement ........ 32
8.2.3. Initial Pressurization Value ................................................. 33
8.3.
A-BPM Preset Programs........................................................ 33
8.3.1. A-BPM Items and Parameters ............................................ 35
8.3.2. A-BPM Program Examples................................................. 38
8.4.
Deleting Measurement Data .................................................. 40
8.5.
Attaching the Product to the Patient....................................... 41
8.5.1. Information for Patients ...................................................... 41
8.5.2. Cuff Cover.......................................................................... 44
8.5.3. Attaching the Cuff, Carrying holder and Recorder .............. 452

8.6.
Blood Pressure Measurement Operations ............................. 48
8.6.1. A-BPM Operations ............................................................. 48
8.6.2. Manual Measurement......................................................... 50
8.6.3. Stopping and Suspending Measurements .......................... 51
8.7.
Connecting the Recorder to a Dedicated Peripheral .............. 52
8.7.1. Connecting with a USB cable ............................................. 52
9.

Maintenance ................................................................................. 54
9.1.
Product Storage, Inspection and Safety Management ........... 54
9.2.
Cleaning the Product ............................................................. 55
9.3.
Periodic Inspection ................................................................ 57
9.3.1. Battery Pre-installation Inspection ...................................... 57
9.3.2. Battery Post-installation Inspection..................................... 58
9.4.
Disposal................................................................................. 59
9.5.
Troubleshooting ..................................................................... 60
9.6.
Error Codes ........................................................................... 61

10.

Optional Items (requiring order) .................................................... 64

11. Appendix ...................................................................................... 66
11.1.
Principle of Blood Pressure Measurement ............................. 66
11.2.
EMD Information.................................................................... 68

3

1. Introduction
Thank you for your Purchase!
The TM-2440 ambulatory blood pressure recorder enables
accurate measurement of patient blood pressure automaticallyfor preset times (e.g. 24-hours continuously). This manualexplains the settings, operation, modes and programs forblood pressure measurement, as well as communication with adedicated peripheral, maintenance, specifications and warnings.
Read this manual for proper use and keep it in an accessible
place.

2. Features
Summary
The recorder is an ambulatory blood pressure monitor that can
non-invasively measure the blood pressure value and pulse rateof the patient under the guidance of a doctor. The purpose is tomeasure and store variation of the blood pressure over a day
during daily life. The recorder is designed to be portable andhave a data management function and simple operation.

Blood pressure measurement target
This recorder is designed for adults (above 12 years of age).

4

Purpose of use
The recorder enables automatic blood pressure measurement
and manual blood pressure measurement. Blood pressure
readings can be used for consulting with doctors and for
self-managing health.
Automatic blood pressure measurement (A-BPM)
This mode can specify six pairs of arbitrary start times andintervals for every 24 hours and can automatically measure
and record blood pressure.
Manual blood pressure measurement
Blood pressure can be measured manually at any time, including
when the A-BPM function is activated.

Portability
The weight of the recorder is approximately 120 g (excluding batteries).
It is palm sized and equipped with a micro-pump.
Two AA alkaline batteries can be used. (LR6 or AA size)
Two rechargeable batteries (AA size, Ni-MH battery) can be used.

Operability
The settings of the recorder and the blood pressure
measurement program can be configured easily using the ABPM
Data Manager installed on the computer (dedicated peripheral).

Extensive analytical performance
The measurement interval time can be set for the automatic bloodpressure measurement.
The blood pressure can be measured immediately using manual
measurement at any time.
The analysis can be carried out effectively using the ABPM DataManager installed on the computer (dedicated peripheral).
5

Shorter measurement time
The deflation speed is controlled to minimize the measurement time.
The pressurization value is controlled to minimize the measurement time.

Simple convenience
A dedicated peripheral can receive data over a USB cable. Data
received can be analyzed and printed easily.

3. Abbreviations & Symbols
Symbols

Meaning

SYS

Systolic blood pressure

DIA

Diastolic blood pressure

PUL

Pulse rate

PP
kPa
mmHg
/min

Pulse pressure

PP = SYS - DIA

Unit of blood pressure
Unit of pulse rate/minuteDisplaying: A-BPM is in operation.
Memory full, delete data to start measurement.
Battery indicator
If the level 1
is displayed, blood pressure
measurement and data communication cannot takeplace. Replace the batteries with 2 new LR6 (AA size)
batteries.
A-BPM sleep markThe mark is displayed during configuration.

Exx

Error codes. xx = 00 to 99

OLED

Organic light emitting diode6

Symbols

Meaning
Alert markDegree of protection against electric shock:Equipment type BF.
Manufacturer of the CE Marking. Date of manufacture.

SMALL

Symbol for small cuff
Arm circumference 15 to 22 cm

5.9" to 8.7"

ADULT

Symbol for adult cuff
Arm circumference 20 to 31 cm

7.8" to 12.2"

LARGE

Symbol for large cuff
Arm circumference 28 to 38 cm 11.0" to 15.0"

EXTLARGE

Symbol for extra-large cuff
Arm circumference 36 to 50 cm 14.2" to 19.7"

adult
cuff

20-31cm7.8"-12.2"

Symbol printed on packing.
The adult cuff is included in the accessories.
Refer to the instruction manual or booklet.
Symbol for "Keep dry" and "Keep away from rain".

SN

Serial number
Symbol printed in the battery compartment.
Direction (polarity) to install battery.

x2
1.5V LR6
1.2V HR6
not included
EMD

Symbol printed on packing.
Batteries are excluded from accessories.
Electromagnetic disturbances
Symbol for "Handle with care".
The symbol for waste electrical and electronicequipment directive.
7

Symbols
BPM

Meaning
Blood pressure measurement

A-BPM

Automatic blood pressure measurement.

Sleep, Cycle, Hour,
A-BPM symbols. #1
START, Operation
Not made with natural Caution for patient. This is printed on
rubber latex.
the cuff.
Cautions on battery cover.
CautionUse alkaline batteries or the• Use alkaline batteries or specified
rechargeable batteries specified
rechargeable batteries andensure correct polarity (+,-).
and ensure correct polarity (+,-).
• Do not mix new, used or different
branded batteries.
Do not mix new, used or• Firmly secure cuff air hose todifferent branded batteries.
main body.
Firmly secure cuff air hose to main body.
#1: Refer to "6.1.Automatic Blood Pressure Measurement (ABPM) " and "8.3.A-BPM Preset Programs" for 24-hours bloodpressure recorder.

8

Waiting mode
The A-BPM waiting mode is a state where the blood pressure is
not being measured during the interval time.
Start time
T

T

Start time
T

T

T

T

SectionBlood pressure measurement
T
SectionTime
T: Interval time

Dedicated peripheral
A dedicated peripheral means the computer on which the ABPM DataManager is installed. The ABPM Data Manager is stored on anaccessory CD.
Use a peripheral device that complies with the requirements for
medical electrical equipment (IEC60601-1) when connecting therecorder to a peripheral device. Do not connect the recorder toanother devices (Example: IEC60950) in an area where medical
equipment is used.
Use a USB cable shorter than 1.5 m (4.9 ft).

9

4. Specifications
4.1. Recorder
Items

Descriptions

Measurement method

Oscillometric measurement method

Pressure detection
methodSemiconductor pressure sensor

Pressure display range

0 to 299 mmHg

Measurement accuracy

Pressure:
Pulse rate:±3 mmHg±5 %Minimum
display division

Pressure:
Pulse rate:

1 mmHg1 beat /minute

Measurement range

Systolic pressure: 60 to 280 mmHg
Diastolic pressure: 30 to 160 mmHg
Pulse rate:
30 to 200 beats /minuteDepressurization

Constant exhaust with a controlled leakage
valve for safety

ExhaustElectromagnetic valve

Pressurization method

Micro-pump

Automatic pressurization 85 to 299 mmHg
Interval time (of A-BPM)

Intervals at each section which divides
24 hours into six parts at the maximum.
Interval: OFF, 5, 10, 15, 20, 30, 60, 120 minutes

Clock24-hour clock

Display

OLED, 96 x 39 pixels, white characters

MemoryMeasurement data: 600 data points max.

10

ItemsPower supply

Measurement countRated voltage

Descriptions
With the same type of batteries:
2 x 1.5V batteries (LR6 or AA size)
Alkaline battery or nickel-hydride battery(Ni-MH) 1900 mAh or more
Backup battery for built-in clock: Lithium
rechargeable coin cell battery ML2016H
200 times or more.
(when new alkaline batteries or nickelhydride batteries are used. It may vary
due to measurement conditions.)
DC 3.0 V (Alkaline battery, LR6),
DC 2.4 V (Nickel-hydrogen battery, AA size)

Interface

USB: USB1.1 compliant.
Cable length: 1.5 m or shorter.
Micro-USB B type terminal can connect todedicated peripheral (using standard
driver software).

Operating condition

Temperature: +10 to +40 °C
Humidity:
30 to 85 %RH (no condensation)

Transport and storage
conditions

Temperature: -20 to +60 °C
Humidity:
10 to 95 %RH (no condensation)

Atmospheric pressure
both for operation andstorage condition

700 to 1060 hPa

Type of protection
against electric shock

Internally powered equipment

Degree of protection
against electric shock

Type BF: The recorder, cuff and tubing aredesigned to provide special protection againstelectrical shock.

CE Marking

The EC directive label for medical device.
11

ItemsDescriptions

C-Tick Marking

The certification trademark registered to the
ACA by the Trademark office.

Dimensions

Approx. 95 (L) × 66 (W) × 24.5 (H) mm

Mass

Approx. 120 g (excluding batteries)

Useful life

Recorder: 5 years. Self-authentication withinternal data. Proper operation andmaintenance in the best conditions.
Durability varies with usage conditions.

Ingress protection

Device: IP22

Default mode

Continuous measurement

Restart time after
defibrillation

Immediately

EMD

IEC 60601-1-2: 2014 + A1: 2020

Note:
# Specifications are subject to change for improvement without
prior notice.
# Clinical trial for this device is performed in based on
ISO 81060-2:2013.
# The recorder is not medical device for monitoring patient.
We don't recommend the way of use that has to monitor
patient in real time at place like intensive care unit.
ACA: Australian Communications Authority

124.2. Dimensions

66

24.5

95

Unit: mm13

5. Component Names
5.1. Recorder
Adult cuff for left arm

Artery position markAir hose
Air plugAir socket
EVENT switch

OLED
START and
STOP switch

Battery compartment and2 LR6 (AA size) batteries
for measurement

Battery cover

Micro USB port (at bottom),Data communication terminal

14

5.2. OLED Display (Organic light emitting diode)Note
To get accurate diagnosis, take care to accurately read the data
displayed on the recorder and interpret it properly.
The state of A-BPM is indicated on the OLED.
Clock time.
The state of settings and operation.
The measurement value of A-BPM.
SYS
DIA
PUL

Systolic blood pressure.
Diastolic blood pressure.
Pulse rate.

mmHg Unit for blood pressure value.
/min
Unit for the pulse rate.
Refer to "3.Abbreviations & Symbols " for the meanings ofsymbols on the OLED.
Meaning

Symbols

The mark is displayed during configuration.
Displaying: A-BPM is performing.
Memory full
A-BPM sleep markBattery indicator155.3. Principal Switch Operations
5.3.1. A-BPM Operations
To start or suspend A-BPM.
Step 1. Store the preset program (of start times and intervals) for A-BPM.
Step 2. Press and hold the EVENT switch to switch between thefollowing states.
"ON"

A-BPM is started and themark is shown.
Blood pressure measurements are performed inaccordance with the preset A-BPM program.
"OFF" ..... A-BPM is suspended and themark turns off.
Manual blood pressure measurement can be
performed by pressing the START switch.

To expand A-BPM interval time.
Step 1. Set the sleep mode to "ON" before the measurement.
Step 2. Start A-BPM by pressing and holding the EVENT switch.
Themark is shown.

Step 3. When the EVENT switch is pressed during A-BPM, the interval
time is doubled.
When the EVENT switch is pressed again, the interval time
returns to basic value.

16

To stop during A-BPM
When the START/STOP switch is pressed during bloodpressure measurement, the air is expelled immediately and thecurrent measurement is stopped. However, A-BPM is continued.
The next blood pressure measurement is performed inaccordance with A-BPM settings.

To set the program for A-BPM.
Step 1. If the display is hidden, press the START/STOP or EVENT
switch to return to the waiting mode display.
Step 2. If themark is shown, press and hold the EVENT switch tosuspend A-BPM.
Step 3. While pressing and holding the START/STOP switch,press and hold the EVENT switch until Sleep is displayedon the OLED.
Step 4. The operation switches are as follows:
Refer to "8.3.1.A-BPM Items and Parameters"
EVENT switch .................Change the current parameter.
START/STOP switch ......Decision, next item, end of settings.

To measure blood pressure during A-BPM immediately.
(Manual blood pressure measurement of A-BPM)
Step 1. If the OLED is hidden, press the START/STOP or EVENT
switch to return to the A-BPM waiting mode display. The A-BPM
waiting mode is a state when blood pressure is notmeasured during the interval time.
Step 2. Press the START/STOP switch during the A-BPM waiting
mode.

17

To adjust the clock.
To set the monitor function of A-BPM.
Step 1. If the display is hidden, press the START/STOP or EVENT
switch to return to waiting mode display.
Step 2. If themark is shown, press and hold the EVENT switch tosuspend A-BPM.
Step 3. While pressing and holding the START/STOP switch, press andhold the EVENT switch until Display (after Sleep ) isdisplayed on the OLED.
Step 4. Operation switches are as follows:
Refer to "8.2.2.The Clock and the Monitor Function of
Measurement"
EVENT switch .................Change the current parameter.
START/STOP switch ......Decision, next item, end of settings.

18

5.3.2. Other Operations
To return from the waiting mode and show the monitor.
If the OLED display is hidden, press the START/STOP
or EVENT switch to return to the waiting mode display.

Deleting measurement data
Step 1. If the display is hidden, press the START/STOP or EVENT
switch to return to the waiting mode display.
Step 2. If themark is shown, press and hold the EVENT switch tosuspend A-BPM.
Step 3. While pressing and holding the START/STOP switch,press and hold the EVENT switch until DataClear(after Sleep and Display ) is displayed on the OLED.
Step 4. Select an operation.
If you wish to delete data, press and hold the START/STOP
switch.
Deleting
Erasing blinks under DataClear on
DataClearDt Cl
the OLED and the deletion of data starts.
OLED Erasing
Proceed to step 5 after deletion.
If you keep (do not delete) data, press
the EVENT switch and proceed to step 5.
Step 5. The recorder returns to waiting mode.

19

6. Blood Pressure Measurement Functions
The recorder is equipped with automatic blood pressure
measurement (A-BPM) and can store measurement statesand measurement results.

6.1. Automatic Blood Pressure Measurement (A-BPM)
CautionWhen the A-BPM function is not used, suspend the function
by pressing and holding the EVENT switch, so that themark turns off. Otherwise, the measurement will startat the next start time and the cuff may burst.
The A-BPM function measures the blood pressure at preset
intervals using the built-in clock and stores the measurement
result in the memory.
A-BPM can be started and suspended by pressing and holding
the EVENT switch.
Themark is displayed on the OLED while A-BPM is used.
Blood pressure is measured automatically at the A-BPM start time.
When themark is displayed on the OLED, the initialpressurization value is set to AUTO, so that a properpressurization value is selected automatically.
When themark is hidden, the initial pressurization value isset to 180 mmHg.
If the first pressurization is insufficient, re-pressurizations are20

performed automatically up to two times.
When you delete data from the memory or suspend A-BPM, thepressurization value is reset to the initial pressurization value.
When a measurement error occurs and the waiting time until
the next start time is longer than 8 minutes, blood pressure ismeasured once after 120 seconds. The measurement result isstored in the memory.
If you want to suspend A-BPM, press and hold theswitch.

EVENT

6.1.1. A-BPM Waiting ModeIn the A-BPM waiting mode, the OLED shows the current time
together with themark as follows.
In the waiting mode, the indicators are hidden automatically.
Press any switch to show the display items.
The A-BPM waiting mode is a state when blood pressure is notmeasured during the interval time.

Current time21

6.1.2. Sleep Function and Interval time
Set the sleep mode to "ON" in the preset program.
When the EVENT switch is pressed during A-BPM,
the interval time doubles.
When the EVENT switch is pressed again in A-BPM,
the interval time returns to its original length.
Refer to "8.3.A-BPM Preset Programs" for information on how
to set the sleep mode.
T: Interval time

Blood pressure measurement
T

T

2T

2T

EVENT switch

2T

T

T

Time

EVENT switch

Start A-BPM
Store parameters of the sleep mode

6.1.3. Stopping Measurement
When the START/STOP switch is pressed during the bloodpressure measurement, the air is expelled immediately and the current
measurement is stopped. However, A-BPM is continued. The next
blood pressure measurement is performed in accordance with
A-BPM settings.

Note
When measurement is stopped, the stop code E07
displayed on the OLED and is stored in the memory.
22is6.2. Measurement Results
6.2.1. Displaying Measurement Results
The monitor function can select "Display ON" or "Display OFF"for the A-BPM measurement result.
The content of the "Display ON" command includes "Pressure
value during the measurement", "Measurement result" and"Error code for the measurement result".
When "Display OFF" is selected, the clock is displayed.
The factory setting is set to "Display ON".
Refer to "8.2.2.The Clock and the Monitor Function of
Measurement".

6.2.2. Storing Measurement Results

Caution
Data processing of the measurement result
Do not use in a strong electromagnetic field.
The memory capacity for the measurement result is 600 data sets.
When the memory is full, themark is displayed and the recorder
cannot perform measurement until data is deleted from the memory.

Note
Delete data from the memory before giving the recorder to a newpatient. We recommend using the memory data of the recorder foreach person separately. If the recorder memorizes data for multiple
people, data may be difficult to process correctly.
23

6.2.3. Outputting Measurement Results
The measurement data stored in the memory can be output to theperipheral using USB data transfer.
Refer to "8.7. Connecting the Recorder to a Dedicated
Peripheral".

Caution
Do not remove the cable while using USB communication.
It may cause damage to the data.

Note
When the battery indicator displays, data transfer cannot
be used. Replace the batteries to use data transfer.

6.2.4. ID numbers
The factory default ID number is "0".
Configure ID numbers using dedicated peripheral.

Note
ID numbers cannot be configured with the recorder and require
use of a dedicated peripheral.

24

7. Preparing the Recorder
7.1. Installing the Batteries (Replacing Batteries)
CautionInstall two new batteries with the correct "+" and "-" direction
inside the battery compartment before attaching the recorder.
Replace both batteries at the same time.
Remove batteries from the recorder if it will not be used fora long period of time. Batteries may leak and cause
a malfunction.
Use two alkaline batteries: type LR6 or designatedrechargeable AA Ni-MH batteries.
When installing the battery in the battery compartment, first,
push the spring terminal using the "-" terminal of the battery.
Next, insert the "+" terminal.
If the battery is installed from the "+" terminal, the coating of
the battery may be damaged by the spring terminal.
Do not mix different kinds of batteries or used batteries andnew batteries. It may cause a leak, heating or damage.

Note
When the level 1of the battery level is displayed, replacewith two new batteries before attaching the recorder.
The recorder cannot perform blood pressure measurement or datatransfer while the level 1
is displayed.
When the battery and built-in battery are flat, nothing is displayed.
Install batteries in accordance with the direction symbol ().

25

Procedure

Install batteries.

Step 1. Open the battery cover.
Step 2. Remove the used batteries.
Step 3. Refer to the direction
symbol () inside of
the battery compartment.
Insert two new batteries in
the proper "+" and "-"direction.

Open.

Push the spring terminal
using the "-" terminal of
the battery.
Step 4. Insert the battery bypushing the "+" terminal.
Step 5. Insert the second battery
using the same method.

Remove batteries.
Close.
Push spring terminal.
Insert.

Step 6. Close the battery cover.

Caution
Keep the batteries and battery cover away from infants andchildren to prevent accidental swallowing or other accidents.
Use standard AA batteries. Do not use a swollen battery,rechargeable battery, or one that is wrapped in tape. It may
become difficult to open the cover.
26

7.1.1. How to Replace Batteries
Measurement results and setting parameters are saved when
the batteries are removed. When the built-in battery runs out
charge, the date is reset to 01/01/2017 00:00.
Check and adjust the current time when the batteries are
replaced. Refer to "8.2.2.The Clock and the Monitor Functionof Measurement" to adjust the clock.

7.2. Preparing the Carry Holder
Note
When the carry holder is attached, use the accessory belt.
We recommend to use a belt to fit the recorder to the patient.

Use the carry holder accessory when therecorder is used.
To attach the carry holder, put the carryholder through the accessory belt or the
belt of the clothes being worn.
Carry holder
Belt

27

7.3. Inspection for Use
CautionInspect the recorder to maintain its performance, safety
and effectiveness before use.
Confirm the following checklist before/after installing thebatteries.
If a problem is found, stop using the recorder and attach a"Malfunction" or "Do not use" message. Contact your local
dealer to repair it.

7.3.1. Battery Pre-installation Checklists
No.

Item

1

Exterior

2

Battery

Check that the batteries are not flat. Replace with
two new batteries before the patient uses it.

3

Cuff

Check that the cuff has not frayed. If the cuff isfrayed, it may burst due to internal pressure.

4

Cuffconnection

5

Attachments

Description
No damage and deformation due from dropping.
No damage and looseness of switches, etc.

Check that there are no kinks and folding in the air
hose.
Check that the air socket and connector isconnected firmly.
Check that there is no damage to accessories.
(Carry holder, belt, etc.)28

7.3.2. Battery Post-installation Checklists
No.
1

PortionBattery

Description
Check that there is no fire, smoke and strong
smells.
Check that there is no strange sound.

2

Display

Check that there is no strange display.

3

Operation

Check that the recorder operates correctly.

4

Check that the measurement can be performed
Measurement correctly and that the attachment of the cuff, themeasurement, display and results are correct.

8. Operation
8.1. Operation Flowchart
Note
The initial settings (of the built-in clock, monitor function and initialpressurization value) and preset program for A-BPM do not need tobe performed every time. Perform the settings when the recorder isused for the first time, when the settings have been lost, or when
the settings should be changed.
These settings can be performed using a dedicated peripheral, too.
Refer to the instruction manual for the ABPM Data Manager
for details.

29Installing the batteries.
The initial settings of the built-in clock,measurement monitor function and pressurization value.

A-BPM

Save A-BPM preset program.
Attach the recorder and cuff.
Start A-BPM by pressing and holding
the EVENT switch.
A-BPM
Suspend A-BPM by pressing and holding
the EVENT switch again.

Connect the recorder to dedicated peripheral.
Data processing.
Clean and keep the product.

Complete procedure for use

30

8.2. Initial Settings
8.2.1. Factory Settings
The factory settings (initial settings) are described below:

Common items of the settings
Item

Factory setting

Monitor function

ON (indicated)

Year, Month, Day, Hour, Minute

Date of shipment

Items of A-BPM
Item

Factory setting

Sleep mode

OFFInterval time when the sleep mode is ON

30 minutes

Start time for section 1

0 hours

Interval time for section 1

30 minutes

Start time for section 2

0 hours #1

Start time for the automated measurement

OFF

Operation time of the automated measurement

OFF

The content of the factory settings
When the EVENT switch is pressed and held, A-BPM starts.
Blood pressure is measured every 30 minutes until A-BPM issuspended by pressing and holding the EVENT switch again.
#1 : The settings between the interval time for section 2 and theinterval time for section 6 are omitted because the start time
for sections 1 and 2 is the same value.

318.2.2. The Clock and the Monitor Function of Measurement
The initial settings can be configured using the following methods.
Using switches on the recorder.
Using a dedicated peripheral that is connected to the recorderusing the USB cable.

Procedure of operation using switches
Step 1. If the display is hidden, press the START/STOP
or EVENT switch to return to the waiting mode display.
Step 2. If themark is shown, press and hold the EVENT
switch to suspend A-BPM. The
mark turns off.
Step 3. While pressing and holding the START/STOP switch,press and hold the EVENT switch until Display(after Sleep ) is displayed on the OLED.
Step 4. The operation switches are as follows:
EVENT switch ................. Change the current parameter.
START/STOP switch .... Decision, next item, end of settings.
Then use these switches in another items.
Step 5. After configuring settings, press theto return to waiting mode.
Item
OLED
Monitor Display
functionxx
ClockYear Year xx
Month ClockMon. xx
Clock
Day
xx
Day
Hour Clock
Hour xx
Clock
Minute Min.
xx

START/STOP switch
Range

xx = OFF, ON
xx =17 to 99.

xx =1 to 12 months

xx =1 to 31 daysxx =0 to 23 hours

xx =0 to 59 minutes
32

Last two digits of year.

Enclosed characters : Factory settings and initial settings whenbatteries are consumed completely.

8.2.3. Initial Pressurization Value
When themark is displayed on the OLED, the initialpressurization value is set to AUTO, so that a properpressurization value is selected automatically.
When themark is hidden, the initial pressurization value isset to 180 mmHg.

8.3. A-BPM Preset Programs
The initial settings can be configured using the following methods.
Using the switches on the recorder.
Using a dedicated peripheral that is connected to the recorderusing the USB cable.
A-BPM can only be used while the automated measurement can be
performed.

NoteSpecify the start time and interval calculated from the timethat themark is initially displayed on the OLED.
It is necessary to specify them again when using another A-BPM.

33

Operation using switches
Step 1. If the display is hidden, press the START/STOP
or EVENT switch to return to the waiting mode display.
Step 2. If themark is shown, press and hold the EVENT switch tosuspend A-BPM. The
mark turns off.
Step 3. While pressing and holding the START/STOP switch, press andhold the EVENT switch until Sleep is displayed on the
OLED.
Step 4. Specify the sleep mode using the following switches.
If the sleep mode is "ON", proceed to step 5.
EVENT switch .................Change the current parameter.
START/STOP switch ......Decision, next item.
Step 5. Specify the start time and interval in up to six sections using thefollowing switches.
EVENT switch .................Change the current parameter.
START/STOP switch ......Decision, next item.
Step 6. Specify the start time and operation time of the automatedmeasurement using the following switches.
EVENT switch .................Change the current parameter.
START/STOP switch ......Decision, next item, end of settings.
Step 7. After completing the settings, the recorder returns to its waiting
mode.

Caution
Do not remove batteries while charging the settings.
If batteries are removed, input settings again.

34

8.3.1. A-BPM Items and Parameters
The preset program for A-BPM is as follows:
Item

OLED
Parameter
Sleep
Sleep mode
#1, #2xx xx = ON, OFFInterval Cycle
time
xx xx = OFF, 5, 10, 15, 20, 30 , 60, 120 minutes
Hour 1
Start time
xx xx = 0 to 23 hours
Section1
Interval Cycle 1
time
xx xx = OFF, 5, 10, 15, 20, 30 , 60, 120 minutes
Hour 2Start time
xx xx = 0 to 23 hours
Section2
Interval Cycle 2
time
xx xx = OFF , 5, 10, 15, 20, 30, 60, 120 minutes
Start time Hour 3 xx = 0 to 23 hours
xx
Section3
Interval Cycle 3
time
xx xx = OFF , 5, 10, 15, 20, 30, 60, 120 minutes
Start time Hour 4 xx = 0 to 23 hours
xx
Section
4
Interval Cycle 4
time
xx xx = OFF , 5, 10, 15, 20, 30, 60, 120 minutes
Start time Hour 5 xx = 0 to 23 hours
xx
Section5
Interval Cycle 5
time
xx xx = OFF , 5, 10, 15, 20, 30, 60, 120 minutes
Start time Hour 6 xx = 0 to 23 hours
xx
Section
6
Interval Cycle 6
time
xx xx = OFF , 5, 10, 15, 20, 30, 60, 120 minutes
START
Start time
#3, #4xx xx = OFF , 0 to 23 hours
Operation Operation#3, #4time
xx xx = OFF , 1 to 27 hours
Automated measurement

Enclosed characters : Factory settings.
35

#1 : When the sleep mode is set to "ON", the start time andoperation time of the automated measurement and theinterval time of the sleep mode can be used. The interval
time for these sections (1 to 6) cannot be used.
#2 : When the sleep mode is set to "OFF", the interval time forthe sleep mode is not displayed.
#3 : If the start time is specified and the operation time is set to"OFF", when the EVENT switch is pressed and held, theautomated measurement starts at the preset start time andcontinues until the EVENT switch is pressed and held.
If the EVENT switch is pressed and held again, theautomated measurement continues immediately.

Note
When the operation time is specified, even if the EVENT
switch is operated during the automated measurement, theautomated measurement continues for the operation timefrom the time that the EVENT switch is initially operated.
#4 : If the start time is set to "OFF" and the operation time isspecified, when the EVENT switch is pressed and held, theautomated measurement performs the first blood pressure
measurement and continues for the operation time.
If the EVENT switch is pressed and held during theautomated measurement, it stops.
If the EVENT switch is pressed and held again, theautomated measurement is performed for the operation
time.

36

Note
When the start time is specified and the EVENT switch
is pressed and held during the automated measurement,
it stops. When the EVENT switch is pressed and held
again, the automated measurement is started immediately.

The content of the item
Sleep mode:
The interval time for the automated measurement can be
specified. The interval time of sections 1 to 6 cannot be used.
Refer to "6.1.2. Sleep Function and Interval time".
Section:24 hours can be divided into six sections at most. Each section
can specify the start time and interval. A-BPM can use only
while the automated measurement can be performed.
Automated measurement:
All of the A-BPM can be controlled. Specify the start time andoperation time. Refer to "8.3.2.A-BPM Program Examples".

37

8.3.2. A-BPM Program Examples
ExampleStart times and intervals. Simplified input.

Double sections
The start time for section 1 =7:00
The interval time for section 1 = 15
The start time for section 2 = 22:00
The interval time for section 2 = 60
The start time for section 3 =7:00 .............. The same as section 1
Section 3 and the following items are not displayed because thestart time of section 3 is the same as for section 1.
When the start time for sections 2, 3, 4, 5 or 6 is the same as
for section 1, these start times and intervals are not displayed.

Example 1 Automatic measurement
The start time for the automated measurement = OFF,The operation time for the automated measurement = OFF.
After A-BPM is started, blood pressure measurement isperformed according to the start time and interval of eachsection until A-BPM is suspended.
Blood pressure measurement
Not measured

Section 1
A-BPM is started.

Section 2
A-BPM is suspended.

38

Time

Example 2 Automatic measurement
The start time for the automated measurement = 7:00,
The operation time for the automated measurement = OFF.
After A-BPM is started, blood pressure measurement is started
at 7:00. A-BPM is continued according to the start time andinterval of each section until it is suspended.
7:00 Blood pressure measurement
Not measured

Section 1
A-BPM is started.

Section 2
A-BPM is suspended.

Time# Even if themark is hidden once and is shown again during
the automated measurement, the automated measurement
continues.

Example 3 Automatic measurement
The start time for the automated measurement = OFF,The operation time for the automated measurement = 26 hours.
After A-BPM is started, blood pressure measurement isperformed according to the start time and interval for eachsection for 26 hours.
Blood pressure measurement
Not measured

Section 1
A-BPM is started.

Section 2
After 26 hours

Time# Even if themark is hidden once and is shown again during
the automated measurement, the automated measurement
does not continue beyond the operation time.
39

8.4. Deleting Measurement Data
Purpose of operation and explanation of function
Measurement data is deleted but the settings are not deleted.
The initial settings can be configured using the following methods.
Using switches on the recorder.
Using a dedicated peripheral that is connected to the recorderusing the USB cable.

CautionIf measurement data is deleted, it cannot be used again.
Backup the data before deletion.
Delete the measurement data for the last patient before
the next patient uses the recorder.
Deleting the data may take around ten seconds.
Do not operate the device whlie the data is being deleted
to ensure that it is deleted correctly.

Procedure of operation using switches
Step 1. If the display is hidden, press the START/STOP
or EVENT switch to return to the waiting mode display.
Step 2. If themark is shown, press and hold EVENT
suspend A-BPM. The
mark turns off.

toStep 3. While pressing and holding the START/STOP switch,press and hold the EVENT switch until DataClear(after Sleep and Display ) is displayed on the OLED.
Step 4. Select an operation.
If you wish to delete data, press and hold the START/STOP
switch. Erasing blinks under DataClear on the OLEDand the deletion of data starts. Proceed to step 5 after deletion.
If you keep (do not delete) data, press the EVENT switch
and proceed to step 5.
Step 5. The recorder returns to the waiting mode.
40

8.5. Attaching the Product to the Patient
8.5.1. Information for Patients
Explain the following to the patient so that they can use therecorder safely.

Precautions during the blood pressure measurement
Relax the arm and stay quiet when inflation begins.
Stay in the same position throughout measurement.
Avoid vibration and noise during measurement.
Blood pressure is measured for approximately 1 minute afterpressurization. Stay still until measurement finishes.
The measurement process between inflating the cuff toreleasing the air requires up to 170 seconds.
The recorder may re-inflate to measure the blood pressure again
after the end of pressurization. This may be caused by body
motion, etc.
The recorder may start blood pressure measurement after
approximately 120 seconds when measurement data is invalid
and the next measurement is 8 minutes later. This may becaused by body motion, etc.
The recorder may obstruct vehicle and machine operation.
Avoid vehicle and machine operation while wearing the recorder.

41

How to stop or suspend the measurement
Press the START/STOP switch to stop blood pressure
measurement. An error code is stored in the memory.
Blood pressure is measured again after 120 seconds.
For A-BPM, only the current blood pressure measurement
is stopped, and measurement will be performed at the next
start time.
To suspend A-BPM, press and hold the EVENT switch,so that themark turns off.
Remove the cuff if the current blood pressure measurement
cannot be stopped using the START/STOP switch.

CautionPress the START/STOP switch to stop the bloodpressure measurement. An error code is stored in thememory.
During A-BPM, only the current blood pressure
measurement is stopped and measurement will be
performed at the next start time.
When pain in the arm or an unexpected condition occur,stop the measurement, remove the cuff and consulta doctor.
Suspend A-BPM by pressing and holding the EVENT
switch, so that themark turns off.
Press and hold the EVENT switch again to resume A-BPM
automated measurement. The
mark is shown on the OLED.
Data is recorded continuously, except during the suspended period.

42

How to use manual measurement during A-BPM
The procedure for temporary measurement that is not included inpreset program.
Step 1. If the OLED display is hidden, press the START/STOP or
EVENT switch to return to the A-BPM waiting mode display.
Step 2. Press the START/STOP switch to immediately measure
the blood pressure during A-BPM.
Step 3. Measurement results are stored in the memory.
When the START/STOP switch is pressed during
measurement, the measurement is suspended.

Precautions when wearing the recorder
The recorder is a precision instrument. Do not drop or jolt therecorder.
The recorder and cuff are not waterproof (water resistant).
Protect the product from contact with rain, sweat and water.
Do not put anything on the product.
When the cuff is moved by excessive motion and exercise,
attach the cuff again.
Arrange the air hose, so that kinks do not form and so that it
does not wrap around your neck at bedtime.

Replacing Batteries
When themark is displayed, the recorder cannot
measure blood pressure or communicate with a dedicatedperipheral. Replace with two new batteries immediately.

43

8.5.2. Cuff Cover
Note
Keep the cuff and cuff cover clean.
Change the cuff cover for each person.
Use the appropriate optional cuff covers.

44

8.5.3. Attaching the Cuff, Carry holder and Recorder

Caution
Do not attach the cuff if the patient has dermatitis, external
wounds, etc.
Remove the cuff and cease use if dermatitis or othersymptoms appear on the patient.
Prevent the air hose from coiling around the neck and body.
Take care when using around infants, as there is a dangerof suffocation.
Insert the connector of the air hose firmly until the end of its
rotation. If the connection is incorrect, it may cause airleakage and a measurement error.

Note
Attach the cuff in the correct position and wrap around the arm
to measure blood pressure correctly.
Prevent the cuff and air hose from vibrating during measurement.
The recorder measures a delicate change in the air pressure
inside the cuff.
The accessory cuff is an adult cuff for the left arm. If the cuff
size does not fit, purchase an optional cuff.
Arm circumference
Small cuff
15 to 22 cm
05.9" to 08.7"
Adult cuff
20 to 31 cm
07.8" to 12.2"
Large cuff
28 to 38 cm
11.0" to 15.0"
Extra large cuff
36 to 50 cm
14.2" to 19.7"
Keep the cuff clean.
We recommend that the patient uses the carry holder and belt.
The cuff is not made from natural rubber latex.
45

How to put on the cuff, recorder and holder
Step 1. Pass the end of the cuff through the ring and make a bracelet
shape.
Step 2. Find the brachial artery in the left arm using palpation.
Step 3. Attach the cuff directly against the skin, so that the white markis directly over the brachial artery and the lower edge of the cuff
is put on approximately 1 - 2 cm above the inside of the elbow.
Step 4. Wrap the cuff, so that the ring is within the range, is flat anddoes not slip down, but there is room to insert two fingers.
Step 5. Fix the air hose using adhesive tape, so that it passes overthe shoulder.
Step 6. Pass the belt through the carry holder.
Step 7. Adjust the belt so that the carry holder is on the left side.
Step 8. Connect the air plug to the air socket on the recorder.
Step 9. Put the recorder into the carry holder.
Ring

Brachial artery
White artery
position mark
Approximately
1 - 2 cm above

Cuff

White artery position markHave room to insert two
fingers46

Air hose

Tape
Clip

Air hose

Cuff

Belt



Carry holder
Air plugAir socket

InsertCarry holder

Belt
47

8.6. Blood Pressure Measurement Operations
8.6.1. A-BPM Operations
When A-BPM is started, the blood pressure is measured inaccordance with the preset parameters.

Note
Set the built-in clock and initial pressurization value before
measurement, as A-BPM uses them. Refer to"8.2.2.The Clock and the Monitor Function of Measurement"and "8.3.A-BPM Preset Programs".
When the recorder is removed, suspend A-BPM by pressing
and holding the EVENT switch.
If the recorder is removed during A-BPM, the inflation of the cuff
starts at the next start time and the cuff may burst.
When A-BPM is resumed, press and hold the EVENT switch
again.
The

mark is displayed while A-BPM is used.

Manual blood pressure measurement can be performed during
A-BPM waiting mode.
The measurement result for the manual blood pressure
measurement can be stored in the memory.
When A-BPM is stopped, the error code
the OLED and stored in the memory.

E07

is displayed on

To start A-BPM
Step 1. Press and hold theStep 2. The

EVENT switch.

mark is shown on the OLED. A-BPM is started.
48

To suspend A-BPM
Step 1. Press and hold theStep 2. The

EVENT switch.

mark is hidden. A-BPM is suspended.

To Stop during A-BPM
When the START/STOP switch is pressed during bloodpressure measurement, the air is expelled immediately andthe current measurement is stopped. However, A-BPM iscontinued. The next blood pressure measurement isperformed in accordance with A-BPM settings.

To measure blood pressure during A-BPM immediately(Manual blood pressure measurement of A-BPM)
Step 1. If the OLED display is hidden, press the START/STOP
or EVENT switch to return to the A-BPM waiting mode
display. The A-BPM waiting mode is a state whereby bloodpressure is not measured during the interval time.
Step 2. Press the START/STOP switch during the A-BPM waitingmode.

To double the interval time or reset it
When sleep mode is "ON" and the EVENT switch ispressed during A-BPM waiting mode, the interval time isdoubled.

49

8.6.2. Manual Measurement
Use manual blood pressure measurement for a tentative test
measurement and immediate blood pressure measurement.

Note
Manual blood pressure measurement can start immediately ina waiting mode.
The measurement result is stored in the memory.

To measure blood pressure during A-BPM immediately.
(Manual blood pressure measurement for A-BPM)
Step 1. If the OLED display is hidden, press the START/STOP
or EVENT switch to return to the A-BPM waiting mode
display. The A-BPM waiting mode is a state that bloodpressure is not measured during the interval time.
Step 2. Press the START/STOP switch during A-BPM waiting mode.

50

8.6.3. Stopping and Suspending Measurements
The A-BPM function can be suspended when necessary.
Ongoing A-BPM or manual blood pressure measurement
can be stopped immediately.

Note
When blood pressure measurement is stopped, the stop code
E07 is displayed on the OLED and is stored in the memory.

To suspend A-BPM
Step 1. Press and hold theStep 2. The

EVENT switch.

mark is hidden. A-BPM is suspended.

To stop ongoing blood pressure measurement
When the START/STOP switch is pressed during bloodpressure measurement, the air is expelled immediately andthe current measurement stops.
However, A-BPM continues.The next blood pressure
measurement is performed in accordance with the A-BPM
settings.

51

8.7. Connecting the Recorder to a Dedicated Peripheral
8.7.1. Connecting with a USB cable
Refer to the instruction manual of ABPM Data Manager
concerning of the communication settings.

CautionConnecting the cable
Connect an authorized USB cable to the micro USB
terminal.
Insert the cable in the correct direction. Improper
connection may cause failure and malfunction.
Confirm that the terminal cable is properly connected.
Blood pressure cannot be measured during USB
communication.
Do not attach to the patient when the recorder is connectedto the cable. The cable may become wrapped around the
body or neck.
Preparation of a dedicated peripheral
Remove the recorder and cuff from the patient before
connecting the recorder (TM-2440) to a dedicatedperipheral.
If the level 1
is displayed, connect the recorder(TM-2440) to the peripherals after replacing the batteries.

52

To connect the recorder to a dedicated peripheral using the USB cable
Step 1. Open the micro USB terminal on the recorder.
Connect the accessory USB cable.
Micro USB terminal
USB cable

To start data communication with a dedicated peripheral
Step 1. Connect the micro USB cable between the recorder and the
dedicated peripheral.
Step 2. The buzzer will sound and the following symbol appears on
the OLED. The data communication enters standby mode.

Standby mode

Step 3. Carry out analysis using the dedicated peripheral.
The data communication only enters active online mode
during USB communication.


Active online mode

To stop data communication with a dedicated peripheral
Step 1. Remove the cable in the standby mode.
53

9. Maintenance9.1. Product Storage, Inspection and Safety Management
Medical instruments, such as this recorder, must be managed sothat they function properly when necessary and reliably ensure
the safety of the patient and the operator. As a basic rule, theoperator should inspect this instrument daily, such as byfollowing the "Inspection before use".
Daily management, such as inspection before use, is necessary
to maintain the performance, safety and effectiveness of therecorder.
We recommend a periodic inspection of the recorder every year.

Note
Medical institutions must perform maintenance management toensure the safe use of the medical instrument.

54

9.2. Cleaning the ProductCautionClean the recorder before use and after use.
Clean the recorder before attaching to the next patient.
Do not spray water and immerse in water to clean the recorder.
This may cause a malfunction.
Dry the recorder after wiping it with water and the antiseptic
solution, so that the liquid does not penetrate the recorder.
Disinfect the recorder periodically to ensure infection prevention.
Do not use a sterilizer on the recorder.
Do not use an organic solvent (for example: thinner) or
povidone-iodine solution to clean the recorder. It may cause
discoloration, damage and malfunction.
Do not use a hair dryer etc. to dry the recorder. It may cause
malfunction and damage.

Confirmation after Cleaning the Cuff
Confirm that the cuff bladder is correctly inserted inside thecuff cloth. If it is not correctly inserted, damage or explosion
may occur during inflation.

Cleaning the recorder
Wipe the dirt and dust from the exterior case of the recorder using
gauze moistened with water or warm water and squeezed well.
When blood or medicines, etc. adhere to the case, firstly, clean
with gauze moistened with antiseptic solution and squeezed well.
Then, wipe the wet case using gauze moistened with water or
warm water and squeezed well.
We recommend using chemicals (ingredient name) from theantiseptic solution listed in the table (Example of useable
antiseptic solution (Ingredient name)).
55

Cleaning the cuff
When you clean and disinfect the cuff cover and cuff cloth,
remove the cuff bladder inside the cuff cloth. Clean the dirt
and dust using gauze moistened with water or warm waterand squeezed well.
Refer to the antiseptic solutions in the table (Example ofuseable antiseptic solution (ingredient name)) whendisinfecting.
Example useable antiseptic solution (Ingredient name)Component Name

Product Name

Benzalkonium chloride

Benzalkonium chloride 10% solution

Isopropanol

70% in 1-propanol

Ethanol

Ethanol for disinfection 76.9 to 81.4 vol%Read the prescription described on the product and use it.

Note
The cuff and air hose are consumables.
If a measurement error occurs frequently or blood pressurecannot be measured, replace them with new ones.
Refer to "10.Optional Items (requiring order)" in this manual.

56

9.3. Periodic Inspection
Perform the daily periodic inspection to use the recordercorrectly. The inspection is described below:

9.3.1. Battery Pre-installation Inspection
Items

Description
No damage or deformation from dropping.
Exterior
No dirt, rust and scratches on any part.
No cracking or rattling of the panel.
Operation
No damage or rattling of switches and buttons.
Display
No dirt or scratches on the display panel.
The air hose must not be folded. If air remains in
the cuff, it may cause peripheral dysfunction fromstopping the blood flow in the arm.
The cuff bladder is correctly inserted inside the cuff
cloth.
No fraying of the cuff. The cuff doesn't ravel.
Replace the cuff when a problem is found.
Measurement The cuff is disposable.
Cuff
If there is a crack or adhesive matter in theconnection between the cuff and cuff bladder.
If the air hose loses its flexibility and becomes hard.
When the surface of the air hose becomes glossy orfeels oily.
When the air bladder has cracks.
We recommend replacing cuffs every three years,
regardless of frequency of use.
Wearing tools No damage in the carry holder, belt and cuff.
Connection
The air plug is connected to the air socket correctly.
57

9.3.2. Battery Post-installation Inspection
Item
Exterior
Operation
Measurement
Cuff
Inspection of bloodpressure value

Description
No fire, smoke or strong smells.
No strange sounds.
No trouble with the functioning of switches
and buttons.
Measurement values are close to the usual
value.
No strange sounds or actions during
measurement.
If blood pressure values are incorrect, contact
your local dealer.

58

9.4. Disposal
Follow the laws of the local government for environment protection
for the disposal and recycling of the product.

Disposal of the cuff
The cuff worn on the patient is medical waste.
Dispose of it properly as medical waste.

Disposal of the rechargeable built-in battery

CautionThe recorder is equipped with a backup battery inside. Whendisposing of the recorder, dispose of the battery properly inaccordance with the local regulations for environmental
protection.

Others
Name

Part
Case
PackageCushionBag
Case
Internal parts
ChassisInside the Backup battery
recorder on the board
Battery

Material
Cardboard
Air cushion, special caseVinyl
ABS + PC resin
General parts
Iron
Lithium rechargeable coin cell battery:
ML2016H
Alkaline battery:
1.5V LR6 or AA size
Rechargeable battery:AA size
Ni-MH batteries, 1900 mAh or more
59

9.5. Troubleshooting
Consult the following checklist and error code list before contacting
your local dealer.
If these measures do not rectify the problem or the problem occurs
again, contact your local dealer.
ProblemMain cause
Treatment
No display afterBattery power has
Replace with newpressing any switches. been consumed.
batteries.
OLED may disappear
No OLED during
Remove batteries anddue to the electrostatic
A-BPM.
reinstall them.
effect.
The backup battery Charge for 48 hours
Frequent clock reset.
does not charge. #1 using new batteries.
Check the cuff and air
Cuff is not connected
No pressurization
hose for folding, kinks
correctly.
and connection.
No USBThe communication
Confirm that the cable iscommunication #2 cable is removed.
connected correctly.
Battery cover cannot Non-standard size
be openedbatteries were used.

Contact your local dealer.

#1: Users (unauthorized maintenance personnel) cannot replace
the backup battery (lithium battery) on the circuit board inside
the recorder. The backup battery is charged from the batteries(LR6 or AA size) for measurement.
#2: A dedicated peripheral is required.

Caution
Do not disassemble or modify the recorder. It may be damaged.
60

9.6. Error Codes
Measurement error codes
Code

Meaning

Cause and treatment

Pressure zero error

Release the air left in the cuff.

Low battery

Replace with new batteries.

Failure ofpressurization

Inflation does not reach the target
pressure.
Check the cuff connection.
If there are no problems with the cuff
connection, the recorder may havemalfunctioned and requires
inspection.

Pressure exceeds
299 mmHg

Body motion may occur during
pressurization. Relax and keep still
during measurement. If this does not
help, inspect the recorder.

Force stop using
START/STOP
switch.

Press the START/STOP switch only
when necessary.

Blood pressure cannot
be measured.

Excessive body
motion.

The heartbeat cannot be detected due
to body motion or noise from clothes.
Relax and do not move.
Confirm the position of the cuff.
If this failure occurs even whenrelaxed, contact your dealer toinspect and repair the recorder.
Relax and keep still during
measurement.
61

Code

Meaning
Out of range,
30
PUL
200
Out of range,
30
DIA
160
Out of range,
60
SYS
280
Out of range,
10PP
150 #1

Cause and treatment
If these errors occur multiple times, try
another blood pressure measurement.
#1
PP = SYS - DIA
SYS: Systolic blood pressure
DIA: Diastolic blood pressure
PP: Pulse pressure

Measurement isabove 180 seconds.

If the inflation speed or exhaust speed isslow, an inspection is necessary.

Exhaust is above
90 seconds.

The exhaust speed may be slow,
an inspection is necessary.

Heartbeat cannot be detected
Heartbeat cannot be because of body motion, etc.
Measure the blood pressure while
detected.
relaxed and do not move.
The settings of theinterval time areincorrect.

If the interval time is set to 120 minutes,
the difference between last start timeand next start time cannot divide into
two hours perfectly.

Zero pressure error
for safety circuit.

Displays at the measurement starttime.
Release the air remaining in the cuff
completely.

62

Code

Meaning

Cause and treatment

Safety circuit detects
over load pressure.

Body motion may be detectedduring pressurization. Relax and do
not move during the measurement.
If this error occurs even whenrelaxed and not moving, contact
your dealer for inspection.

Hardware error codes on the recorder
Code

MeaningMemory error

Cause and treatment
It may happen in case of a strong
impact, such as dropping therecorder.
If this code displays frequently, there
is a malfunction in the built-in memory.
Contact your dealer for inspection.

Note
The error codes may be changed without any notice.

63

10. Optional Items (requiring order)
Cuffs
Name

Description

Order code

Small cuff
for left arm

Arm circumference
15 to 22 cm
5.9" to 8.7"

TM-CF202A

Adult cuff
for left arm

Arm circumference
20 to 31 cm
7.8" to 12.2"

TM-CF302A

Large cuff
for left arm

Arm circumference
TM-CF402A
28 to 38 cm
11.0" to 15.0"

Extra-large cuff
for left arm

Arm circumference
TM-CF502A
36 to 50 cm
14.2" to 19.7"

Adult cuff
Arm circumference
for right arm 20 to 31 cm
7.8" to 12.2"

TM-CF802A

Disposable cuff

10 sheets

TM-CF306A

Small cuff coverfor left arm

10 sheets

AX-133024667-S

Adult cuff coverfor left arm

10 sheets

AX-133024500-S

Large cuff coverfor left arm

10 sheets

AX-133024663-S

Extra-large cuff cover for left arm

10 sheets

AX-133024503-S

Adult cuff coverfor right arm

10 sheets

AX-133024353-S

Small cuff cloth

for left arm

2 sheets

AX-133025101-S

Adult cuff cloth

for left arm

2 sheets

AX-133024487-S

Large cuff cloth

for left arm

2 sheets

AX-133025102-S

Extra-large cloth

for left arm

2 sheets

AX-133025103-S

Adult cuff cloth

for right arm

2 sheets

AX-133025104-S

Air hose adaptor-

64

TM-CT200-110

Data analysis
Name

Description

USB cable-

Order code
AX-KOUSB4C

OthersName
Activity record sheet

Description
10 sheets

Order code
AX-PP181-S

Carry holder-

AX-133025995

Belt

-

AX-00U44189

Clips

5 pieces65

AX-110B-20-S

11. Appendix
11.1. Principle of Blood Pressure Measurement
Measurement procedure: Wrap the cuff around the upper arm.
Inflate the cuff to a pressure exceeding the systolic blood pressure.
Then, exhaust the air from the cuff gradually. While the pressure is
detected in the cuff in the air exhaustion stage, the pulse waveform
appears in synchronization with the heartbeat. The pulse waveform
suddenly increases near the systolic blood pressure. It increases
further with exhaustion until it reaches its highest amplitude, thendecreases gradually. The changes in the pulse waveform areillustrated on the next page. In oscillometric blood pressure
measurement, the systolic blood pressure is specified as the point
where the amplitude increases suddenly after the pulse in the cuff
pressure is detected, while the mean blood pressure is specified as
the point where the amplitude reaches its maximum and the diastolicblood pressure is specified as the point where the amplitudedecreases gradually. Actually, the pressure sensor detects subtle
changes in the cuff pressure over time, stores the pulse waveform
in memory and evaluates the systolic and diastolic blood pressuresaccording to the oscillometric measurement algorithm. The details in
the algorithm vary with the blood pressure monitor. Blood pressure
values for adults and infants are measured by the oscillometricmethod and are compared with those measured by the auscultatory
method. Diastolic blood pressure is defined as the end point ofphase 4 in the auscultatory method. The pulse waveform of thecuff pressure depends on the characteristics of the cuff material.
Therefore, by using the specified cuff and the measurement
algorithm, the measurement accuracy is maintained. The air hoselength is less than 3.5 m, because of the damping characteristics
due to pulse wave propagation.
66

mmHg
200
150
100
50
0

Cuff pressure (Left arm)
Direct method (Left arm)

Cuff pressure (Left arm)

200
150
100
50
0
Systolic blood pressure
Average blood pressure
Diastolic blood pressure

Time
Direct method (Left arm)

Time

Microphone method
Oscillometricmeasurement method

Blood pressure measurement error factors
The pulse graph can be an objective indicator of
the reliability of the measurement accuracy.
When noise occurs due to irregular heart beat or
physical movements, the amplitude of the graphchanges. When the pulse graph is not a smooth
outline, check again or use other methods.

Pulse graph

Cuff position at the same height as heart
Wrap the cuff around the arm at the same level as the heart. If thecuff position is incorrect, a measurement error occurs. For example,
if the cuff is 10 cm lower than the heart level, the blood pressure ismeasured 7 mmHg higher.
67Proper cuff size
Use a cuff of adequate size. If it is too small or too big, ameasurement error occurs. Measurements with a cuff that is too
small tend to be evaluated as high blood pressure, regardless of theproper blood pressure and normal arteries. Measurements with toolarge a cuff tend to be evaluated as low blood pressure, especiallyfor those who suffer from severe arteriosclerosis or have abnormal
arterial valves. The wrong cuff size is a cause of differences between
the direct method and oscillometric measurement method. The cuff
has the range of the arm circumference shown on the label. Selectand attach the proper size cuff for each patient. The accuracy of theblood pressure measurement is guaranteed by the pressure
accuracy of the pressure sensor, exhaust characteristics andmeasurement algorithm, so long as the proper cuff and air hose
are used. Inspect the pressure accuracy of the pressure sensor
and exhaust characteristics periodically.

11.2. EMD Information
The requirements that apply to medical electronic instruments aredescribed below:

Performance within the EMD guidelines
The use of the recorder require special precautions for EMD(Electromagnetic Disturbances). Operate the recorder in accordancewith the warnings for EMD described in this manual. Portable andmobile RF communication equipment (e.g. cell phones) can affectmedical electrical equipment.

68Accessories compliant with EMD standards
The accessories and options for this recorder meet the conditions of
IEC60601-1-2:2014 + A1:2020. If an unauthorized accessory isused, it may cause increasing emissions and lower noise immunity.

Warning
Use accessories designated by the A&D company.
Unauthorized accessories may be influenced by electromagnetic
emission and have reduced immunity against disturbances.

EMISSIONS LIMITS
Phenomenon
Radiated RF emission

Compliance

CISPR11

Group 1, Class B

IMMUNITY TEST LEVELS: Enclosure Port
Phenomenon

Immunity test levels±8 kV contact
Electrostatic discharge
IEC 61000-4-2 ±2 kV, ±4 kV, ±8 kV, ±15 kV air
10 V/mRadiated RF EM fields
80 MHz - 2.7 GHz
IEC 61000-4-3
80 % AM at 1 kHz
See table (Test specifications for
Proximity fields from RF wireless
ENCLOSURE PORT IMMUNITY
communications equipment
to RF wireless communications
IEC 61000-4-3
equipment)
Rated power frequency magnetic 30 A/m
fieldsIEC 61000-4-8 50 Hz / 60 Hz
See table (Test specifications for
Proximity magnetic field
ENCLOSURE PORT IMMUNITY to
IEC61000-4-39
proximity magnetic field)
69

IMMUNITY TEST LEVELS: PATIENT COUPLING Port
Phenomenon
Electrostatic discharge
IEC 61000-4-2

Immunity test levels±8 kV contact±2 kV, ±4 kV, ±8 kV, ±15 kV air

IMMUNITY TEST LEVELS: Signal input/output Port
Phenomenon

Immunity test levels

Electrostatic discharge
IEC 61000-4-2±8 kV contact±2 kV, ±4 kV, ±8 kV, ±15 kV air

Electrical fast transients/bursts
IEC 61000-4-4±1 kV
100 kHz repetition frequency

3 V 0.15 MHz - 80 MHz
Conducted disturbances induced
6 V in ISM and amateur radio bandsby RF fields
between 0.15 MHz and 80 MHz
IEC 61000-4-8
80% AM at 1 kHz

70

Band
(MHz)

Service385

380 - 390TETRA 400450

430 - 470

GMRS 460
FRS 460

704 - 787

LTE Band 13,17

Pulse modulation
217 Hz9800 - 960

GSM 800/900
TETRA 800
iDEN 820CDMA 850
LTE Band 5

Pulse modulation
18 Hz

28

1700-1990

GSM 1800
CDMA 1900
GSM 1900
DECT
LTE Band 1,3,4,25
UMTS

Pulse modulation
217 Hz28

2450

2400-2570

Bluetooth
WLAN 802.11 b/g/n
RFID 2450
LTE Band 7

Pulse modulation
217 Hz

28

5240
5500
5785

5100-5800

WLAN 802.11 a/n

Pulse modulation
217 Hz9

Modulation

Test frequency(MHz)

Immunity test level(V/m)

Test specifications for ENCLOSURE PORT IMMUNITY to RF wirelesscommunications equipment

Pulse modulation
18 Hz
FM±5 kHz deviation
1 kHz sine

27
28

710
745
780
810
870
930
1720
1845
1970

71

Test specifications for ENCLOSURE PORT IMMUNITY to proximity
magnetic field
Test frequency

Modulation

Immunity test level
(A/m)

30kHz

CW

8

134.2kHz
13.56MHz

Pulse modulation
2.1kHzPulse modulation
50kHz

72

65
7.5

7+,63$*(,17(17,21$//</()7%/$1.

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