English (Original)

Recorder for Ambulatory Blood
Pressure Monitor

Ambulatory Blood Pressure Monitor

1WMPD4004156C

2309

2017 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.
The Bluetooth® word mark and logos are registered trademarks
owned by Bluetooth SIG, Inc. and any use of such marks by
A&D is under license.
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.
The device conforms to Radio Equipment Directive 2014/53/EU.
Hereby, A&D Company, Limited declares that the device is incompliance with Radio Equipment Directive 2014/53/EU.
The full text of the EU declaration is available at the following internet
address: https://www.aandd.jp/products/manual/manual_medical.html

Compliance with FCC Rules
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not cause
harmful interference and (2) this device must accept any interference
received, including interference that may cause undesired operation.
(FCC = Federal Communications Commission in the U.S.A.)FCC CAUTION
Changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority tooperate the equipment. This transmitter must not be co-locatedor operated in conjunction with any other antenna or transmitter.
This equipment complies with FCC radiation exposure limits set
forth for an uncontrolled environment and meets the FCC radio
frequency (RF) Exposure Guidelines. This equipment has very
low levels of RF energy that it deemed to comply without testing
the specific absorption ratio (SAR).
iCompliance with IC Rules
This device complies with Industry Canada license-exempt RSS
standard(s). Operation is subject to the following two conditions: (1) thisdevice may not cause interference and (2) this device must accept any
interference, including interference that may cause undesired operationof the device.
This equipment complies with IC radiation exposure limits set forth
for an uncontrolled environment and meets RSS-102 of the IC radio
frequency (RF) Exposure rules. This equipment has very low levelsof RF energy that are deemed to comply without testing the specificabsorption ratio (SAR).

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.

Bluetooth® Transmission
This device is equipped with a Bluetooth wireless function and canconnect to the Bluetooth device that is Bluetooth wireless technology
enabled medical devices.
Applications and devices that are compatible with Bluetooth 4.1.
Each device needs an application to receive data.

ii

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.
iii

Precautions for Use
In order to use the TM-2441 (the recorder for the ambulatory bloodpressure monitor) safely and correctly, read the following
precautions carefully before using the monitor. The following
content summarizes general matters affecting the safety ofpatients and operators, as well as safe handling of the monitor.
Precautions for each operation are described in the pages of thismanual. Read the 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
resonance imaging 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.
iv

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.

vPreparation of the Recorder
Delete the last data stored in the recorder before it is used by thenext 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 turn the AUTO switch "OFF" 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 "+"terminal of the battery compartment. If the battery is installedfrom the "+" terminal, the battery cover may be damaged.
viCaution
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 of different 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 orother vehicles.
Example: The recorder may inhibit the motion of the bodyor arms 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 switch the AUTO switch to"OFF", if the patient feels pain in their arm or the measurement
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-lungmachine.
vii

Note
Instructions for Patient
If the temperature is low, battery power becomes lower andthe measurement 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.
Switch the AUTO switch to "OFF". If you leave theAUTO

switch at "ON", 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 andbreak 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
the cable. Do not pull on the cable.

viii

Note
Precautions After Using the Recorder (TM-2441)
Be sure to process measurement data immediately using
a dedicated peripheral 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 from the 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 isenough 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 bloodpressure measurement and data communication cannot be
performed. Replace with two new AA batteries.
Remove the batteries to prevent the recorder from liquid leakage
from a battery if the recorder is not used for a month or more.

ix

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 therecorder. Contact your dealer.
Stop the recorder immediately when the measurement time
is above 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.

CautionUse 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.
x

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.
Do not use a Bluetooth connection within the range of awireless LAN or other wireless devices, near devices that
emit radio waves such as microwaves, in locations where
there are many obstructions, or in other locations where
signal strength is weak. Doing so may result in frequent lossof connection, very slow communication speeds and errors.

CautionThe following examples are general causes of malfunctions
and their 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 morefrom the recorder.

xi

CautionIf 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.
Use close to an IEEE802.11g/b/n wireless LAN device may
cause mutual interference to occur, which may result in
reduced communication speeds or prevent connection.
In this case, switch off the power supply to the device thatis not being used, or use the monitor in a different location.

9. Environmental Protection

Caution
Before disposing of the recorder, remove the lithium battery
from the recorder.

xii

Precautions For Safe Measurement
This section describes precautions for 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 are measurement
problems. The device guesses that the condition 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 the operationof 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.
xiii

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 bloodpressure by auscultation or palpation.
A measurement error may occur if the cuff is not of the correctarm 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 isworn.
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 wornat the same level as the heart.
xiv

Note
Blood pressure cannot be measured correctly if the patient ismoving 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.

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 theblood pressure.

xv

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
Large cuff

28 to 38 cm (11.0" to 15.0") for left arm
TM-CF402A .............. 1

Adult cuff cover .......................................................................... 2
Large 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
xvi

Adult cuff for left arm
Large cuff for left arm

Blood pressure Recorder

Carry holder

Clip

Belt

ABPM Data Manager CD

Adult cuff coverLarge cuff cover

Activity record sheet (10 sheets)

USB cable

xviiThis instruction manualContents
Compliance .............................................................................................................i
Compliance with European Directive..................................................................i
Compliance with FCC Rules ...............................................................................i
Compliance with IC Rules.................................................................................. ii
Compliance with the Australian EMD Framework ............................................. ii
Bluetooth® Transmission .................................................................................... ii
Warning Definitions............................................................................................... iii
Precautions for Use .............................................................................................. iv
Precautions For Safe Measurement................................................................... xiii
Blood Pressure Measurement ........................................................................ xiii
Cuff.......................................................................................................... xv

Measurement of Pulse Rate ............................................................................ xv
Packing List......................................................................................................... xvi
1.

Introduction ............................................................................................ 5

2.

Features................................................................................................. 53.

Abbreviations & Symbols ...................................................................... 8

4.

Specifications ...................................................................................... 13
4.1.

Recorder .......................................................................................... 13

4.2.

Dimensions ...................................................................................... 16

5.

Component Names.............................................................................. 17
5.1.

Recorder .......................................................................................... 17

5.2.

Display ............................................................................................. 18

5.2.1.

LCD Panel (Liquid crystal display)............................................... 18

5.2.2.

OLED Display (Organic light emitting diode) ............................... 19
1

5.3.

Principal Switch Operations............................................................. 20

5.3.1.

A-BPM Operations ....................................................................... 20

5.3.2.

S-BPM Operations ....................................................................... 23

5.3.3.

Other Operations ......................................................................... 25

6.

Blood Pressure Measurement Functions ............................................ 27
6.1.

Automatic Blood Pressure Measurement (A-BPM)......................... 27

6.1.1.

A-BPM Waiting Mode .................................................................. 29

6.1.2.

Sleep Function and Interval time ................................................. 29

6.1.3.

Stopping Measurement................................................................ 30

6.1.4.
6.2.

Storing Environment Data............................................................ 30
Self Blood Pressure Measurement (S-BPM)................................... 31

6.2.1.

S-BPM Programs ......................................................................... 32

6.2.2.

S-BPM Waiting Mode .................................................................. 36

6.2.3.
6.3.

Stopping and Suspending Measurement .................................... 37
Measurement Results ...................................................................... 38

6.3.1.

Displaying Measurement Results ................................................ 38

6.3.2.

Storing Measurement Results ..................................................... 38

6.3.3.

Outputting Measurement Results ................................................ 39

6.3.4.

ID Numbers .................................................................................. 39

7.

Preparing the Recorder ....................................................................... 40
7.1.
7.1.1.

Installing the Batteries (Replacing Batteries) .................................. 40
How to Replace Batteries ............................................................ 42

7.2.

Preparing the Carry Holder.............................................................. 42

7.3.

Inspection for Use ............................................................................ 43

7.3.1.

Battery Pre-installation Checklists ............................................... 43

7.3.2.

Battery Post-installation Checklists ............................................. 442

8.

Operation ............................................................................................. 45
8.1.

Operation Flowchart ........................................................................ 45

8.2.

Initial Settings .................................................................................. 47

8.2.1.

Factory Settings ........................................................................... 47

8.2.2.

The Clock and the Monitor Function of Measurement ................ 48

8.2.3.
8.3.

Initial Pressurization Value of S-BPM .......................................... 50
A-BPM Preset Programs ................................................................. 50

8.3.1.

A-BPM Items and Parameters ..................................................... 52

8.3.2.

A-BPM Program Examples .......................................................... 55

8.3.3.
8.4.
8.4.1.
8.4.2.

Start Time and Operation Time ................................................... 57
S-BPM Programs ............................................................................. 58
S-BPM Items and Parameters ..................................................... 59
S-BPM Display Examples ............................................................ 60

8.5.

Deleting Measurement Data ............................................................ 63

8.6.

Attaching the Product to the Patient ................................................ 64

8.6.1.

Information for Patients................................................................ 64

8.6.2.

Cuff Cover .................................................................................... 66

8.6.3.
8.7.

Attaching the Cuff, Carry holder and Recorder ........................... 67
Blood Pressure Measurement Operations ...................................... 70

8.7.1.

A-BPM Operations ....................................................................... 70

8.7.2.

S-BPM Operations ....................................................................... 72

8.7.3.

Manual Measurement .................................................................. 74

8.7.4.
8.8.

Stopping and Suspending Measurements .................................. 75
Connecting the Recorder to a Dedicated Peripheral ...................... 77

8.8.1.

Connecting with a USB cable ...................................................... 77

8.8.2.

Using Bluetooth® Communication................................................ 79

8.8.3.

Suspending Bluetooth® Communication (Airplane mode)........... 80

3

9.

Maintenance ........................................................................................ 81
9.1.

Product Storage, Inspection and Safety Management ................... 81

9.2.

Cleaning the Product ....................................................................... 82

9.3.

Periodic Inspection .......................................................................... 84

9.3.1.
9.3.2.

Battery Pre-installation Inspection ............................................... 84
Battery Post-installation Inspection ............................................. 85

9.4.

Disposal ........................................................................................... 86

9.5.

Troubleshooting ............................................................................... 87

9.6.

Error Codes ..................................................................................... 88

10.

Optional Items (requiring order) .......................................................... 91

11.

Appendix .............................................................................................. 93

11.1.

Principle of Blood Pressure Measurement ...................................... 93

11.2.

EMD Information .............................................................................. 96

4

1. Introduction
Thank you for your Purchase!
The TM-2441 ambulatory blood pressure recorder enables
accurate measurement of patient blood pressure automatically forpreset times (e.g. 24-hours continuously). This manual explains
the settings, operation, modes and programs for blood pressure
measurement, as well as communication with a dedicatedperipheral, maintenance, specifications and warnings. Readthis 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).

5

Purpose of use
The recorder is equipped with two modes for blood pressure
measurement. Blood pressure values can be used for consultingwith doctors and self-health management.
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.
Self-blood pressure measurement (S-BPM)
The use of this mode assumes that a patient measures theirown blood pressure at home or in hospital. This mode can use
five types of programs in accordance depending on use.

Portability
The weight of the recorder is approximately 135 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).

6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.
S-BPM is equipped with five programs for varying conditions.
The analysis can be carried out effectively using the ABPM DataManager installed on the computer (dedicated peripheral).

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 data can be analyzed and printed easily.

7

3. Abbreviations & Symbols
Symbols

Meaning

SYS

Systolic blood pressure

DIA

Diastolic blood pressure

PUL

Pulse rate

PP
kPa
mmHg
/min

Pulse pressure

--xx

LCD
OLED

PP = SYS - DIA

Unit of blood pressure
Unit of pulse rate/minuteMark indicating heartbeat during measurement.
Bluetooth is being used.
Displaying: A-BPM is in operation.
Blinking:
Interval time of "1 scope" is performed.
The IHB (Irregular Heart Beat) indicator.
Mute
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.
Out of range or impossible measurement value.
Error codes. xx =to
S-BPM START markS-BPM STOP markLiquid crystal display
Organic light emitting diode
Alert mark8

Symbols

SMALL
ADULT
LARGE
EXTLARGE

Large
cuff
28-38cm11"-15"Adultcuff
20-31cm7.8"-12.2"

SN

Meaning
Degree of protection against electric shock:Equipment type BF.
Manufacturer of the CE Marking. Date of manufacture.
Symbol for small cuff
Arm circumference 15 to 22 cm
5.9" to 8.7"
Symbol for adult cuff
Arm circumference 20 to 31 cm 7.8" to 12.2"
Symbol for large cuff
Arm circumference 28 to 38 cm 11.0" to 15.0"
Symbol for extra-large cuff
Arm circumference 36 to 50 cm 14.2" to 19.7"
Symbol printed on packing.
Large cuff is included in accessories.

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

x2
1.5V LR6 Symbol printed on packing.
1.2V HR6 Batteries are excluded from accessories.
not included
EMD

Electromagnetic disturbances
Symbol for "Handle with care".
The symbol for waste electrical and electronicequipment directive.
9

Symbols
BPM
A-BPM

Meaning
Blood pressure measurement
Automatic blood pressure measurement

Self-blood pressure measurement
S-BPM
Sleep, Cycle, Hour,
A-BPM symbols.
#1
START, Operation
OBP, AOBP, HBP,
S-BPM symbols.
#2
ANBP, ASBP
Pairing, Flight Mode Bluetooth symbols. #3
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.
#2: Refer to "6.2.Self Blood Pressure Measurement (S-BPM)"
and"8.4.S-BPM Programs" for five types of programs.
®
#3: Refer to "8.8.2.Using Bluetooth Communication" and®
"8.8.3.Suspending Bluetooth Communication (Airplanemode)".

10

IHB indicator
When the monitor detects an irregular rhythm during measurement,
the IHB indicator

will appear on the display with themeasurement values. (S-BPM only)

1 scope"1 scope" in S-BPM consists of a set of blood pressure
measurements and interval times which are repeated for thenumber of the measurement count. The last interval time is omitted.
Blood pressure measurement
T
Start time

T

T

Time

T: Interval time

Number of the measurement count

11

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

T

T

T

T

T

T
Time

Section

T: Interval time

SectionThe S-BPM waiting mode is a state when the blood pressure is
not being measured during the interval time and between theprevious "1 scope" and next "1 scope".
Start time
T

T

Start time
Blood pressure measurement
Waiting mode

1 scopeTTTime
1 scope

T: Interval time

Dedicated peripheral
A dedicated peripheral means the computer on which the ABPM
Data Manager is installed. The ABPM Data Manager is stored onan accessory 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 to anotherdevices (Example: IEC60950) in an area where medical equipment isused. Use a USB cable shorter than 1.5 m (4.9 ft).

12

4. Specifications
4.1. Recorder
Items
Measurement method
Pressure detection
methodPressure display range

Descriptions
Oscillometric measurement method
Semiconductor pressure sensor

0 to 299 mmHg
Pressure:±3 mmHg
Measurement accuracy
Pulse rate:±5 %Minimum
Pressure:
1 mmHgdisplay division
Pulse rate:
1 beat / minuteSystolic pressure: 60 to 280 mmHg
Measurement range
Diastolic pressure: 30 to 160 mmHg
Pulse rate:
30 to 200 beats/minuteConstant exhaust with a controlled leakage
Depressurization
valve for safety
ExhaustElectromagnetic valve
Pressurization method Micro-pump
Automatic pressurization 85 to 299 mmHg
Intervals at each section which divides
Interval time (of A-BPM)
24 hours into six parts at the maximum.
Interval: OFF, 5, 10, 15, 20, 30, 60, 120 minutes
Clock
24 hour clock
A-BPM:
OLED, 96 x 39 pixels, white characters
S-BPM:
Display
LCD, 40 x 50 mm, Display: systolicpressure, diastolic pressure, pulse rate,
clock, error, status monitor and symbols
13

ItemsMemoryPower supply

Measurement countRated voltage

Interface

Operating condition
Transport and storage
conditions
Atmospheric pressure
both for operation andstorage condition
Type of protection
against electric shock

Descriptions
Measurement data: 600 data points max.
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)
USB: USB1.1 compliant.
Cable length: 1.5 m or shorter.
Micro-USB B type terminal can connect
to dedicated peripheral (using standard
driver software).
Bluetooth Ver.4.1 (BLE):
Wireless device can be connected.
Temperature: +10 to +40 °C
Humidity:
30 to 85 %RH (no condensation)
Temperature: -20 to +60 °C
Humidity:
10 to 95 %RH (no condensation)
700 to 1060 hPa

Internally powered equipment

14

ItemsDegree of protection
against electric shock
CE Marking
C-Tick Marking
Dimensions
Mass

Useful life

Ingress protection
Default mode
Restart time after
defibrillation
EMD

Descriptions
Type BF: The recorder, cuff and tubing aredesigned to provide special protection againstelectrical shock.
The EC directive label for medical device.
The certification trademark registered to the
ACA by the Trademark office.
Approx. 95 (L) × 66 (W) × 24.5 (H) mm
Approx. 135 g (excluding batteries)
Recorder: 5 years. Self-authentication withinternal data. Proper operation andmaintenance in the best conditions.
Durability varies with usage conditions.
Device: IP22
Continuous measurement
Immediately

IEC 60601-1-2: 2014 +A1: 2020
LBCA2HNZYZ(MURATA Manufacturing Co. Ltd)
Bluetooth Ver.4.1 BLP
Wireless communication Frequency range: 2.4GH (2400 to 2483.5 MHz)
Modulation: GFSK
Effective radiated power: < 20 dBm
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
15

4.2. Dimensions

66

24.5

95

Unit: mm

16

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

Artery position markAir hose
Air plugAir socket
EVENT switch
for A-BPM
OLED for A-BPM
START and
STOP switch

for A-BPM

AUTO switch

LCD

for A-BPM

START and
STOP switch

LOCK switch

for A-BPM

for S-BPM

Battery compartment and2 LR6 (AA size) batteries
for measurement

Battery cover

Micro USB port (at bottom),Data communication terminal

17

5.2. Display
Note
To get accurate diagnosis, take care to accurately read the data
displayed on the recorder and interpret it properly.

5.2.1. LCD Panel (Liquid crystal display)
Upper figures
Middle figures

Lower figures

The following values can be displayed in each mode:
Measurement
ResultA-BPM

Upper figures

Systolic bloodpressureInterval time

Middle figures

Diastolic blood
Remaining time Pressure value
pressure

Lower figures Pulse

Time of clock

S-BPM
Program

Time of clock

Refer to "3.Abbreviations & Symbols" for the meanings ofsymbols on the LCD.

18

5.2.2. OLED Display (Organic light emitting diode)
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

Systolic blood pressure.

DIA

Diastolic blood pressure.

PUL

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.
Blinking:

Interval time of "1 scope" is performing.

Bluetooth is being used.
Memory full
A-BPM sleep markBattery indicator195.3. Principal Switch Operations
5.3.1. A-BPM Operations
To start or suspend A-BPM.
To switch between A-BPM and S-BPM
Step 1. Store the preset program (of start times and intervals) for A-BPM.
Step 2. Set the AUTO switch for the following operations.
"ON" ....... A-BPM is started and themark is shown.

Blood pressure measurements are performedin accordance with the preset A-BPM program.
"OFF" ..... A-BPM is suspended and themark is hidden.

Blood pressure measurement can be performed
using the preset S-BPM programs.

To lock A-BPM to "ON".
Keep the AUTO switch to "ON" using the LOCK switch sothat A-BPM can be performed.

To expand A-BPM interval time.
Step 1. Set the sleep mode to "ON" before measurement.
Step 2. Set the AUTO switch to "ON" to use A-BPM.
The

mark 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.
20

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. Set the AUTO switch to "OFF".
Step 2. If the display is hidden,press the START/STOP or EVENT switch to return to thewaiting mode display.
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 not measured during the interval
time.
Step 2. Press the START/STOP switch during the A-BPM waiting
mode.
21

To adjust the clock.
To set the monitor function of A-BPM.
Step 1. Set the AUTO switch to "OFF".
Step 2. If the display is hidden, press the START/STOP
or EVENT switch to return to the waiting mode display.
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.

22

5.3.2. S-BPM Operations
To start S-BPM.
Step 1. Select the S-BPM program and store its parameters.
Step 2. Set the AUTO switch to "OFF".
Step 3. Operations are as follows:
S-BPM Programs

Operations

Office blood pressure

OBP Press theAutomated night blood pressure

ANBP Preset program entersstandby until the "start time"
ASBP or "start time of alarm".

/
switch to
Automated office blood pressure AOBP start the preset program
Home blood pressure
HBP during waiting mode.

Automated self-blood pressure

To stop S-BPM.
Operations are as follows:
S-BPM Programs

Operations

Office blood pressure
OBP
Automated office
Press the/switch to stop blood
blood pressure AOBP pressure measurement.
Home blood pressure
HBP
Press the/switch to stop blood pressure
Automated nightmeasurement. At the next start time, the blood
blood pressure ANBP
pressure is measured or the buzzer sounds. #1
If you need to stop the recorder completely,
Automated selfremove the batteries from the recorder orblood pressure ASBP
switch to OBP, AOBP, or HBP.
#1: Refer to "6.2.1.S-BPM Programs".
23

To set the program for S-BPM.
Step 1. Set the AUTO switch to "OFF".
Step 2. While pressing and holding the
START/STOP switch until/

switch, press and hold theis displayed on the LCD.

Step 3. The operations are as follows:
Refer to "8.4.S-BPM Programs".
/
switch .....................Change the current parameter.
START/STOP switch ......Decision, next item, end of settings.

To measure the blood pressure during S-BPM immediately.
( Manual blood pressure measurement of S-BPM )Step 1. If the LCD is hidden, press the
START/STOP or EVENT switch to return to the S-BPM
waiting mode display.
Step 2. Press the/switch during the S-BPM waiting mode.

The blood pressure measurements for "1 scope" are performed
immediately.
"1 scope" consists of a set of blood pressure measurements andinterval times which are repeated for the number times in themeasurement count. The last interval time is omitted.
The S-BPM waiting mode is a state when blood pressure
is not measured during the interval time and between the last
"1 scope" and next "1 scope".

245.3.3. Other Operations
To return from the waiting mode and show the monitor.
If the OLED or LCD display is hidden, press the
START/STOP or EVENT switch to return to the waitingmode display.

Deleting measurement data
Step 1. Set the AUTO switch to "OFF".
Step 2. If the indication is hidden, press the START/STOP or
EVENT switch to return to the waiting mode display.
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.
Erasing blinks under DataClear on
the OLED and 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 waiting mode.

25

Deleting
DataClear
OLED Erasing

To pair for Bluetooth® communication.
Step 1. Set the AUTO switch to "OFF".
Step 2. If the display is hidden, press the START/STOP
or EVENT switch to return to the waiting mode display.
Step 3. Press and hold the(afterEVENT

switch until

Pairing

FlightMode ) is displayed on the OLED. The recorder

starts waiting for pairing.
Step 4. When Bluetooth pairing is complete, themark is displayed on

the LCD.
If you cancel the current pairing, press the

EVENT

switch.

The recorder proceeds to the waiting mode display.

To suspend Bluetooth® communication. (Airplane mode)
Step 1. Set the AUTO switch to "OFF".
Step 2. If the display is hidden, press the START/STOP
or EVENT switch to return to the waiting mode display.
Step 3. Press and hold the

EVENT

switch until

FlightModeis displayed on the OLED.
Step 4. Airplane mode can be turned on/off using the START/STOP
switch.
FlightMode
ON
Step 5. Press the

START/STOP switch

EVENT

FlightModeOFF

switch to return to the waiting mode

display.

26

6. Blood Pressure Measurement Functions
The recorder is equipped with automatic blood pressure measurement(A-BPM) and self-blood pressure measurement (S-BPM) and canstore measurement states and measurement results.

6.1. Automatic Blood Pressure Measurement (A-BPM)
When A-BPM is suspended or is not used, set theAUTO

switch to "OFF". If the

AUTO

switch is left

"ON", the measurement will start at the next start time
and the cuff may burst.
Use the

LOCK

switch to prevent theAUTO

switchfrom moving to "OFF" accidentally while A-BPM is used.
AUTO switch to "OFF"AUTO switch to "ON"LOCK switch to "LOCK"AUTO switch
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 with the AUTO switch.
Use the LOCK switch to prevent it from moving accidentally
while A-BPM is used.
27

The

mark is displayed on the LCD while A-BPM is used.

Blood pressure is measured automatically at A-BPM start time.
An initial pressurization value of A-BPM is AUTO, so thata proper pressurization value is selected automatically.
If the first pressurization is insufficient, re-pressurizations are
performed automatically up to two times.
When you delete data from the memory or move the AUTO
switch to "OFF", the pressurization value is reset to the initialpressurization 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, release the LOCK switch andmove the AUTO switch to "OFF".

28

6.1.1. A-BPM Waiting Mode
Items to monitor the measurement state can be displayed on the
LCD during the waiting time for A-BPM.
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.
Measurement interval
Remaining time to next start time
Current time

6.1.2. Sleep Function and Interval time
Set the sleep mode to "ON" in the preset program.
When theEVENT

switch is pressed during A-BPM,

the interval time doubles.
When theEVENT

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.
Blood pressure measurement
T

T

2T

T : Interval time
2T

2T

T

T
Time

EVENT switch
AUTO switch to "ON"Store parameters of the sleep mode
29

EVENT switch

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

is

displayed on the OLED and is stored in the memory.

6.1.4. Storing Environment Data
The environment data is stored while the AUTO switch is set to"ON" for A-BPM.

Note
The environment data can be store for 12 hours at most.
Its download to the ABPM Data Manager may take 50 minutes.

30

6.2. Self Blood Pressure Measurement (S-BPM)
Set the AUTO switch to "OFF" to use S-BPM programs.
The recorder is equipped with five types of S-BPM programs inaccordance with varying measurement environment conditions.
Parameters and measurement results can be stored in the memory.
Descriptions & actions of the program
Items
Office blood pressure
OBP Program for blood pressure measurement by hospital
N.A.
staff. "1 scope": Blood pressure measurement occurs
once.
Automated office blood pressureCount
AOBP Program for blood pressure measurement after restinginside the hospital. "1 scope": Measurement is performed Interval
using the measurement count and interval time.
Home blood pressure#1
Count
HBP Program for blood pressure measurement at home.
"1 scope": Measurement is performed using theIntervalmeasurement count and interval time.
Automated night blood pressure#2 Start time
ANBP Program for blood pressure measurement at night.
Count
It uses the measurement count and interval time.
The ANBP can specify up to six start times a day.
Interval

Name

Automated self-blood pressure#2 Start time
Program that indicates start times with sound fromof alarm
ASBP
the buzzer. Press the/switch to measure theCountblood pressure at home. The buzzer can specify up to
six times a day.
Interval#1:#2:

Blood pressure is measured in accordance with the JapaneseSociety of Hypertension guidelines.
When the measurement count and interval time for ANBP or
ASBP are changed, HBP settings are also changed.
31

6.2.1. S-BPM Programs
Office blood pressure
When the/OBP
switch is pressed, blood pressure is measured

once and is stored in the memory.
Blood pressure measurement
Press the/Timeswitch to start the measurement.

Automated office blood pressure
When the/AOBP

switch is pressed, AOBP is started.

First, the device is idle for the interval time to allow the patient to relax.
Next, the AOBP performs a "1 scope".
"1 scope" consists of a set of blood pressure measurements andinterval times, which are repeated for the number of times of themeasurement count. The last interval time is omitted.
When the/switch is pressed during the "1 scope", the"1 scope" is stopped.
Blood pressure measurement
T

T

Press the/Press the/T

1 scopeT

T

T: Interval timeTTimeswitch to start the "1 scope".

switch to stop the "1 scope".
T

T

T

Not measured
T
Time

Press the/switch to start the "1 scope".

32

Home blood pressure
When the/HBP
switch is pressed, HBP is started.

The HBP performs a "1 scope".
"1 scope" consists of a set of blood pressure measurements
and interval times which are repeated to the number of themeasurement count. The last interval time is omitted.
When the/switch is pressed during the "1 scope", the"1 scope" is stopped.
Blood pressure measurement

1 scope

T

T

T

T: Interval timeT
Time

Press thePress the//switch to start the "1 scope".

switch to stop the "1 scope".

T

T

T

Not measured
T
Time

Press the/switch to start the "1 scope".

33

Automated night blood pressure

ANBP

The ANBP can specify up to six preset start time a day.
When parameters for the ANBP program are stored, the ANBP
is started and a "1 scope" is performed for each start time.
A "1 scope" consists of a set of blood pressure measurements
and interval times which are repeated to the number of themeasurement count. The last interval time is omitted.

Note
Manual blood pressure measurement of the ANBP
When the/switch is pressed in S-BPM waiting mode,a "1 scope" is performed.
1 scopeT

Blood pressure measurementT

1 scopeT

T
Time

Start time

Start time

The ANBP is started at the same time when ANBP program is set.
(The ANBP becomes waiting mode until start time)
1 scope1 scope1 scope

T

T

T

T

T

T
Time

Start time

Press the/switchto start the manual-BPM.

1 scope1 scopeT

T

Start timeT

Not measured

T
Time

Start time

Press the/switchto stop the "1 scope".

T: Interval time34

Automated self-blood pressure

ASBP

The ASBP can specify up to six preset start time for the alarm.
When parameters for the ASBP program are stored, the ASBP
is started and the buzzer sounds at each start time. Press the/switch to perform a "1 scope" when the buzzer sounds.

"1 scope" consists of a set of blood pressure measurements andinterval times, which are repeated up to the number of times of themeasurement count. The last interval time is omitted.

Note
Manual blood pressure measurement for the ASBP
When the/switch is pressed in waiting mode between thelast "1 scope" and the next "1 scope", The "1 scope" is performed.
1 scope Blood pressure measurement 1 scope
T

T

T

T
Time

Press the/switch to start "1 scope".

Press the/switch to start "1 scope".

Start time of alarm

Start time of alarm

The ASBP is started at the same time when ASBP program is set.
(The ASBP becomes waiting mode until start time)
1 scope1 scope1 scope

T

T

T

T

T

T
Time

Press the/switchto perform the manual-BPM.
T: Interval time35

1 scopeT

Not measured

1 scope

T

T

T
Time

Press thePress the//switch to stop "1 scope".

switch to start "1 scope".
T: Interval time

Start time of alarm

6.2.2. S-BPM Waiting Mode
Operation mode and pressure value are displayed on the LCD during
S-BPM waiting mode.
# The LCD will be hidden automatically after no-operation is continued
for few minutes. Even if the LCD is hidden, the manual bloodpressure measurement can be started when the/switchis pressed. When the START/STOP or EVENT switch ispressed, the display resumes.
A "1 scope" consists of a set of blood pressure measurements andinterval times which are repeated up to the number of times of themeasurement count. The last interval time is omitted.
Clock markblinks on the LCD during a "1 scope" interval time.

The S-BPM waiting mode is a state when blood pressure is not being
measured during the "interval time" and between the last "1 scope" andnext "1 scope".
Program of the S-BPM
Pressurization value
Current time36

6.2.3. Stopping and Suspending Measurement
Note
When A-BPM is stopped, the stop codeE07

is displayed on

the LCD and is stored in the memory.
S-BPM Programs

Operations

Office blood pressure
OBP
Automated office
Press the/switch to stop blood
blood pressure AOBP pressure measurement.
Home blood pressure
HBP
Press the/switch to stop blood
Automated nightpressure measurement. At the next start
blood pressure ANBP
time, blood pressure is measured or thebuzzer sounds.
#1
If you need to stop the recorder completely,
Automated selfblood pressure ASBP remove the batteries from the recorder orswitch to OBP, AOBP, or HBP.
#1: Refer to "6.2.1.S-BPM Programs".

37

6.3. Measurement Results
6.3.1. Displaying Measurement Results
The monitor function can select "Display ON" or "Display OFF" for the
A-BPM measurement result. This function cannot be used for S-BPM.
The content of the "Display ON" command includes "Pressure value
during the measurement", "Measurement result" and "Error code forthe 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".

6.3.2. 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.

38

6.3.3. Outputting Measurement Results
The measurement data stored in the memory can be output to theperipheral using USB data transfer.
Refer to "8.8.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.

6.3.4. 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.

39

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 for along period of time. Batteries may leak and cause a malfunction.
Use two alkaline batteries: type LR6 or designated rechargeable
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 thebattery may be damaged by the spring terminal.
Do not mix different kinds of batteries or used batteries and newbatteries. It may cause a leak, heating or damage.

Note
When the level 1of the battery level is displayed, replace with

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 (40).

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.
Open.

Insert two new batteries in
the proper "+" and "-"direction.
Push the spring terminal
using the "-" terminal of
the battery.

Remove batteries.
Close.
Push spring terminal.
Insert.

Step 4. Insert the battery bypushing the "+" terminal.
Step 5. Insert the second battery
using the same method.
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.

41

7.1.1. How to Replace Batteries
Measurement results and setting parameters are saved when thebatteries 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 Function of
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 the recorder isused. To attach the carry holder, put the carry holder
through the accessory belt or the belt of the clothes
being worn.

Carry holder
Belt

42

7.3. Inspection for Use
CautionInspect the recorder to maintain its performance, safety andeffectiveness 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.
1

Item
Exterior

2

Battery3

Cuff

Description
No damage and deformation from dropping.
No damage and looseness of switches, etc.
Check that the batteries are not flat. Replace with
two new batteries before the patient uses it.
Check that the cuff has not frayed. If the cuff isfrayed, it may burst due to internal pressure.
Check that there are no kinks and folding in the air

4

Cuff

hose.

connection

Check that the air socket and connector isconnected firmly.

5

Attachments

Check that there is no damage to accessories.
(Carry holder, belt, etc.)43

7.3.2. Battery Post-installation Checklists
No.

PortionDescription
Check that there is no fire, smoke and strong

1

Batterysmells.
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

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

44

8. Operation
8.1. Operation Flowchart
Note
The initial settings (of the built-in clock, monitor function andinitial pressurization value) and preset program (A-BPM and
S-BPM) do not need to be stored every time. They are stored
when deleted, updated and when the recorder is used for the
first time.
The settings of the recorder can be stored using a dedicatedperipheral. Refer to the instruction manual for the ABPM DataManager.
Measurement procedures for A-BPM and S-BPM are different.
A-BPM can specify six pairs of arbitrary start times andintervals for every 24 hours and can automatically measure
and record blood pressure.
S-BPM assumes that a patient measures their own bloodpressure by self-operation at home or in hospital. This modecan use five types of programs in accordance dependingon use.

45

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

A-BPM

S-BPM

Save A-BPM preset program.

Save S-BPM preset program.

Attach the recorder and cuff.

Attach the recorder and cuff.

Move the AUTO switch
to "ON".

Move the AUTO switch
to "OFF".

A-BPM

Press theMove the AUTO switch
to "OFF".

START switch.

Office blood pressure OBP
Automated office
blood pressure

AOBP

Home blood pressure HBP
Connect the recorder todedicated peripheral.
Data processing.
Clean and keep the product.

Automated night
blood pressure

ANBP

Automated self
blood pressure

ASBP

Complete procedure for use
46

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 AUTO switch is moved to "ON", A-BPM starts.
Blood pressure is measured every 30 minutes until the switch
is moved to "OFF".
#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.

47

Items of S-BPM
Item

Factory setting

Program selection

Office blood pressure (OBP)

Office blood pressure
OBP

N.A.

Measurement countAutomated office bloodpressure
AOBP Interval time

2 counts

Measurement countHome blood pressure
HBP Interval time

2 counts

Start time of section

2 hours

Automated night blood
Measurement countpressure
ANBPInterval time
Start time of alarm
Automated self-blood
Measurement countpressure
ASBP
Interval time

5 minutes
1 minute
2 counts
1 minute
7 hours, 22 hours
2 counts
1 minute

The content of the factory settings
When the/switch is pressed after the AUTO switch is

moved to "OFF", the S-BPM preset program (OBP) is started. The
program (OBP) measures the blood pressure once and stores theresult in the memory.

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 recorder using
the USB cable.
48

Procedure of operation using switches
Step 1. Set theAUTO

switch to "OFF".

Step 2. If the display is hidden, press the START/STOP
or EVENT switch to return to the waiting mode display.
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 the

START/STOP

switchto return to waiting mode.
Item
OLED
Monitor Display
function
xx
Clock
Year
Year xxClock
MonthMon. xx
Clock
Day
Day
xx
Clock
Hour
Hour xx
Clock
Minute
Min.
xx

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

Last two digits of year.

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

49

8.2.3. Initial Pressurization Value of S-BPM
An initial pressurization value of S-BPM can be set beforehand.
160, 180, 210, 240, 270, AUTO [mmHg]
If AUTO is specified, a proper initial pressurization value isselected automatically. The factory setting is 180 mmHg.
Step 1. Set the AUTO switch to "OFF".
Step 2. If the display is hidden, press the START/STOP
or EVENT switch to return to the waiting mode display.
Step 3. Select a pressurization value using the START/STOP switch.
AUTO switch to "OFF"S-BPM program
Pressurization value
Current time

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 the AUTO switch is set to "ON".
It is necessary to specify them again when using another A-BPM.
50

Operation using switches
Step 1. Set the AUTO switch to "OFF".
Step 2. If the display is hidden, press the
START/STOP or EVENT switch to return to the waitingmode display.
Step 3. While pressing and holding the START/STOP switch,press and hold the EVENT switch until Sleep is displayedon 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
the following 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.

51

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

OLED
Parameter
Sleep
xx
=
ON,
OFF
#1, #2xx
Interval 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
Hour 3
Start time
xx xx = 0 to 23 hours
Section3
Interval Cycle 3
time
xx xx = OFF , 5, 10, 15, 20, 30, 60, 120 minutes
Hour 4
Start time
xx xx = 0 to 23 hours
Section
4
Interval Cycle 4
time
xx xx = OFF , 5, 10, 15, 20, 30, 60, 120 minutes
Hour 5
Start time
xx xx = 0 to 23 hours
Section5
Interval Cycle 5
time
xx xx = OFF , 5, 10, 15, 20, 30, 60, 120 minutes
Hour 6
Start time
xx xx = 0 to 23 hours
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

Sleep mode

Automated measurement

Enclosed characters : Factory settings.
52

#1 : When the sleep mode is set to "ON", the start time and operation
time of the automated measurement and the interval time of thesleep 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 for the sleep
mode is not displayed.
#3 : If the start time is specified and the operation time is set to"OFF", when the

AUTO

switch is set "ON", the automatedmeasurement starts at the preset start time and continues
until theAUTO

switch is set to "OFF". If the

AUTO switch

is set to "ON" again, the automated measurement starts at
the preset start time.

Note
When the operation time is specified, even if the

AUTO

switch is operated during the automated measurement, theautomated measurement continues for the operation timefrom the time that theAUTO

switch is initially set to "ON".

#4 : If the start time is set to "OFF" and the operation time isspecified, when the

AUTO

switch is set to "ON", theautomated measurement performs the first blood pressure
measurement and continues for the operation time.
If theAUTO

switch is set to "OFF" during the automatedmeasurement, it stops.
If theAUTO

switch is set to "ON" again, the automatedmeasurement is performed for the operation time.

53

Note
When the start time is specified and theAUTO

switch is

set to "OFF" during the automated measurement, it stops.
When theAUTO

switch is set to "ON" again, theautomated 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 theautomated 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".

54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 the start
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.
When the AUTO switch is set to "ON", A-BPM is performed
according to the start time and interval of each section until the
AUTO switch is set to "OFF".
Blood pressure measurement

Section 1
AUTO switch to "ON"Not measured

Section 2
AUTO switch to "OFF"

55

Time

Example 2 Automatic measurement
The start time for the automated measurement = 7:00,
The operation time for the automated measurement = OFF.
When the AUTO switch is set to "ON", A-BPM is started at 7:00.
A-BPM is continued according to the start time and interval of eachsection until the AUTO switch is set to "OFF".
7:00

Blood pressure measurement

Not measured

Section 1

Section 2

AUTO switch to "ON"AUTO switch to "OFF"Time# Even if the AUTO switch is set to "OFF" and to "ON" again
during the automated measurement, the automatedmeasurement continues.

Example 3 Automatic measurement
The start time for the automated measurement = OFF,The operation time for the automated measurement = 26 hours.
When theAUTO

switch is set to "ON", A-BPM continues

according to the start time and interval for each section for
26 hours.
Blood pressure measurement

Not measured

Section 1

Section 2

AUTO switch to "ON"After 26 hours
56

Time

# Even if the AUTO switch is turned to "OFF" once and isturned to "ON" again during the automated measurement,
the automated measurement does not continue beyond theoperation time.

8.3.3. Start Time and Operation Time
When the start time of the automated measurement is
specified and the AUTO switch is set to "ON" and theautomated measurement is started, the following message
is displayed.
If the start time is earlier than the current time, the automatedmeasurement is started at the start time for the next day.
"---" is displayed until the start time.

The current time

The same "---" is displayed after the operation time of theautomated measurement is finished.

57

8.4. S-BPM Programs
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 for operation using switches
Step 1. Set the AUTO switch to "OFF".
Step 2. While pressing and holding the/switch,press and hold the START/STOP switch until

isdisplayed on the LCD.
Step 3. Select S-BPM program using the following switches.
Program: OBP , AOBP, HBP, ANBP, ASBP/
switch ......................Change the current parameter.
START/STOP switch ........Decision, next item.
Step 4. Specify each item (Measurement count, Interval time, start timeand start time of alarm) using the following switches.
/
switch ......................Change the current parameter.
START/STOP switch ........Decision, next item, end of settings.
Step 5. After completing settings, S-BPM clock is displayed.

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

58

8.4.1. S-BPM Items and Parameters
Item

ProgramParameter

S-BPM program
Program

OBP , AOBP, HBP, ANBP, ASBP

Office blood pressure
OBP

N.A.

N.A.

Automated office blood pressure
AOBP

Measurement count2,

1 to 5 counts

Interval time5,

3 to 10 minutes

Measurement count2,

1 to 5 counts

Interval time1,

1 to 5 minutes

Start time2,

0 to 23 hours

Measurement count2,

1 to 5 counts

Interval time1,

1 to 5 minutes

Home blood pressure
HBP

Automated night blood pressure
ANBP

#1

Automated self-blood pressure
ASBP

Start time of alarm

7 , 22 , 0 to 23 hours

Measurement count2,

1 to 5 counts

Interval time1,

1 to 5 minutes#2

Enclosed characters : Factory settings.
#1:

#2:

24 hours can be separated to six sections in maximum.
Each section can specify the start time of the blood pressure
measurement.
24 hours can be separated to six sections in maximum.
Each section can specify the start time of alarm for the
blood pressure measurement.
59

8.4.2. S-BPM Display Examples
Office blood pressure display

OBP

OBP has no settings to configure.

Automated office blood pressure displayAOBP

AOBP uses preset the measurement count and interval time.
AOBP performs a "1 scope" after a waiting mode to relax.
Refer to "6.2.1.S-BPM Programs" for the "1 scope".

Measurement countInterval time

Home blood pressure display

HBP

HBP uses preset the measurement count and interval time.
HBP performs a "1 scope".
Refer to "6.2.1.S-BPM Programs" for the "1 scope".

Measurement countInterval time60

Automated night blood pressure display

ANBP

The ANBP can specify up to six preset start times for the"1 scope". Refer to "6.2.1.S-BPM Programs" for the "1 scope".
When the last start time is the same as first start time, thesettings for start time finish. Next, specify the measurement countand interval time for the "1 scope".

First start time

2nd start time

Measurement countExample3rd start time

Interval time

Settings and simplified input

The measurement happens at 22:00 and 4:00.
The start time of section 1 =4:00

The start time of section 2 =22:00

The start time of section 3 =4:00 ................. The same as section 1

The measurement count =2 times

The interval time =0:01 minute61

Automated self-blood pressure display

ASBP

The ASBP can specify up to six preset start times for the alarm.
The buzzer sounds at each start time. Press the/switch to perform the "1 scope" when the buzzer sounds.
Refer to "6.2.1.S-BPM Programs" for the "1 scope".
When the last start time is the same as first start time, thesettings for start time finish. Next, specify the measurement
count and interval time for the "1 scope".

First start time of

2nd start time of

3rd start time

alarm

alarm

of alarm

Measurement countExampleInterval time

Settings and simplified input

The buzzer sounds at 22:00 and 7:00.
Press the/switch to perform the "1 scope".

The start time of section 1 =22:00

The start time of section 2 =7:00

The start time of section 3 =22:00 ............... The same as section 1

The measurement count =2 times

The interval time =0:01 minute62

8.5. 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.

If 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. Set the AUTO switch to "OFF".
Step 2. If the indication is hidden, press the START/STOP or
EVENT switch to return to the waiting mode display.
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.
Erasing blinks under DataClear on the OLED and thedeletion 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.
63

8.6. Attaching the Product to the Patient
8.6.1. 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 minuteafter pressurization. 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 startblood 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.

How to stop or suspend the measurement
Press theSTART/STOP

switch to stop blood pressure

measurement. An error code is stored in the memory.
Blood pressure is measured again after 120 seconds.
64For the A-BPM and ANBP and ASBP modes of S-BPM, only thecurrent blood pressure measurement can be suspended and the"1 scope" is performed at the next start time. Set theAUTO

switch to "OFF" to suspend A-BPM.

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 measurement.
The "1 scope" is still performed at the next start time for
A-BPM and the ANBP and ASBP modes of S-BPM.
When pain in the arm or an unexpected condition occur,stop the measurement, remove the cuff and consult a doctor.
Set the AUTO switch to "OFF" to suspend A-BPM.
Set theAUTO

switch to "ON" to resume A-BPM automatedmeasurement. The

mark is shown on the LCD and OLED.

The recording of data continues until switched to "OFF".

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.
65

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.

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

66

8.6.3. 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 measureblood 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.
67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
fingers68

Air hose

Tape
Clip

Air hose

Cuff

Belt
Carrying holder
Air plugAir socket

InsertCarrying holder

Belt
69

8.7. Blood Pressure Measurement Operations
8.7.1. 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 Clockand the Monitor Function of Measurement" and "8.3.A-BPM
Preset Programs".
When the recorder is removed, set the AUTO switch to "OFF".
If the recorder is removed during A-BPM, the inflation of thecuff starts at the next start time and the cuff may burst.
When A-BPM is resumed, set the AUTO switch to "ON".
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 codeE07

is displayed on

the OLED and stored in the memory.

To start A-BPM
Step 1. Set the

AUTO

Step 2. The

mark is shown on the OLED and LCD. A-BPM isswitch to "ON".

started.
70

To suspend A-BPM
Step 1. Set theAUTO

switch to "OFF".

Step 2. The

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 and thecurrent measurement is stopped. However, A-BPM is continued.
The next blood pressure measurement is performed inaccordance 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 blood pressure is not measured during theinterval 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 is pressed
during A-BPM waiting mode, the interval time is doubled.

71

8.7.2. S-BPM Operations
Note
Set the built-in clock and initial pressurization value before
measurement because they are used for S-BPM.
Refer to "8.2.2.The Clock and the Monitor Function of
Measurement" and "8.4.S-BPM Programs".
Remove the batteries when the patient removes the recorder and cuff
when ANBP or ASBP is used (even during the waiting mode). If thebatteries are left in the battery compartment, the cuff may break when
the recorder inflates the cuff at the next "1 scope". If the patient resumes
measurement, insert the batteries and press the/switch.

Manual blood pressure measurement can be performed during
S-BPM waiting mode.
The measurement result for the manual blood pressure
measurement can be stored in the memory.
When S-BPM is stopped, the error code E07 is displayed on the
OLED and stored in the memory.

To start S-BPM
Step 1. Set theAUTO

switch to "OFF".

Step 2. Operations are as follows:
S-BPM Programs

Operations

Office blood pressure

OBP Press theAutomated night blood pressure

ANBP Preset program entersstandby until the "start time"
ASBP
or "start time of alarm".

/
switch to
Automated office blood pressure AOBP start the preset program
Home blood pressure
HBP during waiting mode.

Automated self-blood pressure72

To measure blood pressure during S-BPM immediately.
(Manual blood pressure measurement for S-BPM)
Step 1. If the LCD display is hidden, press the
START/STOP or EVENT switch to return to the S-BPM
waiting mode display.
Step 2. Press the/switch during S-BPM waiting mode.

The blood pressure measurements of "1 scope" are performed
immediately.

To stop or Suspend S-BPM
Operations are as follows:
S-BPM Programs

Operations

Office blood pressure
OBP
Automated office
Press the/switch to stop blood
blood pressure AOBP pressure measurement.
Home blood pressure
HBP
Press the/switch to stop blood
Automated nightpressuremeasurement.
At next start time,
blood pressure ANBP
blood pressure is measured or the buzzer
sounds.
#1
Automated self
If you need to stop the recorder completely,
blood pressure ASBP remove batteries from the recorder or switch
to OBP, AOBP, or HBP.
#1: Refer to "6.2.1.S-BPM Programs".

73

8.7.3. 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 statethat blood pressure is not measured during the interval time.
Step 2. Press the START/STOP switch during A-BPM waiting mode.

To measure blood pressure during S-BPM immediately.
(Manual blood pressure measurement of S-BPM)
Step 1. If the LCD is hidden, press the START/STOP or
EVENT switch to return to the S-BPM waiting mode display.
Step 2. Press the/switch during S-BPM waiting mode.

The blood pressure measurements of "1 scope" are performed
immediately.

74

8.7.4. Stopping and Suspending Measurements
Ongoing A-BPM, S-BPM and manual blood pressure
measurement can be stopped or suspended immediately.

Note
When blood pressure measurement is stopped, the stop codeE07

is displayed on the OLED and is stored in the memory.

To suspend A-BPM
Step 1. Set the AUTO switch to "OFF".
Step 2. The

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 and thecurrent measurement stops. However, A-BPM continues.
The next blood pressure measurement is performed inaccordance with the A-BPM settings.

75

To stop or suspend S-BPM
Operations are as follows:
S-BPM Programs

Operations

Office blood pressure
OBP
Automated office
Press the/switch to stop blood
blood pressure AOBP pressure measurement.
Home blood pressure
HBP
Press the/switch to stop blood
Automated night
blood pressure ANBP pressure measurement. At next start time,
blood pressure is measured or the buzzer
sounds.
#1
Automated selfIf you need to stop the recorder completely,
blood pressure ASBP remove the batteries from the recorder orswitch to OBP, AOBP, or HBP.
#1: Refer to "6.2.1.S-BPM Programs".

76

8.8. Connecting the Recorder to a Dedicated Peripheral
8.8.1. Connecting with a USB cable
Refer to the instruction manual of ABPM Data Manager concerningof 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 theterminal cable is properly connected.
Blood pressure cannot be measured during USB
communication.
Do not attach to the patient when the recorder is connected tothe cable. The cable may become wrapped around the bodyor neck.
Preparation of a dedicated peripheral
Remove the recorder and cuff from the patient before
connecting the recorder (TM-2441) to a dedicated peripheral.
If the level 1

is displayed, connect the recorder(TM-2441) to the peripherals after replacing the batteries.

77

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 dedicatedConnect the micro USB

peripheral.
Step 2. The buzzer sounds andis displayed on the LCD.
The data communication entersstandby mode.

Standbymode

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

Activeonline mode

communication.

To stop data communication with a dedicated peripheral
Step 1. Remove the cable in the standby mode.
78

8.8.2. Using Bluetooth® Communication
A Bluetooth device needs to be paired with a device in order tocommunicate with the device. Once the recorder is paired witha device, devices can automatically communicate.

Note
Be sure to power off all other Bluetooth devices when pairing.
Multiple devices cannot be paired at the same time.
If the recorder is paired with another device, the first device will be
unpaired.
If devices cannot communicate after pairing, try pairing once again.

Bluetooth® Pairing
Step 1. Set the AUTO switch to "OFF".
Step 2. If the display is hidden, press the START/STOP
or EVENT switch to return to the waiting mode display.
Step 3. Press and hold the

EVENT

switch until

Pairing(afterFlightMode ) is displayed on the OLED. The recorder starts
waiting for pairing.
Step 4. When Bluetooth pairing is complete, themark is displayed on

the LCD.
If you cancel the current pairing, press the

EVENT

The recorder proceeds to the waiting mode display.

79

switch.

8.8.3. Suspending Bluetooth® Communication (Airplane mode)
The airplane mode can suspend Bluetooth communication.

Using airplane mode
Step 1. Set the AUTO switch to "OFF".
Step 2. If the display is hidden, press the START/STOP
or EVENT switch to return to the waiting mode display.
Step 3. Press and hold the

EVENT

switch until

FlightModeis displayed on the OLED.
Step 4. Airplane mode can be turned on/off using the START/STOP
switch.
FlightMode
ON
Step 5. Press the

START/STOP switch

EVENT

FlightModeOFF

switch to return to the waiting mode

display.

80

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 thesafety of the patient and the operator. As a basic rule, the operator
should inspect this instrument daily, such as by following the"Inspection before use".
Daily management, such as inspection before use, is necessary tomaintain the performance, safety and effectiveness of the recorder.
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.

81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 the cuff
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 withgauze moistened with antiseptic solution and squeezed well. Then,
wipe the wet case using gauze moistened with water or warm waterand squeezed well. We recommend using chemicals (ingredientname) from the antiseptic solution listed in the table (Example ofuseable antiseptic solution (Ingredient name)).
82

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 water and squeezed well.
Refer to the antiseptic solutions in the table (Example of useable
antiseptic solution (ingredient name)) when disinfecting.
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.

83

9.3. Periodic Inspection
Perform the daily periodic inspection to use the recorder correctly.
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.
The cuff is disposable.
Measurement
If there is a crack or adhesive matter in the
Cuffconnection 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
or feels 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.
84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.

85

9.4. Disposal
Follow the laws of the local government for environmental 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.

OthersName
PackagePart

Material

Case

Cardboard

CushionAir cushion, special case

Bag

Vinyl

Case

ABS + PC resin

Internal parts

General parts

Chassis

Iron

Backup battery Lithium rechargeable coin cell battery:
Recorderon the board
ML2016H
Battery

Alkaline battery:
1.5V LR6 or AA size
Rechargeable battery:AA size
Ni-MH batteries, 1900 mAh or more86

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 been Replace with newpressing any switches. consumed.
batteries.
No OLED display
OLED may disappear due Remove batteries andduring A-BPM.
to the electrostatic effect. reinstall them.
The backup battery does Charge for 48 hours
Frequent clock reset.
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 cablecommunication #2 cable is removed.
is connected correctly.
The dedicated peripheral
Communication
Wait for the end of theis downloading a large
response takes time.
download. It may needamount of environmental#2
50 minutes at most.
data for a long time.
Battery cover cannot Non-standard size
Contact your local
be openedbatteries were used.
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.
87

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.
Inflation does not reach the target
pressure.

Failure ofpressurization

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 or/
switch.

Press the START/STOP or/
switch only when necessary.
The heartbeat cannot be detected due
to body motion or noise from clothes.

Blood pressure cannot
be measured.

Built-in acceleration
sensor error.

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.
Remove the batteries and reinstall
them.

88

Code

Meaning

Cause and treatment

Excessive body
motion.

Relax and keep still during
measurement.

Out of range,
30
PUL

200

Out of range,
30
DIA

If these errors occur multiple times, try
another blood pressure measurement.

160

PP = SYS - DIA
Systolic blood pressure
Diastolic blood pressure
Pulse pressure

Out of range,
60
SYS

#1
SYS:
280 DIA:PP:

Out of range,
10PP
150 #1
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.
detected.
Measure the blood pressure whilerelaxed and do not move.
The settings of theinterval time areincorrect.

Zero pressure error
for safety circuit.

If the interval time is set to 120 minutes,
the difference between last start timeand next start time cannot divide into
two hours perfectly.
Displays at the measurement starttime.
Release the air remaining in the cuff
completely.

89

Code

Meaning

Safety circuit detects
over load pressure.

Cause and treatment
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.

90

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-

91

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 pieces92

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.
93

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 indicatorof the reliability of the measurement accuracy.
When noise occurs due to irregular heartbeat 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.
94Proper cuff size
Use a cuff of adequate size. If it is too small or too big,a measurement 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.

95

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.

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 byelectromagnetic emission and have reduced immunity
against disturbances.

EMISSIONS LIMITS
Phenomenon
Radiated RF emission

Compliance

CISPR1196

Group 1, Class B

IMMUNITY TEST LEVELS: Enclosure Port
Phenomenon

Immunity test levels

Electrostatic discharge±8 kV contact
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)

IMMUNITY TEST LEVELS: PATIENT COUPLING Port
Phenomenon

Immunity test levels

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

IMMUNITY TEST LEVELS: Signal input/output Port
Phenomenon

Immunity test levels

Electrostatic discharge±8 kV contact
IEC 61000-4-2 ±2 kV, ±4 kV, ±8 kV, ±15 kV air
Electrical fast transients/bursts±1 kV
IEC 61000-4-4 100 kHz repetition frequency
Conducted disturbances induced 3 V 0.15 MHz - 80 MHz
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
97

Band
(MHz)

Service385

380 - 390TETRA 400450

430 - 470

GMRS 460
FRS 460

710
745
780

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 Hz

9

810
870
930
1720
1845
1970

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

98

27
28

Test specifications for ENCLOSURE PORT IMMUNITY to proximity
magnetic field
Test frequency
30kHz
134.2kHz
13.56MHz

Modulation

Immunity test level
(A/m)

CW

8

Pulse modulation
2.1kHzPulse modulation
50kHz

99

65
7.5

THIS PAGE INTENTIONALLY LEFT BLANK.

1. Back cover: A&D
GlobalA&D Company, Limited
1-243 Asahi , Kitamoto-shi, Saitama-ken 364-8585 Japan
Telephone: [81] (48) 593-1111
Fax: [81] (48) 593-1119

http://www.aandd.jp

Emergo Europe B.V.
Westervoortsedijk 60, 6827 AT Arnhem, The Netherlands
A&D INSTRUMENTS LIMITED
http://www.andmedical.co.uk/
Unit 24/26 Blacklands Way, Abingdon Business Park, Abingdon, Oxfordshire
OX14 1DY, United Kingdom
Telephone: [44] (1235) 550420
Fax: [44] (1235) 550485
A&D Engineering, Inc.
http://www.andonline.com/medical/
4622 Runway Boulevard, Ann Arbor, MI 48108 USA
Telephone: [1] (888) 726-9966
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http://www.andmedical.com.au/
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Telephone: [61] (8) 8301-8100
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