English (Original)

Recorder for Ambulatory Blood
Pressure Monitor

Ambulatory Blood Pressure Monitor

1WMPD4003500F

2003

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 of 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 evidenced by the CE mark of conformity accompanied by thereference 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-located or
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 testingof specific absorption ratio (SAR).
TM-2441 Instruction manuali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 levels of
RF energy that are deemed to comply without testing of 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 evidenced 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 meaning of these warning signs and marks are as follows.

Warning Definitions
An imminently hazardous situation that will result in deathor serious injury, if not avoided.
A potentially hazardous situation that could result in deathor serious injury, if not avoided.
A potentially hazardous situation that may result in minor
or moderate injury, if not avoided. It may also be used toalert 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".
indicates Mandatory action. The mandatory
The symbol
action is described inside or near the symbol, using text or a
picture. The example indicates general mandatory action.

Other
Note Provides information useful for the user to operate the device.
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 ambulatory bloodpressure monitor) safely and correctly, carefully read the following
precautions before using the monitor. The following content
summarizes general matters regarding the safety of patients andoperators, in addition to safe handling of the monitor. Precautions foreach operation are described in the pages of this manual. Read the
instruction manual before using the device.
1. Precautions When Wearing and Storing the Recorder.
Keep 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.
Don’t use the recorder combined with magnetic resonanceimaging system (MRI).

To preserve capabilities of the device, consider the following
environmental conditions when using and storing the recorder.
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 occurs.
iv

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.
Confirm that the recorder operates safely and correctly.
When the recorder is used in conjunction with other devices, it
may cause an incorrect diagnosis or safety problems. Confirm
that 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. Cautions and warnings are not described in this manual.
For safe and correct use of the recorder, perform inspections
before use.
Leave the recorder in normal operation condition one hour ormore before use and turn on it.
Connect only dedicated peripheral to the USB connector.
Do not connect other devices.
Except for authorized cuff by A&D, do not connect to air
socket.

v

Preparation of the Recorder
Delete last data stored in the recorder before it is used by the next
patient.
Replace 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 : kinkand tension of the air hose, position and direction of the cuff)
Instructions for Patient Wearing the Device
Inform the patient how to turn the AUTO switch "OFF" to stop therecorder when alone if trouble occurs.
Inform the patient to remove the recorder quickly when in pain or if any
trouble occurs.
Take care when using around babies and infants, as there is a dangerof suffocation with air hose accidentally.
3. Precautions for Batteries Used for Blood Pressure Measurement.
Install batteries in accordance with polarity signs "+" and "-"shown on the inside of the battery cover. (Caution for polarities)
Replace consumed batteries to new ones at the same time.
Remove batteries if the recorder is not to be used for a long
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 along the "+"terminal of the battery compartment. If the battery is installed fromthe "+" terminal, the battery cover may be damaged.
viDo not touch the battery and patient at the same time. It
may cause an electric shock.
Do not mix an old battery with a new one. Does not use batteriesof different type and maker. If these use, it may cause of leakage,heat and explosion. The malfunction of the recorder may occur.
4. Precautions During Use.
Do not use the recorder while operating automobiles or othervehicles.
Example : The recorder may inhibit motion of body or arms when
operating vehicle. etc.

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

Stop the use of the recorder and switch the AUTO switch to"OFF", if the patient feels pain in his arm or the measurement isincorrect.
Do not use the recorder in a strong magnetic or electric field.
Do not use the recorder on patient using a heart-lung machine.

vii

Note
Instructions for Patient
If temperature is low, battery power becomes lower and measurement
count is reduced.
5. Precautions After Using the Recorder.
Processing work of Measurement Data
Be sure to process measurement data immediately using
dedicated peripheral.
The Recorder
After cleaning up accessories, arrange and store them.
Clean up the recorder so as to be able to use next measurement.
Switch the AUTO switch to "OFF". If leaving the AUTO switch
to "ON", pressurization of the automatic measurement is started
at next measurement start time and the cuff or other parts may be
broken by the inflation.
Remove batteries from the recorder if it is not used for a long
period of time. Batteries may leak and break the recorder.
Avoid using the recorder by a child oneself. Do not put therecorder in a place within reach of an infant. Doing so may cause
accidents or damage.
Hold the connector housing when connecting and removing thecable. Do not pull the cable.

viii

Note
Precautions After Using the Recorder (TM-2441)
Be sure to process measurement data immediately using dedicatedperipheral after finishing measurement.
Backup Lithium Rechargeable Battery

The recorder is built with a backup lithium battery. This battery supplies
power to the built-in clock when replacing AA batteries used for bloodpressure measurement. The lithium battery is charged from 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 batteries and charge the backup battery. It is enough if the
backup battery is charged for 48 hours or more.
(The backup battery is always charged by AA batteries.)
Replace with two new AA batteries when the battery indicator displays.
Whenis displayed at the battery indicator, the blood pressure

measurement and data communication cannot be performed. Replace
two new AA batteries.
Remove batteries to prevent the recorder from liquid leakage of battery
if the recorder is not used for a month or more.

ix

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

Use a dry lint free cloth for the care of the recorder.
Do not use volatile agents like a thinner, benzine.
Do not use wet cloth.
Do not disassemble or modify the recorder (medical electronic
device). It may cause damage.
x

8. Precautions and Countermeasures of Malfunction Due to Strong
Electromagnetic Wave
The recorder complies with EMD-standard IEC60601-1-2: 2014.
However, to prevent electromagnetic interference with otherdevices, do not use mobile phones near the recorder.
If the recorder is located near strong electromagnetic waves,noise may invade in waveforms and malfunctions may occur.
If unexpected malfunction occur during use, check theelectromagnetic interference and take appropriate actions.
Do not use Bluetooth connection in the range of a wireless LANor 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 loss of connection, very slow
communication speeds and errors.

The following examples are general causes of malfunction andcountermeasures.
Use of mobile phones
Radio waves may cause unexpected malfunctions.
Wireless communication devices, home networking devices
such as walkie-talkies mobile phones, cordless phones andthese types of communication devices can affect the recorder.
Therefore, keep distance of 30 cm or more from thesewireless devices while the recorder measures.

xi

If there is static electricity in the usage environment (discharges
from devices or the surrounding area)
Before using the recorder, ensure that the operator andpatient have discharged static electricity.
Humidify the room.
Using 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 that is not being used,
or use the monitor in a different location.

9. Environmental Protection
Before disposing of the recorder, remove the lithium battery fromthe recorder.

xii

Precautions For Safe Measurement
The section describes precautions concerning the measurement
and sensor. Warn the following contents to patient and explain
enough them. Perform guidance of correct operation to patient.

Blood Pressure Measurement
Ensure the tube is not bent excessively and that air flows
properly. If a bent air hose is used, air pressure may remain thecuff, which may stop blood flow to the arm.
Do not measure the blood pressure on an arm if the patient has
the following circumstances. This may cause an accident or
aggravation of the injury.
1) An injury or disease exists on an arm.
2) An arm receiving an intravenous drip or blood transfusion.
3) Limb shunted for artificial dialysis.
4) Bedridden situation for a long time
(The situation that is possibility of thrombus).

Confirm the condition of the patient if there is measurement
trouble. It guesses that the condition worsens over the limit ofmeasurement or the bending air hose is stopped air flow.
Measuring blood pressure too frequently may cause bodily harm
due to blood flow interference. Confirm that the operation of thedevice does not result in prolonged impairment of blood
circulation, when using the device repeatedly.
Blood pressure measurement may not be accurate if the patient
has continuous arrhythmia, or moves excessively.
xiii

Wear the cuff at the same level as heart. (If the level is different, it
occurs an error of the measurement value.)
The recorder corresponds to artifact and external impact. If there
are any doubts in the measurement value, measure bloodpressure by auscultation or palpation.
Measurement error may occur if the cuff is not of suitable arm
circumference for the patient.
Do not inflate the cuff before it is wrapped around the arm of thepatient. It may cause of damage and explosion of the cuff.

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

Cuff
Dispose of cuffs contaminated by blood to prevent infectious
disease from spreading.
Avoid manner storing the folded cuff or twisted air hose in atightly for extended periods of time. Such treatment may shorten
the life of the components.

Measurement of Pulse Rate
Do not use the displayed pulse rate for the diagnosis of theirregular heartbeat.

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

xv

Packing List
The recorder is a precision instrument so use with caution.
Excessive shock may cause failure and malfunction.

Note
The recorder is shipped out using a special packing box designed
to keep it from damage during transport. When you open this box,
make sure you have everything on the packing list. If you have any
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
Carrying 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

Carrying holder

Clip

Belt

USB cable

Adult cuff coverLarge cuff cover

Activity record sheet (10 sheets)

ABPM Data Manager CD

xvii

This instruction manual[ Blank page ]xviii

Contents
Compliance .......................................................................................................i
Compliance with European Directive .................................................... iCompliance with FCC Rules ................................................................. i
FCC Caution .......................................................................................... iCompliance 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.

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

5.2.2.

Display of OLED ( 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

6.2.

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.

Stopping and Suspending Measurement ............................ 37

6.3.

Measurement Result .............................................................. 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.

I D Numbers ........................................................................... 39

7.

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

Installing Batteries (Replacing Batteries) ............................... 40

7.1.1.

How to Replace Batteries...................................................... 42

7.2.

Preparing the Carrying Holder................................................ 42

7.3.

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

7.3.1.

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

7.3.2.

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

Operations ........................................................................................ 45

8.
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.

Initial Pressurization Value .................................................... 50

8.3.

A-BPM Preset Programs ....................................................... 50

8.3.1.

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

8.3.2.

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

8.4.

S-BPM Programs ................................................................... 57

8.4.1.

S-BPM Items and Parameters ............................................ 58

8.4.2.

S-BPM Display Examples.................................................... 59

8.5.

Deleting Measurement Data................................................... 62

8.6.

Attaching the Product to the Patient ....................................... 63

8.6.1.

Information for Patients ......................................................... 63

8.6.2.

Cuff Cover .............................................................................. 65

8.6.3.

Attaching the Cuff, Carrying holder and Recorder .............. 66

8.7.

Blood Pressure Measurement Operations ............................ 69

8.7.1.

A-BPM Operations ............................................................... 69

8.7.2.

S-BPM Operations ............................................................... 71

8.7.3.

Manual Measurement ........................................................... 73

8.7.4.

Stopping and Suspending Measurements .......................... 74

8.8.

Connecting the Recorder to Dedicated Peripheral ................ 76

8.8.1.

Connecting with USB cable .................................................. 76

8.8.2.

Using Bluetooth® Communication ....................................... 78

8.8.3.

Suspending Bluetooth® Communication (Airplane mode) 79

3

Maintenance ..................................................................................... 80

9.
9.1.

Product Storage, Inspection and Safety Management.......... 80

9.2.

Cleaning the Product .............................................................. 81

9.3.

Periodic Inspection.................................................................. 83

9.3.1.

Battery Pre-installation Inspection ........................................ 83

9.3.2.

Battery Post-installation Inspection....................................... 84

9.4.

Disposal................................................................................... 85

9.5.

Troubleshooting ...................................................................... 86

9.6.

Error Codes ............................................................................. 87

10.

Optional Items (requiring order) ...................................................... 90

11.

Appendix ........................................................................................... 92

11.1. Principle of Blood Pressure Measurement ............................ 92
11.2. EMD Information ..................................................................... 95

4

1. Introduction
Thank you for your Purchase!
The TM-2441 ambulatory blood pressure recorder enables toaccurate measurement of patient blood pressure automaticallyfor preset times (e.g. 24-hours continuously). This manualexplains the settings, operations, modes and programs of bloodpressure measurement as well as communication to dedicatedperipheral, maintenance, specifications and warning. Read thismanual for proper use and keep it in an accessible place.

2. Features
Summary
The recorder is an ambulatory blood pressure monitor that canmeasure non-invasive blood pressure value and pulse rate of thepatient under the guidance of a doctor. The purpose of use is tomeasures and stores variation of the blood pressure in a day during
their daily life. The recorder is designed so as to be equipped withportability, data management function and simple operation.

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

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 andrecord blood pressure.
Self blood pressure measurement ( S-BPM )The use of this mode assumes that a patient measures own
blood pressure by self-operation in home or hospital. This modecan use five types of the programs in accordance with utilization.

Portability
The weight of the recorder is approximately 135 g (excluding batteries).
It is palm size and equipped 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 program of blood pressure
measurement program can be configured easily using ABPM
Data Manager installed in the computer (dedicated peripheral).

6Extensive analytical performance
Measurement interval time can be set for the automatic bloodpressure measurement.
Blood pressure can be measured immediately using manual
measurement anytime.
S-BPM is equipped with five programs for varying conditions.
The analysis can be done effectively using ABPM Data Manager
installed in 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

Dedicated peripheral can receive data using USB cable. Received
data can be analyzed and printed easily.

7

3. Abbreviations & Symbols
Symbols
SYS

Meaning
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 performing.
Blinking :Interval time of "1 scope" is performing.
The IHB / AFib indicator.
Mute
Memory full, Delete data to start the measurement.
Battery indicator When the level 1
isdisplayed, replace batteries to use the recorder.
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"

Adult
cuff

20-31cm7.8"-12.2"

SN

Meaning
Degree of protection against electric shocks :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.
Adult cuff is included in 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 of 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, FlightMode Bluetooth symbols. #3
Not made with natural
Caution for patient. It is printed on the cuff.
rubber latex.
Cautions on battery cover.
Caution• Use alkaline batteries or specified
Use alkaline batteries or specified
rechargeable batteries and ensure
rechargeable batteries and ensure
correct polarity (+,-).
• Do not mix new, used or different
correct polarity (+,-).
branded batteries.
Do not mix new, used or• Firmly secure cuff air hose to
main body.
different branded batteries.
Firmly secure cuff air hose to main body.
#1 : Refer to "6.1. Automatic Blood Pressure Measurement (A-BPM)"

and "8.3. A-BPM Preset Programs" for 24-hours blood pressurerecorder.

#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 (Airplane mode)".

10

IHB / AFib indicator
When the monitor detects an irregular rhythm during themeasurements, the IHB / AFib indicator

will appear on thedisplay with the measurement values. (only S-BPM)

1 scope"1 scope" in S-BPM consists of a set of blood pressure

measurements and interval times which are repeated to the numberof 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

A-BPM waiting mode is a state that blood pressure is not being

measured during the interval time.
Blood pressure measurement
Start time
Start time
T

T

T

T

T

T

SectionT
SectionTime
T : Interval time

S-BPM waiting mode is a state that blood pressure is not being

measured during the interval time and between the last "1 scope"and next "1 scope".
Start time
T

T

Start time
Blood pressure measurement
Waiting mode

1 scopeTT
1 scopeTime
T : Interval time

Dedicated peripheral

Dedicated peripheral means the computer principally that ABPM DataManager is installed. ABPM Data Manager is stored in accessory CD.
Use peripheral device that is complied with the requirements for
medical electrical equipment (IEC60601-1) when connecting therecorder to peripheral device. Do not connect the recorder to otherdevice (Example: IEC60950 ) in the area using medical equipment.
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 beat / minuteConstant exhaust with controlled leakage valve
Depressurization
for safety mechanism
ExhaustElectromagnetic valve
Pressurization method Micro-pump
Automatic pressurization 85 to 299 mmHg
Intervals at each section which divides 24 hours
Interval time ( of A-BPM ) to 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 max.
With the same type of batteries :2 x 1.5V batteries (LR6 or AA size)
Alkaline battery or Nickel-hydrogen 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
Nickel-hydrogen batteries are used. It mayvary 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 shocks.
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
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:# 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

Artery position markAdult cuff and large cuff for left
Air 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. Panel of LCD ( 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. Display of OLED ( 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.
Symbols

Meaning
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 performed inaccordance with 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 the 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 the bloodpressure measurement, the air is exhausted 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 indication of the display is hidden,press the START/STOP or EVENT switch to return to thedisplay of waiting mode.
Step 3. While pressing and holding the START/STOP switch,press and hold the EVENT switch until Sleep is displayed on
the OLED.
Step 4. 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 indication of the OLED is hidden, press the

START/STOP or EVENT switch to return to the display of
A-BPM waiting mode. A-BPM waiting mode is a state thatblood pressure is not measured during the interval time.

Step 2. Press the START/STOP switch during 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 indication of the display is hidden, press the START/STOP
or EVENT switch to return to the display of waiting mode.
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/switch to stop blood
Press theblood pressure AOBP pressure measurement.
Home blood pressure
HBP/
switch to stop blood
Press theAutomated nightpressure measurement. At next start time, blood
blood pressure ANBP
pressure is measured or the buzzer sounds. #1
If you need to stop the recorder completely,
Automated self
remove batteries from the recorder or switch toblood pressure ASBP
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. 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 indication of the LCD is hidden, press the
START/STOP or EVENT switch to return to the display of
S-BPM waiting mode.
Step 2. Press the/switch during S-BPM waiting mode.

The blood pressure measurements of "1 scope" are performed
immediately.
"1 scope" consists of a set of blood pressure measurements andinterval times which are repeated to the number of themeasurement count. The last interval time is omitted.
S-BPM waiting mode is a state that blood pressure is notmeasured during the interval time and between the last
"1 scope" and next "1 scope".

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

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 display of waiting mode.
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 delete data, press and hold the START/STOP switch.
Erasing blinks under DataClear on
the OLED and deletion of data is started.
Proceed to step 5 after deletion.
If you keep (don’t delete) data, press
the EVENT switch and proceed to step 5.
Step 5. The recorder returns to waiting mode.

25

Step 4. Deleting
DataClear
OLED Erasing

To pair for Bluetooth® communication.
Step 1. Set the AUTO switch to "OFF".

Step 2. If the indication of the display is hidden, press the START/STOP
or EVENT switch to return to the display of waiting mode.
Step 3. Press and hold the(afterFlightMode

EVENT

switch until

Pairing) 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 display of waiting mode.

To suspend Bluetooth® communication. (Airplane mode)
Step 1. Set the AUTO switch to "OFF".

Step 2. If the indication of the display is hidden, press the START/STOP
or EVENT switch to return to the display of waiting mode.
Step 3. Press and hold the

EVENT

switch until

FlightModeisdisplayed 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 display of waiting

mode.

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 andthe cuff may burst.
Use the LOCK switch to prevent the AUTO 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 from moving accidentally
while A-BPM is used.
27

The

mark is displayed on the LCD while A-BPM is used. Bloodpressure is measured automatically at the A-BPM start time.
An initial pressurization value can be set beforehand.
160, 180, 210, 240, 270, AUTO [mmHg]
If AUTO is specified to the initial pressurization value, thepressurization value is selected automatically. Factory setting is
180 mmHg. Refer to "8.2.3. Initial Pressurization Value" forinformation on how to select an initial pressurization value.
If the first pressurization is not enough, re-pressurizations are
performed automatically up to two times.
When you delete data in 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 thenext 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 measurement state can be displayed on the
LCD while waiting time of A-BPM.
In waiting mode, the indicators are automatically hidden.
Press any switch to show items.
A-BPM waiting mode is a state that 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, theinterval time doubles.
When theEVENT

switch is pressed again in A-BPM, theinterval time returns to 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

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

2T

T

T

Time

EVENT switch

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

Note
When measurement is stopped, the stop codeE07

displayed on the OLED and is stored in the memory.

30

is6.2. Self Blood Pressure Measurement (S-BPM)
Set the AUTO switch changes to "OFF" to use S-BPM programs.
The recorder is equipped with the S-BPM five types of programs inaccordance with varying measurement environment conditions.
Parameters and measurement results can be stored in the memory.
Name

Descriptions & actions of the program

Items

Office blood pressure
OBP Program for blood pressure measurement by hospital
staff. "1 scope" : Blood pressure measurement is

N.A.

occurs once.
Automated office blood pressure
AOBP Program for blood pressure measurement after restingCount

inside the hospital. "1 scope" : Measurement isInterval

performed using measurement count and interval time.
Home blood pressure#1
HBP Program for blood pressure measurement at home.

Count"1 scope" : Measurement is performed using

Intervalmeasurement count and interval time.
Automated night blood pressure#2 Start time
ANBP Program for blood pressure measurement during night.
Count
It uses measurement count and interval time. The
Interval

ANBP can specify up to six start times a day.
Automated self blood pressure
ASBP

#2

Start time

Program that indicates start times with sound from theof alarmbuzzer. Press the/switch to measure theblood pressure at home. The buzzer can specify up to
six times a day.

Count
Interval#1 : Blood pressure is measured in accordance with the Japanese31Society of Hypertension.
#2 : When the measurement count and interval time of ANBP or
ASBP are changed, HBP settings are also changed.

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

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

/

Automated office blood pressure
When theAOBP

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 to the number of themeasurement count. The last interval time is omitted.
When theswitch is pressed during the "1 scope", the/"1 scope" is stopped.

1 scope

Blood pressure measurement
T

T
Press the/TTswitch to start the "1 scope".

32

T : Interval timeT

TimePress theswitch to stop the "1 scope".

/

T

T

Press the/T

Not measured

T

T

Home blood pressure
When the/Timeswitch to start the "1 scope".

HBP
switch is pressed, HBP is started.

The HBP performs a "1 scope".

"1 scope" consists of a set of blood pressure measurements andinterval 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 scopeT

T

Press thePress the/TTswitch to stop the "1 scope".
T

T
/

Time

switch to start the "1 scope".

/

T
Press theT : Interval time

Not measuredT

switch to start the "1 scope".

33

Time

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 isstarted and a "1 scope" is performed for each start time.

"1 scope" consists of a set of blood pressure measurements andinterval 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 measurement

1 scope
T

T

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

Start timeT

Press the/switchto start the manual-BPM.

T

Time

Start time
1 scope1 scopeT

T

T

Not measured

T

Time

Start time/switchPress theto 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 isstarted and the buzzer sounds at each start time. Press theswitch to perform a "1 scope" when the buzzer sounds.

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

Note
Manual blood pressure measurement of the ASBP
When the/switch is pressed in waiting mode between last
"1 scope" and 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

1 scopeNot measured

T

T
Press thePress the

/

T

Time

switch to stop "1 scope".

switch to start "1 scope".

/

Start time of alarm

T : Interval time

6.2.2. S-BPM Waiting Mode
Operation mode and pressure value are displayed on the LCD during
S-BPM waiting mode.
# The indication of the LCD will be hidden automatically after
no-operation is continued for few minutes. Even if the indication of
the LCD is hidden, the Manual blood pressure measurement can bestarted when the/switch is pressed. When the

START/STOP or EVENT switch is pressed, the indication isresumed.
"1 scope" consists of a set of blood pressure measurements andinterval times which are repeated to the number of themeasurement count. The last interval time is omitted.
Clock markblinks on the LCD during an interval time of"1 scope".

S-BPM waiting mode is a state that blood pressure is not being

measured during the "interval time" and between the last "1 scope"and next "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 code
the LCD and is stored in the memory.
S-BPM Programs

E07

is displayed on

Operations

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

37

6.3. Measurement Result
6.3.1. Displaying Measurement Results
The monitor function can select "Display ON" or "Display OFF"command of the measurement result of A-BPM. This function cannot
use for S-BPM.
The content of "Display ON" command includes "Pressure value
during the measurement", "measurement result" and "Error code forthe measurement result".
When "Display OFF" command is selected, the clock is displayed.
The factory settings is set to "Display ON".

Refer to "8.2.2 The Clock and the Monitor Function of

Measurement".

6.3.2. Storing Measurement Results
Data processing of the measurement result
Do not use in a strong electromagnetic field.
The memory capacity for the measurement result is 600 data set.
When the memory is filled, themark is displayed and the recorder

cannot perform measurement until data is deleted from the memory.

Note
Delete data in the memory before giving the recorder to a new patient.
We recommend to use the memory data of the recorder for each
person separately. If the recorder memorizes data of 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 Dedicated Peripheral".

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

Note
When the battery indicator displays, data transfer cannot be

used. Replace 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
dedicated peripheral.

39

7. Preparing the Recorder

7.1. Installing Batteries (Replacing Batteries)
Install two new batteries in accordance with the correct "+" and"-" direction inside the battery compartment before attaching therecorder.
Replace both batteries at the same time.
Remove batteries from the recorder if it is not used for a long
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 and use different kinds of batteries or used batteries
and new batteries. 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 dead, nothing is displayed.
Install batteries in accordance with the direction symbol (40).

Procedure

Install batteries.

Step 1. Open the battery cover.
Step 2. Remove used batteries.
Step 3. Refer to the direction
symbol () inside of

the battery compartment.
Insert two new batteries in

Step 1. Open.

the proper "+" and "-"direction.
Push the spring terminal
using the "-" terminal of
the battery.
Step 4. Insert the battery by

Step 2. Remove batteries.
Step 6. Close.
Step 3. Push spring terminal.
Step 4. Insert.
Step 5. Insert the second battery
pushing the "+" terminal.
using the same method.
Step 6. Close the battery cover.

Keep batteries and the battery cover away from infants andchildren with reach, to prevent accidental swallowing or otheraccidents.
Use standard AA batteries. Do not use an inflated battery
rechargeable battery, or one that 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 whenbatteries are removed. When the built-in battery runs out charge, thedate is reset to 01/01/2017 00:00.
Check and adjust the current time when batteries are replaced. Referto "8.2.2. The Clock and the Monitor Function of Measurement" toadjust the clock.

7.2. Preparing the Carrying Holder
Note
When the carrying holder is attached, use the accessory belt.
We recommend to use a belt to fit the recorder to the patient.
Use accessory carrying holder when the recorderis used. To attach the carrying holder, put thecarrying holder through accessory belt or the beltof the clothes wearing.

Carrying holder
Belt

42

7.3. Inspection for Use
Inspect the recorder to maintain the performance, safety,
effectively before use.
Confirm the following checklist before / after installing batteries.
If a problem is found, stop to use the recorder and put themessage of "Malfunction" or "Not use". Contact your local dealer
to repair it.

7.3.1. Battery Pre-installation Checklists
No.

Item

1

Exterior

2

Battery3

Cuff

Description
No damage and deformation due to drop.
No damage and shaky fixation to switches and etc.
Check batteries not to be consumed. Replace with
two new batteries before the patient is used.
Check that the cuff has not frayed. If the cuff isfrayed, it may cause burst due to internal pressure.
Check that there are no kinks and folding of the air

4

Cuff
connection

5

Attachments

hose.
Check that the air socket and connector isconnected firmly.
Check that there is no damage to accessories.
(Carrying holder, belt, etc)43

7.3.2. Battery Post-installation Checklists
No.

PortionDescription
Check that there is no fire, smoke and offensive
smells.

1

Battery2

Display

Check that there is no strange display.

3

Operation

Check that the recorder operates correctly.

4

Measurement performed correctly. Attachment cuff, measurement,
display and result are correct.

Check that there is no strange sound.

Check that the measurement operation can be44

8. Operations

8.1. Operation Flowchart
Note
The initial settings (of the built-in clock, monitor function and initialpressurization value) and preset program (A-BPM and S-BPM) do
not need to be stored every time. They are stored them when deleted,
updated and when the recorder is used for the first time.
The settings of the recorder can be stored using dedicated peripheral.
Refer to the instruction manual of ABPM Data Manager.
Measurement procedures of 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 own blood pressure
by self-operation in home or hospital. This mode can use five
types of the programs in accordance with utilization.

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

The whole procedure of use
46

8.2. Initial Settings
8.2.1. Factory Settings
The factory settings (initial settings) are described bellow :Common items of the settings
Item

Factory setting

Monitor function

ON (is indicates them)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 of the section 1

0 hourInterval time of the section 1

30 minutes

Start time of the section 2

0 hour #1

Start time of 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 is started.
Blood pressure is measured every 30 minutes until the switch is
moved to "OFF".
#1 : The settings between the interval time of the section 2 and theinterval time of the section 6 are omitted because the start timeof the section 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

Automated night blood
Measurement countpressure
ANBPInterval time
Start time of alarm

Automated self blood
Measurement countpressure
ASBP
Interval time

5 minutes
1 minute
2 hour2 counts
1 minute
7 hour, 22 hour
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.
The method to use switches on the recorder.
The method to use dedicated peripheral that is connected to therecorder using the USB cable.
48

Procedure of operation using switches
Step 1. Set theAUTO

switch to "OFF".

Step 2. If the indication of the display is hidden, press the START/STOP
or EVENT switch to return to the display of waiting mode.
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. Operation switches are as follows:
EVENT switch .................Change of the current parameter.
START/STOP switch ......Decision, next item, end of settings.
Thereafter, use these switches in another items.
Step 5. After configuring settings, press the

START/STOP

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

Range
xx = OFF, ON
xx =17 to 99.

xx =1 to 12 monthxx =1 to 31 day

xx =0 to 23 hourxx =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
An initial pressurization value can be set beforehand.
160, 180, 210, 240, 270, AUTO [mmHg]
If AUTO is specified as the initial pressurization value, a properpressurization value is selected automatically. Factory setting is
180 mmHg.
Step 1. Set the AUTO switch to "OFF".
Step 2. If the indication of the display is hidden, press the START/STOP
or EVENT switch to return to the display of waiting mode.
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.
The method to use switches on the recorder.
The method to use dedicated peripheral that is connected to therecorder using the USB cable.
A-BPM can use only while the automated measurement can be
performed.

50

Procedure of operation using switches
Step 1. Set the AUTO switch to "OFF".
Step 2. If the indication of the display is hidden, press the
START/STOP or EVENT switch to return to the display of
waiting mode.
Step 3. While pressing and holding START/STOP switch,press and hold the EVENT switch until Sleep is displayed on
the OLED.
Step 4. Specify the sleep mode using the following switches.
If sleep mode is "ON", proceed to step 5.
EVENT switch .................Change of the current parameter.
START/STOP switch ......Decision, next item.
Step 5. Specify the start time and interval up to six sections using thefollowing switches.
EVENT switch .................Change of 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 of the current parameter.
START/STOP switch ......Decision, next item, end of the settings.
Step 7. After completing settings, the recorder returns to waiting mode.

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
Sleep mode
#1, #2xx xx = ON, OFFInterval Cycle
time
xx xx = OFF, 5, 10, 15, 20, 30 , 60, 120 minutes
Start time Hour 1 xx = 0 to 23 hourxx
Section1
Interval Cycle 1
time
xx xx = OFF, 5, 10, 15, 20, 30 , 60, 120 minutes
Hour
2Start time
xx xx = 0 to 23 hour
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 hour
Section3
Interval Cycle 3
time
xx xx = OFF , 5, 10, 15, 20, 30, 60, 120 minutes
Hour
4Start time
xx xx = 0 to 23 hour
Section
4
Interval Cycle 4
time
xx xx = OFF , 5, 10, 15, 20, 30, 60, 120 minutes
Hour
5Start time
xx xx = 0 to 23 hour
Section5
Interval Cycle 5
time
xx xx = OFF , 5, 10, 15, 20, 30, 60, 120 minutes
Start time Hour 6 xx = 0 to 23 hourxx
Section
6
Interval Cycle 6
time
xx xx = OFF , 5, 10, 15, 20, 30, 60, 120 minutes
Start time START#3, #4xx xx = OFF , 0 to 23 hour
Operation Operation#3, #4time
xx xx = OFF , 1 to 27 hour
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 interval time of the sleep

mode can be used. The interval time of these sections (1 to 6)
cannot use.

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

AUTO

switch is set "ON", A-BPM starts at

the preset start time and continues until theis set to "OFF". If the

AUTO

AUTO

switchswitch is set to "ON" again,

A-BPM starts at the preset start time.

Note
If the operation time is specified and theAUTO

switch isoperated during A-BPM, A-BPM is continued for operation
time form this operation.
#4 : Example for automated measurement.
If the start time is set to "OFF" and operation time is specified,
when theAUTO

switch is set to "ON", A-BPM is started forthe operation time. If the

AUTO

during A-BPM, A-BPM stops. If theswitch is set to "OFF"AUTO

switch is set to"ON" again, A-BPM is performed for the operation time.

Note
If the start time is specified and theAUTO

switch isoperated during A-BPM, A-BPM is stopped and is started at
the preset start time next day.

53

The content of the item
Sleep mode :The interval time for the automated measurement can be specified.

The interval time of section 1 to 6 cannot use. Refer to "6.1.2. Sleep
Function and interval time".

Section :24 hours can be separated to six sections in maximum. Each section
can specify the start time and interval. A-BPM can use only while
the automated measurement can be performed.
Automated measurement :The whole of 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 of section 1 =7:00

The start time of section 2 =22:00

The interval time of section 1 = 15

24:00
22:00 00:00

18:00

6:00
7:00
Section 1

The interval time of section 2 = 60

The start time of section 3 =Section 2

12:00..............
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 section 1.
When the start time of section 2, 3, 4, 5 or 6 is the same as section 1,

these start times and intervals are not displayed.

Example 1 Automatic measurement

The start time of the automated measurement = OFF,The operation time of 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 of the automated measurement = 7:00,

The operation time of 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

Example 3 Automatic measurement

The start time of the automated measurement = OFF,The operation time of the automated measurement = 26 hours.
When theAUTO

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

according to the start time and interval of each section for 26
hours.

Not measured

Blood pressure measurement

Section 1

Section 2

AUTO switch to "ON"After 26 hours

56

Time

8.4. S-BPM Programs
The initial settings can be configured using the following methods.
The method to use switches on the recorder.
The method to use dedicated peripheral that is connected to therecorder using the USB cable.

Procedure of 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 of the current parameter.
START/STOP switch ........Decision, next item.
Step 4. Specify each item (Measurement count, Interval time, start
time and start time of alarm) using the following switches.
/
switch .....................Change of the current parameter.

START/STOP switch ........Decision, next item, end of settings.
Step 5. After completing settings, S-BPM clock is displayed.

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

57

8.4.1. S-BPM Items and Parameters
Program

Item

Parameter

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

Home blood pressure
HBP

Automated night blood pressure
ANBP

Start time2,

0 to 23 hour

Measurement count2,

1 to 5 counts

Interval time1,

1 to 5 minutes#1

Automated self blood pressure
ASBP

Start time of alarm

7 , 22 , 0 to 23 hour

Measurement count2,

1 to 5 counts

Interval time1,

1 to 5 minutes#2

Enclosed characters : Factory settings.
#1 : 24 hours can be separated to six sections in maximum.
Each section can specify the start time of the blood pressure
measurement.
#2 : 24 hours can be separated to six sections in maximum.
Each section can specify the start time of alarm for the bloodpressure measurement.
58

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 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 measurement count and interval time.

HBP performs a "1 scope".

Refer to "6.2.1. S-BPM Programs" for the "1 scope".

Measurement countInterval time59

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 last start time is the same as first start time, the settings ofstart time is finished. Next, specify the measurement count andinterval time for the "1 scope".

First start time

2nd start time

Measurement countExample3rd start time

Interval time

Settings and simplified input

The measurement performs at 22:00 and 4:00.

24:00
22:00 00:00
4:00
6:00

18:00

The start time of section 1 = 4:00

The start time of section 2 = 22:00

12:00

The start time of section 3 = 4:00 ................. The same as section 1
The measurement count =The interval time =2 times
0:01 minute60

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 toperform the "1 scope" when the buzzer sounds. Refer to "6.2.1.
S-BPM Programs" for the "1 scope".

When last start time is the same as first start time, the settingsof start time is finished. Next, specify the measurement countand interval time for the "1 scope".

First start timeof alarm

2nd start timeof alarm

Measurement countExampleInterval time

Settings and simplified input

The buzzer sounds at 22:00 and 7:00.
Press the/

3rd start timeof alarm

24:00
22:00 00:00
18:00

switch to perform the "1 scope".

The start time of section 1 = 22:00

The start time of section 2 = 7:00

6:00
7:00
12:00

The start time of section 3 = 22:00 ............... The same as section 1
The measurement count =The interval time =2 times
0:01 minute61

8.5. Deleting Measurement Data
Purpose of operation and explanation of function
Measurement data is deleted but settings are not deleted.
The initial settings can be configured using the following methods.
The method to use switches on the recorder.
The method to use dedicated peripheral that is connected to therecorder using the USB cable.
If measurement data is deleted, it cannot be used again.
Backup data before deletion.
Delete measurement data of last patient before next patientuses the recorder.
Several seconds may be needed to delete data.
Keep no-operation to delete data 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 display of waiting mode.
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 delete data, press and hold the START/STOP switch.
Erasing blinks under DataClear on the OLED and deletionof data is started. Proceed to step 5 after deletion.
If you keep (don’t delete) data, press the EVENT switch andproceed to step 5.
Step 5. The recorder returns to waiting mode.
62

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.
Keep the same position throughput the measurement.
Avoid vibration and noise during the measurement.
Blood pressure is measured for approximately 1 minute afterpressurization. Be quiet until measurement finishes. The
measurement process between inflating the cuff to releasing the
air requires up to 170 seconds.
The recorder may re-inflate to measure the blood pressure again
after the end of pressurization. This may be caused by body
motion, etc.
The recorder may start the blood pressure measurement after
approximately 120 seconds when measurement data is invalid
and next measurement is after 8 minutes. This may be caused bybody 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. Bloodpressure is measured again after 120 seconds.
63

Concerning of A-BPM and ANBP and ASBP mode of S-BPM,
only the current 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.

Press 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 a pain of the arm or unexpected condition occur, stop
the measurement, remove the cuff and consult the doctor.
Set the AUTO switch to "OFF" to suspend A-BPM.
Set the AUTO 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 a temporary measurement that is not included inpreset program.
Step 1. If the indication of the OLED is hidden, press the
START/STOP or EVENT switch to return to the display of
A-BPM waiting mode.
Step 2. Press the START/STOP switch to immediately measure theblood 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.
64Precautions when wearing the recorder
The recorder is precision instrument. Do not drop or shock therecorder.
The recorder and cuff are not waterproof (water resistant).
Prevent the product from contacting 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 the neck at bedtime.

Replacing Batteries
When themark is displayed, the recorder can notmeasure blood pressure or communicate with 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 the cuff cover appropriate optional cuffs.

65

8.6.3. Attaching the Cuff, Carrying holder and Recorder
Do not attach the cuff if the patient has dermatitis, external
wounds, etc.
Remove the cuff and stop use if dermatitis or othersymptom appear to the patient.
Prevent air hose from coiling around 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 ofrotation. If the connection is improper, it may cause airleakage and measurement error.

Note
Attach the cuff at the right position and wrap around the arm tomeasure the blood pressure correctly.
Prevent the cuff and air hose from vibrating during
measurement. The recorder measures delicate change of the airpressure inside the cuff.
The accessory cuff is an adult cuff for the left arm. If cuff size
does not fit, purchase 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 the patient use the carrying holder and belt.
The cuff is not made with natural rubber latex.
66

How to put on the cuff, recorder and holder
Step 1. Pass the end of the cuff through the ring and make the shapeof bracelet.
Step 2. Find the brachial artery of left arm using palpation.
Step 3. Attach the cuff directly against the skin so that the white mark is
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, it is flat anddoes not slip down, but has room to insert two fingers.
Step 5. Fix the air hose using adhesive tape so as to pass over theshoulder.
Step 6. Pass the belt through the carrying holder.
Step 7. Adjust the belt so that the carrying holder is on left side.
Step 8. Connect the air plug to the air socket on the recorder.
Step 9. Put the recorder into the carrying holder.

Step 1. Ring

Cuff

Step 2. Brachial artery
Step 3. White artery
position mark
Approximately
1 - 2 cm above

Step 3. White artery position mark
Step 4. Have room to insert two
fingers

67

Step 5. Air hose

Step 5. Tape
Step 5. Clip

Air hose

Step 5. Cuff

Step 7. Belt
Step 7. Carrying holder
Step 8. Air plug
Step 8. Air socket

Step 9. Insert
Carrying holder

Step 6. Belt
68

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

Note
Set the built-in clock and initial pressurization value before
measurement because A-BPM uses them. Refer to "8.2.2. The
Clock and the Monitor Function of Measurement" and "8.3.

A-BPM Preset Programs".

When the recorder is removed, set the AUTO switch to "OFF".
If the recorder is removed during A-BPM, the inflation of the cuff
is started next start time, the cuff may break. When A-BPM isresumed, 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 of the manual blood pressure
measurement can be stored in the memory.
When A-BPM is stopped, the error code
the OLED and stored in the memory.

E07

is displayed on

To start A-BPM
Step 1. Set theAUTO

switch to "ON".

Step 2. The

mark is shown on the OLED and LCD. A-BPM isstarted.
69

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 the bloodpressure measurement, the air is exhausted 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 indication of the OLED is hidden, press the
START/STOP or EVENT switch to return to the display of
A-BPM waiting mode. A-BPM waiting mode is a state thatblood pressure is not measured during the interval time.

Step 2. Press the START/STOP switch during A-BPM waiting mode.

To expand the interval time, or bring back it
When sleep mode is "ON" and the EVENT switch is pressed
during A-BPM waiting mode, the interval time is doubled.

70

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 batteries when the patient removes the recorder and cuff
when ANBP or ASBP is used (even during the waiting mode). If
batteries 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 batteries and press the/switch.

Manual blood pressure measurement can be performed during
S-BPM waiting mode.
The measurement result of 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 pressure71

To measure blood pressure during S-BPM immediately.
( Manual blood pressure measurement of S-BPM )Step 1. If the indication of the LCD is hidden, press the
START/STOP or EVENT switch to return to the display of
S-BPM waiting mode.
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/switch to stop blood
Press theblood pressure AOBP pressure measurement.
Home blood pressure
HBP/
switch to stop blood
Press theAutomated nightpressuremeasurement.
At next start time,
blood pressure ANBP
blood pressure is measured or the buzzer#1
sounds.
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".

72

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

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

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

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

73

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

74

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

Operations

Office blood pressure
OBP
Automated office/switch to stop blood
Press theblood pressure AOBP pressure measurement.
Home blood pressure
HBP/
switch to stop blood
Press theAutomated nightpressuremeasurement.
At next start time,
blood pressure ANBP
blood pressure is measured or the buzzer#1
sounds.
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".

75

8.8. Connecting the Recorder to Dedicated Peripheral
8.8.1. Connecting with USB cable
Refer to the instruction manual of ABPM Data Manager concerningof the communication settings.

Connection of the cable
Connect an authorized USB cable to the micro USB terminal.
Insert the cable in the correct direction. Improper connection
may cause failure and malfunction. Confirm that the terminal
cable is properly connected.
Blood pressure cannot be measured during USB
communication.
Do not attach to the patient when the recorder is connected tothe cable. Cable may become wrapped around the body or neck.
Preparation of dedicated peripheral
Remove the recorder and cuff from the patient before
connecting the recorder (TM-2441) to dedicated peripheral.

To connect the recorder to dedicated peripheral using the USB cable
Step 1. Open the micro USB terminal on the recorder.
Connect accessory USB cable.
Micro USB terminal
USB cable76

To start data communication with dedicated peripheral
Step 1. Connect the micro USB cable between
the recorder and dedicated peripheral.
Step 2. The buzzer sounds andisConnect the micro USB

displayed on the LCD.
The state of data communication
Standbymode

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

Activeonline mode

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

77

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 with adevice, 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 indication of the display is hidden, press the START/STOP
or EVENT switch to return to the display of waiting mode.
Step 3. Press and hold the
FlightMode

EVENT

switch until

Pairing(after) 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 display of waiting mode.

78

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 indication of the display is hidden, press the START/STOP
or EVENT switch to return to the display of waiting mode.
Step 3. Press and hold the

EVENT

switch until

FlightModeisdisplayed 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 display of waiting

mode.

79

9. Maintenance9.1. Product Storage, Inspection and Safety Management
Medical instruments such as this recorder must be managed so thatthey function properly when necessary and to reliably maintain thesafety of the patient and operator. As basic rule, it is necessary thatthe patient inspects this instrument with daily checks such as the"Inspection before use".
Daily management such as the inspection before use is necessary
to maintain the performance, safety and effectiveness of therecorder.
We recommend to a periodic inspection the recorder every year.

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

80

9.2. Cleaning the ProductClean the recorder before use and after use.
Clean the recorder before attaching to next patient.
Do not spray water and sink into water for cleaning therecorder. It may cause of malfunction.
Clean the recorder after wiping water and antiseptic solution so
as not to invade inside the recorder.
Disinfect the recorder periodically so as to keep infection
prevention. Do not use sterilizer to the recorder.
Do not use organic solvent (Example: thinner), povidone-iodine
solution to clean the recorder. It may cause of discoloration,
damage and malfunction.
Do not use 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 on the exterior case of the recorder using
gauze that is moistened with water or warm water and is squeezed
well. When blood or medicines, etc. is adhered on the case, in first,
clean using gauze that is moistened with antiseptic solution and issqueezed well, next, wipe wet case using gauze that is moistenedwith water or warm water and is squeezed well.
81

We recommend useable chemicals (Ingredient name) of antiseptic
solution on the table (Example of useable antiseptic solution(Ingredient name)).

Cleaning the cuff
When you clean and disinfect cuff cover and cuff cloth, remove thecuff bladder inside the cuff cloth. Clean the dirt and dust using gauzethat is moistened with water or warm water and is squeezed well.
Refer antiseptic solutions of the table (Example of useable
antiseptic solution (Ingredient name)) when disinfecting them.
Example of 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 prescription described on product and use it.

Note
Cuff and air hose are consumables.
If measurement error occurs frequently or blood pressure cannot
measure, it is necessary to replace to new ones. Refer to "10.
Optional Items (requiring order)" of this manual.

82

9.3. Periodic Inspection
Perform the daily periodic inspection to use recorder correctly.
The inspection is described bellow :9.3.1. Battery Pre-installation Inspection
Items

Description
No damage or deformation from drops.
Exterior
No dirt, rust and scratches on any part.
No cracking or rattling of the panel.
Operation
No damage for rattling of switches and buttons.
Display
No dirt or scratches on the display panel.
The air hose is not to be folded. If air remains in thecuff, it may cause peripheral dysfunction due tostopping the blood flow of the arm.
The cuff bladder is correctly inserted inside the cuff
cloth.
No fraying of the cuff. The cuff doesn't ravel.
Replace the cuff when a problem is found.
Measurement The cuff is disposable.
Cuff
If there is a crack or adhesive matter in theconnection between the cuff and cuff bladder.
If the air hose loses its flexibility and becomes hard.
When the surface of the air hose becomes glossy orfeels oily.
When the air bladder has cracks.
We recommend to replace cuffs every three years,
regardless of frequency of use.
Wearing tools No damage in the carrying holder, belt and cuff.
Connection
The air plug is connected to the air socket correctly.
839.3.2. Battery Post-installation Inspection
Item
Exterior
Operation
Measurement
Cuff
Inspection of bloodpressure value

Description
No fire, smoke or offensive smells.
No strange sounds.
No trouble with functioning of switches andbuttons.
Measurement values are closely in usual value.
No strange sounds or actions during
measurement.
If blood pressure values are incorrect, contact
your local dealer.

849.4. Disposal
Concerning the disposal and recycle of the product, for environment
protection, follow the laws of the local government.

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
The recorder equipped backup battery inside. When dispose
the recorder, dispose of the battery properly in accordance withthe local regulations concerning 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 more85

9.5. Troubleshooting
Cosult the following checklist and error code list before contacting
your local dealer.
If this measures do not improve the problem or the problem occurs
again, contact your local dealer.
Problem
No display afterpressing any
switches.

Main cause

Treatment

Battery power has been
Replace to new batteries.
consumed.

No OLED display OLED may disappear by Remove batteries andduring A-BPM.
the electrostatic effect.
reinstall them again.
Frequent clock
reset.

The backup battery does Charge it for 48 hours
not charge.
#1 using new batteries.

No pressurization

Cuff is not exactly
connected.

Check the cuff and air
hose concerning folding,kink and connection.

No USB
Communication cable is Confirm the cable to becommunication #2 removed.
connected correctly.
Battery coverNon-standard size
cannot be opened batteries were used.

Contact your local dealer.

#1 : Users (unauthorized maintenance personnel) cannot replace
the backup battery (lithium battery) placed on the electronicboard inside the recorder. The backup battery is charged fromthe batteries (LR6 or AA size) for the measurement.
#2 : Dedicated peripheral is required.

Do not disassemble or modify the recorder. It may be damaged.
86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

Confirm 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 be occurred in thepressurization. Relax and keep thesilence during measurement. If thetreatment is not enough, inspect therecorder.

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 batteries and reinstall themagain.
87

Code

Meaning

Cause and treatment
Relax and keep silent during themeasurement.

Excessive body
motion.
Out of range,
30
PUL

200

Out of range,
30
DIA
160
Out of range,
60
SYS

280

Out of range,
10PP
150 #1

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

Measurement isabove 180 seconds.

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

Exhaust is above 90
seconds.

The exhaust speed may be slow, aninspection is necessary.

Heartbeat cannot be detected
Heartbeat cannot be because of body motion, etc.
Measure the blood pressure while
detected.
relaxed and do not moving.
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.

88

Code

Meaning

Safety circuit detects
over load pressure.

Cause and treatment
Body motion may be detected at thepressurization. Relax and do not
move while the measurement.
If this error occurs even whenrelaxed and not moving, contact
your dealer for inspection.

Hardware error codes of the recorder
Code

Meaning

Cause and treatment
It may record in case of catchingstrong impact like a dropping down
the recorder.

Memory error

If this code displays frequently,
malfunction of the built-in memory
may cause. Contact your dealer for
inspection.

Note
The error codes may be changed without any notice.

89

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-

90

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

Carrying holder-

AX-133025995

Belt

-

AX-00U44189

Clips

5 pieces91

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 the highest in amplitude, thendecreases gradually. The changes in the pulse waveform areillustrated at next page. In the 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, the mean blood pressure is specified as thepoint where the amplitude reaches the highest, the diastolic bloodpressure is specified as the point where the amplitude decreases
gradually and becomes small. Actually, the pressure sensor detects
the subtle changes in the cuff pressure with time, stores the pulse
waveform in memory, and evaluates the systolic and diastolic bloodpressures according to the oscillometric measurement algorithm.
The details in the algorithm vary with the blood pressure monitor.
Blood pressure values of adults and infants are measured by theoscillometric method and are compared with those measured by the
auscultatory method. Diastolic blood pressure is defined to be theend point of phase 4 in the auscultatory method. The pulse
waveform of the cuff pressure depends on the characteristics of thecuff material. Therefore, by using the specified cuff and themeasurement algorithm, the measurement accuracy is maintained.
Air hose length is within 3.5 m because of the damping
characteristics due to pulse wave propagation.
92

mmHg
200
150
100
50
0

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

Cuff pressure (Left arm)

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

Time
Direct method (Left arm)

Time

Microphone method
Oscillometricmeasurement method

Blood pressure measurement Error factors

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

Cuff position at the same height as heart

Pulse graph

Wrap the cuff on the arm at the same level as the heart. If the cuff
position is incorrect, a measurement error occurs. For example, if thecuff is 10 cm lower than the heart level, the blood pressure ismeasured 7 mmHg higher.
93Proper cuff size

Use a cuff of adequate size. If the size is too small or too big, ameasurement error occurs. Measurements with too small a cuff tend
to be evaluated as high blood pressure, regardless of the proper
blood pressure and normal artery. Measurements with too large acuff tend to be evaluated as low blood pressure, especially for 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 label described range of the arm circumference. Select andattach 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 areused. Inspect the pressure accuracy of the pressure sensor andexhaust characteristics periodically.

94

11.2.

EMD Information

The requirements that apply to medical electronic instruments aredescribed below :Performance concerning of the EMD guidelines

The use of the recorder require special precautions regarding EMD(Electromagnetic Disturbances). Operate the recorder in accordancewith cautions regarding 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 accord with thecondition of IEC60601-1-2:2014. If not authorized accessory is used,
it may cause of increasing emission and lowering noise immunity.

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

CISPR1195

Group 1、Class B

IMMUNITY TEST LEVELS : Enclosure Port
Phenomenon

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

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

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

IMMUNITY TEST LEVELS : Signal input / output Port
Phenomenon

Immunity test levels

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

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

3 V 0.15 MHz - 80 MHz
Conducted disturbances induced
6 V in ISM and amateur radio bandsby RF fields
between 0.15 MHz and 80 MHz
IEC 61000-4-8
80 % AM at 1 kHz
96

450

430 - 470

GMRS 460
FRS 460

710
745
780

704 - 787

LTE Band 13,17

Pulse modulation
1.8
18 Hz
FM
±5 kHz deviation 2
1 kHz sine

GSM 800/900
TETRA 800
870 800 - 960
iDEN 820CDMA 850
930
LTE Band 5
GSM 18001720
CDMA 1900
GSM 1900
1845 1700 - 1990
DECT
LTE Band 1,3,4,25
1970
UMTS
Blutooth
WLAN 802.11 b/g/n
2450 2400 - 2570
RFID 2450
LTE Band 75240
5500 5100 - 5800 WLAN 802.11 a/n
5785

Immunity test level(V/m)

TETRA 400

Distance(m)

Service

380 - 390

Maximum power
(W)

Band
(MHz)

385

Modulation

Test frequency(MHz)

Test specifications for ENCLOSURE PORT IMMUNITY to RF wirelesscommunications equipment

0.3

27

0.3

28

Pulse modulation
217 Hz

0.2

0.3

9

Pulse modulation
18 Hz

2

0.3

28

Pulse modulation
217 Hz2

0.3

28

Pulse modulation
217 Hz2

0.3

28

Pulse modulation
217 Hz

0.2

0.3

9

810

97

MEMO

98

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