A&D TM-2441 User manual

Recorder for Ambulatory Blood
Pressure Monitor
Ambulatory Blood Pressure Monitor
1WMPD4003500H 2201
English (Original)

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 any
means without the written permission of A&D Company, Limited.
The contents of this manual and the specifications for the
instrument covered by this manual are subject to change for
improvement without notice.
The Bluetooth® word mark and logos are registered trademarks
owned by Bluetooth SIG, Inc. and any use of such marks by
A&D is under license.
Other trademarks and trade names are those of their respective
owners.

TM-2441 i
Compliance
Compliance with European Directive
The device conforms to Medical Devices Directive 93/42/EEC.
This is shown by the CE mark of conformity accompanied by
the reference number of a designated authority.
The device conforms to RoHS Directive 2011/65/EU.
The device conforms to Radio Equipment Directive 2014/53/EU.
Hereby, A&D Company, Limited declares that the device is in
compliance 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 to
operate 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 testing
the specific absorption ratio (SAR).

ii
Compliance with IC Rules
This device complies with Industry Canada license-exempt RSS
standard(s). Operation is subject to the following two conditions: (1) this
device may not cause interference and (2) this device must accept any
interference, including interference that may cause undesired operation
of 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 the specific
absorption ratio (SAR).
Compliance with the Australian EMD Framework
The device conforms to the following requirements:
EMD Emission standard for industrial, Scientific & Medical equipment
AS/ NZS 2064:1997, EMD Generic Immunity standard AS/NZS 4252.
1:1994. The above is shown by the C-Tick label.
Bluetooth
®
Transmission
This device is equipped with a Bluetooth wireless function and can
connect 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.

iii
Warning Definitions
To prevent accidents due to inappropriate handling, this product
and its manual contain the following warning signs and marks.
The meanings of these warning signs and marks are as follows.
Warning Definitions
An imminently hazardous situation that will result in death
or serious injury, if not avoided.
A potentially hazardous situation that could result in death
or 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 to
warn against unsafe practice.
Symbol Examples
The symbol indicates "Caution". The nature of the caution
required is described inside or near the symbol, using text or a
picture. The example indicates caution against electrical shock.
The symbol indicates "Do not". The prohibited action is
described inside or near the symbol, using text or a picture.
The example indicates "Do not disassemble".
The symbol indicates mandatory action. The mandatory
action is described inside or near the symbol, using text or
a picture. The example indicates general mandatory action.
Other
Note
Provides information useful for the user when operating the
device.
Precautions for each operation are described in the pages of this
manual. Read the instruction manual before using the device.
Danger
Warning
Caution

iv
Precautions for Use
In order to use the TM-2441 (the recorder for the ambulatory blood
pressure monitor) safely and correctly, read the following
precautions carefully before using the monitor. The following
content summarizes general matters affecting the safety of
patients and operators, as well as safe handling of the monitor.
Precautions for each 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 flammable
anesthetics or flammable gases are present, high-pressure
oxygen chambers and oxygen tents. Using the recorder in
these areas may cause an explosion.
Do not use the recorder together with a magnetic
resonance imaging system (MRI).
To preserve the capabilities of the device, consider the following
environmental conditions when using and storing the recorder.
The performance of the recorder may be affected by excessive
temperature, humidity and altitude.
Avoid locations where the recorder may be splashed by water.
Avoid locations with high temperature, high humidity, direct
sunlight, dust, salt and sulfur in the air.
Avoid locations where the recorder may be tilted, vibrated,
or impacted (including during transportation).
Avoid locations where chemicals are stored or gas is present.
Danger
Caution

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

vi
Preparation of the Recorder
Delete the last data stored in the recorder before it is used by the
next patient.
Replace the batteries before the recorder is used by the next patient.
Device
Use the recorder for diagnosis and countermeasures only.
Confirm that the air hose and cuff are worn correctly. (Example:
kinks and tension in the air hose, position and direction of the cuff)
Instructions for the Patient Wearing the Device
Inform the patient how to turn the AUTO switch "OFF" to stop
the recorder if a problem occurs when alone.
Inform the patient to remove the recorder quickly when in pain or
if any problem occurs.
Take care when using around babies and infants, as there is
a danger of accidental suffocation with the air hose.
3. Precautions for Batteries Used for Blood Pressure Measurement.
Install the batteries in accordance with polarity signs "+" and "-"
shown on the inside of the battery cover. (Note the polarities)
Replace flat batteries with new ones at the same time.
Remove the batteries if the recorder is not going to be used for 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 at the "+"
terminal of the battery compartment. If the battery is installed
from the "+" terminal, the battery cover may be damaged.
Caution

vii
Do not touch the battery and the patient at the same time.
It may cause an electric shock.
Do not mix old batteries with new ones. Do not use
batteries of different type and manufacturer. If these
are used, this may cause leakage, heat and explosion.
The recorder may malfunction.
4. Precautions During Use.
Do not use the recorder while operating automobiles or
other vehicles.
Example: The recorder may inhibit the motion of the body
or arms when operating the vehicle. etc.
This medical device can be only operated by a doctor or a
legally
authorized person. Explain the correct usage to the patient and
ensure they can stop measurement when a problem occurs.
Do not use a mobile phone near the recorder (less than 30 cm).
It may cause a malfunction.
Stop using the recorder and switch the AUTO switch to
"OFF", if the patient feels pain in their arm or the measurement
is incorrect.
Do not use the recorder in a strong magnetic or electric field.
Do not use the recorder on a patient using a heart-lung
machine.
Caution
Danger
Warning
Caution

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

ix
Note
Precautions After Using the Recorder (TM-2441)
Be sure to process measurement data immediately using
a
dedicated peripheral after finishing measurement.
Backup Lithium Rechargeable Battery
The recorder comes with a backup lithium battery. This battery
supplies power to the built-in clock when replacing AA batteries
used for blood pressure measurement. The lithium battery is
charged from the AA batteries.
How to Extend the Life of the Backup Battery
When first using after purchase or after storing for a month or
more, replace the batteries and charge the backup battery. It is
enough if the backup battery is charged for 48 hours or more.
(The backup battery is always charged by the AA batteries.)
Replace with two new AA batteries when the battery indicator
displays .
When is displayed on the battery indicator, the blood
pressure measurement and data communication cannot be
performed. Replace with two new AA batteries.
Remove the batteries to prevent the recorder from liquid leakage
from a battery if the recorder is not used for a month or more.

x
6. Remedies When the Device Has an Error
Stop the operation and remove the AA batteries. If the
battery
terminals are shorted, the battery may be hot.
In the event of a failure, the recorder may get hot during
measurement, please handle it with care.
Put the "Malfunction" "Do not use" notice label on the
recorder. Contact your dealer.
Stop the recorder immediately when the measurement time
is above 180 seconds and the air pressure rises above
299 mmHg.
7. Precautions for Maintenance
Confirm the correct performance and safety of the recorder
when it has not been used for a long period of time.
To maintain correct measurement and safety, perform an
inspection and maintenance before use. The user (hospital,
clinic, etc.) is responsible for the management of the
medical
equipment. If the inspection and maintenance are not
performed correctly, an accident may occur.
Use a dry lint free cloth to clean the recorder.
Do not use volatile agents, such as a thinner or benzine.
Do not use a wet cloth.
Do not disassemble or modify the recorder (medical
electronic device). It may cause damage.
Warning
Warning
Caution

xi
8. Precautions and Remedies for a Malfunction Due to a Strong
Electromagnetic Field
The recorder complies with EMD-standard IEC60601-1-2: 2014.
However, to prevent electromagnetic interference with other
devices, do not use mobile phones near the recorder.
If the recorder is located near strong electromagnetic fields,
noise may affect the
waveforms and malfunctions may occur.
If an unexpected malfunction occurs during use, check for
electromagnetic interference and take appropriate actions.
Do not use a Bluetooth connection within the range of a
wireless LAN or other wireless devices, near devices that
emit radio waves such as microwaves, in locations where
there are many obstructions, or in other locations where
signal strength is weak. Doing so may result in frequent loss
of connection, very slow communication speeds and errors.
The following examples are general causes of malfunctions
and their remedies.
Use of mobile phones
Radio waves may cause unexpected malfunctions.
Wireless communication devices, home networking
devices such as cordless phones and similar
communication devices can affect the recorder. Therefore
,
they must be kept at a distance of at least 30 cm
or more
from the recorder.
Caution
Caution

xii
If there is static electricity in the area of use (
discharges from
devices or the surrounding area)
Before using the recorder, ensure that the operator and
patient have discharged any static electricity.
Humidify the room.
Use close to an IEEE802.11g/b/n wireless LAN device may
cause mutual interference to occur, which may result in
reduced communication speeds or prevent connection.
In this case, switch off the power supply to the device 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
from the recorder.
Caution
Caution

xiii
Precautions For Safe Measurement
This section describes precautions for measurement and the
sensor. Notify the patient of following content and explain it to
them. Guide the patient in the correct use of the device.
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
in the cuff, which may stop blood flow to the arm.
Do not measure the blood pressure on an arm if the patient
has the following conditions. This may cause an accident or
aggravation of the injury.
1) An injury or disease on an arm.
2) An arm receiving an intravenous drip or blood transfusion.
3) A limb that is shunted for artificial dialysis.
4) The patient has been bedridden for a long time
(Where there is a possibility of thrombus).
Confirm the condition of the patient if there are measurement
problems. The device guesses that the condition
is worsening
beyond the limit of measurement or if the air flow ceases
because the air hose is bent.
Measuring blood pressure too frequently may cause bodily
harm due to blood flow interference. Confirm that the operation
of the device does not result in prolonged impairment on
blood
circulation, when using the device repeatedly.
Blood pressure measurement may not be accurate if the
patient has continuous arrhythmia, or moves excessively.
Warning
Caution

xiv
Wear the cuff at the same level as heart. (If the level is
different, an error in the measurement value occurs.)
The recorder responds to artifact and external impact. If there
are any doubts in the measurement value, measure blood
pressure by auscultation or palpation.
A measurement error may occur if the cuff is not of the correct
arm circumference for the patient.
Do not inflate the cuff before it is wrapped around the arm of
the patient. Damage and explosion of the cuff may occur.
Note
Blood pressure measurement may cause subcutaneous bleeding.
This subcutaneous bleeding is temporary and disappears with time.
If the patient uses a heart-lung machine, blood pressure cannot be
measured due to the absence of a heartbeat.
Blood pressure cannot be measured correctly if thick clothing is
worn.
Blood pressure cannot be measured correctly if the clothing is rolled
up and the arm is squeezed.
Blood pressure cannot be measured correctly if peripheral
circulation is insufficient, the blood pressure is excessively low
or if the patient has hypothermia (blood flow is insufficient).
Blood pressure cannot be measured correctly if the patient has
frequent arrhythmia.
Blood pressure cannot be measured correctly with the incorrect
cuff size.
Blood pressure cannot be measured correctly if the cuff is not worn
at the same level as the heart.
Caution

xv
Note
Blood pressure cannot be measured correctly if the patient is
moving or talking during measurement.
Clinical trials have not been conducted on newborn infants and
pregnant women.
Consult a doctor before use if you have had a mastectomy.
Cuff
Dispose of cuffs contaminated by blood to prevent
infectious disease from spreading.
Avoid storing the cuff folded or with a tightly t
wisted air hose
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 an
irregular heartbeat.
Note
The recorder measures the pulse rate when measuring the
blood pressure.
Warning
Warning

xvi
Packing List
The recorder is a precision instrument. Use with caution.
Excessive shock may cause failure and malfunction.
Note
The recorder is shipped using a special packing box designed to
protect 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-CF302B ............. 1
Large cuff 28 to 38 cm (11.0" to 15.0") for left arm
TM-CF402B ............. 1
Adult cuff cover ........................................................................ 2
Large cuff cover ....................................................................... 2
Carry holder ...................................... AX-133025995 ......... 1
Belt ................................................... AX-00U44189 .......... 1
Clip ........................................................................................ 1
Activity record sheet (10 sheets) ....... AX-PP181-S ............ 1
USB cable ......................................... AX-KOUSB4C .......... 1
ABPM Data Manager CD ....................................................... 1
This instruction manual .......................................................... 1
Caution

xvii
Adult cuff for left arm
Blood pressure Recorder Large cuff for left arm
Carry holder Clip Adult cuff cover
Large cuff cover
Belt Activity record sheet (10 sheets)
ABPM Data Manager CD USB cable This instruction manual