A and D TM-2430 INSTRUCTION MANUAL [nl]
TM-2430
TM-2430
RECORDER FOR AMBULATORY
RECORDER FOR AMBULATORY
BLOOD PRESSURE MONITOR
BLOOD PRESSURE MONITOR
INSTRUCTION MANUAL
Ambulatory Blood Pressure Monitor
WM:PD4000136
Rev. 1.1
This mark informs you about the operation of the product.
Note This manual and or the TM-2430 may be changed at any time to
improve the product without notice.
Windows is the registered trademark of the Microsoft Corporation.
Macintosh is the registered trademark of Apple Computer, Inc.
EXCEL is the registered trademark of the Microsoft Corporation.
Contents
Before use
Compliance ----------------------------------------------------------------------------- 2
Definitions ------------------------------------------------------------------------------- 2
Precautions for Use ------------------------------------------------------------------- 3
Notes on the Blood Pressure Recorder------------------------------------------ 4
Welcome
Welcome and Introduction ---------------------------------------------------------- 5
Product overview
Packing List and Component Names -------------------------------------------- 5
Display ----------------------------------------------------------------------------------- 7
Symbols---------------------------------------------------------------------------------- 7
Specifications
Features --------------------------------------------------------------------------------- 8
Functions and Specifications ------------------------------------------------------- 8
Activating the Recorder
Replacing Batteries ------------------------------------------------------------------- 12
Conditions When Recorder Switched On --------------------------------------- 13
Parameters for the Display and Clock ------------------------------------------- 13
Selection for the Automatic Measurement -------------------------------------- 15
Deleting Old Data --------------------------------------------------------------------- 19
Resetting the Recorder -------------------------------------------------------------- 19
Preparing the patient
Patient Instructions-------------------------------------------------------------------- 20
Use of the Cuff Cover ---------------------------------------------------------------- 21
Attaching the Cuff and Recorder -------------------------------------------------- 21
Preparation of the Carrying Case ------------------------------------------------- 23
Operation
Automatic Measurement (by Programed Time Intervals) ------------------- 24
Manual Measurement ---------------------------------------------------------------- 24
To Stop a Current Measurement -------------------------------------------------- 24
Data transfer
Data Transmission to a Printer----------------------------------------------------- 25
Data Transmission to a Computer Using Analysis Software --------------- 27
Options and accessories
Analysis Software and Communication Cables-------------------------------- 28
Cuffs and Other Accessories ------------------------------------------------------- 29
Maintenance
Checking Accuracy ------------------------------------------------------------------- 30
Cleaning the Cuff and Recorder --------------------------------------------------- 31
Periodical inspection------------------------------------------------------------------ 31
Problem Solving ----------------------------------------------------------------------- 31
Error Codes ----------------------------------------------------------------------------- 32
Page 1
Before use
Compliance
Compliance with European Directiv e
93/42 EEC for Medical Pr oducts
The device conforms to the following requirements: European Directive 93/42 EEC for
Medical Products; Medical Products Act; European Standards for Electrical Medical Equipment EN 60601-1 (General Safety Provisions), EN 60601-2-30 (Particular Requirements for
the Safety of Automatic Cycling Indirect Blood Pressure Monitoring Equipment) , EN 606011-2 and EN 55011 (Electromagnetic Compatibility); European Standards pertaining to Non
Invasive Blood Pressure Instruments EN 1060-1 (General Requirements), EN 1060-3
(Supplementary Requirements for Electromechanical Blood Pressure Measuring Systems).
The above is evidenced by the CE mark of conformity accompanied by the reference number
of a designated authority. This device is designed for adults only.
Compliance with FCC Rules
Please note that this equipment generates, uses and can radiate radio frequency energy.
This equipment has been tested and has been found to comply with the limits of a Class A
computing device pursuant to Subpart J of Part 15 of FCC rules. These rules are designed
to provide reasonable protection against interference when this equipment is operated in a
commercial environment. If this unit is operated in a residential area it might cause some
interference and under these circumstances the user would be required to take, at his own
expense, whatever measures are necessary to eliminate the interference. (FCC: Federal
Communications Commission in the U.S.A.)
Compliance with the Australian EMC Frame
work
The device conforms to the following requirements: EMC Emission standard for
industrial, Scientific & Medical equipment AS/ NZS 2064-1997, EMC Generic Immunity
standard AS/ NZS 4252. 1-1994. The above is evidenced by the C-Tick label.
Definitions
SYS Systolic Blood Pressure
DIA Diastolic Blood Pressure
DSD The Difference between Systolic Blood Pressure and Diastolic
Blood Pressure.
Exhaust This means "releasing the cuff air as soon as possible".
Exhaust velocity This means the rate of depressurizing the cuff air.
Measurement cycle This means "a period between the start of cuff inflation and the
end of exhausting the air".
Interval This is called a "block". A block consists of a start time and
frequency.
bpm beats per minute.
Compliance Before use
Page 2
Precautions for Use
Precautions
Batteries
❏ Use alkaline batteries (LR6 type, AA type, Mignon) or suitable Ni-Cd batteries.
❏ Do not mix new and used batteries in the recorder.
❏ If the recorder will not be used for a long period of time, remove the batteries
from the recorder unless there is no risk of a SAFETY HAZARD arising.
A malfunctioning recorder
❏ If the recorder malfunctions, contact your vendor immediately.
Training
❏ Instruct the patient on how to stop the operation if there is an abnormal
measurement, and how to remove the cuff if there is excessive arm pain.
❏ Provide patient with basic training on operation of ABPM system.
Repair
❏ Do not open the recorder case. Patient should avoid magnetic fields and high
frequency equipment. Contact your vendor for further instructions.
Blood pressure measurement
❏ This device is intended for adult use only.
❏ The recorder may not make a measurement when a patient has continuous
arrhythmia or the recorder senses noise due to the patients movement.
❏ Please check measurement values by other methods, if you suspect an
erroneous value.
❏ Do not use this recorder on a person who is in critical condition or is in an
intensive care unit.
❏ This device is intended for ambulatory patients.
Saving power
❏ Turn off the power switch when not in use.
❏ Please transfer the data as soon as possible. All measurement data, clock
parameters, measurement parameters and internal system parameters are
preserved by a backup battery when turning the power switch off. The backup
battery life is few days.
Cuff
❏ Close the cuff fastener properly when attaching the cuff to a patient or
replacing the cuff cloth. If the fastener is closed incorrectly, inflating cuff may
damage the cuff.
Before use Precautions
Page 3
Notes on the Blood Pressure Recorder
Storage
❏ Do not store the recorder in the following places.
Excessive moisture
Excessive heat
Direct sun light
Excessive vibration
Exposure to dust
Exposure to corrosive chemicals
Magnetic fields
Before use
❏ Cover the RS-232C terminal using the rubber cap, to avoid dust.
❏ Confirm that the recorder works correctly.
❏ Confirm that the cuff and air hose are connected properly.
❏ Cuffs should be clean prior to use with patient.
❏ Clear the old data before starting a new measurement.
❏ Avoid strong magnetic field and static electricity.
❏ Do not use this recorder near a high frequency surgical equipment.
During use
❏ The recorder should be operated by a medical professional who knows it well.
❏ Stop using the recorder if the patient feels pain in the arm or if the recorder
does not measure properly.
❏ If the recorder is exposed to excessive moisture, do not use. Immediately
request service from vendor.
After use
❏ Clean the recorder, cuff and accessories for the next use. Do not pull or kink
hoses. Do not use organic solvent, antiseptic solution, etc.
❏ Turn off the power switch.
❏ Please use the original box for transportation of the monitor.
Periodic maintenance
❏ The recorder is a precision instrument. Please check all functions (every year)
periodically. Contact your nearest A&D office for this inspection.
Environmental protection
❏ If you disuse the recorder, remove Ni-Cd battery and built-in Li battery from
this recorder.
❏ Disuse Ni-Cd battery to its exclusive trash can because of recycling it.
Ni-Cd
❏ Dispose of Li ion battery in the recorder as dangerous object properly.
Notes on the Blood Pressure Recorder Before use
Page 4
Welcome
Welcome and Introduction
Thank you for your Purchase!
The A&D TM-2430 ambulatory blood pressure recorder enables you to
accurately take a patient's blood pressure, automatically, at different preset
times throughout a 24-hour period.
Recently, in the treatment of patients with hypertension, there has been an
increasing need to prescribe medication according to the particular blood
pressure fluctuation pattern of the patient. These patterns can be made more
evident by using the TM-2430 recorder, and an analysis by a physician.
This manual will explain in simple language how this recorder works.
Patient
This blood pressure recorder is designed for an adult patient.
Environment
This blood pressure recorder is used in a hospital and / or patient`s home.
where complies with European directives.
Product overview
Packing List and Component Names
When you open this box, make sure you have everything as shown here :
Instruction manual
Blood pressure recorder
(Main unit)
Carrying case
1
1
1
Shoulder band
Belt
Cuff covers for adult cuff
Activity record sheets
Adult cuff for left arm
Welcome Welcome and Introduction
1
1
2
10
1
Page 5
Yellow mark
Shoulder band
Battery cover
Air hose
Adult cuff
Auto ON/OFF key
for left arm
Start Stop key
START
STOP
ON/OFF
0
0
123
1
2
AUTO
PULSE/TIME
456
78
SYS/INTERVAL
DIA
9
AIR
Air hose plug
Air socket
Carrying case
ON
OFF
Reset key
Power switch
RS-232C terminal
Alkaline batteries (type LR6, type AA, Mignon)
The batteries are not included in this pack.
Belt
Name Functions
Power switch This is the main power switch. In the OFF state, all data and
parameters are preserved by an backup battery. The backup
battery life is approximately 10 days with the power off.
AUTO ON/OFF key
• When you press and hold the
AUTO ON/OFF
key, the automatic
measurement is started or stopped alternately.
• When you press the
AUTO ON/OFF
key at mode II of the
automatic measurement, "S" is displayed or turned off alternately. This sign changes the interval for sleep.
START STOP key
• When you press the
START STOP
key, a blood pressure mea-
surement is started at once.
• When you press and hold the
START STOP
key for approx. 3
seconds, the recorder proceeds to "Selection for the automatic measurement".
• When you press and hold the
START STOP
key for approx. 6
seconds, the recorder proceeds to "Parameters for the display
and clock".
• When you press and hold the
START STOP
key for approx. 9
seconds, the recorder proceeds to "Deleting old data".
RS-232C terminal
This terminal is used for data output to a printer or computer.
The optional RS-232C cable is necessary to output the data.
Reset key All data and parameters are deleted.
Packing List and Component Names Product overview
Page 6
Display
Sleep sign
Auto mode sign
Low battery sign
Full memory sign
Sign
SYS/INTERVAL
DIA
PULSE/TIME
SYS
Systolic Blood
Pressure display
INTERVAL
Setup sign of
automatic measurement
Setup sign of
TIME
display and clock
Error display
ex. "Set the clock"
Sign Name Functions
Arrow
The arrow points to the kind of current display in the measurement result and function mode.
A Automatic
measurement
"A" is displayed when the automatic measurement is selected.
When you press and hold the
turned on or off alternately.
S Sleep
When you press the
automatic measurement, "S" is displayed or turned off alternately.
With the "S" turned off, the time interval is 15 minutes.
With the "S" turned on, the time interval is 30 minutes.
AUTO ON/OFF
AUTO ON/OFF
key while in mode II of the
Diastolic Blood
DIA
Pressure display
Pulse display
PULSE
Clock display
key, this sign is
B Low battery
M Full memory
Symbols
Turning on the recorder.
Turning off the recorder.
Direction guide to install batteries.
Direct current.
SN Serial number.
1997
Date of manufacture.
Attention symbol. "See instruction for use."
When the recorder can not operate all functions due to low
battery, this sign is displayed. The clock is still displayed. Please
replace the batteries at once.
When data memory is at full capacity, this sign is displayed. In
this case, you can not perform another measurement. Transfer
the data save in other media and delete. Then the "M" turns off.
Recorder, Cuffs and tubings are designed to have special protection
against electric shocks.
Product overview Display
Page 7
Specifications
Features
Portability
❏ The recorder weighs approx. 215g (including batteries) and is compact.
❏ The recorder is powered by LR6 type (AA) alkaline batteries. It is possible to
replace the batteries with Ni-Cd rechargeable batteries.
Operation & management
❏ Clock and automatic measurement parameters may be set as needed.
❏ If you connect to a computer and use the optional software, clock and
automatic measurement parameters can be easily set.
❏ There are three modes for automatic measurement. Mode 1 and Mode 2 are
preprogrammed. Mode 3 is user programmable.
❏ The recorder can transmit data to a printer directly. (An adaptable printer is
necessary to print the data. Refer to Section "Data Transmission to a Printer"
for specifications of the TM-2480 printer.)
❏ The recorder has the built-in chargeable Li ion battery to keep the clock and
automatic measurement parameters.
Analysis
❏ The time interval may be changed as needed.
❏ The patient's blood pressure can be measured immediately at any time.
❏ If you use the optional software, you can analyze the data extensively.
Smart measurement
❏ The measurement time is shortened by proper exhaust velocity control.
❏ The exhaust velocity adjustment is unnecessary, because the constant
exhaust is properly controlled.
❏ In the automatic measurement cycle, these inflation values and stop values
at exhaust are controlled to reduce the measurement time.
Functions and Specifications
Blood pressure measurement
❏ There are two ways of utilizing this device to record blood pressure measurements.
Automatic measurement - This automatic measurement works in accordance
with internal clock, preset time intervals and preset
mode. The measurement data is saved in memory.
Manual measurement ----- Any time you press the
pressure measurement is performed immediately.
START STOP
key, a blood
The measurement data is saved in the memory.
Features Specifications
Page 8
Automatic measurement
❏ This measurement starts or stops using the
AUTO ON/OFF
key. When this
measurement is started, the recorder begins to work in accordance with
preset time intervals from the preset time of the internal clock. Refer to
"Selection for the automatic measurement".
❏ In the automatic measurement, an "A" appears in the upper left of the display.
❏ The recorder automatically measures the patient's blood pressure at the time that is
pointed out by "the frequency" and "the start time" (by the programed time intervals).
❏ When a measurement error occurs and there is 10 minutes until the next
measurement, the measurement is retried after approx. 30 seconds.
❏ If a measurement is retried, only the data from the retry is saved.
❏ The recorder automatically adjusts the proper pressure, exhaust velocity and
end of measurement.
❏ Refer to "Selection for the automatic measurement" and "Automatic measure-
ment by programed time intervals" about operation and entering parameters.
Stopping a measurement
❏ If you press the
START STOP
key during a measurement, the recorder exhausts
the air and stops the measurement.
Concealing the measurement value
❏ This function works only while using automatic measurement.
❏ This function does not display the SYS, DIA or pulse rate for the automatic
measurement, but the data is saved in memory.
❏ This function can select "reveal" or "conceal" at "Parameters for the display
and clock". Refer to this section.
❏ If you select "conceal", the recorder displays the clock during a measurement.
❏ If you reset the recorder, this parameter is set to "reveal".
Pressurization
❏ The pressure is automatically selected by the recorder while in the automatic
measurement mode.
❏ The first pressure is set to approx. 185 mmHg. This value automatically
adjusts to the proper value after the first measurement. If the first inflation is
not successful, the recorder retries twice.
❏ If you reset the recorder, the first inflation value is reset to 185 mmHg.
Memory
❏ The TM-2430 recorder can store 300 sets of data.
A data set consists of a SYS, a DIA and a pulse rate.
❏ When memory becomes full, the recorder displays an "M". Until you clear the
data, you can not measure blood pressure.
When the recorder saves data for more than one patient, data management
becomes complication. We recommend that patient data is transferred and
cleared from memory.
When a "B" is displayed, the backup batteries that is preserving a patient`s data
are weak. Please replace batteries as soon as possible.
ID number
❏ If you reset the recorder, the ID number is set to "1".
❏ The ID number can be set using the optional software.
Specifications Functions and Specifications
Page 9
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