A&D | TM-2430-13 | Instruction manual | A&D TM-2430-13 Instruction manual

A&D TM-2430-13 Instruction manual
TM-2430
Recorder for Ambulatory blood
pressure monitor
INSTRUCTION MANUAL
Ambulatory Blood Pressure Monitor
1WMPD4000136F
© 2014 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 express written consent of A&D Company, Limited.
The contents of this manual and the specifications of the instruments covered by this manual are
subject to change without notice.
Contents
Before use
Compliance ---------------------------------------------------------------------------------------- 2
Definitions ------------------------------------------------------------------------------------------ 2
Precautions for Use ------------------------------------------------------------------------------ 3
Notes on the Blood Pressure Recorder ----------------------------------------------------- 5
Welcome
Welcome and Intention -------------------------------------------------------------------------- 6
Product overview
Packing List and Component Names -------------------------------------------------------- 7
Display ---------------------------------------------------------------------------------------------- 9
Symbols ------------------------------------------------------------------------------------------- 9
Specifications
Features ------------------------------------------------------------------------------------------ 10
Functions and Specifications ---------------------------------------------------------------- 10
The complete procedure for use
Step by Step Procedure ----------------------------------------------------------------------- 14
Initializing the recorder
Replacing the Batteries ----------------------------------------------------------------------- 16
The State of Turning on the Recorder ----------------------------------------------------- 17
Parameters for the Display and Clock ----------------------------------------------------- 17
Selection for the Automatic Measurement ----------------------------------------------- 19
Deleting Old Data ------------------------------------------------------------------------------ 23
Resetting the Recorder ----------------------------------------------------------------------- 23
Preparing the patient
Patient Instructions ----------------------------------------------------------------------------- 24
Notes on Cuff Use ------------------------------------------------------------------------------ 25
Use of the Cuff Cover ------------------------------------------------------------------------- 26
Attaching the Cuff and Recorder ----------------------------------------------------------- 26
Preparation of the Carrying Case ---------------------------------------------------------- 28
Operation
Automatic Measurement (by Programmed Time Intervals)---------------------------- 29
Manual Measurement ------------------------------------------------------------------------- 29
To Stop the Current Measurement --------------------------------------------------------- 29
Data transfer
Data Transmission to a Printer -------------------------------------------------------------- 30
Data Transmission to a Computer Using Analysis Software ------------------------- 32
Options and accessories
Analysis Software and Communication Cables ----------------------------------------- 33
Cuffs and Other Accessories ---------------------------------------------------------------- 34
Maintenance
Checking Accuracy ----------------------------------------------------------------------------- 35
Cleaning the Cuff and Recorder ------------------------------------------------------------ 36
Periodical Inspection ---------------------------------------------------------------------------- 36
Troubleshooting --------------------------------------------------------------------------------- 36
Error Codes -------------------------------------------------------------------------------------- 37
Appendix
EMC Information -------------------------------------------------------------------------------- 39
Index ----------------------------------------------------------------------------------------------- 42
Page 1
Before use
Compliance
Compliance with European Directive
93/42 EEC for Medical Products
The device conforms to the following requirements: European Directive 93/42 EEC for Medical
Products; Medical Products Act; European Standards for Electrical Medical Equipment
EN60601-1 (General Safety Provisions), EN60601-2-30 (Particular Requirements for the
Safety of Automatic Cycling Indirect Blood Pressure Monitoring Equipment), EN60601-1-2 and
EN55011 (Electromagnetic Compatibility); European Standards pertaining to Non Invasive
Blood Pressure Instruments EN1060-1 (General Requirements), EN1060-3 (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 Framework
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
DIA
DSD
Exhaust
Constant exhaust
Exhaust velocity
During a measurement
Interval
bpm
Systolic Blood Pressure
Diastolic Blood Pressure
The difference between Systolic Blood Pressure and Diastolic
Blood Pressure.
This means "releasing the cuff air as soon as possible".
This means "releasing the cuff air at a constant depressurization rate".
This means the rate of depressurizing the cuff air.
This means "a period between the start of cuff inflation and the
end of exhausting the air".
This is called a "block". A block consists of a start time and frequency.
beats per minute.
Page 2
Precautions for Use
Precautions
Batteries
Use alkaline batteries (LR6 type, AA type, Mignon) or the specified Ni-MH
batteries.
Do not mix new and used batteries in the recorder.
Remove the batteries from the recorder, if it will not be used for a long period of
time and unless there is no risk of a SAFETY HAZARD arising.
A malfunctioning recorder
If the recorder malfunctions, stop the operation, attach a note "Do not use this
recorder" and store in a safe place to avoid misuse.
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.
Advise the patient on how to cope with mis-operation and contingencies
Repair
Do not open the recorder case. Contact your nearest A&D dealer if you have
questions.
Blood pressure measurement
Use the recorder on adults.
The recorder may not make a correct measurement when a patient has continuous
arrhythmia or the recorder senses noise due to the patient’s movement.
Please check measurement values by other methods, if you suspect the values.
Do not use this recorder on a person who is using a heartlung machine and a
defibrillator.
Do not use this recorder on a person who is critical or is in an intensive care unit.
Data in memory
A built-in backup battery keeps the important data in memory while replacing the
main batteries. However it works for a short period of time. Perform the battery
replacement swiftly, or you may lose measurement data, the clock setting
information and automatic measurement condition data. The period varies
depending on the battery condition. The backup battery may take 24 hours or
more to be fully charged (depending on the battery condition).
The built-in backup battery (rechargeable) as well as the primary battery (not
rechargeable) will deteriorate along use, which causes to decrease its capacity.
The built-in backup battery will deteriorate due to repetitive backup operations.
Page 3
To prevent the sudden drop of the built-in battery life, observe the following:
Before using the monitor for the first time after purchase or after an
extended period of no use, charge the battery fully. It takes 24 hours or
more with the power switch turned on. Charging can be performed during
measurement.
After measurement, leave the battery inside and the power switch turned on.
Under this condition, the built-in battery will not deteriorate. (This is true
with the "B" sign displayed.)
When the monitor is not to be used for a month or longer, turn the power
switch off to prevent the main batteries from leaking. During an extended
period of no use, the built-in battery will deteriorate. To prevent the situation,
use the monitor regularly.
When the power switch is turned on and off after a short period of use, the
built-in battery will not be fully charged and the battery life will decrease.
Avoid this situation.
Saving power
Turn off the power switch when not in use.
The backup battery life is a few days. Please transfer the data as soon as
possible.
Cuff
Close the cuff fastener properly when attaching the cuff to a patient or replacing
the cuff cloth. If the fastener is closed incorrectly, the cuff may be damaged during
use.
Page 4
Notes on the Blood Pressure Recorder
Storage
Do not store the recorder in the following places.
Where the recorder could be splashed with water or other liquids. If the
recorder becomes soaked, it needs a repair. (Do not use the recorder.)
Where the temperature and humidity are high, or in direct sunlight.
Where the recorder may be influenced by vibration or shock.
Where there is dust, salt or sulfur vapor.
Where chemicals are stored, or chemicals are evaporating.
Before use
Cover the RS-232C terminal using the cap, to avoid dust.
Confirm that the recorder works correctly and measurement values are proper.
Confirm that the cuff and air hose are connected properly.
Confirm parts in direct contact with the patient. Keep these parts clean.
Use a clean cuff cover. Because it comes into direct contact with the patient.
Delete the old data before starting a new measurement.
Avoid strong magnetic field and static electricity.
Do not use this recorder while using high frequency surgical equipment.
During use
The recorder should be operated by medical personnel who knows it well.
Use the recorder only during the time of diagnosis or medical treatment.
Stop using the recorder, if the patient feels pain in the arm or the recorder does not
measure properly.
The measurement cycle may be reduced due to the environment.
When an inside part of the recorder becomes soaked (wet), turn off the power
switch and request service from your supplier or the A&D service group.
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 after measurement.
Please use the original box for transportation.
Periodic maintenance
The recorder is a precision instrument. Please check all functions periodically
(every year). Contact your nearest A&D dealer for the inspection.
Environmental protection
If you discard the recorder, remove the Ni-MH batteries and built-in Li battery from
the recorder.
Dispose of the Ni-MH batteries in the designated container for recycling.
Dispose of the Li battery properly as a hazardous waste.
Page 5
Welcome
Welcome and Intention
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 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.
Page 6
Product overview
Packing List and Component Names
When you open this box, make sure you have everything as shown below:
Cuff cover for adult cuff
2
Instruction manual
1
Blood pressure recorder
(Main unit)
1
Carrying case
1
Belt
1
Clip
1
Shoulder band
1
Adult cuff for left arm
1
Activity record sheet
10
Page 7
Name
Power switch
Functions
This is the main power switch. At the OFF state, all data and
parameters are stored by a backup battery. This 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
measurement is started.
・ 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.
Page 8
Display
Sleep sign
Auto mode sign
Low battery sign
Full memory sign
Sign
A
S
B
M
Sign
Setup sign of
automatic measurement
Systolic Blood
Pressure display
Diastolic Blood
Pressure display
Setup sign of
display and clock
Pulse display
Error display
ex. "Set the clock"
Clock display
Name
Arrow
Functions
The arrow points to the kind of current display in the measurement
result and function mode.
Automatic
"A" is displayed when the automatic measurement is selected.
measurement When you press and hold the AUTO ON/OFF key, this sign is turned
on or off alternately.
Sleep
When you press the AUTO ON/OFF key while in mode II of the
automatic measurement, "S" is displayed or turned off alternately.
With "S" turned off, the time interval is 15 minutes.
With "S" turned on, the time interval is 30 minutes.
Low battery
When the recorder cannot operate all functions due to low battery,
this sign is displayed. The clock is still displayed. Please replace the
batteries immediately.
Full memory When data memory is at full capacity, this sign is displayed. In this
case, you cannot perform another measurement. Transfer the data,
save in other media and delete. Then "M" turns off.
Symbols
Turning on the recorder.
Turning off the recorder.
Direction guide to install batteries.
Direct current.
Serial number.
Date of manufacture.
Attention symbol. "See instruction for use."
Recorder, Cuff and tubing are designed to have special protection against electric
shocks.
Operating instructions
Refer to instruction manual/booklet
Note: On ME equipment “Follow instruction for use”
WEEE symbol
Page 9
Specifications
Features
Portability
The recorder weighs approx. 215 g (including batteries) and is palm top size,
because a micro-pump is used.
The recorder is powered by LR6 type (Mignon) alkaline batteries. It is possible to
replace the LR6 type batteries with Ni-MH 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 set easily.
There are three modes for automatic measurement.
The recorder can transmit data to a printer directly. (An adaptable printer is
necessary to print the data. Refer to "Data Transmission to a Printer" for
specifications of the printer.)
The recorder has the built-in rechargeable coin Li battery to keep the clock and
automatic measurement parameters.
Charge the rechargeable battery using a charger with CE Marking.
The battery cannot be charged using the recorder.
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 widely.
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, the inflation value and stop value at exhaust is
managed to reduce the measurement time.
Functions and Specifications
Blood pressure measurement
There are two ways of blood pressure measurement.
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 START STOP key, a blood
pressure measurement is performed immediately.
The measurement data is saved in memory.
Page 10
Automatic measurement
The measurement starts or stops using the AUTO ON/OFF key. When the
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, "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 programmed time intervals).
When a measurement error occurs and there is 8 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 Measurement
(by Programmed 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 varies to
the proper value after first measurement. If the first inflation is not successful, the
recorder retries twice.
If you reset the recorder, the first inflation value is set to 185 mmHg.
Memory
The recorder can store 350 sets of data (the memory capacity is 350).
A data set consists of the SYS, DIA and pulse rate.
When memory becomes full, the recorder displays an "M". Until you delete the
data, you cannot measure blood pressure.
When the recorder saves data for more than one patient, data management
becomes complicated. We encourage that each patient's data is recorded, transferred
and is deleted from memory.
When "B" is displayed, the backup battery that stores a patient’s data is weak.
Please transfer the data and save it in other media as soon as possible.
Page 11
ID number
If you reset the recorder, the ID number is set to "1".
The ID number can be set using the optional software.
Performance specifications
Measurement method
Pressurization
Oscillometric
Micro-pump
Display range
0 ~ 320 mmHg
Automatic measurement 85 ~ 300 mmHg (Fitted)
Manual measurement
185 mmHg (Fixed)
Measurement range
Systolic Blood Pressure 60 ~ 280 mmHg
Diastolic Blood Pressure 40 ~ 1 60 mmHg
Pulse rate
30 ~ 200 bpm
+3 mmHg
Accuracy
Pressure
Blood pressure
Conforming to 1992 AAMI standard
+5 %
Pulse rate
Minimum display division Pressure
1 mmHg
Pulse rate
1 bpm
Depressurization
Constant exhaust
Controlled ceramic valve
Exhaust
Ceramic valve
Measurement
Automatic measurement
Manual measurement
Number of measurement Approx. 200 times (Varies depending on the
environment and the condition of the Ni-MH batteries)
Memory
Up to 350 sets of data
Display
Normal
Clock
During a measurement
Pressure value
After a measurement
SYS, DIA and pulse rate
Error code, function of concealing the measurement data
Clock
24-hour (1997-2096, automatic leap year setting)
Batteries
3 x Alkaline battery (type LR6, type AA, Mignon) or
3 x Ni-MH battery (type AA, Mignon)
Type of protecting
Internally powered equipment type BF
against electric shock
CE Marking
The label of the medical device
by the EC directive.
C-Tick Marking
The certification trade mark registered
N92
to the ACA by the Trademark office.
Protection against
Recorder: IP20
IP22 (when both are used)
water and dust
Carrying case (IP02): IP02
AAMI: Association for the Advancement of Medical Instrumentation
ACA: the Australian Communications Authority
CE marking and C-Tick marking are labeled only for the countries where they are required.
Page 12
Interface
Connected to a computer, you can output the data and enter
parameters. Connected to a printer, you can print the data.
EIA RS-232C, Asynchronous, bi-directional, half duplex
Baud rate
9600 bps
Data bits
8 bits
Stop bits
2 bits
X parameter
Used (for computer)
Not used (for printer)
Parity
None
Code
ASCII
Start bit
Data bits
Stop bits
Environment specifications
Operating environment
Transport and Storage
。
。
。
。
+ 10 C ~ +40 C (+50 F ~ +104 F), 10 ~ 85%RH *
。
。
。
。
- 20 C ~ +55 C ( -4 F ~ +131 F), 10 ~ 95%RH *
* Non Condensing
Physical specifications
Dimensions
Weight
72(W) x 100(D) x 27(H) mm
2.8(W) x 3.9(D) x 1.0(H) in.
Approx. 215 g (0.47lb) excluding cuff
Unit: mm
Page 13
The complete procedure for use
Step by Step Procedure
Step 1
Battery replacement.
Replace with new alkaline batteries (note direction).
Refer to "Replacing the Batteries" on page 16.
Step 2
Turn on the recorder using the power switch.
Step 2
Step 3
Follow the procedure, depending on the recorder state.
Step 3
Case 1
Normal state
The buzzer sounds once and the clock is displayed. The
recorder is ready for use. The recorder stores parameters
for "display and clock" and "automatic measurement".
Please proceed to Step 5 .
Case 2
Step 1
Case 1
Normal
Error state
Case 2
Error
When the recorder displays the
error code, it is necessary
to set parameters for "display and clock" and "automatic
measurement". Please proceed to the next step.
Step 4
Step 5
Step 6
Step 7
Set parameters for "display and clock". When you use
automatic measurement, set parameters for automatic
measurement. Refer to "Parameters for the Display and
Clock" and "Selection for the Automatic Measurement".
Please proceed to Step 6 .
Step 4
Set new parameters for "display and clock" and "automatic
measurement", if necessary.
Step 5
Delete the old data stored in the recorder. Refer to "Deleting
Old Data".
Step 6
Explain "Patient Instructions" and " Notes on the Blood
Pressure Recorder "to the patient.
Step 7
Next page
Page 14
Previous page
Step 8
Attach the cuff to the patient. Refer to "Attaching the Cuff
and Recorder".
Step 8
Step 9
Attach the carrying case to the patient and insert the recorder.
Refer to "Attaching the Cuff and Recorder".
Step 9
Step10 Check the recorder using the manual measurement with
Step 10
relaxed, but correct posture. Refer to "Manual Measurement".
Step11 Start the automatic measurement. The recorder displays
Step 11
"A" and starts the automatic measurement sequence.
Refer to "Automatic Measurement".
Step12 When using automatic measurement, consider the following.
Consider the sections "Patient instructions" and "Notes
on the Blood Pressure Recorder".
When the patient uses mode II of automatic
measurement, press the AUTO ON/OFF key with each
rising and going to bed.
Step 12
Step13 When the automatic measurement sequence is finished,
the "A" sign turns off. Refer to "Automatic Measurement".
Step 13
Step14 Remove the cuff and recorder from the patient.
Step 14
Step15 Transfer the patient’s data and save it in other media.
Refer to "Data transfer".
Step 15
Step16 Clean the cuff and recorder and place them in storage.
Refer to "Before use" and "Maintenance".
Step 16
End
Page 15
Initializing the recorder
Replacing the Batteries
Caution
When "B" is displayed before a measurement, the recorder cannot make a
measurement. Please replace with new batteries before using.
If "B" is displayed during the measurement, stop the measurement and replace
with new batteries immediately.
Use alkaline batteries or the specified rechargeable batteries for the recorder.
Do not use new and used batteries at the same time.
Steps for replacing the batteries
Step 1 Open the battery cover.
Step 2 Turn off the power switch.
Step 3 Replace with new batteries. (Note the direction, "+" and "-".)
Step 4 Turn on the power switch.
Step 5 Close the battery cover.
Page 16
The State of Turning on the Recorder
There are three types of state when the recorder is turned on. Select an operation.
Refer to "The complete procedure for use" about use.
Action when the
recorder is turned on.
The buzzer sounds
once and the clock is
displayed. (Normal
state)
The buzzer sounds
once and
is
displayed blinking.
The buzzer sounds
four times and
is
displayed blinking.
State of recorder
The recorder stores
parameters for "display
and clock" and "automatic
measurement".
All parameters are lost.
Treatment
(Operation)
The recorder is ready for
use.
Set parameters for
"display and clock" and
"Automatic measurement".
The state after reset. All
parameters are lost.
Parameters for the Display and Clock
This setting selects the display during automatic measurement sequence and
adjusts the clock parameters. The sequence number tells you which parameter you
are adjusting.
Display & key
Sequence number
Selecting a sequence
number
Parameter
Selecting a parameter
Sign of setting parameters for display and clock
Items
Sequence Value & Meaning of parameters
number
range
0
Displaying clock only in automatic measurement
1
Displaying pressure and result in automatic
1
measurement
5
00 ~ 99 Year (1997 ~ 2096)
6
01 ~ 12 Month
7
01 ~ 31 Day
8
00 ~ 23 Hour
9
00 ~ 59 Minute
Page 17
Steps for setting the display and clock
This explanation uses the following examples.
ex.
After reset, the measurement value is not displayed.
The clock is adjusted to 1997/ 05/ 27 14:28.
Step 1
Press and hold the START STOP key for approx. 6 seconds. The
recorder displays
clock.
START STOP
for adjusting the display and
AUTO ON/OFF
Step 2
Press the AUTO ON/OFF key to display
.
(A selection to display the clock only in automatic measurement)
Step 3
Press the START STOP key. The current year is displayed.
START STOP
Step 4
Press the START STOP key. The current month is displayed.
START STOP
Step 5
Press the AUTO ON/OFF key to display 5 (for May).
AUTO ON/OFF
Step 6
Press the START STOP key. The current day is displayed.
START STOP
Step 7
Press the AUTO ON/OFF key to display 27 (27th day).
AUTO ON/OFF
Step 8
Press the START STOP key. The current hour is displayed.
START STOP
Step 9
Press the AUTO ON/OFF key to display 14 (14th hour).
AUTO ON/OFF
Step10 Press the START STOP key. The current minute is displayed.
START STOP
Step11 Press the AUTO ON/OFF key to display 28 (28th minute).
AUTO ON/OFF
Step12 Press the START STOP key to save these parameters. Then the
START STOP
recorder displays the clock.
Page 18
Selection for the Automatic Measurement
This setting initializes measurement intervals that are based on the internal
24-hour clock.
Mode
mode I
07:00 ~ 21:59
22:00 ~ 06:59
The measurement is performed every quarter hour.
The measurement is performed every half hour.
mode II
The AUTO ON/OFF key is pressed at rising and going to bed so that the
measurement intervals are changed and the time during sleep can be
distinguished on the data.
When "S" is off, the measurement is performed every quarter hour.
When "S" is displayed, the measurement is performed every half hour.
mode III The measurement interval can be changed six times within a maximum of 24
hours. (The recorder can store six measurement intervals (blocks) in 24
hours. A block consists of a start time and frequency.)
Display & key
Selecting a mode
Mode
START
STOP
AUTO
ON/OFF
Saving a mode
Sign of setting parameters
for automatic measurement
Steps for selecting a mode
ex. Mode II is selected.
Step 1
Press and hold the START STOP key for about 3 seconds. The
current mode is displayed.
START STOP
Step 2
Press the AUTO ON/OFF key to display
AUTO ON/OFF
Step 3
Press the START STOP key. The recorder stores the mode and
displays the clock.
Page 19
for mode II.
START STOP
Mode III Settings
Setup procedure
Before you enter into mode III, read the procedure below. Also, refer to the
example on the next page for the setting procedure.
Each block’s finish time is the next block’s start time.
The end of block 6 automatically becomes the start time of block 1.
If you enter the block 1 start time in any other block, these parameters are
saved and this sequence is finished.
When selecting 120 minutes for the current frequency, you must adjust the
start time of the next block so that the current block fits a multiple of 120
minutes. If not, an error code is displayed.
The recorder displays
as 60 minutes and
as 120 minutes.
When you enter the sequence of mode III settings, the recorder initializes each start
time to the start time of block 1 and each frequency to "-" (not used).
To read the current settings, press the START STOP key in this sequence.
Display & key
Sequence number
Parameter
START
STOP
AUTO
ON/OFF
Selecting a
parameter
Selecting a sequence number
Sign of setting parameters
for automatic measurement
Items
Sequence
number
Parameters (monitor)
01
0 ~ 23 o'clock
02
0 ~ 23 o'clock
0 ~ 23 o'clock
0 ~ 23 o'clock
0 ~ 23 o'clock
Start time of fifth block
- , 5, 10, 15, 20, 30, 60, 120 minutes Frequency of fifth block
11
12
Start time of fourth block
- , 5, 10, 15, 20, 30, 60, 120 minutes Frequency of fourth block
09
10
Start time of third block
- , 5, 10, 15, 20, 30, 60, 120 minutes Frequency of third block
07
08
Start time of second block
- , 5, 10, 15, 20, 30, 60, 120 minutes Frequency of second block
05
06
Start time of first block
- , 5, 10, 15, 20, 30, 60, 120 minutes Frequency of first block
03
04
Meaning
0 ~ 23 o'clock
Start time of sixth block
- , 5, 10, 15, 20, 30, 60, 120 minutes Frequency of sixth block
13
0 ~ 23 o'clock
End of sixth block
"-" means "not used".
Page 20
Initial value
Steps for automatic measurement
ex. First block
08:00 ~ 21:59
Second block 22:00 ~ 05:59
Third block
06:00 ~ 07:59
frequency 30 minutes
frequency 60 minutes
frequency 10 minutes
Step 1
Press and hold the START STOP key for approx. 3 seconds. The
current mode is displayed.
START STOP
Step 2
Press the AUTO ON/OFF key to display
AUTO ON/OFF
Step 3
Press the START STOP key. The mode is stored and the current start
time of the first block is displayed.
START STOP
Press the AUTO ON/OFF key to display "8" for 8:00 hours as the
start time of the first block.
AUTO ON/OFF
Press the START STOP key. The current frequency for the first block
is displayed.
START STOP
Press the AUTO ON/OFF key to display "30" for 30 minutes as
the frequency for the first block.
AUTO ON/OFF
Press the START STOP key. The current start time of the second
block is displayed.
START STOP
Press the AUTO ON/OFF key to display "22" for 22:00 hours as the
start time for the second block.
AUTO ON/OFF
Press the START STOP key. The current frequency for the second
block is displayed.
START STOP
Step 4
Step 5
Step 6
Step 7
Step 8
Step 9
Step10 Press the AUTO ON/OFF key to display "
for mode III.
" for 60 minutes as the
frequency of the second block.
AUTO ON/OFF
Step11 Press the START STOP key. The current start time of the third block
is displayed.
START STOP
Step12 Press the AUTO ON/OFF key to display "6" for 6:00 hours as the
start time of the third block.
AUTO ON/OFF
To next page
Page 21
From previous page
Step13 Press the START STOP key. The current frequency of the third
START STOP
block is displayed.
Step14 Press the AUTO ON/OFF key to display "10" for 10 minutes as
the frequency of the third block.
AUTO ON/OFF
Step15 Press the START STOP key. The current start time of the fourth
block is displayed.
START STOP
Step16 Press the AUTO ON/OFF key. The recorder stores these
parameters and displays the clock, (because the current start
time of the fourth block is the same as the start time of the first
block).
Page 22
START STOP
Deleting Old Data
Caution
Confirm that the data has already been transferred and saved, when
the data is to be deleted. It is not possible to recover data that was
deleted.
It is not possible to delete data completely, if the START STOP key is
released while the buzzer sounds at Step 2.
Steps for deleting old data
Step 1
Press and hold the START STOP key for approx. 9 seconds.
If you want to cancel this process, press the AUTO ON/OFF key.
is displayed.
Step 2
Press and hold the START STOP key once more until the buzzer stops.
Resetting the Recorder
If the recorder does not work correctly, press the reset key. The recorder
deletes all data and parameters. The internal system is initialized.
Caution
By resetting, all data and parameters are deleted and the internal
system is initialized.
Do not press the reset key too intensely. Press the key gently so as
not to damage the components inside.
Keep the reset key hole free of foreign materials.
Steps for resetting the recorder
Step 1
Open the battery cover.
Step 2
Turn off the power switch.
Step 3
Remove the batteries from the recorder.
Step 4
Press the reset key gently.
Step 5
Place new batteries in the recorder.
Step 6
Turn on the power switch. The recorder sounds the
buzzer four times and
is displayed blinking.
Step 7
Set the parameters for the display and clock. Also,
adjust the parameters for automatic measurement.
Page 23
Reset key
Preparing the patient
Patient Instructions
Advise the patient on how to cope with mis-operation and contingencies.
Precautions during automatic measurement
Relax and be quiet, when the recorder starts inflating the cuff.
Maintain the same posture during measurement.
Avoid noises and vibrations during measurement.
After inflation, the recorder deflates the cuff and measures the patient's blood pressure. The
maximum measurement time is 90 seconds. Relax and be quiet during measurement.
If you move your body during measurement, the recorder may start inflation
during the deflation process for reevaluating the blood pressure.
If the recorder did not acquire usable data due to the patient’s body movement and the
frequency of the interval is 8 minutes or more, the recorder may start measurement again
approx. 30 seconds after measurement.. Do not move and try to relax during measurement.
Stop using the recorder, if the patient feels pain in the arm.
Stopping or canceling an automatic measurement
To stop the measurement, press the START STOP key. The recorder beeps,
releases the cuff air and an error is displayed. The recorder will inflate the cuff
for the next time period automatically.
To cancel automatic measurement, press and hold the AUTO ON/OFF for approx.
3 seconds. Automatic measurement is canceled and "A" turns off.
To restart automatic measurement after cancellation, press and hold the AUTO ON/OFF
for approx. 3 seconds. "A" appears and the recorder resumes measurement and
records data except the cancelled block.
Manual measurement
To start a measurement, press the START STOP key.
To stop the measurement, press the START STOP key.
Precautions for attaching the cuff and recorder
Do not drop or apply shock to the recorder.
The recorder and cuff are not water resistant. Prevent rain, sweat and water from
wetting the recorder and cuff.
Do not place anything on the recorder.
Re-attach the cuff if the cuff is slipped from the proper position due to the
patient’s movement.
Use caution not to break the air hose or not to entangle around the patient's
neck or body during sleep. Attach the air hose to the patient's body only as
shown on page 27.
Replacing the batteries
Replace with new batteries immediately, when "B" is displayed.
Page 24
Notes on Cuff Use
Note: A cuff is a consumable item and may need replacing if worn or damaged.
Please check the cuff conditions before use.
In the following cases, replace the used cuff with a new one immediately.
When there is a crack or stickiness in the joint of the cuff's bladder or the tube.
When the tube is not flexible or has stiffened.
When the surface of the tube is coated with an oil-like substance.
When there is a defined crease in the bladder.
Confirm the following before use.
Confirm that the zip fastener, for the cuff cover, is closed completely, to the red
stopper cloth, as shown in the illustration below.
If the zip fastener is not closed completely, the internal bladder may escape from
the cuff cover and explode or otherwise be damaged.
Zip fastener
Red stopper cloth
Cuff cover
Page 25
Use of the Cuff Cover
Step 1
Place the cuff on the cuff cover as shown.
When the cuff cover with slits is used, pass the air hose through a slit.
Step 2
Secure the cuff cover to the cuff using the fabric fasteners.
Air hose
Fabric
fastener
Slit
Cuff cover
Slit for air hose
Cuff
Fabric fastener
Air hose
Fabric fastener
Cuff
Cuff cover
Air hose
Fabric fastener
Band
Cuff
Cuff cover
Band
Fabric fastener
Attaching the Cuff and Recorder
Caution
If the cuff is not attached at the proper position, the recorder may not measure
the blood pressure correctly and an error may occur.
The cuff accessory is for use on the left arm, of about 20cm ~ 31cm. If you
need a different cuff, purchase a cuff of the proper size and arm position. Refer
to "Option and accessories".
Do not attach the cuff to an arm with an unhealed wound, dermatitis, etc.
Keep the cuff clean. Change the cuff cover for each patient. The cuff cover
may be used for either right or left arm cuff.
Page 26
Steps for attaching the cuff and recorder
Step 1
Make a circle where the end of the cuff is passed through the ring.
Step 2
Search for the brachial artery using palpation.
Step 3
Attach the cuff directly against the skin so that the artery position mark is
directly over the brachial artery and the lower edge of the cuff is placed one
inch above the inside of the elbow.
Step 4
Wrap the cuff so that the ring is within the slide range, evenly and tight
enough not to slip down but loose enough to insert two fingers. (If the ring
is not within the slide range, you need a proper cuff.)
Step 5
Position the air hose over the shoulder and affix it on the patient using the clip.
Step 6
Assemble the belt and carrying case.
Step 7
Position the belt so that the carrying case is on the right (left) side of the patient,
when a patient attaches the left (right) arm cuff.
Step 8
Connect the air hose plug to the air socket.
Step 9
Place the recorder into the carrying case.
Cuff
Ring
Caution
Do not disturb the cuff or air hose
during the measurement because
the recorder measures small
pressure variations.
Slide range of ring
Clip
Fasten the clip to the sleeve,
pocket or anywhere convenient
to secure the air hose.
Air hose
Ring
Artery position mark
Air hose plug
Approx. 2 cm ~ 3 cm
(Approx. 0.8 in.~ 1.2 in.)
Air socket
Main body
Belt
Artery
Cuff
Carrying case
(IP02)
Ring
Page 27
Preparation of the Carrying Case
Use the belt or shoulder band to attach the carrying case.
We recommend the belt so that the carrying case is not worn out of shape on
the patient.
Carrying case (IP02)
Using the belt
Step 1
Insert the belt through the strap
located on the rear of the
carrying case.
Step 1
Step 2
Step 2
Pull the belt through the strap.
Step 3
Pass the belt through the ring.
Step 4
Pass the belt through the
front-hole and the rear-hole of
the hook.
Step 5
Step 3
Step 5
Ring
Belt
Front-hole
Rear-hole
Hook
Insert the belt into the ring again.
Step 4
Using the shoulder band
Buckle
Step 1
Insert the band into the buckle.
Step 2
Pass the band through the ring.
Step 3
Pass the band through the
buckle as shown in the right
illustration.
Step 1
Step 2
5
Step 3
Carrying case (IP02)
Page 28
Operation
Automatic Measurement
Caution
Automatic measurement uses the internal clock and parameters for automatic
measurement. Refer to "Parameters for the Display and Clock" and "Selection
for the Automatic Measurement" for setting these parameters.
When the patient stops the automatic measurement or removes the cuff, press and hold
the AUTO ON/OFF key for approx. 3 seconds to turn off the "A" sign. If the "A" sign is left
turned on, the recorder may start the next automatic measurement and cause damage to
the cuff.
Starting or re-starting automatic measurement
Step 1
Confirm the parameters for automatic measurement. Refer to "Selection for the
Automatic Measurement".
Step 2
Press and hold the AUTO ON/OFF key for about 3 seconds. Then "A" is displayed and
the recorder starts an automatic measurement based on the internal clock and the
parameters for automatic measurement.
Operation using mode II
Step 1
Press the AUTO ON/OFF key to turn off "S" when the patient wakes up.
Step 2
Press the AUTO ON/OFF key to turn on "S" when the patient goes to bed.
Stopping or canceling automatic measurement
Step 1
Press and hold the AUTO ON/OFF key for about 3 seconds. "A" turns off and the
recorder stops automatic measurement.
Manual Measurement
Step 1
Press the START STOP key. The recorder starts a measurement. The results are
displayed and stored in memory.
To Stop the Current Measurement
Step 1
Press the START STOP key during measurement. The recorder will stop the
measurement and releases the air from the cuff.
Page 29
Data transfer
The recorder transfers data to a printer or computer using the RS-232C terminal.
We recommend analysis of the data using the optional analysis software.
Caution
Cover the RS-232C terminal using the cap, to prevent dust and foreign
materials from entering when this terminal is not in use.
Remove the recorder and cuff from the patient, when the recorder is connected
to a printer or computer.
The personal computer must comply with EN60601-1.
Data Transmission to a Printer
Caution
The recorder intensely consumes the battery power while connected to the
RS-232C cable. Disconnect the cable when not actually transferring data.
Maintain the power-on state while transmitting the data so that the data is not
damaged.
The optional RS-232C cable is required when connecting to a printer.
The printer (to print the data) must have a serial interface and adapt to the
RS-232C protocol of the recorder.
The printer must comply with EN60601-1.
Specifications for an adaptable printer
Transmission
Command
Printer parameters
EIA RS-232C
Asynchronous, bi-directional, half duplex
Baud rate
9600 bps
Start bits
1 bit
Data bits
8 bits
Parity bit
None
Stop bits
2 bits
X parameter
Not used
ETX/ACK
Not used
DSR
Not used
Code
ASCII
Carriage return
0Dh
Next line
0Dh 0Ah
Next page
0Ch 0Dh
Next page
Automatic
Characters per line
72 min.
Buffer size
approx. 32Kbytes
Page 30
Steps for data transmission
Step 1
Enter the parameters into the printer so that the data can be
transmitted.
Setup for
printer
Step 2
Connect the cable to both the recorder and printer. Then the
recorder displays
. Refer to "Analysis Software
and Communication Cables" about the cable.
Connection
Step 3
Set the printer to "ON LINE".
Step 4
Press the START STOP key. Then
and the data is transmitted.
Step 5
When the transmission is finished,
displayed.
Step 6
Remove the cable. The clock is displayed.
On line
(Ready)
Print sample
Page 31
is displayed
is
Remove
the cable
Data Transmission to a Computer Using Analysis Software
Caution
The recorder intensely consumes the battery power while connected to the
RS-232C cable. Disconnect the cable when not actually transferring data.
Maintain the power-on state while transmitting the data so that the data is not
damaged.
Steps for data transmission
Step 1
Connect the cable to both the recorder and printer. The
Connection
recorder displays
. Refer to "Analysis Software
and Communication Cables" about the cable.
Step 2
Read the data using the optional analysis software.
Refer to the software instruction manual.
Step 3
Remove the cable. The clock is displayed.
Page 32
Reading data
with software
Remove
the cable
Options and accessories
Analysis Software and Communication Cables
The analysis software has functions as follows:
Maximum value, minimum value and average are calculated in an arbitrary period
of time. (Partial analysis)
Correlation graph, trend graphis and histogram are displayed.
The patient's data and information are managed.
Data can be saved.
Data can be deleted or copied.
A saved data file can be exported into CSV format so that EXCEL can read it.
Data can be output as a report.
Data is input from the recorder and parameters are written to the recorder.
Name
Order code
Windows-based analysis software
TM2430-13
Communication cable, D-SUB
9pin
socket type
AX-KO1502
Communication cable, D-SUB 25pin
socket type
AX-KO1503
Communication cable, D-SUB 25pin
plug type
AX-KO1504
Page 33
Cuffs and Other Accessories
Cuff
Name
Large cuff
Adult cuff
Small cuff
Adult cuff
for left arm,
for left arm,
for left arm,
for right arm,
28 ~ 36 cm (11 ~ 14 inches)
20 ~ 31 cm ( 8 ~ 12 inches)
15 ~ 22 cm ( 6 ~ 8 inches)
20 ~ 31 cm ( 8 ~ 12 inches)
Cuff cover
Name
Large cuff cover
Adult cuff cover
Small cuff cover
Others
Name
TM-2430 Accuracy Diagnostic Kit
Activity record sheet
Carrying case (IP02)
10 sheets
10 sheets
10 sheets
10 sheets
Page 34
Order code
TM2430-02B
TM2430-06B
TM2430-07B
TM2430-09B
Order code
AX-133002066-S
AX-1133011576-S
AX-13A37410-S
Order code
TM2430-90
AX-PP174-S
AX-133012212
Maintenance
Checking Accuracy
Required equipment
Accurate office mercury sphygmomanometer or aneroid gauge with inflation system.
TM-2430 Accuracy Diagnostic Kit (TM2430-90).
A rigid cylinder sized to fit the cuff pressured.
Steps for checking accuracy
Step 1
Turn off the TM-2430 and remove the air hose from the unit.
Step 2
Construct the check system as shown below
Recorder
Mercury sphygmomanometer
START STOP switch
Inflator bulb
Cuff
Power switch
TM-2430 Accuracy
Diagnostic Kit
A rigid cylinder
Exhaust valve and
adjustment screw
Step 3
Keep the pressure at the air socket to atmospheric pressure.
Step 4
While holding the START STOP key, turn on the power switch. "0" blinks.
Release the START STOP key. "0" stops blinking.
Step 5
Squeeze the inflator bulb until the cuff pressure reaches 50 mmHg.
Check the difference between the blinking display of TM-2430 and mercury
sphygmomanometer is within +3 mmHg.
Step 6
Squeeze the inflator bulb until cuff pressure reaches 150 mmHg.
Check the difference is within +3 mmHg.
Step 7
Squeeze the inflator bulb until cuff pressure reaches 250 mmHg.
Check the difference is within +3 mmHg.
Step 8
Release the cuff air, turn off the TM-2430 and disassemble the check system.
The blood pressure recorder is a precision instrument. Contact your nearest
A&D dealer, if you need repair.
Page 35
Cleaning the Cuff and Recorder
Before cleaning the recorder, remove the battery cover, turn the power switch off
and remove the batteries.
The recorder is not water resistant. Do not allow liquids to splash on or get into the
case while cleaning.
After each use, wipe the case of the recorder with a clean lint free cloth, moistened
with water and a mild detergent.
Do not use antiseptic solutions, Alcohol, etc., to clean the recorder, hose or cuff.
Clean the cuff cloth and cuff cover by washing in water with a mild detergent. Do
not scrub or wring them by hand. If the cuff cloth and cuff cover become
contaminated, replace them with new ones.
Periodical Inspection
This blood pressure recorder is a precision instrument. Please inspect the
functions (once a year) periodically. Contact your nearest A&D dealer for the
inspection.
Confirm the accuracy of the blood pressure monitor once a year.
Troubleshooting
Caution
Do not open the case of the recorder because it uses delicate electrical
components and intricate air unit that could be damaged.
If you cannot locate and fix the problem, request service from your nearest A&D
dealer, or from the A&D service group.
A&D service group will support authorized suppliers about technical information,
spare parts and units.
Problem
No display at turning
on.
Data lost while
replacing batteries.
Cause
Batteries are drained.
Treatment
Replace with new batteries.
The built-in backup
battery is drained
No pressure.
Air leakage at the
connector, hose or cuff.
Turn on the recorder and
display the clock for 24 hours
or more, to fully charge the
backup battery.
Confirm the cuff and air hose
are not damaged and are
connected correctly.
Page 36
Error Codes
Caution
Error
code
The error code may be updated without prior notice.
Meaning
No clock parameter
E00
Status
Operation and Treatment
All parameters are lost.
Enter clock parameters. Refer
Reset status.
to "Parameters for the Display
and Clock"
E03
Pressure zero error
Low battery
E04
An error code is displayed
Release the air from the cuff
without cuff inflation.
completely.
Measurement is stopped.
Replace with new batteries.
An error code is displayed.
Restart the auto mode if you use it.
Auto mode is quit.
Inflation error
Inflation pressure does not Connect the cuff to the main unit
reach the target pressure.
E05
securely. If you cannot clear the
error, there may be an air leak and
repair is necessary
Above 320 mmHg
An error code is displayed.
Do not move and try to relax
during the measurement. If you
E06
cannot clear the error, repair is
necessary
E07
Controlled stop
Air is exhausted. An error Press the STOP key only when
using STOP key
code is displayed.
necessary.
Pulsation cannot be
Measurable pulsation is
Do not move and try to relax
measured
searched to 20mmHg in
during the measurement. The
constant exhaust. An error
error occurs when pulsations
code is displayed.
are not detected due to thick
E08
cloth or quick motion.
E10
Pulsations cannot
In the measurement, quick
Do not move and try to relax
be detected
exhaust is executed. An
during the measurement.
because the patient
error code is displayed.
may have moved.
E20
E21
E22
E23
Pulse rate < 30
An error code is displayed.
200 < Pulse rate
Measure the blood pressure by
other methods.
DIA < 40
160 < DIA
DIA
:
Diastolic Blood Pressure
SYS < 60
SYS :
Systolic Blood Pressure
280 < SYS
DSD :
The Difference between Systolic Blood Pressure
DSD < 10
:and Diastolic Blood Pressure.
150 < DSD
Page 37
Error
code
E30
Meaning
Status
Operation and Treatment
Measurement time
Air is exhausted from the cuff, and
Repair is necessary because of
exceeds 120 seconds.
an error code is displayed.
slow inflation or slow constant
exhaust.
E31
E32
E50
The constant exhaust
Air is exhausted from the cuff, and
Repair is necessary because of
exceeds 60 seconds.
an error code is displayed.
slow constant exhaust.
Clock error.
An error code is displayed.
If you cannot clear this error,
repair is necessary.
Pressure offset
An error code is displayed at
Release the air from the cuff
error to measure
restarting the recorder.
completely, reset the recorder.
pulsation.
If you cannot clear this error,
repair is necessary.
E52
E53
E55
Memory error.
An error code is displayed at
The recorder needs repair.
restarting the recorder.
Battery contact is
The measurement is stopped, air
Replace batteries correctly.
defective.
is released from the cuff and an
If you cannot clear this error,
error code is displayed.
repair is necessary.
An error code is displayed at
Do not move and try to relax
measurement.
during the measurement. If this
Exhaust error.
E56
error occurs frequently, repair is
E57
necessary.
Interval setting error.
E60
Start time is not proper, interval of
Enter parameters for the interval
last block is not set in the unit of
correctly.
120 min.
E70
RS-232C error.
E71
The error code is displayed during
Re-connect the communication
communications.
cable. If you cannot clear this
error, repair is necessary.
E72
E73
E74
E75
Low battery for
Replace batteries with new ones
communication.
and restart communication.
Protocol error due to
Re-connect the communication
external equipment.
cable. If you cannot clear this
error, repair is necessary.
E90
E91
Pressure zero error for
This error code is displayed before Release the air from the cuff
safety circuit.
the measurement.
completely.
Safety circuit detects
Patient moved during the
Relax and try to be quiet during
overload pressure.
measurement.
the measurement. If it occurs
while the patient relaxes and is
quiet, the recorder needs repair.
Other
Monitor code is displayed.
Reset. Turn on the power switch
again.
Page 38
Appendix
EMC Information
EMC guidelines and manufacturer’s declaration
Medical Electrical Equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in the following.
Portable and mobile RF communication equipment (e.g. cell phones) can affect
Medical Electrical Equipment.
The use of accessories and cables other than those specified (other than A&D
original parts) may result in increased emissions or decreased immunity of the unit.
Guidance and manufacturer’s declaration – electromagnetic emissions
The A&D unit is intended for use in the electromagnetic environment specified below.
The customer or the user of the A&D unit should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
Group 1
The A&D unit uses RF energy only for its
CISPR 11
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
Class B
The A&D unit is suitable for use in all
CISPR 11
establishments, including domestic
Harmonic emissions
n.a.
establishments and those directly connected to
IEC 61000-3-2
the public low-voltage power supply
Voltage fluctuations/flicker
n.a.
network that supplies buildings used for
emissions IEC 61000-3-3
domestic purposes.
Recommended separation distances between portable and mobile RF communications
equipment and the A&D unit
The A&D unit is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the A&D unit can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the A&D unit as recommended below, according to
the maximum output power of the communications equipment.
Rated maximum output
Separation distance according to frequency of transmitter
power of transmitter
m
80 MHz to 800 MHz
800 MHz to 2.5 GHz
150 kHz to 80 MHz
W
d = 1.2 P
d = 2.3 P
d = 1.2 P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to the
frequency of the transmitter, where p is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Page 39
Guidance and manufacturer’s declaration – electromagnetic immunity
The A&D unit is intended for use in the electromagnetic environment specified below. The
customer or the user of the A&D unit should assure that it is used in such an environment.
Immunity
IEC 60601
Compliance Electromagnetic environment –
test
test level
level
guidance
Portable and mobile RF
communications equipment should be
used no closer to any part of the A&D
unit, including cables, than the
recommended separation distance
calculated from the
equation applicable to the frequency
of the transmitter.
Recommended separation distance:
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V rms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 V rms
3 V/m
d = 1.2 P
d = 1.2 P
80 MHz to 800 MHz
d = 2.3 P
800 MHz to 2,5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, a
should be less than the compliance
level in each frequency range.b
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
a
b
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the A&D unit is used
exceeds the applicable RF compliance level above, the A&D unit should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the A&D unit.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Page 40
Guidance and manufacturer’s declaration – electromagnetic immunity
The A&D unit is intended for use in the electromagnetic environment specified below. The customer
or the user of the A&D unit should assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance level
Electromagnetic
environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV
contact
± 6 kV
contact
± 8 kV
air
± 8 kV
air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
n.a.
Mains power quality should
be that of a typical
commercial
or
hospital
environment.
Surge
IEC 61000-4-5
± 1 kV
line to line
n.a.
Mains power quality should
be that of a typical
commercial
or
hospital
environment.
n.a.
Mains power quality should be
that of a typical
commercial or hospital
environment. If the user of
the
A&D
unit
requires
continued operation during
power mains interruptions, it is
recommended that the A&D
unit be powered from an
uninterruptible power supply or
a battery.
± 1 kV
for input/output
lines
±2 kV
line to earth
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
< 5% UT
(> 95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(> 95% dip in UT)
for 5 s
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE : UT is the AC mains voltage prior to application of the test level.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Page 41
Index
Symbols
------------------------------------ 9
belt ------------------------------ 7, 8, 27
block------------------------ 2, 19, 20, 21
bpm ----------------------------------------2
---------------------------------- 9
C
------------------------ 9
--------------------------------- 9
---------------------------- 9
---------------------------------- 9
------------------------------- 9
---------------------------------- 9
---------------------------------- 9
---------------------------------- 9
------------------------9, 17,19
---------------------- 19
---------------------- 19
---------------------- 21
-
----------------------------------- 20
----------------- 31, 32
SN --------------------------------------9
A
A --------------------------- 9, 11, 29
AAMI ------------------------------ 12
accuracy ------------------------ 12
adult cuff ------------------------ 34
air hose ----------------- 8, 26, 27
air hose plug --------------- 8, 27
alkaline battery ------- 3, 12, 16
analysis -------------------- 10, 33
arrow ------------------------------ 9
artery ----------------------------- 27
artery position mark --------8, 27
AUTO ON/OFF key ----------- 8
automatic measurement
------------------ 8, 9, 11, 29
B
B ------------------------- 9, 11, 16
battery ----------------------- 3, 16
battery cover -------------------- 8
baud rate ------------------------ 13
cable
---------------------------- 32, 33
----------------------------------- 23
clock -------------------------- 9, 12, 17
code ---------------------------------- 13
concealing the measurement value ------- 11
constant exhaust -------------------- 2
CSV ---------------------------------- 33
cuff -------------------- 4, 8, 26, 27, 34
cuff cover ----------------------- 26, 34
D
D-SUB ------------------------------- 33
data bits ----------------------------- 13
depressurization ------------------- 12
DIA -------------------------------------- 2
diastolic blood pressure ------2, 12, 37
dimensions -------------------------- 13
display ------------------------------- 12
DSD ------------------------------------ 2
E
------------------------- 17, 23, 37
EEC --------------------------------------2
EMC information ------------------ 39
error state --------------------------- 14
EXECL ------------------------------- 33
exhaust -------------------------------- 2
exhaust velocity --------------------- 2
F
fabric fastener--------------------------- 26
FCC ------------------------------------ 2
frequency --------------- 2, 19, 20, 21
full memory --------------------------- 9
I
ID number --------------------------- 12
interface ----------------------------- 13
interval ---------------------------- 2, 19
L
large cuff
Page 42
---------------------------- 34
left arm -------------------------------- 34
low battery ---------------------------- 9
SYS ----------------------------------------2
systolic blood pressure -- 2, 12, 37
M
T
M ------------------------------------- 9, 11
management ------------------------- 10
manual measurement ------------- 10
measurement ----------------------- 12
memory -------------------------- 11, 12
mode I -------------------------------- 19
mode II -------------------------- 19, 29
mode III -------------------------- 19, 20
transmission ------------------------ 30
transport and storage environment ---- 13
W
weight
X
X parameter ---------------------------- 13
N
Ni-MH
----------------------------- 5, 12
O
operating environment
-------------------------------- 13
------------ 13
P
----------------------------------- 31
parity ---------------------------------- 13
patient -------------------------------- 24
portability ----------------------------- 10
power switch ------------------------- 8
printer --------------------------------- 30
pulse ----------------------------------- 9
R
recorder -------------------------- 5, 24
recording sheet --------------------- 34
repair ----------------------------------- 3
reset key ------------------------- 8, 23
right arm ------------------------------ 34
ring ------------------------------------ 27
RS-232C -------------------- 8, 13, 30
S
S ------------------------------------ 9,19
selecting mode --------------------- 19
shoulder band -------------------- 7, 8
sleep ----------------------------------- 9
slit --------------------------------------- 26
small cuff ----------------------------- 34
SN ----------------------------------------9
START STOP key ------------------- 8
start time --------------- 2, 19, 20, 21
stop bits ------------------------------ 13
stopping a measurement --------- 11
storage -------------------------------- 5
Page 43
MEMO
Page 44
1-243 Asahi , Kitamoto-shi, Saitama 364-8585, JAPAN
Telephone: [81] (48) 593-1111
Fax: [81] (48) 593-1119
A&D INSTRUMENTS LIMITED
Unit 24/26 Blacklands Way, Abingdon Business Park, Abingdon, Oxfordshire OX14 1DY United Kingdom
Telephone: [44] (1235) 550420
Fax: [44] (1235) 550485
A&D ENGINEERING, INC.
1756 Automation Parkway, San Jose, California 95131, U.S.A.
Telephone: [1] (408) 263-5333
Fax: [1] (408)263-0119
A&D AUSTRALASIA PTY LTD
32 Dew Street, Thebarton, South Australia 5031, AUSTRALIA
Telephone: [61] (8) 8301-8100
Fax: [61] (8) 8352-7409
OOO A&D RUS
OOO "ЭЙ энд ДИ РУС"
121357, Российская Федерация, г.Москва, ул. Верейская, дом 17
( Business-Center "Vereyskaya Plaza-2" 121357, Russian Federation, Moscow, Vereyskaya Street 17 )
тел.: [7] (495) 937-33-44
факс: [7] (495) 937-55-66
A&D Technology Trading(Shanghai) Co. Ltd
爱安德技研贸易(上海)有限公司
中国 上海市浦东新区浦东大道138号永华大厦21楼A室 邮编200120
( 21F Room A, Majesty Building, No.138 Pudong Avenue, Pudong New Area, Shanghai, 200120, China )
电话: [86] (21) 3393-2340
传真: [86] (21) 3393-2347
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