TM-2430 Instruction Manual

Note

This manual and or the TM-2430 may be changed at any time to improve the product 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 -------------------------------------------------------- 6 Display ---------------------------------------------------------------------------------------------- 8 Symbols ------------------------------------------------------------------------------------------- 8 Specifications Features -------------------------------------------------------------------------------------------- 9 Functions and Specifications ------------------------------------------------------------------ 9 The complete procedure for use Step by Step Procedure ----------------------------------------------------------------------- 13 Initializing the recorder Replacing Batteries ---------------------------------------------------------------------------- 15 The State of Turning on the Recorder ----------------------------------------------------- 16 Parameters for the Display and Clock ----------------------------------------------------- 16 Selection for the Automatic Measurement ----------------------------------------------- 18 Deleting Old Data ------------------------------------------------------------------------------ 22 Resetting the Recorder ----------------------------------------------------------------------- 22 Preparing the patient Patient Instructions ----------------------------------------------------------------------------- 23 Use of the Cuff Cover ------------------------------------------------------------------------- 24 Attaching the Cuff and Recorder ----------------------------------------------------------- 24 Preparation of the Carrying Case ---------------------------------------------------------- 26 Operation Automatic Measurement (by Programed Time Intervals) ------------------------------ 27 Manual Measurement ------------------------------------------------------------------------- 27 To Stop a Current Measurement ------------------------------------------------------------ 27 Data transfer Data Transmission to a Printer -------------------------------------------------------------- 28 Data Transmission to a Computer Using Analysis Software ------------------------- 30 Options and accessories Analysis Software and Communication Cables ----------------------------------------- 31 Cuffs and Other Accessories ---------------------------------------------------------------- 32 Maintenance Checking Accuracy ----------------------------------------------------------------------------- 33 Cleaning the Cuff and Recorder ------------------------------------------------------------ 34 Periodical inspection ---------------------------------------------------------------------------- 34 Problem Solving -------------------------------------------------------------------------------- 34 Error Codes -------------------------------------------------------------------------------------- 35 Index ----------------------------------------------------------------------------------------------- 37 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 in 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 "block". A block consists of a start time and frequency. beats per minute.

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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. 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 mis-use.

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 the nearest A&D office if you have questions.

Blood pressure measurement Use the recorder for adult. 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 value. 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.

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 backup battery when turning the power switch off. The backup battery life is few days.

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 Page 3

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. 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.

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 this cuff. The cuff contains dry natural rubber.

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Notes on the Blood Pressure Recorder Storage Do not store the recorder in the following places. Where the recorder might be splashed with water or other liquids. If the recorder 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. Where medicines are stored, or medicines are evaporating.

Before use Cover the RS-232C terminal using the rubber cap, to avoid dust. Confirm that the recorder works correctly and measurement values are proper. Confirm that the cuff and air house are connected properly. Confirm parts of contact with patient directly. Keep clean for these parts. Use clean cuff cover because of contact with patient directly. Clear the old data before starting a new measurement. Avoid strong magnetic field and static electricity. Do not use this recorder with a high frequency surgical equipment.

During use The recorder should be operated by a physician who knows it well. Use the recorder only during the time of diagnosis or medical treatment. Stop the use, if the patient feels pain in his arm or the recorder does not measure properly. It may reduced the measurement cycle due to environment. When an inside part of the recorder has been soaked (wetted), turn off the power switch and request service to 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 (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. Dispose of Li coin battery in the recorder as dangerous object properly. 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-hours 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.

Product overview Packing List and Component Names When you open this box, make sure you have everything as shown here: Instruction manual

1

Blood pressure recorder (Main unit) Carrying case

1

Shoulder band

1

Belt

1

Cuff covers for adult cuff

2

Activity record sheets

10

Adult cuff for left arm

1

1

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Yellow mark Battery cover

Air hose

Auto ON/OFF key

Shoulder band

Adult cuff for left arm

Start Stop key Air hose plug Air socket Carrying case Belt Reset key Power switch RS-232C terminal

Alkaline batteries (type LR6, type AA, Mignon) The batteries are not included in this pack. Name Power switch

Functions This is the main power switch. At the OFF state, all data and parameters are preserved by an 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 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. Page 7

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 the "S" turned off, the time interval is 15 minutes. With the "S" turned on, the time interval is 30 minutes. Low battery 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. Full memory 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.

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, Cuffs and tubings are designed to have special protection against electric shocks. Page 8

Specifications Features Portability The recorder weighs approx. 215g (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-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 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 Section "Data Transmission to a Printer" for specifications of the printer.) The recorder has the built-in chargeable coin Li 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 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, these 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 the memory. Page 9

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 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 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 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 300 sets of data (the memory capacity is 300). 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 encourage that a patient's data is recorded, transferred and is cleared from memory. Page 10

When a "B" is displayed, the backup batteries that is preserving a patient’s data are weak. Please transfer the data and save it to other media 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.

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 ~ 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 Apporx. 200 times (It may reduce this number due to environment and capacity of Ni-Cd batteries) Memory Up to 300 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-hours (1997~2096year, automatic leap year setting) Batteries 3 x Alkaline battery (type LR6, type AA, Mignon) or 3 x Ni-Cd battery (type AA, Mignon) Type of protecting Internally powered equipment type BF against electric shock CE Marking The label of the medical device 0366 by the EC directive. C-Tick Marking The certification trade mark registered N92 to the ACA by the Trademark office. AAMI : Association for the Advancement of Medical Instrumentation ACA: the Australian Communications Authority CE marking and C-Tick marking are labeled only where they are required. Page 11

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

Stop bits

Data bits

Environment specifications Operating environment Transport and Storage

｡ ｡ ｡ ｡ + 10 C ~ +40 C (+50 F ~ +104 F), Less than 85%RH * ｡ ｡ ｡ ｡ - 20 C ~ +55 C ( -4 F ~ +131 F), Less than 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

SYS/INTERVAL DIA PULSE/TIME

72

START STOP

AUTO ON/OFF

0

1

2

3

4

5

6

7

8

AIR

27

9

0 1 2

100

UNIT:mm Page 12

The complete procedure for use A Step by Step Procedure Step 1

Battery replacement. Replace with new alkaline batteries (note direction). Refer to page 14, "Replacing Batteries".

Step 2

Turn on the recorder using the power switch.

Step 3

With the recorder turned on, select any operation to set the state.

Step 3

Case 1

Case 1 Normal

Normal state

The buzzer is sounded once and the clock is displayed. You can use this recorder at once. The recorder stores parameters for "display and clock" and "automatic measurement". Please proceed to Step 5 .

Case 2

Step 1

Step 2

Error state

Case 2 Error

When the recorder displays the error code, it is necessary to set up parameters for "display and clock" and "automatic measurement". Please proceed to the next step. Step 4

Set up parameters for "display and clock". When you use automatic measurement, set up parameters for automatic measurement. Refer to "Parameters for the Display and Clock" and "Selection for the Automatic Measurement". Please proceed to Step 6 .

Step 5

Set up new parameters for "display and clock" and "automatic measurement", if necessary.

Step 6

Delete the old data stored in the recorder. Refer to the section "Deleting Old Data".

Step 6

Step 7

Explain the "Patient Instructions" and "Notes on the Blood Pressure Recorder "to the patient.

Step 7

Step 4

Step 5

Next page

Page 13

Previous page Step 8

Attach the cuff to the patient. Refer to "Attaching the Cuff and Recorder".

Step 9

Attach the carrying case to patient and insert the recorder. Refer to "Attaching the Cuff and Recorder".

Step 9

Step10 Start the automatic measurement. The recorder displays

Step 10

an "A". Refer to "Automatic Measurement". Step11 The recorder starts the automatic measurement sequence.

Check the recorder using the manual measurement with relaxed, but correct posture. Refer to "Manual Blood Pressure 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.

Step13 When the automatic measurement sequence is finished,

turned off "A" sign. Refer to "Automatic Measurement".

Step 8

Step 11

Step 12

Step 13

Step14 Detach the cuff and recorder from the patient.

Step 14

Step15 Transfer the patient’s data and save it to other media.

Step 15

Refer to "Data transfer". Step16 Clean the cuff and recorder and place in storage. Refer to

the sections "Before use" and "Maintenance".

Step 16

End

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Initializing the recorder Replacing Batteries Caution When "B" is displayed before a measurement, the recorder can not make a measurement. Please replace the new batteries before using. If "B" is displayed during the measurement, stop the measurement and replace the new batteries at once. 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.

Battery cover Step 1 Step 5

Step 4 Step 2

Power switch

Step 3

New alkaline batteries Used batteries

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The State of Turning on the Recorder There are three types of state when the recorder is turned on. Select a operation. Refer to the section "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 is sounded once and is displayed blinking. The buzzer sounds four times and is displayed blinking.

State of recorder The recorder storage parameters of "display and clock" and "automatic measurement". All parameters are lost.

Treatment (Operation) You can use the recorder at once.

Set up parameters of "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 up 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 Years (1997 ~ 2096) 6 01 ~ 12 Month 7 01 ~ 31 Day 8 00 ~ 23 Hour 9 00 ~ 59 Minute Page 16

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 so as to display . (A selection where a clock is displayed 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 17

Selection for the Automatic Measurement This setting initializes measurement intervals that is 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 the "S" is off, the measurement is performed every quarter hour. When the "S" is displayed, the measurement is performed every half hour.

mode III The measurement interval can change 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 so as to display mode II.

AUTO ON/OFF

Step 3

Press the START STOP key. The recorder stores the mode and displays the clock.

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of

START STOP