TM-2430 RECORDER FOR AMBULATORY BLOOD PRESSURE MONITOR INSTRUCTION MANUAL Ambulatory Blood Pressure Monitor WM:PD4000136 Rev. 1.
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Contents Before use Compliance ----------------------------------------------------------------------------Definitions ------------------------------------------------------------------------------Precautions for Use ------------------------------------------------------------------Notes on the Blood Pressure Recorder-----------------------------------------Welcome Welcome and Introduction ---------------------------------------------------------Product overview Packing List and Component Names ------------
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 EN 60601-1 (General Safety Provisions), EN 60601-2-30 (Particular Requirements for the Safety of Automatic Cycling Indirect Blood Pressure Monitoring Equipment) , EN 606011-2 and EN 55011 (Electromagnetic Compatibility); European Standards pertaini
Precautions for Use Precautions ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ Batteries Use alkaline batteries (LR6 type, AA type, Mignon) or suitable Ni-Cd batteries. Do not mix new and used batteries in the recorder. If the recorder will not be used for a long period of time, remove the batteries from the recorder unless there is no risk of a SAFETY HAZARD arising. A malfunctioning recorder If the recorder malfunctions, contact your vendor immediately.
Notes on the Blood Pressure Recorder ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ Ni-Cd ❏ Storage Do not store the recorder in the following places. Excessive moisture Excessive heat Direct sun light Excessive vibration Exposure to dust Exposure to corrosive chemicals Magnetic fields Before use Cover the RS-232C terminal using the rubber cap, to avoid dust. Confirm that the recorder works correctly. Confirm that the cuff and air hose are connected properly. Cuffs should be clean prior to use with patient.
Welcome Welcome and Introduction Thank you for your Purchase! The A&D TM-2430 ambulatory blood pressure recorder enables you to accurately take a patient's blood pressure, automatically, at different preset times throughout a 24-hour period. Recently, in the treatment of patients with hypertension, there has been an increasing need to prescribe medication according to the particular blood pressure fluctuation pattern of the patient.
Yellow mark Shoulder band Air hose Battery cover Adult cuff for left arm Auto ON/OFF key Start Stop key T AR P ST TO S Air hose plug AL RV TE IN ME I S/ SY IA E/T D ULS P TO F AU /OF ON 0 1 0 1 2 3 4 6 IR 5 A 2 7 8 Air socket 9 Carrying case ON OF F Reset key Power switch RS-232C terminal Belt 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.
Display Sleep sign Auto mode sign Low battery sign Full memory sign SYS/INTERVAL DIA PULSE/TIME Sign Setup sign of automatic measurement INTERVAL Setup sign of display and clock TIME Error display ex. "Set the clock" Sign A S SYS DIA Systolic Blood Pressure display Diastolic Blood Pressure display Pulse display PULSE Clock display Name Arrow Functions The arrow points to the kind of current display in the measurement result and function mode.
Specifications Features Portability ❏ The recorder weighs approx. 215g (including batteries) and is compact. ❏ The recorder is powered by LR6 type (AA) alkaline batteries. It is possible to replace the batteries with Ni-Cd rechargeable batteries. Operation & management ❏ Clock and automatic measurement parameters may be set as needed. ❏ If you connect to a computer and use the optional software, clock and automatic measurement parameters can be easily set. ❏ There are three modes for automatic measurement.
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.
Performance specifications Measurement method Oscillometric Pressurization Display range 0 ~ Interval measurement Manual measurement 320 mmHg 85 ~ 300 mmHg (Fitted) 185 mmHg (Fixed) Measurement range Systolic Blood Pressure 60 ~ Diastolic Blood Pressure 40 ~ Pulse rate 30 ~ Accuracy Pressure Blood pressure 280 mmHg 160 mmHg 200 bpm ±3 mmHg Conforming to 1992 AAMI standard (±3 mmHg or ±2% measurement whichever is greater) Pulse rate ±5 % Minimum display division Pressure 1 mmHg Pulse rate 1 bp
Communications/Data Output Interface Specifications Connected to a computer, you can output the data and enter parameters. Connected to a printer, you can print the data.
Activating the recorder Replacing Batteries Caution ❏ When "B" is displayed, the recorder can not take a measurement. Please replace the new batteries before using. ❏ If "B" is displayed during the measurement, replace with new batteries at once. ❏ Use alkaline batteries or the specified rechargeable batteries for the recorder. ❏ Do not mix new and used batteries in the device. Steps for replacing the batteries Step 1 Open the battery cover. Step 2 Turn off the power switch.
Conditions When Recorder Switched On The recorder can be turned on in 3 different modes. When recorder is turned on. The beeper sounds once and the clock is displayed. (Normal mode) The beeper is sounded once and E00 blinks. The buzzer sounds four times and E00 blinks. Condition Actions The recorder parameters You can use the recorder at once. are stored Set up parameters of "display and clock" and "Automatic meaThe mode after reset. All surement". parameters are lost. All parameters are lost.
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 for adjusting the display and clock. START STOP 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.
Selection for the Automatic Measurement This setting initializes measurement intervals that is based on the internal 24hour clock. Mode mode I mode II 07:00 ~ 21:59 22:00 ~ 06:59 The measurement is performed every quarter hour. The measurement is performed every half hour. 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.
Mode III Settings Set up 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 blocks starting time must match the previous blocks finish time. ❏ The end of block 6 automatically equalizes to start time of the block 1. ❏ If you enter the block 1 start time in any other block, these parameters are saved and this sequence is finished.
Steps for automatic measurement ex. First block 08:00 ~ 21:59 frequency is 30 minutes Second block 22:00 ~ 05:59 frequency is 60 minutes Third block 06:00 ~ 07:59 frequency is 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 so as to display mode III. for 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.
From previous page Step13 Press the START STOP key. The current frequency of the third block is displayed. START STOP Step14 Press the AUTO ON/OFF key so as 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 START STOP key.
Deleting Old Data Caution ❏ ❏ When the data is to be deleted, confirm that the data has already been transferred and saved. It is not possible to recover data that has been deleted. It is not possible to completely delete data, if the START STOP key is released while the beeper sounds at Step 2. Steps for deleting old data Step 1 Press and hold the START STOP key until is displayed. If you want to cancel this process, press the AUTO ON/OFF key.
Preparing the patient Patient instructions Advise the patient on how to cope with mis-operation and contingencies. Cautions during automatic measurement ❏ Patient should relax and be quiet, when the recorder starts inflating the cuff. ❏ Minimize noise and movement during the measurements. ❏ The recorder displays the patient's blood pressure within one minute after the measurement. ❏ There is the possibility of re-measuring the blood pressure after the last measurement.
Use of the cuff cover Step 1 Pass the air hose through the slit. Step 2 Place the cover on the cuff as shown. Link them using the three velcro strips. Velcro Slit Cuff cover common use Velcro Velcro Velcro Slit Air hose Velcro Slit for air hose Velcro Air hose Slit for air hose Right arm cuff Left arm cuff Attaching the cuff and recorder Caution ❏ The standard cuff that is included with the TM-2430 is a left arm cuff.
Step 3 Attach the cuff directly against the skin so that the yellow mark is directly over the brachialis artery and space it one inch above the inside of the elbow and the lower edge of the cuff . Step 4 Wrap the cuff so that the ring is within the slide range, it is flat and does not slip down, but has room 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 adhesive tape.
Preparation of the Carrying Case ❏ ❏ Use the belt or shoulder band to attach the carrying case. We recommend the belt be used for added stability. Using the Belt Step 1 Insert the belt into the hole of the carrying case. Step 2 Pull the belt from the hole of the carrying case. Step 3 Carrying case Step 1 Step 2 Example Pass the belt through the ring. Step 3 Step 4 Step 5 Thread the belt through the front-hole and the rear-hole of the hook. Step 5 Ring Belt Insert the belt to the ring again.
Operation Automatic Measurement Caution ❏ Automatic measurement uses the internal clock and parameters of automatic measurement. Refer to section "Parameters for the Display and Clock" and "Selection for the automatic measurement" for setting these parameters. ❏ Press and hold the AUTO ON/OFF key for approx. 3 seconds so as to turn off "A" symbol on display, when the patient stops the automatic measurement or detaches the cuff.
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 "Doctor Pro" analysis software. Caution ❏ Cap the RS-232C terminal to prevent dust and foreign matter 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.
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 Cable" about the cable. Connection Step 3 On line (Ready) Set the printer to "ON LINE". Start Stop Step 4 Press the START STOP key. Then and the data is transmitted. Step 5 When the transmission is finished, played.
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 recorder displays . Refer to "Analysis Software and Communication Cable" about the cable.
Options and accessories Analysis Software and Communication Cables The ABPM Data Analysis Software is a powerful tool for analyzing ambulatory blood pressure data. The following features are incorporated in this program: • Statistical Analysis Statistical data may be viewed in full, partial, sleep, and awake periods by switching between clearly labeled tabs.
Cuffs and Other Accessories Cuffs ( for serial no. M0600001 to M0600500 ) Name Large cuff for left arm, 28 ~ 36 cm (11 ~ 14 inches) Adult cuff for left arm, 20 ~ 31 cm (18 ~ 12 inches) Small cuff for left arm, 15 ~ 22 cm (16 ~ 18 inches) Adult cuff for right arm, 20 ~ 31 cm (18 ~ 12 inches) Order code TM2430-02 TM2430-06 TM2430-07 TM2430-09 Cuffs ( for serial no.
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 this drawing.
Cleaning the cuff and recorder ❏ ❏ ❏ ❏ ❏ Before cleaning the recorder, remove the battery cover and turn the power switch off. 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.
Error codes Caution Error code The error code updates without announcement. Meaning E00 No clock parameter E03 Pressure zero error E04 Low battery Status Operation and Treatment All parameters are lost. Enter clock parameters. Refer to Reset status. "Setup of display and clock" 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.
Error code Meaning Status Operation and Treatment E30 Measurement is Air is exhausted from the Repair is necessary because of slow greater than 120 cuff, and an error code is inflation or slow constant exhaust. seconds. displayed. E31 The constant Air is exhausted from the exhaust is greater cuff, and an error code is than 60 seconds. E32 Clock error. Repair is necessary because of slow constant exhaust. displayed. An error code is displayed.
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