A&D Medical TM-2430 manuale d’uso

WM:PD4000136 Rev. 1.1 Ambulator y Blood Pressure Monitor INSTRUCTION MANUAL TM-2430 TM-2430 RECORDER FOR AMBULATORY RECORDER FOR AMBULATORY BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR[...]

Windows is the registered trademark of the Microsoft Corporation. Macintosh is the registered trademark of Apple Computer, Inc. EXCEL is the registered trademark of the Microsoft Corporation. This mark informs you about the operation of the product. Note This manual and or the TM-2430 may be changed at any time to improve the product without notice[...]

Page 1 Contents Before use Compliance ----------------------------------------------------------------------------- 2 Definitions ------------------------------------------------------------------------------- 2 Precautions for Use ------------------------------------------------------------------- 3 Notes on the Blood Pressure Recorder -----------[...]

Page 2 Compliance Before use Bef ore use Compliance Compliance with Eur opean Directiv e 93/42 EEC f or Medical Pr oducts The device conforms to the following requirements: European Directive 93/42 EEC for Medical Products; Medical Products Act; European Standards for Electrical Medical Equip- ment EN 60601-1 (General Safety Provisions), EN 60601-2[...]

Page 3 Before use Precautions Precautions f or 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[...]

Page 4 Notes on the Blood Pressure Recor der 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 record[...]

Page 5 W elcome W elcome and Intr oduction Thank you for your Pur chase! 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 n[...]

Page 6 ON OFF SYS/INTERV AL DIA PULSE/TIME AIR AUTO ON/OFF ST ART STOP 0 1 2 0 123 456 78 9 Air socket Air hose plug RS-232C terminal Power switch Alkaline batteries (type LR6, type AA, Mignon) Auto ON/OFF key Start Stop key Adult cuff for left arm Air hose The batteries are not included in this pack. Battery cover Reset key Y ellow mark Shoulder b[...]

Page 7 Product overview Display Display Sleep sign Auto mode sign Low battery sign Full memory sign SYS/INTERV AL DIA PULSE/TIME Pulse display Sign Setup sign of automatic measurement Systolic Blood Pressure display Clock display Setup sign of display and clock Error display ex. "Set the clock" Diastolic Blood Pressure display INTERV AL T[...]

Page 8 Features Specifications Specif ications F eatures 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 par[...]

Page 9 Specifications Functions and Specifications Automatic measurement ❏ This measurement starts or stops using the AUT O 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". ❏[...]

Page 10 Functions and Specifications Specifications P erf or mance specif ications Measurement method Oscillometric Pressurization Display range 0 ~ 320 mmHg Interval measurement 85 ~ 300 mmHg (Fitted) Manual measurement 185 mmHg (Fixed) Measurement range Systolic Blood Pressure 60 ~ 280 mmHg Diastolic Blood Pressure 40 ~ 160 mmHg Pulse rate 30 ~ 2[...]

Page 11 01234567 LSB MSB 1 0 -5V +5V ~ ~ RS-232C -15V +15V Stop bits Start bit Data bits Specifications Functions and Specifications Communications/Data Connected to a computer, you can output the data and enter Output parameters. Connected to a printer, you can print the data. Interface Specifications EIA RS-232C, Asynchronous, bi-directional, hal[...]

Page 12 Replacing Batteries Initializing the recorder Activ ating the recorder Replacing Batter ies 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 ba[...]

Page 13 1 5 6 7 8 9 Conditions When Recorder Switched On The recorder can be turned on in 3 different modes. Initializing the recorder Conditions When Recorder Switched On Actions You can use the re- corder at once. Set up parameters of "display and clock" and "Automatic mea- surement". When recorder is turned on. The beeper sou[...]

Page 14 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. AUTO ON/OFF ST AR T ST OP ST AR T ST OP ST AR T ST OP AUTO ON/OFF ST AR T ST OP AUTO ON/OFF ST AR T ST OP AUTO ON/OFF ST AR T ST OP AUTO ON/OFF ST AR T ST[...]

Page 15 Initializing the recorder Selection for the Automatic Measurement Selection f or the A utoma tic Measurement This setting initializes measurement intervals that is based on the internal 24- hour clock. Mode mode I 07:00 ~ 21:59 The measurement is performed every quarter hour. 22:00 ~ 06:59 The measurement is performed every half hour. mode [...]

Page 16 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 [...]

Page 17 Initializing the recorder Selection for the Automatic Measurement Steps for automatic measurement ex. First block 0 8:00 ~ 21:59 frequency is 30 minutes Second block 22:00 ~ 0 5:59 frequency is 60 minutes Third block 0 6:00 ~ 0 7:59 frequency is 10 minutes ST AR T ST OP ST AR T ST OP ST AR T ST OP ST AR T ST OP ST AR T ST OP ST AR T ST OP A[...]

Page 18 AUTO ON/OFF ST AR T ST OP ST AR T ST OP ST AR T ST OP From previous page Step 13 Press the ST AR T ST OP key. The current frequency of the third block is displayed. Step 14 Press the AUT O ON/OFF key so as to display "10" for 10 minutes as the frequency of the third block. Step 15 Press the ST AR T ST OP key. The current start tim[...]

Page 19 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 ST AR T ST OP key is released while the beeper sounds at Step 2. Steps for deleting old data Step 1 Pre[...]

Page 20 Prepar ing the patient P atient instr uctions 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 [...]

Page 21 Use of the cuf f co v er 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. Air hose Slit for air hose Left arm cuf f Air hose Slit for air hose Right arm cuf f Cuf f cover common use Slit V elcro V elcro V elcro Slit V elcro V elcro V elcro Attaching the cuf f an[...]

Page 22 Attaching the Cuff and Recorder Initializing the recorder 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 no[...]

Page 23 Initializing the recorder Attaching the Cuff and Recorder Preparation of the Carr ying 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. S[...]

Page 24 Operation A utomatic 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 AUT O ON/OFF key for approx. 3 seco[...]

Page 25 Data T ransfer ❏ 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[...]

Page 26 Data Transfer Data transmission to a printer Steps for data transmission Setup for printer Connection On line (Ready) Remove the cable Start Stop Step 1 Enter the parameters into the printer so that the data can be transmitted. Step 2 Connect the cable to both the recorder and printer. Then the recorder displays . Refer to "Analy- sis [...]

Page 27 Data Transmission to the Computer with Analysis Software Data transfer Data T ransmission to a Computer Using Analysis Soft- wa r e 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 t[...]

Page 28 Options and accessor ies Analysis Softw are and Comm unication 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 betwee[...]

Page 29 Cuffs and Other Accessories Options and accessories Cuf fs and Other Accessor ies Cuffs ( for serial no. M0600001 to M0600500 ) Name Order code Large cuff for left arm, 28 ~ 36 cm (11 ~ 14 inches) TM2430-02 Adult cuff for left arm, 20 ~ 31 cm ( 1 8 ~ 12 inches) TM2430-06 Small cuff for left arm, 15 ~ 22 cm ( 1 6 ~ 1 8 inches) TM2430-07 Adul[...]

Page 30 Maintenance Chec king Accurac y 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 C[...]

Page 31 Cleaning the cuf f 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, moiste[...]

Page 32 Error Code Maintenance Err or codes Caution The error code updates without announcement. Error code Meaning Status Operation and T reatment E00 E03 E04 E05 E06 E07 E08 E10 E20 E21 E22 E23 No clock parameter Pressure zero error Low battery Inflation error Above 320mmHg Controlled stop using STOP key Pulsation can not be measured Pulsations c[...]

Page 33 Maintenance Error Code Error code Meaning Status Operation and T reatment E30 E31 E32 E50 E52 E53 E55 E56 E57 E60 E70 E71 E72 E73 E74 E75 E90 E91 Other Air is exhausted from the cuff, and an error code is displayed. Air is exhausted from the cuff, and an error code is displayed. An error code is displayed. An error code is displayed at rest[...]

Page 34 MEMO[...]