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TM-2430 RECORDER FOR AMBULATORY BLOOD PRESSURE MONITOR INSTRUCTION MANUAL Ambulatory Blood Pressure Monitor WM:PD Rev. 1.1 This mark informs you about the operation of the product. Note This manual
TM-2430 RECORDER FOR AMBULATORY BLOOD PRESSURE MONITOR INSTRUCTION MANUAL Ambulatory Blood Pressure Monitor WM:PD Rev. 1.1 This mark informs you about the operation of the product. Note This manual and or the TM-2430 may be changed at any time to improve the product without notice. Windows is the registered trademark of the Microsoft Corporation. Macintosh is the registered trademark of Apple Computer, Inc. EXCEL is the registered trademark of the Microsoft Corporation. Contents Before use Compliance Definitions Precautions for Use Notes on the Blood Pressure Recorder Welcome Welcome and Introduction Product overview Packing List and Component Names Display Symbols Specifications Features Functions and Specifications Activating the Recorder Replacing Batteries Conditions When Recorder Switched On Parameters for the Display and Clock Selection for the Automatic Measurement Deleting Old Data Resetting the Recorder Preparing the patient Patient Instructions Use of the Cuff Cover Attaching the Cuff and Recorder Preparation of the Carrying Case Operation Automatic Measurement (by Programed Time Intervals) Manual Measurement To Stop a Current Measurement Data transfer Data Transmission to a Printer Data Transmission to a Computer Using Analysis Software Options and accessories Analysis Software and Communication Cables Cuffs and Other Accessories Maintenance Checking Accuracy Cleaning the Cuff and Recorder Periodical inspection Problem Solving Error Codes 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 EN (General Safety Provisions), EN (Particular Requirements for the Safety of Automatic Cycling Indirect Blood Pressure Monitoring Equipment), EN and EN (Electromagnetic Compatibility); European Standards pertaining to Non Invasive Blood Pressure Instruments EN (General Requirements), EN (Supplementary Requirements for Electromechanical Blood Pressure Measuring Systems). The above is evidenced by the CE mark of conformity accompanied by the reference number of a designated authority. This device is designed for adults only. Compliance with FCC Rules Please note that this equipment generates, uses and can radiate radio frequency energy. This equipment has been tested and has been found to comply with the limits of a Class A computing device pursuant to Subpart J of Part 15 of FCC rules. These rules are designed to provide reasonable protection against interference when this equipment is operated in a commercial environment. If this unit is operated in a residential area it might cause some interference and under these circumstances the user would be required to take, at his own expense, whatever measures are necessary to eliminate the interference. (FCC: Federal Communications Commission in the U.S.A.) Compliance with the Australian EMC Frame work The device conforms to the following requirements: EMC Emission standard for industrial, Scientific & Medical equipment AS/ NZS , EMC Generic Immunity standard AS/ NZS The above is evidenced by the C-Tick label. Definitions SYS DIA DSD Exhaust Exhaust velocity Measurement cycle 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 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. Compliance Page 2 Before use Precautions for Use Precautions Batteries Use alkaline batteries (LR6 type, AA type, Mignon) or suitable Ni-Cd batteries. Do not mix new and used batteries in the recorder. If the recorder will not be used for a long period of time, remove the batteries from the recorder unless there is no risk of a SAFETY HAZARD arising. A malfunctioning recorder If the recorder malfunctions, contact your vendor immediately. Training Instruct the patient on how to stop the operation if there is an abnormal measurement, and how to remove the cuff if there is excessive arm pain. Provide patient with basic training on operation of ABPM system. Repair Do not open the recorder case. Patient should avoid magnetic fields and high frequency equipment. Contact your vendor for further instructions. Blood pressure measurement This device is intended for adult use only. The recorder may not make a measurement when a patient has continuous arrhythmia or the recorder senses noise due to the patients movement. Please check measurement values by other methods, if you suspect an erroneous value. Do not use this recorder on a person who is in critical condition or is in an intensive care unit. This device is intended for ambulatory patients. Saving power Turn off the power switch when not in use. Please transfer the data as soon as possible. All measurement data, clock parameters, measurement parameters and internal system parameters are preserved by a backup battery when turning the power switch off. The backup battery life is few days. Cuff Close the cuff fastener properly when attaching the cuff to a patient or replacing the cuff cloth. If the fastener is closed incorrectly, inflating cuff may damage the cuff. Before use Page 3 Precautions 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. Clear the old data before starting a new measurement. Avoid strong magnetic field and static electricity. Do not use this recorder near a high frequency surgical equipment. During use The recorder should be operated by a medical professional who knows it well. Stop using the recorder if the patient feels pain in the arm or if the recorder does not measure properly. If the recorder is exposed to excessive moisture, do not use. Immediately request service from vendor. After use Clean the recorder, cuff and accessories for the next use. Do not pull or kink hoses. Do not use organic solvent, antiseptic solution, etc. Turn off the power switch. Please use the original box for transportation of the monitor. Periodic maintenance The recorder is a precision instrument. Please check all functions (every year) periodically. Contact your nearest A&D office for this inspection. Environmental protection If you disuse the recorder, remove Ni-Cd battery and built-in Li battery from this recorder. Disuse Ni-Cd battery to its exclusive trash can because of recycling it. Dispose of Li ion battery in the recorder as dangerous object properly. Notes on the Blood Pressure Recorder Page 4 Before use Welcome Welcome and Introduction Thank you for your Purchase! The A&D TM-2430 ambulatory blood pressure recorder enables you to accurately take a patient's blood pressure, automatically, at different preset times throughout a 24-hour period. Recently, in the treatment of patients with hypertension, there has been an increasing need to prescribe medication according to the particular blood pressure fluctuation pattern of the patient. These patterns can be made more evident by using the TM-2430 recorder, and an analysis by a physician. This manual will explain in simple language how this recorder works. Patient This blood pressure recorder is designed for an adult patient. Environment This blood pressure recorder is used in a hospital and / or patient`s home. where complies with European directives. Product overview Packing List and Component Names When you open this box, make sure you have everything as shown here : Instruction manual Blood pressure recorder (Main unit) Carrying case Shoulder band Belt Cuff covers for adult cuff Activity record sheets Adult cuff for left arm Welcome Page 5 Welcome and Introduction 0 1 2 Air hose Battery cover Auto ON/OFF key Start Stop key Adult cuff for left arm Yellow mark Shoulder band START STOP Air hose plug AUTO ON/OFF SYS/INTERVAL DIA PULSE/TIME AIR ON OFF Air socket Carrying case Reset key Belt Power switch RS-232C terminal Alkaline batteries (type LR6, type AA, Mignon) The batteries are not included in this pack. Name Power switch AUTO ON/OFF key START STOP key RS-232C terminal Reset key Functions This is the main power switch. In the OFF state, all data and parameters are preserved by an backup battery. The backup battery life is approximately 10 days with the power off. 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. 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 . This terminal is used for data output to a printer or computer. The optional RS-232C cable is necessary to output the data. All data and parameters are deleted. Packing List and Component Names Page 6 Product overview Display Sleep sign Auto mode sign Low battery sign Full memory sign Sign SYS/INTERVAL DIA PULSE/TIME SYS Systolic Blood Pressure display INTERVAL Setup sign of automatic measurement DIA Diastolic Blood Pressure display TIME Setup sign of display and clock PULSE Pulse display Error display ex. Set the clock Clock display Sign Name Functions Arrow The arrow points to the kind of current display in the measurement A Automatic measurement result and function mode. A is displayed when the automatic measurement is selected. When you press and hold the AUTO ON/OFF key, this sign is S Sleep turned on or off alternately. When you press the AUTO ON/OFF key while in mode II of the B Low battery 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. When the recorder can not operate all functions due to low battery, this sign is displayed. The clock is still displayed. Please M Full memory replace the batteries at once. When data memory is at full capacity, this sign is displayed. In this case, you can not perform another measurement. Transfer the data save in other media and delete. Then the M turns off. Symbols Turning on the recorder. Turning off the recorder. Direction guide to install batteries. Direct current. SN Serial number Date of manufacture. Attention symbol. See instruction for use. Recorder, Cuffs and tubings are designed to have special protection against electric shocks. Product overview Page 7 Display Specifications Features Portability The recorder weighs approx. 215g (including batteries) and is compact. The recorder is powered by LR6 type (AA) alkaline batteries. It is possible to replace the batteries with Ni-Cd rechargeable batteries. Operation & management Clock and automatic measurement parameters may be set as needed. If you connect to a computer and use the optional software, clock and automatic measurement parameters can be easily set. There are three modes for automatic measurement. Mode 1 and Mode 2 are preprogrammed. Mode 3 is user programmable. The recorder can transmit data to a printer directly. (An adaptable printer is necessary to print the data. Refer to Section Data Transmission to a Printer for specifications of the TM-2480 printer.) The recorder has the built-in chargeable Li ion battery to keep the clock and automatic measurement parameters. Analysis The time interval may be changed as needed. The patient's blood pressure can be measured immediately at any time. If you use the optional software, you can analyze the data extensively. Smart measurement The measurement time is shortened by proper exhaust velocity control. The exhaust velocity adjustment is unnecessary, because the constant exhaust is properly controlled. In the automatic measurement cycle, these inflation values and stop values at exhaust are controlled to reduce the measurement time. Functions and Specifications Blood pressure measurement There are two ways of utilizing this device to record blood pressure measurements. Automatic measurement - This automatic measurement works in accordance with internal clock, preset time intervals and preset mode. The measurement data is saved in memory. Manual measurement Any time you press the START STOP key, a blood pressure measurement is performed immediately. The measurement data is saved in the memory. Features Page 8 Specifications Automatic measurement This measurement starts or stops using the AUTO ON/OFF key. When this measurement is started, the recorder begins to work in accordance with preset time intervals from the preset time of the internal clock. Refer to Selection for the automatic measurement . In the automatic measurement, an A appears in the upper left of the display. The recorder automatically measures the patient's blood pressure at the time that is pointed out by the frequency and the start time (by the programed time intervals). When a measurement error occurs and there is 10 minutes until the next measurement, the measurement is retried after approx. 30 seconds. If a measurement is retried, only the data from the retry is saved. The recorder automatically adjusts the proper pressure, exhaust velocity and end of measurement. Refer to Selection for the automatic measurement and Automatic 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 adjusts to the proper value after the first measurement. If the first inflation is not successful, the recorder retries twice. If you reset the recorder, the first inflation value is reset to 185 mmhg. Memory The TM-2430 recorder can store 300 sets of data. A data set consists of a SYS, a DIA and a pulse rate. When memory becomes full, the recorder displays an M . Until you clear the data, you can not measure blood pressure. When the recorder saves data for more than one patient, data management becomes complication. We recommend that patient data is transferred and cleared from memory. When a B is displayed, the backup batteries that is preserving a patient`s data are weak. Please replace batteries as soon as possible. ID number If you reset the recorder, the ID number is set to 1 . The ID number can be set using the optional software. Specifications Page 9 Functions and Specifications Performance specifications 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 ~ 200 bpm Accuracy Pressure ±3 mmhg Blood pressure 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 bpm Measurement Automatic measurement Manual measurement Number of measurements Apporx. 180 (Actual measurement number may vary due to environment and capacity of batteries) Memory Up to 300 sets of data Normal Clock Display During a measurement Pressure value After a measurement SYS, DIA and pulse rate Error code, function of concealing the measurement data Clock 24-hours (1997~2096 year, automatic leap year setting) Batteries 3 x Alkaline battery (type LR6, type AA) or 3 x Ni-Cd battery (type AA) Type of protection 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 to the ACA by the Trademark office. N92 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. Functions and Specifications Page 10 Specifications Communications/Data Output Interface Specifications Start bit 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 RS-232C 1-5V ~ -15V 0 +5V ~ +15V LSB MSB Data bits Stop bits Environment specifications Operating environment +10 C ~ +40 C (+50 F ~ +104 F), Less than 85%RH * Transport and Storage -20 C ~ +55 C (-4 F ~ +131 F), Less than 95%RH * * Non Condensing Physical specifications Dimensions 72(W) x 100(D) x 27(H) mm 2.8(W) x 3.9(D) x 1.0(H) in. Weight Approx. 215 g (0.47lb) excluding cuff SYS/INTERVAL DIA PULSE/TIME START AUTO 72mm STOP ON/OFF 27mm AIR mm Specifications Page 11 Functions and Specifications 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. 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 START STOP AUTO ON/OFF SYS/INTERVAL DIA PULSE/TIME AIR Step 5 Step 3 ON OFF Step 4 Step 2 Power switch New alkaline batteries Used batteries Replacing Batteries Page 12 Initializing the recorder 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 The recorder parameters are stored All parameters are lost. The mode after reset. All parameters are lost. Actions You can use the recorder at once. Set up parameters of display and clock and Automatic measurement 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 Items Sequence number Sequence number Parameter Value & range ~ ~ ~ ~ ~ 59 START STOP Meaning of parameters AUTO ON/OFF Selecting a seque
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