A&D TM-2440 Instruction Manual

A&D TM-2440 Instruction Manual

Recorder for ambulatory blood pressure monitor
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English (Original)
2440
2440
Recorder for Ambulatory Blood
Pressure Monitor
Ambulatory Blood Pressure Monitor
1WMPD4003473
1802

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Table of Contents
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Summary of Contents for A&D TM-2440

  • Page 1 English (Original) 2440 2440 Recorder for Ambulatory Blood Pressure Monitor Ambulatory Blood Pressure Monitor 1WMPD4003473 1802...
  • Page 2 2018 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 written permission of A&D Company, Limited. The contents of this manual and the specifications of the instrument covered by this manual are subject to change for improvement without notice.
  • Page 3: Compliance

    Compliance Compliance with European Directive The device conforms to Medical Devices Directive 93/42/EEC. This is evidenced by the CE mark of conformity accompanied by the reference number of a designated authority. The device conforms to RoHS Directive 2011/65/EU. Compliance with the Australian EMC Framework The device conforms to the following requirements: EMC Emission standard for industrial, Scientific &...
  • Page 4: Warning Definitions

    Warning Definitions To prevent accidents due to inappropriate handling, this product and its manual contain the following warning signs and marks. The meaning of these warning signs and marks are as follows. Warning Definitions An imminently hazardous situation that will result in death or serious injury, if not avoided.
  • Page 5: Precautions For Use

    Precautions for Use In order to use the TM-2440 (the recorder for ambulatory blood pressure monitor) safely and correctly, carefully read the following precautions before using the monitor. The following content summarizes general matters regarding the safety of patients and operators, in addition to safe handling of the monitor.
  • Page 6 Transport and storage conditions : Temperature : - 20 °C to +60 °C, 10 %RH to 95 %RH (no condensation). Humidity : 2. Precautions Before Using the Recorder. Confirm that the recorder operates safely and correctly. When the recorder is used in conjunction with other devices, it may cause an incorrect diagnosis or safety problems.
  • Page 7 Device Use the recorder for diagnosis and countermeasures only. Confirm that the air hose and cuff are worn correctly. (Example : kink and tension of the air hose, position and direction of the cuff) Instructions for Patient Wearing the Device Inform the patient how to suspend automatic blood pressure measurement to stop the recorder when alone if trouble occurs.
  • Page 8 4. Precautions During Use. Do not use the recorder while operating automobiles or other vehicles. Example : The recorder may inhibit motion of body or arms when operating vehicle. etc. This medical device can be only operated by doctor, authorized person by the law.
  • Page 9 Hold the connector housing when connecting and removing the cable. Do not pull the cable. Note Precautions After Using the Recorder (TM-2440) Be sure to process measurement data immediately using dedicated peripheral after finishing measurement. Backup Lithium Rechargeable Battery The recorder is built with a backup lithium battery.
  • Page 10 How to Extend the Life of the Backup Battery When first using after purchase or after storing for a month or more, replace batteries and charge the backup battery. It is enough if the backup battery is charged for 48 hours or more. (The backup battery is always charged by AA batteries.) Replace with two new AA batteries when the battery indicator displays When...
  • Page 11 7. Precautions of Maintenance Confirm correct performance and safety of the recorder when it not used for a long period of time. To maintain correct measurement and safety, perform inspection and maintenance before use. The user (hospital, clinic, etc.) is responsible for management of the medical equipment.
  • Page 12 The following examples are general causes of malfunction and countermeasures. Use of mobile phones Radio waves may cause unexpected malfunctions. Wireless communication devices, home networking devices such as walkie-talkies mobile phones, cordless phones and these types of communication devices can affect the recorder.
  • Page 13: Precautions For Safe Measurement

    Precautions For Safe Measurement The section describes precautions concerning the measurement and sensor. Always consult with a doctor for evaluation of the results and treatment. Self-diagnosis and self-treatment based on results can be dangerous. Blood Pressure Measurement Ensure the tube is not bent excessively and that air flows properly.
  • Page 14 Wear the cuff at the same level as heart. ( If the level is different, it occurs an error of the measurement value.) The recorder corresponds to artifact and shock. If there are any doubts in the measurement value, measure blood pressure by auscultation or palpation.
  • Page 15: Cuff

    Cuff Dispose of cuffs contaminated by blood to prevent infectious disease from spreading. Avoid manner storing the folded cuff or twisted air hose in a tightly for extended periods of time. Such treatment may shorten the life of the components. Measurement of Pulse Rate Do not use the displayed pulse rate for the diagnosis of the irregular heartbeat.
  • Page 16: Packing List

    Packing List The recorder is a precision instrument so use with caution. Excessive shock may cause failure and malfunction. Note The recorder is shipped out using a special packing box designed to keep it from damage during transport. When you open this box, make sure you have everything on the packing list.
  • Page 17: Blood Pressure Recorder

    Blood pressure Recorder Adult cuff for left arm Carrying holder Clip Adult cuff cover Belt Activity record sheet (10 sheets) Analysis software CD USB cable This instruction manual...
  • Page 19: Table Of Contents

    Contents Compliance .......................i Warning Definitions..................ii Precautions for Use ..................iii Precautions For Safe Measurement.............xi Blood Pressure Measurement ............xi Cuff ....................xiii Measurement of Pulse Rate...............xiii Packing List ....................xiv Introduction ..................4 Features ....................4 Abbreviations & Symbols..............6 Specifications..................11 4.1. Recorder.................. 11 4.2.
  • Page 20 Blood pressure measurement Functions........22 6.1. Automatic Blood Pressure Measurement (A-BPM)....22 6.1.1. A-BPM Waiting Mode............23 6.1.2. Sleep Function and Interval time..........24 6.1.3. Stopping Measurement............25 6.2. Measurement Result...............26 6.2.1. Displaying Measurement Results.........26 6.2.2. Storing Measurement Results ..........26 6.2.3. Outputting Measurement Results.........27 ID numbers ................27 6.2.4.
  • Page 21 8.4. Deleting Measurement Data...........43 8.5. Attaching the Product to the Patient........44 8.5.1. Information for Patients............44 8.5.2. Cuff Cover ................47 8.5.3. Attaching the Cuff, Carrying holder and Recorder....48 8.6. Blood Pressure Measurement Operations ......51 8.6.1. A-BPM Operations..............51 8.6.2. Manual Measurement ............53 8.6.3.
  • Page 22: Introduction

    1. Introduction Thank you for your Purchase! The TM-2440 ambulatory blood pressure recorder enables to accurate measurement of patient blood pressure automatically for preset times (e.g. 24-hours continuously). This manual explains the settings, operations, modes and programs of blood pressure measurement as well as communication to dedicated peripheral, maintenance, specifications and warning.
  • Page 23 Manual blood pressure measurement Blood pressure can be measured manually at any time, including when the A-BPM function is activated. Portability The weight of the recorder is approximately 120 g (excluding batteries). It is palm size and equipped a micro-pump. Two AA alkaline batteries can be used.
  • Page 24: Abbreviations & Symbols

    3. Abbreviations & Symbols Symbols Meaning Systolic blood pressure Diastolic blood pressure Pulse rate Pulse pressure PP = SYS - DIA Unit of blood pressure mmHg /minute /min Unit of pulse rate Blood pressure measurement Automatic blood pressure measurement A-BPM 24-hours blood pressure recorder.
  • Page 25 Symbols Meaning Adult Symbol printed on packing. cuff 20-31cm Adult cuff is included in accessories. 7.8"-12.2" Symbol printed on packing. 1.5V LR6 1.2V HR6 Batteries are excluded from accessories. not included Serial number Alert mark Error codes. = 00 to 99 Organic light emitting diode OLED Electromagnetic compatibility...
  • Page 26 Symbols Meaning Sleep, Cycle, Hour, A-BPM symbols. START, Operation Not made with natural Caution for patient. It is printed on the cuff. rubber latex. Cautions on battery cover. Caution Use alkaline batteries or specified • Use alkaline batteries or specified rechargeable batteries and ensure rechargeable batteries and ensure correct polarity (...
  • Page 27 I.H.B. The recorder detects an irregular heartbeat that differs ±25 % from the average pulse rate as I.H.B. ( Irregular Heartbeat ). The principal factors of appearance for I.H.B. are physiological factors along with heart, disease and other factors. Examples include body motion, an increase in body temperature, aging, physiological properties and emotional changes.
  • Page 28 Waiting mode A-BPM waiting mode is a state that blood pressure is not being measured during the interval time. Blood pressure measurement Start time Start time Time T : Interval time Section Section Dedicated peripheral Dedicated peripheral means the computer principally that analysis software is installed.
  • Page 29: Specifications

    4. Specifications 4.1. Recorder Items Descriptions Measurement method Oscillometric measurement method Pressure detection Semiconductor pressure sensor method 0 to 299 mmHg Pressure display range (299 mmHg or more is hidden ) Pressure : ±3 mmHg Measurement accuracy Pulse rate : ±5 % 1 mmHg Minimum...
  • Page 30 Items Descriptions With the same type of batteries : 2 x 1.5V batteries (LR6 or AA size) Alkaline battery or Nickel-hydrogen battery Power supply (Ni-MH) 1900 mAh or more Backup battery for built-in clock : Lithium rechargeable coin cell battery ML2016 DC 2.4 V and DC 3.0 V Rated voltage USB : USB1.1 compliant.
  • Page 31 Items Descriptions Recorder : 5 years. Self-authentication with internal data. Proper operation and Useful life maintenance in the best conditions. Durability varies with usage conditions. Ingress protection Device : IP22 Default mode Continuous measurement Restart time after Immediately defibrillation IEC 60601-1-2: 2007 Note: Specifications are subject to change for improvement without prior notice.
  • Page 32: Dimensions

    4.2. Dimensions 24.5 Unit : mm...
  • Page 33: Component Names

    5. Component Names 5.1. Recorder Artery position mark Adult cuff for left arm Air hose Air plug Air socket switch EVENT OLED display START switch STOP Battery compartment and 2 LR6 (AA size) batteries Battery cover for measurement Micro USB port (at bottom), Data communication terminal...
  • Page 34: Oled Display

    5.2. OLED Display Note To get accurate diagnosis, take care to accurately read the data displayed on the recorder and interpret it properly. The state of A-BPM is indicated on the OLED display. Clock time. The state of settings and operation. The measurement value of A-BPM.
  • Page 35: Principal Switch Operations

    5.3. Principal Switch Operations 5.3.1. A-BPM Operations To start or suspend A-BPM. Step 1. Store the preset program (of start times and intervals) for A-BPM. Step 2. Press and hold the EVENT switch for 3 seconds or more to switch between the following states. "ON"...
  • Page 36 To Stop during A-BPM When the START/STOP switch is pressed during the blood pressure measurement, the air is exhausted immediately and the current measurement is stopped. However, A-BPM is continued. The next blood pressure measurement is performed in accordance with A-BPM settings. To set the program for A-BPM.
  • Page 37 To adjust the clock. To set the monitor function of A-BPM. Step 1. If the indication of the display is hidden, press the START/STOP or EVENT switch to return to the display of waiting mode. Step 2. If the mark is shown, press and hold the EVENT switch for 3 seconds or more to suspend A-BPM.
  • Page 38: Other Operations

    5.3.2. Other Operations To return from waiting mode and show the monitor. If the indication of the OLED display is hidden, press the START/STOP or EVENT switch to return to the display of waiting mode. Deleting measurement data Step 1. If the indication of the display is hidden, press the START/STOP or EVENT switch to return to the display of waiting mode.
  • Page 39 To start data communication with dedicated peripheral using the USB cable. Step 1. Connect the micro USB cable between the recorder and dedicated peripheral. Step 2. The buzzer will sound and the following symbol appears on the OLED display. The state of data communication enters standby mode. Standby mode Step 3.
  • Page 40: Blood Pressure Measurement Functions

    6. Blood pressure measurement Functions The recorder is equipped with automatic blood pressure measurement (A-BPM) and can store measurement states and measurement results. 6.1. Automatic Blood Pressure Measurement (A-BPM) When the A-BPM function is not used, suspend the function by pressing and holding the EVENT switch for 3 seconds or more so that the mark turns off.
  • Page 41: A-Bpm Waiting Mode

    next start time is longer than 8 minutes, blood pressure is measured once after 120 seconds. The measurement result is stored in the memory. If you want to suspend A-BPM, press and hold the EVENT switch for 3 seconds or more. 6.1.1.
  • Page 42: Sleep Function And Interval Time

    6.1.2. Sleep Function and Interval time Set the sleep mode to "ON" in the preset program. When the EVENT switch is pressed during A-BPM, the interval time doubles. When the EVENT switch is pressed again in A-BPM, the interval time returns to original length. Refer to "8.3.
  • Page 43: Stopping Measurement

    6.1.3. Stopping Measurement When the START/STOP switch is pressed during the blood pressure measurement, the air is exhausted immediately and the current measurement is stopped. However, A-BPM is continued. The next blood pressure measurement is performed in accordance with A-BPM settings. Note When measurement is stopped, the stop code E07 is displayed on the OLED display and is stored in the memory.
  • Page 44: Measurement Result

    6.2. Measurement Result 6.2.1. Displaying Measurement Results The monitor function can select "Display ON" or "Display OFF" command of the measurement result of A-BPM. The content of "Display ON" command includes "Pressure value during the measurement", "measurement result" and "Error code for the measurement result".
  • Page 45: Outputting Measurement Results

    6.2.3. Outputting Measurement Results The measurement data stored in the memory can be output to the peripheral using USB data transfer. Refer to "8.7 Connecting the Recorder to Dedicated Peripheral". Note When the battery indicator displays , data transfer cannot be used.
  • Page 46: Preparing The Recorder

    7. Preparing the Recorder 7.1. Installing Batteries (Replacing Batteries) Install two new batteries in accordance with the correct "+" and "-" direction inside the battery compartment before attaching the recorder. Replace both batteries at the same time. Remove batteries from the recorder if it is not used for a long period of time.
  • Page 47 Procedure Install batteries. Step 1. Open the battery cover. Step 2. Remove used batteries. Step 3. Refer to the direction symbol ( ) inside of the battery compartment. Insert two new batteries in the proper "+" and "-" Step 1. Open. direction.
  • Page 48: How To Replace Batteries

    7.1.1. How to Replace Batteries Measurement results and setting parameters are saved when batteries are removed. When the built-in battery runs out charge, the date is reset to 01/01/2017 00:00. Check and adjust the current time when batteries are replaced. Refer to "8.2.2.
  • Page 49: Preparing The Carrying Holder

    7.2. Preparing the Carrying Holder Note When the carrying holder is attached, use the accessory belt. We recommend to use a belt to fit the recorder to the patient. Use accessory carrying holder when the recorder is used. To attach the carrying holder, put the carrying holder through accessory belt or the belt of the clothes wearing.
  • Page 50: Inspection For Use

    7.3. Inspection for Use Inspect the recorder to maintain the performance, safety, effectively before use. Confirm the following checklist before / after installing batteries. If a problem is found, stop to use the recorder and put the message of "Malfunction" or "Not use". Contact your local dealer to repair it.
  • Page 51: Battery Post-Installation Checklists

    7.3.2. Battery Post-installation Checklists Portion Description Check that there is no fire, smoke and offensive smells. Battery Check that there is no strange sound. Display Check that there is no strange display. Operation Check that the recorder operates correctly. Check that the measurement operation can be performed correctly.
  • Page 52 Installing the batteries. The initial settings of the built-in clock, measurement monitor function and pressurization value. A-BPM Save A-BPM preset program. (For 24 hours) Attach the recorder and cuff. Start A-BPM by pressing and holding the EVENT switch for 3 seconds or more. A-BPM Suspend A-BPM by pressing and holding the EVENT switch for 3 seconds or more again.
  • Page 53: Initial Settings

    8.2. Initial Settings 8.2.1. Factory Settings The factory settings (initial settings) are described below : Common items of the settings Item Factory setting Monitor function ON (is indicates them) Year, Month, Day, Hour, Minute Date of shipment Items of A-BPM Item Factory setting Sleep mode...
  • Page 54: The Clock And The Monitor Function Of Measurement

    8.2.2. The Clock and the Monitor Function of Measurement The initial settings can be configured using the following methods. The method to use switches on the recorder. The method to use dedicated peripheral that is connected to the recorder using the USB cable. Procedure of operation using switches Step 1.
  • Page 55: Initial Pressurization Value

    Clock Hour 0 to 23 hour Hour Clock Minute 0 to 59 minutes Min. Enclosed characters : Factory settings and initial settings when batteries are consumed completely. 8.2.3. Initial Pressurization Value The initial pressurization value is set to 180 mmHg at the factory. 8.3.
  • Page 56 Step 4. Specify the sleep mode using the following switches. If sleep mode is "ON", proceed to step 5. EVENT switch ....Change of the current parameter. START/STOP switch ..Decision, next item. Step 5. Specify the start time and interval up to six sections using the following switches.
  • Page 57: A-Bpm Items And Parameters

    8.3.1. A-BPM Items and Parameters The preset program for A-BPM is as follows : Item OLED Parameter Sleep Sleep mode xx xx = ON, OFF Interval Cycle = OFF, 5, 10, 15, 20, 30 , 60, 120 minutes xx xx time Start time Hour = 0 to 23 hour...
  • Page 58 : When the sleep mode is set to "ON", A-BPM is used the Start time and Operation time of the automated measurement. The Interval time of these sections (1 to 6) cannot use. : When sleep mode is set to "OFF", the Interval time is not displayed. : Example for automated measurement.
  • Page 59: A-Bpm Program Examples

    8.3.2. A-BPM Program Examples Example Start times and intervals. Simplified input. 24:00 Double sections 00:00 22:00 Section 2 The start time of section 1 = 7:00 The interval time of section 1 = 18:00 6:00 The start time of section 2 = 7:00 22:00 The interval time of section 2 =...
  • Page 60 Example 2 Automatic measurement The start time of the automated measurement = 7:00, The operation time of the automated measurement = OFF. After A-BPM is started, blood pressure measurement is started at 7:00. A-BPM is continued according to the start time and interval of each section until it is suspended.
  • Page 61: Deleting Measurement Data

    8.4. Deleting Measurement Data Purpose of operation and explanation of function Measurement data is deleted but settings are not deleted. The initial settings can be configured using the following methods. The method to use switches on the recorder. The method to use dedicated peripheral that is connected to the recorder using the USB cable.
  • Page 62: Attaching The Product To The Patient

    8.5. Attaching the Product to the Patient 8.5.1. Information for Patients Explain the following to the patient so that they can use the recorder safely. Precautions during the blood pressure measurement Relax the arm and stay quiet when inflation begins. Keep the same position throughput the measurement.
  • Page 63 How to stop or suspend the measurement Press the START/STOP switch to stop blood pressure measurement. An error code is stored in the memory. Blood pressure is measured again after 120 seconds. Concerning of A-BPM, only the current blood pressure measurement is stopped, and measurement will be performed at the next start time.
  • Page 64 How to use manual measurement during A-BPM Step 1. If the indication of the OLED display is hidden, press the START/STOP or EVENT switch to return to the display of A-BPM waiting mode. Step 2. Press the START/STOP switch to immediately measure the blood pressure during A-BPM.
  • Page 65: Cuff Cover

    8.5.2. Cuff Cover Note Keep the cuff and cuff cover clean. Change the cuff cover for each person. Use the cuff cover appropriate optional cuffs. The cuff cover can be used to on the right arm and left arm.
  • Page 66: Attaching The Cuff, Carrying Holder And Recorder

    8.5.3. Attaching the Cuff, Carrying holder and Recorder Do not attach the cuff if the patient has dermatitis, external wounds, etc. Remove the cuff and stop use if dermatitis or other symptom appear to the patient. Prevent air hose from coiling around neck and body. Take care when using around infants, as there is a danger of suffocation.
  • Page 67 How to put on the cuff, recorder and holder Step 1. Pass the end of the cuff through the ring and make the shape of bracelet. Step 2. Find the brachial artery of left arm using palpation. Step 3. Attach the cuff directly against the skin so that the white mark is directly over the brachial artery and the lower edge of the cuff is put on approximately 1 - 2 cm above the inside of the elbow.
  • Page 68 Step 5. Air hose Step 5. Tape Air hose Step 5. Clip Step 5. Cuff Step 7. Belt Step 7. Carrying holder Step 8. Air plug Step 8. Air socket Step 9. Insert Carrying holder Step 6. Belt...
  • Page 69: Blood Pressure Measurement Operations

    8.6. Blood Pressure Measurement Operations 8.6.1. A-BPM Operations When A-BPM is started, blood pressure is measured in accordance with the preset parameters. Note Set the built-in clock and initial pressurization value before measurement because A-BPM uses them. Refer to "8.2.2. The Clock and the Monitor Function of Measurement"...
  • Page 70 To suspend A-BPM Step 1. Press and hold the EVENT switch for 3 seconds or more. Step 2. The mark is hidden. A-BPM is suspended. To Stop during A-BPM When the START/STOP switch is pressed during the blood pressure measurement, the air is exhausted immediately and the current measurement is stopped.
  • Page 71: Manual Measurement

    8.6.2. Manual Measurement Use the manual blood pressure measurement for a tentative test measurement and immediate blood pressure measurement. Note Manual blood pressure measurement can start immediately in a waiting mode. The measurement result is stored in the memory. To measure blood pressure during A-BPM immediately. ( Manual blood pressure measurement of A-BPM ) Step 1.
  • Page 72: Stopping And Suspending Measurements

    8.6.3. Stopping and Suspending Measurements The A-BPM function can be suspended when necessary. And ongoing A-BPM or manual blood pressure measurement can be stopped immediately. Note When blood pressure measurement is stopped, the stop code E07 is displayed on the OLED display and is stored in the memory.
  • Page 73: Connecting The Recorder To Dedicated Peripheral

    Cable may become wrapped around the body or neck. Preparation of dedicated peripheral Remove the recorder and cuff from the patient before connecting the recorder (TM-2440) to dedicated peripheral. : We recommend to use the product that is complied with the IEC60601-1-2: 2007.
  • Page 74 To start data communication with dedicated peripheral Step 1. Connect the micro USB cable between the recorder and dedicated peripheral. Step 2. The buzzer will sound and the following symbol appears on the OLED display. The state of data communication enters standby mode. Standby mode Step 3.
  • Page 75: Maintenance

    9. Maintenance 9.1. Product Storage, Inspection and Safety Management Medical instruments such as this recorder must be managed so that they function properly when necessary and to reliably maintain the safety of the patient and operator. As basic rule, it is necessary that the patient inspects this instrument with daily checks such as the "Inspection before use".
  • Page 76 Check after Cleaning Confirm that the cuff bladder is correctly inserted inside the cuff cloth. If it is not correctly inserted, damage or explosion may occur during inflation. Cleaning the recorder Wipe the dirt and dust on the exterior of the recorder using soft dry cloth.
  • Page 77: Periodic Inspection

    9.3. Periodic Inspection Perform the daily periodic inspection to use recorder correctly. The inspection is described bellow : 9.3.1. Battery Pre-installation Inspection Items Description No damage or deformation from drops. Exterior No dirt, rust and scratches on any part. No cracking or rattling of the panel. Operation No damage for rattling of switches and buttons.
  • Page 78: Battery Post-Installation Inspection

    9.3.2. Battery Post-installation Inspection Item Description No fire, smoke or offensive smells. Exterior No strange sounds. No trouble with functioning of switches and Operation buttons. Measurement values are closely in usual value. Measurement No strange sounds or actions during Cuff measurement.
  • Page 79: Disposal

    9.4. Disposal Concerning the disposal and recycle of the product, for environment protection, follow the laws of the local government. Disposal of the cuff The cuff worn on the patient is medical waste. Dispose of it properly as medical waste. Disposal of the rechargeable built-in battery Remove and properly dispose of the lithium battery inside the recorder when the recorder is disposed.
  • Page 80: Troubleshooting

    9.5. Troubleshooting Consult the following checklist and error code list before contacting your local dealer. If this measures do not improve the problem or the problem occurs again, contact your local dealer. Problem Main cause Treatment No display after Battery power has been Replace to new batteries.
  • Page 81: Error Codes

    9.6. Error Codes Measurement error codes Code Meaning Cause and treatment Pressure zero error Release the air left in the cuff. Low battery Replace with new batteries. Inflation does not reach the target pressure. Confirm the cuff connection. Failure of If there are no problems with the cuff pressurization connection, the recorder may have...
  • Page 82 Code Meaning Cause and treatment Out of range, 30 ≦ PUL ≦ 200 If these errors occur multiple times, try Out of range, another blood pressure measurement. 30 ≦ DIA ≦ 160 PP = SYS - DIA SYS : Systolic blood pressure Out of range, DIA : Diastolic blood pressure 60 ≦...
  • Page 83 Code Meaning Cause and treatment Body motion may be detected at the pressurization. Relax and do not move while the measurement. Safety circuit detects over load pressure. If this error occurs even when relaxed and not moving, contact your dealer for inspection. Hardware error codes of the recorder Code Meaning...
  • Page 84: Optional Items (Requiring Order)

    10. Optional Items (requiring order) Cuffs Name Description Order code Small cuff Arm circumference TM-CF202A 15 to 22 cm 5.9" to 8.7" for left arm Adult cuff Arm circumference TM-CF302A 20 to 31 cm 7.8" to 12.2" for left arm Large cuff Arm circumference TM-CF402A...
  • Page 85 Data analysis Name Description Order code USB cable AX-KOUSB4C Others Name Description Order code 10 sheets Activity record sheet AX-PP181-S Carrying holder AX-133025995 Belt AX-00U44189 Ni-MH type, AA size, Rechargeable battery AS-3UTG-2BP 2 pieces Adaptor to charge battery AS-NC-M58 5 pieces Clips AX-110B-20-S...
  • Page 86: Appendix

    11. Appendix 11.1. Principle of Blood Pressure Measurement Measurement procedure : Wrap the cuff around the upper arm. Inflate the cuff to a pressure exceeding the systolic blood pressure. Then, exhaust the air from the cuff gradually. While the pressure is detected in the cuff in the air exhaustion stage, the pulse waveform appears in synchronization with the heartbeat.
  • Page 87 Cuff pressure (Left arm) Direct method (Left arm) Time Cuff pressure (Left arm) Direct method (Left arm) Time Systolic blood pressure Average blood pressure Diastolic blood pressure Microphone method Oscillometric measurement method Blood pressure measurement Error factors The pulse graph can be an objective indicator of the reliability of the measurement accuracy.
  • Page 88: Emc Information

    Proper cuff size Use a cuff of adequate size. If the size is too small or too big, a measurement error occurs. Measurements with too small a cuff tend to be evaluated as high blood pressure, regardless of the proper blood pressure and normal artery.
  • Page 89 Accessories compliant with EMC standards The accessories and options for this recorder accord with the condition of IEC60601-1-2:2007. Use accessories designated by the A&D company. Unauthorized accessories may be influenced by electromagnetic emission and have reduced immunity against disturbances. RF electromagnetic emissions Emissions test Compliance Electromagnetic environment...
  • Page 90 Electromagnetic immunity IEC60601-1-2 Compliance Electromagnetic Immunity test test level level environment Floors should be wood, ±6 kV ±8 kV Electrostatic concrete or ceramic tile. contact contact If floors are covered discharge (ESD) with synthetic material, ±8 kV ±15 kV IEC61000-4-2 the relative humidity in air in air...
  • Page 91 IEC60601-1-2 Compliance Electromagnetic Immunity test test level level environment Recommended separation distance : 3 V/m 10 V/m d = 1.2 Radiated RF 80 MHz to 80 MHz to 80 MHz to 800 MHz IEC61000-4-3 2.5 GHz 2.6 GHz d = 2.3 800 MHz to 2.5 GHz <5 % U (>95 % dip in U...
  • Page 92 Electromagnetic environment of Conducted RF and Radiated RF We recommend that the mobile and portable RF communication instruments are spaced from the transmitter by the recommended separation distance meters (m) or more. This is calculated with the frequency of the transmitter. Where is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
  • Page 93 Recommended separation distances The recorder is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Electromagnetic interference can be prevented by maintaining a minimum distance between portable or mobile RF communications equipment (transmitters) and the recorder as recommended below, according to the maximum output power of the communications equipment.
  • Page 94 MEMO...
  • Page 96 http://www.aandd.jp 1-243 Asahi , Kitamoto-shi, Saitama 364-8585, JAPAN Telephone: [81] (48) 593-1111 Fax: [81] (48) 593-1119 A&D INSTRUMENTS LIMITED http://www.andmedical.co.uk/ 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.

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