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A&D TM-2440 Instruction Manual
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A&D TM-2440 Instruction Manual

A&D TM-2440 Instruction Manual

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Ambulatory Blood Pressure Monitor
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1WMPD4004784
2210

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Summary of Contents for A&D TM-2440

  • Page 1 English (Original) Ambulatory Blood Pressure Monitor Español Français 1WMPD4004784 2210...
  • Page 2 2022 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 for the instrument covered by this manual are subject to change for improvement without notice.
  • Page 3 Compliance Compliance with FCC Rules This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation. (FCC = Federal Communications Commission in the U.S.A.) FCC CAUTION Changes or modifications not expressly approved by the party...
  • Page 4 Compliance with the Australian EMD Framework The device conforms to the following requirements: EMD Emission standard for industrial, Scientific & Medical equipment AS/ NZS 2064:1997, EMD Generic Immunity standard AS/NZS 4252. 1:1994. ® Bluetooth Transmission This device is equipped with a Bluetooth wireless function and can connect to the Bluetooth device that is Bluetooth wireless technology enabled medical devices.
  • Page 5 Warning Definitions To prevent accidents due to inappropriate handling, this product and its manual contain the following warning signs and marks. The meanings of these warning signs and marks are as follows. Warning Definitions An imminently hazardous situation that will result in death Danger or serious injury, if not avoided.
  • Page 6 Precautions for Use In order to use the TM-2441 (the recorder for the ambulatory blood pressure monitor) safely and correctly, read the following precautions carefully before using the monitor. The following content summarizes general matters affecting the safety of patients and operators, as well as safe handling of the monitor. Precautions for each operation are described in the pages of this manual.
  • Page 7 Caution Operation conditions: Temperature : +10 °C to +40 °C, Humidity: 30 %RH to 85 %RH (no condensation). Transport and storage conditions: Temperature: -20 °C to +60 °C, Humidity: 10 %RH to 95 %RH (no condensation). 2. Precautions Before Using the Recorder. Caution Confirm that the recorder is operating safely and correctly.
  • Page 8 Preparation of the Recorder Delete the last data stored in the recorder before it is used by the next patient. Replace the batteries before the recorder is used by the next patient. Device Use the recorder for diagnosis and countermeasures only. Confirm that the air hose and cuff are worn correctly.
  • Page 9 Caution Do not touch the battery and the patient at the same time. It may cause an electric shock. Do not mix old batteries with new ones. Do not use batteries of different type and manufacturer. If these are used, this may cause leakage, heat and explosion. The recorder may malfunction.
  • Page 10 Note Instructions for Patient If the temperature is low, battery power becomes lower and the measurement count is reduced. 5. Precautions After Using the Recorder. Caution Processing work of Measurement Data Be sure to process measurement data immediately using a dedicated peripheral. The Recorder After cleaning the accessories, arrange and store them.
  • Page 11 Note Precautions After Using the Recorder (TM-2441) Be sure to process measurement data immediately using a dedicated peripheral after finishing measurement. Backup Lithium Rechargeable Battery The recorder comes with a backup lithium battery. This battery supplies power to the built-in clock when replacing AA batteries used for blood pressure measurement.
  • Page 12 6. Remedies When the Device Has an Error Warning Stop the operation and remove the AA batteries. If the battery terminals are shorted, the battery may be hot. In the event of a failure, the recorder may get hot during measurement, please handle it with care.
  • Page 13 8. Precautions and Remedies for a Malfunction Due to a Strong Electromagnetic Field Caution The recorder complies with EMD-standard IEC60601-1-2: 2014. However, to prevent electromagnetic interference with other devices, do not use mobile phones near the recorder. If the recorder is located near strong electromagnetic fields, noise may affect the waveforms and malfunctions may occur.
  • Page 14 Caution If there is static electricity in the area of use (discharges from devices or the surrounding area) Before using the recorder, ensure that the operator and patient have discharged any static electricity. Humidify the room. Use close to an IEEE802.11g/b/n wireless LAN device may cause mutual interference to occur, which may result in reduced communication speeds or prevent connection.
  • Page 15 Precautions For Safe Measurement This section describes precautions for measurement and the sensor. Notify the patient of following content and explain it to them. Guide the patient in the correct use of the device. Blood Pressure Measurement Warning Ensure the tube is not bent excessively and that air flows properly.
  • Page 16 Caution Wear the cuff at the same level as heart. (If the level is different, an error in the measurement value occurs.) The recorder responds to artifact and external impact. If there are any doubts in the measurement value, measure blood pressure by auscultation or palpation.
  • Page 17 Note Blood pressure cannot be measured correctly if the patient is moving or talking during measurement. Clinical trials have not been conducted on newborn infants and pregnant women. Consult a doctor before use if you have had a mastectomy. Cuff Warning Dispose of cuffs contaminated by blood to prevent infectious disease from spreading.
  • Page 18 Packing List Caution The recorder is a precision instrument. Use with caution. Excessive shock may cause failure and malfunction. Note The recorder is shipped using a special packing box designed to protect it from damage during transport. When you open this box, make sure you have everything on the packing list.
  • Page 19 Adult cuff for left arm Large cuff for left arm Blood pressure recorder Adult cuff cover ×2 Carrying holder Clip Large cuff cover ×2 Belt Activity record sheet (10 sheets) Data manager instruction simplified manual USB cable Quick start guide This instruction manual xvii...
  • Page 20 xviii...

  • Page 21: Table Of Contents

    Contens Compliance ......................i Compliance with FCC Rules ................i Compliance with IC Rules ...................i Compliance with the Australian EMD Framework ..........ii ® Bluetooth Transmission ..................ii Warning Definitions ....................iii Precautions for Use ....................iv Precautions For Safe Measurement ..............xiii Blood Pressure Measurement ................
  • Page 22 5.3.2. S-BPM Operations ............... 23 5.3.3. Other Operations ................. 25 Blood Pressure Measurement Functions ..........27 6.1. Automatic Blood Pressure Measurement (A-BPM) ......27 6.1.1. A-BPM Waiting Mode ..............29 6.1.2. Sleep Function and Interval time ..........29 6.1.3. Stopping Measurement ..............30 6.1.4.
  • Page 23 8.2.3. Initial Pressurization Value of S-BPM .......... 50 8.3. A-BPM Preset Programs ..............50 8.3.1. A-BPM Items and Parameters ............. 52 8.3.2. A-BPM Program Examples ............55 8.3.3. Start Time and Operation Time ........... 57 8.4. S-BPM Programs ................58 8.4.1.
  • Page 24 9.5. Troubleshooting ................88 9.6. Error Codes ..................89 Optional Items (requiring order) ............92 Appendix ....................94 11.1. Principle of Blood Pressure Measurement ........94 11.2. EMD Information ................97 Limited Warranty ..................100...

  • Page 25: Blood Pressure Measurement

    1. Introduction Thank you for your Purchase! The TM-2441 ambulatory blood pressure recorder enables accurate measurement of patient blood pressure automatically for preset times (e.g. 24-hours continuously). This manual explains the settings, operation, modes and programs for blood pressure measurement, as well as communication with a dedicated peripheral, maintenance, specifications and warnings.
  • Page 26 Purpose of use The recorder is equipped with two modes for blood pressure measurement. Blood pressure values can be used for consulting with doctors and self-health management. Automatic blood pressure measurement (A-BPM) This mode can specify six pairs of arbitrary start times and intervals for every 24 hours and can automatically measure and record blood pressure.
  • Page 27 Extensive analytical performance The measurement interval time can be set for the automatic blood pressure measurement. The blood pressure can be measured immediately using manual measurement at any time. S-BPM is equipped with five programs for varying conditions. The analysis can be carried out effectively using the ABPM Data Manager software installed in a computer (dedicated peripheral) or via the cloud-based Heart Track Pro for ABPM app and portal (if purchased).

  • Page 28: 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 /min Unit of pulse rate/minute Mark indicating heartbeat during measurement. Bluetooth is being used. Displaying: A-BPM is in operation.
  • Page 29 Symbols Meaning Degree of protection against electric shock: Equipment type BF. Manufacturer of the CE Marking. Date of manufacture. Symbol for small cuff SMALL Arm circumference 15 to 22 cm 5.9" to 8.7" Symbol for adult cuff ADULT Arm circumference 20 to 31 cm 7.8"...
  • Page 30 Symbols Meaning Blood pressure measurement Automatic blood pressure measurement Self-blood pressure measurement Sleep, Cycle, Hour, BPM symbols. START, Operation OBP, AOBP, HBP, BPM symbols. ANBP, ASBP Pairing, Flight Mode Bluetooth symbols. #3 Not made with natural Caution for patient. This is printed on rubber latex.
  • Page 31 IHB indicator When the monitor detects an irregular rhythm during measurement, the IHB indicator will appear on the display with the measurement values. (S-BPM only) 1 scope "1 scope" in S-BPM consists of a set of blood pressure measurements and interval times which are repeated for the number of the measurement count.
  • Page 32 Waiting mode The A-BPM waiting mode is a state where the blood pressure is not being measured during the interval time. Blood pressure measurement Start time Start time Time T: Interval time Section Section The S-BPM waiting mode is a state when the blood pressure is not being measured during the interval time and between the previous "1 scope"...

  • Page 33: Specifications

    4. Specifications 4.1. Recorder Items Descriptions Measurement method Oscillometric measurement method Pressure detection Semiconductor pressure sensor method Pressure display range 0 to 299 mmHg Pressure: ±3 mmHg Measurement accuracy Pulse rate: ±5 % Minimum Pressure: 1 mmHg display division Pulse rate: 1 beat / minute Systolic pressure: 60 to 280 mmHg...
  • Page 34 Items Descriptions Memory Measurement data: 600 data points max. With the same type of batteries: 2 x 1.5V batteries (LR6 or AA size) Alkaline battery or nickel-hydride battery Power supply (Ni-MH) 1900 mAh or more Backup battery for built-in clock: Lithium rechargeable coin cell battery ML2016H 200 times or more.
  • Page 35 Items Descriptions Degree of protection Type BF: The recorder, cuff and tubing are against electric shock designed to provide special protection against electrical shock. Dimensions Approx. 95 (L) × 66 (W) × 24.5 (H) mm Mass Approx. 135 g (excluding batteries) Recorder: 5 years.

  • Page 36: Dimensions

    4.2. Dimensions 24.5 Unit: mm...

  • Page 37: Component Names

    5. Component Names 5.1. Recorder Artery position mark Adult cuff and large cuff for left arm Air hose Air plug Air socket EVENT switch for A-BPM OLED for A-BPM START switch STOP for A-BPM switch AUTO for A-BPM START switch LOCK switch STOP...

  • Page 38: Display

    5.2. Display Note To get accurate diagnosis, take care to accurately read the data displayed on the recorder and interpret it properly. 5.2.1. LCD Panel (Liquid crystal display) Upper figures Middle figures Lower figures The following values can be displayed in each mode: Measurement A-BPM S-BPM...

  • Page 39: Oled Display (Organic Light Emitting Diode)

    5.2.2. OLED Display (Organic light emitting diode) The state of A-BPM is indicated on the OLED. Clock time. The state of settings and operation. The measurement value of A-BPM. Systolic blood pressure. Diastolic blood pressure. Pulse rate. mmHg Unit for blood pressure value. /min Unit for the pulse rate.

  • Page 40: Principal Switch Operations

    5.3. Principal Switch Operations 5.3.1. A-BPM Operations To start or suspend A-BPM. To switch between A-BPM and S-BPM Step 1. Store the preset program (of start times and intervals) for A-BPM. Step 2. Set the AUTO switch for the following operations. "ON"...
  • Page 41 To stop during A-BPM When the START/STOP switch is pressed during blood pressure measurement, the air is expelled 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 42 To adjust the clock. To set the monitor function of A-BPM. Step 1. Set the AUTO switch to "OFF". Step 2. If the display is hidden, press the START/STOP or EVENT switch to return to the waiting mode display. Step 3. While pressing and holding the START/STOP switch, press and hold the EVENT switch until Display (after Sleep ) is displayed on the OLED.

  • Page 43: S-Bpm Operations

    5.3.2. S-BPM Operations To start S-BPM. Step 1. Select the S-BPM program and store its parameters. Step 2. Set the AUTO switch to "OFF". Step 3. Operations are as follows: S-BPM Programs Operations Office blood pressure OBP Press the switch to Automated office blood pressure AOBP start the preset program during waiting mode.
  • Page 44 To set the program for S-BPM. Step 1. Set the AUTO switch to "OFF". Step 2. While pressing and holding the switch, press and hold the START/STOP switch until is displayed on the LCD. Step 3. The operations are as follows: Refer to "8.4.

  • Page 45: Other Operations

    5.3.3. Other Operations To return from the waiting mode and show the monitor. If the OLED or LCD display is hidden, press the START/STOP or EVENT switch to return to the waiting mode display. Deleting measurement data Step 1. Set the AUTO switch to "OFF". Step 2.
  • Page 46 ® To pair for Bluetooth communication. Step 1. Set the AUTO switch to "OFF". Step 2. If the display is hidden, press the START/STOP or EVENT switch to return to the waiting mode display. Step 3. Press and hold the EVENT switch until Pairing (after FlightMode ) is displayed on the OLED.

  • Page 47: Blood Pressure Measurement Functions

    6. Blood Pressure Measurement Functions The recorder is equipped with automatic blood pressure measurement (A-BPM) and self-blood pressure measurement (S-BPM) and can store measurement states and measurement results. 6.1. Automatic Blood Pressure Measurement (A-BPM) When A-BPM is suspended or is not used, set the AUTO switch to "OFF".
  • Page 48 mark is displayed on the LCD while A-BPM is used. Blood pressure is measured automatically at A-BPM start time. An initial pressurization value of A-BPM is AUTO, so that a proper pressurization value is selected automatically. If the first pressurization is insufficient, re-pressurizations are performed automatically up to two times.

  • Page 49: A-Bpm Waiting Mode

    6.1.1. A-BPM Waiting Mode Items to monitor the measurement state can be displayed on the LCD during the waiting time for A-BPM. In the waiting mode, the indicators are hidden automatically. Press any switch to show the display items. The A-BPM waiting mode is a state when blood pressure is not measured during the interval time.

  • Page 50: Stopping Measurement

    6.1.3. Stopping Measurement When the START/STOP switch is pressed during the blood pressure measurement, the air is expelled 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 displayed on the OLED and is stored in the memory.

  • Page 51: Self Blood Pressure Measurement (S-Bpm)

    6.2. Self Blood Pressure Measurement (S-BPM) Set the AUTO switch to "OFF" to use S-BPM programs. The recorder is equipped with five types of S-BPM programs in accordance with varying measurement environment conditions. Parameters and measurement results can be stored in the memory. Name Descriptions &...

  • Page 52: S-Bpm Programs

    6.2.1. S-BPM Programs Office blood pressure When the switch is pressed, blood pressure is measured once and is stored in the memory. Blood pressure measurement Time Press the switch to start the measurement. Automated office blood pressure AOBP When the switch is pressed, AOBP is started.
  • Page 53 Home blood pressure When the switch is pressed, HBP is started. The HBP performs a "1 scope". "1 scope" consists of a set of blood pressure measurements and interval times which are repeated to the number of the measurement count. The last interval time is omitted. When the switch is pressed during the "1 scope", the "1 scope"...
  • Page 54 Automated night blood pressure ANBP The ANBP can specify up to six preset start time a day. When parameters for the ANBP program are stored, the ANBP is started and a "1 scope" is performed for each start time. A "1 scope" consists of a set of blood pressure measurements and interval times which are repeated to the number of the measurement count.
  • Page 55 Automated self-blood pressure ASBP The ASBP can specify up to six preset start time for the alarm. When parameters for the ASBP program are stored, the ASBP is started and the buzzer sounds at each start time. Press the switch to perform a "1 scope" when the buzzer sounds. "1 scope"...

  • Page 56: S-Bpm Waiting Mode

    1 scope Not measured 1 scope Time Press the switch to stop "1 scope". Press the switch to start "1 scope". T: Interval time Start time of alarm 6.2.2. S-BPM Waiting Mode Operation mode and pressure value are displayed on the LCD during S-BPM waiting mode.

  • Page 57: Stopping And Suspending Measurement

    6.2.3. Stopping and Suspending Measurement Note When A-BPM is stopped, the stop code is displayed on the LCD and is stored in the memory. S-BPM Programs Operations Office blood pressure Automated office Press the switch to stop blood blood pressure AOBP pressure measurement.

  • Page 58: Measurement Results

    6.3. Measurement Results 6.3.1. Displaying Measurement Results The monitor function can select "Display ON" or "Display OFF" for the A-BPM measurement result. This function cannot be used for S-BPM. The content of the "Display ON" command includes "Pressure value during the measurement", "Measurement result" and "Error code for the measurement result".

  • Page 59: Outputting Measurement Results

    6.3.3. Outputting Measurement Results The measurement data stored in the memory can be output to the peripheral using USB data transfer. Refer to "8.8 Connecting the Recorder to a Dedicated Peripheral". Caution Do not remove the cable while using USB communication. It may cause damage to the data.

  • Page 60: Preparing The Recorder

    7. Preparing the Recorder 7.1. Installing the Batteries (Replacing Batteries) Caution Install two new batteries 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 will not be used for a long period of time.
  • Page 61 Procedure Install batteries. Step 1. Open the battery cover. Step 2. Remove the used batteries. Step 3. Refer to the direction symbol ( ) inside of the battery compartment. Insert two new batteries in Open. the proper "+" and "-" direction.

  • Page 62: How To Replace Batteries

    7.1.1. How to Replace Batteries Measurement results and setting parameters are saved when the 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 the batteries are replaced. Refer to "8.2.2.

  • Page 63: Inspection For Use

    7.3. Inspection for Use Caution Inspect the recorder to maintain its performance, safety and effectiveness before use. Confirm the following checklist before/after installing the batteries. If a problem is found, stop using the recorder and attach a "Malfunction" or "Do not use" message. Contact your local dealer to repair it.

  • Page 64: Battery Post-Installation Checklists

    7.3.2. Battery Post-installation Checklists Portion Description Check that there is no fire, smoke and strong 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 can be performed Measurement correctly and that the attachment of the cuff, the measurement, display and results are correct.

  • Page 65: Operation

    8. Operation 8.1. Operation Flowchart Note The initial settings (of the built-in clock, monitor function and initial pressurization value) and preset program (A-BPM and S-BPM) do not need to be stored every time. They are stored when deleted, updated and when the recorder is used for the first time.
  • Page 66 Installing the batteries. The initial settings of the built-in clock, measurement monitor function and pressurization value. A-BPM S-BPM Save A-BPM preset program. Save S-BPM preset program. Attach the recorder and cuff. Attach the recorder and cuff. Move the AUTO switch Move the AUTO switch to "ON".

  • Page 67: 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 (indicated) Year, Month, Day, Hour, Minute Date of shipment Items of A-BPM Item Factory setting Sleep mode Interval time when the sleep mode is ON 30 minutes...

  • Page 68: The Clock And The Monitor Function Of Measurement

    Items of S-BPM Item Factory setting Program selection Office blood pressure (OBP) Office blood pressure N.A. Measurement count 2 counts Automated office blood pressure AOBP Interval time 5 minutes Measurement count 2 counts Home blood pressure Interval time 1 minute Start time of section 2 hours Automated night blood...
  • Page 69 Procedure of operation using switches Step 1. Set the AUTO switch to "OFF". Step 2. If the display is hidden, press the START/STOP or EVENT switch to return to the waiting mode display. Step 3. While pressing and holding the START/STOP switch, press and hold the EVENT switch until Display (after Sleep ) is displayed on the OLED.

  • Page 70: Initial Pressurization Value Of S-Bpm

    8.2.3. Initial Pressurization Value of S-BPM An initial pressurization value of S-BPM can be set beforehand. 160, 180, 210, 240, 270, AUTO [mmHg] If AUTO is specified, a proper initial pressurization value is selected automatically. The factory setting is 180 mmHg. Step 1.
  • Page 71 Operation using switches Step 1. Set the AUTO switch to "OFF". Step 2. If the display is hidden, press the START/STOP or EVENT switch to return to the waiting mode display. Step 3. While pressing and holding the START/STOP switch, press and hold the EVENT switch until Sleep is displayed on the OLED.

  • Page 72: 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 = ON, OFF Interval Cycle xx xx = OFF, 5, 10, 15, 20, 30 , 60, 120 minutes time Hour Start time xx xx = 0 to 23 hours Section Interval...
  • Page 73 : When the sleep mode is set to "ON", the start time and operation time of the automated measurement and the interval time of the sleep mode can be used. The interval time for these sections (1 to 6) cannot be used. : When the sleep mode is set to "OFF", the interval time for the sleep mode is not displayed.
  • Page 74 Note When the start time is specified and the AUTO switch is set to "OFF" during the automated measurement, it stops. When the AUTO switch is set to "ON" again, the automated measurement is started immediately. The content of the item Sleep mode: The interval time for the automated measurement can be specified.

  • Page 75: A-Bpm Program Examples

    8.3.2. A-BPM Program Examples Example Start times and intervals. Simplified input. Double sections The start time for section 1 = 7:00 The interval time for section 1 = 15 The start time for section 2 = 22:00 The interval time for section 2 = 60 7:00 ....
  • Page 76 Example 2 Automatic measurement The start time for the automated measurement = 7:00, The operation time for the automated measurement = OFF. When the AUTO switch is set to "ON", A-BPM is started at 7:00. A-BPM is continued according to the start time and interval of each section until the AUTO switch is set to "OFF".

  • Page 77: Start Time And Operation Time

    Even if the AUTO switch is turned to "OFF" once and is turned to "ON" again during the automated measurement, the automated measurement does not continue beyond the operation time. 8.3.3. Start Time and Operation Time When the start time of the automated measurement is specified and the AUTO switch is set to "ON"...

  • Page 78: S-Bpm Programs

    8.4. S-BPM Programs The initial settings can be configured using the following methods. Using switches on the recorder. Using a dedicated peripheral that is connected to the recorder using the USB cable. Procedure for operation using switches Step 1. Set the AUTO switch to "OFF". Step 2.

  • Page 79: S-Bpm Items And Parameters

    8.4.1. S-BPM Items and Parameters Program Item Parameter S-BPM program Program OBP , AOBP, HBP, ANBP, ASBP Office blood pressure N.A. N.A. Automated office blood pressure Measurement count 1 to 5 counts AOBP Interval time 3 to 10 minutes Home blood pressure Measurement count 1 to 5 counts Interval time...

  • Page 80: S-Bpm Display Examples

    8.4.2. S-BPM Display Examples Office blood pressure display OBP has no settings to configure. Automated office blood pressure display AOBP AOBP uses preset the measurement count and interval time. AOBP performs a "1 scope" after a waiting mode to relax. Refer to "6.2.1.
  • Page 81 Automated night blood pressure display ANBP The ANBP can specify up to six preset start times for the "1 scope". Refer to "6.2.1. S-BPM Programs" for the "1 scope". When the last start time is the same as first start time, the settings for start time finish.
  • Page 82 Automated self-blood pressure display ASBP The ASBP can specify up to six preset start times for the alarm. The buzzer sounds at each start time. Press the switch to perform the "1 scope" when the buzzer sounds. Refer to "6.2.1. S-BPM Programs" for the "1 scope". When the last start time is the same as first start time, the settings for start time finish.

  • Page 83: Deleting Measurement Data

    8.5. Deleting Measurement Data Purpose of operation and explanation of function Measurement data is deleted but the settings are not deleted. The initial settings can be configured using the following methods. Using switches on the recorder. Using a dedicated peripheral that is connected to the recorder using the USB cable.

  • Page 84: Attaching The Product To The Patient

    8.6. Attaching the Product to the Patient 8.6.1. 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. Stay in the same position throughout measurement.
  • Page 85 For the A-BPM and ANBP and ASBP modes of S-BPM, only the current blood pressure measurement can be suspended and the "1 scope" is performed at the next start time. Set the AUTO switch to "OFF" to suspend A-BPM. Remove the cuff if the current blood pressure measurement cannot be stopped using the START/STOP switch.

  • Page 86: Cuff Cover

    Precautions when wearing the recorder The recorder is a precision instrument. Do not drop or jolt the recorder. The recorder and cuff are not waterproof (water resistant). Protect the product from contact with rain, sweat and water. Do not put anything on the product. When the cuff is moved by excessive motion and exercise, attach the cuff again.

  • Page 87: Attaching The Cuff, Carry Holder And Recorder

    8.6.3. Attaching the Cuff, Carry holder and Recorder Caution Do not attach the cuff if the patient has dermatitis, external wounds, etc. Remove the cuff and cease use if dermatitis or other symptoms appear on the patient. Prevent the air hose from coiling around the neck and body. Take care when using around infants, as there is a danger of suffocation.
  • Page 88 How to put on the cuff, recorder and holder Step 1. Pass the end of the cuff through the ring and make a bracelet shape. Step 2. Find the brachial artery in the 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 89 Air hose Tape Clip Air hose Cuff Belt Carry holder Air plug Air socket Insert Carry holder Belt...
  • Page 90 Cuff Arm protector Correct Arm protector flat against the arm. Arm is protected Incorrect Skin can be seen Arm protector folded under the arm. Arm is not protected...

  • Page 91: Blood Pressure Measurement Operations

    8.7. Blood Pressure Measurement Operations 8.7.1. A-BPM Operations When A-BPM is started, the blood pressure is measured in accordance with the preset parameters. Note Set the built-in clock and initial pressurization value before measurement, as A-BPM uses them. Refer to "8.2.2. The Clock and the Monitor Function of Measurement"...
  • Page 92 To suspend A-BPM Step 1. Set the AUTO switch to "OFF". Step 2. The mark is hidden. A-BPM is suspended. To Stop during A-BPM When the START/STOP switch is pressed during blood pressure measurement, the air is expelled immediately and the current measurement is stopped.

  • Page 93: S-Bpm Operations

    8.7.2. S-BPM Operations Note Set the built-in clock and initial pressurization value before measurement because they are used for S-BPM. Refer to "8.2.2. The Clock and the Monitor Function of Measurement" and "8.4. S-BPM Programs". Remove the batteries when the patient removes the recorder and cuff when ANBP or ASBP is used (even during the waiting mode).
  • Page 94 To measure blood pressure during S-BPM immediately. (Manual blood pressure measurement for S-BPM) Step 1. If the LCD display is hidden, press the START/STOP or EVENT switch to return to the S-BPM waiting mode display. Step 2. Press the switch during S-BPM waiting mode. The blood pressure measurements of "1 scope"...

  • Page 95: Manual Measurement

    8.7.3. Manual Measurement Use 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 for A-BPM) Step 1.

  • Page 96: Stopping And Suspending Measurements

    8.7.4. Stopping and Suspending Measurements Ongoing A-BPM, S-BPM and manual blood pressure measurement can be stopped or suspended immediately. Note When blood pressure measurement is stopped, the stop code is displayed on the OLED and is stored in the memory. To suspend A-BPM Step 1.
  • Page 97 To stop or suspend S-BPM Operations are as follows: S-BPM Programs Operations Office blood pressure Automated office Press the switch to stop blood blood pressure AOBP pressure measurement. Home blood pressure Press the switch to stop blood Automated night pressure measurement. At next start time, blood pressure ANBP blood pressure is measured or the buzzer sounds.

  • Page 98: Connecting The Recorder To A Dedicated Peripheral

    8.8. Connecting the Recorder to a Dedicated Peripheral 8.8.1. Connecting with a USB cable Refer to the instruction manual of ABPM Data Manager concerning of the communication settings. Caution Connecting the cable Connect an authorized USB cable to the micro USB terminal. Insert the cable in the correct direction.
  • Page 99 To connect the recorder to a dedicated peripheral using the USB cable Step 1. Open the micro USB terminal on the recorder. Connect the accessory USB cable. Micro USB terminal USB cable To start data communication with a dedicated peripheral Step 1.

  • Page 100: Using Bluetooth ® Communication

    ® 8.8.2. Using Bluetooth Communication A Bluetooth device needs to be paired with a device in order to communicate with the device. Once the recorder is paired with a device, devices can automatically communicate. Heart Track Pro for ABPM If you are using Heart Track Pro for ABPM, you must pair the recorder with a supported tablet or phone to configure blood pressure measurement studies.

  • Page 101: Suspending Bluetooth ® Communication (Airplane Mode)

    Step 4. When Bluetooth pairing is complete, the mark is displayed on the LCD. If you cancel the current pairing, press the EVENT switch. The recorder proceeds to the waiting mode display. ® 8.8.3. Suspending Bluetooth Communication (Airplane mode) The airplane mode can suspend Bluetooth communication. Using airplane mode Step 1.

  • Page 102: 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 reliably ensure the safety of the patient and the operator. As a basic rule, the operator should inspect this instrument daily, such as by following the "Inspection before use".

  • Page 103: Cleaning The Product

    9.2. Cleaning the Product Caution Clean the recorder before use and after use. Clean the recorder before attaching to the next patient. Do not spray water and immerse in water to clean the recorder. This may cause a malfunction. Dry the recorder after wiping it with water and the antiseptic solution, so that the liquid does not penetrate the recorder.
  • Page 104 Cleaning the cuff When you clean and disinfect the cuff cover and cuff cloth, remove the cuff bladder inside the cuff cloth. Clean the dirt and dust using gauze moistened with water or warm water and squeezed well. Refer to the antiseptic solutions in the table (Example of useable antiseptic solution (ingredient name)) when disinfecting.

  • Page 105: Periodic Inspection

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

  • Page 106: Battery Post-Installation Inspection

    9.3.2. Battery Post-installation Inspection Item Description No fire, smoke or strong smells. Exterior No strange sounds. No trouble with the functioning of switches Operation and buttons. Measurement values are close to the usual Measurement value. Cuff No strange sounds or actions during measurement.

  • Page 107: Disposal

    9.4. Disposal Follow the laws of the local government for environmental protection for the disposal and recycling of the product. 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 Caution The recorder is equipped with a backup battery inside.

  • Page 108: Troubleshooting

    9.5. Troubleshooting Consult the following checklist and error code list before contacting your local dealer. If these measures do not rectify the problem or the problem occurs again, contact your local dealer. Problem Main cause Treatment No display after Battery power has been Replace with new pressing any switches.

  • Page 109: 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. Check the cuff connection. Failure of If there are no problems with the cuff pressurization connection, the recorder may have...
  • Page 110 Code Meaning Cause and treatment Excessive body Relax and keep still during motion. measurement. Out of range, If these errors occur multiple times, try Out of range, another blood pressure measurement. PP = SYS - DIA SYS: Systolic blood pressure Out of range, DIA: Diastolic blood pressure Pulse pressure...
  • Page 111 Code Meaning Cause and treatment Body motion may be detected during pressurization. Relax and do not move during 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 on the recorder Code Meaning...

  • Page 112: Optional Items (Requiring Order)

    Optional Items (requiring order) Cuffs Name Description Order code Small cuff Arm circumference TM-CF202D for left arm 15 to 22 cm 5.9" to 8.7" Adult cuff Arm circumference TM-CF302D for left arm 20 to 31 cm 7.8" to 12.2" Large cuff Arm circumference TM-CF402D for left arm...
  • Page 113 Data analysis Name Description Order code USB cable AX-KOUSB4C Others Name Description Order code Activity record sheet 10 sheets AX-PP181-S Carry holder AX-133025995 Belt AX-00U44189 Clips 5 pieces AX-110B-20-S...

  • Page 114: Appendix

    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 115 Cuff pressure (Left arm) mmHg 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 116 Proper cuff size Use a cuff of adequate size. If it is too small or too big, a measurement error occurs. Measurements with a cuff that is too small tend to be evaluated as high blood pressure, regardless of the proper blood pressure and normal arteries.

  • Page 117: Emd Information

    11.2. EMD Information The requirements that apply to medical electronic instruments are described below: Performance within the EMD guidelines The use of the recorder require special precautions for EMD (Electromagnetic Disturbances). Operate the recorder in accordance with the warnings for EMD described in this manual. Portable and mobile RF communication equipment (e.g.
  • Page 118 IMMUNITY TEST LEVELS: Enclosure Port Phenomenon Immunity test levels ±8 kV contact Electrostatic discharge IEC 61000-4-2 ±2 kV, ±4 kV, ±8 kV, ±15 kV air 10 V/m Radiated RF EM fields 80 MHz - 2.7 GHz IEC 61000-4-3 80 % AM at 1 kHz See table (Test specifications for Proximity fields from RF wireless ENCLOSURE PORT IMMUNITY...
  • Page 119 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Pulse modulation 380 - 390 TETRA 400 18 Hz GMRS 460 430 - 470 ±5 kHz deviation FRS 460 1 kHz sine Pulse modulation 704 - 787 LTE Band 13,17 217 Hz GSM 800/900 TETRA 800...

  • Page 120: Limited Warranty

    12. Limited Warranty Monitor Warranty Term: 2 Years Cuff & Accessory Warranty Term: 1 Year Limited Warranty: A&D Medical (“A&D”) warrants to the first purchaser (“the Owner”) that the A&D product the Owner purchased (the “Product”) will be free from defects in material, workmanship and design for the applicable Warranty Term stated above from the date the Owner purchased the Product under normal use.
  • Page 121 have satisfactory proof of the date of Owner’s purchase and a description of the defect. Returns will not be accepted unless a Return Material Authorization (RMA) Number has been issued from A&D Customer Service Representative. This Limited Warranty does not cover, and A&D will not be liable for (i) any shipment damage, (ii) any damage or defect due to misuse, abuse, failure to use reasonable care, failure to follow written instructions enclosed with the Product, accident, subjecting the...
  • Page 122 HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. Some states do not allow the exclusion of incidental or consequential damages, so that the above exclusions may not apply to the Owner. This warranty gives the Owner specific legal rights, and the Owner may also have other rights that may vary from state to state.
  • Page 123 MEMO...
  • Page 124 Manufactured by/ Fabricado por/ Fabriqué par: A&D Company, LTD. 1-243 Asahi, Kitamoto-shi, Saitama-ken 364-8585 JAPAN Telephone: [81] (48) 593-1111 Fax: [81] (48) 593-1119 Manufactured for/ Fabricado para/ Fabriqué pour: A&D Engineering, Inc. 4622 Runway Boulevard Ann Arbor, MI 48108 USA andmedical.com Phone / telephone: 1-888-726-9966 Distributed in Canada by/ Distribué...

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