A&D AND TM-2657P Instruction Manual
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A&D AND TM-2657P Instruction Manual

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English( Original )
 
TM-2657P
Automatic Blood Pressure Monitor
Instruction Manual
1WMPD4002893C
1906

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Summary of Contents for A&D AND TM-2657P

  • Page 1 English( Original )   TM-2657P Automatic Blood Pressure Monitor Instruction Manual 1WMPD4002893C 1906...
  • Page 2 © 2019 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 express written consent of A&D Company, Limited. The contents of this manual and the specifications of the instruments covered by this manual are subject to change without notice.
  • Page 3 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 which, if not avoided, will result in death Danger or serious injury.
  • Page 4 PRECAUTIONS FOR USE In order to use the TM-2657P Automatic 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. 1.
  • Page 5 Caution Use the monitor safely and correctly. Connect all cables correctly and securely. Do not place objects on the monitor or power cable. Ensure cuff cover is fitted before use. Using other devices in conjunction with this monitor may cause incorrect diagnosis or safety problems.
  • Page 6 4. After using the monitor. Caution Use the specified procedure to return switches to their state before usage, then switch the power off. Do not forcibly pull out the cables. Hold the connector with your hand when disconnecting the cables. Clean the accessories and arrange them before storage Keep the monitor clean and in proper operating condition so that it can be used without problem for the next operation.
  • Page 7 7. Be aware that strong electromagnetic waves can cause malfunctions. Caution This monitor complies with EMD-standard IEC60601-1-2:2014. However, to prevent electromagnetic interference with other devices, do not use mobile phones close to within 30 cm of near the monitor. If this monitor is located near strong electromagnetic waves, noise may enter in waveforms and malfunctions may occur.
  • Page 8 PRECUATIONS FOR SAFE MEASUREMENT The following lists precautions related to measurement. Always consult with a doctor for evaluation of the results and treatment. Self-diagnosis and self-treatment from results can be dangerous. Warning Do not measure on an arm receiving an intravenous drip or blood transfusion. This may cause an accident.
  • Page 9 UNPACKING Caution This monitor is a precision device and must be handled carefully. If it receives a strong impact, it may be damaged. Note This monitor has been shipped in specially designed packaging to prevent damage during shipping. Check the monitor for damage when unpacking it. Before using the monitor, ensure that everything is included and then check the main unit and each standard accessory for damage.
  • Page 10 [Blank page] viii...

  • Page 11: Table Of Contents

    TABLE OF CONTENTS INTRODUCTION ..........................3 FEATURES ............................3 ABBREVIATIONS AND SYMBOLS.....................4 SPECIFICATIONS ..........................6 4.1. Model configuration ........................6 4.2. Performance specifications .......................6 4.3. External dimensions ........................7 4.4. Operation principles ........................7 4.5. Standards and compliances ......................7 PART NAMES ...........................8 BEFORE USE ..........................11 6.1.
  • Page 12 10.13. Transmission speed (Mini-DIN) ................... 29 10.14. Transmission speed (D-Sub) ....................29 10.15. Stop bit (Mini-DIN) ....................... 29 10.16. Stop bit (D-Sub) ........................29 10.17. Blood pressure result output ....................29 10.18. Date format .......................... 30 10.19. Time format ......................... 30 10.20.

  • Page 13: Introduction

    INTRODUCTION This device conforms to the European Directive 93/42/EEC for Medical Products. This is evidenced by the CE mark of conformity accompanied by the reference number of a designated authority. This device is a blood pressure monitor that measures systolic and diastolic blood pressure and pulse rate for diagnosis and checkup.

  • Page 14: Abbreviations And Symbols

    ABBREVIATIONS AND SYMBOLS Abbreviation/ Meaning Symbol Alternating current mmHg Blood pressure unit /min. Heartbeats per minute Displayed when measurement is not possible Systolic blood pressure (Used for table printing) Mean arterial blood pressure (Used for printing, depending on settings) Diastolic blood pressure (Used for table printing) Pulse (used for table printing) Measurement time (used for table printing) Irregular Heartbeat symbol (IHB)
  • Page 15 What is IHB (Irregular Heartbeat)? When the monitor detects an irregular rhythm during the measurements, the I.H.B. indicator will appear on the display with the measurement values. Note We recommend contacting your physician if you see this ( ) I.H.B. symbol frequently. When is the IHB mark printed? The IHB mark is printed in the measurement data in the following two cases.

  • Page 16: Specifications

    SPECIFICATIONS 4.1. Model configuration Model TM-2657P-EX TM-2657P-EG Included functions Printer ○ ○ Measurement status LED ○ ○ Time,Date format 24hour,DD/month/YYYY 12hour,month/DD/YYYY 4.2. Performance specifications General AC Power supply 100 V-240 V～50 Hz-60 Hz Power consumption 50-80 VA Safety standard IEC60601-1:2012 MDD Classification Class IIa (continuous operation mode) EMD compliance...

  • Page 17: External Dimensions

    4.3. External dimensions Unit:mm 4.4. Operation principles The cuff pressure is raised to approximately 30 mmHg higher than the anticipated systolic pressure and then gradually depressurized. Pulsations occur in the cuff pressure that matches the heart rate. These pulsations have an undulating pattern. They start small and then gradually increase with depressurization.

  • Page 18: Part Names

    PART NAMES Front Name Description Open printer cover button Opens the printer cover. Printer paper opening Opening for printer paper to eject. Printer cover Holds down the printer paper. Power cable AC power cable. Displays the systolic blood pressure measurement value. Systolic blood pressure When a measurement error occurs, the error code is display...
  • Page 19 Rear Name Description SELECT button Used to change functions. If pressed when the number of measurements to date is displayed, the number of measurements is printed. ▲ button Used to change functions. Displays the number of measurements to date. (See “12.5. COUNT button Checking the number of measurements”) Bitmap SD socket cover...
  • Page 20 External input/output unit (option)  TM-2657-01 External input/output unit RS 2ch（option） Name Description Mini-DIN 8 pin female RS-232C D-Sub 9 pin male RS-232C  TM-2657-03 External input/output unit RS 1ch（option） Name Description D-Sub 9 pin male RS-232C  TM-2657-05 External input/output unit RS+Bluetooth（option） Name Description Bluetooth...

  • Page 21: Before Use

    BEFORE USE See the precautions at the beginning of this manual and install the monitor in an appropriate location using a safe and correct method. 6.1. Monitor installation Attaching the armrest Place the monitor on a stand so that measurement can be TM-2657 Cuff performed in an appropriate posture.

  • Page 22: Attaching The Instruction Panel

    6.4. Attaching the instruction panel See the illustration below to attach the instruction panel to the rear side of the monitor. Caution Make sure to attach the instruction panel to the main unit before use. ■ The instruction panel contains precautions that the patient must observe to use the monitor safely and correctly.

  • Page 23: Pre-Inspection

    6.5. Pre-inspection Warning Perform the pre-inspection every day to ensure safe and correct usage. ■ 6.5.1. Introduction Before using the monitor for the first time each day, perform the following pre-inspection. 6.5.2. Before switching the power on Is there any external deformation or damage to the monitor? Is the monitor wet? Is the monitor in a stable location free of tilting, vibrations and impacts? Blood pressure measurement section...

  • Page 24: Blood Pressure Measurement

    BLOOD PRESSURE MEASUREMENT Warning To stop blood pressure measurement halfway through, press the START/STOP ■ button. The cuff rapidly deflates and returns to its original state. If measurement cannot be stopped by pressing the START/STOP button, ■ press the FAST STOP button (on the front of the monitor). 1.

  • Page 25: Setting The Clock

    SETTING THE CLOCK To set the date and time, use clock setting mode. Clock setting mode has the following display. mmHg Year Selected item flashes mmHg Month /min. Hour Hour Minute Setting the date and time: Use the following buttons. SELECT button: 1.

  • Page 26: Printer

    PRINTER 9.1. Installing the printer paper Caution Do not pull the printer paper during printing. It may damage the printer head. 1. Press the Open printer cover button to open the printer cover. Open printer cover button Printer cover 2. Install the printer paper in the way shown in the illustration below. 3.
  • Page 27 If the high-speed printing mode is used, approximately 700 prints are possible from one printer paper roll. With 3-line printing mode, 600 prints are possible. When the end of the printer paper roll becomes pink, replace the paper. Use thermal paper only. If the following error codes are displayed in the systolic display section, a printer error has occurred.

  • Page 28: Selecting The Print Format

    9.2. Selecting the print format By configuring settings in “10. CHANGING FUNCTIONS”, users can format the information on the printout. The printing area is divided into 4 sections: print header, measurement value, graph and bitmap. Each section has printing items available for selection. For details, see “10.
  • Page 29 Printing example 1: Initial settings Printing example 2: F08: ID printing [3] F05: IHB [on] F05: IHB [on] (IHB detected) (No IHB detected) F26: Date format [1] F26: Date format [1] (EU format) (EU format) F27: Time format [24] F27: Time format [24] (24 hour) (24 hour) F11: Measurement value...

  • Page 30: Changing Functions

    CHANGING FUNCTIONS The multi-functional monitor can be configured for various applications by changing function settings. To change function settings, use the buttons located on the rear panel of the monitor while the monitor is in standby mode. 10.1. Procedure to Change Function Settings 1.
  • Page 31 Diastolic Setting Details Default display Function items section Height and weight values printing OFF Height and Printer mode printing weight values printing Integrated mode printing 〇 Not used ― Beep sound Beep sound on/off Not used ― No connection Mini-DIN: Blood pressure result input/output (STD/RI/RB/BP/RA) 〇...
  • Page 32 Diastolic Setting Details Default display Function items section ICT printing OFF 〇 Bar code printing (CODE39) QR code printing, including ID ICT printing Bar code printing (CODE39 , with check digit (modulus43 ) ) QR code printing V2 , including ID Bluetooth Connection at the end of measurement ○...

  • Page 33: Display Time

    10.2. Display time The display time for measurement results can be set using the function Use the ▲ button to change the setting. This setting appears in the diastolic display section. DIA LED Display time setting Default No display of results (All values are displayed as “---“) 5 seconds 10 seconds 20 seconds...

  • Page 34: Print Quality

    10.5. Print quality The print quality can be set using the function Use the ▲ button to change the setting. This setting appears in the diastolic display section. DIA LED Print quality setting Default Printing off Light printing (high speed) Standard printing Dark high-quality printing (low speed) 10.6.

  • Page 35: Mean Arterial Blood Pressure (Map) Printing

    10.7. Mean arterial pressure (MAP) printing Mean arterial pressure (MAP) printing can be set using the function Use the ▲ button to change the setting. This setting appears in the diastolic display section. DIA LED Mean arterial pressure printing Default Mean arterial pressure (MAP) printing off Mean arterial pressure (MAP) printing on When mean arterial pressure (MAP) printing is on:...

  • Page 36: Measurement Value Printing

    10.8. Measurement value printing Measurement value printing can be set using the function Use the ▲ button to change the setting. This setting appears in the diastolic display section. DIA LED Measurement value printing mode Default High-speed printing Normal 3-line printing Big font printing Table printing When Mean arterial pressure (MAP) printing is off:...

  • Page 37: Graph Printing

    10.9. Graph printing The graph printing settings can be set using the function Use the ▲ button to change the setting. This setting appears in the diastolic display section. DIA LED Graph printing Default Graph printing off Pulse fluctuation graph printing Printing example: Pulse fluctuation graph printing 10.10.

  • Page 38: External Input/Output Protocol

    10.12. External input/output protocol The protocol settings for connections can be set using the function Use the ▲ button to change the setting. This setting appears in the diastolic display section. External input/output unit ＜TM-2657-01＞ DIA LED External input/output unit (option) protocol Default No connection Mini-DIN:...

  • Page 39: Transmission Speed (Mini-Din)

    10.13. Transmission speed (Mini-DIN) The Mini-DIN transmission speed can be set using the function Use the ▲ button to change the setting. This setting appears in the diastolic display section. DIA LED Transmission speed (Mini-DIN) Default 1200 bps 2400 bps 4800 bps 9600 bps 10.14.

  • Page 40: Date Format

    10.18. Date format The printing date format can be set using the function Use the ▲ button to change the setting. This setting appears in the diastolic display section. DIA LED Date format Default DD month., YYYY ※ month DD, YYYY The default setting depends on the destination.

  • Page 41: Bluetooth Connection Timing

    Printing example ） Printing example ） Bar code printing (CODE39) QR code printing, including ID Printing example ） Printing example ） Bar code printing QR code printing V2 , including ID ( CODE39 , with check digit (modulus43 ) ) ※...

  • Page 42: Transmission Specifications

    TRANSMISSION SPECIFICATIONS The monitor can connect to the optional external input/output unit. Various settings for each channel are available from functions Caution The personal computer and medical equipment connected to the device must be located out of reach of the patient. The personal computer or ID reader used must conform to EN60601-1 11.1.
  • Page 43 11.1.1. Mini-DIN 8 pin female（External input/output unit : only TM-2657-01） Transmission specifications Main standard Complies with EIA RS-232C Transmission format Stop-start system (Full duplex) Signal speed 1200, 2400, 4800 and 9600 bps (can be changed using Can be changed using Transmission format Data bit length 8 bits, 7 bits...
  • Page 44 11.1.2. D-Sub 9-pin male（External input/output unit : All units common） Transmission specifications Output standards Complies with EIA RS-232C Transmission format Stop-start system (Full duplex) Signal speed 1200, 2400, 4800 and 9600 bps (can be changed using Transmission format Can be changed using Data bit length 8 bits Parity...
  • Page 45 11.1.3. Bluetooth （External input/output unit : only TM-2657-05） In order to use the Bluetooth transmission function of the TM-2657 series 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 the safe handling of the monitor.
  • Page 46 For good wireless communication Warning Do not use in the vicinity of cell phones. This could cause malfunction. NOTE Ensure wireless device is within view of the monitor. Wireless range is affected by building structure and obstructions. Specifically, reinforced concrete can cause wireless interference.
  • Page 47 Transmission specifications Main standard Bluetooth Ver.2.1 class1 Supported profiles SPP,HDP ●Continua certified devices ●Applications and devices that are compatible with SSP and A&D specifications However, each device needs an application to receive data. For connection methods, refer to the manual for each device. Devices that can Bluetooth devices described the be connected...
  • Page 48 NOTE Other than the operation of the above ②, the monitor will be searchable from the receiver device for about one minute after turning on the power. In this operation, “End/Err” are not displayed in the pulse rate display section when the pairing is over. （※When reset with the FAST STOP button, searching is impossible.）...
  • Page 49 Bluetooth utility mode Configure Bluetooth settings for this monitor in Bluetooth utility mode. To change function settings, use the buttons located on the rear panel of the monitor while the monitor is in standby mode. Hold down the SELECT buttons and turn on the ①...
  • Page 50 Time This monitor has a built-in clock. The measurement data includes the date and time that a measurement was taken. The time is designed to be synced with the time of a receiver device side. Refer to the specifications of the receiver device side. NOTE The clock in the monitor can be automatically set by the receiver device side function.

  • Page 51: Maintenance

    MAINTENANCE 12.1. Inspection and safety management Do not open the device. It uses delicate electronic components and an intricate air unit that could be damaged. If you cannot fix the problem using the troubleshooting instructions, request service from your local dealer or from the A&D service group. The A&D service group will provide technical information, spare parts and units to authorized dealers.
  • Page 52 Rubber pump COUNT button Connection hose Air connector Inspection equipment Cover for pressure inspection area Coupling connector 500 cc air tank 1. Hold the COUNT button on the rear of the blood pressure monitor, and turn the POWER switch on. 2.

  • Page 53: Cleaning

    12.2. Cleaning Caution Before cleaning, switch the power off and disconnect the power cable from the electrical outlet. When cleaning the monitor, never splash it with or soak it in water. The blood pressure monitor is not waterproof device. Do not splash water on it and avoid exposure to moisture.
  • Page 54 Printer head If the printer head has paper debris, or other foreign matter has collected, printing will not be performed correctly. To prevent this, follow the procedure below to clean the printer head. Caution Before cleaning, switch the power off and wait until the printer head has cooled completely.
  • Page 55 4. Clean the printer paper compartment to remove dust, paper debris and other foreign matter. Debris in the paper output path may lower the printing quality. 5. Wait for the cleaned parts to completely dry and install the printer paper. 6.

  • Page 56: Periodic Inspection

    12.3. Periodic inspection To ensure correct use of the monitor, perform a periodic inspection. The main items of the periodic inspection are as follows. Before switching the power on Item Description Check for deformations and damage from drops. Check parts for dirt, rust, scratches. Exterior Check panels for dirt, scratches, damage.

  • Page 57: Replacing The Arm Cuff Cover

    12.4. Replacing the arm cuff cover 1. Use a flathead screwdriver to loosen the screw. 2. Slide the front frame down, and then pull forward. 3. Loosen the screws (armrest securing screws) on the rear side and remove the screws. Lift the armrest and pull back.
  • Page 58 7. Insert the new arm cuff cover and push the vinyl ring into the groove (on the inner side of the frame) to attach. 8. Fit the new arm cuff cover over the front vinyl ring groove. 9.Reversing the steps used to remove, reattach the rear and front frames, return the armrest to its original position, then replace the armrest securing screws (2)

  • Page 59: Checking The Number Of Measurements

    12.5. Checking the number of measurements The monitor can count the number of times blood pressure measurement has been performed. This function is designed to check usage frequency and provide a reference for scheduled cleaning. The count value is stored even after the power is switched off. 12.5.1.

  • Page 60: Disposing Of The Component Parts

    12.6. Disposing of the component parts Dispose of or recycle the monitor in an environmentally friendly manner according to local regulations. Arm cuff cover As there is a danger of infection, dispose of the arm cuff cover as medical waste. Internal backup battery The monitor is equipped with a lithium battery to back up settings and other data.

  • Page 61: Before Requesting Service

    12.7. Before requesting service Before requesting service, please review the following checklist and the error code list in the next section. Problem Check Countermeasure Nothing is displayed Is the power cable connected when the power is Connect the power cable correctly. correctly? switched on.

  • Page 62: Error Codes

    12.8. Error codes When an error occurs, one of the following error codes is displayed in the systolic display section. Printer error codes Error code Error/countermeasure No printer paper. Install a new roll of printer paper. The printer cover is open. Firmly close the printer cover. A printer cutter error.
  • Page 63 Error code Details Check items The cuff pressure during measurement exceeded 300 mmHg. Excess pressure was detected. The patient may have moved or a strong external pressure was applied to the cuff. Watch for errors and try measurement again. For the safety of the patient, measurement was cancelled because the measurement time The time limit for one exceeded 180 seconds.
  • Page 64 Error code Details Check items Other errors Restart the power. Restart the power. If the problem continues, stop A power voltage error was using the monitor immediately. detected inside the monitor. Restart the power. The function settings have been initialized. Check A setting error was detected the settings.

  • Page 65: Accessories And Options List

    ACCESSORIES AND OPTIONS LIST Product name Catalog Number AX-PP147-S Printer paper (5 rolls) Arm cuff cover AX-134005759-S (5pieces) Power cable (cord set) AX-KO243 (Type C) AX-KO242 (Type BF) Power cable (cord set) Fuse rating: T3AH250V Power cable (cord set) AX-KO115-EX (Type A) External input/output unit RS 2ch TM-2657-01-EX External input/output unit RS 1ch...

  • Page 66: Sending Bitmap Patterns

    SENDING BITMAP PATTERNS 15.1. Size of original bitmap patterns Width: 384 pixels (fixed) (Bitmap data other than 384 pixels in width cannot be sent.) Length: maximum 640 pixels (Bitmap data of an optional length from 1 to 640 pixels can be sent.) The maximum size of original bitmap patterns is as shown below: (Windows monochrome bitmap)

  • Page 67: Sending Bitmaps

    15.2. Sending bitmaps 1. Switch off the power of the monitor. Bitmap SD socket cover 2. With the COUNT, ▲ and SELECT buttons pressed, switch the power on. The monitor enters the bitmap transfer mode. 3. Insert the SD card containing the bitmap file (Logo.bmp) saved in “15.1. Size of original bitmap patterns”...

  • Page 68: Appendix: Emd Information

    APPENDIX: EMC INFORMATION Medical Electrical Equipment needs special precautions regarding EMD and needs to be installed and put into service according to the EMD information provided in the following. Portable and mobile RF communication equipment (e.g. cell phones) can affect Medical Electrical Equipment.
  • Page 69 - IMMUNITY TEST LEVELS：Signal input/output Port - Phenomenon IMMUNITY TEST LEVELS ±8 kV contact Electrostatic discharge IEC 61000-4-2 ±2 kV, ±4 kV, ±8 kV, ±15 kV air ±1 kV Electrical fast transients / bursts IEC 61000-4-4 100 kHz repetition frequency 3 V 0.15 MHz - 80 MHz Conducted disturbances induced by RF fields 6 V in ISM and amateur radio bands between 0.15 MHz and 80 MHz...

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