Instruction Manual
34 Pages
Preview
Page 1
Automatic Blood Pressure Monitor
1WMPD4000206H
© 2005 A&D Company Ltd. 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 Ltd. The contents of this manual and the specifications of the instrument covered by this manual are subject to change for improvement without notice.
WARNING DEFINITIONS The warnings described in this manual have the following meanings: WARNING Important information to alert you to a situation that might cause injury and/or damage to your property if instructions are not followed.
CAUTION Important information to alert you to a situation that might cause minor injury and/or damage to your property if instructions are not followed. Note Important information that helps users operate the device.
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COMPLIANCE Compliance with the European Directive 93/42/EEC for Medical Products This device conforms to the following requirements: European Directive 93/42/EEC for Medical Products act; Medical Products Act; European Standards for Electrical Equipment EN 60601-1 (General Safety Provisions), EN 60601-1-2 and EN 55011 (Electromagnetic Compatibility); European Standards pertaining to Non Invasive Blood Pressure Instruments EN 1060-1(General Requirements), EN 1060-3 (Supplementary Requirements for Electromechanical Blood Pressure Measuring Systems). This is evidenced by the
mark of conformity accompanied by the reference number of a
designated authority. This device was designed for use by adults only.
Compliance with the Australian EMC Frame Work This device conforms to the following requirements: EMC Emission Standard for Industrial, Scientific and Medical Equipment AS/NZS 2064-1997, EMC Generic Immunity standard AS/NZS 4252.1-1994. This is evidenced by the C-Tick label.
Environment for use The device is for use in offices, sports facilities, and hospitals (waiting rooms), etc.
NOTE This device does not have the function of automatic cycling measurement. Therefore, a part of this device does not conform to IEC60601-2-30.
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SAFETY PRECAUTIONS WARNING
Grounding To avoid electrical shock, connect the power cable to a medical electrical outlet having a ground terminal for grounding the device.
Fuse To avoid a fire hazard, use only a fuse of the proper type, voltage and current rating as specified on the rear panel. Never bypass a fuse by shorting across the fuse holder and connectors.
Service Internal service or adjustment to this device should be performed by a qualified person only. Do not disassemble or modify the device
Device failure If a device failure occurs, promptly stop using it. Remove the device from the patient and secure the patient’s safety. Turn the power off and disconnect the power cable from the electrical outlet. Affix a notice such as “Out of Order” and “Do Not Use” on the device. Ask the nearest dealer for services
To interpret blood pressure measurements Only a trained medical professional is qualified to interpret the blood pressure measurements. No device can replace regular medical checkups by a doctor. A doctor should verify the blood pressure measurements before making adjustments to medication.
When the device gets wet because of a liquid spill If the device gets wet, promptly stop using it. Remove the device from the patient and secure the patient’s safety. Turn the power off and disconnect the power cable from the electrical outlet. Affix a notice such as “Out of Order” and “Do Not Use” on the device. Ask the nearest dealer for service.
CAUTION
In case of emergency Press the EMERGENCY STOP switch located on the front of the device. This will release the air in the arm cuff so that the arm can be removed easily. It also operates if there is a power failure.
To stop the operation at any time Press the START/STOP switch located on the display panel. The quick exhaust will release the air in the arm cuff and the arm cuff will become loose.
Maintenance/Inspection Check all functions periodically. Ask the nearest dealer for this inspection. Do not disassemble or modify the device. If the device is used for the first time after an extended period of storage, check the device for proper operation. iii
GENERAL PRECAUTIONS Obey the following precautions for safe and correct usage. Precautions unique to the TM-2655/TM-2655P appear on the relevant page in this manual. Read the manual thoroughly before use.
When installing and storing the device Install or store the device away from moisture. Do not install or store the device where the device may be badly affected by extreme temperature, humidity, direct sunlight, draft, dust, salinity or sulfur content in the air. Do not install or store the device where chemicals, and corrosive or explosive gases are stored or present. Install or store the device in a secure, level and stable location. Install or store the device where adequate power is provided. (Where a medical 3P electrical outlet is provided.)
Before use Check to make sure the device operates safely and accurately. Check all cables for proper connection. When other medical equipment is used at the same time, a diagnostic error or dangerous situation may occur. Check all connections to make sure they do not interfere with each other. When other telemeters are used, check that mutual interference will not cause a problem.
During use Check the patient and the device during use. If medical or operational problems are found in the device or the patient, stop using the device immediately, check the status of the patient and take proper action. Do not use the device during MRI scanning. Do not use the device on a patient using a heart-lung machine. High frequency interference by electrosurgery or energy discharged by a defibrillator may damage the device. Follow the precautions described in the manual for each device. Do not use a cellular telephone near the device. It could affect the device’s operation. The personal computer and medical equipment connected to the device are not allowed to be in the patient area. The personal computer used must conform to IEC60950
After use Follow the predetermined procedure to return the operation switches to their original positions, and then turn off the power. Do not forcibly pull out the cables. Hold the connector with your hand when disconnecting the cable. Keep the device clean and in proper operating condition so that it can be used without problem during the next operation. Clean the accessories and arrange them before storage.
Environmental protection Remove the built-in lithium battery from the device when the device is to be disposed of. This device, any part of, and the built-in lithium battery are not treated as ordinary household waste, and must be disposed of according to the applicable regulations. iv
CONTENTS WARNING DEFINITIONS...ⅰ COMPLIANCE...ⅱ SAFETY PRECAUTIONS...ⅲ GENERAL PRECAUTIONS ...ⅳ 1. INTRODUCTION ... 3 1-1 Features...3 1-2 Unpacking and Inspection ...4 1-3 Specifications...5
2. PART NAMES ... 6 2-1 Main Unit...6 2-2 Rear Panel...7 2-3 Symbols ...7
3. INSTALLATION ... 9 4. OPERATION... 10 5. SETTING THE CLOCK ... 12 5-1 Clock Adjustment Mode...12 5-2 A Setting Example...12
6. INSTALLING THE PRINTER PAPER... 14 7. SETTING THE FUNCTIONS ... 15 7-1 Function Setting Mode...15 7-2 Description of the Functions ...16 7-3 Printing Samples...17
8. COMMUNICATION SPECIFICATIONS ... 18 8-1 Channel 1 : Miniature DIN 8-pin ...18 8-2 Channel 2: D-sub 9-pin...19
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9. MAINTENANCE...20 9-1 Replacing the Arm Cuff Cover ... 20 9-2 Replacing the Fuses ... 21 9-3 Checking the Counter ... 21 Displaying the counter... 21 Resetting the counter ... 21 Printing the counter graph... 21 9-4 Error Codes ... 22 9-5 Maintenance ... 22 9-6 Cleaning... 22 9-7 Options and Consumables ... 23
10. TROUBLESHOOTING ...24 11. EXTERNAL DIMENSIONS...25
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1.INTRODUCTION 1-1 Features The TM-2655/TM-2655P is a blood pressure monitor that measures systolic and diastolic blood pressure and pulse. The TM-2655 is a standard model; the TM-2655P is equipped with a printer unit. The features of the devices are as follows:
COMPACT DESIGN Due to its compactness, the TM-2655/TM-2655P can be installed in an area where space is limited. You can measure your blood pressure on either arm.
AUTOMATIC-CUFF SYSTEM / AUTOMATIC-EXHAUST-ADJUSTMENT SYSTEM The arm cuff is wrapped around the arm by pressing the START/STOP switch and deflation speed is automatically controlled. No special adjustment is required. All you have to do is insert your arm into the arm insertion section to the shoulder and press the START/STOP switch. The rest is done automatically. You can easily and quickly measure your blood pressure. The TM-2655/TM-2655P is suitable for mass medical check-ups at firms and sports facilities and in hospital waiting rooms when used for a pre-check of the patient’s health status.
BUILT-IN PRINTER (TM-2655P only) The TM-2655P is equipped with a printer unit, which allows measurement results to be printed out for record keeping. The print format can be selected from results only, results with pulse pressure graph or a list of the results.
BUILT-IN CLOCK The date and time of measurement can be printed along with the measurement results.
COUNTER (UP TO 999999 COUNTS) The counter indicates how often the device is used. It can be a helpful guideline for maintaining the device.
SAFETY SYSTEM The TM-2655/TM-2655P adopts an emergency stop system. In case of emergency, pressing the EMERGENCY STOP switch will release the air in the arm cuff so that the arm can be removed easily. This system also functions if there is a power failure.
REPLACEABLE ARM CUFF COVER The arm cuff cover can be easily replaced.
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1-2 Unpacking and Inspection CAUTION Handle this device carefully at all times. Strong shock to the device may cause trouble during operation. Note Save the packing material for later use. Unpack the TM-2655/TM-2655P carefully and verify that the following items are contained.
Fig.1 Items contained
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1-3 Specifications Table 1 Specifications
Performance specifications General Power supply
120VAC 60 Hz 230VAC 50 Hz (factory-preset)
Power consumption
Approx. 40VA
Protection against electrical shock
Class
Display
LED
EMC
EN 60601-1-2
(For USA area) (For Europe area)
, Type B
Blood pressure measurement Blood pressure measuring method
Oscillometric method
Pressure detection method
Capacitance type pressure transducer
Pressure range
0 – 300 mmHg
Accuracy
Pressure: ±3 mmHg Pulse rate: ±5%
Measurement range
Blood pressure: 10 – 280 mmHg Pulse rate: 30 – 200 bpm
Pressurizing method
Micro pump
Air pressure control method
Rubber valve, ceramic valve
Rapid air exhaust system
Electromagnetic valve
Safety mechanism
The electromagnetic valve is released when approx. 320 mmHg or greater is detected.
Communications functions
Serial output: RS232C level
Environment specifications Operating temperature and humidity
10 to 40°C, 85%RH or less, non condensing
Storage/transporting temperature and humidity
-20 to 60°C, 95%RH or less, non condensing
Physical specifications Overall dimensions
245(W) X 320(H) X 390(D) mm
Weight
Approx. 9 kg
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2. PART NAMES 2-1 Main Unit
Fig.2 TM-2655/TM-2655P whole view
Note The printer unit is available only for the TM-2655P. The human sensor area appears the same for both models, but it functions only for the TM-2655P. The illustration above is not to scale.
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2-2 Rear Panel
Fig.3 TM-2655/TM-2655P rear panel (The illustration above is not to scale.)
2-3 Symbols The symbols used with the TM-2655/TM-2655P have the following functions or meanings. Table 2 Symbol descriptions
Symbols
Function/Meaning Starts and stops a measurement. Turns the device on. Turns the device off. Alternating current Serial number Fuse RS-232C serial interface Date of manufacture Type B: Device, cuff and tubing are designed to provide special protection against electrical shocks. The medical device label by the EC directive The certification trade mark registered to the Australian Communications Authority by the Trademarks office.
SYSTOLIC SYS DIASTOLIC DIA PULSE PUL
Systolic blood pressure in mmHg Diastolic blood pressure in mmHg Pulse beats per minute See the instruction manual. WEEE label
MAP Exx
Irregular Heartbeat indicator. (I.H.B.)The indicator that prints out when an irregular heartbeat or any excessive body movement is detected during the measurement. Means arterial pressure in mmHg Error code ( xx = 00 - 99 ) 7
What is An Irregular Heartbeat? The TM-2655P provides a blood pressure and pulse rate measurement even when an irregular heartbeat occurs. An irregular heartbeat is defined as a heartbeat that varies by 25% from the average of all heartbeats during the blood pressure measurement. It is important that you are relaxed, remain still and do not talk during measurements. Note logo We recommend that physician should re-examine the patient if the appears on the printout or request a second reading. ) to occur if a patient moves position or It is possible for an Irregular Heartbeat ( engages in conversation during a reading so care should be taken to eliminate the possibility of these events recurring.
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3.INSTALLATION Follow the procedure below to install the TM-2655/TM-2655P. 1. To ensure that the TM-2655/TM-2655P works properly, install the device in an environment where: The temperature range is from 10°C to 40°C (50°F to 104°F). The humidity is less than 85% (non condensing). It is away from water, dust, chemicals, and corrosive or explosive gases. It is not exposed to direct sunlight. 2. Place the TM-2655/TM-2655P on a table solid enough to support its weight. 3. Adjust the height of the chair and table so that the arm insertion section is at the user’s heart level.
Fig.4 Proper installation
4. Use the power cable provided with the device to connect between the AC INPUT connector and an electrical outlet. Using the anti-theft opening, secure the device to the table with a solid chain.
Fig.5 Power cable connection
Note Be sure to use the correct voltage for the power source. 9
4. OPERATION 1. Turn on the POWER switch located on the rear panel. When the POWER switch is turned on, all of the display symbols will appear for several seconds. Then; (TM-2655)
“0” (zero) appears in the SYSTOLIC pressure display, indicating that the device is ready for measurement.
(TM-2655P) The human sensor functions for three minutes. When it does not detect a person, “ . “ (dot) appears in the SYSTOLIC pressure display, indicating that the device is ready for measurement. Fig.6 POWER switch and SYSTOLIC display (TM-2566)
Note
Please do not press the START/STOP switch when you turn on the power switch. Pressing and holding the START/STOP switch while all of the LED indicators are illuminated, will cause the device to enter the internal inspection mode. 2. Take off your jacket. If you wear a thick jacket, take it off for a better measurement. Note Wearing a thick jacket may cause a faint pulse, and result in a measurement error. 3. Adjust the height of the chair and table. Adjust the height of the chair and table so that the arm insertion section is at your heart level. 4. Insert your arm into the arm insertion section. Note
Fig.7 Proper posture
Be sure to insert your arm to the shoulder. 5. Press the START/STOP switch to start measurement.
6. The cuff will be pressurized automatically up to the predetermined pressure. Refer to “7-2 Description of the Functions” for details.
7. When pressurization is complete, the automatic exhaust mechanism will gradually reduce the pressure in the cuff. Just relax and remain still.
Fig.8 Measuring procedure
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8. When the measurement is complete, the air is automatically released from the cuff and the cuff will become loose.
9. The measurement results appear in the display.
10. (TM-2655P) The measurement results are output to the printer.
Fig.9 Measurement results
Note To stop the measurement at any time, press the START/STOP switch. The quick exhaust will reduce the pressure in the cuff and the cuff will become loose. If the air is not exhausted even when the START/STOP switch is pressed, press the EMERGENCY STOP switch. If your arm can not be removed from the cuff due to the power failure, press the safety lever located on the front lower part of the device. It disconnects the clutch to loosen the cuff. Please wait for about 10 minutes before repeating the measurement.
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5.SETTING THE CLOCK 5-1 Clock Adjustment Mode The clock is set in the clock adjustment mode. The clock adjustment mode display and switches used are as shown below:
Fig.10 Switches for setting the clock and the clock adjustment mode display Table 3 Switches for setting the clock
SELECT switch
(1) Press to enter the clock adjustment mode. (2) (In the clock adjustment mode) Press to select the unit to be adjusted. The selected unit flashes. Each time the switch is pressed, the flashing unit changes: from “Year” to “Month”, “Date”, “Hours”, and “Minutes”. (3) Press to quit the clock adjustment mode.
switch
Press to change the flashing digit(s).
5-2 A Setting Example The following is the procedure to adjust the clock to 14:07, April 20, 2001. 1. Press the SELECT switch to make the SYSTOLIC display flash. 2. Press the
switch to display “01” for 2001.
3. Press the SELECT switch to make the DIASTOLIC display flash. 4. Press the
switch to display “4” for April.
5. Press the SELECT switch to make the PULSE display flash. 6. Press the
switch to display “20”.
7. Press the SELECT switch to make the hours section of the TIME display flash.
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8. Press the
switch to display “14”.
9. Press the SELECT switch to make the minutes section of the TIME display flash. 10. Press the
switch to display “07”.
11. Press the SELECT switch to return to the measurement mode. Note If no operation is performed for one minute, while setting the minutes section and for five seconds while setting the others, the settings performed so far will be confirmed and the device will return to the measurement mode. The clock can be set up to December 31, 2091.
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6. INSTALLING THE PRINTER PAPER (This chapter is applicable only to the TM-2655P.) With the power turned on, install the printer paper as follows: 1. Cut the top end of the printer paper with scissors. If the end is not smooth, it may cause a paper jam or damage the printer head.
2. Press lightly on the center of the printer cover to open the cover.
3. Raise the lever located on the right side of the printer. Insert the printer paper into the paper feed slot as shown. The paper is fed automatically.
4. Press the PAPER FEED switch to feed the paper by 10 cm. Confirm that the paper is fed straight. If not, re-install the paper because it may cause a paper jam. 5. Lower the lever and feed the paper. The paper will be cut automatically.
6. Close the cover. Press lightly on the center of the printer cover to secure it in position.
Note With high-speed printing, about 700 printings can be performed. With four-line printing, about 500 printings. Replace the printer paper when the red end is reached. Use the specified thermal paper, which is sold separately. 14
Fig.11 Paper installation procedure