ebso: holter marca fukuda modelo fm 180

Before using the FM-180, read this manual thoroughly.

Remember to keep this manual in an easily accessible place near the recorder for reference.

●

●

OPERATION MANUAL

Digital Holter RecorderFM-180

DIGITAL WALKAmbulatory ECG Recorder

0086

Copyright © 2006 by Fukuda Denshi Co., Ltd.

No part of this document may be copied or transmitted in any form without the prior written permis-

sion of Fukuda Denshi Co., Ltd.

CAUTION

• Only physicians or persons instructed by physicians are allowed to use the FM-180.

• The information contained in this document is subject to change without notice due

to improvements in the FM-180.

Printed in Japan

0086

The device bears the CE label in accordance with the provisions of Medical

Device Directive 93/42/EEC.

THE PERSONS RESPONSIBLE FOR PLACING DEVICES ON THE EC MARKET

UNDER MDD 93/42/EEC

NAME : FUKUDA DENSHI UK

ADDRESS : 13 WESTMINSTER COURT, HIPLEY STREET

OLD WOKING, SURREY GU22 9LG, U.K.

i

Foreword

Thank you for purchasing the Ambulatory ECG Recorder, Model FM-180. Before using the

FM-180, please read this operation manual thoroughly and carefully. This manual includes operational procedures required to use FM-180 Digital Holter Recorder DIGITAL WALK. This manual contains the contents indicated below. Foreword Part 1 Operation Part 2 Attaching ECG electrodes Part 3 Error Messages and Maintenance Part 4 Specifications and Accessories Please read this manual thoroughly from Foreword in order to ensure the correct operational and recording method of FM-180.

ii

Precautions and Notes Warning Label The warning label which put on this product contains important information for the proper and safe use of this machine. Please be careful not to damage or remove the label as that information may be crucial to ensure safety for the operator or the patient being tested. Observation of Precautions For your safety, it is important that this product be used and undergone periodic inspection as instructed in this guidebook. Please read this guidebook carefully before use.

iii

Safety Precautions

Safety notification The following is a description of the safety and precaution messages used in this manual. Each symbol contains different meaning as indicated below. Read the Safety Precautions in this section thoroughly to ensure proper and safe use of the product. Warning notifications The following warning labels are classified by the extent of the damage and harm that may result from incorrect use of the recorder by neglecting the safety precautions.

Danger Failure to follow this message may pose a high risk of causing death or serious injury to the patient or operator, or result in fire.

Warning Failure to follow this message may pose a risk of causing death or serious injury to the patient or operator, or result in fire.

Caution Failure to follow this message may pose a risk of causing injury to the patient or operator or damage to the equipment.

The symbol “ ”on the unit indicates that there is a possibility that some hazards might be present. Relevant information is supplied in this operation manual.

NOTE A NOTE is not related to product safety. A NOTE provides supplementary information about the proper use and operating methods to prevent incorrect operation and trouble with the unit.

Symbolic notification The following safety symbols are classified by the extent of the actions instructed such as prohibition or compulsion.

This denotes that the action is prohibited.

The message associated with this symbol contains information concerning danger, warning, or caution.

This denotes that the action is compulsory or instructed.

iv

Safety Precautions Design Specification

The FM-180 is the equipment that complies with the safety requirements provided by Japanese Industrial Standard, JIS T 0601-1 Medical electrical equipment Part 1: General requirement for the safety, and classified as internally powered equipment, Type-B applied part. 1. Classification by the types of protection against electric shock.

Internally powered equipment 2. Classification of applied parts by the extent of protection against electrical shock.

Type-B applied parts. 3. Classification by the extent of protection against harmful water immersion.

IPX8 classified equipment. 4. Classification by the extent of safe for use in an area where there is flammable anesthetic

mixture with air, flammable anesthetic mixture with oxygen or nitrous oxide. Equipments are not safe for use in areas where there is flammable anesthetic mixture with air, flammable anesthetic mixture with oxygen or nitrous oxide.

5. Classification by operation mode. Equipment for continuous operation

Preventive Maintenance

The purpose of Preventive Maintenance is to eliminate potential problems and to keep the instrument in a condition which insure safe, satisfactory operation. Preventive maintenance should be performed at least once a year. This maintenance should include a complete inspection to find any external damage of the body, connectors, and leads. Immediate maintenance must be performed: ・ If the equipment is subjected to strong impact such as a heavy fall. ・ If the equipment is subjected to spilled liquid. ・ If the function of the equipment is to be interrupted or disturbed due to possible

malfunction. ・ If parts of enclosure of the instrument is cracked, splintered, or broken. Periodic Replacement

Battery case lid with waterproof gasket requires annual replacement. To ensure containing waterproof performance, it is strongly recommended to replace the packing once a year. Please consult your dealer or Fukuda Denshi personnel for the replacement. Failure to change the packing may cause malfunction due to the water leakage while taking a bath or in the shower.

v

Danger of Explosion

Danger

● Do not use the FM-180 in an area where there is a danger of explosion. ● Do not use the FM-180 in an area where using combustible or flammable

gas or liquid such as anesthetic, oxygen, or hydrogen. Simultaneous use with MRI

Danger

● Any attempt to use FM-180 in an area where MRI is operating will

mutually generate negative effects.

Protection against Defibrillator This instrument is not protected against the defibrillator. When using the defibrillator, remove FM-180 from the patients. High-frequency Surgical Apparatus This instrument is not protected against the high-frequency surgical apparatus. When using the high-frequency surgical apparatus, remove FM-180 from the patients. Application to the heart Since FM-180 is the instrument of Type-B applied parts, it is not directly applicable to the heart. Precautions for Transportation When transporting FM-180, pack it into the package material specified by Fukuda Denshi. Care of Proper Disposal of the Unit and Accessories When disposing the unit and accessories, commission the professional waste disposer.

vi

Notifications Described in this Manual 【Storage of the FM-180】

Caution

● Store the FM-180 in an area free from water or humidity ● Take care to avoid areas subject to high humidity, poor ventilation and

direct sunlight; store the FM-180 in an area free from any adverse effects of surrounding air containing dust, sodium, and sulfur.

● Do not store the FM-180 in an area where chemicals are kept or which is exposed to chemical fumes or vapors.

【Preoperational preparations】

Caution

● Do not connect FM-180 other than the specified equipment for your safety

and optimal performance.

● Check that electrodes are correctly and completely installed. ● When using this recorder in combination with any other equipment, refer

to a qualified service technician for correct handling.

● Attach the FM-180 to the patient after a battery and a multimedia card are installed, and the cover is closed.

【Precautions for operation of the FM-180】

Danger ● Any attempt to use in an area where using combustible or flammable gas or liquid

such as anesthetic, oxygen, or hydrogen will generate explosion or fire. ● Use the FM-180 in an environment free from flammable materials.

vii

Caution

● This instrument is not protected against defibrillation. ● This instrument is not protected against high-frequency surgical

apparatus.

● Keep away from a heater or other higher temperature environment. ● Keep away from exposure to paint thinner, benzine, or similar volatile

chemicals. ● Do not inflict high impacts, viblation, or drops. The waterproof function

could be damaged. ● Take precautions to prevent the patient from touching device except for

the EVENT switch during ECG recording. ● Do not use the FM-180 in the area where MRI is operating. ● During ECG recording, do not attempt to remove the FM-180 from the

carrying case and to open the covers of the recorder. ● If the cover becomes open during ECG recording, close the cover, taking

great care not to touch the dry cell, the multimedia card, or inside of the recorder. Especially when the cover for the battery compartment opens, the power will be turned OFF.

● Exposure to any continuous noise or similar electrical disturbance (hum) for an extended period of time will result in failure to record for the full 24 hours. Avoid using the FM-180 in an environment susceptible to hum interference (eg. electric blanket, electric carpet, etc.). Make sure to avoid possible noise interference, read [PART 2 Attaching ECG electrodes] carefully and perform the secure recording.

● To avoid possible noise or other electromagnetic interference, keep away from cellular phones, transceivers, or radio-controlled toys, or other such radio/electromagnetic waves generating devices.

● Leaving the electrodes attached in the same positions for several days may result in inflammation. For the patient with the delicate skin or the patient skin from inflammation of the skin, select different attachment positions of electrodes, or for cleaning of the skin, use alcohol absorbent cotton instead of the skin cleaner.

● FM-180 allows you to bathe when using Excerode W THE-04DAW electrodes. Please be note the following when bathing: Do not soak in a hot tub above 40 degrees Centigrade / 104 degrees Fahrenheit for more than 10 minutes as it may cause electrodes to peel-off or noise interference due to sweat. Do not use FM-180 in a sauna, Jacuzzi, hot spring or do not use with bath agent. It may cause electrodes peel-off or noise interference or malfunction. Do not rub electrodes with a towel etc. It may cause electrodes peel-off or noise interference.

viii

【Precautions after use of the FM-180】

Caution

● Take care to prevent dust from entering the multimedia card connector, the multimedia card slot, and the dry cell terminals in the battery compartment. Do not touch them with your bare hand.

● Turn off the switch with taking care to follow the specified steps. ● Disconnect the electrodes in a correct procedures.

【Precautions for inspection of the FM-180】

Caution

● Never attempt to modify or to disassemble the FM-180.

● Do not open the case except for by our service person. ● Take care to prevent liquid such as alcohol from entering internal part of

the unit.

● To ensure the safety of the FM-180, be sure to perform the daily

inspection. ● Make sure to carry out the periodic inspection every three or four months

for the safety of the equipment. ● The periodic inspection should be performed by the professionals once a

year for the safety of the FM-180. 【Precautions for maintenance of the FM-180】

Caution

● Take care to prevent chemicals from entering the connector or internal part of the unit.

● Any attempt to use cleaner containing organic solvent, thinner, toluene, or benzine for cleaning of the FM-180 will generate the damage of the housing.

● When cleaning FM-180, wipe with a cloth soaked with regular household cleaner diluted with water.

● Do not polish the housing with abrasive or chemical cleanser.

ix

【Precautions for consumables and accessories】

Caution

● Take care not to drop the multimedia card, because it may cause damage

and inoperative multimedia card. ● Leaving the ECG electrodes attached in the same positions for several

days may result in skin inflammation. For patients with the delicate skin, or those who suffer from inflammation, select different attachment positions or disinfect the skin with alcohol absorbent cotton instead of the skin cleaner.

【Precautions for use of batteries】

Caution

● Install a dry cell in the correct polarity. ● To prevent a possible leakage, remove a dry cell from the battery

compartment promptly after use. ● Any attempt to charge a dry cell may cause them leakage or breakage. ● Any attempt to short out, disassemble, or heat a dry cell may cause a

leakage, exothermic heat, or breakage of a dry cell, that may pose the breakdown of instrument and personal injury.

x

Symbolic Notifications on the FM-180 The following is the symbolic notifications indicated on the FM-180.

This symbol denotes that this instrument is the Type-B applied parts.

This symbol indicates that the contents are explained in this operation manual.

xi

Contents

Foreword･･･････････････････････････････････････････････････････････････ⅰ

Precautions and Notes before Operation･･････････････････････････････････････ⅱ

Safety Precautions･････････････････････････････････････････････････････････ⅲ

Symbolic Notifications on the FM-180････････････････････････････････････････ⅹ

PART1. Operation

1. General Description･･･････････････････････････････････････････････････1-1

2. Controls and Indicators････････････････････････････････････････････････1-2

2.1 Switches, connectors, and display･･････････････････････････････････････1-2

3. The Multimedia card (MMC-64) ････････････････････････････････････････1-4

3.1 General description･････････････････････････････････････････････････1-4

3.2 Handling････････････････････････････････････････････････････････1-4

4. Installing the Dry Cell and the Multimedia Card･･･････････････････････････1-5

4.1 Opening the battery compartment lid･･･････････････････････････････････1-5

4.2 Installing the multimedia card･････････････････････････････････････････1-6

4.3 Installing the dry cell･･･････････････････････････････････････････････1-7

4.4 Removing the dry cell･････････････････････････････････････････････1-8

4.5 Removing the multimedia card ･････････････････････････････････････1-8

4.6 Closing the battery compartment lid･･･････････････････････････････････1-8

5. Connecting the Electrode･････････････････････････････････････････････1-9

5.1 Connecting the patient cable･･････････････････････････････････････････1-9

5.2 Disconnecting the patient cable････････････････････････････････････････1-9

6. Turning ON/OFF the FM-180･･････････････････････････････････････････1-10

6.1 Turning ON the FM-180････････････････････････････････････････････1-10

6.2 Turning OFF the FM-180･･･････････････････････････････････････････1-11

7. Setting Up the Recorder･･････････････････････････････････････････････1-12

7.1 ECG setting･･････････････････････････････････････････････････････1-13

7.2 Setting the pacemaker detection･･････････････････････････････････････1-14

7.3 Entering the patient’s ID････････････････････････････････････････････1-15

7.4 Setting up the clock････････････････････････････････････････････････1-16

7.5 Other setting･････････････････････････････････････････････････････1-17

xii

8. Starting ECG Recording･･････････････････････････････････････････････････････1-18 8.1 Checking ECG data････････････････････････････････････････････････1-18 8.2 Starting the ECG recording･･････････････････････････････････････････1-19 8.3 Carrying the FM-180･･･････････････････････････････････････････････1-19 8.4 EVENT switch････････････････････････････････････････････････････1-20 8.5 Checking a patient’s ID･･･････････････････････････････････････････1-21 8.6 Notes during ECG recording･････････････････････････････････････････1-22 8.7 Notes during taking a bath･････････････････････････････････････････････････1-22 9. Completing ECG Recording and Analyzing the Recorded Data･･････････1-23

PART 2. Attaching ECG Electrodes

1. Attaching ECG Electrodes･････････････････････････････････････････････2-1 1.1 Preparation for ECG electrodes attachment･･････････････････････････････2-2 1.2 Attaching ECG electrodes (EXCERODE W)････････････････････････････2-2 1.3 Attaching ECG electrodes (T-form electrodes)････････････････････････････2-2 2. ECG Electrodes Attachment Positions･･･････････････････････････････････2-3

PART 3. Error Messages and Maintenance

1. Error messages and Corrective Action･･･････････････････････････････････3-1 2. Maintenance･････････････････････････････････････････････････････････3-5 2.1 Cleaning the FM-180･････････････････････････････････････････････3-5 2.2 Storage of the FM-180･･･････････････････････････････････････････････3-5 2.3 Maintenance check･････････････････････････････････････････････････3-6

2.3.1 Daily check････････････････････････････････････････････････････3-7 2.3.2 Periodic check･････････････････････････････････････････････････3-9

2.4 Troubleshooting･･･････････････････････････････････････････････････3-16

PART 4. Specifications and Accessories

1. Specifications････････････････････････････････････････････････････････4-1 2. Accessories･･････････････････････････････････････････････････････････4-3 3. Option･･････････････････････････････････････････････････････････4-4

PART 1 Operation

PART 1 Operation 1-1

1．General Description The ambulatory ECG recorder, Digital Walk, Model FM-180 is a digital ECG recorder allowing continuous 24-hour recording of ECG waveforms in daily life. Different from conventional cassette tape-recording Holter recorders, this instrument features digital recording of ECG waveforms on the multimedia card, MMC-64. The FM-180 can also store information of pacemaker pulses, acceleration sensor, and position sensor. Note: The multimedia card is an IC card composed of electrically erasable,

non-volatile IC memory referred to as “flash memory”. This offers the advantage that the data contained in the IC card is retained while the power is shut down, thereby eliminating the need for backup batteries.

・ CAUTION The FM-180 accepts only the multimedia card, MMC-64. Any attempt to use any other cards will cause the card error, or malfunction of the recorder.

Outline


2．Controls and Indicators 2.1 Switches, connectors, and display

①LCD A Liquid Crystal Display (LCD) for indication of time, set-up

items, set-up values, operating conditions, and ECG waveforms. During ECG recording, time of day is displayed.

②EVENT switch Patient activated event switch. When pressed for one second or

more during ECG recording, the time is annotated on the recorded data. Used when the patient is aware of adverse symptoms. If pressed when ECG waveforms are displayed during the set up period, ECG recording begins, regardless of the status of the set-up. By pressing the EVENT and ON ◎ /ENTER switches simultaneously for 3 seconds or more, the power supply is turned OFF.

③ON◎/ENTER switch Press once to turn ON the power to the recorder.

This switch is used for changing the channels of ECG waveforms on the LCD during the set-up period. Pressing this switch for about 2 seconds brings to the display of set-up items. When in the set up mode, this switch functions as the ENTER switch. When pressed during ECG recording, ID No. will be displayed for confirmation. When the ON◎ /ENTER and EVENT switches are pressed simultaneously for 3 seconds or more, the power supply will be turned OFF.

④OUTPUT connector Connector used for viewing ECG waveforms on the

Electrocardiography. The monitor adapter is connected to this connector. When the connector is not in use, it should be covered with the provided cap.

①LCD

②EVENT switch

③ON◎/ENTER switch

④OUTPUT connector


2．Controls and Indicators

⑤Battery compartment lid This is to insert LR-03 (size LR03) alkaline batteries ⑥PATIENT input connector This connector is used for connecting the electrode. ⑦Battery compartment Open the Battery compartment lid and insert battery with

correct polarity and close the lid. ⑧Multimedia card slot Open the Battery compartment lid and insert Multimedia

card face up and close the lid.

• Do not open the Battery compartment lid while the power is ON or the recorder is attached to the patient. With leaving the lid open, water leakage may be caused and waterproof function may become weakened. Do not forcibly push the multimedia card in the reverse orientation or insert any card other than the specified one into the multimedia card slot to prevent possible malfunction of the recorder.

• Do not insert any objects other than the multimedia card to avoid serious damage to the unit.

⑤Battery compartment lid

⑥PATIENT input connector

⑦Battery compartment

⑧Multimedia card slot


3．The Multimedia Card (MMC-64) 3.1 General description The multimedia card (MMC-64) is a memory card that is 64 MB formatted exclusively for recording biological information. This card is an IC card composed of electrically erasable, non-volatile IC memory referred to as “flash memory”. This offers the advantage that the data contained in the IC card is retained while the power is shut down, thereby eliminating the need for backup batteries.

3.2 Handling

The multimedia card can be used only with the recorder and the holter analysis system specified by Fukuda Denshi.

・ CAUTION • The multimedia card (MMC-64) is exclusively for recording biological

information. To prevent possible malfunction of the recorder, use care for the following description.

• Any attempt to use the multimedia card installed in other than genuin Fukuda Denshi equipment may damage data in the card, or generate a malfunction of the card.

• To avoid possible malfunction of both the card and the holter analysis system, when inserting the card into the equipment, read the operation manual supplied with the holter analysis system carefully and follow the instructions of it.

• Remove the card from the equipment correctly as instructed in the operation manual. Removing the card before the power is turned OFF will cause a damage of the data or malfunction of the card.

• Fukuda Denshi digital recorder supports only FAT(FAT16) as the file system. The data cannot be recorded using IC card formatted as FAT32 or NTFS and all. Format IC card as FAT(FAT16)

• Exposure to any continuous noise or similar electrical disturbance (hum) for an extended period of time will result in failure to record for the full 24 hours. Avoid using the FM-180 in an environment susceptible to hum interference (electrical blanket, electric carpet, etc.).

• Do not touch the multimedia card terminals with your bare hand or metals. • When not using the multimedia card, place in the provided storage case, and

store in an areas free from exposure to high temperature, high humidity, dust, or chemicals. While storing the card, take care not to inflict any impact.


4. Installing the Dry Cell and the Multimedia Card Before the ECG recording, the ambulatory ECG recorder, Digital Walk, Model FM-180 requires installing a fresh LR03 alkaline dry cell and a reusable multimedia card. A dry cell and a multimedia card should be installed in the recorder.

4.1 Opening the Battery compartment lid Make sure that the power is OFF (with nothing displayed on the LCD), and then lift to open the lock lever as shown in the illustration. If the power is ON, turn OFF the FM-180 by pressing and holding the ON◎ /ENTER and EVENT switches at the same time for three seconds or more.

・ CAUTION Make sure to open the battery cover when the FM-180 is not powered. Do not open the battery cover while the recorder is ON or it is attached to the patient.


4. Installing the Dry Cell and the Multimedia Card 4.2 Installing the multimedia card

The multimedia card (MMC-64) can only be inserted in one direction. As indicated in the illustration on the left, push the multimedia card by your fingers in the orientation indicated by the ▲ mark on the card into the slot far enough so that it becomes tight.

・ CAUTION • To prevent possible malfunction of the

FM-180, do not attempt to forcibly push the multimedia card in the reverse orientation from that shown in the illustration, or to insert any card other than the specified one.

• To avoid serious damage to the unit, do not insert any objects other than the multimedia card.

• This instrument does not accept any cards other than the multimedia cards provided by Fukuda Denshi. Any attempt to insert any card other than the genuine Fukuda Denshi cards will generate an alarm buzzer along with an error message displayed on the LCD during the power-on sequence, causing shutdown of the FM-180 or stop running.

• An optionally available card adapter is used only in scannig. Any attempt to load the FM-180 with a card adapter will generate a breakage of the recorder.


4. Installing the Dry Cell and the Multimedia Card 4.3 Installing the dry cell Insert a fresh LR03 alkaline dry cell in the battery compartment. As indicated in the illustration, be sure to first insert from the negative terminal. Pay special attention to the correct polarity of the dry cell.

Note:・This instrument is designed not to turn

ON if the polarity of a battery is reversed.

・Dust and dirt on the battery contacts may cause malfunctioning. Wipe the battery contacts with a soft cloth to remove them.

・ After cleaning the battery contacts, make sure that all the dust and dirt were removed.

・Do not touch battery contacts except for cleaning purpose.

・ Remember to use a fresh LR03 alkaline dry cell. Using any dry cell other than a fresh alkaline dry cell may cause recording time to be reduced from the full 24 hours.

・Do not set a battery with ON◎/ENTER switch pushed. It may break the clock.

・ CAUTION

• Install a dry cell with correct polarity. • To prevent a possible leakage, remove a dry cell from the battery

compartment promptly after use. • Any attempt to charge a dry cell may cause them leakage or breakage. • Any attempt to short out, disassemble, or heat a dry cell may cause a

leakage, exothermic heat, or breakage of the dry cell that may pose the breakdown of instrument or personal injury.


4. Installing the Dry Cell and the Multimedia Card 4.4 Removing the dry cell When removing the dry cell, make sure that the FM-180 is OFF (with nothing displayed on the LCD). To remove the dry cell, open the battery compartment lid and be sure to first remove from the positive terminal battery out of the compartment as shown in the illustration.

Any attempt to remove the dry cell without turning OFF the power may cause a possible malfunction of the unit.

4.5 Removing the multimedia card

Before removing the multimedia card, make sure that the FM-180 is turned OFF. To remove the multimedia card, simply push the multimedia card with your finger as far as it will go, then release your finger from it. The card will pop partially out of the slot.

CAUTION

• Any attempt to remove the multimedia card when the recorder is powered may cause a corruption and loss of the recorded data.

• Be careful not to drop the multimedia card. It may causes a possible malfunciton, and may not be able to use it..

4.6 Closing the battery compartment lid

As indicated in the illustration, close the lid and press the lock lever lightly to hook on the projection on the body. Press the other end of the lock lever until you hear a click of the lever.

Note: ・Make sure to turn ON the FM-180 after closing the battery cover.

・Do not allow dirt or hair to accumulate between the battery compartment lid. When removing those objects, be sure to open the lid, and close afterwards.


5. To connect the Patient Cable

5.1 Connecting the Patient Cable

Insert the Patient Cable into PATIENT input connector correctly as shown in the illustration. Make sure to insert the Connecting Cable until there is no space between the cable and the unit. Then turn the small lever on the root of the Connecting Cable from “Open” to “Lock” position to fasten the Connecting Cable.

5.2 Disconnecting the Patient Cable

When disconnecting the Patient Cable, turn back the small lever to “OPEN” position and hold the root of the Cable to pull it straight out.

• Be careful not to connect or disconnect the Connecting Cable upside down or at an angle into the PATIENT input connector on the FM-180. This may result in damage to both the Connecting Cable and the PATIENT input connector.

• Do not insert into the PATIENT input connector on the FM-180 any other than the Connecting Cable.

Damage can result to the both the PATIENT input connector and Connecting Cable, causing the serious problems.

＜Locked＞

＜Unlocked＞


6. Turning ON/OFF the FM-180 The FM-180 does not equip a power indicator. Check the LCD to see if the power is turned ON/OFF. The LCD displays nothing when the power is OFF, but when the power is turned ON, it provides the current time or other necessary information.

6.1 Turning ON the FM-180 Check whether the dry cell and the multimedia card are properly installed and the ECHORODE is correctly connected to the FM-180. Press the ON◎/ENTER switch and the power to the recorder will be turned ON. When the power turns ON, the LCD displays the self-diagnosed information, and then “INIT.” and ECG waveforms will be displayed with an alarm buzzer.

Note:・When the error is detected, such as “the multimedia card is not installed” or “the battery voltage is low”, a corresponding error message is displayed on the LCD with an alarm buzzer, then the power will be turned OFF automatically. For further information, refer to [PART 3, Section 1, Error Messages and Corrective Action].

・Due to the upgrade of the dry cell, it may be possible to record even after 24 hour recording. Even in this case, change an old dry cell to new one for the next recording.

・If the multimedia card remains installed in the FM-180 after the previous recording without scanning, an alarm buzzer will sound and an error message will be displayed on the LCD. If you want to continue to record the data, press the ON ◎ /ENTER switch. However, note that in this case, all the recorded data in the multimedia card will be lost. If you want to stop recording without erasing the recorded data, press and hold both the ON◎/ENTER and EVENT switches at the same time for 3 seconds or more. With an alarm buzzer, the LCD will display the END message, and then the power will be turned OFF automatically.

・For further information, refer to [PART 3, Section 1, Error Messages and Corrective Action].

FM-180

・・・・・

Self CheckRAM Check 512K

FUKUDA DENSHICO. , LTD

Self-diagnosis LCD

FM-180 (V01-01)

2005/09/30

09:46

S/No.0000000

Patient’s ID Display

INIT. TC:3.2s

1

2

ECG waveforms Display


6. Turning ON/OFF the FM-180 6.2 Turning OFF the FM-180 After 24 hours have elapsed from the start of ECG recording, the unit automatically shuts down the recording. Upon shutting down, the alarm buzzer will sound, the END message will be displayed on the LCD, and then the power will be turned OFF. The recording is shut down in increments of ten minutes of displayed time. For example, if you start recording at 10:15, the recording will be shut down at 10:20 the next day.

You may shut down a recording in progress at any time during a 24 hour recording by pressing and holding both the ON ◎ /ENTER and EVENT switches at the same time for three seconds or more. The alarm buzzer will sound, the END message will be displayed on the LCD, and then the power will be turned off automatically.


7. Setting Up the Recorder The FM-180 provides a set up period of ten minutes after the power-on sequence to allow viewing of ECG data and setting up parameters. During the set-up period, “INIT.” is displayed on the LCD.

During the last minute of the set-up period, “INIT.” displayed on the LCD will blink to give you notice of the end of the set-up period.

To display the “set-up screen” on the LCD during the set-up period, hold down ON◎/ENTER switch for a few seconds from ECG waveform display. To move between parameters, press EVENT switch. To go to set-up screen of each parameter, or to return to ECG wave form display, press ON◎/ENTER . To return to ECG wave form display, select “Return”. Available Set-up Parameters ・ ECG Setting ・ Pace Setting ・ ID Setting ・ Time Setting ・ Other Setting

When you want to immediately start ECG recording because you either have no operating parameter to change, or have completed parameter set-up in just few minutes, hold down the EVENT switch for a few seconds. The FM-180 will skip the remaining set-up time and start ECG recording immediately. This immediate startup of recording will not affect the validity of operating parameters currently set up in the recorder. In this case, patient’s events are not recorded by pressing the EVENT switch. Note: ･ In the middle of the setting up of parameters, ECG recording will not start

even the EVENT switch is pressed. In the display of ECG waveforms after the setting up is completed, press the EVENT switch to start recording.

･ You can change parameters only during the set-up period. Complete all parameters set-up by the end of the set-up period.

INIT. TC:3.2s

1

2

TC:3.2sINIT.

ECG SettingPace SettingID Setting

Other Setting

Return

Time Setting

<Set-up screen>


7. Setting Up the Recorder

7.1 ECG setting On the ECG setting screen, you can setup; the number of recording channels (Lead) 2ch/3ch/T (select “T” for T-form electrode), time constant (TC)3.2s/0.3s, heart rate detection channel (HR)1ch/2ch/3ch, and the recording sensitivity of each channel x1, x0.5. Select “ECG Setting” from the Set-up screen, <ECG set-up screen 1> will be displayed. To move between items, press EVENT switch. To adjust the settings, press ON◎/ENTER switch. Confirmed values will be highlighted. Select NEXT to display <ECG set-up screen 2>. On <ECG set-up screen 2>, you can switch the sensitivity (gain) of each channel. x1 is for 10mm/1mv, x0.5 is for 5mm/1mv setting. To move between channnels, press EVENT switch. To adjust the value settings, press ON◎/ENTER switch. To go back to <ECG set-up screen 1>, select “Back” and press the ON◎/ENTER switch. To return to the “Settings” screen, press the ON◎/ENTER switch.

Note:･With ECHORODE attached, drift noise

may be increased While taking a bath. Please set the time consistent to “0.3s”.

ECG Setting

HR ch1/ch2/ch3

Lead 3ch/2ch /TTC 3.2s/0.3s

ch1

NEXT OK

2ch

3.2s

INIT. TC:3.2s

＜ECG set-up screen 1＞

Back

ch1 ×1/×0.5

ch2 ×1/×0.5ch3 ×1/×0.5

ECG Setting

OK

INIT. TC:3.2s

×1

×1

×1

×1

＜ECG set-up screen 2＞

INIT. TC:3.2s

1

2

＜2ch. display screen＞

INIT. TC:3.2s

1

2

3

＜3ch. display screen＞

Example


7. Setting Up the Recorder 7.2 Setting the pacemaker detection On Pace Setting screen, you can select; the pace maker pusle detection mode (Detect) ON/OFF, the channel for the pacemaker (Channel) 1ch / 2ch / 3ch when the pacemaker pulse detection is “ON”, the pacemaker detection sensitivity (Level) 1 / 2 / 3 / 4. (※underlined numeric is the default value) (Level) 1 is the lowest, and (Level) 4 is the highest sensitivity. Select “Pace Setting” from the Set-up screen and press the ON◎/ENTER switch to display the pace setting screen. To move between items, press EVENT switch. To adjust the settings, press the ON◎/ENTER switch. Confirmed values will be highlighted. (<Pace set-up screen 1>) When “ON” is selected, the selected channel(s) will appear on the top of the screen and detecting markers for pacemaker pulses will appear at the bottom of the waveforms. The channel(s) for the pacemaker pulse will remain displayed as you move to other screens. When all the set-ups are completed, move the cursor to “OK” and press the ON ◎ /ENTER switch to go back to the Set-up screen. (<pace set-up screen 2>)

Note:･The pacemaker detection should be turned ON only for the patient with a pacemaker.

･While the power is OFF, your se lec t ion o f ON/OFF o f the pacemaker detection is retained.

OK

INIT. TC 3.2s

Pace Setting

Level. 1 /2/3/41Channel. ch1/ch2/ch3ch2

Detect ON/OFFON

P:ch2

＜Pace set-up screen１＞

TC:3.2s

INIT. P:ch2

1

2

Detecting markers for pacemaker pulses

Pacemaker detection channel

OK

INIT. TC 3.2s

Pace Setting

Level. 1 /2/3/41Channel. ch1/ch2/ch3ch2

Detect ON/OFFON

P:ch2

OK

＜Pace set-up screen 2＞

TC:3.2sINIT.


Other Setting

Pace Setting

Time Setting

Return

＜Set-up screen＞


7.Setting Up the Recorder 7.3 Entering the patient’s ID The FM-180 has the function of entering the patient’s ID before recording for facilitating the identification of the data in analysis. To go to the ID set-up screen, return to the “Settings” screen, select “ID Setting” and press the ON◎/ENTER switch. The cursor is first sitting directly over the “OK”. If you do not need to change the initial condition, press the ON◎/ENTER switch to return to the “Settings” screen. Press the EVENT switch twice to move the cursor (↑) to the position of the leftmost character and allows you to enter a character. This ID field accepts up to 12 characters. (<ID set-up screen 1>) Each time you press the ON◎/ENTER switch once, the character changes in rotation of numeric (0-9), hyphen (-), alphabets (A-Z), and space ( ). By pressing and holding the ON◎/ENTER switch for two seconds or more, it changes continuously. (<ID set-up screen 2>) Press the EVENT switch once to move the cursor (↑) one space to the right, and then you are allowed to enter the next character. To erase a character, move the cursor (↑) to the position of the character and enter a space over the character. To erase all the characters at once, press the EVENT switch to move the cursor to the position of the “CLEAR”, and to be confirmed by pressing the ON◎/ENTER switch.

Pace Setting

TC:3.2sINIT.

ECG Setting

ID Setting

Other SettingTime SettingID Setting

Return

＜Set-up screen＞

INIT. TC:3.2s

OK

ID Setting

ーーーーーーーーーーーー

CLEAR

＜ID Set-up screen 1＞

TC:3.2s

ーーーーーーーーーーーーＡＢＣＤＥＦＧＨ０１２３

INIT.

OK CLEAR

ID Setting

＜ID Set-up screen 2＞


7. Setting Up the Recorder 7.4 Setting up the clock On “Time Setting”, you can set up the clock. From the Set-up screen, select “Time Setting” and press the ON◎/ENTER switch to move to time set-up screen.

When the “Time Setting” screen is displayed, the cursor is first sitting directly over the “OK”. In the case that the time and the date are not required to change, press the ON◎/ENTER switch to return to the LCD displaying ECG waveforms. (<Time set-up screen 1>)

To set the clock, press the EVENT switch once to move the cursor to the position of the Year allowing the set-up of the Year. (<Time set-up screen 2>) Each time you press the ON◎/ENTER switch, the Year value will increase by one. When you hold down the switch, the Year changes continuously. Press the EVENT switch and the cursor will move to the Month, allowing setting up of the Month. Set up the correct Month in the same manner as the set-up of the Year. Each time you press the EVENT switch, the cursor moves from up Year → Month → Date → Hour → Minute → Year, in this sequence, allowing the set-up of the clock.

16:01

INIT. TC:3.2s

Time Setting

2005 / 10 / 05

OK

＜Time Set-up screen 2＞

TC:3.2sINIT.


Other SettingTime Setting

Return

＜Set-up screen＞

16:01

INIT. TC:3.2s

Time Setting

2005 / 10 / 05

OK

＜Time-set-up screen 1＞


7. Setting Up the Recorder 7.5 Other Setting On “Other Setting”, you can set up biological information display (Display) ON/OFF and Reverse display (Reverse) ON/OFF. (※Underlined option is the default setting) To go to Other Setting screen, return to the Set-up screen and select “Other Setting” and press the ON◎/ENTER switch. To move between items, press EVENT switch. To go to set-up screen of each item, or to return to ECG waveform display, press ON ◎ /ENTER switch. Confirmed values will be highlighted. Available Set-up items ・Biological information display setting (Display): It is to set up biological information (ECG waveform, heart rate, pacemaker pulse detection) ON / OFF. ・Reverse display (Reverse): The screen is reversely displayed for Patients to confirm LCD display.

TC:3.2sINIT.

Other Setting

ECG Setting

Pace SettingID SettingTime Setting

Other Setting

Return

＜Set-up screen＞

INIT. TC:3.2s

OK

Other Setting

Display ON / OFF Reverse ON / OFF

O N

O N

＜Biological information display setting＞

15:54

TC:3.2s

＜Reverse display＞


8. Starting ECG Recording

8.1 Checking ECG data One of the most important element for holter

recorders is the quality of ECG waveforms during recording. To save valuable time, remember to check the FM-180 for the correct output of ECG waveforms.

(1) Using the LCD During the set-up period, you can check the ECG waveforms on the LCD. Each channels No. and the bars that indicate the amplitude of ECG signals are displayed on the left side of the LCD. The upper half of the bar represents 1 mV, and the lower half of the bar represents 1 mV, which bring the total to 2 mV. When using a multimedia card which has a patient’s name registered via a holter analysis system, the patient’s name will be appear under the ID section on 1 channel display screen on the FM-180. Each time the ON◎/ENTER switch is pressed, channels displayed on the LCD will change. By pressing the ON◎/ENTER switch once, the LCD will shift from the current display to channel 1. To display selected # of ECG channels simultaneously, press the ON◎/ENTER switch again. Press the ON◎/ENTER switch once to go back to the channel 1 display. Note: The maximum value of the ECG

waveforms displayed on the LCD is ±2mV in one channel display, and ±1mV in two channels display.

TC:3.2s

1

60

INT.

ID:

＜Channel 1 display＞

INIT. TC:3.2s

1

2

＜Channel 1,2 simultaneous display＞

INIT. TC:3.2s

1

2

3

＜Channel 1,2,3 simultaneous display＞


8. Starting the ECG Recording 8.2 Starting the ECG recording The ECG recording starts after the set-up period expires. The set-up period automatically expires 10 minutes after the power is turned ON. Alternatively, to skip the set-up period and start the recording immediately, hold down the EVENT switch for a few seconds during the set-up period. “INIT.” sign which is indicated on the upper left corner of the LCD, and ECG waveforms displayed on the LCD will disappear, then the “RECORDING” sign which include the current time, the starting time, and the ending time will appear. The LCD will be shown reversely when ON is selected at the Reverse Setting in “Other Setting”. (See 7.4 Other Setting) 8.3 Carrying the FM-180 To carry the FM 180, use the carrying case. [Attaching the carrying case] Wrap a belt (the carrying case is attached) around the patient’s waist and fasten the hook. Adjust the length of the strap if needed. When the set-ups of the FM-180 and attachment of the electrodes are done, insert the FM-180 into the carrying case, then close the hook and loop fastener tightly to place the FM-180 stably.

CAUTION

FM-180 has a built-in position sensor, and it records body position information. To obtain correct position information, fix the FM-180 to the right position (in the center of the patient’s abdomen) and adjust the strap to the proper length to fit to the patient’s waist.

15:54

TC:3.2s

＜Recording＞


8. Starting ECG Recording When the recording is completed, open the fastener and take the FM-180 out from the case.

Note: Disposable carrying case is single-use and is to be discarded after each removal. Please use new one for each recording.

8.4 EVENT switch If the patient feels any kind of disorder on the recording, he/she should press the EVENT switch. Each time the EVENT switch is pressed, the time is recorded, so that the moment he/she feels discomfort may be easily pinpointed in analysis. When the patient is aware of any particular disorder, he/she should hold down the EVENT switch from over the clothes for one second. The alarm buzzer will sound, and then the LCD will display the EVENT message. Only one EVENT is recorded within five seconds.

Note:･In the case that the patient is heavily clothed or is in a noisy area, even if he/she presses the EVENT switch, the alarm buzzer is hard to be heard. Make sure to instruct the patient to press the EVENT switch firmly.

･Instruct the patient to make a note of subjective symptoms on the provided event recording card every time he/she presses the EVENT switch.

･Instruct the patient to keep a detailed record on the provided event recording card to facilitate the precise analysis and interpretation of the recorded data.

TC:3.2s

ＥＶＥＮＴ

＜EVENT switch＞


8. Starting ECG Recording 8.5 Checking the patient’s ID During ECG recording, you can check the patient’s ID entered during the set-up period. During the recording, press the ON◎ /ENTER switch, then the LCD displays following screens when the biological information display (Display)is ON: Time display(①)→1ch. ECG waveform display+ heart rate display+ pacemaker pulse detection display( ② ) → 2ch. ECG waveforms display+ pacemaker pulse detection display (③) →Current Time + heart rate display( ④ ) → ID checking display(⑤) OFF: Time display→ID checking display When pressing the ON◎/ENTER switch again, the LCD displays the time in place of the patient’s ID. Leaving the LCD to display the patient’s ID does not affect ECG recording.

<1ch. ECG waveform display+ heart rate display+ pacemaker pulse detection display >②

TC:3 .2s

1

60

P:ch1

15:54

TC:3.2s

<Time display> ①

TC:3.2s

1

2

P:ch1

<Time + heart rate display>④

15:54

TC:3.2s

60

TC:3.2s

ID No.

START 02/20 12:35END 02/21 12:40

<ID checking display>⑤

<2ch. ECG waveform display+ heart rate display+ pacemakerpulse detection display >③ (※3 waveforms will be displayed when the 3ch. is selected)


8. Starting ECG Recording 8.6 Notes during ECG recording

Provide the patient with the below listed instructions to be observed during ECG recording. If the patient does not observe these instructions correctly, the FM-180 may be damaged, or ECG recording may fail to continue for 24 hours.

CAUTION

● Keep away from a heater or other higher temperature environment. ● Keep away from exposure to paint thinner, benzine, or similar volatile

chemicals. ● Do not inflict high impacts, viblations, or drops. It may cause water

leakage and waterproof function may become weakened. ● Do not use the FM-180 in the area where MRI is operating. ● During ECG recording, do not attempt to remove the FM-180 from the

carrying case and to open the covers of the recorder. ● If the lid becomes open during ECG recording, close the lid, taking great

care not to touch the dry cell, the mutimedia card, or inside of the recorder. ● Exposure to any continuous noise or similar electrical disturbance (hum) for

an extended period of time will result in failure to record for the full 24 hours. Avoid using the FM-180 in an environment susceptible to hum interference (eg. electric blanket, electric carpet, etc.) Make sure to avoid noise interfering for stable recording, follow the instructions described in [PART 2, Attching ECG Electrodes]. To avoid possible noise interference, read [PART 2 Attaching ECG electrodes] carefully and perform the secure recording.

● To avoid possible noise or other electromagnetic interference, keep away from cellular phones, transceivers, or radio-controlled toys, or other such radio/electromagnetic waves generating devices.

8.7 Notes during taking a bath

FM-180 allows you to bathe with in combination of ECHORODE TEH-04DAW. Please give following instructions to the patient when he/she bathe:

CAUTION

● Do not soak in a hot tub above 40 degrees Celsius / 104 degrees Fahrenheit for more than 10 minutes as it may cause electrodes peel-off or noise interference due to sweat. Do not use FM-180 in sauna, Jacuzzi, hot spring or do not use with bath agent. It may cause electrodes peel-off or noise or malfunction.

● Do not rub electrodes with a towel etc. It may cause electrodes peel-off or noise.


9. Completing ECG Recording and Analyzing the Recorded Data

The ECG recording will be automatically shut down 24 hours after the start. An alarm buzzer sounds, the LCD displays the END message for a few seconds, and the power then turns OFF. （<END Message display>/<END display>） The recording is shut down in increments of ten minutes of displayed time. For example, if you start recording at 10:15, the recording will be shut down at 10:20 the next day. To end the ECG recording before 24 hours elapse, press the ON◎/ENTER and EVENT switches simultaneously for 3 seconds or more, the power supply is turned OFF forcibly after displaying the Shut Down display. Before removing the multimedia card from the FM-180 for scanning (analysis), remember to check that the power is turned OFF. The scanning (analysis) is performed through the personal computer installed Holter software. When inserting the multimedia card into the drive, use the card adapter and ensure the right direction of the card. All the operations are available on the holter analysis system. For further information regarding the scanning (analysis), refer to the operation manual supplied with the Holter software.

＜END display＞

01ｈ04ｍ　 0.9ＭＢ

START 02/20 12:35END 02/20 13:39

Record Aborted(User Int.)

＜Shut Down display＞

PART 2 Attaching ECG Electrodes

PART 2 Attaching ECG Electrodes 2-1

1. Attaching ECG Electrodes The FM-180 includes ECHORODE as standard accessories.

・ CAUTION

Leaving the electrodes attached in the same positions for several days may result in inflammation. For the patient with the delicate skin or the patient suffering from inflammation of the skin, select different attachment positions of electrodes, or for cleaning of the skin, use alcohol absorbent cotton instead of the skin cleaner.

PART 2 Attaching ECG Electrodes 2-2

1. Attaching ECG Electrodes

1.1 Preparation for ECG electrodes attachment

Wipe the electrode attachment areas several times with gauze moistened with skin cleaner. Shave off thick body hair beforehand. Attaching electrodes on the contaminated skin or the skin covered with the excessive hair can cause electrodes to peel off or unstable recording.

1.2 Attaching ECG electrodes Stretch a portion of the skin and apply the electrode. Hook up the connector of the patient cable to the electrode. Make sure that the connection is secure by turning patient cable connector.

Note: ・ Make sure to attach the ECHORODE securely without unsticking.

・If there is a possibility of patient’s profuse sweating due to bathing or exercise during the 24-hour recording, please secure ECHORODE with provided adhesive tape or surgical tape.

PART 3 Error Messages and Maintenance

PART3 Error messages and Maintenance 3-1

1. Error Messages and Corrective Action The FM-180 is designed to sound the audible alarm and display error messages if any unusual condition is discovered during the power-on sequence or during the operation. This section describes error messages that can be encountered with the FM-180, as well as corrective actions.

(1) The multimedia card is not installed

・Error message display ・Error description If you attempt to turn ON the unit without installing the multimedia card, this message will appear for 3 seconds as the alarm buzzer sounds, and the power will then be turned OFF automatically. ・Corrective action Insert the multimedia card in the FM-180 then turn ON the FM-180.

(2) The multimedia card is not scanned

・Error message display ・Error description When you turn ON the FM-180, this message will be displayed as the alarm buzzer sounds to indicate that the ECG data stored in the multimedia card has not been read (the previously recorded data is not read out). ・Corrective action If you want to start recording new data without reading out the previously recorded data, press the ON◎/ENTER switch. If you read the recorded data in the multimedia card for analysis, turn OFF the FM-180 by pressing and holding both the ON ◎ /ENTER and EVENT switches at the same time for 3 seconds or more. Remove the multimedia card, and scan the card in the analysis system. When the FM-180 is left in the recorder for 10 minutes without any operation, the ECG recording will start automatically.

PART 3 Error messages and Maintenance 3-2

1. Error Messages and Corrective Action

(3) Incorrect multimedia card (The multimedia card is not the product supplied by Fukuda Denshi.)

・Error message display ・Error description To indicate the multimedia card is different from those supplied by Fukuda Denshi (MMC-64), this message will be displayed for 3 seconds as the alarm buzzer sounds, and the power will then be turned OFF. ・Corrective action The FM-180 cannot accept any multimedia card other than those supplied by Fukuda Denshi (MMC-64). Remove the card and change to the card specified by Fukuda Denshi.

(4) Low voltage in a dry cell

・Error message display ・Error description The message is displayed for 3 seconds as the alarm buzzer sounds, and the power will then be turned OFF to indicate that the voltage of a dry cell is found to be low. ・Corrective action Replace the dry cell with a fresh one.

(5) Low voltage in battery for the clock

・Error message display ・Error description When the FM-180 is turned ON, this message is displayed as the alarm buzzer sounds, to indicate low voltage of the built-in backup battery for the internal clock. ・Corrective action If you want to start recording without replacing the built-in backup battery, press the ON◎ /ENTER switch. Remember to check the clock data (Year/Month/Day/Hour/Minute) during the set-up period and if any items are found to be incorrect, set up the correct value. When replacing the built-in back up battery for the internal clock with new one, turn OFF the FM-180 (see [PART 1, Section 6.2, Turning OFF the FM-180]) and contact the FM-180 dealer. When the FM-180 is left in the recorder for 10 minutes without any operation, the ECG recording will start automatically.


1. Error Messages and Corrective Action

(6) RAM abnormality

・Error message display ・Error description To indicate that abnormal condition in the RAM inside of the FM-180 when the recorder is powered or during operation, this message is displayed for 3 seconds as the alarm buzzer sounds, and the power is then turned OFF. ・Corrective action Make note of error message and consult your dealer.

(7) RTC abnormality

・Error message display ・Error description To indicate the occurrence of abnormality in the internal RTC of the FM-180 when the recorder is turned ON or during operation, the message is displayed for 3 seconds as the alarm buzzer sounds, and the power will then be turned OFF. ・Corrective action Make a note of error message and consult your dealer.

(8) Other error messages

・Error message display For any other messages, the corresponding Error No. is displayed in 3 figures as shown in the illustration. Many available Error Nos. are listed on the following page along with their types and descriptions. ・Error description If any subsequent trouble occurs during the power-on sequence or during operation, Error No. is displayed on the LCD for 3 seconds as the alarm buzzer sounds, and the power is then turned OFF. ・Corrective action Make a note of Error No. and consult the FM-180 dealer.


1. Error Messages and Corrective Action Error No. – Types and descriptions

・ 002 ： Selected file does not exist ・ 005 ： I/O error ・ 017 ： Selected file already exists ・ 019 ： Incorrect access ・ 020 ： Selected directory does not exist ・ 021 ： Writing is attempted onto the directory ・ 022 ： Invalid parameter was passed ・ 023 ： Selected file is full and does not open ・ 028 ： No available storage space remains on the device ・ 032 ： CPU malfunction ・ 033 ： The divisor was 0 at the division process ・ 034 ： Faulty internal serial communication ・ 035 ： Failure to capture an available area ・ 048 ： The card is used by another operation. ・ 049 ： The card is not ready when making access to the card ・ 050 ： Time-out during the process of data transmission ・ 051 ： Incorrect data request ・ 052 ： Abnormal command termination ・ 053 ： Time-out during the last data transmission ・ 054 ： Failure to become ready after the end of command ・ 055 ： Command error ・ 056 ： Protocol error ・ 057 ： Writing failure ・ 058 ： Command time-out ・ 059 ： Bad block detected ・ 060 ： Uncorrectable error ・ 061 ： Incorrect sector ID is requested ・ 062 ： Incorrect command issued ・ 063 ： Error other than the above


2. Maintenance 2.1 Cleaning the FM-180 To clean the FM-180, wipe with a dry clothe or a cloth soaked with regular household cleaner diluted with water. Wipe the Battery compartment lid packing with a soft cloth gently.

・ CAUTION

• Take care to prevent chemicals from entering the connector or internal part of the unit.

• Any attempt to use cleaner containing organic solvent, thinner, toluene, or benzine to clean the FM-180 will generate the damage of the housing.

• To clean the FM-180, wipe with a dry clothe or a cloth soaked with regular household cleaner diluted with water.

• Do not polish the housing with abrasive or chemical cleanser. 2.2 Storage of the FM-180 Before storage, make sure to remove a dry cell and a multimedia card from the FM-180 and close the cover tightly. Store the recorder in the provided storage case.

CAUTION

Take care to prevent dust from entering the multimedia card connector, the multimedia card slot, or dry cell terminals in the battery compartment. Do not touch them with your bare hand.

• Take care to avoid areas subject to high humidity, poor ventilation and direct sunlight; store the FM-180 in an area free from any adverse effects of surrounding air containing dust, salt, or sulfur.

• Do not store the FM-180 in an area where chemicals are kept or which is exposed to chemical fumes or vapors.

Surface of the packing


2. Maintenance 2.3 Maintenance check ・ The items listed in this section are maintenance check items for the FM-180. ・ To use this unit safely and to maintain proper functionality and performance, daily check

and periodic check are indispensable. We assume no responsibility for any accidents caused by lack of the maintenance and check.

CAUTION

• Do not open the case except for by our service personnel. • Take care to prevent liquid such as alcohol from entering internal part of

the unit. ■ Daily check Before using the FM-180, execute the daily check of the unit in accordance with the daily check procedure. In case that any rejected items are found as a result of the daily check, it will be totally judged as rejection. Take the corrective measures as the rejected items. Use the recorder after all the items become accepted. ■ Periodic check The periodic check is essential for the medical electrical equipments to prevent accidents or failure of the unit, and to maintain the safety and effectiveness of the unit. Periodic check shall be performed by each medical institution, or by Fukuda Denshi personnel, representative agent, or an authorized third party. For more details, do not hesitate to consult your dealer or Fukuda Denshi personnel. If any rejected items may be found as a result of the check, the unit will be totally judged as a rejection. Take the corrective measures as the rejected items. Use the recorder after all the items are accepted in the check. If any rejected items may be found in the test mode, stop the test immediately and take the corrective maintenance as the rejected items. After the correction, perform all the items in the test mode. Periodic Replacement ■ Battery compartment lid with waterproof gasket

(see illustration on the right) requires annual replacement. To ensure the waterproof performance, it is strongly encouraged to replace the gasket a year. Please consult your dealer or Fukuda Denshi personnel for the replacement. Failure to change the packing may cause malfunction due to the water leakage while taking a bath or in the shower.

＜Battery compartment lid＞


2. Maintenance 2.3.1 Daily check

Daily Check Procedure

Item Details of the check Check Method Criteria

1. Multimedia Card Visually check for scratches and damage.

Must be free from scratches and damage.

Accessories

2. Operation manual Check that the operation manual is kept in a predetermined place.

Should be kept in a predetermined place.

1. Cracks and Distortion of the Exterior

Visually check the exterior of the main body for cracks and distortion.

Must be free from cracks and distortion.

2. Peeling and Dirt of Nameplate

Visually check the nameplate for peeling and dirt.

Must be free from peeling and dirt.

3. Battery Compartment Lid packing

Check whether dirt or hair is not accumulated between the battery compartment lid

Must be free from dirt or hair.

Visual Check

Main B

ody

4. Lids and Other Parts Visually check the lid and other parts of the main body for cracks and damage.

Must be free from cracks and damage.

1. Switches Check whether the switches work smoothly.

Must work smoothly.

2. Cover Check whether the cover is locked correctly.

Must be locked correctly.

Main U

nit 3. Battery Spring in the Battery compartment

Visually check the battery spring for strain, skew, and corrosion.

Must be free from strain, skew, and corrosion.

Mechanical C

heck

Accessories

1. Connectors Check whether the connections of each of connectors to the main body are secure and in good condition.

Must be secure and in good condition.

1. Power Switch Press the ON◎/ENTER switch to check whether the LCD displays the initial screen.

The power should be turned ON.

2. LCD display Check whether the LCD screen is free from flickers and abnormality.

Must be free from flickers and abnormality.

Electrical C

heck

Performance

3. Switches Press the switches to check whether they operate normally.

Must operate normally.

Cleaning Refer to [PART 3, Section 2.1, Cleaning]. Total Judgment All the items are accepted.


2. Maintenance

Daily Check Record Perform the daily check according to the daily check procedure.

Item Details of the check Criteria Judgment Remarks

1. Multimedia Card Must be free from scratches and damage.

OK / Not good Accessories

2. Operation manual Should be kept in a predetermined place.

OK / Not good


The exterior must be free from cracks and distortion.

OK / Not good



OK / Not good

3. Battery Compartment Lid Packing

Must be free from dirt or hair. OK / Not good

Visual Check

Main B

ody

4. Lids and Other Parts

Visually check the lid and other parts of the main body for cracks and damage.

OK / Not good

1. Switches Must work smoothly. OK / Not good

2. Cover Must be locked correctly. OK / Not good

Main B

ody

3. Battery Spring in the Battery compartment


OK / Not good

Mechanical C

heck

Accessories

1. Connectors The connections of each of connectors to the main body must be secure and in good condition.

OK / Not good

1. Power Switch The power should be turned ON.

OK / Not good

2. LCD display Must be free from flickers and abnormality.

OK / Not good

Electrical C

heck

Performance 3. Switches Must operate normally. OK / Not good

Cleaning Refer to [PART 3, Section 2.1, Cleaning]. OK / Not good Total Judgment All the items are accepted. OK / Not good

Model Digital Holter Recorder Type FM-180 Serial Number Installation place Purchase Date

Check Date Checker Approved by


2. Maintenance 2.3.2 Periodic check

Periodic Check Procedure (1) 1/2

Item Details of the check Check Method Criteria 1. Multimedia Card Visually check for scratches and

damage. Must be free from scratches and damage.

Accessories

1. Operation Manual Check that operation manual (FM-180) is kept in a predetermined place.

Should be kept in a predetermined place.


Visually check the exterior of the main body for cracks and distortion.



Visually check the nameplate for peeling and dirt.


3. Battery Compartment Lid Packing

Check whether dirt or hair is not accumulated between the battery compartment lid

Must be free from dirt or hair.

Visual Check

Main B

ody


Visually check the lids and other parts of the main body for cracks and damage.


1. Switches Check whether the switches work smoothly.

Must work smoothly.

2. Cover Check whether the cover is locked correctly.

Must be locked correctly.

Main B

ody 3. Battery Spring in the Battery compartment

Visually check the battery spring for strain, skew, and corrosion.


Mechanical C

heck

Accessories

1. Connector Check whether the connections of each of connectors to the main body are secure and in good condition.

Must be secure and in good condition.

1. Power Switch Press the ON◎/ENTER switch to check whether the LCD displays the initial screen.

The power should be turned ON.

2. LCD Display Check whether the LCD screen is free from flickers and abnormality.

Must be free from flickers and abnormality.

Electrical C

heck

Performance

3. Switches Press each switch to check whether they operate normally.

Must operate normally.


2. Maintenance Periodic Check Procedure (1)

2/2 Item Details of the check Check Method Criteria

1. Display Test Turn ON the power in test mode. The LCD display should light up without abnormality and flickers. Alarm buzzer should sound.

Display 2. Switch Test Check the LCD display when

pressing each switch. When each switch is pressed, the name of the switch should appear on the LCD.

Mem

ory

1. Memory Test After the switch test, press the ON◎/ENTER switch to check the LCD display.

SRAM OK should appear on the LCD.

Card

1. Card Test After the memory test, press the ON◎/ENTER switch to check the LCD display.

CARD OK should appear on the LCD.

1. Internal Clock Test

After the card test, press the ON◎/ENTER switch to check the LCD display.

RTC OK should appear on the LCD.

2. Position Sensor Test

After the internal clock test, press the ON◎/ENTER switch to check the LCD display.

Refer to p3-12

3. Main Battery Voltage Test

After the internal clock test, press the ON◎/ENTER switch to check the LCD display.

The value of the Main Battery Voltage should appear on the LCD.

4. Backup Battery Voltage Test

After the main battery voltage test, press the ON◎/ENTER switch to check the LCD display.

BBAT OK should be displayed on the LCD.

Test Mode

Performance

5. Acceleration Sensor Test

After the backup battery voltage test, press the ON◎/ENTER switch to check the LCD display.

Refer to p3-12

1. Power ON Press the ON◎/ENTER switch to check whether the LCD lights up.

The switch should be turned ON.

Others

Power Sw

itch

2. Power OFF Press and hold the ON◎/ENTER and EVENT switches together for 3 seconds or more to check visually whether the power is turned OFF.

The power should be turned OFF.

Cleaning Refer to [PART 3, Section 2.1, Cleaning]. Replacement

Parts Change the Battery Compartment Lid.

Total Judgment All the items are accepted.


2. Maintenance Entering the test mode With connecting the patient cable, install a fresh AAA alkaline dry cell and a multimedia card in the FM-180, and press the ON◎/ENTER switch to turn ON the recorder. When the recorder starts to display self-diagnosed information on the LCD, press and hold the EVENT switch until the end of the self-diagnosis. 1. Display test

After the alarm buzzer has sounded, the LCD displays checkerboard blinking, then stop operation. Press the ON◎/ENTER switch to end display test.

2. Switch test Press each switch in the following order to check whether the LCD displays the messages below. ON◎/ENTER switch → ENTER EVENT switch → EVENT In case that the LCD does not display above messages when pressing the switches, the malfunction of the switches may be considered. 3. Memory test After checking the EVENT switch, pressing the ON◎/ENTER switch will bring you to the memory test. The LCD will display the following displays. SRAM OK → OK SRAM NG → No Good 4. Card test After the memory test, press the ON◎/ENTER switch to move on to the card test. The LCD will display the following messages. CARD OK → OK CARD NG → No Good


2. Maintenance 5. Internal clock test After the card test, press the ON◎/ENTER switch to move on to the internal clock test. The LCD will display the following messages.

RTC OK → OK

RTC NG → No Good 6. Position sensor test After the internal clock test, press the ON◎/ENTER switch to move on to the position sensor test. The LCD will display the following messages.

STAND → upright position SUPINE → supine position

PRONE → prone position RIGHT → right lateral decubitus position

LEFT → left lateral decubitus position 7. Main battery voltage test After the internal clock test finished, pressing the ON◎/ENTER switch will bring you to the main battery voltage test. The LCD will display the following characters. MB ＊＊V : the voltage value of the main battery will be displayed. 8. Backup battery voltage test After the main battery voltage test, press the ON◎/ENTER switch to move on to the backup battery voltage test. The LCD will display the following messages. BBAT OK → OK BBAT NG → No Good


9. Acceleration sensor After the backup battery voltage test, press the ON◎/ENTER switch to move on to the acceleration sensor test. Shake Wait In 3 seconds, the LCD will change to “Shake Start”. Then, jiggle the FM-180 up and down. The value displayed on the LCD will increase.

Above 16 → OK Below 15 → No Good

In the case of OK, the display will change to “Shake Finish” Shutting down the test mode Press both the ON◎/ENTER and EVENT switches together for 3 seconds or more. The LCD will display the “END” message, and then the power will be turned off.


2. Maintenance

Periodic Check Record Perform the periodic check according to periodic check procedure (1). 1/2


1. Multimedia Card Must be free from scratches and damage.

OK / No Good

Accessories

2. Operation Manual Should be kept in a predetermined place.

OK / No Good

1. Cracks and Distortion


OK / No Good



OK / No Good

3. Battery Compartment Lid packing

Must be free from dirt or hair. OK / No Good

Visual Check

Main B

ody



OK / No Good

1. Switches Must work smoothly. OK / No Good

2. Lids Must be locked correctly. OK / No Good

Main B

ody 3. Battery Spring in the Battery compartment


OK / No Good

Mechanical C

heck

Accesso

-ries

1. Connector The connections of connectors to the main body must be secure and in good condition.

OK / No Good

1. Display Test The LCD checkerboard display should appear without abnormality and flickers.

OK / No Good

D

isplay 2. Switch Test When each switch is pressed, the name of the switch should appear on the LCD.

OK / No Good

Me 1. Memory Test SRAM OK should appear on the

LCD. OK / No Good

Test Mode

Card 1. Card Test CARD OK should appear on the

LCD. OK / No Good


2. Maintenance

Periodic Check Record 2/2


1. Internal Clock Test

RTC OK should appear on the LCD.

OK / No Good

2. Position Sensor Test

OK / No Good

3. Main Battery Voltage Test

The value of the Main Battery Voltage should appear on the LCD.

OK / No Good

4. Backup Battery Voltage Test

BBAT OK should appear on the LCD.

OK / No Good

Test Mode

Performance

5. Acceleration Sensor Test

OK / No Good

1. Power switch The power should be turned ON. OK / No Good

Others

Power

Supply 2. Power switch The power should be turned OFF OK / No Good

Cleaning Refer to [PART 3, Section 2.1, Cleaning]. OK /

No Good

Total Judgment All the items are accepted. OK /

No Good

Model Digital Holter Recorder Type FM-180 Serial Number

Installation place Purchase Date

Check Date Checker Approved by


2. Maintenance 2.4 Troubleshooting

Symptom Possible Cause(s) Solution

The LCD does not light up when the ON◎/ENTER switch is pressed.

・ The power cannot be turned ON.

・ Install a new dry cell. ・ Check for the correct

polarity (positive/negative) of a dry cell.

・ Change the exhausted dry cell to new one.

When the ON◎/ENTER switch is pressed, the LCD lights up, error message is displayed, and then the LCD will light off.

・ A multimedia card is not installed.

・ A multimedia card other than Fukuda’s is installed.

・ New dry cell is not loaded.

Refer to [PART 3, Section 1, Error Messages and Corrective Action] and follow the corrective action.

The LCD lights up, but the LCD or the electrocardiograph connected to the FM-180 through the monitor adapter provides no ECG waveform.

・ Broken patient cable or electrode.

・ Contact failure between the patient cable and the recorder.

・ Check for the broken patient cable or electrode. If broken, change them to new one.

・ Check for the electrode is connected to the patient cable correctly.

・ Check for the locking lever locks correctly.

PART 4 Specifications and Accessories

PART 4 Specifications and Accessories 4-1

1. Specifications

Overall ⋅ CPU : 16 bit single chip ⋅ SRAM : 512 K Bytes ⋅ LCD Resolution : 112 dot × 72 dot (graphics) ⋅ Recording time : Continuous 24 hours ⋅ Internal Clock : RTC ⋅ Backup battery : Lithium battery

Service life six (6) years or more ⋅ Patient EVENT recording : EVENT switch

Records up to twelve (12) times / min ⋅ Recording media : Multimedia card (MMC-64) ⋅ ECG signal recording unit

Number of recording channels : bi-polar 2/3 channels, unipolar 2/3 channel Input impedance : 10 MΩ or more CMRR : 60 dB or more Gain ratio : 300x (A/D input) : 300x (Monitor output) Frequency response : 0.05/0.67～40Hz Monitor output : 300 mV/1mV Quantifying bit number : 10 bits Sampling frequency : 125 Hz Dynamic range : ±5.00mV Minimum resolution : ±9.76μV

⋅ Pacemaker pulse detection Detection channel : given 1 channel ⋅ Acceleration sensor : 3 axial directions (static position

information detection) ⋅ Switches : 2 units (EVENT, ON◎ENTER) ⋅ Buzzer : 1 unit (separate excitation) ⋅ Power supply : AAA battery ⋅ Dimensions (W×H×D mm) : Approx. 65×62×18 ⋅ Weight (g) : Approx. 78g (incl. a dry cell and a

multimedia card)


1. Specifications Multimedia Card (MMC-64) ⋅ Memory capacity : 64 M Byte ⋅ Interface : MMC System Standard ⋅ Dimensions (W×D×H mm) : 24×1.4×32 ⋅ Weight (g) : Approx. 1.5g ⋅ Backup battery : Not required ⋅ Card type : MMC System Standard ⋅ Service life (Electrical) : Rewritable 100,000 times (Approx. 247

years / everyday use) ⋅ (Mechanical) : Endures Load/Eject 10,000 times (Approx.

7 years/ 4-Load/Eject a day) ⋅ Error Rate : 52.8FIT ⋅ Mean Time Between Failures (MTBF) : 18,914,171 hours ⋅ Vibration-resistance (Operating) : 15 Gpp (MAX)

(Non-operating) : 15 Gpp (MAX) ⋅ Shock resistance (Operating) : 500G (MAX) (Non operating) : 500G (MAX) ⋅ Acceptable card : Fukuda Denshi encoded. Commercially

produced multi media cards are not usable. Environmental conditions Operating environments Temperature : +10℃ - +40℃ (50°F to 140°F) Relative humidity : 30-85% (No condensation) Storage environments Temperature : -10℃ - +60℃ (14°F to 140°F) Relative humidity : 10-95% (No condensation)


2. Accessories ■ Standard Accessories No. Article Name Type Qty. Remarks Item No. ① MMC Card MMC-64 (CE) 1 ② Storage case ABH-180S 1 ③ Carrying case ABH-180C-L 1 ④ Patient Cable CMH-06FMJ1.2EU 1 ⑤ Operation Manual

①

②

③

④

To make full use of the FM-180, use only genuine Fukuda Denshi products. When ordering such products, specify types as well as article names.


3. Option ■ Option No. Article Name Type Remarks Item No.

① MMC Card MMC-64 (CE) ② Portable case ABH-180C-L ③ Disposable case ABH-180D-L

④ Patient Cable CMH-05FMJEU Bipolar 2 channels, place under the clothes

⑤ Patient Cable CMH-05FMJ (EV) EU Bipolar 2 channels, place under the clothes, w / Event switch

⑥ Patient Cable CMH-05FMJ1.2EU Bipolar 2 channels, place over the clothes

⑦ Patient Cable CMH-06FMJ1.2EU Bipolar 3 channels, place over the clothes

⑧ Patient Cable CMH-07FMJ1.2EU Monopolar 2 channels, place over the clothes

⑨ Patient Cable CMH-08FMJ1.2EU Monopolar 3 channels, place over the clothes

⑩ Patient Cable CIH-01CM ⑪ Patient Cable CIH-01CM (EV) ⑫ Excerode THE-04DAW

⑬ Patient diary card

OA-425W

Available optional accessories for the FM-180 are as listed on the left. These optional products are not provided with the FM-180 as standard. When ordering the optional products from your dealer, specify types as well as article names

39-4, Hongo 3-chome, Bunkyo-ku, Tokyo, Japan

Phone:+81-3-3815-2121 Fax:+81-3-3814-1222

4L3849 200603

ebso: holter marca fukuda modelo fm 180

Health & Medicine