cardiofax Q ECG 9110K User Manual Rev G

Model:

ECG-9110K

Manual code no.: 0614-004431G

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CONTENTS

Contents GENERAL HANDLING PRECAUTIONS ... i WARRANTY POLICY ... ii EMC Related Caution ... iii Conventions Used in this Manual and Instrument ... iv Warnings, Cautions and Notes ... iv Explanations of the Symbols in this Manual and Instrument ... iv

Section 1

General ...1C.1 Introduction ... 1.1 Important Safety Information ... 1.2 Panel Descriptions ... 1.5 Top Panel ... 1.5 Operation Panel ... 1.6 Right Side Panel ... 1.8 Left Side Panel ... 1.9 Outline of the Functions ... 1.10 AC Operation and Battery Operation ... 1.11

Section 2

Preparation ...2C.1 Selecting a Suitable Location ... 2.1 Connecting the Power Cord ... 2.2 Equipotential Grounding ... 2.2 Necessity of Equipotential Grounding ... 2.2 Battery ... 2.3 Safety Information for Battery ... 2.3 Inserting a Battery ... 2.4 Charging the Battery ... 2.5 Mounting the Cardiograph on the Cart ... 2.6 Mounting the Cardiograph on the KC-010A or KD-010A Cart ... 2.6 Setting the Recording Paper ... 2.7 Recording Paper ... 2.8 Setting the Z-fold Type Recording Paper ... 2.9 Setting the Roll Type Recording Paper ... 2.10 Setting the Z-fold Type Recording Paper on the Cart. ... 2.11 Changing the Setting for Recording Paper ... 2.12 Out of Paper Indication ... 2.12 Feeding the Paper ... 2.12 Connecting the Patient Cable ... 2.13 Power On Procedure ... 2.14

Section 3

Changing Settings before Measurement ...3C.1 General ... 3.1

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CONTENTS List of Settings ... 3.2 Recording Settings ... 3.2 Machine Settings ... 3.4 Communication Settings ... 3.5 Manual Recording Settings ... 3.5 Auto Recording Settings ... 3.5 Periodic Recording Settings ... 3.5 Power on Settings ... 3.6 Changing Settings and Printing ... 3.7 Calling Up the System Setup Mode ... 3.7 Changing the Settings ... 3.7 Pinting the List of the Sytem Settings ... 3.7

Section 4

Attaching the Electrodes ...4C.1 Attaching the Electrodes ... 4.1 Attaching the Limb Electrodes ... 4.1 Attaching the Chest Electrodes ... 4.2 Patient Cable Tip Color Coding ... 4.3 Lead Connection ... 4.4 Error Indication When the Electrode Is Not Attached Firmly ... 4.5 Lead Lamp Indication ... 4.5 Indication on the Paper ... 4.5 Countermeasure ... 4.6

Section 5

Recording Resting ECG Waveforms ...5C.1 General ... 5.1 Flow of Resting ECG Waveform Recording ... 5.2 Notes for Accurate Measurement ... 5.3 Before Starting the Recording ... 5.3 Detecting QRS Waves ... 5.3 Counting the Heart Rate ... 5.3 Using the High-cut Filter ... 5.3 ECG Analysis ... 5.4 Automatic Recording ... 5.5 General ... 5.5 Preparation for Automatic Recording ... 5.5 Automatic Recording Procedure ... 5.7 Copy Recording ... 5.8 Manual Recording ... 5.9 General ... 5.9 Preparation for Manual Recording ... 5.9 Manual Recording Procedure ... 5.10 Rhythm Recording ... 5.12 General ... 5.12 Rhythm Recording Procedure ... 5.12 Recording Example ... 5.13

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Operator's Manual ECG-9110

CONTENTS

Section 6

Periodic ECG Recording ...6C.1 General ... 6.1 Preparation for Periodic ECG Recording ... 6.2 Recording Procedure ... 6.3 Recording Example ... 6.4

Section 7

External Signal Recording ...7C.1 General ... 7.1 Connecting an External Instrument ... 7.2 Recording Procedure ... 7.3 Recording Example ... 7.4

Section 8

Troubleshooting ...8C.1 Recording Clear ECG Waveforms ... 8.1 AC Interference ... 8.1 Muscle Tremor Interference (EMG) ... 8.1 Wandering Baseline ... 8.2 Other ... 8.2 Troubleshooting ... 8.3

Section 9

Maintenance and System Test ...9C.1 Maintenance ... 9.1 Check Items After Use ... 9.1 Cleaning ... 9.2 Clean the Cardiograph ... 9.2 Cleaning the Electrode and Tips of the Patient Cable ... 9.2 Cleaning the Thermal Head ... 9.3 Periodical Replacement Schedule ... 9.4 System Test ... 9.5 Repair Parts Availability Policy ... 9.5

Section 10

Reference...10C.1 Specifications ... 10.1 Standard Accessories ... 10.4 For All Countries exept for Canada, China and U.S.A. ... 10.4 For Canada and U.S.A. ... 10.5 For China ... 10.5 Options ... 10.6 Accessory Kit ... 10.6 Cart KC-010A, KD-010A, KD-104E ... 10.7 Patient Cable Hanger KH-801E ... 10.7 Patient Cable BJ-903D, BA-903D ... 10.7 Data Filing Software, ECG Viewer II QB-903E ... 10.7 Connector Pin Assignment ... 10.8 Attaching the Ferrite Core ... 10.8

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CONTENTS EXT-IN 1, 2 Connector ... 10.9 CRO-OUT Connector ... 10.9 SIO Connector ... 10.10

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Operator's Manual ECG-9110

GENERAL HANDLING PRECAUTIONS This device is intended for use only by qualified medical personnel. Use only Nihon Kohden approved products with this device. Use of non-approved products or in a non-approved manner may affect the performance specifications of the device. This includes, but is not limited to, batteries, recording paper, pens, extension cables, electrode leads and AC power. Please read these precautions thoroughly before attempting to operate the instrument. 1. To safely and effectively use the instrument, its operation must be fully understood. 2. When installing or storing the instrument, take the following precautions: (1) Avoid moisture or contact with water, dust, extreme atmospheric pressure, excessive humidity and temperatures, poorly ventilated areas, and saline or sulphuric air. (2) Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport. (3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage. (4) The power line source to be applied to the instrument must correspond in frequency and voltage to product specifications, and have sufficient current capacity. (5) Choose a room where a proper grounding facility is available. 3. Before Operation (1) Check that the instrument is in perfect operating order. (2) Check that the instrument is grounded properly. (3) Check that all cords are connected properly. (4) Pay extra attention when the instrument is in combination with other instruments to avoid misdiagnosis or other problems. (5) All circuitry used for direct patient connection must be doubly checked. (6) Check that battery level is acceptable and battery condition is good when using battery-operated models. 4. During Operation (1) Both the instrument and the patient must receive continual, careful attention. (2) Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety. (3) Avoid direct contact between the instrument housing and the patient. 5. To Shutdown After Use (1) Turn power off with all controls returned to their original positions. (2) Remove the cords gently; do not use force to remove them. (3) Clean the instrument together with all accessories for their next use. 6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is not functioning properly, it should be clearly marked to avoid operation while it is out of order. 7. The instrument must not be altered or modified in any way. 8. Maintenance and Inspection: (1) The instrument and parts must undergo regular maintenance inspection at least every 6 months. (2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition. Operator's Manual ECG-9110

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(3) Technical information such as parts list, descriptions, calibration instructions or other information is available for qualified user technical personnel upon request from your Nihon Kohden distributor. 9. When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/or location of electrodes and/or transducers to avoid possible burn to the patient. 10. When the instrument is used with a defibrillator, make sure that the instrument is protected against defibrillator discharge. If not, remove patient cables and/or transducers from the instrument to avoid possible damage.

WARRANTY POLICY Nihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one year from the date of delivery. However, consumable materials such as recording paper, ink, stylus and battery are excluded from the warranty. NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period, provided these products are used as prescribed by the operating instructions given in the operator’s and service manuals. No other party is authorized to make any warranty or assume liability for NKC’s products. NKC will not recognize any other warranty, either implied or in writing. In addition, service, technical modification or any other product change performed by someone other than NKC or its authorized agents without prior consent of NKC may be cause for voiding this warranty. Defective products or parts must be returned to NKC or its authorized agents, along with an explanation of the failure. Shipping costs must be pre-paid. This warranty does not apply to products that have been modified, disassembled, reinstalled or repaired without Nihon Kohden approval or which have been subjected to neglect or accident, damage due to accident, fire, lightning, vandalism, water or other casualty, improper installation or application, or on which the original identification marks have been removed. In the USA and Canada other warranty policies may apply.

CAUTION United States law restricts this device to sale by or on the order of a physician.

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Operator's Manual ECG-9110

EMC RELATED CAUTION This equipment and/or system complies with the International Standard IEC60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or system. However, an electromagnetic environment that exceeds the limits or levels stipulated in the IEC60601-1-2, can cause harmful interference to the equipment and/or system or cause the equipment and/or system to fail to perform its intended function or degrade its intended performance. Therefore, during the operation of the equipment and/or system, if there is any undesired deviation from its intended operational performance, you must avoid, identify and resolve the adverse electromagnetic effect before continuing to use the equipment and/or system. The following describes some common interference sources and remedial actions: 1. Strong electromagnetic interference from a nearby emitter source such as an authorized radio station or cellular phone: Install the equipment and/or system at another location if it is interfered with by an emitter source such as an authorized radio station. Keep the emitter source such as cellular phone away from the equipment and/or system. 2. Radio-frequency interference from other equipment through the AC power supply of the equipment and/ or system: Identify the cause of this interference and if possible remove this interference source. If this is not possible, use a different power supply. 3. Effect of direct or indirect electrostatic discharge: Make sure all users and patients in contact with the equipment and/or system are free from direct or indirect electrostatic energy before using it. 4. Electromagnetic interference with any radio wave receiver such as radio or television: If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or system as far as possible from the radio wave receiver. If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden Corporation subsidiary or distributor for additional suggestions.

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Conventions Used in this Manual and Instrument Warnings, Cautions and Notes Warnings, cautions and notes are used in this manual to alert or signal the reader to specific information.

WARNING A warning alerts the user to possible injury or death associated with the use or misuse of the instrument.

CAUTION A caution alerts the user to possible injury or problems with the instrument associated with its use or misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other property.

NOTE A note provides specific information, in the form of recommendations, requirements, alternative methods or supplemental information.

Explanations of the Symbols in this Manual and Instrument The following symbols found in this manual/instrument bear the respective descriptions as given. Cardiograph

Attention, consult operator’s manual

Input terminal for analog signal

Type CF applied part

Equipotential terminal

Output terminal for analog signal

Serial input/output terminal

Eject (magazine release button)

The CE mark is a protected conformity mark of European Community. The products herewith comply with the requirements of the Medical Device Directive 93/42/EEC.

Battery

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Operator's Manual ECG-9110

Operation panel

Alternating current

Rhythm recording

Filter

“On” only for a part of equipment

Age

Copy

“Off” only for a part of equipment

Paper speed

Calibration

Battery charging

Gain

START/STOP recording

Battery check lamp

Reset

Automatic control

QRS sync lamp

Paper feed

Manual control

Periodic recording

Mark

Patient cable

Attention, consult operator’s manual

Operator's Manual ECG-9110

Defibrillation-proof Type CF applied part

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Operator's Manual ECG-9110

Section 1 General

Introduction ... 1.1 Important Safety Information ... 1.2 Panel Descriptions ... 1.5 Top Panel ... 1.5 Operation Panel ... 1.6 Right Side Panel ... 1.8 Left Side Panel ... 1.9 Outline of the Functions ... 1.10 AC Operation and Battery Operation ... 1.11

Operator's Manual ECG-9110

1C.1

1. GENERAL

Introduction The cardiofax Q ECG-9110 is a real time cardiograph with 12-channel recorder. The cardiofax features simple use and a built-in battery. The cardiograph has the following features: • Compact and lightweight design is easy to carry. – A4 file size, 4.4 kg including battery • Up to 12 channel recordings on 210 mm recording paper

Operator's Manual ECG-9110

1.1

1. GENERAL

Important Safety Information

WARNING • Never use the cardiograph in the presence of any flammable anesthetic gas or high-concentration oxygen atmosphere. Failure to follow this warning may cause explosion or fire. • Never use the cardiograph in a high-pressure oxygen medical care tank. Failure to follow this warning may cause explosion or fire. Using with a defibrillator • Before defibrillation, make sure all persons around the patient are clear of the patient’s body and all metal parts of the cardiograph connected to the patient. Failure to follow this warning may cause electrical shock. • Before defibrillation, remove all electrodes and creams, patches, etc. from the patient’s chest. When the defibrillator paddle directly contacts these materials, the discharged energy may cause serious electrical burn to the patient. • Use only the specified patient cable. Failure to follow this warning may cause serious electrical burn where the electrode is attached and damage the cardiograph. • Before MRI examination, remove electrodes and transducers from the patient which are connected from this cardiograph. Failure to follow this warning may cause serious electrical burn on the patient due to local heating caused by dielectric electromotive force. For details, refer to the MRI Operator’s manual. • When the cardiograph is used with an electrosurgical unit (ESU), firmly attach the entire area of the ESU return plate. Otherwise current from the ESU flows into the electrodes of the cardiograph, causing serious electrical burn where the electrode is attached. For details, refer to the ESU Operator’s manual. Battery • Do not contact the plus (+) terminal and minus (-) terminal. • Do not discard the battery near open flame. • Do not damage, disassemble, drop or give impact to the battery. • Do not leave the battery where infants or small children can reach it. • If battery liquid (diluted sulfuric acid) contacts skin or clothes, immediately wash it off with running water.

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Operator's Manual ECG-9110

1. GENERAL Patient cable • Use only the following specified patient cable. When the specified patient cable is connected, the cardiograph is the type CF defibrillation-proof compliance. Failure to follow this warning causes serious electrical burn where the electrode is attached and damage the cardiograph due to discharge energy when defibrillation is performed. Patient cable: BJ-901D – IEC standard, 3 mm diameter tip BJ-902D – IEC/DIN standard, 4 mm diameter tip BJ-903D – IEC/DIN standard, clip BA-901D – AHA standard, 3 mm diameter tip BA-903D – AHA standard, clip

CAUTION • Only use the 3-prong power cord provided with the cardiograph. Failure to follow this caution may cause electrical shock to the patient and operator. • When the provided 3-prong power cord cannot be used, operate the cardiograph on battery power. When another type of power cord (especially 2-prong power cord) is used, this may cause electrical shock to the patient and operator. • When several medical instruments are used together, ground all instruments at the same one-point ground to protect the patient and operator from electrical shock. Any potential difference between instruments may cause electrical shock to the patient and operator. • Use Nihon Kohden parts and accessories to assure maximum performance from your cardiograph. When non-specified recording paper or electrodes is used, this may cause incorrect ECG recording result and accelerate deterioration of the cardiograph. • When connecting an external instrument to the connectors marked with

, ensure that the external instrument complies with the

IEC60601-1 safety standard for medical equipment or CISPR 11 Section Edition 1990-09, Group 1 and Class B standard. When the external instrument does not comply with either of these standards, use a locally available medical use isolation transformer unit between the external instrument and the AC outlet. • Do not use the output signal from the output connector for a synchronization signal such as the synchronized cardioversion signal. There is a time delay between the input ECG signal and output signal.

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1.3

1. GENERAL • This cardiograph provides automatic ECG analysis function. The automatic ECG analysis is performed for acquired ECG waveforms only and does not reflect all conditions of the patient. The results of the analysis may not correspond to the judgment of a physician. • Overall judgement must be performed by the physician, referring to the analysis result, clinical findings, and other examination results. After the physician’s overall judgement, the analysis results should be signed or initialed by the physician. • Take care when judging the ECG recording because the 25 Hz EMG filter may cause greater distortion of P-waves and QRS-waves depending on the waveform shape. The characteristics of the EMG filter are similar to a conventional analog filter. • When the cardiograph operates on battery power and large leakage current is input from the connected external instrument, ground the cardiograph or use an isolation transformer for the external instrument. Failure to follow this caution may cause electrical shock to patient and operator. • Use only the KC-010A, KD-010A or KD-104E Cart for the cardiograph. When another cart is used, the cardiograph may fall off or the cart may tip over. • Never use the cardiograph with its side panel downward. Failure to follow this caution may cause the cardiograph to fall over or cause battery liquid leakage. • Always install the battery even when the cardiograph operates on AC power. Otherwise sudden power down occurs when any electrode is detached during recording.

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Operator's Manual ECG-9110

1. GENERAL

Panel Descriptions Top Panel

QRS sync lamp Magazine

Electrode detachment indicator

Operation panel

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1.5

1. GENERAL

Operation Panel 2

3

4

5

7

6

1

9

10

8 I

11 Name 1. POWER key

12

13

14

15

16

Function Turns the cardiograph on/off. : The cardiograph is turned on. : The cardiograph is turned off.

2. Battery charge lamp

Indicates the battery charge status. Lit: The battery is being charged. Blinking: The battery is almost fully charged. Off: The battery is fully charged.

NOTE After charging is complete, the battery charge lamp blinks. This is because a small current is supplied to the battery (supplementary recharging) in order to prevent self-discharging of the battery. Keep the power cord plugged into the AC outlet. 3. Battery operation lamp

During battery operation, indicates the remaining battery power with the color and lighting state. Blinking in orange indicates that the battery is almost discharged.

4. AC power lamp

Lit when AC power is supplied.

5. PERIODIC key/lamp

Selects the Resting or Periodic ECG recording. Lamp off: Resting ECG recording Lamp on: Periodic ECG recording

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Operator's Manual ECG-9110

1. GENERAL

6. RHYTHM key/lamp

Performs the rhythm recording in resting ECG examination. The lamp is lit while waveforms are acquired.

7. AGE key/lamp

Selects the patient age zone (Adult or Child). Child: From 3 to 15 years old. The lamp is lit. Adult: 16 years old or more. The lamp is not lit.

8. SPEED key/lamp

Selects the paper speed (5, 10, 12.5, 25 or 50 mm/s) for manual recording. The corresponding speed lamp is lit. : 50 mm/s : 25 mm/s :

5, 10, or 12.5mm/s (Refer to “Slow paper speed” in Section 3 “Changing settings before measurement”)

9. GAIN key/lamp

Selects the sensitivity (2.5, 5, 10, or 20 mm/mV) for manual recording. The corresponding lamp is lit. : ×2 (20 mm/mV)

: ×1 (10 mm/mV)

: ×1/2 (5 mm/mV)

: ×1/4 (2.5 mm/mV)

10. LEAD keys/lamp

Selects the ECG lead groups. The lamp of the selected lead group is lit.

11. RESET key

Use this key to return waveforms to the baseline position.

12. FEED/MARK key

Paper feeding: Paper with the paper mark (black rectangle) at the bottom of the paper: Feeds the recording paper until the next paper mark is detected. Paper without the paper mark: Feeds the recording paper continuously while this key is pressed. Refer to “Feeding the paper” in Section 2. Event mark: In the manual recording mode, you can annotate the ECG waveform by pressing this key. An event mark is recorded.

13. FILTER key/lamp

Turns the EMG filter on/off. The lamp lights when the EMG filter is turned on.

14. COPY/CAL key/lamp

Automatic recording mode: Prints any number of copies of the recording results. When copy is available, the lamp is lit. Manual recording mode: Records the calibration waveforms. For external input signals, this key is not operative.

15. START/STOP key/lamp

Starts or stops recording. During recording, the lamp is lit.

16. AUTO/MANUAL key/lamp

Selects automatic or manual recording. Lamp on: Automatic recording Lamp off: Manual recording

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