CT100 User Manual



[pic]

.au

CT100 Electrocardiograph

User Manual

[pic]

.au

CT100 Electrocardiograph

User Manual

Designed and manufactured in Australia

Manual Revision 6

Macquarie Medical Systems 2003

[pic]

Warnings and Cautions

Please read the following information before using your CT100.

A DANGER: Risk of explosion if used in the presence of flammable anesthetics.

A WARNING: Do not operate the unit in the presence of electromagnetic interference. Interference may be caused by electrosurgery, diathermy, or magnetic resonance imaging equipment.

A CAUTION: The type of electrodes used can effect the systems recovery from overload, especially recovery time after defibrillator pulses. Use electrodes that minimise electrode polarisation.

A CAUTION: This device is intended for use by persons trained in professional health care. The operator must be thoroughly familiar with the contents of this manual before using the device.

A CAUTION: Use only the AC adapter (plug pack) supplied to recharge the CT100. Other adapters may not meet required safety standards.

A CAUTION: Do not operate the CT100 near high voltage equipment that may generate sparks or in an environment where high static electricity is present.

A CAUTION: Please ensure the patient leads are in the correct locations on the patients body, and ensure that all leads are connected. If it is impossible to connect certain chest leads to the patient, then connect the unused chest leads to the right leg.

A CAUTION: To maintain patient safety ensure that equipment connected to the output socket of the unit does not exceed enclosure leakage current limits.

A CAUTION: Use only the defibrillator protected patient cable DPC 12943 as supplied by Macquarie Medical Systems Pty Ltd. Use of a non-Macquarie Medical Systems cable can cause damage to equipment or harm to patient or give an incorrect reading.

A CAUTION: The CT100 should not be subjected to water and liquid spillage. It should only be used in a dry environment.

A CAUTION: Dropping the CT100 may cause device failure or intermittent operation. Contact service if this occurs.

A CAUTION: The CT100 is not recommended to be used on neo-natal patients.

A CAUTION: Certain brands of ECG gel may irritate the patients skin. If this occurs, the health care professional should choose an appropriate alternative brand or electrode option.

A CAUTION: The CT100 is not recommended to be used in critical care situations.

A CAUTION: Do not mix disposable and reusable electrodes together on the same patient at the same time. It may cause electrode polarisation.

Contents

Warnings and Cautions 2

Introduction 4

Quick Start 5

Patient Connections 6

CT100 Operation 7

Parts of the CT100

Display

Battery charging

Automatic recording formats

Automatic recording

Manual recording

Filters

Calibration

Loading and feeding paper

Attaching to a stand

Problems and solutions 12

Service and maintenance 15

Ordering accessories 16

Technical Information 17

Warranty 18

Medical Product Range 19

Introduction

CT100 Electrocardiograph

The CT100 Electrocardiograph is a simple to use but very powerful ECG recorder. Its compact size, light weight, and long battery life make it suitable for portable use, and its formatted printing makes it ideal for use in a clinic or medical centre.

Manual Contents

This manual covers basic ECG recording with the CT100, explaining how to use the different features of the unit to simplify the recording process.

Quick Start

Automatic 12 Lead Recording

1. Push the patient cable plug firmly into the socket on the right-hand side of the unit.

2. Attach the leads to the patient.

3. Press [pic] (ON/STBY) to switch on the unit.

4. The display panel at the top of the unit will show the battery level and the pulse rate, and prompt the user with a message.

5. To start a 12-lead automatic recording WAIT until the heart rate display has settled ( about 10 secs ) and press [pic] (AUTO RECORD).

6. When the recording is complete press  [pic] (ON/STBY) to switch the unit off.

For further details on the steps above and other operating information refer to the Operating Instructions section.

Patient Connections

Electrodes

Good electrode connection is the most important factor in recording a good quality ECG. By following a few basic steps consistent, clean recordings can be achieved.

1. Clean the electrode sites with an alcohol swab.

2. Place a small amount of ECG electrode gel on the metal electrode of the limb strap or clamp. Non-conductive gels (such as ultrasound gel) and water are not suitable for ECG connections.

[pic]

Where body hair is present at the electrode sites, use more gel to ensure a good connection. It is not usually necessary to shave the patient.

3. Connect the electrodes a short distance above the ankle or wrist, with the metal part placed on the fleshy part of the limb.

4. Place a small amount of gel at each of the chest electrode sites, and attach the suction bulbs.

[pic]

Follow the same procedure for disposable electrodes (no gel is required). Disposable electrodes must only be used once. Re-using these electrodes will always result in poor recordings.

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Lead Connections

The following lead name abbreviations and colours are used for the electrode leads:

Australia/USA Europe

|Lead Name |Code |Colour |Code |Colour |

|Right Arm |RA |White |R |Red |

|Left Arm |LA |Black |L |Yellow |

|Left Leg |LL |Red |F |Green |

|Chest 1 |V1 |Red/Brown |C1 |Red/White |

|Chest 2 |V2 |Yellow/Brown |C2 |Yellow/White |

|Chest 3 |V3 |Green/Brown |C3 |Green/White |

|Chest 4 |V4 |Blue/Brown |C4 |Brown/White |

|Chest 5 |V5 |Orange/Brown |C5 |Black/White |

|Chest 6 |V6 |Purple/Brown |C6 |Purple/White |

|Right Leg |RL |Green |N |Black |

CT100 Operation

The CT100

Display

The display area shows the amount of battery charge, the time, the patients pulse rate, and help information.

Battery level Pulse rate

[pic]

Prompt message

The pulse rate is only present when a patient is fully connected to the CT100. If the patient is not connected the time and a message to check electrodes will be displayed.

Battery Charging

The rechargeable battery in the CT100 gives over 80 recordings when fully charged. To recharge the battery plug the mains adaptor into a mains socket and into the power input of the CT100. The green "Battery On Charge" indicator will light if the battery is being charged.

The amount of charge in the battery is shown on the display.

This bar height indicates that the battery is very low. Only a few more recordings will be possible

[pic]

[pic]

This bar height indicates that the battery is fully charged.

If the battery is low the CT100 will beep and display the message Recharge battery.

If the battery is too low for reliable operation, the message Flat Battery will appear and the CT100 will switch itself off. If this occurs, connecting the CT100 to the mains adaptor will allow normal operation while charging the battery. The battery should be charged for 8 hours to reach full capacity.

The CT100 can safely be stored and used while on charge. It is good practice to always leave the CT100 on charge overnight, to avoid an unexpected flat battery.

The CT100 will switch itself off after 10 minutes without use to conserve the battery.

Automatic Recording Formats

The CT100 has a number of pre-set automatic recording formats. These formats save time by controlling the recording process. A format is selected by pressing the [pic] (FORMAT) key once to display the current format, and repeating the press until the desired format is displayed. The following formats are available:

Standard+ Rhythm - 3 Channel: A strip of Leads I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 recorded in 3 channel format, with the addition of a Lead II rhythm strip. The recording time for the leads is pre-set to 3 secs and 6 secs for the rhythm strip.

Standard + Rhythm - 1 Channel: Standard format as above, recorded in 1 channel format.

Note: Veterinarian models have the V leads omitted in the above two formats.

Standard + Rhythm + Respiration: Standard format with automatic prompting to move Lead V3 to the right of the chest, and for the patient to hold their breath during a second recording of Lead III, in 3 channel format.

To start a recording in the selected format, press [pic] (AUTO RECORD).

Automatic Recording

A recording in the automatic format selected is started by pressing the [pic] (AUTO RECORD) key. A calibration pulse, settings, and the time and date will be printed at the start of the recording. A pulse rate and a calibration pulse will be printed at the end of the recording. To stop recording at any time press the [pic] (STOP) key.

The CT100 uses "simultaneous acquisition" to store all 12 leads in memory at the same time, so that the print of every lead shows the same time interval, and the patient only needs to remain still for a short time.

The pulse rate printed on the recording is an average over the previous 10 seconds. If a recording is started too soon after connecting the patient, this measurement may not have reached the correct value. Before starting a recording, check the pulse rate displayed on the screen to confirm that the patient is settled and the measurement is stable.

The size of the recorded ECG can be changed by pressing the [pic] (SIZE) key. The speed of the recording can be changed by pressing the [pic] (SPEED) key. Press the keys once to see the current setting, and repeat the press to change the setting.

Manual Recording

A single lead can be recorded by pressing the [pic] (MANUAL RECORD) key. The recording will continue until the [pic] (STOP) key is pressed or if 99 seconds has passed.

The lead recorded is selected by pressing the [pic] (LEAD SELECT) key. Press once to see the current lead, and repeat the press to change the lead.

The size and speed of the recording can be changed as described above.

Filters

The CT100 has a range of filter settings to remove muscle noise and mains interference from the recorded ECG.

The muscle noise filter is controlled by the [pic] (FILTER) key. Press the key once to see the current filter setting, and repeat the press to change the setting. The normal setting of 'Filter On' will give a noise-free recording in most circumstances.

The mains filter is automatic and will remove mains interference when it is present.

Calibration

A 1mV calibration pulse will be recorded as part of the automatic formats. To record a calibration pulse at any other time press the [pic] (CALIBRATION) key. The current setting of size, speed, and filter will be printed underneath the calibration pulse

Loading and Feeding Paper

1. Remove the paper cover by sliding it to the left. Remove the paper spindle.

2. Unroll a short length of paper, and cut the end square. Push the paper into the slot at the bottom of the paper holder and press [pic] (FEED PAPER) to feed the paper through the plotter.

3. Place the spindle through the roll, and fit the roll into the cavity. For large paper rolls the outer slots hold the spindle.

4. Replace the paper cover. The cover is left off for large paper rolls.

Pressing [pic] (FEED PAPER) at any time feeds blank paper.

Changing Printing (light/dark)

Pressing [pic] the print (light/dark) key allows you to adjust your CT100 to print

L light or D dark. This shall be displayed on the LCD.

Attaching to a stand

The CT100 can be mounted on the CT100 Stand or on a general equipment stand. Thread the screw through the stand and screw into the hole at the back of the CT100.

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CAUTION: To avoid damage to the CT100 use only the 10mm M6 screw provided

The CT100 stand can be used in a number of ways:

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Problems and Solutions

This guide can be used to solve any problems encountered while using the CT100.

Power

|PROBLEM |CAUSE |SOLUTION |

|The CT100 will not turn |The battery is flat |Plug in the plug-pack, and wait a few|

|on | |minutes for the battery to recover. |

| | |Make charging the unit overnight your|

| | |normal practice. |

| | | |

| |The CT100 is faulty |Call service |

Print Quality

|PROBLEM |CAUSE |SOLUTION |

|Printout is faint or |The paper is the wrong type or|Use paper supplied (see |

|patchy |poor quality |"Ordering Accessories"). You must use|

| | |thermal paper |

Electrode Contact

|PROBLEM |CAUSE |SOLUTION |

|Printout is aborted after|No pulse rate detected due to |Connect all leads to the patient or |

|printing the first lead |one or more electrodes being |connect unused leads to the RL lead. |

|and a message 'Check |disconnected. |All the leads must be connected for a|

|lead contact' | |good recording. |

|One or more leads are |The lead(s) is (are) |The lead(s) which is (are) |

|printed as a flat line |disconnected from the patient.|disconnected is indicated. |

|with a message |If either of the leads V1,V3 |Connect all leads to the patient or |

|'Check lead contact' |or V6 are disconnected, then |connect unused leads to the RL lead. |

| |all |All the leads must be connected for a|

| |three will be affected in |good recording. |

| |the printout. | |

Signal Quality

|PROBLEM |CAUSE |SOLUTION |

|The measured pulse rate |The measurement did not reach |Wait until the displayed pulse rate |

|does not match the rate |its final value before the |is stable before starting a |

|printed on the recording |recording started. |recording. |

| | | |

| |The patient moved during the |Check the conditions below. The CT100|

| |recording or the quality of |may not measure the rate correctly if|

| |the recorded ECG was poor. |it cannot "see" a good ECG signal on |

| | |Lead II. |

|The quality of the |The patient's skin is not |Wash with alcohol or soap and reapply|

|recorded ECG is poor |clean |ECG Electrode Gel |

| | | |

| |The suction bulbs or limb |Wash with alcohol or soap after each |

| |straps have built up a residue|use. Very dirty electrodes may need |

| |of gel. |to be cleaned with a metal polish or |

| | |replaced. |

| | | |

| |Disposable electrodes have |Do not use disposable electrodes on |

| |been re-used. |more than one patient. If an |

| | |electrode falls off, make sure it is |

| | |still "sticky" before replacing it. |

| | | |

| |Electrode terminals are loose |Tighten the terminals and make sure |

| |or in poor contact with the |that the electrical connections are |

| |patient leads |clean |

| | | |

| |Limb straps are loose |Tighten the straps so that the |

| | |electrodes are held firmly against |

| | |the patient |

| | | |

| |The patient moved or spoke |Make sure that the patient is warm |

| |during the recording or the |and comfortable, and ask them to |

| |patient is tense (not |relax during the recording. |

| |relaxed). | |

Printout is aborted and the message Print Limit appears while using the 3 channel format. |The printing of some leads can surpass the allocated paper space due to a large ECG signal. |Reduce the size to 5mm/mV, or use a single channel format, or examine the lead in question with the Manual format. | |

|PROBLEM |CAUSE |SOLUTION |

|The quality of the |Not enough ECG electrode gel |Apply more gel to the electrodes. Use |

|recorded ECG is poor |has been applied |extra gel if there is hair at the |

|(continued) | |electrode sites. |

| | | |

| |Disposable electrodes have |Check the "Use By" date and re-apply |

| |dried out during storage |electrodes if required |

| | | |

| |X-Ray, diathermy or other |Switch off the interfering equipment or|

| |equipment are causing |use the CT100 in another room. Also, |

| |interference |try recording with the plug-pack |

| | |disconnected |

| | | |

| |A metal bed is causing |Make sure that the bed is grounded. If |

| |interference |not, ask a biomedical technician to |

| | |ground it |

| | | |

| |The patient cable is faulty |Replace the cable (see How to Order |

| | |Accessories) |

| | | |

| |The CT100 is faulty |Call service |

Printer Problems

PROBLEM |CAUSE |SOLUTION | |Paper Jam |Wrong paper being used

Incorrect loading of paper. |Check that you are using the 57mm thermal paper roll supplied by Macquarie Medical Systems only.

Please refer to page 10 of the user manual “Loading and Feeding Paper”

If Problem persist, please contact service. | |Unit is out of paper | |Please refer to page 10 of the user manual “Loading and Feeding Paper”

Contact Macquarie Medical Systems or your local supplier to order more paper. | |Unit is not printing |Incorrect paper is being used.

The print head is faulty. |Check that you are using the 57mm thermal paper roll supplied by Macquarie Medical Systems only.

Please contact you local service or Macquarie Medical Systems for repair. | |Service and Maintenance

Maintaining the CT100

The CT100 needs no special maintenance for reliable operation.

Suction bulbs and limb straps should be cleaned after each use with warm soapy water. Electrodes with a build up of gel or corrosion can be cleaned with a metal polish, but may need to be replaced for best results. Patient cable connectors should be cleaned with alcohol.

Clean the CT100 with warm soapy water, taking care to avoid water ingress. Do not use acetone, alcohol or other solvents to clean the CT100 as they may damage surfaces.

Service

If problems do occur with the CT100 first check the Problems and Solutions section of the manual. If the problem persists, contact your supplier, an authorised service centre, or Macquarie Medical Systems at the address below:

Macquarie Medical Systems

Service Department

35 Moore St

Leichhardt NSW 2040

AUSTRALIA

Telephone: +61 2 9692 7911

Facsimile: +61 2 9692 7965

EMail: mms@.au

Ordering Accessories

Accessories, supplies, and replacement parts can be ordered from your supplier by quoting the following numbers:

Carry case for CT100 and accessories e2-0001

Multi-functional stand e2-0002

M6 Screw e2-0003

Pens - 4 colour ex-001

Pens - 4 black ex-002

Pens - 4 blue ex-003

Paper roll - small with grid e5-002

Paper roll - large with grid e4-004

Patient leads (European colour code) e3-0001

Patient leads (US Colour code) e3-0002

Limb electrodes (set of 4) e4-007

Chest electrodes (set of 6) e4-004

Limb straps (set of 4) e4-008

Limb clamps - small (set of 4) e4-005

Limb clamps - large (set of 4) e4-006

ECG electrode gel e4-009

Disposable electrodes (pack of 100) e4-001

Electrode clips for above ("alligator") e4-002

CT100 User Manual e1-0001

Plug pack - 240V 50Hz e6-003

Plug pack - 120V 60Hz e6-001

Rechargeable battery, with mounting tape e6-005

Spindle for paper roll e2-0005

Plotter lid e2-0006

Paper lid e2-0007

Technical Information

Classification Class II/Internally Powered, Type CF Defibrillator Proof

Input Standard 12 lead US or European coded as per IEC 62D

Power Supply Internal battery power recharged using mains adaptor supplied. Can be directly connected to a 9-16V 1A AC/DC supply which conforms with the requirements of IEC601.1

Battery type: 6V 3AH lead-acid

Weight 1.5kg

Dimensions 210mm x 165mm x 45mm

Safety Standards Approved to IEC601.1

Approved to AS3200.1-1990

Approved to AS3200-1986

Approved to MIL-STD 810D Methods 514.3, 516.3

Designed to meet or exceed requirements of AAMI EC11-1983 and UL544

Test methods EC11-1983 3.2.7.2: Frequency response tested by methods A, B, and C

Note: Digital Recording

The CT100 uses a digitally controlled plotter mechanism. Close examination of the recorded ECG waveform will reveal small steps in the trace. These steps are 0.1mm is size and represent the smallest feature printable by the CT100. At waveform settings of 10mm/mV and 25mm/sec these steps are 1/100th of a millivolt high or 1/250th of a second long. Features this large are negligible in ECG recording.

The CT100 uses digital techniques to accurately record the ECG signal. The trace recorded by the CT100 may appear "rougher" than a recording made with an older style thermal recorder. This is because the CT100 can measure and draw finer details than older style thermal recorders.

It is a characteristic of all digital or sampled systems that there can be a modulation effect between the sampling rate and the recorded signal. This can result in amplitude differences between cycles in high repetition rate signals, such as a paediatric ECG or a sinusoidal test waveform.

Warranty

1. Macquarie Medical Systems warrants this product for a period of twelve months from the date of delivery. This warranty covers any defects in material or manufacture provided that this product has not been subject to accident, misuse, negligence or abuse.

2. The warranty is limited to repair or replacement of faulty components or sub-assemblies and applies when the faulty unit is returned to an authorised service centre.

3. Due to their nature, connectors, cables and batteries cannot be covered by this warranty.

4. Macquarie Medical Systems cannot be held responsible for any damage that may occur to other instruments or equipment connected to this product.

5. Macquarie Medical Systems' objective is to design and manufacture quality medical equipment for health care professionals. We need feedback from our customers to constantly improve our products. Please send any comments, suggestions or complaints to:

The Product Manager

Macquarie Medical Systems

Service Department

35 Moore St

Leichhardt NSW 2040

AUSTRALIA

Telephone: +61 2 9692 7911

Facsimile: +61 2 9692 7965

EMail: mms@.au

Medical Product Range

Macquarie Medical Systems manufacture and supply a range of medical equipment:

CT100 Portable single channel electrocardiograph

CT200 Portable, programmable electrocardiograph with Printer Link and PC Link, 1/3/6 & 12 channel.

CT1000 Bedside monitor with ECG

CT2000 Bedside monitor with ECG and paper recorder

CT3000 Bedside monitor with ECG, SaO2 and NIBP

CT3100 Bedside monitor with ECG and SaO2

CT3200 Bedside monitor with ECG and NIBP

CS3000 Central Monitoring System for 8 beds with multiparameter

Contact your supplier for more details on these products.

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