CardioCall 20 and VS20 Physician’s Instruction Manual Issue 4

◆ Instruction Manual ◆

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CardioCall20/VS20

◆ DEL MAR REYNOLDS MEDICAL ◆

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CONTENTS

CardioCall

20/VS20 ◆ Instruction Manual ◆

CONTENTS Page Introduction

4

Explanation of markings & controls

6

Specifications

7

Safety

9

Using CardioCall

11

Patient instructions - Post Activation Event Recording

12

Looper Recording

13

Patient instructions - Looper Recording

14

Monitor & Replay Recording using an ECG Monitor

17

How to Check the Memory & Battery, and Erase the Memory

18

Programming CardioCall VS20

19

Alert Sounds

21

Technical Details

21

How CardioCall Uses Memory

21

Selecting Loop or Post Activation Event Mode

22

Transmitting Recordings by Telephone

22

Transfer of Recordings to a Personal Computer

23

Transmission Format

24

Recording Quality

25

Maintenance

25

Accessories

27

Index

28

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INTRODUCTION ◆ Instruction Manual ◆

CardioCall20/VS20

INTRODUCTION The CardioCall is an easy to use patient-activated ECG event recorder monitor. Model ‘CardioCall20’ is a fixed event-interval recorder. Model ‘CardioCallVS20’ is a programmable (variable) event-interval recorder. The CardioCall recorder is indicated if it is desired to record the electrocardiogram at the time when a patient experiences intermittent or transient symptoms such as dizziness, palpitations, or shortness of breath, and the patient is capable of activating the recorder at these times. The electrocardiogram is stored in memory and can be sent to the diagnostic centre by telephone at a later time, or transferred directly via a cable into a computer or ECG writer.

CardioCall features two recording modes: 1. Looping (continuous) mode. A patient cable and conventional ECG electrodes are used, and the CardioCall continuously records the ECG so that at any time it has the pre-event interval stored in memory. On experiencing a symptom (as indicated by the physician), the patient pushes an Event Button. The CardioCall then freezes the recording of the pre-event interval and records the post-event interval. In model VS20, the interval lengths and the number of channels are programmable. 2. Post-Activation Event (non-continuous) mode. This mode uses the electrode pads that are embedded on the recorder case. On experiencing symptoms, the patient holds the recorder to the chest and pushes the Event Button. In model VS20, the interval length is programmable.

CardioCall senses whether the patient cable is fitted and selects the recording mode automatically. The unit can store a total of 20 minutes of ECG and offers three methods for transmitting, or transferring, the recordings: 4

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INTRODUCTION

CardioCall

20/VS20 ◆ Instruction Manual ◆

1. Transtelephonic Transmission. The patient telephones a receiving centre and is directed to push the Transmit button on the CardioCall, which transmits the recordings using industry standard Frequency Modulated (FM) tones. Receiving centres consist of either a system supplied by Del Mar Reynolds Medical Ltd or other compatible trans-telephonic systems. Systems supplied by Del Mar Reynolds Medical will automatically identify the particular CardioCall making the transmission. 2. Transfer to Personal Computer. Del Mar Reynolds Medical CardioConnect software and connection cable allow CardioCall recordings to be transferred, stored, edited and printed. 3. Transfer to an ECG writer or cardioscope using the CardioCall monitor cable. Any of these three methods may be used to monitor the ECG while making a recording.

CardioCall is powered by one standard ‘AA’ cell. This manual gives detailed instructions and information for the Physician. There are separate brief operating guides for the patient.

CAUTION CardioCall does not detect pacemaker signals, and should not be used on patients subject to defibrillation.

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SPECIFICATIONS ◆ Instruction Manual ◆

CardioCall20/VS20

EXPLANATIONS OF MARKINGS AND CONTROLS Yellow lamp

Green lamp

Data Connector

Green ‘REC’ Button

Patient Lead Connector

Speaker Yellow ‘TX’ Button Battery Cover

0088

Electrode Feet

CE MARK This equipment is in conformity with the essential requirements and provisions of Council Directive 93/42/EEC concerning medical devices. YEAR OF MANUFACTURE

WARNING This symbol means you should refer to the accompanying documents. TYPE B EQUIPMENT Type B equipment regarding protection against electric shock. TX

TRANSMIT

- Button used to transmit recordings

REC

RECORD

- Button used to make recordings

SPEAKER INDICATOR

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SPECIFICATIONS

CardioCall

20/VS20 ◆ Instruction Manual ◆

SPECIFICATIONS PHYSICAL Size Weight

56 x 71 x 28 mm 89g (including battery)

ELECTRICAL Frequency response CMRR

0.05Hz - 30Hz (Looper) 0.5Hz - 30Hz (Post Activation Event) >70dB

DC offset rejection Dynamic range

+/-300 mV 5 mV

Transmission centre frequency Frequency deviation

1850 Hz 100 Hz/mV

POWER SOURCE Type

1.5V Alkaline battery MN1500 (AA/LR6)

Operational life, with 1 record/transmit cycle per day (approximate)

Looper - 6 weeks Post Activation Event Recorder - 6 months

Additional data retention period 4 weeks (minimum), with audible battery warning.

OPERATING CONDITIONS Temperature Humidity Atmospheric pressure

0˚ C to 40˚ C 30% to 95% non-condensing 700 hPa to 1060 hPa

TRANSPORT AND STORAGE CONDITIONS (in original packaging) Temperature Humidity Atmospheric pressure

-10˚ C to 45˚ C 10% to 95% non-condensing 500 hPa to 1060 hPa

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SPECIFICATIONS ◆ Instruction Manual ◆

FUNCTIONAL Transmitting Modes

CardioCall20/VS20

FM transtelephonic with calibration/event markers, recorder ID, event date and time stamping. PC download (Reynolds Medical CardioConnect). ECG writer/monitor (with CardioCall monitor cable). (Also real time channel 1 only in each case)

Recording Modes

Post Activation or Loop (automatic selection)

Event Interval

Programmable (CardioCall VS20) 1 minute Post-activation, 1 minute pre + 1 minute post looper (CardioCall 20)

Memory capacity

20 minutes

Unit Identification

Transtelephonic serial number (by DTMF)

COMPATIBILITY The CardioCall may be used with any transtelephonic receiving station that accepts FM tones in the range 1600 Hz to 2100 Hz, and scales the signal 1 mV per 100 Hz. The CardioCall transmission includes 1 mV calibration pulses to allow the scaling to be verified. Technical manuals and further technical information are available from Del Mar Reynolds Medical Limited.

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SAFETY

CardioCall

20/VS20 ◆ Instruction Manual ◆

INTENDED USE OF EQUIPMENT This equipment has been designed and supplied specifically for patient-activated monitoring of electrocardiograms. It shall not be used for any other purposes. In particular, the equipment shall not be used for DIRECT CARDIAC APPLICATION. The equipment is safe for use by untrained personnel.

SAFETY CLASSIFICATION In accordance with EN60601-1 : 1990; IEC601-1 : 1988 and amendments 1 and 2: 1. EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE. The equipment is designed to be battery operated only. Under NO circumstances shall a mains powered battery eliminator or any other external power source be used with the equipment. Batteries should be removed if equipment is not likely to be used for some time. 2. TYPE B EQUIPMENT. 3. ORDINARY EQUIPMENT. Enclosed equipment without protection against ingress of liquid. 4. This equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide, or flammable cleaning agents. 5. Rated for CONTINUOUS OPERATION. 6. EQUIPMENT with an APPLIED PART, specifically designed for applications where a CONDUCTIVE CONNECTION is made to the PATIENT, but not directly to the heart. 7. Adjustment, replacement of parts, maintenance and repair: The equipment requires no routine adjustments to maintain its operation. The equipment contains no user serviceable parts. It shall be serviced only by Del Mar Reynolds Medical or by an agent accredited by them to service equipment of this type. Unauthorised repairs or dismantling of the equipment will invalidate the guarantee.

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SAFETY ◆ Instruction Manual ◆

CardioCall20/VS20

DEFECTS AND ABNORMAL STRESSES For continued safety the equipment must not be maltreated, used outside its specified operation conditions, or stored outside its specified storage conditions. Whenever it is likely that protection has been impaired, the equipment shall be made inoperative and secured against any unintended operation. The protection is likely to be impaired if, for example, the equipment :a) shows visible damage b) fails to perform the intended operation c) has been subjected to prolonged storage under unfavourable conditions d) has been subjected to severe transport stresses e) has been connected to a patient during defibrillation.

MODIFICATIONS For continued safety, the equipment shall not be subjected to any unauthorised modifications and must be used only for the purpose for which it was originally supplied. DEFIBRILLATION The equipment contains no defibrillation protection and may be damaged if attached to a patient receiving defibrillation. External conductive parts of the equipment may present the defibrillation voltage if the equipment is attached during defibrillation and you are advised to REMOVE the equipment before defibrillating.

FEDERAL LAW RESTRICTS THIS DEVICE TO SALE OR USE BY OR ON THE ORDER OF A LICENSED PHYSICIAN.

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POST-ACTIVATION EVENT

CardioCall

20/VS20 ◆ Instruction Manual ◆

USING CARDIOCALL Before giving the CardioCall to a new patient, it is important to erase all recordings of the previous patient and to check that the battery is in good condition. See page 18, ‘How to Check the Memory and Battery, and Erase the Memory'. Note: the patient does NOT need to know how to erase the memory. See page 21 for details of CardioCall’s memory management.

POST-ACTIVATION EVENT MODE USING DIRECT CHEST APPLICATION

Make test recordings/transmissions or use the monitor cable (see page 17) to ascertain the best position on the chest for the CardioCall. Recording quality will be much improved if the area is shaved (if necessary). ECG sound can be enabled/disabled by pressing the YELLOW (TX) button. The CardioCall records between the points shown in Figure 1.

Figure 1 Reference CH1-

CH1+ CH2+

+

CH2-

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POST-ACTIVATION EVENT ◆ Instruction Manual ◆

CardioCall20/VS20

PATIENT INSTRUCTIONS POST-ACTIVATION EVENT RECORDING (These instructions are repeated in a simpler form in the Patient’s Guide). When you experience symptoms... 1. First, follow any advice your hospital or physician has given you. 2. Press the “metal feet” of the CardioCall to your bare chest, as instructed by your physician. 3. Press the GREEN (REC) button until you hear 3 beeps. This starts the recording. Release the button and please remain still during the recording. • if you hear only 1 beep when you press the button, the memory is full and you must send the recordings to your physician. • to enable/disable the ECG ‘whistle’, press the YELLOW (TX) button. • if you start a recording by mistake, you can abandon it by pressing the GREEN button again until you hear 2 beeps. 4. When you hear a long beep, the recording has finished. You should send each recording to your physician as soon as you can. • if the CardioCall also makes a ‘ringing’ sound, the memory is full and you must send the recordings to your physician now. To send the recording to your physician... 1. Dial the telephone number you have been given. When it is answered, listen to any instructions. 2. When told to send your ECG recording, hold the telephone mouthpiece against the CardioCall speaker and press the YELLOW (TX) button until you hear a beep. Release the button and hold the CardioCall still on the telephone whilst the recording is transmitted (during which time ‘whistles’ will be heard). 3. When the whistles have finished, remove the CardioCall and hang up the telephone. The CardioCall will switch off automatically - there is no need to press the button. The CardioCall is now ready for your next recording.

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LOOPER

CardioCall

20/VS20 ◆ Instruction Manual ◆

LOOPER RECORDING USING THE PATIENT CABLE Prepare the electrode sites then hook up the patient. Suitable sites include any bipolar lead chosen for ambulatory ECG (Holter) monitoring. Check the chosen sites by making a test recording/transmission or using the monitor cable (see page 17). ECG sound can be enabled/disabled by pressing the YELLOW (TX) button.

Two Channel Cable

Single Channel Cable

RED = CH1+, CH2+

SHAVE HAIR

YELLOW = CH1-

GREEN = CH2-

RUB FOR 10 SECONDS WITH A

CLEAN WITH ALCOHOL

COTTON SWAB & A LITTLE GEL

SWAB

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LOOPER ◆ Instruction Manual ◆

CardioCall20/VS20

Advice Medicotest VLC single-use disposable electrodes are recommended for looper recording.

Use stress loops to minimise artifact.

Results will be impaired if the skin is especially dry, greasy or hairy.

HOOK-UP TEST Patient hook-up can be checked at any time by disconnecting the patient cable from the recorder and then reconnecting it. A short ring tone indicates good skin preparation and electrode attachment. A beep indicates that the connection impedances are higher than is desirable and electrode attachment should be checked. Low impedances may not be achievable with all patients, or with dry electrodes. To test a patient cable on its own, stick two gel electrodes (new or used) back-to-back, connect the cable poppers, and then plug the cable into the recorder. A short ring tone indicates that there is good connection through the cable and electrodes. A short ‘beep’ indicates that the connection is poor or that there is no connection.

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LOOPER

CardioCall

20/VS20 ◆ Instruction Manual ◆

PATIENT INSTRUCTIONS LOOPER RECORDING (These instructions are repeated in a simpler form in the Patient’s Guide). When you experience symptoms... 1. First, follow any advice your hospital or physician has given you. 2. Press the GREEN (REC) button until you hear 3 beeps. This starts the recording. Release the button and please remain still during the recording. • if you hear only 1 beep when you press the button, the memory is full and you must send the recordings to your physician. • if you start a recording by mistake, you can abandon it by pressing the GREEN button again until you hear 2 beeps. 3. When you hear a long beep, the recording has finished. You should send each recording to your physician as soon as you can. • if the CardioCall makes a ‘ringing’ sound, the memory is full and you must send the recordings to your physician. To send the recording to your physician... 1. Unplug the cable from the CardioCall. 2. Dial the telephone number you have been given. When it is answered, listen to any instructions. 3. When told to send your ECG recording, hold the telephone mouthpiece against the CardioCall speaker and press the YELLOW (TX) button until you hear a beep. Release the button and hold the CardioCall still on the telephone whilst the recording is transmitted (during which time ‘whistles’ will be heard). 4. When the whistles have finished, remove the CardioCall and hang up the telephone. Plug the cable back in to the CardioCall. The CardioCall is now ready for your next recording.

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CARRYING CARDIOCALL ◆ Instruction Manual ◆

CardioCall20/VS20

CARRYING THE CARDIOCALL The patient should wear the CardioCall using the belt clip. Because of the light and compact design of CardioCall, the patient may prefer carrying it in a pocket or in their own bag. In this case please take care that the CardioCall is not likely to be dropped or damaged and that the patient lead (if used) will not become entangled or damaged. The CardioCall should always be convenient for immediate use.

IMPORTANT NOTE - MEMORY FULL • As soon as CardioCall is full of untransmitted recordings, it will make a “telephone ringer” sound (except for model VS20 programmed for “single event”). • If the patient attempts to make another recording, they will hear a short “beep” when they press the REC button and no recording will be made. • At least one recording must be transmitted - this will always be the oldest recording. After this, the CardioCall will allow further recording. The next recording will displace the oldest recording which will be lost. • Any recording which has been fully transmitted will be deleted upon completing the next new recording.

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MONITORING

CardioCall

20/VS20 ◆ Instruction Manual ◆

MONITORING RECORDING USING AN ECG MONITOR Using the optional monitor cable, you can display the ECG during recording on an ECG monitor. Connect the monitor cable to the ECG monitor, then plug the monitor cable into the CardioCall Data Connector. When the GREEN (REC) button is pressed to start a recording, channel 1 ECG will be displayed on the monitor. (No ECG sound will be heard with the monitor connected). Caution: use only type BF

ECG monitors. The monitor cable is not patient-isolated.

Note: If excessive noise is seen on the Monitor, unplug the RL lead and ask the patient to hold the lead instead.

LA (Yellow) RA (Red) RL (Black)

ECG MONITOR LEAD I MONITOR CABLE CARDIOCALL

REPLAYING THE STORED RECORDINGS ON AN ECG MONITOR Connect the monitor cable as described above. When the YELLOW (TX) button is pressed, all “new” events will be displayed in sequence on the ECG monitor. If no “new” events exist, all “old” events will be displayed. ◆ DEL MAR REYNOLDS MEDICAL ◆

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CHECK MEMORY & BATTERY ◆ Instruction Manual ◆

CardioCall20/VS20

HOW TO CHECK THE MEMORY AND BATTERY, AND ERASE THE MEMORY Push the GREEN and YELLOW buttons together until you hear a ‘beep’, then release.

M E M O RY

1

CHECK

The Green lamp shows how much memory is available for recording, the Yellow lamp shows untransmitted recordings. The duration of each lamp indicates the relative memory use.

2 B AT T E RY

CHECK

A series of audible tones is used to indicate the battery condition: Rising in pitch: battery is good - a new battery gives the sharpest rise in pitch Falling in pitch: battery is poor - replace it once all recordings have been transmitted

3 ERASE

PROMPT

If there are any recordings in the memory, the lamps will alternate rapidly after the battery check. To erase the recordings, push both buttons of the recorder until the lamps stop flashing. The recorder will beep and then repeat the memory indicator with only green flashes showing that the memory has been erased.

4 NORMAL

O P E R AT I O N

If you do not erase the recordings, the recorder will return to normal operation immediately the lamps stop flashing. Note: You can also erase the memory by removing the battery, and from a menu option in the CardioConnect PC program. The patient does NOT need to know how to erase the memory. See page 21 for details of CardioCall’s memory management.

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PROGRAMMING CARDIOCALL

CardioCall

20/VS20 ◆ Instruction Manual ◆

PROGRAMMING CARDIOCALL VS20 You can program the event intervals and number of events in CardioCallVS20 by using the programming key. Plug the programming key into the data socket. You will hear a short ‘jingle’ when the CardioCall is ready for programming. If you just want to know the current setting, remove the key at this point and the setting will be displayed.

1

2

Six recording programs are available as shown in the table below. The required program is selected by pushing the GREEN (REC) button. For example, to select the 3rd program, push the button 3 times.

POST-ACTIVATION

LOOPER

GREEN BUTTON

EVENT LENGTH

NO. OF CHANNELS

PRE-EVENT

POST-EVENT

1

30s

1

60s

60s

2

60s

1

45s

15s

3

30s

2

2m

30s

4

60s

2

4m30s

30s

5

60s

1

9m

1m

6

60s

1

0

60s

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PROGRAMMING CARDIOCALL ◆ Instruction Manual ◆

CardioCall20/VS20

3 To set the maximum number of events before a transmission must be made, push the YELLOW (TX) button according to the table below. When the total number of events allowed have been recorded, the patient must transmit them to the hospital before new recordings can be made.

YELLOW BUTTON PRESS

MAXIMUM NUMBER OF EVENTS

1

1

▲ In these modes the CardioCall will make

2▲

2*

a “ringing” sound when the maximum

3▲

until memory is full (20 minutes)

number of events has been reached.

* Except program 5, if using 2 channel looper.

4 Remove the programming key. The CardioCall will ‘beep’ a number of times, to confirm your program selection. ☞ Don’t leave the key inserted - this will rapidly drain the battery.

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