CardioCall ST80 Physician’s Instruction Manual Issue 1

◆ Instruction Manual ◆

2

CardioCallST80

◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

CONTENTS

CardioCall

ST80

◆ Instruction Manual ◆

CONTENTS Page Introduction

4

Explanation of markings & controls

6

Specifications

7

Safety

9

Using CardioCall ST80

11

Looper Recording

11

Patient instructions - Looper Recording

13

Monitor & Replay Recording using an ECG Monitor

15

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

16

Programming CardioCall ST80

17

Technical Details

19

Alert Sounds

19

How CardioCall ST80 Uses Memory

19

Transmitting Recordings by Telephone

20

Transfer of Recordings to a Personal Computer

20

Transmission Format

21

Recording Quality

21

Maintenance

22

Accessories

23

Index

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◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

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INTRODUCTION ◆ Instruction Manual ◆

CardioCallST80

INTRODUCTION The CardioCall ST80 is an easy to use patient-activated ECG event recorder monitor with a programmable (variable) event interval. The CardioCall ST80 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 ST80 features a looping (continuous) recording mode. A patient cable and conventional ECG electrodes are used, and the CardioCall ST80 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 ST80 then freezes the recording of the pre-event interval and records the post-event interval. A special program option enables the CardioCall ST80 to make automatic recordings at fixed intervals. The unit can store a total of 85 minutes of ECG and offers three methods for transmitting, or transferring, the recordings: 1. Transtelephonic Transmission. The patient telephones a receiving centre and is directed to push the Transmit button on the CardioCall ST80, which transmits the recordings using industry standard Frequency Modulated (FM) tones. Receiving centres consist of either a system supplied by Reynolds Medical Ltd or other compatible trans-telephonic systems. Systems supplied by Reynolds Medical will automatically identify the particular CardioCall ST80 making the transmission.

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◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

INTRODUCTION

CardioCall

ST80

◆ Instruction Manual ◆

2. Transfer to Personal Computer. Reynolds Medical CardioConnect software and connection cable allow CardioCall ST80 recordings to be transferred, stored, edited and printed. 3. Transfer to an ECG writer or cardioscope using the CardioCall ST80 monitor cable. This method is recommended for monitoring the ECG whilst making a recording.

CardioCall ST80 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 ST80 does not detect pacemaker signals, and should not be used on patients subject to defibrillation.

◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

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SPECIFICATIONS ◆ Instruction Manual ◆

CardioCallST80

EXPLANATIONS OF MARKINGS AND CONTROLS Yellow lamp

Green lamp

Data Connector

Green ‘REC’ Button

Patient Lead Connector

Speaker Yellow ‘TX’ Button Battery Cover

0088

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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◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

SPECIFICATIONS

CardioCall

ST80

◆ Instruction Manual ◆

SPECIFICATIONS PHYSICAL Size Weight

56 x 71 x 28 mm 79g (including battery)

ELECTRICAL Frequency response CMRR

0.05Hz - 30Hz >70dB

DC offset rejection Dynamic range

+/-300 mV 5 mV

Transmission centre frequency Frequency deviation Sampling frequency

1850 Hz 100 Hz/mV 100 Hz (800 Hz oversampled)

POWER SOURCE Type

1.5V Alkaline battery MN1500 (AA/LR6)

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

6 weeks

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

◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

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SPECIFICATIONS ◆ Instruction Manual ◆

FUNCTIONAL Transmitting Modes

CardioCallST80

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)

Recording Mode

Looping

Event Interval

Programmable, looping or post-activation.

Memory capacity

85 minutes

Unit Identification

Transtelephonic serial number (by DTMF)

COMPATIBILITY The CardioCall ST80 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 ST80 transmission includes 1 mV calibration pulses to allow the scaling to be verified. Technical manuals and further technical information are available from Reynolds Medical Limited.

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◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

SAFETY

CardioCall

ST80

◆ 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 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.

◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

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SAFETY ◆ Instruction Manual ◆

CardioCallST80

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. If the equipment is attached during defibrillation, the energy delivered to the patient may be reduced, and so 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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◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

LOOPER RECORDING

CardioCall

ST80

◆ Instruction Manual ◆

USING CARDIOCALL ST80 Before giving the CardioCall ST80 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 16, ‘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 19 for details of CardioCall ST80’s memory management.

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 15). ECG sound can be enabled/disabled by pressing the YELLOW (TX) button.

Two Channel Cable

Single Channel Cable

RED (V5)= CH1+, CH2+

YELLOW (M) = CH1-

GREEN (V1) = CH2-

◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

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LOOPER ◆ Instruction Manual ◆

SHAVE HAIR

CardioCallST80

RUB FOR 10 SECONDS WITH A

CLEAN WITH ALCOHOL

COTTON SWAB & A LITTLE GEL

SWAB

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. After a few seconds 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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◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

LOOPER

CardioCall

ST80

◆ 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 ST80 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 ST80. 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 ST80 speaker and press the YELLOW (TX) button until you hear a beep. Release the button and hold the CardioCall ST80 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 ST80 and hang up the telephone. Plug the cable back in to the CardioCall ST80. The CardioCall ST80 is now ready for your next recording.

◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

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CARRYING CARDIOCALL ◆ Instruction Manual ◆

CardioCallST80

CARRYING THE CARDIOCALL ST80 The patient should wear the CardioCall ST80 using the belt clip. The CardioCall ST80 should always be convenient for immediate use.

IMPORTANT NOTE - MEMORY FULL • As soon as CardioCall ST80 is full of untransmitted recordings, it will make a “telephone ringer” sound. • 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 ST80 will allow further recording. The next recording will displace the oldest recording which will be lost. • If all the recordings are transmitted, they will all be deleted the next time a new recording is completed.

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◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

MONITORING

CardioCall

ST80

◆ 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 ST80 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. ◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

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CHECK MEMORY & BATTERY ◆ Instruction Manual ◆

CardioCallST80

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 19 for details of CardioCall ST80’s memory management.

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◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

PROGRAMMING CARDIOCALL

CardioCall

ST80

◆ Instruction Manual ◆

PROGRAMMING CARDIOCALL ST80 You can program the event intervals in CardioCall ST80 by using the programming key.

1

① Plug the programming key into the data socket. You will hear a short ‘jingle’ when the CardioCall ST80 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.

2 ② Seven standard 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. ☞ You can change programs if there are already stored events they will not be affected. Single Channel Cable GREEN

MINS.

MINS.

BUTTON

PRE

POST

1

0

20s

2

1

3

APPLICATIONS*

Two Channel Cable EVENT COUNT

MINS.

MINS.

PRE

POST

R

253

0

20s

R

126

1

A

42

1

1

A

21

9

1

A/ST

8

9

1

A/ST

4

4

30

10

A/ST/FH

2

30

10

A/ST/FH

1

5

0

30

A/HRV/FH

2

0

30

A/HRV/FH

1

6

0

60

A/HRV/FH

1

15

5

A/ST

2

7

80

5

A/FH/ST

1

10

10

A/ST/FH

2

[* suggested applications: ST Symptomatic ST segment recording FH ‘First hour’ study. Useful for recording events experienced soon after waking when statistically most cardiac abnormalities occur.

A HRV R

APPLICATIONS*

EVENT COUNT

Symptomatic arrhythmias/syncope Heart Rate Variability studies Rhythm/postural change/hook up strips]. Use these configurations to check ECG quality then choose another program as appropriate before sending the patient away.

◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

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PROGRAMMING CARDIOCALL ◆ Instruction Manual ◆

CardioCallST80

3 ➂ Automatic Program Option Press the GREEN and YELLOW buttons together if you want to select this program option. The CardioCall ST80 will make recordings at regular intervals as shown below. The patient may also make additional manual recordings.

SINGLE CHANNEL CABLE PATIENT ACTIVATED AUTOMATIC RECORDING PrePostEvent Repeat Time time time length interval to fill 2m

20 s

20 s

1 hr

10 dy

TWO CHANNEL CABLE PATIENT ACTIVATED AUTOMATIC RECORDING PrePostEvent Repeat Time time time length interval to fill 2m

20 s

20 s

1 hr

5.3 dy

To deselect the automatic program, press the GREEN and YELLOW buttons again (you must deselect this program first if you want to use one of the standard programs instead). ☞ Selecting or deselecting the automatic program will erase the memory. ☞ Automatic operation is suspended when the patient cable is unplugged, and resumes when reconnected.

4 ➃ Remove the programming key. The CardioCall ST80 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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◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

TECHNICAL DETAILS

CardioCall

ST80

◆ Instruction Manual ◆

ALERT SOUNDS ONE BEEP . . . • when you press the GREEN button to make a recording

The memory is full. You must send the recordings.

• every 16 seconds, when no button is being pressed

The battery is low. Send the recordings before changing the battery.

RINGING SOUND . . . • after making a recording

The memory is full. You must send the recordings.

TECHNICAL DETAILS HOW THE CARDIOCALL ST80 USES MEMORY The CardioCall ST80 can have two types of recording in its memory - “old” and “new”. A “new” recording is one that has not been transmitted. It becomes an “old” recording once it has been fully transmitted either by telephone or via the monitor cable.

1 NEW

1 OLD

Recording in Memory

Recording in Memory

When a transmission is started, the CardioCall ST80 will replay all “new” recordings in sequence, starting with the oldest. If there are no “new” recordings, it will replay all “old” recordings in sequence, starting with the oldest.

◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1

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TECHNICAL DETAILS ◆ Instruction Manual ◆

CardioCallST80

If there is no other memory space available, the recorder will make the next recording over the oldest “old” recording, which will be lost. It will not record over a “new” recording. Any recordings that are transmitted will all be deleted when the next recording is completed. You must wait for the appropriate ‘Pre-event’ period (depending on the program selected) before pushing the REC button. If the button is pushed just after hooking up the patient, abandoning a recording or finishing a transmission, the first part of the recording will consist of a square wave. The patient cable is disconnected by holding the plug and pulling firmly - do not twist it or pull on the cable. Disconnect the cable if the CardioCall ST80 is not in use for a while, as the battery drain is lower.

TRANSMITTING ECG RECORDINGS BY TELEPHONE The patient cable must be unplugged before transmitting. Once the receiving centre is ready to accept the signal from the recorder, ask the patient to press the YELLOW (TX) button on the recorder until a tone is heard, while holding the loudspeaker to the telephone mouthpiece. The CardioCall ST80 will ‘whistle’ throughout the transmission. If the transmission is too long for the receiving station to accept, it can be stopped by pushing the YELLOW (TX) button again. The CardioCall ST80 will mark recordings that have been completely transmitted as “old”, and they will not appear in the next transmission unless there are no untransmitted (“new”) recordings.

TRANSFER OF RECORDINGS TO THE CARDIOCONNECT/CARDIONAVIGATOR PROGRAM Connect the Download Cable between the PC and the CardioCall ST80 Data Connector before starting the program. CardioConnect V4 (and above) will initiate transfer automatically from a menu option. All recordings (“old” and “new”) are transmitted to the PC, and the CardioConnect software separates the recordings, calling the oldest “Strip 1”, etc. Once the recorder memory has been successfully transmitted to the PC, it should be erased (see page 16).

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◆ REYNOLDS MEDICAL ◆ Drawing No. 039/0058/0 CN3403 Issue 1