Related Manuals for Spacelabs Healthcare CardioCall VS20
Summary of Contents for Spacelabs Healthcare CardioCall VS20
- Page 1 CardioCall VS20 & ST80 Physician & Patient Instruction Manual For CardioCall models VS20 and ST80 manufactured after September 2012 070-2220-00 Rev.C...
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Page 3: Table Of Contents
Contents Section 1: General About this manual Disclaimer Warnings, Cautions and Notes Applicability CardioCall Accessories Markings on accessories Manufacturer and contact information Entry into service Patient population 1.10 Special skills, training and knowledge 1.11 Maintenance personnel 1.12 Service personnel Section 2: Quick Start Guide About the CardioCall Next steps with the CardioCall Section 3: Instructions for use... - Page 4 3.24 Connecting the patient cable 3.25 Using post-activation event mode (VS20 models only) 3.26 Using looping mode (all models) 3.27 Using ECG Electrodes 3.28 Recording when the memory is full 3.29 Recovering from use errors 3.30 Changes in performance 3.31 Prepare the CardioCall for re-issue 3.32 Troubleshooting guide...
- Page 5 ©Copyright 2011 Spacelabs Healthcare Ltd. Warranty Subject to the conditions set out below, Spacelabs Healthcare (“The Company”) warrants that its Products will be free from defects in material and workmanship for a period of 12 months from delivery. This warranty is given by The Company subject to the following conditions:...
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Page 7: Section 1: General
Every effort has been taken to ensure the accuracy of this manual but Spacelabs Healthcare cannot accept liability for consequences caused by errors or omissions. You are recommended to check with Spacelabs Healthcare on items on which you are unsure or need confi rmation. -
Page 8: Cardiocall Accessories
CardioCall Accessories Note: Use only accessories approved or supplied by Spacelabs Healthcare. The use of unapproved accessories can decrease performance and cause unsatisfactory ECG recordings. A list of the accessories for use with the CardioCall is written in the table. -
Page 9: Markings On Accessories
Markings on accessories The accessories are identifi ed with the name or trademark of Spacelabs Healthcare or their supplier, and with a model or type reference. These markings are usually on the packaging for the accessories, and not on the accessories themselves. -
Page 10: Special Skills, Training And Knowledge
The maintenance should be done by the physician or by another professional operator. 1.12 Service personnel The CardioCall must be repaired by only organizations approved by Spacelabs Healthcare. Physician & Patient Instruction Manual... -
Page 11: Section 2: Quick Start Guide
Section 2: Quick Start Guide WARNING: The successful and safe use of the device requires a procedure and awareness of important safety information. Because of this, consulting this manual is a mandatory action About the CardioCall The CardioCall is a patient-activated electrocardiogram (ECG) event recorder for the home healthcare environment. -
Page 12: Next Steps With The Cardiocall
If you used looping mode, unplug the patient cable. You can listen to the recording by pressing SEND. The CardioCall replays the recording through its loudspeaker, ready for a transfer by telephone to a remote receiving station. Push SEND again to stop the playback. Send the recording for analysis. -
Page 13: Section 3: Instructions For Use
ECG electrodes, and (for VS20 models) a post-activation event mode in which the device is held to the chest of the patient. Both the CardioCall VS20 and ST80 are programmable (variable event-interval) recorders. The model VS20 has four built-in electrodes for the post-activation event mode, and the model ST80 has a special program option enabling it to make recordings automatically at fi... -
Page 14: General Arrangement
SEND button on the CardioCall. The CardioCall transmits the recording using industry-standard,frequency-modulated tones. Receiving centres can use a system supplied by Spacelabs Healthcare, or other compatible trans-telephonic systems. Systems supplied by Spacelabs Healthcare will automatically identify the individual CardioCall device making the transmission. -
Page 15: Restrictions To Sale
Restrictions to sale In North America, Federal law restricts this device to sale by or on the order of a medical practitioner licensed by the law of the State in whichhe practices to use or order the use of the device. Frequently used functions The frequently used functions of the CardioCall are written in the table. -
Page 16: Equipment Classifi Cations
Equipment classifi cations The CardioCall has the equipment classifi cations written in the table. Parameter Values Power supply The CardioCall is an item of internally powered medical electrical equipment (IEC 60601-1: 2005) Applied parts The CardioCall has applied parts which make an electrically conductive connection to the patient, but not directly to the heart. -
Page 17: Electrical Power Source
3.11 Electrical power source WARNING: Do not connect the CardioCall to an external power source or battery charger. Connecting the CardioCall to a power source or charger could cause an electric shock or cause damage to the device. The CardioCall is powered by an AA battery, which meets the specifi cation written in the table. The use of the Duracell MN1500 is recommended. - Page 18 You can confi gure the CardioCall to use a particular program for event recording, and you can set audio progress tones to be on or off. The CardioCall retains these confi guration settings when you remove the battery. Performance characteristics The important performance characteristics of the CardioCall are written in the table.
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Page 19: Applied Parts
3.13 Applied parts The applied parts of the CardioCall are the patient electrodes. These are the ECG electrodes, connected through the patient cable, and (for VS20 models) the four case electrodes. In normal use, the applied parts touch the bare chest of the patient. Classifi... -
Page 20: Connect The Cardiocall To Other Equipment
3.17 Connect the CardioCall to other equipment WARNING: Use only the download cable, part number 23-0026, to connect the CardioCall to other equipment. The download cable includes isolating circuits, which provide a safety barrier in the event of an electrical fault in the other equipment. - Page 21 • The audio tones include a tune with a rising pitch to show the battery is healthy. Confi gure the device to make the desired type of recording. If looping mode is indicated, choose the appropriate patient cable either a 1channel supplied with model VS20 or a 2 channel supplied with model ST80.
- Page 22 You can also set the maximum number of events to be stored in memory. When the patient has recorded the permitted number of events, the patient has to transmit them to the hospital or physician before they can make new recordings. Do the following: Put the programming key into the data socket on the CardioCall and wait for a short tune.
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Page 23: Confi Gure The Model St80
3.20 Confi gure the model ST80 You can confi gure the event intervals for the CardioCall ST80. You can choose one of seven pre-set programs, or an automatic program option. Use a 1 channel cable (available separately) to make one-channel recordings, or a 2 channel cable (supplied) to make two- channel recordings. - Page 24 In the automatic program mode, the CardioCall ST80 makes recordings at regular intervals. Automatic operation starts when the patient cable is connected and stops when it is removed. The patient can also make manual recordings. The details of the automatic program mode are written in the table.
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Page 25: Check The Battery And Memory
3.21 Check the battery and memory Note: The patient does not need to know how to do this The CardioCall has a built-in test facility you can use to examine the state of the battery and memory and, if desired, erase the memory. You can also erase the memory by removing the battery, and from a menu option in the CardioConnect PC program. -
Page 26: Precautions For The Home Healthcare Environment
and give the best quality recordings. If looping mode is indicated, the device can be used when sleeping. In this case, the device can be activated by a carer in the same room or, if the patient wakes on experiencing symptoms, by the patient themselves. 3.23 Precautions for the home healthcare environment The CardioCall should be worn close to the patient’s body, away from other portable electrical equipment such as mobile telephones (cell phones). - Page 27 Using the CardioCall at a height The CardioCall is designed to withstand being accidentally dropped from a height of about one metre. The device will not survive being dropped from large heights, such as from scaffolding or a balcony. The use of the lanyard or the belt clip is indicated for patients whose occupation or lifestyle takes them to signifi...
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Page 28: Connecting The Patient Cable
3.25 Using post-activation event mode (VS20 models only) Looping mode (direct chest application) is supported by CardioCall VS20 models. Make test recordings and transmissions to fi nd the best position on the chest for the CardioCall. •... - Page 29 Patient instructions for post-activation event mode Note: These instructions are repeated in a simpler form in the Patient’s Guide. When you have symptoms, do the following: Follow the advice your hospital or physician has given you. Hold the metal feet of the CardioCall to your bare chest, as instructed by your physician.
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Page 30: Using Looping Mode (All Models)
3.26 Using looping mode (all models) Looping mode is supported by all CardioCall models. Do the following: Prepare the electrode sites and then hook up the patient. Suitable sites include those for a bipolar lead chosen for ambulatory ECG (Holter) monitoring.Results will be impaired if the skin is especially dry, greasy or hairy. -
Page 31: Using Ecg Electrodes
Positioning electrodes with a 2 channel cable Place the three ECG electrodes in the locations shown in the illustration. Yellow Green Note: RedCH1+ and CH2+, Yellow = CH1– Green = CH2– 3.27 Using ECG Electrodes Electrodes designed for long-term wear are recommended for looping mode. Tell the patient (or their carer) the electrodes are single-use only, and to be careful to clean the skin and not trap foreign material below an electrode. - Page 32 Test the patient hook-up You can check patient hook-up by disconnecting the patient cable from the CardioCall 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. Check the electrode attachment, but be aware that low impedances are not achiev- able with all patients, or with dry electrodes.
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Page 33: Recording When The Memory Is Full
Release the button and hold the CardioCall still on the telephone while the recording is transmitted. • You will hear ‘whistles’ while the CardioCall sends the recording. After the whistles have fi nished, remove the CardioCall and hang up the telephone. Plug the cable in to the CardioCall. -
Page 34: Changes In Performance
3.30 Changes in performance The CardioCall does not have any essential performance. If there is a fault and a parameter fails to meet its expected value, the most serious consequence will be a delayed diagnosis. If the performance of the CardioCall changes, and the problem cannot be traced to problems with the electrodes or the patient cable, the device should be taken out of service, cleaned, and returned for servicing. -
Page 35: Troubleshooting Guide
3.32 Troubleshooting guide WARNING: Make sure you know about any hazards associated with the device you are working on—whether electrical, mechanical, chemical or bacterial. Take all the precautions needed, including personal protection such as gloves. When in doubt as to a hazard, assume it is present.. This troubleshooting guide is for use when there are indications of a malfunction in the CardioCall during start-up or operation. -
Page 36: Messages And Alerts
Attach two ECG electrodes (new or used) back-to-back, connect the cable poppers, and then plug the cable into the CardioCall: • A short ring tone shows there is a good connection through the cable and electrodes (a 2 channel cable should produce two ring tones). •... -
Page 37: Cleaning And Disinfection
3.35 Cleaning and disinfection The CardioCall will not need regular cleaning in normal use. Try to keep the device away from surfaces which can be contaminated with dirt or bacteria or a virus. These could cause an infection. If the CardioCall becomes dirty, clean the outside of the enclosure using a soft, lint-free cloth moistened with water and a little disinfectant. -
Page 38: Service Life Of The Aa Battery
3.37 Service life of the AA battery A new alkaline AA battery will operate the CardioCall in looping mode for about 50 days. The actual battery life depends on several factors, including the number of recording and playback operations, the temperature at the location of the patient, and the characteristics of the individual battery. -
Page 39: Accessories And Supplementary Equipment
When the CardioCall reaches the end of its service life, it becomes an item of waste electrical and electronic equipment (WEEE) and it should be disposed of in a suitably environmentally responsible way. It is recommended the device is returned to Spacelabs Healthcare for recovery and recycling. - Page 40 Physician & Patient Instruction Manual...
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Page 41: Section 4: Technical Description
1600 to 2100 Hz and scales the signal at a rate of 1mV / 100 Hz. Models VS20x4 and ST80x4 are compatible with only the Spacelabs Healthcare EventStation and with other receiving stations that can decode the transmitted data and present the ECG at the correct rate. -
Page 42: Transmission Format
The CardioCall adds coded signals to the ECG signal to send information about the recorder and the recordings. The information gives the date, time and recording mode of each strip. It is encoded by frequency shift keying (FSK) and can be interpreted by the Spacelabs Healthcare EventStation. -
Page 43: Characteristics Of Ecg Recordings
Characteristics of ECG recordings The CardioCall has features to minimise unwanted effects, such as changing electrode offsets and power frequency artefacts. Baseline restore feature Electrode offsets change quickly in some circumstances, and the CardioCall includes a baseline restore feature which centres both channels if either channel becomes saturated. This is most commonly seen at the start of a recording using the case electrodes, when the electrode/skin interface stabilises. - Page 44 Automatic fi lter switching The CardioCall incorporates fi lters to remove power frequency artefacts and prevent signal aliasing. However, fi lters can mask problems such as an electrode failure or lead detachment. To stop this happening, each fi lter is switched off automatically if a high-frequency artefact in its channel increases to a level that might distort the ECG.
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Page 45: Cardiocall Power Consumption
CardioCall power consumption The average power consumption of the CardioCall is typically less than 0.003 VA. Preparing the CardioCall for use The CardioCall does not require special preparation before its fi rst use. Follow the start-up procedure. Hygienic maintenance CAUTION: Do not try to sterilize the CardioCall. -
Page 46: Physical Specifi Cations
Seal the bag. Complete a decontamination sheet / form detailing any cleaning that has taken place and which bodily fl uids the unit may have come into contact with. If no form exists within your facility, make a note and and provide with the shipment Contact your supplier for advice. - Page 47 In testing the immunity of the CardioCall series, the following were regarded as essential performance in accordance with EN60601-1-2: • Recording of ECG with no noise suffi cient to interfere with diagnosis • Maintenance of stored ECG • No changes of operating mode or set-up selections •...
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Page 48: Guidance And Manufacturer's Declaration- Electromagnetic Emissions
4.12.1 Guidance and manufacturer’s declaration– electromagnetic emissions The CardioCall is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the CardioCall should make sure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment - guidance... -
Page 49: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
4.12.2 Guidance and manufacturer’s declaration – electromagnetic immunity The CardioCall is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the CardioCall should make sure that it is used in such an environment. IMMUNITY test IEC 60601 test Compliance level... -
Page 50: Guidance And Manufacturer's Declaration - Electromagnetic Susceptibility
4.12.3 Guidance and manufacturer’s declaration – electromagnetic susceptibility The CardioCall is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the CardioCall should make sure that it is used in such an environment. IMMUNITY test IEC 60601 test Compliance... -
Page 51: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Cardiocall
4.12.4 Recommended separation distances between portable and mobile RF communications equipment and the CardioCall The CardioCall is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CardioCall can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CardioCall as recommended below, according to the maximum output power of the communications equipment. -
Page 52: Circuit Diagrams, Component Part Lists And Other Technical Information
Spacelabs Healthcare will make available on request circuit diagrams, component part lists, descriptions, and other information that will help service personnel to repair those parts of the device that are designated as repairable. -
Page 53: Signs And Symbols
Signs and Symbols The following list of international and safety symbols describes all symbols used on Spacelabs Healthcare products. No one product contains every symbol General Safety Consult Documents Consult instructions for use THIS SYMBOL MEANS available on accompanying YOU MUST READ CD or via the Spacelabs THE ACCOMPANYING Healthcare website... - Page 54 General Use ON — Power Connection to OFF — Power Disconnection Mains from Mains OFF Position for Push Button ON/OFF Power Switch STANDBY Key Power ON/ START (NIBP) Key OFF Key START/STOP STOP or CANCEL Key Frequently Used Functions Infra Red Communications Video Output Port PRINT REPORT Key...
- Page 55 Packaging Non Sterile PVC-Free Federal (USA) law restricts this devoce to safe by or o the order of a medical practitioner Do Not Reuse; Single Use licensed by the law of the Only state in which he practices to use or order the use of the device.
- Page 56 Manufacturer Information and Traceability Manufacturer Date of Manufacture Serial Number The letters ‘SN’ stand for Catalog Number ‘Serial Number’ Each device has its own unique serial number Notations and Abbreviations Abbreviations used as symbols are shown below. C.O. ECG Channel Cardiac Output ECG Channels –...
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