CardioPAL SAVI / SAVI AFB

Transcription

1 CardioPAL SAVI / SAVI AFB Event Monitor USER S GUIDE

2 2 - UTM May 2009 UTM410-09

3 NOTICE Federal law restricts the CardioPAL SAVI / SAVI AFB event monitor to sale by, or on the order of, a licensed medical practitioner. The data obtained from these devices are for review by a physician. It is recommended that a physician overread the results. CAUTION This CardioPAL SAVI / SAVI AFB event monitor is not intended for use by patients who are unable to activate the Symptom switch when they are experiencing a symptom. Diogenes is a product of Medicomp. NuPrep is a product of Weaver & Company. CardioPAL SAVI / SAVI AFB is a product of Medicomp, Inc. Sporicidin is a product of Sporicidin International. Copyright Medicomp, Inc All rights reserved. No part of this publication may be reproduced or distributed in any form or by any means without prior written permission from Medicomp, Inc.

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5 CardioPAL SAVI / SAVI AFB Event Monitor Indications for Use The CardioPAL SAVI / SAVI AFB event monitor is a pager-sized, handheld or patient-worn device designed specifically to record, store, and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature. Intended Use The CardioPAL SAVI / SAVI AFB is designed to acquire, store, and transmit ECG signals from surface ECG electrodes on ambulatory patients.

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7 7 TABLE OF CONTENTS Introduction...9 SAVI / SAVI AFB Monitor Description...9 Operating Modes...11 Auto Looper Recording Mode...11 Manual Looper Mode...11 Finger Electrode Mode...12 Transmission Mode...12 EVENT PROCEDURE SETUP...13 Patient Preparation...14 Step 1 - Identify Electrode Sites Step 2 - Prepare the Skin Step 3 - Apply Electrodes and Cable Step 4 - Discuss Event Procedure Details Step 5 - Connect the Monitor to the Patient Step 6 - Select the Monitoring Mode Auto Looper (Auto-capture) Setup...21 Manual Looper / Finger Electrode Mode Setup...26 Transmitting a Baseline Strip...28 Number of Strips Stored...28 ECG TRANSMISSION...29 Recording Format...30 MAINTENANCE...31 MARKINGS and SAFETY...33 SPECIFICATIONS...34 CARDIOPAL SAVI SETUP DETAILS and TROUBLESHOOTING...35 Quality Test Problems in Auto Looper Mode...36 Error Displays...36 Testing Leads...37 Testing Lead Positions...38 Testing Skin Prep...40 CardioPAL SAVI Setup Quality-Test Modes...41 QRS Shapes Codes for Typical Beats that are Intrinsic...41 QRS Shape Codes for Typical Beats that are Paced...42 Deleting/Restarting an Event Procedure...43 Changing the CardioPAL SAVI Date and Time...43 INDEX...45 CardioPAL SAVI User s Guide

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9 Overview 9 The contents of this User s Guide include the following topics: 1. Description of the CardioPAL SAVI / SAVI AFB auto-capture event monitor, including its operating modes. From this point on, and since the user operation is nearly identical with both units, the CardioPAL SAVI and CardioPAL SAVI AFB will be referred to as the SAVI monitor, to simplify the text. The difference between the two monitors is detailed in the paragraphs below. 2. Preparation of the patient; application of electrodes, lead wires and/or cable connections. 3. Auto-Looper mode: Explanation of the quality tests performed by the monitor during patient hookup. These tests, performed automatically after startup, assess the ECG signal and skin prep quality. 4. Manual-Looper recording mode. 5. Finger-Electrode recording mode. 6. ECG transmission mode. 7. Details on SAVI maintenance and battery replacement. 8. Descriptions of problems that may be encountered while performing the hookup, and the possible solutions to those problems. Introduction The CardioPAL SAVI is a hand-held device specifically designed to record and document transient ECG events that are symptomatic to the patient. Although it is recommended that the patient transmit each strip to a monitoring center as soon as possible after recording the strip, the unit is capable of storing twenty minutes of ECG data in user-definable segments. This means that the patient can wait until a more convenient time to transmit. The SAVI, when connected to the patient through electrodes, uses the Diogenes algorithm to identify and record arrhythmias that may be asymptomatic to the patient; when operating in this mode, the SAVI is auto-capturing the asymptomatic arrhythmias. SAVI AFB (Atrial Fibrillation Burden) In addition to operating as an event monitor, the SAVI AFB takes pre-defined, periodic recordings of the patient s ECG. The interval is 3 minutes, and the length of each recording is 15 seconds, but may be modified. This setting is configured only at the factory. Monitor Description The SAVI is pager-sized and very lightweight; it has three buttons, a display for technician and/or patient interaction, and an optional finger-electrode accessory: SYMPTOM/RECORD (front panel): The patient presses this button when experiencing a symptom. The display shows a countdown message while the recording takes place. YES/SEND (right side, bottom switch): The patient presses this button to start ECG strip transmission. The YES button is also used for technician interaction during patient setup. NO (right side, top switch): Unless directed by a monitoring center or service technician, the patient does not use this button; it is used for technician interaction during patient setup. Labeling may vary depending upon the SAVI model type you have. CardioPAL SAVI User s Guide

10 10 - Overview The display shows, Monitoring, with the current date and time while the procedure is running in autocapture mode. When in manual mode (auto-capture is off), the displays shows, Ready, with the current date and time. The display is blank in the finger-electrode mode, until the Symptom/Record button is pressed. A connector on the top of the unit serves as a connector to the patient cable or to a PC (factory operation only). The patient may wear the SAVI using a belt clip or lanyard. Both the location of the belt clip and the metal loop for lanyard attachment (housed near a corner of the unit) depend upon the SAVI model type. CAUTION Lanyard is to be worn by adults only; it should not be worn during sleep or while operating machinery. The optional, finger-electrode accessory is used when the patient cannot tolerate wearing the electrodes: The accessory attaches to the connector on the top of the SAVI, and is inserted into this connector in the same manner as the patient cable; the design of the accessory s base varies depending upon the SAVI model type you have. The finger accessory remains inserted as long as the patient does not wear electrodes. No auto-capture monitoring or AFB recordings can be made while the unit is operating in this mode. The location of the SAVI s battery compartment varies according to the model type. The compartment houses a single, AA battery. For information about changing the battery, see Replacing and Loading the Alkaline Battery on page 32. Note: The monitor should be worn outside the clothing if there is any chance that moisture (e.g. sweat) might come in contact with the unit. The unit should be worn under outer wear, such as raincoats or jackets, for protection during wet or cold conditions. UTM410-09

11 Operating Modes 11 The monitor has three recording modes and a transmission mode; each is briefly described below, with more complete details on the pages that follow. Auto Looper (Auto-capture) Recording Mode In Auto Looper mode, the SAVI records symptomatic activity when the patient activates the Symptom/ Record button. The unit is connected to the patient cable, which in turn is attached to electrodes that are on the patient s chest. As an auto-capture device, the SAVI also continuously analyzes the signal as it occurs. When a signal abnormality is detected, the monitor stores the event pictorially (ECG strip), according to pre-defined protocols. The unit s memory that is devoted to auto-captured events is dynamically managed and can be overwritten by new activity that occurs. Therefore, the SAVI emits a beep and displays a Time to transmit message periodically. In this way, the auto-captured activity that has occurred in the procedure is made available. As mentioned above, the monitor in the Auto Looper Recording mode also acts as a traditional looping recorder, independently of the auto-capture operation. The monitor reads ECG data in a continuous loop at all times. When the patient presses the Symptom/Record button, the unit emits a beep and displays the message, Patient Cable Recording with a countdown of time. During this time, the monitor stops looping and saves an additional number of seconds of ECG data. This results in an ECG recording that documents time before and after the patient pressed the Symptom/Record button. After recording a complete ECG strip, the unit repeats the beep and displays, To transmit call/(phone number). The recording loop and additional seconds saved can be programmed at setup. The monitor s memory that is devoted to patient-activated strips is never overwritten or erased. This memory does run out if the patient presses the Symptom/Record button enough times. When this occurs, the unit displays, Memory Full and Time to transmit messages until the transmission is performed. Manual Looper Mode In Manual Looper mode, the SAVI is connected to the patient cable, which in turn is attached to electrodes that are located on the patient s chest. The monitor reads ECG data in a continuous loop for a specified period of time. When the patient presses the Symptom/Record button, the unit emits a beep and displays the message, Patient Cable Recording with a countdown of time. During this time, the monitor stops looping and saves an additional number of seconds of ECG data. This results in an ECG recording that documents time before and after the patient pressed the Symptom/Record button. After recording a complete ECG strip, the unit repeats the beep and displays, To transmit call/(phone number). The recording loop and additional seconds saved are programmed at setup. CardioPAL SAVI User s Guide

12 12 - Overview Finger Electrode Mode The finger electrode mode is recommended only for those patients who have extreme electrode adhesive sensitivity, or for some other reason cannot wear the electrodes. The patient is instructed to carry the device where it is convenient and easy to access. While in this mode, the monitor s display is blank to conserve power. When the patient experiences a symptom, he or she presses the Symptom/Record button and watches the monitor s display, which shows a countdown to record message. When this countdown is finished, the unit then displays, Finger Electrode Recording XX, where XX is the number of seconds that were specified during monitor setup. The monitor counts down to 0 from this number, and then displays the transmit message. Transmission Mode This mode is used to send the recorded ECG strips to a monitoring center via the telephone. Since the monitor is able to save only a limited amount of ECG data, it is recommended that the strips be transmitted as soon as possible after being recorded. Use a land-line phone to transmit recordings, instead of cordless or cellular phones. UTM410-09

13 EVENT PROCEDURE SETUP 13 CardioPAL SAVI User s Guide

14 14 - EVENT PROCEDURE SETUP Patient Preparation This section contains step-by-step instructions that describe how to prepare the patient for a CardioPAL SAVI Looper procedure (requires chest electrode application). Please follow the skin preparation sequence as closely as possible. This will greatly enhance the ECG signal quality and optimize analysis. NOTE If you know at the start of the procedure that the patient will be using the CardioPAL SAVI in the finger-electrode mode, you should set up the SAVI in the Manual Looper mode first, without the patient cable inserted. After the setup is complete, the unit s display goes blank, and the patient can then place the monitor where it is convenient to access when symptoms occur later. UTM410-09

15 Step 1 - Identify Electrode Sites. 15 Leads V5/MCL5 and V1/MCL1 (when used) provide optimal beat and rhythm sensing for ambulatory monitoring. By convention in the event reports, V5 is Channel A and V1 is Channel B. Refer to the figures below for the electrode placement that corresponds to the number of electrodes you are using: For 2-electrode placement, use A+ (red) and A- (white). (used in Manual Looper mode only) For 3-electrode placement, use A+ (red), A- (white) and G (green). SAVI AFB Setup For 3-electrode, twochannel setup and placement, use A+ (red), A- (white) and Bl (in this application, Blk is negative pole). Bl Five-electrode placement may be used for both standard SAVI and SAVI AFB. For women with large breasts, the following electrode positions are recommended: B+ (Brown) on the chest over the sternum; A+ (Red) in the left axillary line (V6 position) and G (Green) [or B- (Black) with SAVI AFB monitors] in the right axillary line. This lead placement may eliminate potential skin prep problems and minimizes occurrences of artifact. CardioPAL SAVI User s Guide

16 16 - EVENT PROCEDURE SETUP Step 2 - Prepare the Skin. Because the patient may be wearing the electrodes for many days, skin preparation is similar to that used for long-term Holter recording. In order to obtain the best ECG recording, the following procedure is recommended for initial patient hookup: 1. Whenever possible, place the patient in an upright sitting position. This may be useful if any setup problems occur that concern the signal voltage. 2. Following the lead placement diagram, select sites that are flat and bony. Avoid skin folds or creases, irritated skin or scar tissue, and highly muscular areas. 3. If necessary, shave an area at each site slightly larger than the size of the electrode you will be using. 4. If the patient has applied powder, lotion, sun block, etc. to the chest, or has excessively oily skin, it may be necessary to wash each site with plain soap and water. Do not use a soap that contains lotion or oil. 5. Wipe each site using at least 10 strokes of alcohol-soaked gauze pads to thoroughly remove body oils that may prohibit good adhesion. Wait until completely dry. 6. Place a very small amount (about the size of the tip of a cotton swab) of NuPrep gel on an ordinary paper towel. Wrap the paper towel around your finger and, using a circular motion, rub firmly into the skin at the first electrode site. DO NOT use your finger or a gauze pad to apply the gel. Repeat for each site and wipe off any excess gel. The above skin prep procedure is only required at the beginning of the procedure, during monitor initialization. Patients will not be required to perform this type of preparation each time they re-locate electrodes. When the monitor is reconnected to the patient cable, the unit performs a less restrictive setup. Note: Although NuPrep is strongly recommended, you may substitute light abrasion with a scrub pad. In some cases a combination of these prep methods may be required to achieve acceptable results. UTM410-09

17 Step 3 - Apply Electrodes and Cable. 17 Attach the cable wires to fresh electrodes. Then, remove the backing from each electrode and inspect its gel cup for moistness before application. (Gel that has dried out inhibits signal conduction.) Carefully position the electrodes at the appropriate color-coded sites: Fig. 4 5-Electrode Lead Connections For 2-electrode connections, use A+ (red) and A- (white). For 3-electrode connections, use A+ (red), A- (white) and G (green). For SAVI AFB monitors with 3-electrode, 2-channel configuration, use A+ (red), A- (white). Place B- (Black) in the G (green) location. (Black electrode becomes negative pole in this application.) PLEASE take the time NOW to explain some procedure details to the patient (Step 4). This will allow some extra time for the patient s skin to absorb the electrode gel, which may help skin prep errors from occurring. CardioPAL SAVI User s Guide

18 18 - EVENT PROCEDURE SETUP Step 4 - Discuss Event Procedure Details. Become familiar with the information in the Patient Guide and make sure your patient receives one. The following are some questions your patients may ask: How do I record and transmit my strips? 1. When you feel a symptom, or at those times requested by your doctor, press and release the Symptom/ Record button. The monitor beeps and displays a countdown message. (If you press Symptom/Record by mistake, you can stop the recording by pressing the NO button. The monitor displays, Recording aborted, and continues with monitoring.) 2. Limit movement and breathe normally. Wait for the unit to emit the second beep and/or watch the countdown menu until the message, Recording Complete is seen. Transmit the ECG data as soon as possible after the recording session. (If you press YES(/SEND*) by mistake, and you hear the transmission tones, you can stop them by pressing the NO button. The monitor displays, Transmission aborted, and continues with monitoring.) 3. The YES(/SEND*) button is used to transmit your ECG recordings to the monitoring center. For details and illustrations, see ECG TRANSMISSION on page 29. Use land-line phones to transmit recordings, instead of cordless or cellular phones. How do I wear the monitor when I have the electrodes attached? Wear the monitor where it is most convenient, but be sure the Symptom/Record button is easily accessible. Avoid areas where the buttons might accidentally be pressed. At bedtime, clip your monitor (if belt clip is present) to sleepwear or place it next to you where its location is the most comfortable. Can I shower? You can shower, but you must remove the SAVI beforehand. First, disconnect the cable from the monitor and set the unit aside. Second, unsnap the wires from your electrodes. A diagram in the Patient Guide will help you to replace them correctly when you connect yourself again. Last, remove the electrodes if your skin is very irritated or if it has been 72 hours or more (per electrode manufacturer s directive) since the last electrode change. If you don t need to remove the electrodes, just make sure that water does not fall directly on them. After showering, decide where you will be placing your electrodes (refer to the diagram in the Patient Guide for placement) and dry your skin well in those areas. Snap the wires onto the electrodes. Now, carefully remove the back plastic cover from each electrode in turn and press the patch to your skin so that complete contact is made with the adhesive backing. Plug the cable into the monitor. The monitor will turn on with this action and resume operation. * Note: Labeling of the YES button varies, depending upon the SAVI model used. Later models are labeled, YES/ SEND, to clarify this button s dual functionality. UTM410-09

19 What can I expect to see on the monitor s display? Some of the SAVI display messages are shown below. Some messages may alternate on the display with other status messages: NOTE 19 In the Finger Electrode mode, the monitor display is blank when not in use. Monitoring Date Time Ready + Ready Memory Full! / Transmit Strips Memory Full! / Transmit Now Call (number) / Date Time Memory Full! / Unable to Record To transmit call (number) No stored data to send Battery too low / Shutting down! The monitor is in auto-capture, looping mode. The auto-capture algorithm is suspended. Disconnect, then reconnect the patient cable. The display should return to Monitoring momentarily. The monitor is in the manual looper mode. Even if the unit was originally set up in the auto-capture mode, a problematic condition has changed its operation to disable auto-capture. No recovery to autocapture status is possible. However, the monitor can be re-started via a specific YES/NO button sequence so that the auto-capture mode can be resumed. If the patient is wearing a SAVI AFB monitor, you should first contact the Cardiac Monitoring Center before restarting the monitor. See page 44. Strips must be transmitted before any further recordings can be made. There are strips to transmit. There are no strips in the monitor to transmit. The monitor cannot continue and will turn off. A fresh battery must be installed to continue operation. When the unit is not connected to the patient and is left idle for a period of time, it will turn off to conserve power. If its display goes blank while the patient is wearing it (and it s not a low battery condition), have the patient disconnect, then reconnect the cable. The monitor should turn on. If it doesn t, or if the time does not change on the unit at any time during the procedure, then the patient should call the monitoring center. CardioPAL SAVI User s Guide

20 20 - EVENT PROCEDURE SETUP Step 5 - Connect the Monitor to the Patient. Insert a fresh AA battery into the CardioPAL SAVI and connect the patient cable. Align the plug on the end of the cable with the receptacle on top of the monitor and push in firmly. When a complete connection is made, the unit turns on automatically and executes the following sequence (this sequence may vary, depending upon which SAVI model and program version you have): CardioPAL SAVI/SAVI AFB-IS Copyright(c) (year) MEDICOMP PROM: XX.XX Alg: XX.XX. When these tests have finished successfully, the monitor displays, Setup Auto Looper? Now, you must select which mode you wish to use. UTM410-09

21 21 Step 6 - Select the Monitoring Mode. For Auto Looper (auto-capture) mode setup, press YES and continue below. Press NO to start the Manual mode setup and skip to page 26...you must use the Manual mode setup if you know ahead of time that the patient will ONLY be using the finger electrode accessory. Note: If the SAVI detects a battery voltage that is not enough to start the procedure, a message is displayed. You ll have to replace the low battery with a new one before the monitor will continue the setup. Auto Looper (Auto-capture) Setup Mode IMPORTANT POINT The finger-electrode attachment may be used with a monitor that has been set up in the auto-capture mode. During the event monitoring period, the patient need only disconnect the patient cable and insert the attachment. The monitor turns off to conserve battery power, and the patient should be instructed to press the Symptom/Record button whenever a symptom is experienced. To switch back to the auto-capture mode, the attachment must be removed and the patient cable reinserted. The monitor display will show, Monitoring, upon start-up of the auto-capture program. Once you have answered YES to the Auto Looper question, the monitor displays the following: Time Zone OK? Eastern Press NO to cycle through the time-zone selections: Eastern, Central, Mountain and Pacific. When you see your time zone, press YES. The SAVI then displays the current date and time, adjusted according to the selected time zone. 12:00 am DST* 01 Jan 2008 If time or date is incorrect, press NO, see page 44 to make changes, and then return to this page to continue. The next option is the Pacemaker selection: Pacemaker Option Off You must turn this option On when your patient has a pacemaker, so that the SAVI recognizes the pacemaker spikes. The default setting is Off. If a pacemaker is present, press the NO button to turn this option On, then press YES to accept. Auto Looper Settings OK? If there are no other settings you wish to change, press YES and turn to page 24 to continue with the Quality tests and patient hookup. Otherwise, press NO and continue on the next page. * DST only appears if Daylight Savings Time might be applicable, and only during setup. CardioPAL SAVI User s Guide

22 22 - EVENT PROCEDURE SETUP After you press NO, the Pacemaker option will appear again. Repeat the sequence of the previous page for this option. The next option is the clinical protocol: Clinical Protocol A clinical protocol should be selected based on the patient's clinical need for the event procedure. The Standard protocol is the default setting and the unit reverts to this setting with the start of each new procedure. The table below provides a description of each protocol: Table 1: Clinical Protocols PROTOCOL Standard Bradycardic Atrial Fib Symptomatic Std Pediatric APPLICATION Average ambulatory patient. (Recommended default protocol) Suspected bradycardic arrhythmias or pacemaker patient with low rate. Chronic atrial fibrillation. Symptomatic Standard Pediatric patients with rhythm irregularities, rate changes, and pauses. Normal sinus rhythm is defined as bpm. Press NO until the appropriate protocol is displayed, then press YES to accept it. The monitor then continues with additional parameters (see next page). UTM410-09

23 23 CardioPAL SAVI Settings for the Auto Looper (Auto-capture) Mode The monitor s programming allows customization of several parameters. As a rule, you press NO to change the setting and YES to accept the setting that is displayed: Override Auto/Manual/Test Storage: Multi Size 60/30 OK? Automatic - automatically accept marginal hookup conditions Manual - ask for acceptance of marginal hookup conditions Test - display actual values of impedance and voltage (for troubleshooting with Medicomp technical support) Storage: Allow storage of multiple strips or only one strip. Pre-Event and Post-Event settings: That is, what amount of time the monitor saves before and after the patient presses the Symptom/Record button...60/30 is the default. Settings are 15, 30, 45, 60, 90, 120 seconds. The Post-Event time also specifies the length of the entire recording when the finger-electrode accessory is used. 08:00:00 AM 01 Jan 2008 OK? Can display time in 12-hour format or 24-hour ( military ) format. Please see page 44 for specific step-by-step instructions on changing the date and time in the monitor. Auto-transmit 11:30am 24Hr OK? This displays the periodic time that the SAVI will automatically remind the patient to call in to the Monitoring Center to transmit strips. The time and frequency can be changed. The frequency settings are (every) 24, 48, 72, 96 hours, and OFF, which means that the patient will not be reminded to transmit at all. The patient is reminded to call in strips only if a clinically-significant event has been captured. Transmit 8:00AM 3X Med Hdr OK? Auto Looper Settings OK? Transmit time: Routine daily call-in time is set to a reasonable, but random time...can be changed here and during the procedure. Transmit Speed: 1X, 2X and 3X. Default is 3X. Transmit Header: Medicomp, Digital, Digital32 or None. Default is Medicomp. You can press YES to continue with patient hookup or NO to go back and make more changes. CardioPAL SAVI User s Guide

24 24 - EVENT PROCEDURE SETUP Quality Hookup Tests The Quality Hookup tests evaluate skin preparation and cable connections. The monitor has a predefined range of values for skin prep and QRS voltage that are considered either acceptable, marginal or unacceptable. If a skin prep or voltage value is acceptable, then the monitor activates and begins the procedure. If one of these values is marginal, then there is a problem, but the monitor is able to activate. If one of these values is unacceptable, the monitor will not activate. The option that is used to define how the monitor handles these conditions is called the Override option. All SAVI event monitors are shipped in the Override - On setting, which allows marginal values to be overridden without any action by you, the operator. If you decide that you do not want this automatic capability, you should contact Medicomp technical support to discuss changing it. One additional Override mode is the Test mode. This mode is reserved for use when working with Medicomp technical support personnel. With the start of the Quality Hookup Tests, the monitor momentarily displays: Testing Leads The monitor is checking for very high resistances that may indicate a breakage somewhere in the cable. If this test passes, the monitor displays: Testing Lead Positions During this test, the monitor is adjusting the signal gain for optimal analysis. After the gain is set appropriately, the unit selects a typical beat. In most cases, the monitor will normally pick a typical beat and continue with the next part of the Quality Hookup Test. However, if the patient has a pacemaker and a paced beat was selected as typical, the monitor displays a massage similar to: QRS Shape: Paced A:Pos Monophasic \ B:Neg Monophasic Accept? See QRS Shape Codes for Typical Beats that are Paced on page 43 for illustrations. Once a QRS shape has been selected, the final part of the tests begins and the monitor displays: Testing Skin Prep The monitor is evaluating the patient's skin prep to minimize signal artifact, thereby obtaining a more accurate analysis. When the monitor displays: Monitoring Date Time...the procedure has begun. The patient is ready to be discharged once stress loops are secured (optional, see page 25), and a baseline transmission has been made. If you encounter any problems with these quality tests, refer to Quality Test Problems in Auto Looper (Auto-Capture) Mode on page 36. UTM410-09

25 25 If you disconnect the patient cable from the monitor, it will display: Please insert patient cable If the cable remains out for at least 2 minutes, then the monitor turns off. When you re-insert the cable, the monitor will turn on, and resume monitoring after checking for good signal characteristics. Two examples of stress loops are shown below. This is a good way to secure lead wires to prevent pulling, thus minimizing noise interference during the event procedure. Fig. 4 Lead Wire Stress Loops Secure the monitor to the patient, allowing for comfort and convenience. Attach the unit to the patient via belt clip or lanyard. Continue on page 28 for instructions on transmitting a baseline strip. CardioPAL SAVI User s Guide

26 26 - EVENT PROCEDURE SETUP Manual Looper / Finger Electrode Mode Setup Press YES when you see, Setup Manual Looper? ; the SAVI displays the following: Time Zone OK? Eastern Press NO to cycle through the time-zone selections: Eastern, Central, Mountain and Pacific. When you see your time zone, press YES. The SAVI then displays the current date and time, adjusted according to the selected time zone. 12:00 am DST* 01 Jan 2005 If time or date is incorrect, press NO, see page 44 to make changes, and then return to this page to continue. The next option is the Pacemaker selection: Pacemaker Option Off/On This option is used when the patient you are setting up for the event procedure has a pacemaker. You must turn this option on so that the SAVI recognizes and identifies the pacemaker spikes. The default setting is Off. If your patient has a pacemaker, press the NO button to turn this option On, then press YES to accept. Manual Looper Settings OK? If there are no other settings you wish to change, press YES, and the monitor will display, Manual Looper Setup Complete. Otherwise, press NO and turn to page 28 for additional manual settings. * DST only appears if Daylight Savings Time might be applicable. UTM410-09

27 27 While the patient is wearing the monitor in the Manual Looper mode, the display shows: Ready Jan 01 12:00 AM If the patient disconnects the patient cable from the monitor, it will display: Please insert patient cable If the cable remains out for at least 2 minutes, then the monitor turns off. When cable is re-inserted, the monitor will turn on again. Finger-Electrode Procedures For patients who are using the monitor with the finger-electrode attachment, the monitor should be placed in an area that is convenient and easy to access for those times when symptoms occur. IMPORTANT POINT The finger-electrode attachment may be used with a monitor that has been set up in the auto-capture mode. During the event monitoring period, the patient need only disconnect the patient cable and insert the attachment. The monitor will turn off to conserve battery power, and the patient should be instructed to press the Symptom/Record button whenever a symptom is experienced. To switch back to the autocapture mode, the attachment must be removed and the patient cable reinserted. The monitor display will show, Monitoring, upon start-up of the auto-capture program. CardioPAL SAVI User s Guide

28 28 - EVENT PROCEDURE SETUP CardioPAL SAVI Settings for the Manual Looper Mode The monitor s programming allows customization of several parameters. When you select NO to the question, Manual Looper Settings OK?, the following stepwise options will appear. Refer to the text on the right hand side of the table to help you make your choices: Pacemaker Option Off/On Verify the option you selected previously (page 26). Storage: Multi Size 60/30 OK? Storage: Allow storage of multiple strips or only one strip. Pre-Event and Post-Event settings: That is, what amount of time the monitor saves before and after the patient presses the Symptom/Record button...60/30 is the default. Settings are 15, 30, 45, 60, 90, 120 seconds. The Post-Event time also specifies the length of the entire recording when the finger-electrode accessory is used. 08:00:00 AM 01 Jan 2008 OK? Can display time in 12-hour format or 24-hour ( military ) format. Please see page 44 for specific step-by-step instructions on changing the date and time in the monitor. Transmit 3X Dig Hdr OK? Transmit Speed: 1X, 2X and 3X. Default is 3X. Transmit Header: Digital or None. Default is Digital. Manual Looper Settings OK? You can press YES to continue with patient hookup or NO to go back and make more changes. If you pressed YES to Manual Looper Settings OK?, then the monitor displays, Manual Looper Setup Complete for approximately 5 seconds, then turns off to conserve power. Transmitting a Baseline Strip It is recommended that you transmit a test strip after the hookup is complete. In this way, the signal can be checked and any appropriate changes made before beginning the recording period. Wait at least one minute after connecting the patient before you start a recording, to allow time for the looping memory to fill. Continue on page 29 with ECG Transmission. Number of Strips Stored The number of strips the event monitor stores depends on the length of each strip. To determine the number of strips that the unit will store, divide 1200 seconds (20 minutes) by the total strip length (in seconds). This number is independent of any auto-capture recordings. UTM410-09

29 ECG TRANSMISSION 29 The Transmission mode allows the recorded ECG strips to be sent to a monitoring center using a telephone (phones using land-lines are preferred to portable phones). When the patient presses the YES/SEND button, the monitor emits a tone and then transmits all the ECG strips in memory. Patients must use land-line phones to transmit their recordings, instead of cordless or cellular phones. IMPORTANT POINT Once transmission has begun, the unit ignores any Symptom/Record button presses and any cable changes. Instructions for the Patient The patient should try to transmit the ECG data after every recording session. However, because the monitor can store multiple strips, the patient can transmit at a more convenient time. The monitor will remind the patient to transmit by showing an alternating Time to Call message with the Time/Date display. To transmit the ECG, the patient should follow these five steps: 1. Call the Monitoring Center and follow the directions given. Be prepared to provide name and symptoms to the technician handling the call. 2. Grasp the connector end of the patient cable and gently but firmly pull the cable straight out of the monitor. 3. Stand the monitor up (connector-end up) on a flat surface near the telephone. DO NOT ATTEMPT TO HOLD THE MONITOR AND/OR PHONE WHILE TRANSMITTING YOUR STRIPS. 4. Place the handset of the phone on the same surface so that the mouthpiece is directly behind, but not touching the monitor. This will minimize transmission interruption. If possible, transmit in a quiet environment, and try not to disturb the monitor while the transmission is taking place. 5. Press and release the YES(/SEND) button to begin transmitting the ECG. During transmission the monitor emits a series of tones. When the tones stop, transmission is complete and it is safe to move the monitor. Pick up the phone and verify with the monitoring center technician that your recordings were transmitted correctly. CardioPAL SAVI User s Guide

30 30 - ECG TRANSMISSION Re-Transmitting Strips If necessary, the patient can re-transmit ECG strips. If the patient presses the YES(/SEND) button and there are no new strips to send, the monitor displays, All data sent, resend old data? The following selections are available: Last transmitted Last 24 hours Last 48 hours All None (cancels the transmission operation altogether) Use 2nd channel If 2nd channel is selected, the original set of items is cycled through on the display again. This option enables transmission of the second channel of ECG data (if both cable and monitor are configured to allow this). Last transmitted Last 24 hours Last 48 hours All None (cancels the transmission operation altogether) Recording Format Pre-Event Memory Not Full There may be times when the patient (feeling a symptom) presses the Symptom/Record button very soon after the patient cable has been plugged into the device. In this situation, the monitor may not have had enough time to record all of the pre-event ECG. When this occurs, the resultant ECG strip will contain square waves during the time that the ECG is missing. If the patient presses the Symptom/Record button very soon after pressing it the first time, the second strip s pre-event ECG may contain ECG that was also in the first strip. The technician in the Cardiac Monitoring Center should recognize this condition by noting that the times of the two strips are very close to one another. UTM410-09

31 MAINTENANCE 31 Please take special note of the recommendations listed below: When the monitor needs cleaning, use a solution containing a minimum of 70% isopropyl alcohol on the outside cover of the monitor only. Do not use a super-saturated cloth, as the liquid may seep down inside the case. When the monitor requires disinfecting, it is recommended that Sporicidin be used. Do not use a super-saturated cloth, as the liquid may seep down inside the case. Disconnect the cable from the monitor before cleaning and disinfecting it. Once disconnected, use a cloth moistened with soap and water or hospital-grade disinfecting solution to clean the cable. CAUTION Do not submerge the monitor in any liquid. Equipment that has been penetrated by liquid or foreign matter MUST be cleaned and checked by a Service specialist before it is used again. DO NOT return the SAVI for service until the following steps have been taken: 1. Seal the unit in a bag marked for contaminated equipment. 2. Call the service department for advice. CardioPAL SAVI User s Guide

32 32 - MAINTENANCE Replacing and Loading the Alkaline Battery The location of the battery compartment and battery replacement vary depending upon the model of SAVI monitor you have. Please refer to the appropriate illustrations for your monitor type: Variation 1 1. Use your fingernail or a coin to push the latch in the direction of the inscribed arrow and unlock the battery door. 2. Open the door and tilt the monitor so that the old battery slides out. 3. Insert the new battery, with the bump facing out. 4. Close the battery door and push the latch back to the locked position. If the unit is left idle for several minutes, it will turn off to conserve power, and the display will go blank. For detailed specifications, see page 34. Variation 2 1. Use your fingers to push the battery compartment cover in the direction of the inscribed arrow; remove the cover. 2. Pull up on the ribbon to pop the old battery out. Replace the ribbon on the bottom of the compartment, making sure it extends outward from the monitor. 3. Using the picture inside the compartment as your guide, insert the new battery over the ribbon and tuck the remainder of the ribbon into the compartment. 4. Align the cover to the compartment and slide it firmly back into position. For detailed specifications, see page 34. UTM410-09

33 MARKINGS and SAFETY 33 Explanation of Markings Equipment markings and caution labels are important for safe and reliable use; they must not be removed. This symbol informs the user that additional safety information is available. Refer to the Safety section of the manual. The SAVI (PM410) is an ANSI/AAMI EC38 Type 3 Device. Safety Intended use: This equipment has been designed and supplied specifically for patient-activated monitoring of electrocardiograms. It shall not be used for any other purposes. The equipment shall not be used for direct cardiac application. The equipment is safe for use by untrained personnel. Safety Classification: In accordance with IEC601-1, 1998, and Amendments 1 and 2: This equipment is designed to be operated with one AA battery, and under no circumstances shall power be supplied in any other manner. Type BF equipment. Rated for Continuous Operation. Ordinary Equipment. Enclosed equipment without protection against ingress of liquid. This equipment shall not be used in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide, or flammable cleaning agents. Equipment with an Applied Part, specifically designed for applications where a Conductive Connection is made to the Patient, but not directly to the heart. The equipment requires no adjustment. The equipment contains no user-serviceable parts. It shall be serviced only by Medicomp, Inc. Unauthorized repairs of the equipment will void the warranty. Modifications For continued safety, equipment should not be modified in any manner and must be used only as indicated. Defibrillation Type BF equipment: equipment with isolated patient connections, connections not defibrillation-proof. The external parts of the equipment may provide a source of the defibrillation voltage if it is not removed from the patient during defibrillation. Due to the small size of the unit and patient connectors, the cable or connector may break down and cause the defibrillation voltage to be shunted and make it less effective for the patient. The unit and cable MUST be removed prior to defibrillation. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE OR USE BY OR ON THE ORDER OF A LICENSED PHYSICIAN. CardioPAL SAVI User s Guide

34 34 - SPECIFICATIONS SPECIFICATIONS Electrical Bandwidth: Dynamic Range: Digitizing Resolution: Sampling Rate: 0.05 Hz to 40 Hz (-3dB) +/- 5mV 12 bits (2.4uV RTI/bit) 250 samples/second Battery: 1.5V DC (one 1.5V AA cell) Storage Solid State Physical Height: 2 inches (5.1 cm) Length: 3.2 inches (8.1 cm) Width: 0.8 inches (2.0 cm) Weight: 3.7 oz, with battery (105 g) User Interface: 2-line, 32-character LCD 3 interactive buttons audible beeper I/O Ports 10-pin D female connector: provides interface to patient cable only or USB (to base computer) only Environmental Operating Temperature: 0 C (32 F) to 45 C (113 F) Operating Humidity: 10% to 95% relative, non-condensing Storage Temperature: -20 C (-4 F) to 55 C (131 F) Storage Humidity: 10% to 95% relative, non-condensing UTM410-09

35 CARDIOPAL SAVI SETUP DETAILS and TROUBLESHOOTING 35 This section helps you resolve any problems you may encounter while you are setting up the SAVI in the Auto Looper (Auto-capture) mode. You can reduce the likelihood of seeing errors by making sure you are using fresh electrodes, the cable is in good condition and securely connected, and you have taken care to perform the recommended skin preparation. Some problems are unavoidable due to a patient's particular heart condition or the unexpected failure of a component. However, these cases are infrequently encountered. When the SAVI is connected to the patient and begins its startup sequence, it assesses the quality of the ECG signal. The monitor is informing you if there is a problem with the connections or if the signal voltage is too high or too low for ideal auto-capturing. Messages on the monitor s display try to help you make any necessary corrections. However, because there are physiological variations between patients, e.g. skin quality, heart orientation and chest anatomy, it may not be possible to set the unit up in the Auto Looper mode. In these situations, and only after every attempt has been made to correct the problem, you can decide to switch the unit to the Manual Looper mode. The SAVI will then function as a traditional event recorder. CardioPAL SAVI User s Guide

36 36 - Quality Test Problems in Auto Looper (Auto-Capture) Mode Quality Test Problems in Auto Looper (Auto-Capture) Mode During patient hookup, the CardioPAL SAVI tests for cable breakage, and checks that its minimal requirements for skin prep and signal voltage are met. These tests might last only a few seconds or may take longer, depending on what the monitor detects. The monitor s objective is to make sure that it receives a good signal. This ensures optimal auto-capturing and good report results. Error Displays You will see three different types of displays on the SAVI when quality testing is done. They are listed below and performed in the same sequence: Testing Leads Testing Lead Positions Testing Skin Prep IMPORTANT POINTS With very few exceptions, only errors seen during Testing Lead Positions require that electrodes be relocated on the patient s chest. Most of the time, errors seen during Testing Leads and Testing Skin Prep require re-prepping or equipment changes. Each time you make a change to correct a problem, you will need to press the YES button to have the monitor continue testing. The SAVI can be switched to the Manual Looper mode if you encounter setup problems that you cannot resolve, even after several attempts. The unit will then function as a traditional event recorder. You will not be able to set up patients who are wearing neurostimulating devices. The operation of these devices interferes with the monitor s ability to acquire the ECG signal. If allowed, these devices should be turned off while the patient is wearing the monitor. UTM410-09

37 Testing Leads 37 Lead errors occur when the SAVI detects a very high resistance that may be caused by one or more of the following conditions: 1. Very poor skin preparation. Skin prep has been done incorrectly or not at all; the monitor reads the high resistance as a lead wire or cable problem. 2. Poor electrode contact with the skin. 3. Internal breakage in the patient cable. When an error occurs during Testing Leads, the monitor displays a message similar to (This is an example of a problem at the Red electrode site): Lead Error, check Red* The other abbreviated color codes are: Wht = White electrode site (A-) Brn = Brown electrode site (B+) Blk = Black electrode site (B-) Grn = Ground electrode site (G) *Note: For lead configurations with a Ground electrode, the monitor determines the resistance of all electrode sites using this electrode, so this site is always tested for good values first. If your displays shows Check G, then you must correct this before you proceed. Skip directly to the solutions for skin prep or electrode problems on the next page. First, determine whether the problem is with the wire cable. Unsnap two lead wires and switch them on the chest. Press the YES button and watch the display. If the monitor continues to display the same message, then the problem lies in the cable. If the monitor displays, Lead Error check (new site), then the problem is with the skin prep or electrode at the original electrode site that displayed the problem. To correct a skin prep or electrode problem: 1. The skin resistance may be so high that the SAVI sees the error as a cable problem. If you have not done so already, thoroughly wash the site with PLAIN (no lotion or oil) soap and water. Apply a small amount (about the size of the tip of a cotton swab) of NuPrep gel to a paper towel and firmly rub it into the skin at the gel cup site. Wipe off the excess gel. Always apply a new electrode to the site. In difficult cases, light abrasion with a scrub pad may also be required; this may occur with patients who have very oily skin. 2. Electrode contact with the skin is poor. a) Press down on the center snap of the electrode and press the YES button on the monitor. If the SAVI proceeds through to Testing Lead Positions, then change the electrode, this time assuring good contact. b) Check the expiration date on the electrodes. Inspect the electrode(s) in question to verify moist gel cups. If the gel is dry, you will need to replace the electrode. (You may want to check and track the lot number of the electrodes because an entire package or box may be faulty.) To correct a cable problem: Change the cable. When the problem is corrected the error message will disappear from the display. Return the lead wires to their original locations. The monitor will begin to test for adequate signal voltage. (See next page.) CardioPAL SAVI User s Guide

38 38 - Quality Test Problems in Auto Looper (Auto-Capture) Mode Testing Lead Positions Although the CardioPAL SAVI automatically adjusts the signal size (voltage) to ensure optimal analysis, some patients may have cardiac anomalies that result in unacceptable signal voltage. The signal may be too large or too small. Low Voltage in Channel A (red [A+]/white [A-] electrode pair) Sometimes, just having the patient lean back in a chair will increase the ECG voltage. In the Automatic Override mode, the monitor s message for this error is: Low: A Move Red First, move the red electrode as indicated by the arrow. After repositioning, press YES. If the monitor continues to display the error, try an electrode location on the opposite side of the red (A+) electrode pictured. Don t try more than a few different locations. If you continue to have problems, see page 40 for help with troubleshooting. Low Voltage in Channel B (if present) (brown [B+]/black [B-] electrode pair Channel B in AFB monitors is comprised of the black [B-]/red [B+] electrode pair; see page 38 for resolving this error with AFB units. Sometimes, just having the patient lean back in a chair will increase the ECG voltage. In the Automatic Override mode, the monitor s message for this error is: Low: B Move Brn (A quick fix for low signal in Channel B that sometimes works: Unsnap the brown and green lead wires from the electrodes and switch them. If this works, make a note of it in the Patient Chart.) Don t try more than a few different locations. If you continue to have problems, see page 40 for help with troubleshooting. Move the brown electrode as pictured. After repositioning, press YES. If the monitor continues to display the error, see page 40 for help with troubleshooting. UTM410-09

39 39 In the Automatic Override mode, the AFB monitor s message for a low voltage in Channel B is: Low: B Move Blk First, move the black electrode as indicated by the arrow. After repositioning, press YES. If the monitor continues to display the error, try an electrode location on the opposite side of the Black (B-) electrode pictured. B- A- A+ B+ Don t try more than a few different locations. If you continue to have problems, see page 40 for help with troubleshooting. Move the black electrode as pictured. After repositioning, press YES. If the monitor continues to display the error, see page 40 for help with troubleshooting. High Voltage in Channel A (red [A+]/white [A-] electrode pair) In the Automatic Override mode, the monitor s message for this error is: High: A Move Red First, move the red electrode to the location of the black circle in the picture. After repositioning, press YES. If the monitor continues to display the error, try moving the electrode to a location halfway to the brown electrode, but under the left breast. Don t try more than a few different locations. If you continue to have problems,see page 40 for help with troubleshooting. High Voltage in Channel B (if present) (brown [B+]/black [B-] electrode pair) Channel B in AFB monitors is comprised of the black [B-]/red [B+] electrode pair; see page 40 for resolving this error with AFB units. In the Automatic Override mode, the monitor s message for this error is: High: B Move Brn Move the brown electrode to the location indicated by the black circle in the figure. After repositioning, press YES. If the monitor continues to display the error, move the brown electrode halfway to the red electrode. Don t try more than a few different locations. If you continue to have problems, see page 40 for help with troubleshooting. CardioPAL SAVI User s Guide

40 40 - Quality Test Problems in Auto Looper (Auto-Capture) Mode In the Automatic Override mode, the AFB monitor s message for a high voltage in Channel B is: Low: B Move Blk First, move the black electrode as indicated by the arrow. After repositioning, press YES. If the monitor continues to display the error, try an electrode location on the opposite side of the Black (B-) electrode pictured. B- A- A+ B+ Don t try more than a few different locations. If you continue to have problems, see page 40 for help with troubleshooting. Move the black electrode as pictured. After repositioning, press YES. If the monitor continues to display the error, see page 40 for help with troubleshooting. Voltage Errors that Cannot be Resolved after Several Attempts If you have inadequate signal voltage (can be either low or high) in one channel while the other one is okay, you can place the electrodes in a parallel, or side-by-side lead arrangement. Identify the channel that has the acceptable voltage and place the electrodes of the problem channel side-by-side with it. For example: Channel A good, Channel B bad - place Black electrode next to White and Brown next to Red. You will then have the black and white electrodes on the right upper chest, and the brown and red electrodes underneath the left breast. Channel B good, Channel A bad - place White next to Black and Red next to Brown. You will then have the black and white electrodes on the left upper chest electrodes, and the red electrode as close as possible to the location of the brown electrode that is (usually) over the sternum. UTM410-09

41 Testing Skin Prep 41 When the SAVI displays a message similar to the following, it has detected an unacceptable skin resistance at the electrode sites indicated by the abbreviated color codes. In the example figure below, the red electrode site has been identified as having a high resistance. To resolve the prep error, refer to #1 and #2 in the list on page 37. Bad prep, retry? The other abbreviated color codes are: Wht = White Lead (A-) Brn = Brown Lead (B+) Blk = Black Lead (B-) Grn = Ground Once the skin prep error is resolved, the monitor will repeat the skin prep test. In the Manual Override mode: When the SAVI displays a message similar to the following, it has detected a poor skin resistance at the electrode sites indicated by the abbreviated color codes that may be overridden. In the example figure below, the red electrode site has been identified as having a high resistance: Marg prep, Use? Red The other abbreviated color codes are: Wht = White Lead (A-) Brn = Brown Lead (B+) Blk = Black Lead (B-) Grn = Ground If you want the monitor to accept the marginal skin prep, press YES to override. To decrease artifact during analysis, it is recommended that you resolve the prep error (see list on page 37) rather than accept the override. After you have corrected the problem, press NO to reject the override. The monitor will repeat the test and complete the hookup sequence if an acceptable value is found. Continue on page 24. CardioPAL SAVI User s Guide

42 42 - Quality Test Problems in Auto Looper (Auto-Capture) Mode CardioPAL SAVI Setup Quality-Test Modes When setting up the SAVI for Auto Looper (auto-capture) operation, you have three test modes to choose from: AUTOMATIC: A SAVI operating in this mode accepts marginal skin prep and voltage values that are detected during patient setup; this is the default status of all SAVI event monitors from the factory. MANUAL: A SAVI operating in this mode displays and asks for acceptance of marginal values; if you decide not to accept marginal values, then changes in skin prep or lead positions need to be made before the SAVI can begin the procedure. TEST: A SAVI operating in this mode displays actual values of skin resistance and voltage so that when you make skin prep or lead position changes, you can see the effects of your changes. In the manual and test modes, you will see additional displays when the SAVI finds an acceptable ECG signal. The following pages contain illustrations of the signals with their descriptive text label. These text displays appear after the quality checks have been completed and the monitor is ready to be the procedure. QRS Shape Codes for Typical Beats that are Intrinsic When an intrinsic beat is detected, the CardioPAL SAVI displays the following text labels to describe the deflection and shape of the beat: Pos Monophasic Pos Diphasic Pos Notched Neg Monophasic Neg Diphasic Neg Notched Fig. 3 QRS Shapes - Intrinsic (Nonpaced) When a shape code is displayed, the SAVI is actually prompting you for acceptance of the code, so pressing YES will then trigger the monitor to begin the event procedure. UTM410-09