available 24 hours a day - medicomp inc. · 5 simply put, savi air is a heart monitor that measures...

Patient User Manual

877-996-5553Available 24 hours a day

SAVI AirWireless Event Monitor

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This monitor is a diagnostic tool. If you are experiencing distress, or feel you need immediate medical attention, call 911.

Continue to use the monitor during this time until instructed otherwise by a medical professional.

You may call the Medicomp Cardiac Monitoring Center with questions any time during the process of hooking up your monitor and during your procedure.

We’re here to help you 24 hours a day, everyday.

Call 877-996-5553

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This Patient User Manual will walk you through each step of hooking up the SAVI Air monitor for your heart monitoring procedure, as prescribed by your physician. You will see detailed explanations as well as photographs to assist you in becoming familiar with each of the components in your monitor kit.

Some icons you will see as you review this manual:

Symbol indicates good information to know that aids in a successful procedure.

Symbol indicates a point to be taken into consideration to ensure the safe and effective operation of the equipment and accessories.

Symbol indicates information that could affect test results or other medically important information.

How to use this Guide

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Table of Contents

What is SAVI Air? ........................................... 5

What This Monitor Does ............................... 6

Kit Contents ................................................... 8

Monitor Diagram ............................................ 9

Smartphone ................................................ 9

Pendant .................................................... 10

Getting Started ............................................ 11

Setting Up Your Monitor ............................ 11

Step 1 – Preparing Your Skin ..................... 12

Step 2 – Applying Electrode Patches ......... 13

Step 3 – Starting the Pendant ................... 14

Step 4 – Starting the Smartphone ............. 15

During Your Procedure ............................... 18

Recording and Sending Your Symptoms ... 18

Diary Entries .............................................. 19

Wearing Your Monitor ................................ 24

Charging the Smartphone ......................... 26

Replacing Pendant Batteries ..................... 26

Extra Supplies ........................................... 28

Skin Irritation ............................................. 28

After Your Procedure ................................... 29

Frequently Asked Questions ...................... 31

Troubleshooting ........................................... 36

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Simply put, SAVI Air is a heart monitor that measures the electrical activity of your heart to determine if any cardiac irregularities exist.

Specifically, SAVI Air is a type of ambulatory cardiac monitor called an event monitor: it records “events” – periods of possible abnormal heart activity. Events are recorded either manually when you press a button or automatically when the device’s artificial intelligence determines a possible arrhythmia has occurred. These recordings are wirelessly sent to Medicomp’s Cardiac Monitoring Center (CMC) for analysis by highly trained, certified cardiac technicians, who, in turn, create reports for your doctor to interpret.

Due to the patented, highly advanced artificial intelligence in our monitors, Medicomp has been shown to deliver more clinically significant data to your doctor faster than any other event monitor available today.

To provide your doctor with the best data to evaluate your cardiac health, it is important that you use the monitor properly and for the prescribed length of time. Please read this document thoroughly. Call us if you have any questions: 877-996-5553.

What is SAVI Air?

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Pendant The SAVI Air Pendant records and transmits your heart’s ECG data to the Smartphone via Bluetooth technology. If you are wearing the Pendant and are away from the Smartphone, ECG data is still recorded and stored. Once you are within range of the Smartphone again (approximately 10 feet), the data will be transmitted to the CMC.

Smartphone The Medicomp Smartphone receives ECG data from the Pendant via Bluetooth technology, analyzes it for potential arrhythmias using our patented advanced algorithm, and then transmits the data to the CMC. The Smartphone can store up to 30 days of data.

Illustration of process

What This Monitor Does

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About Bluetooth Bluetooth is a wireless technology that enables the Pendant and the Smartphone to communicate with each other. For this communication to take place, both the Pendant and Smartphone must be powered on and remain within 10 feet of each other.

About Cellular Transmission The Smartphone sends data to Medicomp’s Cardiac Monitoring Center (CMC) via the cellular network. The Smartphone must be in an area with cellular coverage to transmit. If you travel outside an area of cellular coverage, the Smartphone will not be able to send data to the CMC. It will store the data until you are in a coverage area again, and then it will transmit. If, during your prescribed monitoring period, you will be outside cellular coverage areas the majority of the time, you should talk to your doctor about using a transtelephonic event monitor instead, such as Medicomp’s CardioPAL SAVI. A transtelephonic monitor (TTM) sends data via a landline telephone.

About the CMC Your heart’s recorded ECG data is sent to one of multiple Medicomp Cardiac Monitoring Centers, where it is analyzed by highly trained, certified cardiac technicians, and compiled into reports sent to your doctor for interpretation. Our CMCs are open 24 hours a day, everyday of the year.

What This Monitor Does

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The SAVI Air kit contains the following:

Quick Start Patient Guide

Kit Contents

SAVI Air Pendant with patient cable

Medicomp Smartphone and case

Skin prep pads Electrode patches “AA” Batteries

Pendant belt clip Smartphone charger Pendant lanyardPostage paid

return envelopePatient Survey & Return checklist

SAVI Air Patient Education DVD

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The display screen on the Smartphone will “go to sleep” and appear blank to save battery life. When this occurs the Pendant and Smartphone are still gathering and transmitting data. Simply press any key on the Smartphone to “wake up” the screen.

Monitor Diagram

Smartphone

Charger Plug-in

Right Soft Key

Back Key

Select Key

Left Soft Key

Power (On/Off)Button

Directional ArrowsUp, Down, Left, Right

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Try to keep the Pendant and the Smartphone within 10 feet of each other.

Lanyard Hookup

Record/SendButton

Patient Cable Plug-in

On/OffButton

Monitor Diagram

Pendant

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Setting Up Your MonitorIf you were hooked up in your doctor’s office or hospital, the medical staff probably set up the monitor, and then had you leave once it was operating properly. If you need to confirm that the monitor is setup and working properly, please call the phone number on the back of your monitor and ask. If something is not working properly, a Medicomp technician will be able to help you.

If you received your monitor in the mail, this user manual along with the DVD included in your monitor kit will help you get set up. You may watch the DVD in a DVD player and on most computers. If you need assistance, please call 877-996-5553.

Getting Started

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Left

Left

Right

Right

Getting Started

Step 1 – Preparing Your SkinTake care in preparing your skin for application of the adhesive skin patches (electrodes). Good skin preparation means better ECG signal traces that, in turn, are easier for the doctor to review and evaluate.

1. Using the illustration to the right as a guide, choose areas of the chest that are flat and not very muscular. Avoid skin folds or creases, irritated skin and scars.

2. Shave areas with hair using the skin patch (electrode) as a guide for the size of the area to shave. This insures good contact and makes electrode removal easier.

3. Wash each site well with PLAIN soap and water and dry thoroughly. You should not use soap that contains lotion or oil.

4. Use the Electrode Prep Pad the first time you affix the electrodes to remove oils and assist with prepping the skin. Let dry.

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Getting Started

Step 2 – Applying the Electrode Patches1. Snap the wires onto the electrodes while they are

still attached to the strip of plastic backing.

2. One by one, peel each electrode from the backing and apply it to the chest, using the placement in the illustrations and being mindful of where the white, red and black electrodes should be placed.

3. Remember, White on Right when applying electrodes. This will help you remember to always place the white electrode on the upper right side of your chest.

4. Please review the DVD and Patient User Manual for details on electrode placement.

Minor skin irritation is normal while wearing electrode patches. But if you experience excessive irritation that may interrupt your procedure, please call us for assistance at 877-996-5553.

Change the electrode patches every two days. When re-applied, change their location slightly to prevent skin irritation.

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Step 3 – Starting the Pendant 1. Insert a fresh battery into the Pendant as pictured on

the right. Pendant batteries need to be changed about every 1½ to 2 days.

Getting Started

Pendant (Pd) and Smartphone (SP) battery percentages are found on the main screen of the Smartphone.

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2. Press and hold the On/Off button on the side of the Pendant until you see the device lights blink and hear a three-tone chirp.

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Step 4 – Starting the Smartphone1. Turn on the Smartphone by pressing and releasing the POWER button

located on the upper left side.2. Wait for the Smartphone to run through its initialization process until the

main screen appears (middle image below). This may take a few minutes.3. Press the Left Soft Key on the Smartphone under Start Procedure. A

list of Patient Preparation instructions will appear, which you can skip if already completed.

4. Press the Left Soft Key under OK.

Getting Started

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Step 4 – Starting the Smartphone, continued5. If you have a pacemaker, please follow the instructions

below. If not, skip to number 6 below.

a. Press the Right Soft Key under Change Settings. The Settings menu pops up in the lower-right portion of the display.

b. Press the Select Key to choose the Pacemaker option.

c. Press the Down Arrow Key to highlight Yes, and then press the Select Key. The menu disappears, and the screen will show Patient has Pacemaker = Yes.

6. Press the Left Soft Key under Accept Settings to continue. A busy indicator may appear while the Smartphone finishes initializing and acquires your ECG signal. Example displays are shown to the right.

Getting Started

If you are connecting a child, please call us at 877-996-5553 for assistance.

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Step 4 – Starting the Smartphone, continuedWhen the Smartphone has recognized your ECG, the ECG waveform will disappear and the screen will display Monitoring.

Your wireless event procedure is now running. Wear the Pendant and Smartphone where you are able to quickly and easily access one of the Record/Send buttons on either device. Protect both devices from perspiration and moisture.

Getting Started

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Recording and Sending Your SymptomsWhen you experience symptoms that concern you, you will need to manually make recordings of your heart’s activity.

There are two options to record a symptom with SAVI Air:

Option 1: On the Pendant – Pressing the Record/Send button on the Pendant.

Option 2: On the Smartphone – Pressing the Left Soft Key under Record/Send on the Smartphone.

Either option will initiate Recording in Progress and the Smartphone’s display will show a progress bar. Now, make your diary entry.

During Your Procedure

If you believe you’re having a medical emergency, call 911. Continue to wear the monitor until advised by a medical professional.

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Diary EntriesIt is important for your doctor to know the symptom you felt, your location and what activity you were doing each time you make a manual recording.

In addition to the manual recordings you make, SAVI Air will make recordings automatically without your intervention whenever its advanced artificial intelligence determines a cardiac event is occurring, which means it will catch possible abnormal heart activity even when you don’t feel symptoms. That’s why it’s important to always wear the monitor and keep it powered on – even while you sleep.


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There are two methods for making diary entries with this monitoring system:

Method 1: Select Options – Manually selecting options from lists on the Smartphone.

Method 2: Audio Diary – Verbally record the information in your voice into the Smartphone.


Diary entries can only be made while Recording in Progress is displayed on the Smartphone.

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Method 1: Select Options1. While Recording in Progress is displayed on the Smartphone, press the

Left Soft Key under Diary.

2. Press the Left Soft Key under Select Options.

3. Press the Select key to display a list of symptoms from which to choose.

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Method 1: Select Options (continued)4. Use the Up Arrow and Down Arrow keys to move through the list. Press

the Select key when the desired symptom is highlighted

5. Repeat these steps to enter your Location and Activity.

6. When finished, press the Left Soft Key under Save. The Recording or Monitoring display will return.


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Method 2: Audio DiaryYou also have the option to make a voice recording as your diary entry.

1. Press the Left Soft Key under Diary.

2. Press the Right Soft Key under Audio Diary (right top image), and then follow the on-screen instructions.

3. Speak clearly and slowly into the phone. Hold the phone in the same manner you would if you were placing a phone call. Please remember to briefly describe your symptom, location and activity in a slow, clear voice. For example: “Skipped heartbeat. At home. Watching TV.”

4. When you have finished your voice recording, press the Left Soft Key under Done.


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Wearing Your Monitor

Wearing the Pendant

You may wear the Pendant around your neck using the lanyard or on your belt or clothing using the belt clip.

You should wear the Pendant with the electrodes hooked up to you as much as possible during the length of your procedure, including when you sleep and during your regular daily activities (that do not involve being in water) such as working, exercising, sexual activity, etc. But always follow your doctor’s instructions.

Avoid getting the Pendant wet. Therefore, DO NOT wear it while bathing, swimming, etc. Wear the Pendant above a layer of clothing to avoid perspiration on the device.

As much as possible, keep the Pendant and Smartphone powered on and within 10 feet of each other.


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Bathing/Showering Before you shower or bathe, unsnap the wires from your chest patches (electrodes).You may leave the patches on your chest, but avoid applying water or soap directly to them if you do not plan on changing them. If you do plan on changing them, wetting the electrode patches may make them easier to remove.

Sleeping Some suggestions for sleeping:

• Wear the Pendant on the waistband of your night clothing

• Place the Pendant beside you with the wires extended as much as possible so that you don’t roll over the unit

• Wear a shirt with a breast pocket, and place the Pendant in the pocket

Wearing the Smartphone The Smartphone may be kept in a pocket or purse, or you may clip it to your belt or waistband using the belt clip case included in your monitor kit. Around the house, keep it on a nearby table. While sleeping, set it on a bedside night stand. As much as possible, keep the Pendant and Smartphone within 10 feet of each other so that they may communicate.


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Charging the SmartphoneThe Smartphone will display the battery life of both the Smartphone (SP Batt) and the Pendant (Pd Batt). The Smartphone must be kept charged to continue receiving ECG information from the Pendant as well as transmitting that data to the CMC.

To charge your Smartphone, connect the charging cable to the charger plug-in port on the Smartphone and to a standard electrical outlet. Make sure the electrical outlet is not controlled by a light switch. A red indicator light should show on the top of the Smartphone while charging. It is recommended to charge the Smartphone daily.

Charging on a night stand while you sleep is a good practice.

Replacing Pendant BatteriesThe Pendant uses one “AA” alkaline battery that needs to be replaced periodically. The Smartphone will alert you when the Pendant’s battery needs to be changed. Also, the Pendant will beep periodically when it’s time to change the battery.


Smartphone Charger

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Replacing Pendant Batteries (continued)1. First, turn off the Pendant by holding the On/Off button until you

hear three solid tones.

2. Press down and push the battery door in the direction of the embossed arrows on the case.

3. Slide the battery door off the body of the Pendant, and then pull up on the black ribbon to pop out the old battery. (Alkaline batteries can be safely disposed of with normal household waste.)

4. Push the flat, negative (“-”) end of a fresh “AA” battery into the compartment against the spring end first (as pictured). Then, place the positive (“+”) end of the battery over the ribbon and push that end down into the compartment securely.

5. Close the battery compartment by aligning the door in the grooves on each side of the compartment. Slide the door toward the housing. The door will be secured when you hear a clicking sound.

Always turn the Pendant OFF before removing the battery. Failure to do so may cause loss of ECG data. Use only standard “AA” alkaline batteries in the Pendant. DO NOT use rechargeable batteries, which can damage the device.


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Extra Supplies

Your kit contains a supply of electrodes and “AA” batteries to last for the duration of your procedure when changing the electrodes every other day and the Pendant battery every 1½ to 2 days. If you find that you are changing them more frequently contact us at 877-996-5553

If anything happens to other accessories in your kit (belt clip, wires, etc.), please let us know as soon as possible.

Skin Irritation

Medicomp supplies only hypoallergenic electrode patches. Some irritation from wearing any electrodes for an extended period of time is normal. When changing the electrodes, move their location slightly to help prevent irritation.

Excessive irritation is not common. Should you experience irritation that may interrupt your procedure, please let us know as soon as possible.


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Returning the Monitor

On the 30th day after starting your procedure, the Smartphone will alert you that your procedure is complete and to return the monitor.

If your doctor prescribed your procedure for fewer than 30 days or if a replacement monitor was sent to you during your procedure, the Smartphone will not alert you when it’s time to return it. You may, however, receive an automated phone call letting you know that your procedure is complete and to return the monitor.

Please follow these steps:

1. Turn off the Pendant and remove the “AA” battery. Dispose of used batteries.

2. Turn the Smartphone off by pressing and holding the Power button until it shuts down.

3. Fill out the blue Patient Survey form.

4. Place the Pendant, Smartphone, accessories, patient survey, and all unused supplies into the kit, and then zip it securely.

5. Place the whole kit in the prepaid return envelope (located in the zippered pouch in the lid of the kit) and mail it back. No postage is necessary. It may be placed in a U.S. mailbox or given to a U.S. Postal carrier.

After Your Procedure

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Reminder Calls

As your procedure end date nears you may hear from Medicomp.

• Three days prior to the end of your procedure you may receive an automated reminder call that your procedure completion day is near.

• On the last day of your procedure, you may receive an additional call letting you know it is the final day of your procedure. These calls will also review how to return your monitor to Medicomp.

One week after your procedure, you may receive another automated reminder call to return your monitor if we have not received it yet. Please note, after you mail back the monitor, it may take several days for Medicomp to receive it. You may ignore the final reminder call if you have already sent the monitor back. All reminder calls are made based on the end date of your procedure. If you have questions about your monitor being received back to our office call 877-996-5553.

After Your Procedure

Your doctor can review the results of your monitoring procedure with you at your next visit.

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Why do I have to wear this cardiac monitor? Your doctor ordered this monitor to make ECG recordings of your heart,

which in turn can help diagnose any heart irregularities, called arrhythmias.

What is an ECG? ECG stands for electrocardiogram. It is a recording of the electrical activity of

your heart. Your doctor can use an electrocardiogram to look for patterns in your ECG that can help to diagnose various arrhythmias.

What is an arrhythmia? An arrhythmia is a condition in which the heart beats with an irregular or

abnormal rhythm. Some arrhythmias are harmless; others may indicate serious threats to your health.

How long do I have to wear the monitor? This monitor is designed for patients who have infrequent symptoms.

Therefore, it is meant to be worn for a long term, typically 30 days. But your doctor will determine the specific length of time you should wear the monitor.

Frequently Asked Questions

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When should I press the Record/Send button? Whenever you feel a symptom you believe could be related to your heart.

For example: shortness of breath, dizziness, pain, weakness, etc. Follow your doctor’s orders for when you should make recordings.

What if I don’t have symptoms every day? Many patients do not have symptoms every day, but you should continue to

wear the monitor every day because it can detect possible arrhythmias and make recordings on its own – even when you don’t feel any symptoms.

Do I wear the monitor while I sleep? Yes. The monitor can detect possible arrhythmias and make recordings on

its own – even while you’re sleeping.

Can I continue my active lifestyle? Generally, yes, but follow your doctor’s instructions. This monitor is meant

to go with you as you go about your daily routine, including exercising and most of your regular activities. Wear the monitor outside your clothing to avoid perspiration coming in contact with the devices.


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Can I wear the monitor while bathing, showering or swimming? No. Neither the Pendant nor the Smartphone should get wet. Avoid any

moisture from coming in contact with the devices. If your monitor gets wet, please call us. You may need a replacement.

Why does the Smartphone screen go blank/turn black? The Smartphone conserves its internal battery by “going to sleep” and turns

its display screen off. Wake it up by pressing any button on the Smartphone. The monitor continues to function while it’s in sleep mode.

How do I know if the monitor is working? When you see the word Monitoring on the Smartphone screen, the monitor

is working. Remember, you may have to press a key on the Smartphone to wake it up if the screen has gone blank.

How do I know if the monitor is within range of the cellular network? Check to see if 3G is displayed in the upper-right corner of the Smartphone

screen. If 3G is displayed, you are within range. If, instead, you see a small icon of an antenna (looks like a tiny funnel), you may be out of range.


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How often should I change batteries in the Pendant? Typically, you’ll need to change the “AA” batteries in the Pendant every 1½

to 2 days. The Smartphone will indicate when the Pendant batteries need to be changed. Look for the percentage of battery power available next to the Pd Batt. Change the battery when the Pd percentage reaches 5%. But if it is at 15% or below when going to bed, change the battery so that it does not run out of power while you’re sleeping.

How often should I charge the Smartphone? We recommend charging the Smartphone daily. Charging on a night stand

while you’re sleeping is a good practice. The Smartphone will indicate when it needs to be recharged. Look for the percentage of power available next to SP Batt. Recharge the Smartphone when the SP percentage reaches 20%.

What should I do with the monitor when I’m done? Send the monitor back to Medicomp in the postage-paid envelope provided

in your kit. Please refer to page 29 of this guide.

How do I find out the results of the test? Your doctor can share the test results with you.

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Will my insurance pay for this test? This test is covered by most insurance companies, including Medicare. Of

course, you’ll still be responsible for any co-pays or deductibles. Our friendly billing team is available if you have any questions about insurance or billing. Call toll-free: 800-234-3278, ext. 2040.

Am I billed every time I press Record/Send? No. Your test is billed as a set-term diagnostic procedure, regardless of how

many recordings you make, or how many days your doctor prescribed the procedure length, or how many days you actually wear it.

I think something’s wrong with the monitor. What do I do? Check the Troubleshooting section starting on the next page or call us for

assistance at 877-996-5553.

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Troubleshooting

Issue ResolutionSearching for Pendant Displayed on Smartphone

The Pendant and Smartphone are not communicating with each other. • Make sure the Pendant and Smartphone are within 10 feet of

each other. • Make sure the Pendant is turned on. You may have turned it off

accidentally or forgot to turn it on after replacing its battery. • Make sure the “AA” battery in the Pendant is inserted correctly. • Insert a fresh “AA” battery in the Pendant. • Turn the Smartphone off and then back on. • After trying the actions above, if this message remains after

15 minutes, call the CMC at 877-996-5553.Auto Capture Suspended Displayed on Smartphone

This message may appear from time to time throughout your procedure. •Waitforonehour.Themessageshouldclearwithinanhour.

• During this period manual recordings can still be made. If you experience a symptom, press the Record/Send button.

• If, after waiting one hour the message still appears, turn the Smartphone off and then back on.

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Light Setup Failed Displayed on Smartphone

The monitor is unable to capture your ECG. • Turn the Smartphone off and then back on. • If this message persists, call the CMC at 877-996-5553.

Call CMC or Call 911 Displayed on Smartphone

The Right Soft Key under Call was pressed accidentally. Press the Right Soft Key, and the message should disappear.

BT or ECG Data is Flashing on Smartphone

This indicates normal communication between the Pendant and Smartphone. They will flash frequently. The blue ring on the Pendant will flash in tandem.

Smartphone Won’t Turn On or Off Please keep the Smartphone powered on. There’s usually no need to turn it off except when troubleshooting. • Press and hold the Power button on the top left-side of the

Smartphone (the “skinny” side). Samsung will display when turned on, and Goodbye will display when turned off.

• If it still will not turn on or off, call the CMC at 877-996-5553.

Troubleshooting

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Smartphone Not Holding Charge After a full recharge, the Smartphone should remain charged for 8-12 hours. • Make sure the Smartphone is being charged daily for at least

four hours. • Make sure the red light on the upper-right hand corner of the

Smartphone comes on when plugged into the charger. • Make sure the electrical outlet where the charger is plugged is

not controlled by a switch that’s turned off. • Try plugging the charger into a different outlet. • Make sure the charger is inserted into the Smartphone properly. • If you continue to experience this issue, call the CMC at

877-996-5553.Smartphone Screen Stuck or Phone Unlocked

• Turn the Smartphone off and then back on. • If the issue persists, call the CMC at 877-996-5553.

Troubleshooting

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Pendant Won’t Turn On • Change the “AA” battery in the Pendant. • Make sure the battery is inserted correctly (flat end toward

the spring). • Make sure the ribbon is not covering the contact or spring

in the Pendant’s battery compartment. • Press and hold the On/Off button for about two seconds.

Listen for the tones. • If it still will not turn on, call the CMC at 1-877-996-5553.

Pendant Beeping • The Pendant will beep when the Record/Send button is pressed either on the Pendant or on the Smartphone.

• The Pendant will beep when the On/Off button is pressed. • The Pendant will beep every 5-15 minutes when its “AA” battery

is low. Change the battery. (Note: If the battery is too low, the Pendant will make a solid beeping tone three times and turn off. After replacing the battery, remember to turn the Pendant back on.)

Troubleshooting

ULS-98-454454 B

If you are having an emergency or feel you need immediate medical assistance, call 911.

Continue to use the monitor during this time so that we can assist your doctor in capturing important ECG data while emergency medical service is on its way.

available 24 hours a day - medicomp inc. · 5 simply put, savi air is a heart monitor that measures...

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