PATIENT INSTRUCTIONS FOR ACT EX™

Your physician has ordered ACT Ex services to monitor your heart rhythm. This service can last up to 30 days.

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PATIEiNT MONITORING PROCESS FOR RAPID RESULTS

In the first 24-48 hours:

The monitor will analyze your heart rhythm and provide your physician with an initial summary. A LifeWatch representative may call to advise you on charging the cell phone and to help you locate a high quality cell phone signal.

CONTINUE To WEAR THE MONITOR

UNLESS You RECEIVE A CAll THAT INSTRUCTS You To Do DIFFERENTLY.

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Correct electrode placement

Inserting sensor battery

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REMEMBER THE FIVE 11(" TIPS FOR SUCCESSFUL MONITORIING

CHARGE the phone every night and whenever possible throughout the day.
CHECK the phone every 4-5 hours by pressing any button to verify the "beating heart",
C;HANGE electrodes every day.
CHANGE the sensor battery as instructed in the Patient Instruction Manual.
CALL the Client Care Center for any assistance or if you have any questions at:
1-800-517-6330 Press option #2 and then option #1 REFER TO THE ACT III PATIENT MANUAL FOUND IN THE KIT FOR MORE DETAILED INSTRUCTIONS

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PATIENT INSTRUCTIONS LIFESTAR ACT

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PLEASE CALL 1.800.517.6330 FOR24nCUSTOMERSUPPORT

Please call 911 in an emergency.

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About LifeStar ACT

LifeStar ACT is an automatically activated cardiac monitoring system that requires no patient intervention to capture or transmit an arrhythmia when it occurs. When an arrhythmia is detected, the LifeStar ACT utilizes an integrated cell phone monitor to transmit the data to the LifeWatch Monitoring Center for analysis.

Sensor

The sensor records and transmits the data to the monitor. It can hold up to 2 hours of data in its memory, This means that if a patient is away from the monitor, the data is still being recorded, Once the patient is in range (within 10 feet) of the monitor, the data will be transmitted,

Cell Phone Monitor

The monitor receives the ECG data from the sensor via Bluetooth and can store the data for up to 30 days, The monitor has a special application to convert the raw ECG data into usable information that is sent to LifeWatch using a cellular network, or, in the case of no cellular coverage, by using a landline phone and a modem,

Batteries

The batteries we send are special batteries. DO NOT use over the counter AA batteries, DO NOT dispose of the batteries - they should be returned to LifeWatch in the kit when your monitoring session is completed.

About Bluetooth

Bluetooth Is a wireless technology that enables the sensor and cell phone monitor to communicate with each other.

The LifeStar ACT system uses Bluetooth technology to transmit ECG data from the sensor to the phone. While using a cellular phone as an ACT monitor, the internal Bluetooth component is on and running continuously (24 hours a day) for the entire enrollment period; therefore, the cell phone must be ON at all times. Bluetooth operates like a radio and is susceptible to interference. If the sensor and phone are more than 10 feet apart and a Bluetooth connection cannot be made, the screen on the monitor will display "Can't receive data" or "waiting for connection". No data loss will occur as long as the sensor and monitor are reconnected within two hours; however, the energy used by the sensor during the connection attempts will cause the battery to drain faster.

When the sensor and monitor are within 1 0 feet of one another, the Bluetooth will automatically re-connect. In order to minimize interference and maximize battery consumption for both the sensor and phone, keep the sensor and phone within 10 feet of each other and charge the phone every night and whenever possible

throughout the day. .

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LifeStar™ ACT Kit Contents

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1<150 1'I,$.bD 1.1i:i-bE!

LifeStar ACT Sensor (Medallion)

Batteries for LifeStar ACT Sensor

LifeStar ACT Cell Phone Monitor

Cell Phone Charger

Electrodes (Sticky Patches)

Cell Phone Carrying Pouch

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Pre-Paid Return Envelope

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SKIN PREPARATION AND ELECTRODE PLACEMENT

o ~ttach the white lead wire with electrode under the second right rib. (3 . fingers below the collarbone).

e Attach the red lead wire with electrode on the lower right portion of your . chest.

e Attach the black lead wire with electrode to the lower left portion of your chest.

Skin Preparation

If you have sensitive skin or participate in active sports, please contact LifeWatch. Special electrodes (sticky patches) are available for sensitive skin and active individuals.

Wash the skin on your chest and abdomen using warm water and gentle soap.

Remove excess hair by carefully clipping with scissors .. Avoid shaving 'in order to minimize irritation. Make sure that your skin is clean and fully dry before proceeding.

Do not apply electrodes to skin that is broken or Irritated.

If you have any concerns contact LifeWatch.

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•

Snap sensor on the black lanyard and wear lanyard around your neck. If you experience discomfort wearing the sensor on the lanyard, you may attach an electrode (sticky patch) to your waist and snap the sensor to the electrode.

Remove electrodes (sticky patches) from the electrode package.

Snap each lead wire onto an electrode (all 3 of them).

o

White

Electrode Placement

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lead wire

Red lead wire

Black lead wire

Remove the backing from each electrode.

Look down at your chest when placing the electrodes (see picture below). Refer to page 9 for electrode change and replacement.

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4

ACTIVATING THE SERVICE

Before calling LifeWatch to activate your service, we recommend that you position the electrodes accordingly, as instructed on pages 7-9.

To activate the service call 1.800.517.6330 using a phone that is NOT the LifeStarACT cell phone.

NOTE: This phone is the property of LifeWatch and is intended for medical use only. If you use this phone for personal use/text messages you will be charged for all associated fees. Please do not use the LifeStar ACT Cell phone to make outgoing calls other than an emergency call to 911.

Power Button ..

Navigation Key ----fl---K.:

opens

menu above

menu above

When instructed by the LifeWatch technician, press and hold the POWER button of the LiJeStar ACT cell phone for 5 seconds until the screen lights up.

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While activating the service (to create a "Baseline") the following screens will .appear on the ACT cell phone:

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Diagram 1: Welcome screen to call LifeWatch for activating service

Diagram 2: Data is being collected.

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Diagram 3: Baseline ECG (heart rhythm) is being transmitted to LifeWatch ,

Diagram 4: Electrode placement is being tested for proper position

After activating the service with a LifeWatch technician, please perform the following steps for successful monitoring:

Step 1: Charging ACT cell phone

Step 2: Changing sensor battery

Step 3: Charging electrodes

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Slide the battery cover off the back of the sensor.

Sensor Battery

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Charge ACT Cell Phone Every Night and Whenever I

Possible Throughout the Day I

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1. Charge the cell phone every night within 10 feet of your sensor.

2. Charge the cell phone whenever possible during the day.

3. You must take the fully charged cell phone with you and wear the sensor at all times (except when showering or bathing).

Cell Phone Symbols

~ Cell phone battery indicator (One bar means battery needs charging)

Cellular signal type

Beating heart (indicates device is functioning properly)

Cellular signal strength

" , Leads are placed correctly

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- If this symbol appears on the

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phone screen - please disregard

The screen at right will appear on the cell phone if a lead wire has become disconnected,

To resolve make sure all electrodes and lead wires are securely attached.

Insert battery according to the "+" symbol.

Replace battery cover. The sensor will beep once.

Change the sensor battery when the following occurs:

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1, The sensor beeps two times

2. A "Low sensor battery" alert is displayed on the cell phone screen

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For a visually or hearing impaired patient, replace the sensor battery EVERY 3 days.

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Changing Electrodes

Tips for Successful Moni~oring

CHECK

•

Replace electrodes (sticky patches) every three days or when the adhesive is not firmly attached to the skin.

Call1.800.S17.6330 for customer support with any questions or when additional supplies are required.

Check the phone every 4-5 hours by pressing any button to verify the beating heart.

Check the electrodes daily by pulling gently to verify that the adhesive is firmly attached to your skin. If an electrode is not firmly attached, change all the electrodes per the instructions on page 3 and 4.

CHARGE Charge the phone every night and whenever possible throughout the day.

Disconnect the lead wire from the electrode.

CHANGE Change electrodes every three days.

Change the sensor battery as needed.

•

Gently remove electrodes, by grasping the edge/tab of the electrode and peeling back in a slow continuous motion. You may want to remove the electrodes in the shower or use a wet, warm wash cloth. Do not rapidly remove the electrode to avoid skin damage.

CALL

Remove any excess adhesive or dead skin between electrode changes, using a wet, warm washcloth or gauze pad. Completely dry before attaching new electrodes.

If electrodes become dislodgedlloose prior to 3 days, replace electrode(s) per instructions above.

Minor skin irritation can occur with electrode use. If skin irritation occurs, do not re-apply electrode to the immediate area. Apply in close proximity to that location on healthy skin.

• If irritation worsens or becomes severe, contact LifeWatch.

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If You Experience Dizziness, Fatigue, Chest Pain or Any Other Symptom, Make A Manual Recording:

Choose one of the two options to make a manual recording:

First option for making a manual recording:

1. Press both sides of the sensor and release when you hear the sensor beep (you will hear a doorbell sound from the phone). A new screen will appear on the cell phone.

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2. Select and mark the symptom by pressing down on the lower part of the navigation key (big square) until it highlights the symptom (see screen at left).

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3. Press the center of the navigation key to select the symptom and press SEND by using the right soft key.

Resume your normal activity.

Call LifeWatch at 1.800.517.6330 if you experience any problems.

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Second option for making a manual recording:

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Press the right soft key on the phone, under the words "MANUAL EVENT" (you will hear a doorbell sound from the phone).

1. Press the left soft key under Yes on the screen. A new screen will appear on the cell phone.

2. Select and mark the symptom by pressing down on the lower part of the navigation key (big square) until it highlights the symptom (see screen at lower left).

~.~~:t+!---- 3. Press the center of the navigation key to select the symptom and press SEND by using the right soft key.

Resume your normal activity.

Call LifeWatch at 1.800.517.6330 if you experience any problems.

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Frequently Asked Questions

What do the sounds mean ... ?

Sensor Sound

1 beep, one time

Description What To Do ...

Normal and follows No Action

insertion of battery

Low Battery warning Replace battery

2 beeps, repetitive 3 beeps, repetitive

Clinical error, system stops

Remove battery from sensor for 30 seconds, then replace. Allow up to 3 minutes for sensor and monitor to reconnect.

Why does the cellular phone monitor screen turn black?

The screen goes black to conserve power. To turn on the screen press any button on the phone.

How do I know if my phone monitor is working?

When you see the beating heart on the screen, the cell phone is working properly. The beating heart means that the cell phone is communicating with the sensor and the Bluetooth connection is intact. The device is functioning and there is no need to do anything.

My cell phone indicates Hwaiting for connection" or "can't receive data". This means the cell phone is not communicating with the sensor. To reconnect, make sure that the cell phone is within 10 feet of the sensor. If the cell phone does not reconnect within 5 minutes, do the following:

1 . Remove the battery from the sensor

2. Re-insert the battery

You should hear one beep. Connection should be re-established in about 3 minutes. If it does not, please call LifeWatch Client Care Center at 800.517.6330; choose prompt #2 then prompt #1 for further assistance.

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Why does my cell phone turn itself off and how do I turn it back on? The cell phone turns itself off because:

1. The battery is out of charge.

How to resolve: Plug the phone into a charger, after one minute press the ON/OFF button to turn it on.

2. The ON/OFF button has been pressed.

How to resolve: Press the ON/OFF button to turn it on.

It is ESSENTIAL to charge the phone every night and whenever possible throughout the day. A car charger 'is available upon request. (Don't worry - the phone will not become overcharged!)

Are the LifeStarACT cell phone and sensor water resistant?

No, the monitor, sensor and wires must not get wet. While bathing or showering, they should be placed in a dry environment, outside of the bathroom. The electrode patches may be worn in the shower or bath as long as they are disconnected from the sensor (medallion).

Can I use over-the-counter batteries?

No. Over-the-counter batteries can seriously damage the sensor: Only use the specialized batteries included in the kit. If more batteries are needed, contact the LifeWatch Client Care Center at 1.800.517.6330.

How often should I change the battery in the sensor? Change the sensor battery when the following occurs:

1 . The sensor beeps two times

2. A "Low sensor battery" alert is displayed on the cell phone screen

For a visually or hearing impaired patient, replace the sensor battery EVERY 3

days. •

How often should I charge the Life Star ACT cell phone?

Ch.arge the LifeStar ACT cell phone every night within 10 feet of your bed and whenever possible throughout the day.

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Is the device safe for usage while wearing an oxygen mask?

The ACT device is safe for use in conjunction with supplemental oxygen with the exception of pure oxygen environments such as a hyperbaric chamber or oxygen tents.

Can I continue my active lifestyle?

Yes, unless otherwise instructed by your physician.

Will my insurance pay for this test?

Lifevyatch is a p~rticipating provider with most insurance companies, including Medicare. We will contact your insurance company to verify your benefits and coverage for LifeStar ACT. LifeWatch will call you to inform you of your coverage and schedule the delivery of the ACT system.

For questions or information regarding billing and insurance coverage, please call the Patient Advocate Department at 1.800.336.3866 Monday - Friday 8:00AM to 5:00PM Central Time.

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The LifeStar ACT device is safe for use by a patient attached to an oxygen mask for breathing.

The LifeStar ACT device is safe for use by patients who have a Pacemaker

t** C AUT ION ***

NOT for use in a hyperbaric chamber, or within an oxygen tent.

NOT for use with Implantable Cardioverter-defibrillator (ICD) ..

A\ This symbol is intended to alert the user to the presence of important operating ill and maintenance (servicing) instructions in literature accompanying the device.

I 1\ I This symbol indicates type BF equipment classified in accordance with IEC Publication 601-Safety of medical electrical equipment.

( E0344MDD (Medical Device Directive) certification.

6) Bluetooth trademark indicating conformity to specifications. F@ Symbol of FCC compliance.

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Return Instructions

1. At the end of your enrollment period, please place the kit in the pre-paid envelope.

2. Drop the envelope in any USPS mailbox.

Billing Information

General Information

Patients traveling outside of the U.S. are responsible for any applicable cell phone roaming charges on the LifeStar™ ACT.

The device will not transmit to LifeWatch after your enrollment period has ended.

If the equipment is not returned or is damaged you will be charged a $1,315.00 replacement fee. The replacement fee will be charged to your credit card if on file, or billed to you directly.

Patient Financial Obligations & Billing Information.

LifeWatch will bill your insurance carrier on your behalf. You may be responsible for a capay, coinsurance and/or deductible as determined by your insurance policy. You will be responsible for charges not covered by your insurance carrier. Any amount determined to be your responsibility will be charged to your credit card if on file, or billed to you directly. For questions or information regarding billing and insurance coverage, please call the patient advocate department at 1.800.336.3866 Monday - Friday 8:00AM to 5:00PM Central Time.

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CAUTION: Important Safeguard in the Medical Environment

This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications.

This device is dependent on cellular phone service and Bluetooth technology to function. Limitations may occur if there is limited cellular service in the area (a modem is provided for areas of limited cellular service) and/or if interference with the wireless Bluetooth connection is experienced. Limitations may also occur if the power sources for the LifeStar ACT monitor and the Sensor are not adequately charged. You should charge your LifeStar ACT Cellular Phone Monitor each night and change the battery in the Sensor as instructed. Cellular limitations may also occur in areas that typically receive high quality cellular service. As the patient, you may occasionally experience a delay in the ability to send recorded events due to unexpected cellular limitations. The introduction of a number of wireless devices may make your wireless connection more difficult to achieve and/or maintain. If this occurs, you must contact LifeWatch as soon as possible. Any technical difficulties that are experienced should be reported as quickly as possible so LifeWatch may resolve the issue with minimal interruption to the service.

Disclaimer: Operation of the LifeStar ACT system may be subject to governmental and business restrictions, including but not limited to air travel and hospital visitations.

Ownership and Use of the Device

This device is the sole and exclusive property of LifeWatch. The device may be used only for purposes of diagnosis and is not intended for use as an emergency response system for patients who may experience serious or life threatening medical problems. Patient agrees that he/she will not, in whole or in part, sublicense, provide access to, tamper with, modify, distribute, export in violation of applicable laws and regulations, rent, loan, transfer, disassemble or reverse engineer or create derivative work of the device.

Copyright Declaration

The BLUETOOTH trademarks are owned by Bluetooth SIG, Inc., U.S.A. and licensed to Taiyo Yuden Co., Ltd. ©2009 LifeWatch Corp. All-riqhts reserved. LifeWatch, LifeStar, ACT, and ACT III Platinum are trademarks or registered trademarks of LifeWatch Corp.

The information provided in this manual is subject to change without notice.

Card Guard Scientific Survival Ltd. SHALL NOT BE LIABLE FOR TECHNICAL OR EDITORIAL ERRORS OR OMISSIONS CONTAINED HEREIN; NOR FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE FURNISHING, PERFORMANCE, OR USE OF THIS MATERIAL.

WARNING

To prevent fire or shock hazard, do not expose the unit to rain or moisture. Refer servicing to qu alified personnel on Iy.

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