PATIENTAPPLICATION INSTRUCTIONS

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GET STARTED WITH ZIO XT

FIND YOUR INSTRUCTIONS AND TOOLS

First make sure you have the following: the Patient Application Instructions (this booklet), the Skin Prep & Placement Kit and the Patient Instructions & Button Press Log, located inside the white pouch in your box.

PLEASE NOTE: Do not register on zioreports.com. Your doctor has already enrolled you in the Zio service.

Please use only these Patient Application Instructions to prep, place and activate your Zio patch.

The Skin Prep & Placement Kit contains all the necessary tools for prep, placement and activation.

SKIN PREP & PLACEMENT KIT

Use These Tools:

PATIENT APPLICATION INSTRUCTIONS

Use This Booklet:

0808 189 3411

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APPLY IN FOUR EASY STEPSAttention: Complete each step before moving to the next. Proper skin prep will ensure your Zio patch sticks to your chest correctly.

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WEARING YOUR ZIO XT

Refer to the “Zio XT Important Information” on page 21 for indications, safety information, package contents and symbols glossary.

WE’RE HERE TO HELPWhether you have a quick question or would like step-by-step guidance.

Call Customer Care:

0808 189 3411

Prep Skin Apply Patch Finish & ActivatePosition

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1

1 Remove this linerAFTER

application

STOP

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Zio Card Template

POSITION

Stand in front of a mirror and remove clothing. Your entire chest should be visible and clear.

Hold the Zio card template or the Zio device to the upper-left side of your chest. It should be on the flattest spot just below your collarbone with the arrow pointing straight up.

Imagine a box surrounding the patch, about an inch wider than the top and bottom edges.

You will prep your skin in this area.

Use this Zio card template or the Zio XT device to properly size the prep area.

Please use this Zio card template to accurately size your prep area.

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22Find the razor in your Skin Prep & Placement Kit.

IMPORTANT: Proper skin prep will ensure your Zio patch sticks to your chest correctly. PREP SKIN

Shave area.

Use the included razor or use your own. Make sure your skin is clean and dry before continuing.

Hold the sides of the razor packaging with one hand. With the other hand, pull the razor handle to expose the blade.

CONTINUE STEP 2

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Find the abrader in your Skin Prep & Placement Kit.

Hold the abrader disc by the orange tab.

Rub the abrader in 40 broad strokes across the entire prep area.

Follow the arrows as shown, applying 10 strokes in each direction.

22Find the alcohol wipes in your Skin Prep & Placement Kit.

Clean the prep area thoroughly using all alcohol pads.

Let dry for one minute.

PREP SKIN (cont’d)IMPORTANT: Proper skin prep will ensure your Zio patch sticks to your chest correctly.

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1

2 Remove this linerAFTER

application

STOP

APPLY PATCH

Press the Zio patch firmly onto your skin and rub the adhesive for two minutes.

Do not move the patch after it is applied to your skin.

Find the Zio patch in your Skin Prep & Placement Kit.

Hold the middle section of the Zio patch and remove the clear backing.

Aim for the upper-left side of your chest, on the flattest spot just below your collarbone, with the arrow pointing straight up. Then stick the patch on.

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2

44 FINISH & ACTIVATE

Peel off the white label starting with the tab marked “1” and then “2.”

Now rub the adhesive for two more minutes.

Press and release the button in the center of the patch.

The patch will flash green.

Once the flashes stop, the Zio patch will begin recording your heartbeat.

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WEARING YOUR ZIO XT

Find and read the Zio XT Patient Instructions & Button Press Log.

When you feel a symptom, such as lightheadedness or palpitations, press the button in the middle of your Zio patch. You should hear a small click. The patch will not flash and you do not need to hold down the button.

Then, record your symptoms in the Button Press Log.

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...while I was:

...because I felt:anxiousarm or neck pain/tinglingchest pain or pressuredizzinessfainted

light headed

pounding fluttering or racing short of breathskipped beat(s), irregular beatsother

I pressed the button on:

describe activity

describe

1 min or less10 mins or less

...for this duration:

1 hour or lessMore than 1 hour

:hm m AM

PM

h

dm

y

dm

y

x

getting out of bed

2 90 7

xx

x

0 54 5

1 9x

BUTTON PRESS LOG

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REMEMBER:Do not shower for

first 24 hours

Take short showers with back facing shower head; do not submerge

Keep lotions away

Return Zio patch & Button Press Log

Press button to log your symptoms

Excess sweating can shorten wear time

WEARING YOUR ZIO XT (cont’d)

At the end of the wear period, remove your patch following the directions in the Button Press Log.

Place your Button Press Log, including the patch, in the pre-paid box and mail back to iRhythm.

To ensure your doctor gets your heart rhythm information quickly, mail the box immediately after removing the patch.

IMPORTANT INFORMATION

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CONTRAINDICATIONS

• Do not use the Zio XT Patch for patients with symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the patient.

• Do not use the Zio XT Patch in combination with external cardiac de fibrillators or high frequency surgical equipment near strong magnetic fields or devices such as MRI.

• Do not use the Zio XT Patch on patients with neuro-stimulator as it may disrupt the quality of ECG data

• Do not use the Zio XT Patch on patients who do not have the competency to wear the device for the prescribed monitoring period.

DESCRIPTION

The Zio ECG Monitoring System is a ambulatory Electrocardiogram (ECG) monitoring system. The Zio ECG Monitoring System consists of two components: (1) Zio Monitor ECG Recorder and the (2) proprietary algorithm software.

The Zio XT Patch is a single-patient-use ECG monitor that provides a continuous, single-channel recording for up to 14 days. The Zio XT Patch records ECG without patient interaction, with the goal of improving patient compliance via simplicity of operation. Patients have the option of pressing a convenient trigger button and filling out a log to document symptomatic events, which will support symptom-rhythm correlation in the diagnostic report.

After conclusion of the wear period (up to 14 days), the patient removes the Zio XT Patch and returns it by post to iRhythm for processing. After receipt, the data is analyzed by iRhythm’s proprietary algorithm before a Certified Cardiographic Technician (CCT) reviews the results and generates a report of the key findings.

INDICATIONS FOR USE

The Zio XT Patch is a prescription-only, single patient use, continuously recording ECG monitor that can be worn up to 14 days. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety.

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WARNINGS

• Do not use the Zio XT Patch on patients with known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies. Patient may experience skin irritation.

• Do not reuse the Zio XT Patch on multiple patients. It is a single patient use device. Reuse will cause incorrect patient data and the patient may experience skin irritation.

• Prior to patch application, examine the skin area of the patient for certain skin conditions (such as dermatitis, eczema, rashes/hives), acute/chronic cutaneous infections or irritation.

• The product may elicit anaphylactic responses in individuals who are allergic to latex.

If skin irritation such as severe redness, itching or allergic symptoms develop, remove the Zio XT Patch from the patient’s chest.

Please call 0808 189 3411.

CAUTION: Federal (USA) law restricts the sale of this device to or on the order of a physician.

PRECAUTIONS

• The Zio XT Patch includes temperature and humidity limitations. If exposed, patients may experience degradation of adhesive performance causing the device to slip or fall off during the patient wear duration.

• The Zio XT Patch has a shelf-life date. Use of expired device may cause a degradation of ECG signal quality and/or low battery condition.

• Do not use the Zio XT Patch if package is damaged. Device may not perform as intended.

• Safety and effectiveness of the Zio XT Patch on pediatric patients (younger than 18 years old) has not been established.

• Safety and effectiveness of the Zio XT Patch on patients receiving any form of pacing therapy has not been established. Paced cardiac rhythms may not be accurately detected and may be incorrectly classified.

Consult instructions for use Catalog number Prescription use only ManufacturerAuthorized representative in

the European community

Date of manufacture Serial number Use by Net quantity of contents Temperature limitations

Humidity limitations Do Not Reuse Do not use if package is damaged Type BF applied part Separate collection

Caution Splash-proof equipment

IPx4

QTY:

EC REP

CE MARK INFORMATION

The Zio XT ECG Monitoring System bears the CE marking CE-0050, indication its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfulls the essential requirements of Annex I of this directive.

The medical device has been assigned to class IIa as specified in Annex IX of the Directive 93/42/EEC.

SYMBOLS

COMPLIANCE

0050

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ZIO XT PATCH ANALYSIS

The Zio XT Patch heart monitor is analysed at the iRhythm Clinical Center. iRhythm is an Independent Diagnostic Testing Facility (IDTF) dedicated to providing world-class diagnostic service. As an IDTF, we adhere to Medicare Independent Diagnostic Testing Facility Performance Standards. A link to these standards (42 C.F.R.section 410.33) can be found at the iRhythm website www.irhythmtech.com.

NOTICE OF PRIVACY PRACTICES

iRhythm is committed to upholding patient privacy and protecting personal information, in particular health information collected and processed in conjunction with our Zio Service. We commit to complying with all applicable privacy laws and allowing patients to exercise their rights. For more information, please refer to the Patient Notice which is also available at www.irhythmtech.com/content/privacy-eu.

iRhythm Technologies, Inc.Seal House 56 London Road Bagshot GU19 5HL

Tel 0808 189 3411 supportuk@irhythmtech.comirhythmtech.co.uk

DEVICE SPECIFICATIONS

PERFORMANCE CHARACTERISTICS

ECG Channels 1 channel

Memory capacity 14 days

Recording Format Continuous

Service Life Up to 14 days

Shelf Life 6 months

ELECTRICAL CHARACTERISTICS

Frequency Response 0.5 Hz to 30 Hz

Input Impedance ≥ 10 Mohm

Differential Range ± 1.65 mV

A/D Sampling Rate 200 Hz

Resolution 10 bits

Gain Accuracy Maximum amplitude error <5%

Gain Stability <3% over a 24-hour period

Timing Accuracy < 30sec over 24 hours

POWER SPECIFICATIONS

Battery Type 2 Lithium Manganese Dioxide Coin Cells

Battery Life 14 days

PHYSICAL CHARACTERISTICS

Dimensions 5.20 x 2.02 x 0.53 in / 132 x 51 x 14 mm

Weight 24.5 g

ENVIRONMENTAL SPECIFICATIONS

Operational Temperature 36 to 104° F / 2 - 40° C

Operational Altitude -1,000 to 10,000 ft / -305 - 3,048 m

Allowable Transit Temperature -4 - 104° F / -20 - 40° C

Recommended Storage Temperature

64 - 80° F / 18 - 27° C

Storage Humidity 10% - 95% (non-condensing)

Storage Altitude -1,000 to 14,000 ft / -305 - 4,267 m

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ELECTRICAL SAFETY AND COMPATIBILITY

Table 1: Guidance and manufacturer’s declaration— electromagnetic emissions

The Zio XT Patch is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio XT Patch should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1The Zio XT Patch device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class BThe Zio XT Patch is suitable for use in all establishments, including domestic establishments.

• CAUTION: The Zio XT Patch needs special precautions regarding EMC and needs to be utilized according to the EMC information provided in the following tables.

• CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment.

• WARNING: The Zio XT Patch should not be used adjacent to or stacked with other equipment.

Table 2: Guidance and manufacturer’s declaration—electromagnetic immunity

The Zio XT Patch is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio XT Patch should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/mPower frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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Table 3: Guidance and manufacturer’s declaration—electromagnetic immunity

The Zio XT Patch is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio XT Patch should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

3 Vrms

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the Zio XT Patch, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.2√P d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

Table 3, Continued

NOTE 1—At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Zio XT Patch is used exceeds the applicable RF compliance level above, the Zio XT Patch should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Zio XT Patch.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 4: Recommended separation distances between portable and mobile RF communications equipment and the Zio XT Patch

The Zio XT Patch is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Zio XT Patch can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Zio XT Patch as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitter

m

150 kHz to 80 MHz 80 MHz to 800 MHz 80 MHz to 2.5 GHz

d = 1.2√P d = 1.2√P d = 2.3√P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1—At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

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34©2020 iRhythm Technologies, Inc. All rights reserved.

NLB0054.01

iRhythm Technologies, Inc. 699 8th St., Suite 600 San Francisco, CA 94103 USA Tel: +1.888.693.2401 (USA Only) Tel: +1.224.543.4200 (International) Fax: +1.888.693.2402 (USA Only)

EC REP

Emergo Europe Prinsessegracht 20 2514 AP, The Hague The Netherlands Tel: +31.70.345.8570 Fax: +31.70.346.7299 0050

iRhythm Technologies Ltd. Seal House 56 London Road Bagshot Surrey GU19 5HL Tel: 0808 189 3411 Fax: 0808 189 3303 Email: supportuk@irhythmtech.com irhythmtech.co.uk