clinical RefeRence Manual

Contact Information
iRhythm Technologies, Inc.
650 Townsend Street, Suite 380
San Francisco, CA 94103
www.irhythmtech.com
iRhythm National Clinical Center
Tel: 1-888-693-2401
Fax: 1-888-693-2402
24 hours / 7 days a week
iRhythm Technologies, Inc., the manufacturer and provider
of Zio™ products and services, markets Zio™ in collaboration
with St. Jude Medical, Inc.
ST. JUDE MEDICAL, the nine-squares symbol, and MORE CONTROL. LESS RISK. are registered and unregistered trademarks
and service marks of St. Jude Medical, Inc. and its related companies.
Zio™ is a trademark of iRhythm Technologies, Inc. ©2010 iRhythm Technologies, Inc. All rights reserved.
clinical Reference Manual
Table of Contents
Zio™ Event Card Package Components
3
Patient Enrollment
4
In-Office Preparation & Device Activation
5
Visual and Audible Indicators 7
Clinician Quick Reference
8
Patient General Usage Guide & Reminders
9
Warnings
10
Contact Information
11
Device Specifications
12
1
Clinical Indications
The Zio™ Event Card is a prescription-only, single patient use, ECG looping
monitor that can be worn for up to 30 days. It is indicated for use on patients
who experience transient symptoms such as syncope, palpitations, shortness of
breath, or dizziness.
Contraindications
There are no known contraindications related to the safety and operation of the
Zio™ Event Card. The Zio™ Event Card does not have the ability to automatically
detect arrhythmias.
CAUTION: Federal (USA) law restricts the sale of this device to or on the order
of a physician.
Patient Compliance
The innovative design of the Zio™ Event Card is intended to improve patient
compliance and monitoring outcomes. The device can be worn via a neck
lanyard or a belt clip, thereby improving overall patient comfort and diagnostic
ECG results.
iRhythm Recycling Program
iRhythm recycles 100% of each device that is returned to us. No part of the
device will end up in a landfill.
2
Zio™ Event Card Package Components
1 Zio™ Event Card Monitor
with attached lead wires
32 Lead-Lok® electrodes included
The patient should change the electrodes:
• Every 2 to 3 days
• If the electrode detaches from the skin
• If the Zio™ Event Card indicates an
error condition
1 Patient Instructions
1 lanyard, plus
1 belt clip
1 pre-paid return envelope addressed
to Recycling Program at iRhythm
Technologies, Inc.
3
Patient Enrollment
You may enroll patients either online, by fax, or by phone.
For online enrollment, visit:
www.zioreports.com
Fax enrollment form to: iRhythm National Clinical Center (iNCC)
Fax: 1-888-693-2402
For phone enrollment, call:
Tel: 1-888-693-2401
4
In-Office Preparation & Device Activation
1. Connect Zio™ Event Card
A. Shave electrode area if hair is present.
Clean skin with alcohol. Abrade skin in
‘x’ and ‘+’ motion.
B. Remove two of the enclosed Lead-Lok®
electrodes from the package; re-seal to
keep remaining electrodes fresh.
C. Snap wires of the Zio™ Event Card to
the electrodes. Lift bottom tab at slit and
place the wire underneath through the
slit (Fig. 1).
Lead-Lok® Electrode
D. Position the electrodes on chest (Fig. 2)
(white on the right
of chest; black on
left
on lower rib).
E. Ensure that the electrodes are securely
stuck to chest.
2. Turn on Zio™ Event Card
A. To activate Zio™ Event Card, press and
hold the ‘RECORD’ button for a few
seconds.
Electrode Placement
• The Zio™ Event Card will flash green, beep
and give an upward tone indicating the Zio™
Event Card is now on.
Note: Once Zio™ Event Card is activated and
connected to a patient, it will continue to run
for 30 days.
3. Create Baseline Recording
Patient Recording an Event
A. After connecting and turning on the
Zio™ Event Card, press the ‘RECORD’
button for 1 second and check for a
green flashing light.
• If light is orange, check to ensure
electrodes are securely attached to patient.
• If light is green, proceed to next step.
Zio™ Event Card Sound Port
5
B. Once Zio™ Event Card is connected to
the patient, wait 1 minute for device to
warm up.
C. After Zio™ Event Card is warmed up,
press the ‘RECORD’ button to record the
baseline (Fig. 3).
• You will hear 3 short beeps and see a
flashing green light for 3 seconds.
• When completed after 1 minute, the
monitor will emit 1 short beep and flash
green again for 3 seconds.
4. Transmit Baseline
A. Find a quiet location. Loud noise can
interfere with transmission of data.
• You must send from a landline or portable
phone. Do not transmit from a cell phone.
• A technician will explain the transmission
process.
Call iRhythm National Clinical Center at
Tel: 1-888-693-2401
B. When instructed, place fingers on
electrodes and unsnap the wires from
the electrodes.
C. Place the Zio™ Event Card face up on a
flat stable surface.
D. Place the mouthpiece of the phone
directly over the sound port located
next to the phone icon on the Zio™ Event
Card (Fig. 4).
E. Press and hold ‘SEND’ button for a few
seconds until you hear the Zio™ Event Card
beep and see a green light flashing (Fig. 5).
F. During transmission, a fax-like warbling
tone should be heard.
• When tone ends, pick up phone and speak
with technician.
G. If needed, the technician may instruct
you to retransmit your data.
6
Press ‘SEND’ Button
Reminders
for Patients
• Remove Zio™ Event Card
from electrodes before
bathing or showering.
Electrodes can remain on
your chest.
• Change electrodes every
2 to 3 days or when they
start to peel away from
the body.
• Do not use lotion or
moisturizer in the
areas of the skin where
electrodes will be
attached. Lotions prevent
electrode contact.
• To avoid skin irritation,
when changing
electrodes move the
electrodes slightly from
previous position.
• As the device is
recording or transmitting
an event, remain still and
refrain from talking.
Visual and Audible Indicators
• “RECORD” button only works when the device is attached to electrodes
• “SEND” button only works when the device is not attached to an electrode
NORMAL CONDITIONS
Device Action
Audible Indicator
Visual Indicator
Device Activated
for First Time
1 upward tone
Green flashing light (3 sec)
Leads Snapped to
Electrodes (any time after
initial activation)
1 upward tone
Green flashing light (3 sec)
Recording Started
3 short beeps
Green flashing light (15 sec)
Recording Finished
1 short beep
Green flashing light stops
Leads Unsnapped from
Electrodes
1 downward tone
Orange flashing light (3 sec)
SEND an Event
1 upward tone, pause,
continuous warbling
transmission tone
Green flashing light (3 sec)
Sending Complete
End of warbling
transmission tone
None
Memory Full
none
Orange flashing light (every 10 sec)
Device Action
Audible Indicator
Visual Indicator
SEND button pressed, but
no recordings stored
1 downward tone
Orange flashing light (1 sec)
SEND button pressed, but
leads are attached
1 downward tone
Orange flashing light (1 sec)
RECORD button pressed,
but leads are not attached
1 downward tone
Orange flashing light (1 sec)
RECORD button pressed
while device transmitting
none
Orange flashing light (1 sec)
SEND button pressed again
if device transmitting
none
Orange flashing light (1 sec)
Low battery (replace device)
none
Orange flashing light (continuous)
ERROR CONDITIONS
7
Clinician Quick Reference
Battery
No battery change required.
Completion of Monitoring Period
When 30-day monitoring with the Zio™ Event Card is completed, the patient will
return the monitor to iRhythm for recycling in the pre-paid envelope included in
the original packaging.
• If the patient should lose the included envelope, s/he should take the monitor
to an applicable collection point for the recycling of electrical and electronic
equipment, or s/he can mail it to:
Attn: Recycling Department
iRhythm Technologies, Inc.
650 Townsend Street, Suite 380
San Francisco, CA 94103
Electrodes
Each Zio™ Event Card package contains 32 electrodes.
The patient should change the electrodes:
• Every 2 to 3 days
• If the electrode detaches from the chest
• If the Zio™ Event Card indicates an error condition
The patient can leave electrodes on while showering, bathing or swimming for
2-3 days or until the electrodes peel away from skin
method of wear
• Lanyard
• Belt Clip
Patient Enrollment / Initiate Service
• Complete the enrollment online, by fax, or by phone:
Online: www.zioreports.com
Fax: (888) 693-2402
Tel: (888) 693-2401
• Review the “Patient Instructions,” included in the Zio™ Event Card packaging,
with the patient.
8
General Usage Guide & Reminders for Patients
WARNING: If you experience severe symptoms or you feel the need for
immediate medical attention, call 911. The Zio™ Event Card monitor will not
provide any medical assistance and cannot contact medical personnel for you.
Wearing the Zio™ Event Card
You can wear the Zio™ Event Card in one of two ways: belt clip or lanyard.
Lanyard:
• To adjust the length of the lanyard, use the silver adjustment bead.
• Be sure the bead rests on the back of the neck and slide it up or down
according to your desired length.
• If the lanyard becomes dirty, it can be hand washed. Remove it from
the Zio™ Event Card by sliding it through the slit at the top of the device.
WASH THE LANYARD ONLY.
Changing Electrodes
• The electrodes should be changed every 2 to 3 days or when they start to peel
away from the body. This will ensure your recordings are clear.
• If you experience skin irritation while wearing the electrodes, reposition a new
set close to the original position. If you are unsure of where to reposition the
electrodes, contact the iRhythm National Clinical Center at 1-888-693-2401.
Recording and Transmitting
• Press the ‘RECORD’ button if you experience any symptoms.
• ECG recordings are very sensitive. When experiencing symptoms, refrain from
talking and try to remain as still as possible.
• Be sure to transmit your data as soon as possible. The Zio™ Event Card can
store up to 2 recordings.
• If the memory is full, the Zio™ Event Card will flash orange every 10 seconds,
indicating you have to transmit your data.
• When transmitting, place the Zio™ Event Card on a flat stable surface and be
sure that mouthpiece is placed directly over the sound port (next to the phone
icon) on the device.
• Once the recordings are transmitted, the memory clears itself when
reconnected and is ready for a new recording.
Completion of Monitoring
• Return the Zio™ Event Card device to iRhythm Technologies, Inc. for recycling.
A postage-paid envelope addressed to iRhythm’s Recycling Program is
included in the original packaging.
9
Warnings
• Do not use the Zio™ Event Card in combination with external cardiac defibrillators or high frequency surgical equipment.
• Unless otherwise instructed, you are to wear the Zio™ Event Card monitor
continuously during your normal daily activities.
• Heavy exercise or other activities that expose the Zio™ Event Card to moisture
can cause temporary failure. It is recommended to wear the device away from
the body during these activities, such as in a shirt pocket or on the belt clip.
• Avoid contact with water.
• Remove the Zio™ Event Card before showering, bathing or swimming.
The recorder is not waterproof.
• You may leave the electrodes on if they are still firmly attached to the skin.
Showering
• CAUTION: The Zio™ Event Card is NOT waterproof. Do not shower or bathe
with the monitor attached to the electrodes.
• Before taking a shower or bath, unsnap the lead wires from the electrodes
(that are attached to chest) and place the recorder in a dry place.
• Water will not affect the electrodes, so you do not need to remove them
before showering if they are still firmly attached to the skin.
• If you shower with your electrodes, gently pat them dry with a towel before
reconnecting the lead wires to the electrodes.
General Device Precautions
CAUTION: Portable and mobile RF communications equipment can affect
medical electrical equipment. This device should not be used adjacent to or
stacked with other equipment in accordance with the directions described in the
Practice Reference Manual.
Warning: Lead wires should not contact other conductive equipment or
electric ground including earth.
• This is an EC 38 Type 3 AECG device.
• Lead failures are detected by a 10 mV peak, 50% duty cycle rectangular pulse,
which is applied to each patient electrode connection through a 4.9Mohm
resistor at a rate of 15 Hz with respect to the system ground.
• This is a prescribed medical device, not a toy; keep away from small children.
• In the event of exposed electronics, discontinue use and call iRhythm
National Clinical Center (1-888-693-2401) for return and replacement.
10
This product shall not be treated as household waste. It should
be taken to an applicable collection point for the recycling of
electrical and electronic equipment. Please return Zio™ Event
Card to iRhythm Technologies, Inc. in the included postagepaid envelope for recycling. iRhythm recycles 100% of each
device that is returned to us. No part of the device will end up
in a landfill.
Contact Information
iRhythm National Clinical Center (iNCC)
2 Marriott Drive
Lincolnshire, IL 60069
Tel: 1-888-693-2401
Fax: 1-888-693-2402
www.zioreports.com
iRhythm Technologies, Inc. Corporate Headquarters
650 Townsend Street, Suite 380
San Francisco, CA 94103
www.irhythmtech.com
iRhythm Technologies, Inc. Orange County
14462 Astronautics Lane
Huntington Beach, CA 92647
11
Device Specifications
technical Features
Simple 1-button operation to record ECG
Memory Characteristics
ECG Channels
Maximum Capacity 1 channel
2 recordings, 60s each
Electrical Characteristics
Frequency Response
Input Impedance
Differential Range
A/D Sampling Rate
Resolution
0.5Hz to 30 Hz
≥ 2.0 Mohm
+/- 2.0mV
120 samples/second
8 bits
Physical Characteristics
Dimensions
Weight
82 x 48 x 7.5mm
< 2 ounces (lanyard and cables included)
Power Requirements
Battery type
Battery Life
2 Lithium coin cells
30 days (no changes required), typical usage
Standards Compliance
AAMI/ANSI EC38
IEC 60601-1
E100A4010.06 | Nov. 2010
12
Contact Information
iRhythm Technologies, Inc.
650 Townsend Street, Suite 380
San Francisco, CA 94103
www.irhythmtech.com
iRhythm National Clinical Center
Tel: 1-888-693-2401
Fax: 1-888-693-2402
24 hours / 7 days a week
iRhythm Technologies, Inc., the manufacturer and provider
of Zio™ products and services, markets Zio™ in collaboration
with St. Jude Medical, Inc.
ST. JUDE MEDICAL, the nine-squares symbol, and MORE CONTROL. LESS RISK. are registered and unregistered trademarks
and service marks of St. Jude Medical, Inc. and its related companies.
Zio™ is a trademark of iRhythm Technologies, Inc. ©2010 iRhythm Technologies, Inc. All rights reserved.
clinical Reference Manual