iRhythm Technologies Inc. AT18G Manual De Usuario
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Warnings (cont’d)
• The Zio AT system is MR Unsafe!
- Do not expose the Zio AT patch or gateway to a magnetic
resonance (MR) environment.
- The Zio AT patch or gateway may present a risk of
projectile injury due to the presence of ferromagnetic
materials that can be attracted by the MR magnet core.
materials that can be attracted by the MR magnet core.
- Thermal injury and burns may occur due to the metal
components of the Zio AT patch that can heat during MR
scanning.
scanning.
- The Zio AT patch may generate artifacts in the MR image.
- The Zio AT patch or gateway may not function properly
due to the strong magnetic and radiofrequency fields
generated by the MR scanner.
generated by the MR scanner.
If skin irritation such as severe redness, itching or
allergic symptoms develop, remove the Zio AT Patch
from the patient’s chest. Call iRhythm Customer
Service at 1.888.693.2401
allergic symptoms develop, remove the Zio AT Patch
from the patient’s chest. Call iRhythm Customer
Service at 1.888.693.2401
CAUTION: Federal (USA) law restricts the sale of this
device to or on the order of a physician.
device to or on the order of a physician.
Precautions
• Safety and effectiveness of the Zio AT 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.
been established. Paced cardiac rhythms may not be
accurately detected and may be incorrectly classified.
• Safety and effectiveness of the Zio AT system on pediatric
patients (younger than 18 years old) has not been
established.
established.
• The Zio AT system includes temperature and humidity
limitations when stored/transported. If exposed during
storage/transport, patients may experience degradation
of adhesive performance causing the Zio AT patch to slip
or fall off during the patient wear duration.
storage/transport, patients may experience degradation
of adhesive performance causing the Zio AT patch to slip
or fall off during the patient wear duration.
• The Zio AT system has a shelf-life date. Use of expired
device may cause a degradation of ECG signal quality
and/or low battery condition.
and/or low battery condition.
• Do not use the Zio AT system if package is damaged.
Device may not perform as intended.
• Keep device and packaging away from young children.
Contents may be harmful if swallowed. Patch contains
button cell batteries that are not accessible during
normal use but, if exposed, are known choking hazards
and may cause severe tissue injury if ingested.
button cell batteries that are not accessible during
normal use but, if exposed, are known choking hazards
and may cause severe tissue injury if ingested.
• Registration errors may result in limited functionality
or erroneous ECG reporting. Utmost caution should be
applied to ensure that patient registration is accurate and
complete.
applied to ensure that patient registration is accurate and
complete.
The patient is an intended operator
Package Contents
1 Zio AT patch
1 Zio AT gateway, containing:
1 postage-paid return envelope
1 Skin Prep & Placement Kit containing:
1 patch card template
1 disposable razor
1 abrader disc
4 alcohol wipes
1 Application instructions
1 Wearing your Zio manual & button press log containing:
1 adhesive remover wipe