AMT MiniACE Button Gebrauchsanleitung Seite 6

Non-clinical testing demonstrated that the MiniACE
safely in an MR system under the following conditions:



MR Conditional
Under the scan conditions defined, the MiniACE
15 minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the MiniACE
when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.
Low-profile balloon cecostomy devices are meant to be periodically replaced for optimal performance and functionality.
Exact device longevity cannot be predicted. Device performance and functionality can degrade over time depending on
usage and environmental conditions. Typical device longevity will vary for each patient depending on a number of factors,
with typical device longevity ranging from 1-6 months. Some factors that can lead to reduced longevity include: intestinal
pH, diet of the patient, medications, balloon fill volume, trauma to the device, contact with sharp or abrasive objects,
incorrect stoma length measurement, and overall tube care.
For optimal performance, it is recommended that MiniACE
indicated by your healthcare professional. Proactive replacement of the device will help ensure optimal functionality and will
help prevent unexpected device failure. If devices are failing or performance is degrading earlier than the typical range for
device longevity, it is recommended that you speak with your healthcare professional regarding eliminating common factors
that can lead to early device degradation. Also reference the TROUBLESHOOTING section for additional information
regarding device performance issues.
NOTE: To help prevent un-needed hospital visits, it is recommended that a spare device is kept on hand at all times for
replacement in case device failure occurs prior to scheduled replacement.
Thank you for choosing AMT. For additional help and information regarding the use of our device, feel free to contact AMT
with the contact information on the back of the instructions for use. We are happy to hear your thoughts and help with your
concerns and questions.
Australian users please visit us at the link below for the MiniACE® Balloon Button Patient Information Leaflet:
Do Not Resterilize
Not made with natural rubber latex
®
The ENFit connection is intended to reduce misconnections
with other non-enteral healthcare applications.
MRI SAFETY INFORMATION
Static magnetic field of 1.5-Tesla and 3-Tesla, only
Maximum spatial gradient magnetic field of 1,000-gauss/cm (10-T/m)
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for
15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode
®
DEVICE LONGEVITY
www.appliedmedical.net/resources/miniace_aus_pil.pdf
Sterilized Using Ethylene
Oxide
®
Button is MR Conditional. A patient with this device can be scanned
Button is expected to produce a maximum temperature rise of 1.6°C after
®
Button extends approximately 20-mm from this device
®
Button devices be changed every 3 months or as often as
THANK YOU!
Rx Only
Single Use Only
ENFit
Enteral Device Supplier Association, Inc.
Prescription Only
Do not use if package is dam-
aged
Not made with DEHP (Di(2-
ethylhexyl) Phthalate)
®
is a registered trademark of Global
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