COOK Medical Entuit Gastrostomy BR Gebrauchsanweisung Seite 5

TUBE REMOVAL (continued)
3. Remove any contents inside the balloon using a syringe.
4. Pull device out of stoma while simultaneously applying counter-pressure to the patient's
abdomen.
5. Clean stoma site with mild soap and water. Allow area to dry.
6. Dispose of device following the guidelines for biohazardous waste provided by the healthcare
institution.
7. If a replacement device is required, follow instructions provided in "DEVICE PREPARATION" and
"DEVICE PLACEMENT" instructions above.
Caution: Stoma tract may begin to close in the first hour following device removal.
TUBE MAINTENANCE
1. The stoma site should be inspected and cleaned regularly. Cleaning should be performed with
mild soap and water, remove moisture afterwards. Notify physician if signs of infection or
irritation are observed.
2. Clean residual contents from the external area of the feeding tube with mild soap and water as
needed; remove moisture afterwards.
3. Rotate device daily to allow for adequate air circulation. Consult with physician if device does
not rotate freely.
4. In order to prevent feeding tube clogging, always flush feeding lumen with prescribed amount
of water after feeding administration, every 4-6 hours during continuous feeding, before
administering medication and after medication administration is complete.
Note: The amount of water used for flushing will depend on patient's need, clinical condition and
if patient is an infant or adult.
5. Assess the feeding tube daily for damage, clogging or abnormal discoloration.
6. Check balloon volume weekly, or as recommended by the physician, and compare to initial volume
used to inflate balloon in order to determine balloon integrity.
7. A loss of volume over time may be compensated for by refilling the balloon. A large drop in fill
volume may indicate the need for device replacement.
8. Replace device as or if necessary following the "DEVICE PREPARATION" and "DEVICE PLACEMENT"
instructions in the section above.
MRI SAFETY INFORMATION
This device is MR Conditional.
Non-clinical testing demonstrated that this device is MR Conditional. A patient with this device can
be scanned safely, immediately after placement under the following conditions:
• Static magnetic field of 3 Tesla or 1.5 Tesla
• Maximum spatial gradient magnetic field of 1,000-Gauss/cm or less
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of
4-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the First Level Controlled
Operating Mode of operation for the MR system
MRI-RELATED HEATING
Under the scan conditions above, this device is expected to produce a maximum temperature rise of
less than 2.2°C after 15 minutes of continuous scanning.
ARTIFACT INFORMATION
The maximum artifact size as seen on the gradient echo pulse sequence at 3-Tesla extends
approximately 20-mm relative to the size of the shape of this device.
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