File
Name
IFU of
AMSure
®
Enteral
Feeding
Pump and Feeding Set
REF
#
L10196_US
Version
B
Page
6
of
81
AMSINO Confidential
1.2 Contraindication
1.
Do not use the
AMSure
®
enteral feeding pump and feeding set for
parenteral feeding. This device is not intended for intravenous use.
2. Do not use the
AMSure
®
enteral feeding pump and feeding set if enteral
feeding is contraindicated. We recommend you contact your healthcare
provider for further instructions.
3. The
AMSure
®
enteral feeding pump and feeding set should only be used
for patients who can tolerate the flow rates and the accuracy levels
delivered by the pump.
4. The
AMSure
®
enteral feeding pump and feeding set are only intended for
adult patients, not for pediatric use.
1.3 Warning
Please read the following warning information carefully. If not avoided, could
result in death or serious injury.
Read these instructions thoroughly before using the pump.
1.
Do not use the pump and set for parenteral feeding of patients and the
infusion of blood, analgesia, anesthesia, insulin, and chemotherapy
drugs.
2.
Do not operate the pump by untrained personnel. Users should read this
manual carefully to prevent medical accidents caused by improper
operation. Operator shall stand in front of the pump while setting it up
and operating.
3.
Do not install the pump in dusty places or in an environment where
flammable or explosive materials are placed to prevent fire or explosion.
Such as flammable anesthetic gas or a mixture of oxygen and nitrous
oxide gas.
4.
Do not use the pump in an environment of strong shocking vibrations and
strong external electromagnetic interference and radiation, such as MRI
environments.
5.
Do not immerse the pump in the liquid. The pump is an IPX4 water-proof
device. Avoid liquid infiltration into the pump, including nutrient solution,
and always keep the pump clean and dry.
6.
Do not use the enteral feeding set which is not listed in this instruction
for use for enteral feeding, otherwise feeding may not accurate. Use of
the RFID technology, when enabled on the pump, is one of the solutions
for user to avoid using incorrect sets.
7.
Do not use an enteral feeding set for over 24 hours.
8.
Do not place the pump adjacent to or stacking together with other
equipment unless it is necessary to do so. Ensure the pump is working
correctly if it is proximity to other equipment.
If the same or similar
equipment is used in a separate area, there will be dangers if different
alarm presets are used, such as an intensive care unit or a heart
operating room.
9.
Do not connect other tubes to the patient's gastric tube when pump is in
a feeding at the same time. This may affect patient feeding.
10.
Do not use the pump as a portable device.
