Download EndoVive™ 3s Low Profile Balloon

Boston Scientific, Master Brand User’s Manual Template 8.5in x 5.5in EN, 20-0993-PCG Rev/Ver. AB
EndoVive™ 3s
Low Profile Balloon
With ENFit™ Connector
Patient Care Guide
“Helping you and your loved one manage your nutritional needs”
Black (K) ∆E ≤5.0
Guide to the Guide
Introduction to Enteral feeding............................................................ 3
Gastric Decompression....................................................................... 12
EndoVive™ 3s Low Profile Balloon Kit Contents............................. 4
Replacing the EndoVive 3s Low Profile Balloon............................ 13
About the EndoVive 3s Low Profile Balloon...................................... 5
Device Maintenance and Stoma Site Care..................................... 15
About the EndoVive 3s Extension Sets............................................... 6
Stoma Site Care and Concerns.......................................................... 17
Why the EndoVive 3s Low Profile Balloon........................................ 7
Patient Concerns.................................................................................. 18
Extension Set Assembly........................................................................ 8
Special Care for Pediatric Patients.................................................. 20
Feeding with the EndoVive 3s Low Profile Balloon......................... 9
Problem Solving................................................................................... 22
Bolus Feeding....................................................................................... 10
Patient Information Sheet................................................................... 24
Continuous Feeding............................................................................. 11
Ordering Information........................................................................... 26
Delivering Medications...................................................................... 12
2
Introduction to Enteral Feeding
Adequate nutrition is essential for supporting life. There are several health conditions that can make conventional nutrition difficult or
impossible to achieve. In such cases, a gastrostomy feeding tube may be surgically placed for providing direct access into the stomach and
facilitating the delivery of nutrients by means of enteral feeding. The use of feeding tubes, in many cases, is expected to have a positive impact
on the overall health and clinical management of patients, specifically, by aiding in the replacement of a body function and by significantly
improving patient management and quality of life.
What is tube feeding?
Enteral feeding, or tube feeding, is a way to deliver nutrients through a tube if you cannot take food or drink through your mouth. In
some cases, you may only need tube feeding for a short period of time during your hospital stay. In other cases, you may need to
go home with the tube in place and continue to receive nutrition this way. It may be temporary or long term.
Why tube feeding?
Tube feeding provides you with proper nutrition when a condition makes it difficult, unsafe, or impossible to take food in through
your mouth. Fluids and medicines can also be given through the tube. Commercially prepared or homemade nutritional formulas
are used for enteral feeding; however, proper nutrition depends on the right types and amounts of nutritional formulas. Physicians
will prescribe each patient with the feeding procedure, formula and amount of water for effective nutritional support.
The information provided in this guide is for assisting patients and caregivers during use and care of the EndoVive™ 3s Low Profile Balloon.
This information is for guideline purposes only and is not intended to replace your doctor’s advice and instructions.
3
Kit Contents
EndoVive™ 3s Low Profile Balloon
(low profile device) is a silicone
gastrostomy tube that provides direct
access into the stomach for enteral
feeding, delivery of medications and for
gastric decompression.
Water-Soluble Lubricating
Jelly for tube lubrication
Bolus Feeding Extension Set for bolus feeding.
Continuous Feeding Extension Set
for continuous feeding and medication delivery.
WATER SOLUBLE LUBRICATING JELLY
Two (2) Gauze Pads for ease of tube
lubrication.
Stiffener for facilitating insertion of the
low profile device.
Only available with 12, 14 and 16 French size kits.
Feeding Port Transition Connector to allow
connection of catheter/slip tip feeding syringes
and Christmas tree connectors commonly used
with feeding extension sets.
Medication Port Transition Connector to allow connection of
luer slip and luer lock medication syringes.
Feeding Syringe for bolus feeding
and for flushing the low profile device
with water when connected to an
Extension Set.
Inflation Syringe for balloon inflation
and deflation.
4
About the EndoVive™ 3s Low Profile Balloon
Stiffener
Only available with 12, 14 and 16 French size kits
Feeding Port
The feeding port connects to Extension
Sets for feeding, medication delivery and
decompression.
External Bolster
The bolster is for external device retention.
Its flexible design is intended to increase
patient comfort.
Balloon Inflation Valve
A luer slip inflation syringe is connected
to the inflation valve to inflate and deflate
the balloon. It is angled for easy access.
Feeding Port Cap
The cap is used to cover the feeding port
when the device is not in use. It has a
reinforced strap.
Dome Valve
The dome valve opens when Extension
Sets are connected to the feeding
port for feeding, medication delivery
or decompression. The one-way valve
prevents leakage of gastric contents
when device is not in use.
Balloon
Once inside the stomach, the balloon is inflated for internal device
retention. The balloon is then deflated for device removal. The
recommended balloon fill volume is printed on top of the balloon
inflation valve. Its
French (Fr) Size
Recommended Balloon Fill Volume
inflated pancake12 Fr
4 mL
14 Fr
4.5 mL
shaped design is
16 Fr
5 mL
intended to minimize
18 Fr
6 mL
accidental removal
20 Fr
7 mL
and promote sealing
22 Fr
8 mL
24 Fr
10 mL
at the stoma site.
Radiopaque Marker
The radiopaque marker is for
fluoroscopic visualization.
5
About the EndoVive™ 3s Extension Sets
Note: This device incorporates ENFit™ connectors which are designed to reduce the likelihood of tubing misconnections; however, the
potential to misconnect this device with medical devices of other healthcare applications still exists.
Port Caps
Bolus Feeding Port
Feeding Port
Medication Port
Pinch Clamp
Pinch Clamp
Right Angle Extension
Set Connector
Straight Extension
Set Connector
6
Why the EndoVive™ 3s Low Profile Balloon Kit
• Balloon shape is designed to promote sealing at the stoma site
• Designed to minimize leakage through the device
• B
alloon durability longer than Mic-Key™ and AMT Mini One when tested in
accordance to ASTM F2528-06(G)
• E ndoVive 3s Extension Sets are compatible with Mic-Key and AMT Mini One low
profile devices
• Recessed balloon is designed to allow ease of insertion into the stoma tract
• Recessed distal tip when balloon is inflated
• Designed for initial placement or replacement procedures
• Adult and Pediatric Indication
• Flexible Bolster for patient comfort
• Includes radiopaque marker for fluoroscopic visualization
7
Extension Set Assembly
The Extension Sets provided in this kit are intended for enteral use only. Do NOT connect with medical devices that are not intended for
enteral feeding.
Note: Before and after each use, the extension set should be washed with warm water.
1. Remove feeding port cap.
2. While firmly holding the external bolster of the low profile device, insert the extension set connector into the feeding port using
the printed alignment marks as reference. Holding the device during extension set assembly helps prevent patient discomfort
which may happen due to forces applied during the connection and removal of extension sets.
3. Rotate the extension set connector CLOCKWISE until the connector stops (approximately ¾ of a turn). Do not use excessive
force when inserting and rotating the extension set connector. Do not rotate extension set connector past the stop mechanism.
Fig. 1 Device
Fig. 2 Inserted
Fig. 3 Lock
Fig. 4 Unlock
4. To remove the extension set, firmly hold external bolster and rotate connector COUNTER-CLOCKWISE until the mark on the
extension set connectors is aligned with the black mark on the feeding port.
5. Remove extension set.
6. Reconnect the feeding port cap of the low profile device.
8
Feeding with the EndoVive™ 3s Low Profile Balloon
VERIFICATION OF DEVICE PLACEMENT
Verify proper device placement before feeding administration.
1. Determine the extension set type (Bolus or Continuous) required for feeding and then connect to the low profile device following
the instructions provided on pages 10-11.
2. Draw 10mL of water into the feeding syringe provided in this kit and insert into the extension set port.
3. Gently pull back on syringe plunger until stomach contents (typically yellow or clear unless food is in patient’s stomach) are
removed and visible in the tube of the extension set.
Note: The presence of gastric contents in the feeding lumen confirms correct positioning and that feeding tube is inside the stomach lumen.
4. Flush contents with the 10mL of water in the feeding syringe.
Contact physician if proper device placement cannot be confirmed with this method.
FEEDING ADMINISTRATION Feeding administration should be performed according to instructions provided by physician. Do not
administer solids through feeding tube or extension sets.
9
Bolus Feeding
Bolus feeding is often prescribed for patients able to feed themselves without the assistance of a caregiver. Usually Bolus feeding patients
can tolerate a large amount of formula at one time. The formula is poured into a large syringe or feeding bag. A tube on the feeding bag or
the tip of the Bolus feeding syringe is connected to the patient’s feeding port. The formula moves from the bag, or syringe, into the patient’s
stomach. A clamp on the tube controls how fast the formula moves through the tube. Bolus feedings are usually given three or four times a
day. Each feeding takes approximately 15 to 30 minutes.
Use with transition connectors
Connectors found in separate
patient care bag in kit box.
10
Continuous Feeding
Continuous feeding is used primarily for patients who cannot tolerate large amounts of formula at one time (Bolus feeding). The
physician prescribes small amounts to drip slowly and constantly into the stomach or jejunum. The formula moves from a feeding bag to the
patient’s feeding port, sometimes with the help of a pump, at a prescribed flow rate over a period of 8 to 24 hours.
1
Use with transition connectors
Connectors found in separate
patient care bag in kit box.
11
Delivering Medications
• O
nly administer medication after confirmation of proper feeding tube placement. Administration of medication should be performed
according to the instructions provided by your physician.
• Do not crush medication that has an enteric coating and do not mix medication with feeding
formula. Use medication in liquid form whenever possible. If only solid medication is available,
seek advice from your physician on how to administer medication.
1. Connect an extension set (Medication or Continuous) to the low profile device.
2. Before administering medication, flush device with prescribed amount of water using the feeding
syringe contained within this kit.
3. Connect medication port transition connector to the medication port of the extension set.
4. Administer medications by connecting the syringe to the medication port transition connector.
5. Flush device with prescribed amount of water using the feeding syringe.
Gastric Decompression
1
• D
ecompression or “venting” is conducted for removing gas or fluid from the stomach. Additional
instructions for decompressing the stomach and for monitoring stomach residual will be provided by your physician.
1. Connect an extension set to the low profile device according to the instructions provided on page 8.
2. Decompression should be conducted according to the instructions provided by your physician. If prescribed, drain stomach
contents into a container.
3. When decompression is complete, flush the extension set and low profile device with the prescribed amount of water.
4. Disconnect the extension set and then rinse with mild detergent and warm water. Allow to dry thoroughly.
12
Replacing the EndoVive™ 3s Low Profile Balloon
Wash hands thoroughly before handling devices. Always read the Directions for Use included within this kit before device replacement.
DEVICE REMOVAL
1. Use powder-free gloves before touching stoma site.
2. Gently rotate the low profile device to ensure the tube moves freely and easily.
CAUTION: If the device does not rotate freely, do not attempt to remove. Contact your physician immediately.
3. Do not use excessive force when removing device. If you feel resistance, apply lubricating jelly and manipulate tube by pushing
and rotating until tube moves freely and easily. Contact physician if you are not able to remove feeding tube.
4. While firmly holding the external bolster of the device, deflate the balloon using the inflation syringe.
5. Pull device out of stoma while simultaneously applying counter-pressure to the patient’s abdomen.
Note: Stoma tract may begin to close in the first hour following device removal.
DEVICE PREPARATION
The length of the stoma should be measured prior to device replacement to ensure appropriate sizing. Ask your physician about this.
1. Inspect integrity of device packaging and kit contents before using the new device. Do not use device if package or contents are damaged.
2. Using the inflation syringe contained within this kit, inflate the balloon of the new device to the recommended fill volume printed on top
of the balloon inflation valve with sterile or distilled water. Verify balloon integrity by visually inspecting inflated balloon for symmetry
and by gently squeezing the balloon to determine if the balloon is leaking. Do not use device if any suspected characteristics that may
affect the performance of the balloon are noted. Deflate balloon by removing all water from balloon using the inflation syringe. Do not
attempt to use device if balloon cannot be deflated. Do not use air, saline, feeding formula or medication for balloon inflation.
3. When using 12, 14 and 16 French devices:
3.1 Insert the stiffener into the feeding port of the low profile device.
Do not use device if the tip of the stiffener protrudes past the tip of the low profile device.
13
Replacing the EndoVive™ Low Profile Balloon
DEVICE PLACEMENT
1. Lubricate the tip of the device with the lubricating jelly for ease of insertion. Gauze pads provided in this kit may be used for ease
of tip lubrication. Do not use petroleum jelly or mineral oil for tip lubrication.
2. Carefully insert device through the established stoma and into the stomach lumen.
3. Verify proper device placement following the instructions provided on page 9.
4. While firmly holding the device’s external bolster, inflate the balloon to the recommended fill volume printed on top of the balloon
inflation valve with sterile or distilled water.
French (Fr) Size Recommended Balloon Fill Volume French (Fr) Size
12 Fr
14 Fr
4 mL
4.5 mL
16 Fr
5 mL
18 Fr
6 mL
Recommended Balloon Fill Volume
20 Fr
22 Fr
7 mL
8 mL
24 Fr
10 mL
Note: “Fr” means “French” and “mL” means milliliters
5. Ensure that the external bolster is flush with the stomach. Verify that there is no leakage of gastric contents around the stoma
site and that there is not excessive pressure between the balloon and external bolster. Inflating balloon with less volume than
the recommended volume may result in leakage of gastric contents and/or device migration. Inflating balloon with more
volume than the recommended volume may decrease balloon performance and reduce available stomach volume.
6. If stiffener is present (for 12, 14, and 16 French devices only), firmly hold the external bolster of the low profile device, and slowly
remove the stiffener.
7. Clean any contents remaining on the device with mild soap and water.
8. Clean stoma site with mild soap and water or as directed by physician. Allow area to dry.
Always have an additional EndoVive 3s Low Profile Balloon kit available in the case that emergency replacement is necessary.
14
Device Maintenance and Stoma Site Care
DEVICE MAINTENANCE
1. Check balloon volume weekly, or as recommended by the physician. Remove contents from inflated balloon and compare to
initial volume used to inflate balloon. Re-inflate balloon with recommended fill volume (see page 14).
2. Rotate low profile device daily to allow for adequate air circulation. Consult with physician if device does not rotate freely.
3. The feeding devices should be visually inspected and cleaned regularly. Cleaning should be performed with mild soap and water.
Allow devices to dry thoroughly after cleaning.
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.
5. Assess the feeding tube daily for damage, clogging or abnormal discoloration.
6. Contact your physician if there are any questions regarding the integrity of the devices.
DEVICE-RELATED CONCERNS
• Disconnections between feeding devices:
• Immediately stop feeding if devices are disconnected. Estimate the amount of formula lost. Wash the Extension Set and rinse
the other tube connections with mild soap and water until free from formula buildup. Clean inside the feeding ports with mild
soap and water. Flush the gastrostomy tube with warm water and allow connectors to dry. Replace the estimated volume lost
during the disconnection, reconnect the feeding devices and resume feeding as normal.
• Tube occlusion/clogging:
• Improper cleaning, use and maintenance of gastrostomy tubes may lead to tube occlusions. If your tube is clogged, try
flushing with 10-20 mL of warm water. If the tube remains clogged, carefully massage the tube and skin to help remove the
occlusion. Contact your doctor if your tube remains clogged. Do not place foreign objects down the center of the low profile
device as this may damage the device or lead to patient injury.
15
Device Maintenance and Stoma Site Care
• Tube occlusion/clogging: (Continued)
• To prevent tube clogging, feeding formula should not be mixed with medications and, whenever possible, medication should be
delivered in liquid form. Ensure that the flushing frequency is adequate. Unless your doctor instructs you otherwise, always ensure
to flush your gastrostomy tube every 3 - 4 hours during continuous feeding, after checking stomach residuals, and before and after
administering nutrition or medications.
• Inadvertent device removal:
• While the EndoVive™ 3s Low Profile Balloon is designed to decrease the probability of inadvertent device removals, the gastrostomy
tube may be accidently removed if pulled or if the balloon ruptures. In certain cases, a confused or disoriented patient may attempt to
pull his/her own device out. Do not panic if device pullout occurs. Immediately call your doctor and go to the emergency room since the
stoma may begin to close within the first hour after the device is removed. Do not attempt to replace the low profile gastrostomy tube,
unless you have been trained by physician or healthcare provider. Refer to page 13 of this guide for device replacement instructions.
• Balloon performance:
• The life span of the balloon will vary and depends on several factors. Over time, the balloon on your device may leak or rupture due to
poor device maintenance, volume/type of fluid used for balloon inflation, the types of medications/feeding solution being administered,
stomach pH level, stomach pressure, level of patient activity and the patient’s health condition. Do not remove the low profile device
until a replacement is available.
• Leaks within the device:
• Stop feeding if devices are leaking feeding formula. Clean devices and allow for drying. Firmly reconnect the feeding devices and
resume feeding. Inspect the site where leaking occurred. If leakage continues, the device may have to be replaced.
• If the balloon will not deflate, clean the inflation valve to remove any feeding formula, medication or other contaminants that may be
obstructing the inflation valve. Connect a luer slip syringe to the inflation valve. Simultaneously push and rotate syringe slightly while
checking if balloon deflates. Try pulling back on the syringe plunger. If the balloon cannot be deflated, call your doctor.
16
Stoma Site Care and Concerns
STOMA SITE CARE
1. The stoma site should be inspected and cleaned regularly. Cleaning should be performed with mild soap and water or as
directed by physician. The stoma may also be cleaned during a bath. Always allow stoma site to dry thoroughly after cleaning.
Notify physician if signs of infection or irritation.
2. Check stoma site daily for redness, crusting, bleeding, pain, swelling or unusual contents or odor. Contact your physician if any
of these conditions occur.
3. Rotate low profile device daily to allow for adequate air circulation. Consult with your doctor if device does not rotate freely.
STOMA-RELATED CONCERNS
• Excessive pressure at stoma site:
• If you feel excessive pressure in or around your stoma, verify that your gastrostomy tube rotates freely around the stoma and
that there is no redness or bleeding at the stoma site. Call your doctor if your tube does not rotate freely or there is redness/
bleeding present. Your doctor may have to remeasure your stoma and replace your device.
• Applying tension to your device may also lead to excessive pressure at the stoma site.
• Leakage around stoma site:
• Stomach contents may leak around the tube and out of the stoma. Always verify stomach residual to ensure that the stomach
is not too full. If there is excessive stomach residual, the patient may be having a hard time emptying the stomach or may be
getting too much formula at one time. Talk to your physician about decreasing feeding flow rates and frequencies.
• Check the integrity of the balloon by gently pulling the tube away from the abdomen and verifying resistance. If no resistance
is felt, the balloon may have ruptured and a new device will need to be placed. If resistance is felt, remove water from
inflated balloon and compare against the previous volume that was used to inflate the balloon. If volume is missing, refill the
balloon with the rated fill volume and after a few minutes verify the balloon integrity using the same procedure.
17
Stoma Site Care and Concerns
• Leakage around the stoma site may also occur if your gastrostomy tube is too loose around the stoma or if it has pulled away
from the inner abdominal wall. Having your device fit too tight around the stoma can cause your stoma tract to become
enlarged and may eventually cause some leakage. Talk to your doctor if you notice any of these conditions.
• Granulation tissue:
• Granulation tissue is typically red or pink soft tissue that is a result of the body trying to attempt to heal the stoma site after
the surgical incision. Granulation tissue bleeds very easily and can rapidly grow. Contact your physician if continuous
buildup of granulation tissue or bleeding persists.
• To reduce friction against the granulation tissue, stabilize Extension Sets by securing them against the abdomen and
away from the tissue. Leakage may also occur as a result of granulation tissue. Keeping the area dry and open to the air
is extremely important for repairing of the tissue and diminishing leakage. Using dressings and pads can also help reduce
friction and absorb leakage to keep the area dry.
Patient Concerns
• Caring for the mouth:
• The mouth should be cared for even if the patient is not eating. Brush teeth, gums and tongue every day. Older patients may
use a mild mouthwash if the doctor allows. Infants who still need to suck may use a pacifier. Lips should be moistened with
water or a moisturizing lotion. Report any persistent bleeding of the gums.
• Constipation:
• Constipation may occur when patients are inactive for long periods of time, when the patient is receiving insufficient amounts of
water or when there are changes in feeding formulas, medications or in feeding routines. Certain formulas can cause constipation
in different individuals. Using the restroom as soon as needed, exercising and staying active may help with constipation.
• Diarrhea:
• Administering spoiled formula or delivering formula too quickly can cause diarrhea. Try feeding at different schedules and
18
Patient Concerns
slower flow rates. Always ensure that leftover formula is refrigerated, new formula is mixed prior to each feeding and that
mixed formula is not kept for longer than 24 hours.
• Hands must be washed thoroughly before preparing formula and handling feeding devices. It is important to maintain the
cleanliness of devices and feeding formulas. Ensure that feeding devices are thoroughly washed with mild soap and water.
Call your doctor if nausea or diarrhea persists.
• In some cases, diarrhea may lead to dehydration. Abnormal thirst, dry lips, weakness, a fever and urine color or odor are
signs of dehydration. Contact your doctor if dehydration is suspected.
• Upset Stomach/Vomiting:
• Patients may experience an upset stomach if too much formula is administered or if the formula is delivered too fast at one time. If
the patient feels nauseous, do not force the feeding. Wait an hour or so before continuing, or try decompressing the stomach. If the
nausea continues, try giving smaller, more frequent feedings. Ask the doctor or health care provider if the formula may be diluted
with water. Skip the feeding if vomiting occurs. You may resume feeding in an hour or so, but stop completely if the vomiting occurs
again. If the upset stomach doesn’t stop enough to start regular feedings again in 24 hours, call the doctor or health care provider.
• Aspiration:
• When vomiting occurs, it is possible to inhale formula and stomach contents into the lungs. Aspiration (inhalation of food or
stomach contents into the lungs) can lead to serious medical problems. Stop feeding if aspiration occurs. If there is difficulty
with breathing, immediately place the patient on his/her side or propped up while you call your doctor or healthcare provider.
Call your doctor if any of the following occurs:
• Vomiting or difficulty breathing
• Diarrhea, dehydration, weakness or fever
• Redness, blood, crusting, puss, inflammation, pain
or drainage with bad odor around your stoma site
• Drastic changes in your weight
• If your device has been accidentally removed and you cannot replace it
• If your device is clogged and you cannot free the clog
• If there is repetitive leakage of food or stomach contents. If there is
leakage, the low profile feeding tube may be too loose or too tight and
should be re-measured. Call your doctor to have the low profile feeding
tube re-measured.
19
Special Care for Pediatric Patients
Pediatric patients have smaller stomach volumes than adult patients and are less tolerable to larger and more frequent feeding sessions.
Children have special needs and as such require special care. The following information may be beneficial if you care for a pediatric patient.
• Smaller stomachs:
• Infants have small stomachs and have difficulty with holding large amounts of food. Feeding administration for children
usually begins with small amounts of formula and frequent feeding sessions. It is important to be patient and to gradually
increase the amount of formula given during feeding sessions.
• Feeding device tubing shall be primed with water or feeding solution before feeding to prevent air from entering the stomach.
• In certain situations, formula may leak around the stoma site if the child has a full stomach. This may lead the child to vomit or
burp up formula. Consult with your physician to determine if stomach decompression and residual monitoring is appropriate
for the child.
• Constantly developing bodies:
• Children that use gastrostomy tubes have the same basic growth and developmental needs as other children. Children
develop the capacity to hold large feedings in their stomachs as they grow.
• Measure stoma size and length periodically to ensure proper fit.
• As your child’s body develops, there will also be a need for the amount of feeding to increase. Ask your specialist for
additional feeding guidelines.
• Talk to your specialist about ways to promote normal development.
• Emotional needs:
• It is normal for children to feel worried or embarrassed about having a gastrostomy tube. Some children may feel
uncomfortable or nervous when being fed in presence of other people. These emotions may be overcome by hiding the
gastrostomy tube under clothing. The EndoVive™ 3s Low Profile Balloon has a low profile design that sits closer to the
20
Special Care for Pediatric Patients
abdomen making it less visible under clothing. Always remind your child that the gastrostomy tube helps sustain life and
improve his/her quality of life. If emotions persist, offer resources to help your child cope, including help from specially
trained social workers or child psychologists.
• When receiving nutrition through the use of a gastrostomy tube, it is of great importance for children to participate with family
members at the table during meals. Unless your doctor advises otherwise, always encourage the child to touch and taste
food. This gives children the opportunity to feel included and to develop an experience with food.
• In most cases, infants are able to suck even when they cannot tolerate conventional nutrition. You may use pacifiers to
stimulate your baby’s lips, gums, and tongue during feedings. You may find that the use of a pacifier will relax and comfort
your baby during feeding sessions. Experiment with additional methods to chew and suck as your baby grows. Consult with
your doctor/specialist about ways to provide oral stimulation for your child.
•
Tube sizes:
• Low profile gastrostomy tubes used in children are normally shorter and have smaller diameters than the tubes used in
adults. Smaller tubes require less water for flushing, but clog more easily than the larger tubes. It is important to inspect the
tube to ensure that it is not clogged on a daily basis and flush it as you administer feeding solutions and deliver medications.
•
Activity level:
• As part of the normal development process, babies will learn to crawl and move around. Many times babies will roll over
on their stomachs. The EndoVive™ 3s Low Profile Balloon is designed with an external profile that lay’s against the baby’s
stomach to reduce the likelihood of tube migration as they baby moves around. This low profile device helps support a child’s
level of activity which will ultimately have a positive impact in the quality of life of children.
21
Problem Solving
PROBLEM
POSSIBLE CAUSES
ACTIONS
Leakage around the device
• Make sure the balloon is filled. (Resistance should be felt when
Causes for leakage:
gently pulling on the tube.) Make sure the balloon is filled to the
• Incorrect size
prescribed volume.
• Weight change
• Check that the low profile balloon corresponds to the prescribed
• Amount of water in balloon may be too
French size and length. If the incorrect device is in place, call your
much or too little
doctor.
• Tension at stoma site (from extension sets) • The low profile balloon may be too tight or too loose. Call your
• Stomach may need to be decompressed
doctor to have the stoma remeasured. For new placements, it may
take time for the stoma tract to naturally heal, firm up around the
• G.I. function has decreased, or feeding
tube, and conform to the balloon. If leaking persists contact your
rate may be too rapid
healthcare provider.
• Be sure to rotate the tube daily.
Balloon failure
A balloon may leak or burst over time due
to medications, balloon inflation volume,
stomach acid, g-tube care, or natural wear.
Always keep an extra g-tube on hand in case of incident. Do NOT
remove g-tube until a replacement is available in order to prevent the
stoma from closing.
Balloon will not deflate
Various
Clean the balloon port with a cotton swab to make sure formula/
medication or other contaminants are not blocking the balloon
port. Insert a slip tip syringe, push and twist one-quarter turn. If the
problem persists call your doctor.
Skin redness or irritation
around gastrostomy site
Stomach contents leak around the tube
Check stomach for residual. If excessive residual occurs often, the
patient may be receiving too much formula at one time, the stomach
may not be emptying normally, or the low profile balloon may be too
loose or too tight. Call your doctor to have the stoma remeasured.
22
Problem Solving
PROBLEM
POSSIBLE CAUSES
ACTIONS
Feeding tube becomes
disconnected
Various
Stop the feeding pump and estimate the amount of formula lost. Wipe tube connections
thoroughly with soap & water. Clean the inside of the extension set feeding port with a
cotton swab and soap and water. Dry connectors and reconnect tubes. Resume feeding,
adding additional formula for the estimated loss.
Feeding tube becomes
blocked/occluded
Inadequate flushing
Flush low profile balloon with 5 ml (10-20 ml for adults) warm water before and after
administering food or medication, every 3-4 hours of continuous feeding, and after checking
for stomach content residual. Do NOT place foreign objects down the center of the low
profile balloon. This will damage the low profile balloon causing it to become nonfunctional.
Make sure the low profile balloon is in the correct location within the stomach.
Tube is too tight against
the skin
Various
The low profile balloon should be able to turn easily without resistance from the patient’s
skin. If low profile balloon does not turn easily or redness/bleeding occurs at the stoma or
the area directly underneath the low profile balloon, call your doctor. The patient may need
to be remeasured for a longer low profile balloon.
Feeding tube is pulled
out of the patient
Various
Although the low profile balloon is designed to decrease the number of pull outs, a low
profile balloon may become accidentally dislodged. Replace the device immediately or
call your doctor as the stoma may begin to close within the first hour a device is removed.
Refer to pages 12-15 and/or the Directions for Use. Always be sure to have a replacement
low profile balloon on hand for immediate replacement.
Vomiting
Various
Aspiration (inhalation of food or stomach contents into the lungs) may occur while
vomiting, causing difficulty in breathing or other serious medical conditions. Stop feeding
and decompress the stomach immediately if incidence occurs. Contact emergency care
immediately if difficulty in breathing occurs or aspiration is suspected. Do not feed while
the patient is laying flat.
23
Patient Information Sheet
On this page, space has been provided for recording all of the doctor’s instructions for the patient. Take time and record all information
with the help of the patient’s doctor or health care professional. This information will be helpful when you actually begin feedings, and any
substitute caregiver will also have the information necessary to give the feedings correctly and safely.
Your Patient’s Specific Needs:
Name:________________________________________________________
has been fitted with a Balloon.
Manufacturer’s Lot #:________________________________________________________
French Size Length:_________________________________________________________
Balloon was inserted (DATE):_________________________________________________
Balloon replacement date:___________________________________________________
Balloon fill volume:_________________________________________________________
Formula.
Formula Name:____________________________________________________________
Ready-to-Use Powdered Concentrate:__________________________________________
Ready-to-Use Formula.
Total amount of formula to be fed per day:_______________________________________
Total amount of water to be fed per day:_________________________________________
24
Place device sticker here
Notes
Patient Information Sheet
Powdered Formula.
Concentrated Liquid Formula.
Total amount of formula to be fed per day:___________________ Total amount of formula to be fed per day:__________________
Mixed powder to water:_________________________________ Mixed concentrate to water:____________________________
Total additional water to be fed per day:_____________________ Total additional water to be fed per day:___________________
Blenderized Table Foods. Follow Doctor’s instructions.
Type of Feeding:Type of Feeding:
Bolus. Feeding schedule: Every________________________Hours
Continuous. Place Formula in feeding container every ____ Hours.
For each feeding: Place following amount of formula in container:_ RATE: Feed Formula/hour. (Follow manufacturer’s instructions
for setting pump rate.)
RATE: Feeding should take ______ Minutes to go in (drips/minute).
Give ____________ Water after each feeding.
Give _______ of water in the feeding container every Hour.
Decompression (if prescribed).
Bolus. Decompress for_________Minutes before/after feeding___________Hours
Continuous. Decompress for______Minutes before/after feeding every_______ Hours
Special Instructions:________________________________________________________________________________________________
________________________________________________________________________________________________________________
________________________________________________________________________________________________________________
25
12Fr
Ordering Information
(4.00mm)
1.0cm
EndoVive™ 3s Low Profile Balloon Kit with ENFit™ Connector
12 French
14 French
16 French
18 French
20 French
22 French
24 French
M00548210
0.8 cm
M00548330
0.8 cm
M00548500
1.0 cm
M00548660
1.0 cm
M00548820
1.0 cm
M00549310
1.0 cm
M00549470
1.5 cm
M00548220
1.0 cm
M00548340
1.0 cm
M00548510
1.2 cm
M00548670
1.2 cm
M00548830
1.2 cm
M00549320
1.2 cm
M00549480
1.7 cm
M00548230
1.2 cm
M00548350
1.2 cm
M00548520
1.5 cm
M00548680
1.5 cm
M00548840
1.5 cm
M00549330
1.5 cm
M00549490
2.0 cm
M00548240
1.5 cm
M00548360
1.5 cm
M00548530
1.7 cm
M00548690
1.7 cm
M00548850
1.7 cm
M00549340
1.7 cm
M00549500
2.3 cm
M00548250
1.7 cm
M00548370
1.7 cm
M00548540
2.0 cm
M00548700
2.0 cm
M00548860
2.0 cm
M00549350
2.0 cm
M00549510
2.5 cm
M00548260
2.0 cm
M00548380
2.0 cm
M00548550
2.3 cm
M00548710
2.3 cm
M00548870
2.3 cm
M00549360
2.3 cm
M00549520
2.7 cm
M00548270
2.3 cm
M00548390
2.3 cm
M00548560
2.5 cm
M00548720
2.5 cm
M00548880
2.5 cm
M00549370
2.5 cm
M00549530
3.0 cm
M00548280
2.5 cm
M00548400
2.5 cm
M00548570
2.7 cm
M00548730
2.7 cm
M00548890
2.7 cm
M00549380
2.7 cm
M00549540
3.5 cm
M00548290
2.7 cm
M00548410
2.7 cm
M00548580
3.0 cm
M00548740
3.0 cm
M00548900
3.0 cm
M00549390
3.0 cm
M00549550
4.0 cm
M00548300
3.0 cm
M00548420
3.0 cm
M00548590
3.5 cm
M00548750
3.5 cm
M00548910
3.5 cm
M00549400
3.5 cm
M00549560
4.5 cm
M00548310
3.5 cm
M00548430
3.5 cm
M00548600
4.0 cm
M00548760
4.0 cm
M00548920
4.0 cm
M00549410
4.0 cm
M00549570
5.0 cm
M00548320
4.0 cm
M00548440
4.0 cm
M00548610
4.5 cm
M00548770
4.5 cm
M00548930
4.5 cm
M00549420
4.5 cm
M00549580
5.5 cm
M00548450
4.5 cm
M00548620
5.0 cm
M00548780
5.0 cm
M00548940
5.0 cm
M00549430
5.0 cm
M00549590
6.0 cm
M00548460
5.0 cm
M00548630
5.5 cm
M00548790
5.5 cm
M00548950
5.5 cm
M00549440
5.5 cm
M00549600
6.5 cm
M00548470
5.5 cm
M00548640
6.0 cm
M00548800
6.0 cm
M00548960
6.0 cm
M00549450
6.0 cm
M00548480
6.0 cm
M00548650
6.5 cm
M00548810
6.5 cm
M00548970
6.5 cm
M00549460
6.5 cm
M00548490
6.5 cm
26
Ordering Information
EndoVive™ 3s Extension Sets with ENFit™ Connector
M00549611
12" Bolus Straight Extension Set, 5 pack
M00549621
24" Bolus Straight Extension Set, 5 pack
M00549631
12" Bolus Right Angle Extension Set, 5 pack
M00549641
24" Bolus Right Angle Extension Set, 5 pack
M00549651
12" Continuous Right Angle Extension Set, 5 pack
M00549661
24" Continuous Right Angle Extension Set, 5 pack
M00549671
2" Medication Extension Set, 5 pack
For 24/7 clinical support and ordering information, please call: (888) 272-8437.
ENFit is a registered trademark of GEDSA used with their permission.
Mic-Key is a trademark of Avent, Inc.
27
Manufactured by:
Xeridiem Medical Devices
4700 S. Overland Drive
Tucson, AZ 85714
USA
Distributed by:
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
USA
USA Customer Service 888-272-1001
Do not use if package
is damaged.
Recyclable
Package
EC
REP
EU Authorized
Representative
EMERGO
EUROPEInternational S.A.
Boston
Scientific
Molenstraat
55
avenue des15Champs Pierreux
251351101
BH, The Hague
TSA
The Netherlands
92729
NANTERRE CEDEX
FRANCE
AUS
Boston Scientific, Master Brand User’s Manual Template 8.5in x 5.5in EN, 20-0993-PCG Rev/Ver. AC
Legal
Manufacturer
Australian
Sponsor Address
Boston Scientific (Australia) Pty Ltd
PO Box 332
BOTANY
NSW 1455
Australia
Free Phone 1800 676 133
Free Fax 1800 836 666
ARG
Argentina
Local Contact
Para obtener información de
contacto de Boston Scientific
Argentina SA, por favor, acceda al
link www.bostonscientific.com/arg
1 800 776 OLEY
www.oley.org
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
20-0993 REV. C
2015-09
Black (K) ∆E ≤5.0