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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