Halyard Mic-key User manual

MIC-KEY

GASTRIC-JEJUNAL

FEEDING TUBE

Endoscopic/Radiologic Placement

Low-Profile

GJ-Tube

Instructions for Use

Fig. 1

Fig. 3

Fig. 2

{

Fig. 4

Fig. 5

Fig. 1-A

Single Use Only Do not use

if package is damaged

Product is NOT made with DEHP

as a plasticizer Caution

Rx Only

Balloon Volume

Sterilized by

Gamma Irradiation Do not resterilize

Diameter Stoma Length Jejunal Length

Consult instructions

for use

Not made with

natural rubber latex

17 AUG 2015 • 15-H1-044-0-00 • Folded size: 8”x10”

Instructions for Use

Rx Only: Federal Law (USA) restricts this device to sale by or on the order of a

physician.

Description

The HALYARD* MICKEY* Gastric-Jejunal FeedingTube (Fig 1) provides for

simultaneous gastric decompression / drainage and delivery of enteral nutrition

into the distal duodenum or proximal jejunum.

Indications For Use

The HALYARD* MICKEY* Gastric-Jejunal FeedingTube is indicated for use

in patients who cannot absorb adequate nutrition through the stomach,

who have intestinal motility problems, gastric outlet obstruction, severe

gastroesophageal reux, are at risk of aspiration, or in those who have had

previous esophagectomy or gastrectomy.

Contraindications

Contraindications for placement of a Gastric-Jejunal Feeding Tube include, but

are not limited to ascites, colonic interposition, portal hypertension, peritonitis

and morbid obesity.

Warning

Do not reuse, reprocess, or resterilize this medical device. Reuse,

reprocessing, or resterilization may 1) adversely aect the known

biocompatibility characteristics of the device, 2) compromise the

structural integrity of the device, 3) lead to the device not performing

as intended, or 4) create a risk of contamination and cause the

transmission of infectious diseases resulting in patient injury, illness,

or death.

Complications

The following complications may be associated with any Gastric-Jejunal Feeding

Tube:

• Skin Breakdown • Infection

• HypergranulationTissue • Stomach or Duodenal Ulcers

• Intraperitoneal Leakage • Pressure Necrosis

Note:Verify package integrity. Do not use if package is damaged or sterile

barrier compromised.

Placement

The HALYARD* MICKEY* Gastric-Jejunal FeedingTube may be placed

percutaneously under uoroscopic or endoscopic guidance or as a replacement

to an existing device using an established stoma tract.

Caution: A gastropexy must be performed to ax the stomach to the

anterior abdominal wall, the feeding tube insertion site identied, stoma tract

dilated and measured prior to initial tube insertion to ensure patient safety and

comfort. The length of the tube should be sucient to be placed 10–15 cm

beyond the ligament of treitz.

Caution: Do not use the retention balloon of the feeding tube as a

gastropexy device. The balloon may burst and fail to attach the stomach to the

anterior abdominal wall.

Tube Preparation

1. Select the appropriate size MICKEY* Gastric-Jejunal Feeding Tube, remove

from the package and inspect for damage.

2. Using the 6 ml Luer slip syringe contained in the kit, inate the balloon with

5 ml sterile or distilled water through the balloon port. (Fig 1-A)

3. Remove the syringe and verify balloon integrity by gently squeezing the

balloon to check for leaks. Visually inspect the balloon to verify symmetry.

Symmetry may be achieved by gently rolling the balloon between the

ngers. Reinsert the syringe and remove all the water from the balloon.

4. Using a 6 ml Luer slip syringe, ush water through both the gastric and

jejunal ports (Fig 1-A & B) to verify patency.

5. Lubricate the distal end of the tube with water-soluble lubricant.

Do not use mineral oil or petroleum jelly.

6. Generously lubricate the jejunal lumen with water-soluble lubricant.

Do not use mineral oil or petroleum jelly.

7. Insert the introducer cannula (Fig 5) into the Jejunal port until the hub is in

contact with the Jejunal feeding port and the introducer cannula is clearly

visible inside the tube. The introducer cannula opens the one-way valve

and protects it from damage by the guidewire.

Suggested Radiologic Placement Procedure

1. Place the patient in the supine position.

2. Prep and sedate the patient according to clinical protocol.

3. Insure that the left lobe of the liver is not over the fundus or the body of the

stomach.

4. Identify the medial edge of the liver by CT scan or ultrasound.

5. Glucagon 0.5 to 1.0 mg IV may be administered to diminish gastric

peristalsis.

Caution: Consult Glucagon instructions for use for rate of IV injection

and recommendations for use with insulin dependent patients.

6. Insuate the stomach with air using a nasogastric catheter, usually 500

to 1,000 ml or until adequate distention is achieved. It is often necessary

to continue air insuation during the procedure, especially at the time of

needle puncture and tract dilation, to keep the stomach distended so as to

oppose the gastric wall against the anterior abdominal wall.

7. Choose a catheter insertion site in the left sub-costal region, preferably

over the lateral aspect or lateral to the rectus abdominis muscle (N.B. the

superior epigastric artery courses along the medial aspect of the rectus)

and directly over the body of the stomach toward the greater curvature.

Using uoroscopy, choose a location that allows as direct a vertical needle

path as possible. Obtain a cross table lateral view prior to placement of

gastrostomy when interposed colon or small bowel anterior to the stomach

is suspected.

Note:PO/NG contrast may be administered the night prior or an enema

administered prior to placement to opacify the transverse colon.

8. Prep and drape according to facility protocol.

Gastropexy Placement

Caution: It is recommended to perform a three point gastropexy in a

triangle conguration to ensure attachment of the gastric wall to the anterior

abdominal wall.

1. Place a skin mark at the tube insertion site. Dene the gastropexy pattern

by placing three skin marks equidistant from the tube insertion site and in a

triangle conguration.

Warning: Allow adequate distance between the insertion

site and gastropexy placement to prevent interference of the

T-Fastener and inated balloon.

2. Localize the puncture sites with 1% lidocaine and administer local

anesthesia to the skin and peritoneum.

3. Place the rstT-Fastener and conrm Intragastric position. Repeat the

procedure until all threeT-Fasteners are inserted at the corners of the

triangle.

4. Secure the stomach to the anterior abdominal wall and complete the

procedure.

Create the Stoma Tract

1. Create the stoma tract with the stomach still insuated and in apposition

to the abdominal wall. Identify the puncture site at the center of the

gastropexy pattern. With uoroscopic guidance conrm that the site

overlies the distal body of the stomach below the costal margin and above

the transverse colon.

Caution: Avoid the epigastric artery that courses at the junction of the

medial two-thirds and lateral one-third of the rectus muscle.

Warning: Take care not to advance the puncture needle too

deeply in order to avoid puncturing the posterior gastric wall,

pancreas, left kidney, aorta or spleen.

2. Anesthetize the puncture site with local injection of 1% lidocaine down to

the peritoneal surface.

3. Insert a .038”compatible introducer needle at the center of the gastropexy

pattern into the gastric lumen directed toward the pylorus.

Note:The best angle of insertion is a 45 degree angle to the surface of the

skin.

4. Use uoroscopic visualization to verify correct needle placement.

Additionally, to aid in verication, a water lled syringe may be attached to

the needle hub and air aspirated from the gastric lumen.

Note: Contrast may be injected upon return of air to visualize gastric folds

and conrm position.

5. Advance a guidewire, up to .038”, through the needle and coil in the fundus

of the stomach. Conrm position.

6. Remove the introducer needle, leaving the guidewire in place and dispose

of according to facility protocol.

7. Advance a .038”compatible exible catheter over the guidewire and using

uoroscopic guidance, manipulate the guidewire into the antrum of the

stomach.

8. Advance the guidewire and exible catheter until the catheter tip is at the

pylorus.

9. Negotiate through the pylorus and advance the guidewire and catheter into

the duodenum and 10–15 cm beyond the Ligament ofTreitz.

10. Remove the catheter and leave the guidewire in place.

Dilation

1. Use a #11 scalpel blade to create a small skin incision that extends

alongside the guidewire, downward through the subcutaneous tissue and

fascia of the abdominal musculature. After the incision is made, dispose of

according to facility protocol.

2. Advance a dilator over the guidewire and dilate the stoma tract to the

desired size.

3. Remove the dilator over the guidewire, leaving the guidewire in place.

4. Measure the Stoma Length with the HALYARD* Stoma Measuring Device.

Measuring the Stoma Length

Caution: Selection of the correct size MICKEY* is critical for the safety

and comfort of the patient. Measure the length of the patient’s stoma with the

Stoma Measuring Device. The shaft length of the MICKEY* selected should be

the same as the length of the stoma. An inappropriately sized MICKEY* can

cause necrosis, buried bumper syndrome and/or hypergranulation tissue.

1. Moisten the tip of the Stoma Measuring Device with water soluble

lubricant. Do not us mineral oil. Do not use petroleum jelly.

2. Advance the Stoma Measuring Device over the guidewire, through the

stoma and into the stomach. DO NOT USE FORCE.

3. Fill the Luer slip syringe with 5ml of water and attach to the balloon port.

Depress the syringe plunger and inate the balloon.

4. Gently pull the device toward the abdomen until the balloon rests against

the inside of the stomach wall.

5. Slide the plastic disc down to the abdomen and record the measurement

above the disc.

6. Add 4–5 mm to the recorded measurement to ensure the proper stoma

length and t in any position. Record the measurement.

7. Using a Luer slip syringe, remove the water in the balloon.

8. Remove the stoma measuring device.

9. Document the date, lot number and measured centimeter shaft length.

Tube Placement

Note:A peel-away sheath may be used to facilitate advancement of the tube

through the stoma tract.

1. Select the appropriate MICKEY* Gastric-Jejunal FeedingTube and prepare

according to the directions in the Tube Preparation section listed above.

2. Advance the distal end of the tube over the guidewire until the proximal

end of the guidewire exits the introducer cannula.

Note:Direct visualization and manipulation of the introducer and guidewire

may be required to pass the guidewire through the end of the introducer.

3. Hold the introducer hub and jejunal feeding port while advancing the tube

over the guidewire and into the stomach.

4. Rotate the HALYARD* MICKEY* Gastric-Jejunal FeedingTube while

advancing to facilitate passage of the tube through the pylorus and into the

jejunum.

5. Advance the tube until the tip of the tube is 10–15 cm beyond the

Ligament ofTreitz and the balloon is in the stomach.

6. Ensure the external bolster is ush with the skin.

7. Using a Luer slip syringe, inate the balloon.

• Inate the balloon with 3–5 ml of sterile or distilled water for pediatric

sized tubes (REF numbers ending in -15 -22 or -30)

Caution: Do not exceed 5 ml total balloon volume. Do not use air. Do

not inject contrast into the balloon.

• Inate the balloon with 7–10 ml of sterile or distilled water for adult

sized tubes (REF numbers ending in -45).

Caution: Do not exceed 10 ml total balloon volume. Do not use air. Do

not inject contrast into the balloon.

8. Remove the guidewire through the introducer cannula while holding the

cannula in position. Remove the introducer cannula.

Verify Tube Position

1. Verify proper tube placement radiographically to avoid potential

complication (e.g. bowel irritation or perforation) and ensure the tube is

not looped within the stomach or small bowel.

Note:The jejunal portion of the tube contains tungsten which is radiopaque

and can be used to radiographically conrm position. Do not inject contrast

into the balloon.

2. Flush the lumen to verify patency.

3. Check for moisture around the stoma. If there are signs of gastric leakage,

check the tube position and external bolster placement. Add uid as need

in 1–2 ml increments.

Caution: Do not exceed total balloon volume indicated above.

4. Check to assure that the external bolster is not placed too tightly against

the skin and rests 2–3 mm above the abdomen.

5. Document the date, the type, the size and lot number of the tube, the

ll volume of the balloon, skin condition and patient tolerance to the

procedure. Start feeding and medication administration per physician

orders and after conrmation of proper tube placement and patency.

Radiologic Placement Through An Established

Gastrostomy Tract

1. Under uoroscopic guidance, insert a oppy-tipped guidewire, up to .038”,

through the indwelling gastrostomy tube.

2. Remove the gastrostomy tube over the guidewire.

3. Direct the guidewire through the stoma and coil in the stomach.

4. Advance a .038”guidewire compatible exible catheter over the guidewire

until the catheter tip is at the pylorus.

HALYARD*MICKEY*Gastric-Jejunal Feeding Tube (Low-Prole GJ-Tube)

Endoscopic / Radiologic Placement

5. Negotiate the pylorus and advance the guidewire into the duodenum. If the

catheter is dicult to advance through the pylorus, reduce the length of the

catheter coiled in the stomach. A rotational motion on the exible catheter

may allow easier passage over the guidewire.

6. Advance the guidewire and catheter to a point 10–15 cm beyond the

Ligament ofTreitz.

7. Remove the catheter and leave the guidewire in place.

8. Measure the stoma length with the HALYARD* Stoma Measuring Device.

Tube Placement

1. Select the appropriate size MICKEY* Gastric-Jejunal Feeding Tube and

prepare according to the directions in theTube Preparation section above.

2. Advance the distal end of the tube over the guidewire and into the stomach.

3. Rotate the HALYARD* MICKEY* Gastric-Jejunal FeedingTube while

advancing to facilitate passage of the tube through the pylorus and into the

jejunum.

4. Advance the tube until the tip of the tube is 10–15 cm beyond the Ligament

of Treitz and the balloon is in the stomach.

5. Using a Luer slip syringe, inate the balloon.

• Inate the balloon with 3–5 ml of sterile or distilled water for pediatric

sized tubes (REF numbers ending in -15, -22 or -30)

Caution: Do not exceed 5 ml total balloon volume. Do not use air. Do

not inject contrast into the balloon.

• Inate the balloon with 7–10 ml of sterile or distilled water for adult sized

tubes (REF numbers ending in -45).

Caution: Do not exceed 10 ml total balloon volume. Do not use air. Do

not inject contrast into the balloon.

6. Remove the guidewire through the introducer cannula while holding the

cannula in position.

7. Remove the introducer cannula.

8. Verify proper tube placement according to Verify Tube Position section

above.

Suggested Endoscopic Placement Procedure

1. Perform routine Esophagogastroduodenoscopy (EGD). Once the procedure

is complete and no abnormalities are identied that could pose a

contraindication to placement of the tube, place the patient in the supine

position and insuate the stomach with air.

2. Transilluminate through the anterior abdominal wall to select a gastrostomy

site that is free of major vessels, viscera and scar tissue. The site is usually

one third the distance from the umbilicus to the left costal margin at the

midclavicular line.

3. Depress the intended insertion site with a nger. The endoscopist should

clearly see the resulting depression on the anterior surface of the gastric

wall.

4. Prep and drape the skin at the selected insertion site.

Gastropexy Placement

Caution: It is recommended to perform a three point gastropexy in a

triangle conguration to ensure attachment of the gastric wall to the anterior

abdominal wall.

1. Place a skin mark at the tube insertion site. Dene the gastropexy pattern

by placing three skin marks equidistant from the tube insertion site and in a

triangle conguration.

Warning: Allow adequate distance between the insertion

site and gastropexy placement to prevent interference of the

T-Fastener and inated balloon.

2. Localize the puncture sites with 1% lidocaine and administer local

anesthesia to the skin and peritoneum.

3. Place the rstT-Fastener and conrm Intragastric position. Repeat the

procedure until all threeT-Fasteners are inserted at the corners of the

triangle.

4. Secure the stomach to the anterior abdominal wall and complete the

procedure.

Create the Stoma Tract

1. Create the stoma tract with the stomach still insuated and in apposition

to the abdominal wall. Identify the puncture site at the center of the

gastropexy pattern. With endoscopic guidance conrm that the site overlies

the distal body of the stomach below the costal margin and above the

transverse colon.

Caution: Avoid the epigastric artery that courses at the junction of the

medial two-thirds and lateral one-third of the rectus muscle.

Warning: Take care not to advance the puncture needle too

deeply in order to avoid puncturing the posterior gastric wall,

pancreas, left kidney, aorta or spleen.

2. Anesthetize the puncture site with local injection of 1% lidocaine down to

the peritoneal surface.

3. Insert a .038”compatible introducer needle at the center of the gastropexy

pattern into the gastric lumen directed toward the pylorus.

Note:The best angle of insertion is a 45 degree angle to the surface of the

skin.

4. Use endoscopic visualization to verify correct needle placement.

5. Advance a guidewire, up to .038”, through the needle into the stomach.

Using endoscopic visualization, grasp the guidewire with atraumatic

forceps.

6. Remove the introducer needle, leaving the guidewire in place and dispose

of according to facility protocol.

Dilation

1. Use a #11 scalpel blade to create a small skin incision that extends alongside

the guidewire, downward through the subcutaneous tissue and fascia of the

abdominal musculature. After the incision is made, dispose of according to

facility protocol.

2. Advance a dilator over the guidewire and dilate the stoma tract to the

desired size.

3. Remove the dilator over the guidewire, leaving the guidewire in place.

4. Measure the stoma length with the HALYARD* Stoma Measuring Device.

Measuring the Stoma Length

Caution: Selection of the correct size MICKEY* is critical for the safety

and comfort of the patient. Measure the length of the patient’s stoma with the

Stoma Measuring Device. The shaft length of the MICKEY* selected should be

the same as the length of the stoma. An inappropriately sized MICKEY* can

cause necrosis, buried bumper syndrome and/or hypergranulation tissue.

1. Moisten the tip of the Stoma Measuring Device with water soluble lubricant.

Do not us mineral oil. Do not use petroleum jelly.

2. Advance the Stoma Measuring Device over the guidewire, through the

stoma and into the stomach. DO NOT USE FORCE.

3. Fill the Luer slip syringe with 5ml of water and attach to the balloon port.

Depress the syringe plunger and inate the balloon.

4. Gently pull the device toward the abdomen until the balloon rests against

the inside of the stomach wall.

5. Slide the plastic disc down to the abdomen and record the measurement

above the disc.

6. Add 4–5 mm to the recorded measurement to ensure the proper stoma

length and t in any position. Record the measurement.

7. Using a Luer slip syringe, remove the water in the balloon.

8. Remove the stoma measuring device.

9. Document the date, lot number and measured centimeter shaft length.

Tube Placement

1. Select the appropriate sized MICKEY* Gastric-Jejunal Feeding Tube and

prepare according to the directions in theTube Preparation section listed

above.

2. Advance the distal end of the tube over the guidewire until the proximal

end of the guidewire exits the introducer cannula.

Note:Direct visualization and manipulation of the introducer and guidewire

may be required to pass the guidewire through the end of the introducer.

3. Hold the introducer hub and jejunal port while advancing the tube over the

guidewire and into the stomach.

4. Using endoscopic guidance, grasp the suture loop or the tip of the tube with

atraumatic forceps.

5. Advance the HALYARD* MICKEY* Gastric-Jejunal FeedingTube through

the pylorus and upper duodenum. Continue to advance the tube using the

forceps until the tip is positioned 10–15 cm beyond the Ligament of Treitz

and the balloon is in the stomach.

6. Release the tube and withdraw the endoscope and forceps in tandem,

leaving the tube in place.

7. Ensure that the external bolster is ush with the skin.

8. Using a Luer slip syringe, inate the balloon.

• Inate the balloon with 3–5 ml of sterile or distilled water for pediatric

sized tubes (REF numbers ending in -15, -22 or -30).

Caution: Do not exceed 5 ml total balloon volume. Do not use air. Do

not inject contrast into the balloon.

• Inate the balloon with 7–10 ml of sterile or distilled water for adult sized

tubes (REF numbers ending in -45).

Caution: Do not exceed the 10 ml total balloon volume. Do not use air.

Do not inject contrast into the balloon.

9. Remove the guidewire through the introducer cannula while holding the

cannula in place.

10. Remove the cannula.

Verify Tube Position

1. Verify proper tube placement radiographically to avoid potential

complication (e.g., bowel irritation or perforation) and ensure that the tube

is not looped within the stomach or small bowel.

Note:The jejunal portion of the tube contains tungsten which is radiopaque

and can be used to radiographically conrm position. Do not inject contrast

into the balloon.

2. Flush the gastric and jejunal lumens to verify patency.

3. Check for moisture around the stoma. If there are signs of gastric leakage,

check the tube position and the external bolster placement. Add uid as

needed in 1–2 ml increments.

Caution: Do not exceed total balloon volume indicated above.

4. Check to assure that the external bolster is not placed too tightly against the

skin and rest 2–3mm above the abdomen.

5. Document the date, the type, the size, and lot number of the tube, the

ll volume of the balloon, skin condition and patient tolerance to the

procedure. Start feeding and medication administration per physician

orders and after conrmation of proper tube placement and patency.

Endoscopic Placement Through An Existing Gastros-

tomy Tract

1. Following established protocol, perform routine

Esophagogastroduodenoscopy (EGD). Once the procedure is complete

and no abnormalities are identied that could pose a contraindication

to placement of the tube, place the patient in the supine position and

insuate the stomach with air.

2. Manipulate the endoscope until the indwelling gastrostomy tube is in the

visual eld.

3. Insert a oppy-tip guidewire through the indwelling gastrostomy tube and

remove the tube.

4. Measure the stoma length with the HALYARD* Stoma Measuring Device.

Tube Placement

1. Select the appropriate sized MICKEY* Gastric-Jejunal Feeding Tube and

prepare according to the directions in theTube Preparation section above.

2. Hold the introducer cannula and jejunal hub while advancing the HALYARD*

MICKEY* Gastric-Jejunal FeedingTube over the guidewire and into the

stomach.

3. Refer to step 2 in theTube Placement section above and complete the

procedure according to the steps listed.

4. Verify proper placement according to the directions in the Verify Tube

Position section listed above.

Extension Set Assembly For Jejunal Feeding

1. Open the feeding port cover (Fig 1-C) located at the top of the MICKEY*

Gastric-Jejunal FeedingTube.

2. Insert the MICKEY* extension set (Fig 2) into the port labeled“Jejunal”by

aligning the lock and key connector. Align the black orientation marking on

the set with the corresponding black orientation line on the jejunal feeding

port.

3. Lock the set into the jejunal feeding port by pushing in and rotating the

connector clockwise until a slight resistance is felt (approximately 1/4 turn)

Do not rotate the connector past the stop point.

4. Remove the extension set by rotating the connector counter clockwise until

the black line on the set aligns with the black line on the jejunal feeding

port.

5. Remove the set and cap the gastric and jejunal ports with the attached port

cover.

Caution: Never connect the jejunal port to suction. Do not measure

residuals from the jejunal port.

Extension Set Assembly For Gastric

Decompression

1. Open the feeding port cover located at the top of the MICKEY* Gastric-

Jejunal FeedingTube.

2. Insert the MICKEY* Bolus Extension set (Fig 3) into the port labeled

“Gastric”by aligning the lock and key connector. Align the black orientation

marking on the set with the corresponding black orientation line on the

gastric port.

3. Lock the set into the gastric decompression port by pushing in and rotating

the connector clockwise until a slight resistance is felt (approximately 1/4

turn).

Note: Do not rotate the connector past the stop point.

4. Remove the extension set by rotating the connector counter-clockwise until

the black line on the set aligns with the black line on the gastric port.

5. Remove the set and cap the gastric and jejunal ports with the attached port

cover.

Caution: Do not use continuous or high intermittent suctions. High

pressure could collapse the tube or injure the stomach tissue and cause

bleeding.

Medication Administration

Use liquid medication when possible and consult the pharmacist to determine

if it is safe to crush solid medication and mix with water. If safe, pulverize the

solid medication into a ne powder form and dissolve the powder in water

before administering through the feeding tube. Never crush enteric coated

medication or mix medication with formula.

Using a catheter tip syringe ush the tube with the prescribed amount of water.

Tube Patency Guidelines

Proper tube ushing is the best way to avoid clogging and maintain tube

patency. The following are guidelines to avoid clogging and maintain tube

patency.

• Flush the feeding tube with water every 4–6 hours during continuous

feeding, anytime the feeding is interrupted, before and after every

intermittent feeding, or at least every 8 hours if the tube is not being used.

17 AUG 2015 • 15-H1-044-0-00 • Folded size: 8”x10”

• Flush the feeding tube before and after medication administration and

between medications.This will prevent the medication from interacting

with formula and potentially causing the tube to clog.

• Use liquid medication when possible and consult the pharmacist to

determine if it is safe to crush solid medication and to mix with water. If

safe, pulverize the solid medication into a ne powder form and dissolve

the powder in warm water before administering through the feeding tube.

Never crush enteric-coated medication or mix medication with formula.

• Avoid using acidic irrigants such as cranberry juice and cola beverages to

ush feeding tubes as the acidic quality when combined with formula

proteins may actually contribute to tube clogging.

General Flushing Guidelines

• Use a 30 to 60 ml catheter tip syringe. Do not use smaller size syringes as

this can increase pressure on the tube and potentially rupture smaller tubes.

• Use room temperature tap water for tube ushing. Sterile water may be

appropriate where the quality of municipal water supplies is of concern.The

amount of water will depend on the patient’s needs, clinical condition, and

type of tube, but the average volume ranges from 10 to 50 mls for adults,

and 3 to 10 mls for infants. Hydration status also inuences the volume used

for ushing feeding tubes. In many cases, increasing the ushing volume

can avoid the need for supplemental intravenous uid. However, individuals

with renal failure and other uid restrictions should receive the minimum

ushing volume necessary to maintain patency.

• Do not use excessive force to ush the tube. Excessive force can perforate

the tube and can cause injury to the gastrointestinal tract.

• Document the time and amount of water used in the patient’s record.This

will enable all caregivers to monitor the patient’s needs more accurately.

Daily Care & Maintenance Checklist

Assess the patient

Assess the patient for any signs of pain, pressure or discomfort, warmth, rashes,

purulent or gastrointestinal drainage.

Assess the patient for any signs of pressure necrosis, skin

breakdown or hypergranulation tissue.

Clean the stoma site

Use warm water and mild soap.

Use a circular motion moving from the tube outwards.

Clean sutures, external bolsters and any stabilizing devices using a cotton-

tipped applicator.

Rinse thoroughly and dry well.

Assess the tube

Assess the tube for any abnormalities such as damage, clogging or abnormal

discoloration.

Clean the feeding tube

Use warm water and mild soap being careful not to pull or manipulate the tube

excessively.

Rinse thoroughly, dry well.

Clean the jejunal, gastric and balloon ports

Use a cotton tip applicator or soft cloth to remove all residual

formula and medication.

Do not rotate the external bolster

This will cause the tube to kink and possibly lose position.

Verify placement of the external bolster

Verify that the external bolster rests 2–3mm above the skin.

Flush the feeding tube

Flush the feeding tube with water every 4–6 hours during continuous feeding,

anytime the feeding is interrupted, or at least every 8 hours if the tube is not

being used.

Flush the feeding tube after checking gastric residuals.

Flush the feeding tube before and after medication administration.

Avoid using acidic irrigants such as cranberry juice and cola beverages to ush

feeding tubes.

Balloon Maintenance

Check the water volume in the balloon once a week.

• Insert a Luer slip syringe into the balloon ination port and withdraw the

uid while holding the tube in place. Compare the amount of water in the

syringe to the amount recommended or the amount initially prescribed and

documented in the patient record. If the amount is less than recommended

or prescribed, rell the balloon with the water initially removed, then draw

up and add the amount needed to bring the balloon volume up to the

recommended and prescribed amount of water. Be aware as you deate the

balloon there may be some gastric contents that can leak from around the

tube. Document the uid volume, the amount of volume to be replaced (if

any), the date and time.

• Wait 10–20 minutes and repeat the procedure.The balloon is leaking if

it has lost uid, and the tube should be replaced. A deated or ruptured

balloon could cause the tube to dislodge or be displaced. If the balloon is

ruptured, it will need to be replaced. Secure the tube into position using

tape, then follow facility protocol and/or call the physician for instructions.

Note:Rell the balloon using sterile or distilled water, not air or saline. Saline

can crystallize and clog the balloon valve or lumen, and air may seep out and

cause the balloon to collapse. Be sure to use the recommended amount of

water as over-ination can obstruct the lumen or decrease balloon life and

under-ination will not secure the tube properly.

Tube Occlusion

Tube occlusion is generally caused by:

• Poor ushing techniques

• Failure to ush after measurement of gastric residuals

• Inappropriate administration of medication

• Pill fragments

• Viscous medications

• Thick formulas, such as concentrated or enriched formulas that are generally

thicker and more likely to obstruct tubes

• Formula contamination that leads to coagulation

• Reux of gastric or intestinal contents up the tube

To Unclog A Tube

1. Make sure that the feeding tube is not kinked or clamped o.

2. If the clog is visible above the skin surface, gently massage or milk the tube

between ngers to break up the clog.

3. Next, place a catheter tip syringe lled with warm water into the

appropriate adaptor or lumen of the tube and gently pull back on then

depress the plunger to dislodge the clog.

4. If the clog remains, repeat step #3. Gentle suction alternating with syringe

pressure will relieve most obstructions.

5. If this fails, consult with the physician. Do not use cranberry juice, cola

drinks, meat tenderizer or chymotrypsin, as they can actually cause clogs or

create adverse reactions in some patients. If the clog is stubborn and cannot

be removed, the tube will have to be replaced.

Balloon Longevity

Precise balloon life cannot be predicted. Silicone balloons generally last 1–8

months, but the life span of the balloon varies according to several factors.

These factors may include medications, volume of water used to inate the

balloon, gastric pH and tube care.

Kit Contents:

1 Low-Prole Gastric-Jejunal FeedingTube

1 Introducer Cannula

1 6 ml Luer Slip Syringe

1 35 ml CatheterTip Syringe

1 MICKEY* Continuous Feed Extension Set with SECUR-LOK* Right Angle

Connector and 2 Port“Y”and Clamp 12

1 MICKEY* Bolus Feed Extension Set with CathTip, SECUR-LOK* Straight

Connector and Clamp 12

4 Gauze Pads

Warning: For enteral nutrition and /or medication only.

For more information, please call 1-844-425-9273 in the United States,

or visit our web site at www.halyardhealth.com.

Educational Booklets: “A Guide to Proper Care” and “A Stoma Site and Enteral

Feeding Tube Troubleshooting Guide” is available upon request. Please

contact your local representative or contact Customer Care.

Mode d’emploi

Rx Only: Sur ordonnance uniquement : aux États-Unis, la loi fédérale restreint la

vente de ce dispositif par un médecin ou sur son ordonnance.

Description

La sonde d’alimentation gastrique-jéjunale MICKEY* de HALYARD* (Fig

1) assure simultanément la décompression/le drainage gastriques et

l’administration d’une nutrition entérale dans le duodénum distal ou le jéjunum

proximal.

Indications d’emploi

La sonde d’alimentation gastrique-jéjunale MICKEY* de HALYARD* est

indiquée chez les patients incapables d’absorber une nutrition adéquate par

l’estomac, sourant de troubles de la motilité intestinale, d’obstruction du délé

gastrique, de reux gastro-œsophagien grave, courant un risque d’aspiration ou

qui ont subi auparavant une œsophagectomie ou une gastrectomie.

Contre-indications

Parmi les contre-indications à la mise en place d’une sonde d’alimentation

gastrique-jéjunale on compte, mais sans caractère limitatif, les ascites,

l’interposition du côlon, l’hypertension portale, la péritonite et l’obésité

morbide.

Avertissement :

Ne pas réutiliser, retraiter ou restériliser ce dispositif médical.

Toute réutilisation, tout retraitement ou toute restérilisation peut:

1) aecter négativement les caractéristiques de biocompatibilité

connues du dispositif, 2) compromettre l’intégrité structurelle du

dispositif, 3) conduire à une performance non prévue du dispositif

ou 4) créer un risque de contamination et entraîner la transmission

de maladies infectieuses pouvant se traduire par une blessure, une

maladie ou même le décès du patient.

Complications

Les complications suivantes peuvent être associées à l’usage de toute sonde

d’alimentation transgastrique-jéjunale :

• Lésions cutanées • Infection

• Hypergranulation • Ulcère gastrique ou duodénal

• Fuite intrapéritonéale • Nécrose par pression

Remarque : Vérier l’intégrité de l’emballage. Ne pas utiliser si l’emballage est

endommagé ou si la protection stérile est compromise.

Mise en place

La sonde d’alimentation transgastrique-jéjunale MICKEY* de HALYARD* peut

être mise en place de manière percutanée, sous guidage uoroscopique ou

endoscopique ou en remplacement d’un dispositif existant, en utilisant un

tractus de stomie établi.

Attention : Une gastropexie doit être réalisée pour xer l’estomac à la paroi

abdominale antérieure, le site d’insertion de la sonde d’alimentation doit être

identié, le tractus de la stomie dilaté et mesuré avant l’insertion initiale de la

sonde, an d’assurer la sécurité et le confort du patient. La longueur de la sonde

doit être susante pour être placée 10 à 15 cm au-delà du ligament suspenseur

de l’angle duodéno-jéjunal.

Attention : Ne pas utiliser le ballonnet de rétention de la sonde

d’alimentation comme dispositif de gastropexie. Le ballonnet peut éclater et ne

pas réussir à xer l’estomac à la paroi abdominale antérieure.

Préparation de la sonde

1. Sélectionner la sonde d’alimentation gastrique-jéjunale MICKEY* de

taille appropriée, la sortir de l’emballage et l’examiner pour déceler tout

endommagement.

2. À l’aide de la seringue Luer-slip de 6 ml, contenue dans le kit, goner le

ballonnet avec 5 ml d’eau stérile ou distillée à travers l’orice du ballonnet.

(Fig 1-A)

3. Retirer la seringue et vérier l’intégrité du ballonnet en pressant

délicatement dessus pour révéler toute fuite. Procéder à un examen visuel

du ballonnet pour s’assurer de sa symétrie. La symétrie peut être atteinte en

faisant doucement rouler le ballonnet entre les doigts. Réinsérer la seringue

et retirer toute l’eau du ballonnet.

4. À l’aide d’une seringue Luer-slip de 6 ml, rincer à la fois l’orice gastrique et

l’orice jéjunal à l’eau (Fig 1-A & B) pour s’assurer de leur perméabilité.

5. Lubrier l’extrémité distale de la sonde à l’aide d’un lubriant hydrosoluble.

Ne pas utiliser d’huile minérale ni de vaseline.

6. Lubrier généreusement la lumière jéjunale à l’aide d’un lubriant

hydrosoluble. Ne pas utiliser d’huile minérale ni de vaseline.

7. Insérer la canule de l’introducteur (Fig 5) dans l’orice jéjunal jusqu’à ce

que la garde de l’introducteur soit en contact avec l’orice d’alimentation

jéjunale et que la canule soit clairement visible à l’intérieur de la sonde. La

canule de l’introducteur ouvre la valve unidirectionnelle et la protège contre

tout dommage éventuel dû au l-guide.

Suggestion de mise en place radiologique

1. Placer le patient en décubitus dorsal.

2. Préparer le patient et lui donner un sédatif conformément au protocole

clinique.

3. S’assurer que le lobe gauche du foie ne se trouve pas au-dessus du fundus

(grosse tubérosité) ou du corps de l’estomac.

4. Identier le bord médian du foie par tomodensitogramme ou ultrasons.

5. 0,5 à 1,0 mg de glucagon peut être administré par i.v., an de réduire tout

péristaltisme gastrique.

Attention : Consulter le mode d’emploi du glucagon pour la vitesse

d’injection par i.v. Et les recommandations d’emploi pour les patients

insulino-dépendants.

6. Insuer de l’air dans l’estomac à l’aide d’un cathéter nasogastrique,

habituellement de 500 à 1 000 ml ou jusqu’à obtention d’une distension

adéquate. Il s’avère souvent nécessaire de poursuivre l’insuation d’air

pendant l’intervention, surtout au moment de la ponction par l’aiguille et

de la dilatation du tractus, an de conserver l’estomac distendu, de manière

à opposer la paroi gastrique à la paroi abdominale antérieure.

7. Choisir un site d’insertion du cathéter dans la région sous costale gauche,

de préférence au-dessus de la face latérale ou latéralement au muscle

grand droit de l’abdomen (N.B. l’artère épigastrique supérieure suit le

long de la face médiane du grand droit) et directement au-dessus du

corps de l’estomac vers la plus grande courbure. Sous uoroscopie, choisir

un emplacement permettant un trajet d’aiguille vertical aussi direct que

possible. Obtenir un cliché de prol chirurgical à rayon horizontal avant la

mise en place de la gastrostomie en cas de suspicion de côlon interposé ou

de l’intestin grêle avant l’estomac.

Remarque : Un produit de contraste PO/NG peut être administré la nuit

avant ou un lavement eectué avant la mise en place pour opacier le côlon

transverse.

8. Préparer et recouvrir de champs opératoires conformément au protocole de

l’établissement.

Mise en place de la gastropexie

Attention : Il est recommandé de réaliser une gastropexie à trois points,

selon une conguration triangulaire pour assurer la xation de la paroi gastrique

à la paroi abdominale antérieure.

1. Placer un repère cutané au niveau du site d’insertion de la sonde. Dénir le

modèle de gastropexie en plaçant trois repères cutanés équidistants du site

d’insertion de la sonde et selon une conguration triangulaire.

Avertissement : Prévoir susamment de distance entre le site

d’insertion et la mise en place de la gastropexie, an d’éviter toute

interférence entre le point d’ancrage (T-Fastener) et le ballonnet

goné.

2. Repérer les sites de ponction à l’aide de lidocaïne à 1 % et administrer un

anesthésique local sur la peau et le péritoine.

3. Placer le premier point d’ancrage et conrmer la position intragastrique.

Répéter l’intervention jusqu’à ce que les trois points d’ancrage soient insérés

aux coins du triangle.

4. Fixer l’estomac à la paroi abdominale antérieure et terminer l’intervention.

Création du tractus de la stomie

1. Créer le tractus de la stomie avec l’estomac encore insué et en apposition

à la paroi abdominale. Identier le site de ponction au centre du modèle de

gastropexie. Sous guidage uoroscopique, conrmer que le site recouvre

le corps distal de l’estomac sous le rebord costal et au-dessus du côlon

transverse.

Attention : Éviter l’artère épigastrique qui passe à la jonction de la

partie des deux-tiers médians et du tiers latéral du muscle droit.

Avertissement : Prendre soin de ne pas faire avancer l’aiguille

de ponction trop profondément, an d’éviter toute ponction de la

paroi gastrique postérieure, du pancréas, du rein gauche, de l’aorte

ou de la rate.

2. Anesthésier le site de ponction à l’aide d’une injection locale de lidocaïne à 1

% jusque sur la surface du péritoine.

3. Insérer une aiguille introductrice compatible de 0,038 po. au centre du

modèle de gastropexie, dans la lumière gastrique en direction du pylore.

Remarque : Le meilleur angle d’insertion est un angle de 45 degrés par

rapport à la surface de la peau.

4. Se servir de la visualisation uoroscopique pour vérier la mise en place

correcte de l’aiguille. De plus, pour faciliter la vérication, une seringue

remplie d’eau peut être xée au raccord d’aiguille et de l’air aspiré à travers

la lumière gastrique.

Remarque : Du produit de contraste peut être injecté au retour d’air pour

visualiser les plis gastriques et conrmer la position.

5. Faire avancer un l-guide, jusqu’à 0,038 po., à travers l’aiguille et l’enrouler

dans la grosse tubérosité de l’estomac. Conrmer la position.

6. Retirer l’aiguille introductrice, en laissant le l-guide en place et la mettre

au rebut conformément au protocole de l’établissement.

7. Faire avancer un cathéter souple compatible de 0,038 po. sur le l-guide

et manipuler ce dernier dans l’antre de l’estomac en se servant du guidage

uoroscopique.

8. Faire progresser le l-guide et le cathéter souple jusqu’à ce que l’extrémité

du cathéter atteigne le pylore.

9. Franchir le pylore et faire progresser le l-guide et le cathéter dans le

duodénum et 10 à 15 cm au-delà du ligament de Treitz.

10. Retirer le cathéter et laisser le l-guide en place.

Dilatation

1. À l’aide d’une lame de scalpel No. 11, créer une petite incision cutanée qui

s’étend le long du l-guide vers le bas, à travers les tissus sous-cutanés et le

fascia des muscles abdominaux. Une fois l’incision réalisée, mettre au rebut

conformément au protocole de l’établissement.

2. Faire avancer un dilatateur au-dessus du l-guide et dilater le tractus de la

stomie à la taille souhaitée.

3. Retirer le dilatateur au-dessus du l-guide en laissant ce dernier en place.

4. Mesurer la longueur de la stomie à l’aide du dispositif de mesure de stomie

HALYARD*.

Mesure de la longueur de la stomie

Attention : La sélection de la taille correcte de sonde d’alimentation

MICKEY* est cruciale à la sécurité et au confort du patient. Mesurer la longueur

de la stomie du patient à l’aide du dispositif de mesure de stomie. La longueur

du corps de la sonde d’alimentation MICKEY* sélectionnée doit être identique

à la longueur de la stomie. Une sonde d’alimentation MICKEY* de taille

inadéquate peut provoquer une nécrose, le syndrome du buttoir enfoui et/ou

une hypergranulation.

1. Humecter l’extrémité du dispositif de mesure de stomie à l’aide d’un

lubriant hydrosoluble. Ne pas utiliser d’huile minérale. Ne pas utiliser de

vaseline.

2. Faire progresser le dispositif de mesure de stomie sur le l-guide, à travers la

stomie et jusque dans l’estomac. NE PAS FORCER.

3. Remplir la seringue Luer-slip de 5 ml d’eau et la xer à l’orice du ballonnet.

Enfoncer le piston de la seringue et goner le ballonnet.

4. Tirer délicatement le dispositif vers l’abdomen jusqu’à ce que le ballonnet

repose contre l’intérieur de la paroi de l’estomac.

5. Faire glisser le disque en plastique vers le bas jusqu’à l’abdomen et

enregistrer la mesure au-dessus du disque.

6. Ajouter 4 à 5 mm à la mesure enregistrée pour assurer une longueur et une

taille adéquates, dans n’importe quelle position. Enregistrer la mesure.

7. Utiliser une seringue Luer-slip, retirer l’eau du ballonnet.

8. Retirer le dispositif de mesure de stomie.

9. Noter la date, le numéro du lot et la longueur du corps de la sonde mesurée

en centimètres.

Mise en place de la sonde

Remarque : Une gaine pelable peut être utilisée pour faciliter l’avancement de la

sonde à travers le tractus de la stomie.

1. Sélectionner la sonde d’alimentation gastrique-jéjunale MICKEY*

appropriée et la préparer selon les instructions de la section sur la

préparation de la sonde gurant ci-dessus.

2. Faire progresser l’extrémité distale de la sonde sur le l-guide jusqu’à ce que

l’extrémité du l-guide sorte de la canule de l’introducteur.

Remarque : Une visualisation et une manipulation directes de l’introducteur

et du l-guide peuvent s’avérer nécessaire pour passer le l-guide à travers

l’extrémité de l’introducteur.

3. Tenir la garde de l’introducteur et l’orice d’alimentation jéjunale tout en

faisant progresser la sonde sur le l-guide, puis dans l’estomac.

4. Faire tourner la sonde gastrique-jéjunale MICKEY* de HALYARD* tout en la

faisant progresser pour en faciliter le passage à travers le pylore et dans le

jéjunum.

5. Faire progresser la sonde jusqu’à ce que l’extrémité de celle-ci se trouve de

10 à 15 cm au-delà du ligament de Treitz et que le ballonnet soit à l’intérieur

de l’estomac.

6. S’assurer que la collerette externe est à ras de la peau.

7. Goner le ballonnet à l’aide d’une seringue Luer-slip.

• Pour les sondes de taille pédiatrique (numéros de réf. se terminant par

-15, -22 ou -30), goner le ballonnet avec 3 à 5 ml d’eau stérile ou distillée.

Attention : Le volume total du ballonnet ne doit pas excéder 5 ml. Ne

pas utiliser d’air. Ne pas injecter de produit de contraste dans le ballonnet.

• Pour les sondes de taille adulte (numéros de réf. se terminant par -45),

goner le ballonnet avec 7 à 10 ml d’eau stérile ou distillée.

Attention : Le volume total du ballonnet ne doit pas excéder 10 ml. Ne

pas utiliser d’air. Ne pas injecter de produit de contraste dans le ballonnet.

8. Retirer le l-guide à travers la canule de l’introducteur tout en maintenant la

canule en place. Retirer la canule de l’introducteur.

Sonde d’alimentation gastrique-jéjunale (sonde GJ extra-plate) MIC-KEY* de HALYARD*

Mise en place endoscopique/radiologique



17 AUG 2015 • 15-H1-044-0-00 • Folded size: 8”x10”

Vérication de la position de la sonde

1. Vérier radiographiquement la mise en place correcte de la sonde, an

d’éviter toute complication potentielle (par ex. : irritation ou perforation des

intestins) et s’assurer que la sonde ne forme pas de boucle dans l’estomac ou

l’intestin grêle.

Remarque : La partie jéjunale de la sonde contient du tungstène opaque aux

rayons X pouvant être utilisée pour conrmer radiographiquement la position

de la sonde. Ne pas injecter de produit de contraste dans le ballonnet.

2. Rincer la lumière pour en vérier la non-obstruction.

3. Vérier l’absence d’humidité autour de la stomie. En présence de signes de

fuites gastriques, vérier la position de la sonde et la mise en place de la

collerette externe. Ajouter du liquide selon les besoins par incréments de 1

à 2 ml.

Attention : Ne pas dépasser le volume total du ballonnet indiqué

ci-dessus.

4. Procéder à une vérication pour s’assurer que la collerette externe n’est pas

placée trop fermement contre la peau et repose de 2 à 3 mm au-dessus de

l’abdomen.

5. Indiquer la date, le type, la taille et le numéro de lot de la sonde, le volume

de remplissage du ballonnet, la condition cutanée et la tolérance du patient

à cette intervention. Commencer l’alimentation et l’administration des

médicaments selon l’ordonnance du médecin et après conrmation de la

bonne mise en place et perméabilité de la sonde.

Mise en place radiologique par un tractus de

gastrostomie établi

1. Sous guidage uoroscopique, introduire un l-guide à embout souple,

jusqu’à 0,038 po., à travers la sonde de gastrostomie à demeure.

2. Retirer la sonde de gastrostomie au-dessus du l-guide.

3. Diriger le l-guide à travers la stomie et l’enrouler dans l’estomac.

4. Faire avancer un cathéter souple compatible avec le l-guide de 0,038 po.

sur ce dernier jusqu’à ce que l’extrémité du cathéter atteigne le pylore.

5. Franchir le pylore et faire progresser le l-guide dans le duodénum. S’il est

dicile de faire progresser le cathéter dans le pylore, essayer de réduire la

longueur du cathéter enroulé dans l’estomac. Un mouvement de rotation du

cathéter souple peut faciliter le passage sur le l-guide.

6. Faire progresser le l-guide et le cathéter jusqu’à un point situé de

10 à 15 cm au-delà du ligament de Treitz.

7. Retirer le cathéter et laisser le l-guide en place.

8. Mesurer la longueur de la stomie à l’aide du dispositif de mesure de stomie

HALYARD*.

Mise en place de la sonde

1. Sélectionner la sonde d’alimentation gastrique-jéjunale MICKEY* de

taille appropriée et la préparer selon les instructions de la section sur la

préparation de la sonde gurant ci-dessus.

2. Faire progresser l’extrémité distale de la sonde sur le l-guide jusque dans

l’estomac.

3. Faire tourner la sonde gastrique-jéjunale MICKEY* de HALYARD* tout en la

faisant progresser pour en faciliter le passage à travers le pylore et dans le

jéjunum.

4. Faire progresser la sonde jusqu’à ce que l’extrémité de celle-ci se trouve de

10 à 15 cm au-delà du ligament de Treitz et que le ballonnet soit à l’intérieur

de l’estomac.

5. Goner le ballonnet à l’aide d’une seringue Luer-slip.