Halyard Mic series User manual

Nutrition Administration

1. Open the cap to an access port of the MIC* PEG Tube and unclamp the tube.

2. Use an ENFit™ syringe to ush the tube with the prescribed amount of water as

described in the General Flushing Guidelines.

3. Remove the ushing syringe from the access port.

4. Securely connect an ENFit™ feed set or an ENFit™ syringe to the access port.

Caution: Do not over-tighten the feed set connector or the syringe to the

access port.

5. Complete feeding per the clinician’s instructions.

6. Remove the feed set or syringe from the access port.

7. Use an ENFit™ syringe to ush the tube with the prescribed amount of water as

described in the General Flushing Guidelines.

8. Remove the ushing syringe from the access port.

9. Close the cap to the access port.

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 warm water before

administering through the feeding tube. Never crush enteric coated medication or

mix medication with formula.

1. Open the cap to an access port of the MIC* PEG Tube and unclamp the tube.

2. Use an ENFit™ syringe to ush the tube with the prescribed amount of water as

described in the General Flushing Guidelines.

3. Remove the ushing syringe from the access port.

4. Securely connect an ENFit™ syringe containing the medication to the access port.

Caution: Do not over-tighten the syringe to the access port.

5. Deliver the medication by depressing the ENFit™ syringe plunger.

6. Remove the syringe from the access port.

7. Use an ENFit™ syringe to ush the tube with the prescribed amount of water as

described in the General Flushing Guidelines.

8. Remove the ushing syringe from the access port.

9. Close the cap to the access port.

Gastric Decompression

Gastric decompression may be performed via either gravity drainage or low

intermittent suction.

1. Open the cap to the access port of the MIC* PEG Tube and unclamp the tube.

2. For gravity drainage, place the opened access port of the MIC* PEG Tube directly

over the opening of an appropriate container.

Note: Ensure the open access port is positioned below the stoma.

3. For low intermittent suction, connect an ENFit™ syringe to the access port.

4. Apply low intermittent suction by slowly retracting the plunger of the syringe in

short intervals.

Caution: Do not use continuous or high pressure suction. High pressure

could collapse the tube or injure the stomach tissue and cause bleeding.

5. Disconnect the decompression syringe from the access port.

6. Use an ENFit™ syringe to ush the tube with the prescribed amount of water as

described In the General Flushing Guidelines.

7. Remove the ushing syringe from the access port.

8. Close the cap to the access port.

Daily Care & Maintenance Check List

Assess the patient Assess the patient for any signs of pain, pressure or

discomfort.

Assess the stoma

site

Assess the patient for any signs of infection, such

as redness, irritation, edema, swelling, tenderness,

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 and dry well.

Clean the gastric

ports

Use a cotton tip applicator or soft cloth to remove all

residual formula and medication.

Rotate the tube Rotate the tube 360 degrees plus a quarter turn daily.

Verify placement of

the external bolster

Verify that the external bolster rests 1–2 mm above

the skin.

Flush the feeding

tube

Flush the feeding tube as described in the General

Flushing Guidelines section above.

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

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

generally thicker and may contain particulates

• 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. Connect an ENFit™ syringe lled with warm water into the appropriate access

port 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.

Warning: For enteral nutrition and/or medication only.

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

website at 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.

MIC

PERCUTANEOUS ENDOSCOPIC

GASTROSTOMY (PEG) KIT

with ENFit™ Connectors

Instructions for Use

PULL

Technique

Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004 • In USA, please call 1-844-425-9273 • halyardhealth.com

Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004 USA; Halyard Belgium BVBA, Leonardo Da Vincilaan 1, 1930 Zaventem, Belgium

Sponsored in Australia by Halyard Australia Pty Limited; 52 Alfred Street, Milsons Point, NSW 2061

製造販売元ハリヤード・ヘルスケア・インク横浜市西区みなとみらい二丁目2番1号

™ ENFit is a registered trademark of GEDSA used with their permission.

Sterilized using

Ethylene oxide

Do not use

if package

is damaged

Rx Only Consult

instructions

for use

Caution

Do not

resterilize

Single Use

Only

Rx Only: Federal Law (USA) restricts this device to sale by or

on the order of a physician.

Description

The HALYARD* family of MIC* gastrostomy feeding tubes allows for delivery of enteral nutrition and

medication directly into the stomach and/or gastric decompression.

Indications for Use

Gastrostomy tube feeding may be indicated for patients needing long-term enteral support or

hydration secondary to a primary condition relating to the head and/or neck. These conditions

include stroke; cancer; head and neck tumors, Injuries, or trauma; and neurological disorders

resulting in a chewing or swallowing abnormality. This device (sold in a kit) is intended as an initial

placement device.The device is placed by one of two techniques, the PULL technique and the over-

the-guidewire technique (PUSH technique). This guidance covers the PULL technique.

Contraindications

Contraindications for placement of a gastrostomy feeding tube include, but are not limited to colonic

interposition, portal hypertension, peritonitis, morbid obesity and esophageal stenosis.

Warnings

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.

After MIC* PEG Tube placement, proper positioning of the internal bumper against the

gastric mucosa must be veried endoscopically. Tension on the MIC* PEG Tube should be

avoided to minimize the risk of complications.

Failure to comply with these warnings may result in pressure necrosis of the gastric

mucosa with subsequent erosion, perforation, and/or leakage of gastric contents into

the peritoneum. Migration of the internal bumper into the stoma tract or embedding

into the stomach wall may also occur over time.

Dispose of all sharps according to facility protocol.

Complications

The following complications may be associated with any gastrostomy feeding tube:

• Skin Breakdown

• Infection

• Hypergranulation Tissue

• Stomach Ulcers

• Intraperitoneal Leakage

• Pressure Necrosis

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

PULL Placement Procedure

1. Use a clinically approved method to prep and sedate the patient for an endoscopic procedure.

2. Use a clinically approved procedure to perform the gastric endoscopy.

3. With the patient in a supine position, insuate the stomach with air and transilluminate the

abdominal wall.

Caution: Proper selection of the insertion site is critical to the success of this procedure.

4. Select gastrostomy site.This site (typically the upper left quadrant) should be free of major

vessels, viscera, and scar tissue.

5. Depress the intended insertion site with a nger. The endoscopist should clearly see the resulting

depression on the anterior surface of the gastric wall.

6. Prep and drape the skin at the selected insertion site. Locally anesthetize the insertion site.

7. Following local anesthesia, make a 1 cm (approximate) incision through the skin with the

scalpel.

8. Insert the introducer needle system through the incision, advancing through the peritoneum

and the stomach wall.

Fig. 1

9. When the introducer needle is observed in the stomach, remove the introducer needle from the

introducer cannula by rmly holding the cannula hub and pulling back on the needle hub.

10. Insert the retrieval snare intro the endoscope, and push the retrieval snare through endoscope

until observed in the stomach.

11. Place the looped placement wire through the introducer cannula into the stomach. Grasp the

looped placement wire with a retrieval snare.Withdraw the retrieval snare into the endoscope

channel. Fig. 2

12. Remove the endoscope and the looped placement wire through the oropharynx. Pull

approximately 5 inches (13 cm) of the looped placement wire from the mouth.

13. Slowly and smoothly feed the looped placement wire into the introducer

cannula as the endoscope is retracted. Keep the introducer cannula in

place in the stomach with the distal end of the placement loop outside the

abdomen. Fig. 3

14. Connect the looped placement wire with the tube loop. Fig. 4

15. Lubricate the MIC* PEGTube with a water-soluble lubricant. Apply traction

to pull the placement loop and the tube back through the oropharynx,

esophagus, and into the stomach. Fig. 5

16. Re-enter the esophagus with the endoscope and visually follow the

gastrostomy tube as it enters the stomach. Slide the introducer cannula out

of the incision site and gently pull the PEG dilator tip through the abdominal

wall.

17. Use a rotating motion to slowly work the tube up and out until the internal

bumper gently rests against the gastric mucosa.

Note: Graduated markings on the body of the tube will assist in determining

the progress of the tube as it exits the abdomen.

Caution: Do not use excessive force to pull the tube into place.This could

harm the patient and damage the tube.

18. Cleanse the tube and stoma site and apply a sterile gauze dressing. Cut the

tube loop wire with scissors and discard the tube loop and placement wire.

19. Slide the external bolster over the proximal end of the MIC* PEG Tube and

push the external bolster into place next to the sterile gauze dressing.

Visually verify that the internal bumper is properly placed. Remove the

endoscope.The external bolster should be positioned approximately 2 mm

above the skin.

Caution: Do not apply excessive tension. There should be no

compression of the gastric mucosa or the skin. Optionally, a suture loop (not

supplied) may be tied around the external bolster to minimize movement of

the MIC* PEG Tube while the stoma is healing.

20. Cut the MIC* PEGTube straight across, leaving an appropriate length to

attach a MIC* Feedhead Adapter. Fig 6 Discard the removed portion of the

tubing.

21. Slide the clamp on the MIC* PEG Tube.

22. Insert the barb connector of the MIC* Feedhead Adapter completely into the

proximal end of the MIC* PEGTube.

Skin and Stoma Care

1. Keep the skin around the MIC* PEGTube stoma site clean, dry, and free of

drainage.

2. After the stoma is healed, a dressing is not necessary with the MIC* PEG Tube

and may even cause moisture retention resulting in skin irritation.

Removal of the MIC* PEG Tube

The MIC* PEGTube should be removed by either traction removal through the

stoma or through endoscopic retrieval.

Caution: It is not recommended that a portion of the tube be cut to allow

the internal bumper to pass.

Caution: When the 14 Fr PEG is used, use endoscopic removal method only.

Warning: Never attempt to change the tube unless trained by the

physician or other health care provider.

Traction Removal of the MIC* PEG Tube

1. When the physician determines that the tract is formed (usually within 4–6

weeks after placement of PEG), the MIC* PEGTube may be replaced with an

alternative feeding device. We recommend using one of the following:

• MIC-KEY* Low-Prole GastrostomyTube

• MIC* GastrostomyTube

2. Ensure that this type of tube can be replaced at the bedside.

3. To remove the tube, prep the patient for MIC* PEG Tube removal using

standard procedure.

4. Lubricate the skin and tube around the stoma with a watersoluble lubricant.

Rotate the tube 360° and move the tube in and out slightly.

Warning: If the tube does not move without restriction in the

tract, do not attempt to use traction as a method of removal.

Removal of feeding tubes using traction may result in tract

separation and associated complications. Feeding tubes that have

been in place for several months may have an increased potential

for internal bumper separation during traction removal.

Caution: When the 14 Fr PEG is used, use endoscopic removal method

only.

5. Position one hand on the abdomen around the stoma with the thumb and

forenger approximately two Inches apart to stabilize the abdominal wall.

6. Grasp the tube with the opposite hand next to the stoma site. Firmly, but

gently, pull the MIC* PEG Tube until the internal bumper emerges through

the stoma.

7. Replace the MIC* PEG Tube with the appropriately sized gastrostomy tube.

8. If the tube cannot be removed with a reasonable amount of traction, it

should be removed by endoscopic retrieval.

Endoscopic Removal of the MIC* PEG Tube

1. When the physician determines that the tract is formed (usually within 4-6

weeks after placement of PEG), the MIC* PEGTube may be replaced with an

alternative feeding device. We recommend using one of the following:

• MIC-KEY* Low-Prole GastrostomyTube

• MIC* GastrostomyTube

2. To remove the tube, prep the patient for MIC* PEG Tube endoscopic removal

using standard procedure.

3. Cut the MIC* PEGTube at skin level.

4. Retrieve the MIC* PEGTube using endoscopic tools according to facility

protocol.

5. Replace the MIC* PEG Tube with the appropriately sized gastrostomy tube.

Feedhead Adapter with ENFit™ Connectors Replacement

Procedure

1. Cleanse the skin around the stoma site and allow the area to air dry.

2. Clamp the tube and trim the MIC* PEG Tube as necessary using scissors. Cut

the tube straight across.

3. Push the Replacement Feedhead Adapter with ENFit™ Connectors

completely into the MIC* PEGTube.

4. Unclamp the tube to resume use.

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.

• Flush the feeding tube after checking gastric residuals.

• 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 uids 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

Flush the feeding tube with water using an ENFit™ syringe 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.

• Unclamp the MIC* PEG Tube before ushing.

• Use a 30 to 60 ml ENFit™ syringe. Do not use smaller size syringes as this can

increase pressure on the tube and potentially rupture smaller tubes.

• Ensure the second access port (if applicable) is closed with the tethered cap

prior to ushing.

• Use room temperature 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 ml for adults,

and 3 to 10 ml 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.

HALYARD*MIC*Percutaneous Endoscopic Gastrostomy (PEG) Kit

with ENFit™ Connectors

PULL Technique

Fig. 1

Fig. 4

Fig. 2

Fig. 5

Fig. 3

Fig. 6