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PERCUTANEOUS STOMA MEASURING DEVICE – INSTRUCTIONS FOR USE

Precau�ons

Possible Complica�ons

Pack Contents

Prior to Use

The Fidmi Medical Low Profile Gastrostomy Device is intended for use only with and following the use of 

the Fidmi Medical Stoma Measuring Device a�er determining the required device length.

If the measured stoma length falls between two marking, the one which indicates for a longer device 

should be selected.

Trained physicians who are experienced in percutaneous diagnos�cs and interven�onal techniques should 

use this product. Standard PEG placement steps should be employed with reference to the instruc�ons 

depicted here forth.

Complica�ons that may occur with the use of an enteral feeding device include fever, gastric distension, 

infec�on, blockage, �ssue necrosis.

Prepare and sedate the pa�ent using clinically approved methods indicated for endoscopic procedures.

Perform a gastric endoscopy procedure using a clinically approved method.

Posi�on the pa�ent in a supine posi�on and insufflate the stomach with air and trans-illuminate the 

abdominal wall.

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Needle Grip Handle

Summary of Contents for 20F

Page 1: ...PERCUTANEOUS STOMA MEASURING DEVICE INSTRUCTIONS FOR USE For 20F Devices EN ...

Page 2: ... infec on Do not use with pa ents treated with an coagulant drugs Do not use with pa ents which suffer from condi ons which would otherwise contraindicate endoscopic procedures Inspect the Low Profile PEG Placement Kit package and contents to verify that no damage has occurred as a result of shipping handling and or storage If damage to the sterile barrier or the device is noted DO NOT USE the devic...

Page 3: ...o are experienced in percutaneous diagnos cs and interven onal techniques should use this product Standard PEG placement steps should be employed with reference to the instruc ons depicted here forth Complica ons that may occur with the use of an enteral feeding device include fever gastric distension infec on blockage ssue necrosis Prepare and sedate the pa ent using clinically approved methods i...

Page 4: ...ra and or scar ssue Cau on The success of the procedure relies on proper selec on of the stoma site 1 Prepare and drape desired site Create a 1cm 0 4 incision in the skin at the desired loca on 2 Remove the Stoma Measuring Device s protec ve sheath Insert the Stoma Measuring Device through the incision passing the peritoneum into and through the stomach wall 3 4 PAGE 4 ...

Page 5: ...elected Note Do not let go of the wire 7 Pass the Retrieval Wire s down the already placed Measuring Device Cannula Upon visualiza on of the Wire grasp the Wire with the Snare 8 Withdraw the snare while grasping the Retrieval Wire simultaneously with the scope from the pa ent s mouth Note upon no cing that the Retrieval Wire s looped end exits through the pa ent s mouth stop when you no ce both of...

Page 6: ...Labeling symbols used as part of the Fidmi Medical Ltd Percutaneous Stoma Measuring Device Labeling PERCUTANEOUS STOMA MEASURING DEVICE INSTRUCTIONS FOR USE PAGE 6 March 2021 LAB 01 018 Rev 03 ...

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Page 8: ...treet 3079500 Israel Tel 972 77 362 8362 support fidmimedical com Distributed by Micro Tech USA Inc 2855 Boardwalk Drive Ann Arbor MI 48104 USA Toll Free 877 552 4027 customercare mtendoscopy com PERCUTANEOUS STOMA MEASURING DEVICE INSTRUCTIONS FOR USE For 20F Devices ...

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