Medtronic CYTO-KIT-USM Instructions for Use

en

Instructions for Use

CYTO-KIT-USM

Cytosponge™*

Cell Collection Kit

Cytosponge™*

Cell Collection Kit

Quick Reference Guide

1. Remove the Cytosponge™* cell collection device from the box. Do not use if

the pouch has been damaged or the packaging has been compromised.

2. Check the Specimen Jar with Preservative. Do not use if the seal is not intact or

the preservative has leaked.

3. Seat patient in an upright position.

4. Peel open the Cytosponge™* cell collection device pouch and remove the

device.

Note: For further details, and a complete list of contraindications, warnings, and
cautions, please refer to the Cytosponge™* cell collection device instructions for
use.

5. Detach capsule from the retainer card and carefully unwind the string from the

card.

6. Prepare the capsule and string for swallowing by bundling the string against

the capsule. Hold the capsule between your thumb and index finger and fold
the string back and forth in 2 cm lengths against the capsule. Use your thumb
and index finger to hold the folds adjacent to the capsule as you go. Stop
bundling when there is approximately 10 cm of string remaining from the
retainer card.

Caution

Do not wrap the string around the capsule.

Note: Bundling the string like an accordion will help to avoid tangles and knots
when swallowed.

7. Instruct the patient to open his or her mouth and extend his or her tongue.

Place capsule and string bundle in the patient’s mouth at the back of his or her
tongue.

8. Hold the retainer card so that approximately 10 cm of string remains outside of

the patient’s mouth.

9. Have the patient drink 150-250 mL of room temperature water to swallow the

capsule and string.

Note: Drinking water will help ensure that the string will properly travel down the
throat and the capsule will reach the stomach.

10. Check the patient’s mouth to ensure that all of the bundled string has been

Caution

Keep the Specimen Jar with Preservative out of reach of the patient.

swallowed. If there is excess string still present, have the patient drink
additional water and continue swallowing.

11. Set a timer for 7 min., 30 sec. Start the timer after the capsule and string have

been swallowed.

12. Prepare the Specimen Jar with Preservative prior to retrieving the

Cytosponge™* cell collection device by breaking the seal and removing the lid.

Note: For further details, and a complete list of contraindications, warnings, and

Caution

Center the string to the middle of the throat before pulling.

cautions, please refer to the Specimen Jar with Preservative instructions for use.

13. After 7 min., 30 sec. has elapsed, tilt the patients head back slightly, grip the

retainer card and string, and in a smooth, quick, and continuous fashion pull
the string until the sponge exits the patient’s mouth.

Note:

• Failure to wait the entire time period may result in inadequate samples.

• Removal of the Cytosponge™* cell collection device may trigger a brief

pharyngeal reflex; pulling smoothly, quickly, and continuously will lessen the
patient’s discomfort upon removal.

• Increased resistance may be encountered as the sponge passes the lower

esophageal sphincter and upper esophageal sphincter. This can potentially
require a slight increase of force to be exerted on the string.

14. Immediately place the Cytosponge™* cell collection device in the Specimen Jar

with Preservative.

15. Cut the string near the sponge and discard the retainer card and excess string.

16. Close the Specimen Jar with Preservative. Then label the jar according to

laboratory procedures.

17. Place the jar in the biohazard bag with the absorbent pad and seal the bag,

leaving little air in the bag.

Cytosponge™*

CYTO-201

Cell Collection Device

Indications for Use

The Cytosponge™* cell collection device is indicated for use in the collection and
retrieval of surface cells in the esophagus for cytological and histological analyses.

Do not use if package is opened or damaged

Target Population

Patient’s aged 18 and over.

Intended User Group

The Cytosponge™* device is to be administered by healthcare professionals such as
medical doctors, registered nurses, and other qualified health professionals trained
in use of the device.

General Warnings and Cautions

Warning

Use of this device has not been studied in, or may be more difficult, less effective,
or less well tolerated in patients under 18 years of age.

Use of this device in patients taking anti-thrombotic drugs which cannot be
temporarily stopped before and after the procedure is contraindicated.

Potential complications include:

• Aspiration

• Mucosal laceration or perforation requiring secondary intervention

• Major and minor bleeding

• Airway obstruction

• Infection

Warning

• Intestinal obstruction

• Tissue damage

treat any of the potential complications listed above.

The sponge may detach from the string during removal of the device.

In the event of the separation of the sponge and suture, an endoscopic retrieval
procedure (e.g. use of a Roth Net™* retriever) may be necessary.

• Allergic reaction

• Dysphagia

• Pain

Secondary intervention including endoscopy and/or surgery may be required to