Instructions for Use

The Colonix Medical cell collection procedure involves the use of the single-use Colonix Cell Sampler™. The device is used in conjunction with a dedicated and disposable (single-use – supplied) proctoscope. This procedure can be performed by any competent nurse or clinician and does not require any specific or formal additional training.

The following indication is abbreviated and does not constitute or replace the official IFU (Instructions For Use) that is supplied with the device;it should not be used as an official or actual instruction for use. The official IFU (supplied with the product) should be followed at all times during the procedure. Please contact us for more information.

Step 1.
The patient is first asked to lie on their side upon a clinical couch with their rectal opening facing the clinician. Following a ‘standard pre-proctoscopy’ digital examination, the dedicated and supplied proctoscope should be suitably lubricated and inserted into the rectum according to standard proctoscopy principles.

Step 2.
The Colonix™ device should be prepared (as directed in the actual Instructions For Use supplied)), and then inserted and locked into the proctoscope. The device at this time does not protrude beyond the proctal (or open) end of the proctoscope. The device plunger is then slowly pressed in to its full level of travel in order to inflate the membrane.

Step 3.
The membrane therefore makes gentle contact with the rectal mucosa, and is held in position for 10 seconds (this gives time for the exfoliated cells to adhere to the membrane).

Step 4.
The plunger is then withdrawn, and the membrane is inverted to its original state with the collected cells safely contained within. The proctoscope and device are both now removed. The proctoscope is disposed of according to local clinical waste legislation.

Step 5.
The ‘collection vessel’ component is now removed from the main device, and a
buffer-incorporating cap is attached to the sampling end. A base cap is attached to the syringe end. The buffer cap is activated, and the sample is sent to the nearest Colonix™ authorised sample laboratory along with a patient data sheet that primarily contains diet control information.