INSTRUCTIONS FOR USE SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER

BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.

IMPORTANT! This information is designed to assist in using this product. It is not a reference document for surgical stapling techniques. INDICATIONS The CHEX CS stapler is used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic techniques. CONTRAINDICATIONS 1. Do not use the CHEX CS stapler on any tissue that compresses to less

than 1mm or more than 2.0mm in thickness. In such cases, the staples will not be tight enough to ensure haemostasis.

2. The instrument should not be used if unusual effort is required to turn the Wing Nut in order to visualise pointer within fitting permitted area (green area of tissue approximation window). Overly thick inverted tissue could be crushed when the cartridge and anvil are closed. Failure to create a stoma, poor healing or narrowing of the anastomosis could result.

3. The CHEX CS stapler should not be used if the tissue is stretched or thinned out by introducing a cartridge that is too large for the diameter of the structure. Leakage and narrowing of the Anastomosis could occur. Therefore, do not use the CHEX CS 21 stapler on any tubular structure less than 20.8 mm in diameter. Do not use the CHEX CS 25 stapler on any tubular structure less than 24.8 mm diameter. Do not use the CHEX CS 28 stapler on any tubular structure less than 27.8 mm diameter. Do not use the CHEX CS 32 on any tubular structure less than 31.8 mm in diameter.

4. Do not use CHEX CS staplers unless there is sufficient tissue to allow proper inversion of tissue edges so staples can be placed securely. The purse-string suture must be tied snugly around the centre rod.

5. Do not use the stapler where the adequacy of haemostasis cannot be verified visually after firing.

INSTRUMENT PERFORMANCE The CHEX CS stapler places a circular, double staggered row of titanium staples. Immediately after staple formation, the instruments knife blade resects the excess tissue, creating a circular Anastomosis. The instrument is activated by squeezing the handle firmly as far as it will go. The diameter of the staple line is determined by the selection of the 21mm, 25mm, 28mm or 32mm stapler. SCHEMATIC VIEW

A). RED BAND B). INSTRUMENT SHAFT C). RED SAFETY LEVER D). INSTRUMENT FIRING HANDLE E.) WING NUT

F).APPROXIMATION INDICATOR G).CENTRE ROD H). PURSE-STRING KNOTCH I). ANVIL

INSTRUMENT OPERATION Upon removal of stapler from the package remove radiopaque trocar from the instrument (if supplied) and keep in sterile field for later use. 1. Remove spacer tab by rotating adjusting Wing Nut counterclockwise

(2 turns Max). Place purse-string sutures in the organs to be anastomosed. Based on surgeon experience and judgement, a closed lumen technique (double or triple stapling technique) may be employed.

2. For a double stapling technique open the instrument using the Wing Nut, and turning counterclockwise, until the red band is fully visible.

3. Remove the detachable head assembly to expose the trocar. 4. Retract the trocar by rotating the Wing Nut clockwise until the trocar

tip is below the cartridge surface.. 5. Check trocar to verify that it is retracted before proceeding. Note: The

instrument may also be inserted without removing the detachable head assembly if the preferred application is a sutured purse-string technique. In this case, however, prior to insertion, the detachable head assembly and the staple housing must be closed by rotating the Wing Nut clockwise.Insert the detachable head assembly into the lumen and secure the purse-string onto the anvil shaft above the tying notch.

6. Insert the instrument up to the closed lumen with the detachable head assembly removed and the trocar retracted. Fully extend the trocar and pierce tissue by rotating the Wing Nut counterclockwise. Push the tissue down until the red band is visible. Caution: Keep the trocar visible at all times to prevent personal injury or inadvertent trauma to adjacent structures. Reattach the detachable head assembly by sliding the anvil shaft over the trocar and pushing until the detachable head assembly snaps into its fully seated position. Caution: DO NOT clamp across or grip on the locking springs when attempting to reattach the detachable head assembly. To avoid inclusion of tissue within the anvil shaft, DO NOT use it for piercing. Instead, insert the ancillary trocar (included with stapler) to the anvil shaft. While closing the instrument, keep the organ segments in proper orientation. Inspect to ensure extraneous tissue is excluded. Turn the Wing Nut clockwise to close the instrument.

7. As the final adjusting revolution is approached, the orange indicator moves into the green range of the gap setting scale. If the tissue segments to be anastomosed appear unusually thick or thin, the surgeon should adjust the instrument until, in his/her judgment, the tissue is adequately compressed or properly anastomosed (providing the orange indicator falls fully within the green range of the gap

setting scale). This allows the surgeon to place staples at the height required for desired tissue. Caution: DO NOT fire the instrument if the orange indicator is not fully within the green range of the gap setting scale.

8. To fire the instrument, draw the red safety lever back toward the adjusting knob until it seats into the body of the instrument. If the safety cannot be released, the instrument is not in the safe firing range.

9. Once released, squeeze the firing handle with a firm, steady pressure. The surgeon will feel reduced trigger pressure and hear a “crunch” as the instrument completes the firing cycle.

10. After firing, release the firing handle, allowing it to return to its original position, and re-engage the safety.

11. To reset the safety, pull the firing handle back to its original position, if necessary.

12. Open the instrument by turning the Wing Nut counterclockwise as indicated on the end of the knob. For easy removal, only open the instrument one-half to three-quarters revolutions.

13. To assure the anvil is free from tissue, rotate the instrument 90° in both directions.

14. To withdraw the open instrument, gently apply rearward traction while simultaneously rotating.

To inspect the donuts, remove the detachable head assembly, washer (if present), and donuts from within the circular knife. Examine the integrity of the donuts. Donuts should be intact and include all tissue layers. If donuts are not complete, the anastomosis should be carefully checked for leakage and appropriate repairs made. Caution: Squeezing the firing handle exposes the knife. Engage the red safety prior to removing the washer and donuts from within the circular knife. STAPLER INFORMATION Product

code Colour Size of staple

Outside diameter

Cutting diameter

Staple Qty.

Working Length

CS21 Orange 3.8mm

4.2mm

21mm 13mm 16 420mm

CS25 White 4mm

5mm

25mm 17mm 20 420mm

CS28 Blue As above 28mm 20mm 24 420mm CS32 Green As above 32mm 24mm 28 420mm

CS21L Orange 3.8mm

4.2mm

21mm 13mm 16 520mm

CS25L White 4mm

5mm

25mm 17mm 20 520mm

CS28L Blue As above 28mm 20mm 24 520mm CS32L Green As above 32mm 24mm 28 520mm

CS21C Orange 3.8mm

4.2mm 21mm 13mm 16 425mm

CS25C White 4mm

5mm 25mm 17mm 20 425mm

CS28C Blue As above 28mm 20mm 24 425mm CS32C Green As above 32mm 24mm 28 425mm

CS21F Orange 3.8mm

4.2mm

21mm 13mm 16 420mm

CS25F White 4mm

5mm

25mm 17mm 20 420mm

CS28F Blue As above 28mm 20mm 24 420mm CS32F Green As above 32mm 24mm 28 420mm

WARNINGS AND PRECAUTIONS 1. The product has been terminally sterilised with radiation (Cobalt 60).

Never use any product with damaged packaging. 2. This product is for single use only. DISCARD AFTER USE. DO NOT

RESTERILISE. Any reprocessing or re-sterilisation may affect the instrument’s integrity and cause the product to fail during use.

3. Pre-operative radiotherapy may result in changes to tissues. These changes can, for example, cause the tissue thickness to exceed the indicated range for the staple. Careful consideration should be given to any pre-surgical treatment the patient may have undergone to ensure appropriateness of device application.

4. Purse-string sutures must be placed no more than 2.5mm from the cut edge of the tissue to avoid excessive tissue within the closed anvil and cartridge, which could cause staple malformation or leakage.

5. Cleaning the bowel too far from the cut edge could result in devascularising the inverted tissue, therefore causing poor healing. The safety range for cleaning back tissue is as follows: A. CS 21 stapler – 0.5cm B. CS 25 stapler – 0.5cm C. CS 28 stapler – 1 cm D. CS 32 stapler – 1.5cm

6. Make certain that the section of tissue to be stapled is free from any metal clips or other similar structures otherwise knife-blade may not cut.

7. Make certain that the space between the cartridge and anvil is closed snugly and the tissue compressed. Inspect and ensure that the tissue approximation indicator is visibly within correct compression zone prior to firing the stapler. If the compression indicator is outside of the recommended range do not attempt to fire the stapler.

8. When opening the stapler prior to removal DO NOT TURN THE WING NUT MORE THAN 0.50-0.75 TURNS.

9. After removal of the stapler, always inspect the staple line for haemostasis. Minor bleeding can be controlled by means of electrocautery or manual sutures.

10. The tissue specimens should be inspected to ensue that all tissue layers have been incorporated in the anastomosis. If the specimens are not complete, a leak could result and cause narrowing.

11. Contact of the CHEX CS stapler with mercuric chloride solutions may cause a chemical reaction and therefore should be avoided.

12. DISCARD AFTER USE. RECOMMENDED STORAGE CONDITIONS STORE AT ROOM TEMPERATURE. AWAY FROM MOISTURE AND DIRECT HEAT. DO NOT EXPOSE TO TEMPERATURES ABOVE 54° C (130 DEGREES FAHRENHEIT). THE CHEX CS STAPLER IS PROVIDED STERILIZED BY IRRADIATION. THE EXPIRY DATE AS INDICATED ON THE PACKAGING WILL BE FIVE YEARS FROM IRRADIATION IF THE PACKAGING IS NOT BROKEN.

ENGLISH

CHEX CS

!

E

DC

B

E

DC

B

E

B

CD

CS F series

CS C series

CS & CS L series