Better Post-Op Pain Control Starts Here

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1 Better Post-Op Pain Control Starts Here POST-OP PAIN CONTROL PUMP

2 It s Easy to Get Started About the ACCUFUSER Pump Thank you for considering the This brochure makes it easy for For complete information on The ACCUFUSER pump delivers a continuous fixed- ACCUFUSER Post-Op Pain you and your team to get started operating the ACCUFUSER pump, rate infusion of non-narcotic local anesthetic to the Control Pump from Curlin using the ACCUFUSER pump for please refer to the Clinician surgical site through a catheter which is inserted at Medical. It s the pump you your surgical procedures. If you Directions for Use included in the the site during surgery. It is a non-electronic infuser would have designed yourself need additional assistance, ACCUFUSER pump procedure kit. that is disposed of after a single use. for better effectiveness, safety and satisfaction in managing post-operative pain following any surgical procedure. please call your Curlin representative or Curlin Customer Service at , toll-free, 24/7. An optional bolus-dose button allows patients to self-deliver additional local anesthetic for enhanced pain relief and satisfaction. The non-latex ACCUFUSER pump is safe, simple and Rigid Outer Housing Flow Indicator lightweight, so that patients can take it with them anywhere they go during their recovery. A carrying pouch makes the ACCUFUSER pump easy to wear during recovery. Fill Port POST-OP PAIN CONTROL PUMP Medication Reservoir Bolus Button Curlin Saturation Catheter Y-connector Air Elimination Filter On/Off Clamp Curlin Saturation Catheter

3 About the ACCUFUSER Procedure Kit Pump Specifications to Consider Order Your Selected ACCUFUSER Pump and Catheter Prepare the ACCUFUSER System for Use You can order the ACCUFUSER pump and either a standard catheter or a Curlin Saturation Catheter in different combinations to meet the needs of your surgical procedure. You ll receive the pump and catheter you specified, plus everything else needed to use the system, in a single convenient procedure kit. Within the procedure kit, the pump and catheter are provided in separate packs so that the pump may be pre-filled without opening the sterile catheter pack. Separate packaging assists the facility in complying with sterile compounding standards. Your ACCUFUSER pump procedure kit contains: Your specified ACCUFUSER pump Your specified catheter pack Directions for Use Patient Guide Chart labels Pump labels Carry pouch (carry clip for 100 ml pump) The catheter pack includes: Your specified catheter(s) with luer cap(s) Introducer(s) 60 cc filling syringe 5 cc flushing syringe Transparent dressing Adhesive suture strips Bifurcated set (dual packs only) Prep tray Select the ACCUFUSER System for Your Procedure Use the ACCUFUSER Catheter Placement Guides ACCUFUSER Catheter Placement Guides specific to surgical procedures are available from your Curlin representative. These Guides provide suggestions for catheter placement. They also provide tables of commonly-used ACCUFUSER pumps and catheters for each surgical procedure, making it easy for you to select a pump/catheter combination for your own procedure. The ACCUFUSER pump options given in the Catheter Placement Guides are based on the experience of other users and are intended for your guidance only. You should also consider the pump specifications as they relate to your own surgical case: Do you want your patient to use a bolus-dose button? Clinical research shows that patients given continuous local anesthetic combined with bolus dosing receive equivalent or superior analgesia and use less pain medication, compared to patients given continuous-only or bolus-only infusion. 1 At most available flow rates of continuous infusion, there are ACCUFUSER pump models that offer the bolus-dose feature. The two bolus dose options are 1 ml and 2 ml. Your choices for a bolus lockout time, during which period the patient cannot deliver another bolus dose, are 15, 30 and 60 minutes. How many days of therapy do you wish to provide your patient? The pump s fluid fill capacity and infusion flow rate determine how many days of therapy it will deliver. ACCUFUSER pumps are available in 100 ml, 275 ml and 550 ml fill volumes, and infuse at flow rates from 0.5 ml/hr to 10 ml/hr. Depending on their specifications, ACCUFUSER pumps provide delivery times from approximately one to five days. Other considerations may include the invasiveness of the procedure, your patient s weight and your patient s pain threshold. Catheter Specifications to Consider The catheter options given in the Catheter Placement Guides are based on the experience of other users and are intended for your guidance only. You should also consider the catheter specifications as they relate to your own surgical case: The Curlin Saturation Catheter is generally preferred for surgery because it is fenestrated, containing a pattern of tiny holes around its circumference to deliver uniform medication coverage around the wound area. Curlin Saturation Catheters are available in 2.5, 5 and 10 lengths. Shorter lengths are generally used for small incisions, subcutaneous placement, intra-articular placement and placement near nerve bundles. Longer catheters are generally used for large incisions and deep fascia, sub-muscular or tunneled placements. Standard catheters have three holes at the end and may be preferred for small incisions or in joint surgery. Dual catheters provide enhanced anesthetic coverage for longer incisions, or for bilateral placement, as in knee or breast procedures. To order your selected ACCUFUSER pump/catheter combination(s), note the Order Code(s) from both selection tables below and contact your Curlin representative or call Curlin Customer Service toll-free at Choose The ACCUFUSER Pump For Your Procedure: Fill Flow Continuous-Only or Delivery Order Volume Rate with Bolus Option Time Code (ml) (ml/hr) (Dose & Lockout) (Days) Continuous-only 5 C0005M Continuous-only 4 C0010M min lockout 2 to 4 M1015M Continuous-only 2 C0020M min lockout 1 to 2 M2015M min lockout 1 to 2 M2060M min lockout 1 to 2 T2015M min lockout 1 to 2 T2060M Continuous-only 5 C0020L min lockout 2 to 5 T2015L min lockout 4 to 5 T2060L Continuous-only 3 C0040L min lockout 1 to 3 T4030L min lockout 2 to 3 T4060L Continuous-only 2 C0050L min lockout 1 to 2 T5015L min lockout 1 to 2 T5060L Continuous-only 1.5 C0080L min lockout 1 to 1.5 T8015L min lockout 1 to 1.5 T8060L Continuous-only 1 C0100L Continuous-only 4.5 C0050XL min lockout 1 to 5 T5015XL min lockout 3 to 5 T5060XL Continuous-only 3 C0080XL min lockout 1 to 3 T8015XL min lockout 2 to 3 T8060XL Catheter Description 2.5 Fixed-Hub Curlin Saturation Catheter Order Code SK6 YK6 Dual Standard Catheter & 2.5 Curlin Saturation Catheter YK26 5 Fixed-Hub Curlin Saturation Catheter 10 Fixed-Hub Curlin Saturation Catheter Standard Fixed-Hub Catheter SK5 YK5 SK10 YK10 SK2 YK2 CAUTION: Use aseptic or sterile technique when preparing the ACCUFUSER pump for use. 1. Determine what medication is desired for this patient. 4. Save enough local anesthetic (approx 10 ml) to fill the 5 ml syringe for use in bolusing the catheter after closing is complete. 7. Connect the filled 60 ml syringe to the fill port and inject the local anesthetic into the pump reservoir. 9. Replace the luer cap on the fill port. Note: It is normal to see an air bubble inside the pump reservoir. The air-eliminating filter in the tubing set will eliminate this air. 11. To prime the bolus chamber, press down fully on the bolus button to expel air and allow the chamber to begin refilling. After a few minutes, press down on the bolus button again to expel any remaining air. 2. Fill the 5 ml syringe from the catheter pack with local anesthetic, and then use it to prime the catheter(s). Look for beading at the catheter holes. Step 7 5. Use the remaining local anesthetic to fill the 60 ml syringe from the catheter pack. This will be used to fill the pump. 10. Open the tubing clamp and remove the luer cap from the tubing distal end. The tubing will prime by itself. Step If using dual catheters, attach the Y-connector to the distal pump tubing. 6. Close the tubing clamp on the pump and remove the luer cap from the fill port on the tubing. 8. Repeat the filling procedure until the reservoir contains the desired volume. 12. Once fluid begins to drip from the distal end of the tubing, pump setup is complete. Clamp the tubing and replace the distal luer cap until the pump is ready to be connected to the patient. Note: It may be more convenient to connect to the patient after breaking scrub and removing the drapes.

4 Insert and Secure the Catheter in the Surgical Site Start Infusion to the Patient ACCUFUSER System Set-up Overview Note: To review common catheter placement locations for your surgical procedure, refer to the ACCUFUSER Catheter Placement Guides available from your Curlin representative. Prior to placement: Remove the catheter(s) from the pack and have ready for use. Also have the introducer(s) provided in the catheter pack ready for use. Adhesive suture strips and transparent dressing are provided in the catheter pack for use after closing. 1. Start infusion of the local anesthetic by opening the pump tubing clamp. 2. Place the pump in its carrying pouch. If using the 100 ml pump model, clip it to the patient s gown. 3. Make sure the bolus button is accessible to the patient. 1. Insert the split-sheath introducer 3 to 5 cm from the incision/trocar site and advance it into position for catheter placement. 2. Holding the split-sheath introducer in place, remove the needle from the introducer. Instruct the Patient in Proper Pump Use A patient brochure entitled About Your ACCUFUSER Post-Op Pain Control Pump is included in the ACCUFUSER pump procedure kit. Using this brochure, instruct the patient in proper use of the pump during the recovery period, including these key topics: Starting and stopping infusion Checking progress of infusion Using the bolus button What to do when infusion is complete Removing the catheter (if patient will be removing catheter) Symptoms to watch for (according to the drug manufacturer s recommendations) Who to contact if necessary Give the brochure to the patient to take home. ACCUFUSER System 3. Insert the catheter through the split-sheath introducer. 5. Break apart the T-handle and peel away the sheath while leaving the catheter in place. 4. Maintain the catheter position inside the incision while removing the split-sheath introducer COMPLETELY out of the skin. 6. After the incision has been closed, bolus the catheter(s) with approx. 5 ml of local anesthetic. Then either keep the syringe connected or place a leur cap on the catheter hub until ready to connect to the pump. Important: To confirm proper placement, always place the catheter under direct visualization before closing the wound. 7. Secure the catheter near the insertion site using the adhesive suture strips provided in the catheter pack. During the Infusion 1. Monitor the progress of infusion by noting the position of the flow indicator along the number scale on the pump reservoir. 2. Check for the following during infusion: ACCUFUSER pump is delivering medication There is no leakage from the ACCUFUSER system Air has not entered the pump reservoir The tubing is not kinked All system connections are secure 3. Check to make sure the patient is not experiencing symptoms of side effects, as according to the drug manufacturer s recommendations. These may include: Increased pain Redness, swelling, pain or discharge at the incision or catheter sites Skin rash or hives Metallic taste in the mouth Excitation or restlessness Dizziness or light-headedness Excessive drowsiness Surgical Site Insertion Site/ Dressing When the Infusion Is Complete If You Need Help 8. Coil the catheter two to three times and secure it with additional adhesive suture strips. 9. Cover the insertion site and the coiled catheter with the transparent dressing provided in the catheter pack. Note: You may cover the catheter transparent dressing with the tape from the incisional dressing. However, to prevent the catheter from possibly becoming dislodged when the incisional dressing is changed, cover the catheter transparent dressing with a 4 x 4 in. gauze. 10. After breaking scrub and removing the drapes, connect the pump to the catheter. If desired, this step may be performed in the post-op area instead. Upon completion of infusion, the ACCUFUSER pump is removed and discarded. The catheter may be removed by staff or the patient may be instructed in how to remove it. CAUTION: The ACCUFUSER pump is for single patient use only. Do not re-use or re-sterilize. Contact your Curlin representative whose business card is attached or whose information is imprinted on the back cover of this brochure. Or call Curlin Clinical Services at , toll-free, 24/7.

5 About Curlin Medical Curlin Medical, Inc. is an innovative medical technology company dedicated to improving infusion therapy and pain management. Through continuing investment in research and development, our mission is to provide best-in-class product solutions that improve medication safety, optimize clinical performance and reduce infusion costs. Our industry-leading infusion and pain management solutions include both electronic ambulatory pumps and non-electronic disposable infusers. A wide range of Curlin pumps are used in hospitals, surgery centers, clinics and patients homes for pain control, total parenteral nutrition, antibiotic delivery, chemotherapy and other infusion therapies. Contact Your Curlin Representative For more information or 24/7 clinical/technical support, call toll-free: or visit: Curlin Medical, Inc Graham Street Huntington Beach, CA USA (toll-free) (fax) Reference: 1 Singelyn FJ, Seguy S, Gouverneur JM. Interscalene brachial plexus analgesia after open shoulder surgery: continuous versus patient-controlled infusion. Anesth Analg 1999; 89: CAUTION: Before use, the user must become thoroughly familiar with the information contained in the ACCUFUSER pump operating instructions. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician 2007 by Curlin Medical, Inc. All rights reserved. ACCUFUSER is a registered trademark, and Curlin Saturation Catheter is a trademark, of Curlin Medical, Inc. U.S. Patents 6,024,724; 6,689,110B2; 6,676,643B Rev. A

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