1 July 2007 P48610 Rev.2 SmartInfuser PainPump ™ P49220, P49224N Operation Instructions

2 Smart Flow Control Systems אפליקציות טיפוליות נוספות

3 System Contents Regulating Set (SmartInfuser Set ™) Catheter Set (for P49220 only) - SmartCatheter - Peal away introducer - Catheter Instructions Compression Unit - Compression Unit loaded over empty 500 ml bag - Pump labels - Medication labels Carry pouch - Carry Pouch - Patient Guidelines and Instructions Syringe Wound DressingPhysician Guidelines and Instructions

4 Notes Intended for patients under the care of physician or licensed health care provider. The SmartInfuser PainPump™ is for single patient use only. Do not re-sterilize. Medications used with this system should be administrated in accordance with the instructions provided by the drug manufacturer. Patients should be advised to contact their physician or licensed health care provider if any of the system connections become disconnected or the catheter exits the surgical site. Avoid dropping the pump. In the event of damage or leakage, advise patient to contact their physician or licensed health care provider. In case of emergency, advise patients to close the clamp on the administration set in order to stop the flow of medication immediately. Do not suture catheter.

5 Considerations SmartInfuser PainPump™ is not for intravenous, intra-arterial, or epidural. SmartInfuser PainPump™ is not intended for delivery of blood, blood products or lipids.

6 (1) Prepare the Administration Set Remove the SmartInfuser Set ™ and the SmartCatheter from the sterile packaging. The SmartCatheter and SmartInfuser Set ™ comprise the Administration Set. SmartInfuser Set ™ Catheter Set

7 (2) Connecting the Administration Set (b) Tear off the bag port cover and insert the spike. (c) Verify the spike is positioned all the way in. (a) Connect the SmartCatheter to the Regulating Set using the luer connectors.

8 (3) Fill the Pump (a) Position the SmartReg® at C (Closed position). (b) I.Fill the syringe with medication. II.Drain any remaining air, and connect it to the set Check Valve. III.While the Check Valve is supported by the table, push down the syringe plunger until it is empty. IV.Repeat the filling process until the desired fill volume is reached. Maximum volume: 500ml Warning: Use aseptic technique to fill the pump. After use, handle and discard in accordance with standard medical protocol. C

9 (4) Prime the System (a) Position the SmartReg® at P (Priming position). (b) I. IMPORTANT: Hold BOTH the Compression Unit AND the Mutli-Bolus with tubes positioned vertically/upward. II.The SmartCatheter is flushed during priming. III.Set the SmartReg® at R (Regulating Position) once all air bubbles have drained from the set tube and the catheter been flushed. RP

10 (5) Set the Regulating Set I.Set the system flow rate by dialing the Adjusting Ring: the digit aligned represents the particular ml/hr. II.Lock the selected flow rate by pushing the Adjusting Ring toward the regulator. It will “click” when locked in place. Push to Lock

11 (6) Set the Multi-Bolus (a) Set the bolus volume by dialing the Push Button using the Key: the digit represents the particular ml selected for the bolus. (b) Lock the selected volume by pushing in the Safe Lock using the Key.

12 (7) Placing the Introducer While holding the T-handle, remove the protector from the introducer needle. Insert the introducer needle through the skin to the wound site at a distance of approximately 1.5” to 2” (see photo a). While holding the T-handle, pull out the introducer needle (see photo b). ab

13 (8) Placing the Catheter cd Cut the catheter infusion segment to the desire length (see photo c). Insert the catheter through the opening of the introducer’s T-handle to the wound site (see photo d).

14 (9) Placing the Catheter (continue) While holding the edge of the catheter, pull the introducer’s T-handle all the way off the skin (see photo e). Peel off the introducer by pulling out the handles; each handle to other direction (see photo f). ef Warning Care should be taken during catheter placement to assure that occlusion will not occur during use and that catheter removal will not be impeded. Ensure that the catheter tip has not been placed in a vein or artery!

15 (10) Fix the Catheter Make certain the catheter’s infusion tubing is entirely positioned at the wound site. The end of the infusion tubing is marked by a black band that should be positioned just below the skin surface (see photo g). Secure the catheter by coiling it close to the insertion site and attach it to the patient skin using the wound dressing (see photo h). gh Caution Do not cover the filter of SmartInfuser Set™ End of infusion tubing Filter

16 (11) Organizing the System Place the pump in the Carry Pouch: verify the regulator laying loosely within the the body of the pouch to avoid any kinks.

17 (12) Using the Bolus (a) Place the bolus over the wrist and secure it by tighten the strip. (b) Push the bolus button for an extra dose of medication when suffering exceptional pain.

18 THANK YOU! Thank you for your attention