Teleflex Medical
Autofuser Disposable Pain Control Pump with Autoselector Variable Flow Regulator
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AutoFuser/AutoSelector products do not require periodic maintenance. If desired, clean the pump using a damp cloth. Note: Do not use cleaning agents as they may damage the pump. Do not immerse the pump in water or other fluid. When showering, the patient should keep the pump outside of the shower or place it in a waterproof bag. Do not tamper with the pump. Take care to prevent entry of any foreign substances inside the pump.
TECHNICAL SPECIFICATIONS
Flow Rate: AutoSelector models allow the user to select from 8 preset rates using the AutoSelector dial: A Type: 0.5mL/hr to 7.0mL/hr. B Type: 1.0mL/hr to 14.0mL/hr. Flow rate options are printed on the front of the AutoSelector regulator. Balloon Pressure: Approximately 8 psi (average). Reservoir Volume: 100, 275 or 550mL. Bolus Volume: If applicable, 1.0, 2.0, or 5.0mL. Bolus Lock-Out Time: If applicable, 15, 30, or 60 minutes. Residual Volume: 100mL: 5mL or less; 275mL: 10mL or less; 550mL: 15mL or less. Filter: 1.2 micron particulate and air-eliminating filter. Sterilization Method: Ethylene Oxide. Fluid Contact Materials: ABS, Acrylic, Acrylated Urethane, Polycarbonate, Polyethersulfone, Polyurethane, PTFE, PVC, Silicone and Soda Lime Glass. Not made with natural rubber latex or DEHP.
Hourly Flow Rate (% of AVG flow rate over full Infusion)
Important reminders:
Temperature changes, medication viscosity and head height can affect flow rate. AutoFuser is calibrated with no head height, flowing 0.9% normal saline at room temperature (approximately 77°F or 25°C). Standard conditions: • A 10°F (5.5°C) raise in temperature will increase flow rate by 10%. • Drugs in a D5W base will flow approximately 10% slower. • Raising the pump approximately 22” (56cm) above the infusion site will increase flow rate by 10%. Flow Rate Accuracy: Average flow rate (total volume divided by total infusion time) +/- 15% of the labeled nominal rate (measured at +/- 2 SD) for the the 100mL, 275mL and 550mL reservoirs when flowing at the standard conditions (see above). Flow also varies over the course of the delivery as the balloon stretches and recovers (see graphs below for typical flow profile). Note: Pump samples representative of normal range of performance (multiple lots tested). Traces show how flow rate changes at hourly intervals as the reservoir empties.
Volume Delivered (mL)
Labeled Reservoir Volume
100 mL
275 mL
550 mL
Maximum Reservoir Volume
120 mL
330 mL
650 mL
Minimum Reservoir Volume
75 mL
195 mL
385 mL
AUTOFUSER® DISPOSABLE PAIN CONTROL PUMP WITH AUTOSELECTOR® VARIABLE FLOW REGULATOR INSTRUCTIONS FOR USE
Note: Filling the pump less than minimum reservoir volume may decrease flow rate. Filling pump greater than maximum reservoir volume may increase flow rate.
TEMPERATURE AND HEIGHT EFFECTS •
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Hourly Flow Rate (% of AVG flow rate over full Infusion)
To monitor medication delivery, check the position of the fluid against the graduation scale on the clear protective housing. The reservoir empties slowly, so the patient may need to re-check in a few hours. During use, periodically check for the following: • The AutoFuser pump is emptying. • The system is not leaking. • The catheter and tubing are not kinked. • All system connections are secure. • The clamp is open. • The AutoSelector flow rate is set directly on a number greater than zero. • The AutoSelector dial has been removed and, if the patient is not in an acute care setting, the zip tie has been engaged. • The patient is not experiencing side effects, which may include but are not limited to: - Increased pain. - Redness, swelling, pain or discharge at incision or catheter site. - Skin rash or hives. - Excitation or restlessness. - Light-headed or dizzy feeling. - Excessive drowsiness. - Metallic taste in mouth. - Other side effects as identified by the physician, clinician, pharmacist, medication manufacturer, et al.
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If using a drug in a normal saline base, the male luer connector at the end of the tubing (or the bolus button for PCA models or the AutoSelector module for variable rate models) should be at room temperature of approximately 77°F. If the unit is contacting the patient’s skin (about 10°F warmer), the warmer temperature will make it flow about 10% faster than normal. Lowering the pump about 22” below the infusion site will offset the temperature effect and bring flow back to normal. If using a drug in a 5% Dextrose (D5W) base, the male luer connector at the end of the tubing (or the bolus button for PCA models) should be at skin temperature of approximately 87°F. If the unit is not contacting the patient’s skin, the cooler room temperature will cause it to flow slower than normal. The pump can be raised above the infusion site to offset the temperature effect. If the pump is being used in combination with hot or cold therapy, always keep the pump and tubing at least 6 inches (15.2cm) away from the hot or cold source to avoid impacting the medication flow rate.
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STERILIZE
Do not use if package has been opened or damaged.
Non-pyrogenic CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Note: This diagram may not reflect the exact pump configuration supplied.
INDICATIONS •
Not made with natural rubber latex. Not made with DEHP.
Volume Delivered (mL)
Distributed by:
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Hourly Flow Rate (% of AVG flow rate over full Infusion)
INFORMATION FOR DAILY USE
• Manufactured by: ACEMEDICAL Made in Korea US Patent 7,264,610 Teleflex is a registered trademark of Teleflex Incorporated.AutoFuser and AutoSelector are registered trademarks of Ace Medical Co., Ltd. Volume Delivered (mL)
©2013, 2015 Teleflex Incorporated. All rights reserved.
L05518 R01
The AutoFuser®/AutoSelector® family of disposable pain control pumps with integrated administration set and variable rate regulator(s), either separately or as part of a convenience pack, is intended for general infusion use. Routes of administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into intra-operative (soft tissue/body cavity) sites. Within the AutoFuser/AutoSelector family are pump models intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, peri-operative and post-operative surgery.
CONTRAINDICATIONS
The AutoFuser/AutoSelector Disposable Pain Control Pump is contraindicated for: • Infusion of blood and blood products. • Infusion of lipids or fat emulsions. • Infusion of critical or life-supporting medications whose stoppage, interruption, over-delivery or under-delivery would likely cause serious injury or death. • Infusion of any solution that is incompatible with the materials of the AutoFuser/AutoSelector system. • Use in ambulatory regimens by patients who do not possess the mental, physical or emotional capability to self-administer their therapy; or who are not under the care of a responsible individual.
WARNINGS
Some studies have suggested a possible correlation between the intra-articular use of pain pumps in shoulders and the development of chondrolysis, particularly when epinephrine is used in conjunction with a local anesthetic. While these studies are not conclusive, we give the following warnings: • Use of local anesthetics containing epinephrine for continuous infusion is not recommended. • Continuous infusion of local anesthetics for intraarticular infusion is not recommended. Under all circumstances, decisions about methods of treatment and types of medication to be used are solely up to the treating physician. Intended for single use only. Do not re-use or re-sterilize. The accuracy and sterility of this device and fluid path cannot be guaranteed if the device is refilled.
PRECAUTIONS •
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As with all elastomeric infusion pumps, the AutoFuser’s flow rate varies as the balloon empties. Review the Flow Profile Graphs and Accuracy Information to verify the appropriateness of the AutoFuser for the intended infusion therapy. Do not use the pump if the packaging is damaged or previously opened. The product is sterile only in unopened, undamaged packaging. Utilize aseptic technique when preparing AutoFuser/ AutoSelector for use. AutoSelector models have eight preset rates. Reservoir volumes are fixed. Choose the appropriate nominal flow rate(s) and volume for the prescribed therapy. Do not fill the AutoFuser/AutoSelector pump with more than the maximum reservoir volume. Overfilling will increase the flow rate. As with any infusion system, medications may interact with the AutoFuser/AutoSelector materials. Consult the drug manufacturer’s insert for precautions, guidelines, and instructions for preparing and using the medication. Purge the air from the infusion line before connecting to the patient.
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The AutoSelector variable rate controller has several patient safety options that require clinician intervention including removing the dial after setting the flow rate and locking the protective cover with the included zip tie. Do not utilize near or in an MRI (magnetic resonance imaging) procedure or environment. The pump and catheter could have trace amounts of metal that will react to a strong magnetic field. The clinician is responsible for ensuring that the AutoFuser/AutoSelector and medications are used according to the physician’s infusion therapy prescription. The clinician is responsible for ensuring that the correct route of administration is used. Consult drug manufacturer’s labeling prior to using the AutoFuser/ AutoSelector to deliver the medication. The clinician is responsible for educating the patient in proper use of the system. Refer to the AutoFuser/ AutoSelector “A Patient’s Guide to Post-Operative Pain Relief.” Store at room temperature and protect from direct sunlight.
DIRECTIONS FOR USE
SETTING UP THE AUTOSELECTOR PUMP CAUTION: Use proper aseptic technique when setting up the AutoFuser/ AutoSelector disposable pump system. 1. Make sure the package is intact. The pump may not be sterile if the package is damaged or Step 3 previously opened. 2. Determine the prescribed medication, concentration, and volume. 3. Close the tubing clamp. Remove and save the fill port cover. 4. Fill the pump with prescribed medication. Note: Do not fill beyond Step 4 the maximum reservoir volume. Overfilling will result in increased flow rate until the reservoir empties to the normal capacity point. Underfilling the pump may also affect accuracy. 5. Replace fill-port cover when finished. Note: Do not over-tighten fill-port cover. 6. Open the tubing clamp to begin priming. Note: It is not necessary to remove the Step 5 vented cap for priming. 7. With PCA (bolus) models, prime the bolus according to the bolus type supplied with the pump. Refer to Step 7a and Step 7b to determine the appropriate method to prime Step 7 the bolus. a. For PCA (bolus) models not equipped with bolus priming device, wait until fluid has reached the tubing below the bolus. Using your thumb, prime the bolus by firmly and completely pressing the button all the way
down. This will expel the air and the bolus will slowly refill with medication. Press the button again after a few minutes to confirm that all air has been expelled. b. For PCA (bolus) models equipped Step 7a with bolus priming device, leave bolus priming device in place until medication is detected in the line below the bolus button. Remove bolus priming device and allow bolus to fill. Firmly and completely press the button after a few minutes to confirm that all air has been expelled. Step 7b 8. Open the protective cover of the AutoSelector regulator. Set the desired basal rate and remove the dial. Close the protective cover. Note: The dial must be set directly on one of the flow rate numbers shown on the blue portion of the regulator. If the dial is set in between these numbers, infusion will not occur. The exact numbers will vary depending on the AutoSelector type (Type A = 0.5-7mL/ hr, Type B = 1-14mL/hr). Step 8 9. Confirm that priming is complete and fluid is dripping from the tubing end at the expected flow rate (1mL/ hr = approximately 1 drop every 3 minutes). a. If pump is filled for immediate patient use, it is not necessary to Step 8 clamp pump tubing or adjust the AutoSelector dial. b. If pump is pre-filled for future use, clamp pump tubing, set the AutoSelector dial back to the zero position, and place the blue plug provided loose in the pump packaging on the end of Step 8 the tubing. CAUTION: If the user chooses to store a filled pump with the AutoSelector set to a flow rate (not set to the zero position), then a slide clamp must be closed on the tubing above the AutoSelector prior to storage. The recommended procedure in this situation is to fill and prime the system per normal procedure; clamp the tubing above the AutoSelector; place the blue plug on the end of the tubing; set the AutoSelector to the desired flow rate. Note: Any air remaining in the balloon or above the filter will automatically be removed by the air-eliminating filter. 10. After the catheter has been properly Step 10 primed and placed in the patient (see catheter manufacturer’s instructions for use), bolus the catheter with approximately 5mL of medication. Remove the blue plug (if applicable) from the end of the pump and connect catheter hub to the AutoFuser/AutoSelector pump tubing. Note: If the catheter is placed prior to the surgical procedure, it is still critical
to flush the catheter prior to connecting to the pump to ensure catheter patency. 11. Secure the catheter at the insertion site, following the catheter manufacturer’s instructions for use. Cover catheter hub/pump tubing connection with transparent dressing. Note: Do not tape over the filter or an air-lock may occur (the small hole on Step 11 the side of the filter is an air vent). 12. If the tubing clamp has been engaged, open the clamp to start the infusion. a. For continuous only models, medication flow rate may be slower than expected if the tubing/catheter connection is not taped to the patient’s skin due to temperature variances. b. For bolus-equipped models, use the wrist strap to hold the bolus on the patient’s wrist or other location next to the patient’s skin. Note: See “Temperature and Height Effects” and Technical Specifications” sections of this document for additional information. 13. If the AutoSelector regulator has been reset to zero following priming, reopen the protective cover and replace the removable Step 13 dial. Set the desired basal rate, remove the dial again, and reclose the protective cover. Note: If the physician requires variable flow rates during continuous peripheral nerve blocks or similar procedures, this step can be repeated multiple times as long as the dial is removed each time for patient safety. Refer to Step 8 for full instructions and accompanying drawings. 14. When the physician determines that variable flow rates are no longer required and/or the patient is being removed from an acute care setting, Step 14 set the final fixed basal rate, remove the dial and close the protective cover. Insert the zip tie provided in the pump package through the holes at the top of the clear blue protective cover and the white AutoSelector for additional patient security. 15. Place pump in carrying pouch or secure to patient with clip at or near incisional level to achieve optimal flow rate accuracy. Note: Make sure bolus button is accessible to patient. Step 15 16. Use the AutoFuser/AutoSelector “A Patient’s Guide to Post- Operative Pain Relief” to instruct the patient on daily use including use of the bolus button, starting and stopping medication delivery, and other clinical watch-outs. Remind the patient that the AutoSelector has been set to the appropriate flow rate as determined by the physician and should not be manipulated. Fill in the patient name, medication/contact details, and any special instructions prior to giving the guide to the patient.