Teleflex Medical
Autofuser Disposable Pain Control Pump with Autoselector Variable Flow Regulator
2 Pages
Preview
Page 1
•
• •
AutoFuser does 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: Flow rate is fixed for each model. See flow rate information printed on the pump. 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. 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).
Hourly Flow Rate (% of AVG flow rate over full Infusion)
Important reminders:
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 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.
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
INSTRUCTIONS FOR USE
TEMPERATURE AND HEIGHT EFFECTS •
Volume Delivered (mL)
•
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) 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.
Do not use if package has been opened or damaged. Non-pyrogenic Volume Delivered (mL)
AUTOFUSER® DISPOSABLE PAIN CONTROL PUMP
Note: Filling the pump less than minimum reservoir volume may decrease flow rate. Filling pump greater than maximum reservoir volume may increase flow rate.
•
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 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.
Not made with natural rubber latex.
Not made with DEHP.
Note: This diagram may not reflect the exact pump configuration supplied.
INDICATIONS •
The AutoFuser® family of disposable pain control pumps with integrated administration set, 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 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.
CAUTION: Federal law restricts this device to sale by or on the order of a healthcare practioner. WARNING: Read all package insert warnings, precautions, and instructions prior to use. Failure to do so may result in severe patient injury or death.
Hourly Flow Rate (% of AVG flow rate over full Infusion)
INFORMATION FOR DAILY USE
Distributed by:
3015 Carrington Mill Blvd Morrisville, NC 27560 USA USA: (866) 246 6990 International: +1 919 544 8000 www.teleflex.com
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)
© Copyright 2013, 2020 Teleflex
L05519 R01 (2020-10)
CONTRAINDICATIONS
The AutoFuser 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 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 •
• • • • •
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 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 for use. Flow rate and reservoir volumes are fixed. Choose the appropriate nominal flow rate and volume for the prescribed therapy. Do not fill the AutoFuser with more than the maximum reservoir volume. Overfilling will increase the flow rate. As with any infusion system, medications may interact with the AutoFuser 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. 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 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 to deliver the medication. The clinician is responsible for educating the patient in proper use of the system. Refer to the AutoFuser “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 disposable pump system. 1. Make sure the package is intact. The pump may not be sterile if the package is damaged or previously opened. Step 3 2. Determine the prescribed medication, concentration, and volume. Check pump to ensure desired flow rate (printed on the bottom front of the reservoir) has been selected. 3. Close the tubing clamp. Remove and save the fill port cover. 4. Fill the pump with prescribed medication. Note: Do not fill beyond the maximum reservoir volume. Overfilling will result in increased flow rate until the reservoir empties to the normal capacity point. Underfilling the Step 4 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 vented cap for priming. 7. With PCA (bolus) models, prime the Step 5 bolus according to the bolus type
with the pump. Refer to Step 7a and Step 7b to determine the appropriate method to prime the bolus: Step 7 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 Step 7a 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 with bolus priming device, leave in place until medication is detected in the line below the bolus button. Remove bolus priming device and allow bolus to fill. Firmly and Step 7b completely press the button after a few minutes to confirm that all air has been expelled. 8. 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 clamp pump tubing. b. If pump is pre-filled for future use, clamp pump tubing and place the blue plug provided loose in the pump packaging on the end of the tubing. Note: Any air remaining in the balloon or above the filter will automatically be removed by the aireliminating filter. 9. After the catheter has been properly primed and placed in the patient (see catheter manufacturer’s instructions for use), bolus the catheter with approxStep 9 imately 5mL of medication. Remove the blue plug (if applicable) from the end of the pump and connect catheter hub to the AutoFuser 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. 10. Coil the catheter two to three times and secure with adhesive suture strip(s). Cover the insertion site and the coiled catheter hub/pump tubing connection with transparent dressing. Note: Do not tape over the Step 10 filter or an air-lock may occur (the
small hole on the side of the filter is an air vent). 11. 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. 12. 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 Step 12 button is accessible to patient. 13. 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.