Directions for Use
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Pressure Infusor Directions for Use READ AND UNDERSTAND INSTRUCTIONS PRIOR TO USE AND FOLLOW ALL WARNINGS AND PRECAUTIONS.
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90ºF 32ºC 50ºF 10ºC
English
0086
Rx ONLY
DEVICE DESCRIPTION
INTENDED USE
ConMed Pressure Infusors control the flow of Irrigation Fluid to the operative site during surgery. To control the flow of Irrigation Fluid the ConMed Pressure Infusors utilize an external source of pressurized gas. The desired amount of Irrigation Fluid flow can be selected by the user by adjusting the external gas pressure used to expand the Inflation Bladder which in turn pressurizes the bag of Irrigation Fluid. Because there are a variety of sources of pressurized gas see “Warnings” and “Instructions for Use” sections listed below for the correct selection.
ConMed Pressure Infusors have been specifically designed to provide delivery of pressurized Irrigation Fluid to the operative site during surgery. ConMed Pressure Infusors utilize external pressurized gas to provide variable irrigation pressures up to 750 mmHg. The Pressure Infusor allows the use of irrigation fluid bags by pressurizing the bag within a closed chamber to control the flow of Irrigant Fluid into the irrigation instrument. The ConMed 1 Liter and Dual 1 Liter Pressure Infusors will accept bags ranging from 500mL to 1L. The ConMed 3 Liter Pressure Infusor will accept bags ranging from 500mL to 3L.
The ConMed Pressure Infusor consists of several parts. Located on the Pressure Infusor Control Panel (1) there are three user interfaces used to control the flow of Irrigation Fluid. The irrigation Pressure Gauge (2) is used to display the irrigation pressure selected by the user. The Irrigation Pressure Adjustment Knob (3) is used by the user to adjust or select the desired irrigation pressure. The Pressure/Depressurize Toggle Switch (4) is used to either pressurize (Turn On) or depressurize (Turn Off) the device. Other features of the Pressure Infusor are the Door (5), the Bag Harness (6), the Inflation Bladder (7), the Thumb Handle and Door Latch (8), the IV pole clamps (9), and the External Pressurized Gas Input fitting (10) The use of the Pressure Infusor features, are further described in the sections below.
INDICATIONS FOR USE The ConMed Pressure Infusors are indicated for irrigation and infiltration during general surgical procedures.
CONTRAINDICATIONS There are no contraindications associated with this product.
WARNINGS 1.
Do not use for infusion of blood or IVs.
2.
Do not use for distention of the operating field, e.g. not for use in procedures including hysteroscopy, TURP (trans-urethral resection of the prostate), TCRE (trans-cervical resection of the endometrium) or cystoscopy.
3.
Do not pressurize the Infusor using oxygen, because of the risk of fire or exposure when the Pressure Infusor depressurizes.
4.
Do not pressurize the Infusor using nitrous oxide because of the risk of exposing staff to anesthetic gas when the Pressure Infusor depressurizes.
5.
External Pressurized gas source must be equipped with a low pressure regulator and a pressure gauge. The maximum output pressure of the regulated gas source must not exceed 60 psi.
6.
Pressure Infusors should only be used by medical professionals thoroughly trained in the use of the device and applicable procedures.
7.
During use, particular attention to fluid volumes should be observed to avoid any clinical complications arising from systemic absorption. Always use the minimum pressure necessary to maintain adequate irrigation flow during the procedure.
8.
Do not modify this device; modifications may pose significant possible hazards and/or impair the continuous safe operation of the device.
(I. V. Pole)
PRECAUTIONS (Tubing/Hose)
1.
Control Panel
2.
Irrigation Pressure Gauge
3.
Irrigation Pressure Adjustment Knob
4.
Pressure/Depressurize Toggle Switch
5.
Door
6.
Bag Harness
7.
Inflation Bladder (behind door)
8.
Thumb Handle and Door Latch
9.
IV pole clamps
10. External Pressurized Gas Input Fitting (Quick-Connect for Domestic Pressure Infusors or threaded fitting for European Pressure Infusors)
1.
Federal law (USA) restricts sale of this device by or on the order of a physician.
2.
Follow irrigation fluid manufacturer’s recommendations for irrigation fluid heating guidelines to aid in avoiding unplanned hypothermia. Avoid excessive or prolonged heating of irrigation bags to avoid risk of thermal injury and to maintain pharmacological integrity of the irrigant.
3.
Avoid mounting the Pressure Infusor on an IV pole above equipment which may be susceptible to fluid ingress.
4.
Ensure irrigation fluid bag is securely spiked to avoid risk of irrigant fluid leakage.
5.
If transferring the Infusor to a hard surface, avoid contact between the surface and the gas line fitting to prevent damage to the External Pressurized Gas input fitting.
6.
The Pressure Infusor and External Pressurized Gas Source Tubing/Hose are provided non-sterile, reusable and are to be used outside the sterile field only. The Infusor and External Pressurized Gas Source Tubing/Hose must be thoroughly cleaned before the first use and after every use (see “Cleaning and Storage” section).
7.
Close the door of the unit before pressurizing the bladder. Failure to do so will result in detachment of the bladder.
RE-ATTACHMENT OF INFLATION BLADDER
8.
Do not spike the irrigation fluid bag if under pressure.
In the event that the Inflation Bladder becomes detached read and conduct the following:
INSTRUCTIONS FOR USE For proper Pressure Infusor Installation read and conduct the following: 1.
Prior to each use, inspect the equipment including the External Pressurized Gas Source Tubing/Hose for damage or wear. If wear, cracks or damage are observed, remove from service and return to ConMed for repair or replacement. (See “Return Policy” section).
2.
Mount the Pressure Infusor on the IV pole (Control Panel located on top) at a height to enable easy user access to the Irrigation Pressure Adjustment Knob, Pressure/Depressurize Toggle Switch and the irrigant bag. The height of the Pressure Infusor should not exceed 5’ 6” [1.68m] and the IV pole diameter should be between 3/4” [1.9cm] and 1 1/2” [3.8cm].
3.
4.
5.
6.
Securely fasten the IV pole clamps at the back of the unit around the IV pole and tighten knob-screws until unit is stable. Tighten the top IV pole clamp on the Pressure Infusor first to prevent the unit from tipping forward during the installation. Connect the External Gas Source Tubing/Hose to the source of regulated pressurized gas; see “Warnings” section for proper pressure selection. It is possible to utilize bottled/tank compressed air, carbon dioxide or nitrogen. The External Pressurized Gas Source Tubing/Hose includes a fitting that allows connection to the compressed air, carbon dioxide or nitrogen source via an appropriate mating connector. The mating connector is not provided. Connect the External Pressurized Gas Source Tubing/Hose to the Pressure Infusor External Pressurized Gas input fitting. For Domestic Pressure Infusors equipped with a Quick-Connect fitting, insert the External Pressurized Gas Source Tubing fitting into the External Pressurized Gas input Quick-Connect fitting and check that it is secure. For European Pressure Infusors equipped with threaded fitting, align the threaded nut of the External Pressurized Gas Source Hose with the External Pressurized Gas input threaded fitting. Hand tighten the hex nut and then tighten to a snug fit with an adjustable wrench. Do not crimp, kink or roll over the External Pressurized Gas Source Tubing/Hose with carts or other equipment. Damage to the Tubing/Hose may result.
OPERATING INSTRUCTIONS
1.
Place or ensure that the Pressure/Depressurize Toggle switch, located on the Control Panel, in the “DEPRESSURIZE” position.
2.
If the Pressure Infusor is attached to an IV pole ensure the IV pole clamp knob-screws on the back of the unit are securely tightened and the unit is stable. Pressure Infusor may also be removed from the IV pole for this procedure.
3.
Align the opening in the Inflation Bladder with the stainless steel fitting in the pressurization chamber.
4.
Beginning on the fitting edge that is closest to the door latch, press the Inflation Bladder against the outside edge of the fitting while stretching the opening of the bladder over the remaining fitting surface.
5.
Pull on the upper edge of the bladder to ensure it is securely seated on the fitting.
6.
Follow the applicable installation steps to replace the unit on the IV pole, if necessary.
POST SURGICAL PROCEDURE 1.
Prior to opening door, place the Pressure/Depressurize Toggle switch, located on the Control Panel, in the “DEPRESSURIZE” position.
2.
With the heel of the left hand on middle section of door, place fingers of your right hand on the back edge of the unit and place thumb on the thumb handle of the door latch. Press against door with heel of hand and squeeze the thumb handle until latch clears door. Release door and open.
3.
Remove used bag(s) and discard along with any other single-use components.
CLEANING AND STORAGE The unit exterior, pressurization chamber and External Pressurized Gas Source Tubing/Hose should be wiped down with a damp cloth and germicide, mixed to manufacturer’s specifications. Do not use alcohol or solvents to clean any part of the Pressure Infusor. Failure of the door and other parts may be caused by application of cleaning solutions containing alcohol or solvents. Do not use abrasive cleaning methods.
Prior to opening door, place the Pressure/Depressurize Toggle switch, located on the Control Panel, in the “DEPRESSURIZE” position.
Do not disassemble the unit for cleaning.
With the heel of the left hand on middle section of door, place fingers of your right hand on the back edge of the unit and place thumb on the thumb handle of the door latch. Press against door with heel of hand and squeeze the thumb handle until latch clears door. Release door and open.
Do not sterilize the Pressure Infusor.
3.
Using hospital sterile procedures and techniques, remove the irrigation tubing set from the sterile pouch.
For service and technical support, call ConMed Corporation.
4.
Within the sterile field, attach the Luer lock connector of the irrigation tubing to the opposing Luer connector on the irrigation handpiece.
SERVICE INTERVALS
5.
Pass the proximal end of the irrigation tubing set (end with bag spike[s]) outside the sterile field.
6.
Place the irrigation bag(s) into the Bag Harness and spike the bag with the bag spike attached to the irrigation tubing set.
7.
Close door and latch securely.
8.
Place the Pressure/Depressurize Toggle switch in the “PRESSURIZE” position.
9.
Adjust irrigation pressure to desired setting. The pressure may be adjusted at any time during the procedure from 0-750 mmHg by pulling and rotating the Irrigation Pressure Adjustment Knob clockwise to increase irrigation pressure or counter clockwise to decrease irrigation pressure. When finished adjusting irrigation pressure push knob in to lock.
1. 2.
10. Prior to use of the Pressure Infusor, purge all air from the irrigation tubing and handpiece and confirm handpiece has adequate irrigation pressure output by pressing the irrigation button on the handpiece until fluid flows. 11. To change the bag of irrigation fluid repeat steps 1 though 10 above removing and discarding the empty bag(s) at the end of step 2.
DO NOT immerse unit in liquids The Pressure Infusor should be covered and stored off the floor in a dry location. Care should be taken not to drop or unduly jar unit.
ConMed Pressure Infusors do not have any defined service intervals.
TROUBLESHOOTING Problem
No Irrigation
RETURN POLICY
Cause
Solution
External Regulator of pressurized gas not set correctly
Check external regulator and adjust if needed
Pressure Infusor not hooked up to gas source
Connect Infusor to pressurized gas source.
P r e s s u r e / Depressurize switch is not in “Pressurized” position
Place Pressure/Depressurize switch in the “Pressurized” position
Irrigation pressure is set to zero
All ConMed products, except products that are obsolete, discontinued, or damaged and speciality products, may be returned within 60 days after date of purchase for credit subject to the following: 1.
A copy of the invoice number and date of purchase and a Return Authorization Number must accompany the returned goods with the reason for the return stated in writing. Contact ConMed Customer Service for the Return Authorization Number at 1-800-448-6506.
2.
Pull Pressure Adjustment Knob and turn clockwise to increase irrigation pressure. Push knob to lock.
All returned goods would be subject to a minimum of 15% restocking charge. The exact amount of credit to be given, if any, will be determined by a Quality Assurance inspection. Sterile packaged products may be returned for credit only if returned in the original, unopened shelf package.
3.
If the return is due to our error in shipping, full credit will be given.
Clogged probe
Clean and or replace probe
4.
All returns should be addressed as indicated by Return Authorization.
Inflation Bladder is not installed correctly
Refer to instructions for proper reattachment of Inflation bladder
Contact ConMed Customer Service for further details on the Return Goods Policy:
Bag not spiked securely
Secure spike in bag
Domestic Customer Service: Tel: 315-797-8375 Fax: 1-800-438-3051
Improper connection of handpiece to the cannula
Disconnect handpiece and cannulae. Inspect connectors for potential damage or imperfections. If visible damage to connector, replace damaged device and continue. If not, reconnect and hand tighten connectors. Disconnect Luer connectors and inspect for imperfections. Luer (male) to Luer (female) connection. Visible damage to connector, replace tubing/hose. If not, reconnect and tighten connectors.
Improper connection of the tubing to the handpiece
appropriate
Leakage of irrigation fluid at Infusor
Bag not spiked securely
Secure spike in bag
Leakage of gas at Infusor gas source connection
External Pressurized Gas Tubing/Hose connection not adequately inserted or tightened
Domestic Pressure Infusors: Ensure Gas Source Tubing is securely seated in the quick-connect fitting.
Leakage at handpiece/tubing connection
Improper connection of the irrigation tubing to the handpiece
Disconnect handpiece and cannulae. Inspect connectors for potential damage or imperfections. If visible damage to connector, replace damaged device and continue. If not, reconnect and hand tighten connectors.
Leakage at handpiece or cannula
Improper connection of handpiece to the cannula
Disconnect handpiece and cannulae. Inspect connectors for potential damage or imperfections. If visible damage to connector, replace damaged device and continue. If not, reconnect and hand tighten connectors.
International Sales: Tel: +1 315-797-8375 Fax: +1 315-735-6235
European Pressure Infusors: Ensure that threaded fitting of the Gas Source Hose is tightly connected.
WARRANTY ConMed Corporation warrants to the initial purchaser that each new Pressure Infusor will be free from defects in workmanship or materials for the period of one (1) year from the date of purchase. ConMed’s sole obligation under this warranty is to provide the purchaser with a replacement. To request a replacement under warranty, contact ConMed Corporation for a return authorization number. If ConMed determines that a product is to be replaced under warranty, this will be replaced and the cost of shipment covered. All other shipping costs shall be the responsibility of the purchaser. The foregoing warranties shall not apply if the Product has been repaired other than by ConMed or in accordance with written instructions provided by ConMed, or altered by anyone other than ConMed, or if the Product has been subject to abuse, misuse, negligence or accident. ConMed shall not be otherwise liable for any damages including but not limited to incidental damages, consequential damages, or special damages. There are no express or implied warranties which extent beyond the warranties hereinabove set forth. ConMed makes no warranty of merchantability or witness for a particular purpose with respect to the product or parts thereof. For further details of warranty, contact ConMed Customer Service:
European Authorized Representative MDSS GmbH Schiffgraben 41 D-30175 Hannover Germany
Domestic Customer Service: Tel: 315-797-8375 Fax: 1-800-438-3051
525 FRENCH ROAD, UTICA, N.Y. 13502-5994 USA
International Sales: Tel: +1 315-797-8375 Fax: +1 315-735-6235
(315) 797-8375 • FAX 1-800-438-3051 Customer Service (USA) 1-800-448-6506 email: [email protected]
For International order or inquires, Please contact CONMED International Sales +1 (315) 797-8375 • FAX +1 (315) 735-6235 www.conmed.com
© CONMED Corporation, Printed in USA
P/N 480031 REV E 01/13