ConMed Corp

Pressure Infusor Directions for Use Rev E Jan 2013

Directions for Use

35 Pages

Pressure Infusor Directions for Use READ AND UNDERSTAND INSTRUCTIONS PRIOR TO USE AND FOLLOW ALL WARNINGS AND PRECAUTIONS.  .  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).
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