CURLIN MEDICAL 340-9009-REV F User Manual
Contents
1. CURLIN MEDICAL Addendum to the 2000 Plus and 2000 CMS Ambulatory Infusion Systems User Manual 340 9009 REV F nse CE O 0050 MEDICAL DEVICES CURLIN MEDICAL INC 15751 Graham Street Huntington Beach CA 92649 Phone 714 893 2200 Fax 714 894 2602 www curlinmedical com For 24 hour Clinical or Technical Support call toll free 888 287 5999 THIS DOCUMENT REPLACES ALL PREVIOUS REVISIONS OF THIS ADDENDUM Copyright 2006 2008 Curlin Medical Inc All Rights Reserved Revision C Re order Number 340 9009 ADD 01 Rev C Purpose of this Addendum This addendum provides patients technicians and caregivers additional information important to the safe and effective use of the Curlin 2000 series ambulatory infusion system The Curlin 2000 series infusion system has been designed to meet exceed all international standards for ruggedness and performance associated with an ambulatory medical product in normal use In recent months Curlin has seen an increase in the number of pumps involved in over infusion or free flow incidents where the pump has been dropped with the door open resulting in deformation of the door and a loss of delivery accuracy To help reduce the number of these incidents and to improve the prominence of cautionary statements already in the operator s manual Curlin is making the following modifications to the operator s manual P N 340 9009 In addition the Volumetric Delivery Test in the User2. Manual has been improved to provide better test resolution in determining accuracy and the possibility of a free flow condition Therefore this addendum also modifies the method for executing the Volumetric Delivery Test Page 5 Caution Bullet Number 2 on page 5 of the User Manual has been elevated to a Warning It has not been modified It reads as follows e Visually inspect the pump pumping chamber and administration set before use Do not use any pump or administration set that appears to be damaged or tampered with or if there is any indication of improper function Caution Bullet Number 13 on page 5 of the User Manual has been elevated to a Warning The text has been modified as follows e Donot subject the pump to dropping or hitting against a hard surface If at any time the pump is dropped or hit the pump must be checked for volumetric accuracy prior to reuse The pump can only be brought back into service if the volumetric accuracy test passes per the user manual If the pump fails volumetric accuracy it must be returned to Curlin Medical for evaluation Page 146 Replace the Purpose statement with the following Procedure for Checking Pumps Between Patients Purpose This procedure is provided for use by caregivers to ensure pumps meet all critical performance specifications prior to use of the product on new patients This procedure is for use by technicians to inspect test and prepare a pump for use by a new patient Th
3. e test checks for volumetric accuracy and all pump safety systems Also various parameters are initialized This procedure is intended to be used by technicians familiar with operation of the Curlin 2000 series infusion pump Page 2 of 4 340 9009 ADD 01 Rev C Note This procedure does not replace the recommended Annual Preventive Maintenance The pump should receive preventive maintenance by a qualified technician at least annually Outpatient Home Care Alternate Care Site Environment If the pump is used in an outpatient Home Care or Alternate Care setting the pump must be checked between patients using the following procedure Inpatient Hospital Environment Curlin Medical offers delivery sets with an anti siphon valve for use in clinical situations where in between patient checks may not be practical Use of the supplied anti siphon valve removes the recommendation for in between patient testing when determined by the institution to be impractical In this event Curlin recommends establishment by the institution of practical regular intervals for volumetric testing using the following procedure to ensure the pump continues to meet specifications Page146 Replace the Volumetric Delivery Test with the following Refer to the picture below when executing the following instructions 1 Volumetric Delivery Test a Install a new primed Administration Set in the pump and latch the door Page 3 of 4 340 9009 ADD 01 Rev C Co
4. nnect the up stream side of administration set to a water source 12 inches 2 inches above the pump Connect the downstream side of the administration set to a volumetric accuracy measurement device i e a calibrated scale or burette at the same level as the pump 2 inches Program the following CONTINUOUS Infusion Pre Rx UNITS ml DELAY OFF Titrate OFF NEXT YES Prescription BAG VOL 100 ml VOL TBI 10 0 ml RATE 125 ml hr TIME 0 04 HH MM KVO Rate 0 0 ml hr DONE YES Start the continuous therapy running by pressing RUN button When the 10 ml infusion is over observe the amount volume infused as measured on the measurement device Passing measurement is 9 5 g to 10 5 g 9 5ml to 10 5ml When Infusion complete occurs verify that the Audio Alarm is beeping and that the Green and Red LEDs are flashing Page 4 of 4 340 9009 ADD 01 Rev C
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CURLIN MEDICAL 340 9009 REV F User Manual