CURLIN MEDICAL
Addendum to the 2000 Plus™ and 2000 CMS™
Ambulatory Infusion Systems
User Manual
340-9009-REV F
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. A ll Ri ghts Reserv ed.
0050
Re-order Number: 340-9009-ADD-01 Rev. C
Revision 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 o pen
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 User 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.
• Visually inspect the pump, pumping chamber and admi nistration set b efore use. Do not u se
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 ha s been elevated t o a Warning. The t ext has
been modified as follows:
• Do not subject the pump to dropping or hitti ng against a hard surf ace. If at any time the pump
is dropped or hit, the pump must be checked for vol umetric accura cy prior to reu se. The pump
can only be brought back into service if the volumetri c accuracy test p asses per t he user
manual. If the pump fails volumetric accuracy it must be ret urned 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. The 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 2000series infusion pump.
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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.
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340-9009-ADD-01 Rev. C
b Connect the up-stream side of administration set to a water source 12 inches +/-2 inches
above the pump.
c 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.
d 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
e Start the continuous therapy running by pressing RUN button.
f When the 10 ml infusion is over, observe the amount volume infused as measure d on the
measurement device. Passing measurement is: 9.5 g to 10.5 g (9.5ml to 10.5ml).
g When Infusion complete occurs verify that the Audio Alarm is beeping and that the Green
and Red LEDs are flashing.
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