Curlin Medical PainSmart IOD User manual

CURLIN MEDICAL
Addendum to the PainSmart™ IOD
Ambulatory Infusion Systems
User Manual
360-9043-REVA
0050
CURLIN MEDICAL, INC.
15751 Graham Street
Huntington Beach, CA 92649
Phone [phone]
Fax [phone]
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: 360-9043-ADD-02 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 PainSmart™ IOD ambulatory infusion system.
The Curlin PainSmart™ IOD 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 360-9043).
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. The text
has not been modified. It reads as follows.
•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:
•Do not 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 116
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.
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This procedure is intended to be used by technicians familiar with operation of the Curlin
PainSmart™ IOD infusion pump.
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.
Page 117
Replace the Volumetric Delivery Test with the following:
Refer to the picture below when executing the following instructions.
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1 Volumetric Delivery Test:
a Install a new primed Administration Set in the pump and latch the door.
b Connect the up-stream side of administration set to a water source 12 inches +/-2 inches
above the pump.
EPI IV
Pre Rx: Pre Rx:
UNITS: ml UNITS: mg
Admin Rt: EPI CONC: 1 mg/ml
Load Dose: 0.0 ml Admin Rt: IV
MedLIMITS: OFF Load Dose: OFF
NEXT? YES MedLIMITS: OFF
NEXT? YES
Prescription: Prescription:
BAG VOL: 100 ml BAG VOL: 100 ml
RATE: 0 ml/hr RATE: 0 mg/ml
Pt Bolus: 9.9 ml Pt Bolus: 9.9 mg
BOLS INT: 1 min BOLS INT: 1 min
#BOLS/hr 1 #BOLS/hr 1
DONE? YES DONE? YES
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 one of the following Infusions based on the default in the pump:
e Start the pump by pressing RUN button.
f Press the BOLUS key to start a bolus.
g When the 9.9 ml infusion is over, observe the amount volume infused as measured on
the measurement device. Passing measurement is: 9.4 g to 10.4 g (9.4 ml to
10.4 ml).
h When Infusion complete occurs verify that the Audio Alarm beeps and that the Green
LED is flashing.
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