CURLIN MEDICAL 360-9043-REVA User Guide

CURLIN MEDICAL

Addendum to the PainSmart™ IOD

Ambulatory Infusion Systems

User Manual

360-9043-REV A

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. A ll Ri ghts Reserv ed.

0050

Re-order Number: 360-9043-ADD-02 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 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 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 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 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 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.

Page 2 of 4

360-9043-ADD-02 Rev. C