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In response to our customers’ request, Curlin Medical, Inc. (“Curlin Medical”) has released a standard operating procedure for Non Factory Self Recertification. This procedure enables a qualified biomedical technician to check, and reset the maintenance date of their own pumps that are up to specification. Pumps that are out of the specifications will have to be sent back to Curlin Medical for maintenance.

For safety, regulatory and liability concerns, we require that customers who implement the Non Factory Self Recertification procedure, to limit the use only to pumps owned by them (no third party recertification,) and follow very carefully the Directions for Use (DFU’s) provided with the kit and comply with all the requirements. Specifically,

1. Sign and return to Curlin Medical the Order Form and the Introducing Non-Factory Self Recertification Kit.
2. Register and obtain an authorization number from Curlin Medical to install the software.
3. Assign competent employees and qualified biomedical technicians experienced in infusion pumps to certify Curlin infusion systems.
4. Provide continuing education and technical training to employees involved in certifying Curlin infusion pumps to assure that competency levels are maintained. Education will be based on Curlin Medical publications, and will include any changes or upgrades to procedures and equipment, as well as notification of inherent problems, product alerts, or recalls that might be identified and published by Curlin Medical.
5. Maintain a Device History Record for each unit serviced, and provide Curlin Medical with a signed copy of the Recertification Traveler 350-9256, accurately, and completely filled out per procedure 350-9257. This documentation must comply with QSR and ISO 13485 standards.
6. Perform preventative maintenance in accordance with all applicable local, state and federal requirements, including performing periodic calibration of the testing equipment (i.e. scales. timers, and gauges) used in certifying Curlin infusion pumps.
7. Maintain adequate insurance to cover the cost of liabilities related to work performed on Curlin pumps