How to, US procedure to be followed for installation of Injector products

How to, US procedure to be followed for installation of Injector products How to, procedure to be followed for installation of Injector products. See letter in long Description for US. Acist & E-Z-EM (Bracco): 888-670-7701 Covidien (Liebel-Flarsheim, Mallinckrodt): 800-877-0791 (Option 2) Medrad: 800-633-7237 _____________________________________________ Date: January 22, 2009 To: Field Service and Installation Teams From: DI Accessories Team Regarding: Injector Installations (Revision to prior Field Bulletin, dated: March 28, 2008) _____________________________________________ Team, Please find the following procedure to be followed for installation of Injector products in the US. This covers scenarios where the injector is sold with or without modality equipment and also covers all of the injector manufacturers that GEHC distributes. 1.1. US Injector Installations The original equipment manufacturer (OEM) of the Injector accessory is responsible for providing the device installation instructions. The customer is responsible for site preparation and documentation unless contracted to GEHC. There are 2 installation scenarios that this document will cover: Injectors Installed with Modality Equipment and Injectors Installed without Modality Equipment. 1.1.1. Injectors Installed with Modality Equipment (as part of a system order) This section covers the installation of injectors that were sold and installed with a larger GE System, including MR, CT, PET or X-ray products. GEHC or an affiliated subcontractor shall follow the installation instructions provided by the injector OEM for unpacking, assembling, installing and connecting the injector system. These activities should include terminating the interface cable between the system and injector (if applicable). 1.1.1.1. Installation of GE-Nemoto Injectors For installations of the GE-Nemoto injectors, a GEHC Field CT Service Engineers shall complete the installation by performing the Installation Checkout procedure as outlined in the Nemoto Installation and Checkout Manual. This procedure may require the use of a Nemoto Service tool kit (GE Part #: 5308826) that are located in the tool depots. The installer shall complete the Nemoto Warranty Activation and Install / Checkout Checklist and forward to Nemoto and HHS as specified in the document. NOTE: Service training for the GE-Nemoto injector has been developed by Morten Lindstad, our CT Service Instructor, in collaboration with the CT businesses service group, engineering and Nemoto. The training can be accessed on MyLearning as course ID is CT6008. 1.1.1.2. Installation of other Injectors brands For installations of all other Injector OEMs, the installer shall contact the injector OEM Service Team to perform the Installation Checkout Procedure. · Acist & E-Z-EM (Bracco): 888-670-7701 · Covidien (Liebel-Flarsheim, Mallinckrodt): 800-877-0791 (Option 2) · Medrad: 800-633-7237 NOTE: If the device is installed by the OEM, customer, or non-affiliated subcontractor, GEHC is not required to document the inspection and testing records. 1.1.2. Injectors Installed without Modality Equipment This section covers the installation of injectors that were sold as an after-market product and not installed with a larger GEHC system. 1.1.2.1. Installation of GE-Nemoto Injectors GEHC or an affiliated subcontractor shall follow the installation instructions provided for unpacking, assembling, installing and connecting the GE-Nemoto injector system. A GEHC Field CT Service Engineers or an injector service certified affiliated subcontractor shall complete the installation by performing the Installation Checkout procedure as outlined in the Nemoto Installation and Checkout Manual. This procedure may require the use of a Nemoto Service tool kit (GE Part #: 5308826) that are located in the tool depots. The installer shall complete the Nemoto Warranty Activation and Install / Checkout Checklist and forward to Nemoto and HHS as specified in the document. NOTE: Service training for the GE-Nemoto injector has been developed by Morten Lindstad, our CT Service Instructor, in collaboration with the CT businesses service group, engineering and Nemoto. The training can be accessed on MyLearning as course ID is CT6008. 1.1.2.2. Installation of other Injectors brands For installations of all other Injector OEMs, GEHC or the customer shall contact the injector OEM Service Team to perform the complete installation and to perform the Installation Checkout Procedure. · Acist & E-Z-EM (Bracco) 888-670-7701 · Covidien (Liebel-Flarsheim, Mallinckrodt): 800-877-0791 (Option 2) · Medrad: 800-633-7237 NOTE: If the device is installed by the OEM, customer, or non-affiliated subcontractor, GEHC is not required to document the inspection and testing records. 1.2. Revision History March 28, 2008: Initial release January 22, 2009: Changes to the SOP are required due to the Bracco’s acquisition of E-Z-EM (combining the Acist and E-Z-EM product support), update to Medrad’s phone number, as well as clarification regarding pin terminations on interfaced injectors. ------------------------------------ Please feel free to contact me with additional questions or concerns. Regards, Bill William J. Jaworski Global Product Manager - Contrast Delivery Solutions GE Healthcare Healthcare Systems Accessories & Supplies T +1 262-548-2061 M +1 414-305-1413 F +1 262-548-2071 [email protected] 3114 N Grandview Blvd. W-544 Waukesha, WI 53188, USA General Electric Company