Draeger Sole Source Svc_Maint_Notification.pdf

Draeger, Inc.

3135 Quarry Road Telford, PA 18969, USA Tel +1 800 4DRAGER (+1 800 437 2437) info.usa@draeger.com

Dräger Sole Source Service & Maintenance Notification December 14, 2023

Dear Customer, Dräger is the original manufacturer of all Dräger Medical Devices. This is life sustaining equipment used when patients are most vulnerable – during surgery or receiving critical care. Therefore, due to the risk of serious patient harm, including death, services must ONLY be performed by Dräger factory trained technicians, who have evidence of current factory training authorization / certification on the specific device being serviced (Dräger Ventilation, Anesthesia, Monitor, or Neonatal Device). Dräger does not authorize or certify third-party companies. Further, Dräger uses only original factory validated parts for servicing these devices.

Although third-party companies do exist that offer service on Dräger equipment, Dräger assumes no liability for the safety and efficacy of service provided by such third-party companies.

Customers cannot be sure that these individuals use only Dräger OEM parts or that such companies have only factory trained technicians providing the services. Furthermore, if work by non-Dräger parties, the use of non-OEM parts, negligent or untrained workmanship is detected, it may invalidate the customer’s warranty.

Therefore, Dräger highly recommends that customers ONLY obtain post-warranty service from Dräger. If the customer feels they must put this service out for bid, please use the requirements listed below and note that no other company, besides Dräger can meet ALL of these requirements.

Requirements:

1. Services must ONLY be performed by Dräger trained technicians, who have evidence of current factory training on the specific device being serviced (Dräger Ventilation, Anesthesia, Monitor, or Neonatal device).

2. Must provide evidence of equipment standards and traceability and final device performance testing that follows and complies with all manufacturer’s procedural requirements.

3. Must guarantee that safety inspections performed will comply with all applicable federal, state, and regulatory requirements, manufacturer standards, and meet FDA alerts and recall requirements.

4. Each technician must be certified on the applicable Dräger (Ventilation, Anesthesia, Monitor, or Neonatal) device prior to performing any service and/or maintenance on Dräger manufactured equipment.

Phone +1 267 272-1101 E-mail mark.grabowski@Dräger.com

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5. Must provide evidence of recent attendance and successful completion of the Dräger Factory Training Seminars for each product serviced.

6. Must maintain continuous access to the Dräger ServiceConnect system, which provides all the relevant and up-to-date Technical Documentation and information for each of the Dräger device serviced.

7. Must guarantee execution of all Manufacturer Service Recommendations during each service incident, including the use of ONLY manufacturer planned maintenance and repair parts.

(Note: Failure to utilize original manufacturer parts may result in the improper operation of the equipment.)

8. Must possess the legal rights to proprietary equipment diagnostic software. Proprietary service manuals and software tools are only provided to parties attending the Dräger Service Academy. (Note: Failure to utilize the Proprietary Software may result in the inability to identify equipment operating parameters and to accurately calibrate the equipment.)

9. The service technician must have completed training for each specific device by a Dräger Authorized Trainer prior to performing service on said device.

Kind regards, Mark C Grabowski Director of Marketing - Medical Service Solutions, North America