ENGINEERING CHANGE NOTICE/DOCUMENT CHANGE CONTROL
                                                                         
                                                   Date:                               
                                                   ECN #:                            
                                                   REA #:                           
PART I
   
   Model or                                                    ActionEffective  
   Part No.Description of Change, Assemblies affected and reason(s) for change(s)      Code(s)Date     






























Change Action Required

Make/order New Parts:                                                                                            
Current Parts:     þ Use until depleted       þ Return for credit      þ Scrap         þ Save for spares
Rework parts:  þ In stock      þ In process   þ Finished goods
Service Repair:þ Reference onlyþ Change parts in fieldþ Notify customer 
Other:                                                                                                                       
Other:                                                                                                                       
Comments:                                                                                                                 
                                                                                                                                
                                                                                                                                
PART II

To assure an orderly, controlled and complete implementation of a change to all aspects of the
manufacture of a device and related documentation, the following checklist should be completed
along with appropriate revisions and updating of all copies of documents.  Attach additional paper
for instructions or comments if necessary.

                    Affected                                Initials/Date
Document Item       Yes/No    Description              Assigned ToWhen Finished


Engineering/Manufacturing

Specifications Sheetþ   þ                                                
Bill of Materials   þ   þ                                                
Mfg. Procedures, Schematics
  (Assembly Manuals)þ   þ                                                
Testing Procedures  þ   þ                                                
Inspection and QC Proceduresþ   þ                                        
Procurement Documentationþ   þ                                           
Labeling            þ   þ                                                
Packaging           þ   þ                                                
Operation/Service Manualsþ   þ                                           
Drawings/Manuals    þ   þ                                                
Schematics/Manuals  þ   þ                                                
                    þ   þ                                                
                    þ   þ                                                


Sales/Marketing

Product Literature (brochures)þ   þ                                      
Price Catalog       þ   þ                                                
                    þ   þ                                                
                    þ   þ                                                


Regulatory Compliance

FDA (510K)          þ   þ                                                
Government Contracts (NSN)þ   þ                                          
UL, ETL, etc.       þ   þ                                                
                    þ   þ                                                
                    þ   þ                                                
               




Authorization(s):   Engineering          Authorization(s):    Quality Assurance

By:                                      By:                                                    

Title:                                   Title:                                                 

Date:                                    Date: