Operation Manual Update
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Operation Manual Update ClosureRFG™ Radiofrequency Generator RFG3 Operation Manual CD Part Number PT00054359 July 2019 Medtronic reference: FA876 Dear Risk Manager or Healthcare Professional, This notification is to provide you with important information regarding an update to the Operation Manual for the Medtronic ClosureRFG™ Radiofrequency Generator (RFG3). This issue does not affect the RFG3 device itself or its operation. This Operation Manual revision corrects six errors and adds clarity and/or corrects language in several sections of the manual (outlined in the enclosed document). The RFG3 maintains compliance to all applicable medical device safety standards. There are no other model numbers of Medtronic devices affected by this revision. Through July 9, 2019, Medtronic has received zero (0) complaints as a result of these revisions. Medtronic is not retrieving product from the field as no patient safety risk has been identified. Patients who have been, or will be, treated with RFG3 should continue to be managed according to your standard patient management protocols. Customer Actions Please complete the following actions: • Review the Operation Manual Updated Language as provided in this letter and enclosed document. • Store a copy of this letter and the enclosure with your current ClosureRFG™ Radiofrequency Generator RFG3 Operation Manual. • If you wish to receive the most updated copy of the Operation Manual (SPN-PT00080736), please call Mr.Waleed Ibrahim Mobile # +966562321432 /email: [email protected] • Please share this information with healthcare professionals in your facility that use RFG3. Also share this information with any other organization where these devices may have been transferred. Please maintain a copy of this notice in your records. We are committed to patient safety and welcome any questions you may have regarding this communication. Please contact your Medtronic representative with questions. Sincerely, Mohamed Owaini APV-Business Manager Enclosure: ClosureRFG™ Radiofrequency Generator RFG3 Operation Manual Updates
ClosureRFG™ Radiofrequency Generator RFG3 Operation Manual Updates: Manual version PT00080736 replacing version PT00054359 Effective July 2019 Location of Change
Updated Language (highlighted in yellow) Applies to new PT00080736 “RF Ramp up: Repeating series of three short, lower-volume mid frequency pure tones”
Old Language (highlighted in yellow) Applies to old PT00054359 “RF Ramp up: Single, long, lower-volume mid-frequency pure tone”
“If the catheter is unsupported, the message area shows, “The connected device is unsupported. Please connect another device.”
“If the connected catheter is unknown or invalid, the message area shows, “The device is invalid.”
Page 1-3, Chapter 1 Overview & General Features
Page 2-9, Chapter 2 Closure RFG Generator Setup
“Would you like to reset the timer value?”
Page 5-2, Chapter 5 Treatment Times
ClosureRFG™ Radiofrequency Generator RFG3 Operation Manual Update Manual version PT00080736 replacing version PT00054359 Effective July 2019 Page 1 of 3
“Would you like to retain the total treatment timer value?”
Location of Change
Updated Language (highlighted in yellow) Applies to new PT00080736
Old Language (highlighted in yellow) Applies to old PT00054359
“High Power Low Temperature And Low Impedance Advisory” “Advisory: Temperature low. Power high. Impedance low”.
“High Power Low Temperature And Low Impedance Advisory” “Advisory: Temperature low. Power high. Impedance high”.
Page 6-2, Chapter 6 Messages, Tones, and Responses
Page 10-1, Chapter 10 Service & Maintenance
“The appliance inlet serves as the means of disconnect from supply mains. Using a power cord that does not meet the specifications in Chapter 9, Technical Specifications may present a potential for an electrical shock or affect the performance of the ClosureRFG generator.”
“The AC power switch on the front panel serves as the means of disconnection from supply mains, This switch also isolates the ClosureRFG generator electrically from the supply mains on both poles simultaneously. Using a power cord that does not meet the specifications in this Service and Maintenance section may present a potential for an electrical shock or affect the performance of the ClosureRFG generator.”
ClosureRFG™ Radiofrequency Generator RFG3 Operation Manual Update Manual version PT00080736 replacing version PT00054359 Effective July 2019 Page 2 of 3
Location of Change
Updated Language (highlighted in yellow) Applies to new PT00080736
Old Language (highlighted in yellow) Applies to old PT00054359
“Fuse must be replaced with 5 A/250 V, 5x20 mm fuses.”
“Fuses must be replaced with 5 A/250 A, 5x20 mm fuses.”
Page 10-2, Chapter 10 Service & Maintenance
NOTE: Additional minor changes (grammar, formatting and precise wording) were made for clarification that are not referenced above. In your geography, the updated Operations Manual language may differ slightly from the content of this communication based on the Operations Manual approved by local regulatory agencies, where required.
ClosureRFG™ Radiofrequency Generator RFG3 Operation Manual Update Manual version PT00080736 replacing version PT00054359 Effective July 2019 Page 3 of 3