The document summarizes a technical service bulletin for the Savina ventilator. It details new software version 2.10 which includes improvements to battery management, lung mechanics measurements, synchronization, and offers non-invasive ventilation. The software update is mandatory and must be completed by September 30, 2003. Instructions are provided for downloading the update and validating settings.
The document summarizes a technical service bulletin for the Savina ventilator. It details new software version 2.10 which includes improvements to battery management, lung mechanics measurements, synchronization, and offers non-invasive ventilation. The software update is mandatory and must be completed by September 30, 2003. Instructions are provided for downloading the update and validating settings.
The document summarizes a technical service bulletin for the Savina ventilator. It details new software version 2.10 which includes improvements to battery management, lung mechanics measurements, synchronization, and offers non-invasive ventilation. The software update is mandatory and must be completed by September 30, 2003. Instructions are provided for downloading the update and validating settings.
The document summarizes a technical service bulletin for the Savina ventilator. It details new software version 2.10 which includes improvements to battery management, lung mechanics measurements, synchronization, and offers non-invasive ventilation. The software update is mandatory and must be completed by September 30, 2003. Instructions are provided for downloading the update and validating settings.
Re: New software version 2.10 and new Operating Instructions
Date: May 12, 2003
Reference Doc: N/A
Reason: Draeger Medical AG & Co. KGaA has released software version 2.10 which includes the following improvements:
♦ Improved battery management
- Battery capacity display. The battery symbol in the display shows the remaining capacity of the internal battery. - Energy saving mode. The speed of the blower is reduced when running on internal battery. - Improved Alarm concept of internal batteries “Caution” when remaining capacity is below 30% “Warning” when remaining capacity is below 10% ♦ Lung mechanics: Measurement of static Compliance and Resistance
♦ Improved synchronization between patient and ventilator:
Automatically leak compensated trigger criteria for in- and expiration
♦ Extended flow sensor lifetime
“Hot calibration” will be carried out only if required.
♦ Non invasive ventilation via face mask as an option
Devices affected: The software update with software version 2.10 is mandatory for all Savina units in the USA and Canada.
When: By September 30, 2003
Cost: Free of charge
Ordering Info: SW 2.10 Kit Savina P/N 8415594
5664.900 Savina TSB No. 8 05.2003 1/3
Reporting: Feedback for DrägerService (direct) will be captured using the DrägerService Dispatch System. All other distributors will be required to complete the attached Mandatory Action Completion form and either fax or mail to the following:
Mail: Drager Medical Inc.
3122 Commerce Drive Telford, PA 18969 Attn: Regulatory Affairs Dept.
FAX: (215) 721-5784 Attn: Tony Achey
Additional Info: Replace all US Operating Instructions P/N 9037222 with new Operating Instructions 2.1n P/N 9037626, included in the SW 2.10 kit.
Distribution: DrägerService Personnel and authorized Service Organizations for
CCS products. ( Lifetronics, Brathwaites, ABS Medical, Freedom Medical ).
Addition Info 1: After downloading SW 2.10 you will see an error 65.0020 on the initial power up. This is to be expected after download of SW 2.10. Enter DS mode once and cycle power and the error will be cleared.
Additional Info 2: After downloading SW 2.10 the following steps must be performed:
1. Verify that valve classes have remained accurate (test 15)
2. Reset/verify ambient pressure (test 27) 3. Perform insp/exp airway pressure sensors (test 23) 4. Perform O2 calibration (test 22) 5. Perform PMC of unit. 6. Clear error log. 7. Leave updated manual in place of old version manual. Enter s/n of Savina in block on back page of manual.
NOTE: Steps 1 through 4 in Additional Info 2 are executed via the
Internal Service Mode. See “Service Mode” section of Savina service documentation on CD-ROM.
If you have any questions, please contact Technical Support by
phone at 1-800-543-5047 or by fax at 1-215-721-5789.
Dräger Medical, Inc.
Technical Product Manager
5664.900 Savina TSB No. 8 05.2003 2/3
Savina Mandatory Field Correction Form TSB # 8
Device: Savina Part Number: 8413600
Location Of Device(s):______________________________________________________ (include address) ______________________________________________________ ______________________________________________________ ______________________________________________________
Device serial numbers: (list all devices at location that have been completed)
