Service Bulletin
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Switzerland t CareFusion 317 Sàrl
A-One Business Centre Z.A. Vers-La-Pièce n°10 1180 Rolle / Switzerland +41 21 556 30 00 tel +41 21 556 30 99 fax carefusion.com
Information Notice: IN0201
Subject:
Alaris™ GH/CC Syringe Pump Mk4 Alarm Changes
Issue:
1
Date Issued:
July 2015
Models:
8002MED01, 8002MED01-G, 8003MED01, 8003MED01-G, 8002TIG01, 8002TIG01-G, 8003TIG01, 8003TIG01-G
Status:
Information Only
4.3.x or above
Change Order:
14567
Software Version:
OVERVIEW This Information Notice relates to the Alaris™ GH/CC Syringe Pumps Mk4 (Pump) release with alarm changes for 60601 3rd Edition compliance. SCOPE This communication is to identify all the alarm changes for the Pumps from the information in the Technical Service Manual for the Pump. DESCRIPTION Changes to the Pump software to meet 60601 3rd Edition requirements include the following: • Reminder Signal under GENERAL OPTIONS • Alarm Presets option The Technical Service Manual and the Directions For Use should be referred to for all further information. GENERAL OPTIONS 1. Hold down b and turn the pump on. 2. Enter the access code 251 using the f keys and the NEXT softkey. 3. When the code shows on screen, press OK to confirm. 4. Select GENERAL OPTIONS from the Configured Options menu using the f keys and press the OK softkey. 5. Select the option required to enable/disable or adjust and press the MODIFY softkey. 6. When all the required modifications have been carried out press the QUIT softkey. 7. Either select the next configuration option from the menu or turn the Pump off, returning it to operation as required. NURSE CALL FITTED
Enables Nurse Call (hardware option).
NURSE CALL INVERT
When enabled, the nurse call output is inverted.
RS232 SELECTED
Sets the Pump's communications to use RS232 (hardware option). The NURSE CALL FITTED option must be enabled to allow RS232 to be enabled.
REMINDER SIGNAL
When enabled there is a 10 minute audible notification for the Low Battery and Near End Of Infusion alarms.
© 2015 CareFusion Corporation or one of its affiliates. All rights reserved. CareFusion, Alaris and the CareFusion Logo are trademarks or registered trademarks of CareFusion Corporation or one of its affiliates. All rights reserved. For additional information, please contact your local office or distributor. IN0201 Issue 1
Page 1 of 3
Switzerland t CareFusion 317 Sàrl
ALARM PRESETS
A-One Business Centre Z.A. Vers-La-Pièce n°10 1180 Rolle / Switzerland +41 21 556 30 00 tel +41 21 556 30 99 fax carefusion.com
Pumps with version 4.3.x software have 2 alarm tones to choose from during configuration: • Single tone: Low, medium and high priority alarm tones in accordance with IEC 60601-18: 2012 and IEC 60601-2-24:2012 • Classic tone: Low, medium and high priority alarm tones that sound like the auditory alarms and warnings from software versions prior to 4.3.x Note: The alarm preset default is single tone alarms in accordance with IEC 60601-1-8: 2012 and IEC 60601-2-24:2012. 1. Hold down b and turn the pump on. 2. Enter the access code 418 using the f keys and the NEXT softkey. 3. When the code shows on screen, press OK to confirm. 4. Use the f keys to select alternative alarm tones. 5. When the desired alarm tone has been selected press OK softkey. 6. When all modifications have been carried out press QUIT softkey. 7. Turn the Pump off, returning it to operation as required.
A
All pumps in a single care area should be configured with the same alarm tones to avoid User confusion. The Hospital/Facility is responsible for selecting and configuring the desired alarm scheme. Alaris Gateway Workstation (Workstation) with software versions 1.1.3, 1.1.3 MR, 1.1.5, 1.2 or 1.5 do not support the new Pump low priority visual alarms scheme defined in IEC 60601-1-8: 2012. For Pumps with version 4.3.x software or higher docked into these Workstations there will be a mismatch of alarm priority displayed. As a result, Near End Of Infusion, AC Power Fail, Add Drug Not Complete, and Attention alarms will display as a medium visual priority alarms on the Workstation beacon and a low priority alarm on the Pump. Additionally, for certain information signals, e.g. those associated with Add Drug Not Complete and Titration Not Confirmed, the Workstation beacon will illuminate while the beacon on the pump will not. In the event of an alarm priority mismatch, the User should refer to the alarm on the Pump for the correct priority.
© 2015 CareFusion Corporation or one of its affiliates. All rights reserved. CareFusion, Alaris and the CareFusion Logo are trademarks or registered trademarks of CareFusion Corporation or one of its affiliates. All rights reserved. For additional information, please contact your local office or distributor. IN0201 Issue 1
Page 2 of 3
Switzerland t CareFusion 317 Sàrl
A-One Business Centre Z.A. Vers-La-Pièce n°10 1180 Rolle / Switzerland +41 21 556 30 00 tel +41 21 556 30 99 fax carefusion.com
REFERENCES Alaris Syringe Pump Technical Service Manual Alaris Syringe Pump Directions For Use
1000SM00001 English
1000DF01000
Bulgarian
1000DF01001
Czech
1000DF01002
Danish
1000DF01003
German
1000DF01004
Greek
1000DF01005
Spanish
1000DF01006
Estonian
1000DF01007
Finnish
1000DF01008
French
1000DF01009
Croatian
1000DF01010
Hungarian
1000DF01011
Italian
1000DF01012
Latvian
1000DF01013
Macedonian
1000DF01014
Dutch
1000DF01015
Norwegian
1000DF01016
Polish
1000DF01017
Portuguese
1000DF01018
Romanian
1000DF01019
Russian
1000DF01020
Slovenian
1000DF01021
Serbian
1000DF01022
Swedish
1000DF01023
Turkish
1000DF01024
Chinese
1000DF01025
© 2015 CareFusion Corporation or one of its affiliates. All rights reserved. CareFusion, Alaris and the CareFusion Logo are trademarks or registered trademarks of CareFusion Corporation or one of its affiliates. All rights reserved. For additional information, please contact your local office or distributor. IN0201 Issue 1
Page 3 of 3