BD
Alaris Syringe Pump Series
Alaris PK Syringe Pump MK4 sw ver 3.4x and above has alarm changes Issue 1 July 2015
Service Bulletin
4 Pages
Preview
Page 1
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: IN0207 Issue:
1
Date Issued:
July 2015
Status:
Information Only
Change Order:
14673
Subject:
Alaris™ PK Syringe Pump Mk4
Models:
8005TIG01
Software Version
3.4.x or above
OVERVIEW This Information Notice relates to the Alaris™ PK Syringe Pump MK4 (Pump) release. As part of CareFusion process of continuous improvement, a number of components and assemblies for the Pump have been revised to meet the latest regulatory standards. Note: The User Interface and operation is identical to that of the MK3 Pump and the performance remains unaffected. With a revision to the display technology and LED backlighting, the updated module will deliver a slight change in colour appearance and an improved viewing angle.
A
The Pumps can be identified as MK4 version by the MK4 on the label on the rear case, see image right, or by verifying the software version as 3.4.x or above on power up.
The Alaris PK Syringe Pump MK4 software version 3.4.x or above release has alarm changes for 60601 3rd Edition compliance. SCOPE This communication is to identify all the changes for the Alaris PK Syringe Pump MK4 from the information in the Technical Service Manual for the Pump. DESCRIPTION The MK4 syringe pumps bring a significant update in PCB Assembly components with no change to the intuitive User Interface. Major enhancements include: • Quicker key response driven by a faster microprocessor, twice the speed of MK3 • Smaller Control Board, simplifying assembly • Integrated RS232 and Nurse call functionality • Enhanced cabling and shielding • New enhanced display, improved contrast and viewing angle
© 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. IN0207 Issue 1
Page 1 of 4
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
The table below shows all the new MK4 part numbers available: Description
New Mk4 Part Number
Alaris PK MK4 v3.4.x S/W CD
1000SP01905
Alaris SP MK4 Front Case Kit PK
1000SP01909
Alaris SP MK4 Rear Case Kit PK
1000SP01910
Alaris PK Control PCB MK4
1000SP01607
Two Layer Options Lbl - PK MK4
1000SP01906
Alaris PK MK4 On/Off Keypad Kit
1000SP01911
Alaris SP MK4 Keypad Kit PK
1000SP01908
Alaris PK, Label Set MK4
1000LB01689
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 softkey 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. IN0207 Issue 1
Page 2 of 4
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 3.4.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 3.4.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 softkey 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.
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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 3.4.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.
ACTIONS Please note all previously released Alaris PK Syringe Pump versions remain fully supported by CareFusion through the standard life-cycle support timeframe. CareFusion will not be supporting any product upgrade programs.
© 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. IN0207 Issue 1
Page 3 of 4
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
1000DF01047
Danish
1000DF01048
German
1000DF01049
Spanish
1000DF01050
Estonian
1000DF01051
Finnish
1000DF01052
French
1000DF01053
Hungarian
1000DF01054
Italian
1000DF01055
Dutch
1000DF01056
Norwegian
1000DF01057
Polish
1000DF01058
Portuguese
1000DF01059
Russian
1000DF01060
Swedish
1000DF01061
Turkish
1000DF01062
Chinese
1000DF01063
© 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. IN0207 Issue 1
Page 4 of 4