Carefusion Alaris Service manual
s
Alaris® Syringe Pump
Technical Service Manual
Alaris® Syringe Pump
Contents
General Information .............................................................5
Introduction ...........................................................................................5
Product Familiarity
Purpose of this manual
Conventions Used in this Manual
General precautions
Front panel and main display
Configuration and Calibration ....................................................8
Access codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Dedication options (301/302)
Data Set Activation (612)
Handsfree Bolus (175)
Power Lock (711)
Configuration options (251)
Teach Learn
Teach Learn Procedure (Software versions V1.4.13 and above)
Data Set Transfer
Data Set Upload and Download (401 and 499)
Download CQI Event Log (402)
Calibration procedures (243)
SYRINGE CLAMP calibration
PLUNGER POS (position) calibration ................................................................17
SYRINGE FORCE calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
LINE PRESSURE calibration – Alaris® CC Syringe Pump only ............................................
20
BATTERY calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
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Preventative Maintenance ..................................................... 22
Preventative Maintenance ............................................................................22
Visual Inspection
Recommended Cleaning
Updates
Battery Test and Replacement
Self-test Procedure (123)
Calibration Verification Mode (240)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Upgrading software
Pole Clamp Arm Update
Motor Plate Strain Beam Update
Transmission Buffer Pad Update
Linear (PL3) Update. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Replace the Main Battery
Self-tests included in full test
Self-tests not included in full test
Comms Test (123). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
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1000SM00001 Iss. 18
2/86
Alaris® Syringe Pump
Performance Verification Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Troubleshooting .............................................................. 34
Review logs ...........................................................................................34
Event Log download
Information Logs (376)
Software fault codes
PL3 Error
Exception error handling
General fault diagnosis
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Introduction
Failure causes
Diagnosis
Actions
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Circuit Descriptions ............................................................ 43
Functional module block diagram .....................................................................43
Module overview functional description
Control PCB
Pressure Transducer (Model CC)
Power Supply Unit PCB
Display PCB
Battery
Transmission
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Corrective Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Corrective Maintenance ...............................................................................46
Access to pump
Rear case and subassemblies
Power Supply Unit and Speaker
Mains inlet, PE stud and magnet
Pole clamp and RS232
Rail cam
Front case and subassemblies
Control PCB and RS232 (if option fitted)
Display PCB
Chassis PCB and Plunger assembly
Chassis assembly and Pressure Transducer (Model CC only)
Syringe Sizing assembly
Chassis assembly breakdown
Plunger assembly breakdown
Pressure Transducer Assembly (Model CC only)
Keypads and labels
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Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
1000SM00001 Iss. 18
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3/86
Alaris® Syringe Pump
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
Recommended Separation Distances for LIFE SUPPORT Equipment between portable and mobile RF
communications equipment and the Alaris
Disposal
..............................................................................................74
Information on Disposal for Users of Waste Electrical and Electronic Equipment
Information on Disposal in Countries outside the European Union
Battery Removal
Spare Parts Listing
Electrical Parts Listing
Front Case Parts Listing
Rear Case Parts Listing
Keypads and Labels
Transmission Parts Listings
Software
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Test Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Fitting and Replacement Guidelines
General assembly information
Torque guide
Service Contacts
Document History
Software Upgrade Record
......................................................................................81
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® Syringe Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
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1000SM00001 Iss. 18
4/86
Alaris® Syringe Pump
General Information
General Information1
Introduction
The Alaris® Syringe Pumps are designed to deliver a continuous and accurate infusion whenever small fluid volumes need to be
administered with great precision. High performance, comprehensive alarm protection and sophisticated monitoring systems
combined with simple operation make these syringe pumps suitable for both general and critical infusions in a variety of areas within a
hospital.
The Asena® brand name has been changed to the Alaris® brand name. This change in brand name has no effect on the intended use or
functionality of the product. Recommended disposable products for use with this product may refer to either the Asena® brand name or
Alaris® brand name and both types are suitable for use with this infusion pump.
Product Familiarity
Ensure that you are fully familiar with this syringe pump by carefully studying the Directions for Use (DFU) prior to attempting any
repairs or servicing.
As part of a policy of continuous improvement, product enhancements and changes are introduced from time to time.
Purpose of this manual
This Technical Service Manual shows how to set up, test and maintain the following Alaris® Syringe Pump models:
Alaris® CC Syringe Pump• Alaris® GH Syringe Pump (with Plus software)•
Alaris® GH Syringe Pump• Alaris® GH Guardrails® Syringe Pump (with Plus software)•
Alaris® TIVA Syringe Pump• Alaris® CC Syringe Pump (with Plus software)•
Alaris® GS Syringe Pump• Alaris® CC Guardrails® Syringe Pump (with Plus software)•
Alaris® PK Syringe Pump• Alaris® CC Guardrails® Syringe Pump (with Compatible Pre-filled syringe)•
Alaris® GH Guardrails® Syringe Pump• Alaris® GH Guardrails® Syringe Pump (with Compatible Pre-filled syringe)•
Alaris® CC Guardrails® Syringe Pump•
It is intended for use by personnel experienced in medical equipment testing and maintenance procedures .
Conventions Used in this Manual
BOLD Used for Display names, self-test codes, controls and indicators referenced in this manual, for example,
Battery Indicator, access code 212, ON/OFF button.
'Single quotes' Used to indicate cross-references made to another section of this manual. For example, see Chapter 2,
'Configuration and Calibration'.
underline Used to indicate a link to another section within this manual.
Italics Used to refer to other documents or manuals. For example, refer to the relevant Directions for Use (DFU) for
further information. Also used for emphasis, for example, ...if the gap still measures less than...
A
Wherever this symbol is shown a Hints and Tips note is found. These notes provide useful advice or
information that may help to perform the task more effectively.
Wherever this symbol is shown an Update note is found. A typical example is drawing attention to a software
upgrade that should be confirmed has been installed.
Wherever this symbol is shown an Important note is found. These notes highlight an aspect of test or
maintenance that is important to know about.
1000SM00001 Iss. 18
5/86
General precautions
Please read the general Operating Precautions described in the Directions for Use carefully prior to using the
pump.
w
This pump contains static-sensitive components. Observe strict precautions for the protection of static
sensitive components when attempting to repair and service the pump.
An explosion hazard exists if the pump is used in the presence of flammable anaesthetics. Exercise care to
locate the pump away from any such hazardous sources.
B
An electrical shock hazard exists if the pumps casing is opened or removed. Refer all servicing to qualified
service personnel.
A
This pump is protected against the effects of high energy radio frequency emissions and is designed to fail safe
if extremely high levels of interference are encountered. Should false alarm conditions be encountered, either
M
remove the source of the interference or regulate the infusion by another appropriate means.
If the pump is dropped, subjected to excessive moisture, humidity or high temperature, or otherwise
suspected to have been damaged, remove it from service for inspection by qualified service personnel.
L
When connected to an external power source, a three-wire (Live, Neutral, Earth) supply must be used. If the
integrity of the external protective conductor in the installation or its arrangement is in doubt, the pump
should be operated from the battery.
Alaris® Syringe Pump
General Information
1000SM00001 Iss. 18
6/86
Alaris® Syringe Pump
General Information
Front panel and main display
The display shown is for general guidance only. For pump specific front panel and main display information refer to relevant Directions
For Use.
Syringe Type Fitted / Drug Name / Profile*
Time Remaining Icon
Infusion Status
Infusion Rate Volume Infused
Blank Softkeys
* “Profile” is only available on an Alaris® Syringe Pumps with a Data Set loaded.
** Pressure Information is only displayed on the Alaris® CC Syringe Pumps.
Controls and indicators
a
b
h
ON/OFF button - Press once to switch the pump ON. Press and hold down for 3 seconds to switch the pump
OFF.
RUN button - Press to start the infusion. The Green LED will flash during infusion.
HOLD button - Press to put the infusion on hold. The amber LED will be lit while on hold.
Pressure Information** /
Pressure Icon (if enabled)
Pressure button (not available on the
Alaris® GS Syringe Pump)
c
i
d
e
g
f
j
k
MUTE button - Press to silence alarms.
PURGE/BOLUS button - Press to access PURGE or BOLUS soft keys. Press and hold down soft key to operate.
PURGE the extension set during set up.
Pump is on hold •
Extension set is not connected to the patient•
Volume Infused (VI) is not added •
BOLUS fluid or drug delivered at an accelerated rate.
Pump is infusing •
Extension set is connected to the patient •
VI is added•
OPTION button - Press to access optional features.
PRESSURE button - Press to display the pumping pressure and alarm level.
BLANK SOFTKEYS - Use in conjunction with the prompts shown on the display.
CHEVRON keys - Double or single for faster/slower, increase or decrease of values shown on main display.
BATTERY indicator - When illuminated, indicates that the pump is running on the internal battery. When
flashing, indicates that the battery power is low, with less than 30 minutes of use remaining.
AC POWER indicator - When illuminated, indicates that the pump is connected to an AC power supply and the
battery is being charged.
1000SM00001 Iss. 18
7/86
Alaris® Syringe Pump
Configuration and Calibration
Configuration and Calibration2
Access codes
The syringe pump software contains a number of configuration and test routines that can be accessed by the user. The majority of tests
are ‘MENU’ driven from a technical access code (see below).
Note: The pump
should be power
cycled after entering
any new calibration or
configuration information
prior to performing any
validation tests.
Code Description
123 Self Test Procedure
166 External Reprogramming
167 Teach Learn Procedure
175 Handsfree Bolus
243 Calibration Selection Menu
251 User Configuration Menu
301 Fully Dedicated
302 Semi-dedicated
376 Service Access Menu
401 Upload Data Set to Pump (Guardrails® Software enabled Pumps and the Alaris® PK Syringe Pump)
402 Download CQI Event Log from Pump (Guardrails® Software enabled Pumps only)
418 Alternative Alarm Tone. (Not available for Guardrails® Software enabled Pumps and the Alaris® PK Syringe Pump)
499 Download Data Set from Pump (Guardrails® Software enabled Pumps and the Alaris® PK Syringe Pump)
611 Cold Start (RAM Clear)
612 Data Set activation (Alaris® PK Syringe Pump)
711 Power Lock (Alaris® PK Syringe Pump)
Codes available on Alaris® Syringe Pumps (with Plus software):
Code Description
123 Self Test Procedure
166 External Reprogramming
167 Teach Learn Procedure
240 Calibration Verification Mode
243 Calibration Selection Menu
251 User Configuration Menu
301 Fully Dedicated
302 Semi-dedicated
376 Service Access Menu
401 Upload Data Set to Pump
402 Download CQI Event Log from Pump (Guardrails® Software enabled Pumps)
611 Cold Start (RAM Clear)
Each MENU (and some unique items) has its own three-digit access code that can be entered using the following procedure:
1. b and turn the pump ON.
Hold down
Enter the required access code using the
2. f keys and the NEXT softkey.
When the required code shows on screen, press
3. OK to confirm.
1000SM00001 Iss. 18
8/86
Alaris® Syringe Pump
Configuration and Calibration
Dedication options (301/302)
Fully Dedicated (set using access code 301) will remind a user that a pressure disc must be fitted to start any infusion. In this mode
occlusion pressures are always displayed in mmHg.
Semi-Dedicated (set using access code 302) will remind a user that a pressure disc must be fitted when drugs and dosing features are
used. When a pressure disc is not in use, pressure levels L-0 to L-10 will be displayed.
Data Set Activation (612)
This code is used to load the predefined pump configuration and drug setup into the non-volatile storage. It is necessary to enter the
code 612 after a cold start (code 611); the configuration and drug setup will then be available in normal operation.
Alternatively a data set may be uploaded as appropriate. See directions for use contained within the Alaris® PK Editor Software package.
Handsfree Bolus (175)
Enable or disable the Handsfree Bolus. If enabled pressing bolus button displays screen prompting for hands free or hands on. Default
volume after clear setup is 0.0. Upper amount restricted to bolus volume limit in general options or drug protocol bolus volume limit.
Power Lock (711)
Available on the Alaris® PK Syringe Pumps with software V2.3.11 and above.
Disabled The new alternative Power Down sequence now allows the user to Power Down the pump whilst the infusion is
suspended (on hold) in TCI mode and predictive TIVA mode.
Enabled The Power Down sequence (Power Lock) remains the same where the user may only Power Down the pump by stopping
the infusion, selecting ‘new operation’ from the options menu, confirming the selection, then Powering Down the pump.
1000SM00001 Iss. 18
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Configuration options (251)
Enter access code 251 to display the User Configuration menu:
Alaris® Syringe Pump
Configuration and Calibration
Drug Library*
Set drug names list on a Model GH - Select Character Group f(double chevrons) Select Character
f(single chevrons). To go to next Character use NEXT.
Set drug names and protocols for Models CC and TIVA (see drug protocol setup instructions on following
pages).
General Options* See general options table later in this chapter.
Clock Set
Hospital Name* Enables establishment name (max 20 characters) to be displayed during the power-up sequence.
Enable Syringes* Configure the type and size of syringes permitted for use.
Language Configure the language used for messages shown on display.
Contrast
Enable Units*
Warning -
A
When entering a drug name the character "%" should not be used as it may cause the pump to lock up and the safety
processor alarm to sound. The word "percent" or an abbreviation is recommended for use. Only the Models GH and
CC are affected by this anomaly.
Set the current date and time. To set the clock, use
To set the hospital name, use
To enable syringes, use
Select language required using
Set the display panel contrast. Use
Select the type of units permitted for use on the pump. To enable units, use
enable/disable and OK to store.
f and NEXT to adjust and OK to store.
f and SELECT, to enable/disable and OK to store.
f and SELECT to store.
f to adjust contrast and OK to store.
f and NEXT to adjust and OK to store.
f and MODIFY, to
*Note: For Guardrails® Software
enabled pumps, pumps with Plus
software and the Alaris® PK Syringe
Pump these options may vary or
will not be available. Please refer to
the relevant pump or PC software
Directions For Use for comprehensive
information.
1000SM00001 Iss. 18
10/86
Alaris® Syringe Pump
Configuration and Calibration
Alaris® TIVA Syringe Pump drug protocol setup
Select Drug Library from Configuration Options (1. 251).
Use
2. f to select drug and press MODIFY to modify selected drug or NEW to create new drug name.
QUIT
3. will return to 251 main menu.
When modifying a drug protocol, pressing
4. BACK at any time will take you to the previous step.
Modify - Existing drug
5.
ENABLE/DISABLEa) - Enables or disables the drug being available.
DELETE
b) - Select Yes to delete from drug library.
EDIT
c) - See table below.
Edit Drug Protocol - New or existing drug
6.
Press a) OK softkey to confirm each step.
Drug Option
Drug Name
Concentration Units
Minimum Concentration
Default Concentration
Maximum Concentration
Dose Rate Units
Induction Dose
Induction Time
Pause After Induction MODIFY
Maintenance Rate
Bolus Dose
Bolus Rate RATE
To Adjust
(Softkeys are shown in Bold)
Select Character Group
Select Character
To go to next Character NEXT
f
f or OFF
f or OFF
f or OFF
f
f or OFF
f
f
f
f (double chevrons)
f (single chevrons)
Hands Free Bolus MODIFY
1000SM00001 Iss. 18
11/86
Alaris® Syringe Pump
Configuration and Calibration
Alaris® CC Syringe Pump* drug protocol setup
Select Drug Library from Configuration Options (1. 251).
Use
2. f to select drug and press MODIFY to modify selected drug or NEW to create new drug name.
QUIT
3. will return to 251 main menu.
When modifying a drug protocol, pressing
4. BACK at any time will take you to the previous step.
Modify - Existing drug
5.
ENABLE/DISABLEa) - Enables or disables the drug being available.
DELETE
b) - Select Yes to delete from drug library.
EDIT
c) - See table below.
Edit Drug Protocol - New or existing drug
6.
Press a) OK softkey to confirm each step.
*Note:
For Guardrails® Software enabled pumps this option will not be available. Please refer to the relevant Alaris® Syringe Pump
Directions For Use or Guardrails® Editor Directions For Use for comprehensive information.
Drug Option
Drug Name
Dose Rate Units
Maximum Dose
Default Dose
Minimum Dose
Concentration Units
Minimum Concentration
Default Concentration
Maximum Concentration
Maximum Bolus
Bolus Rate
Pressure Alarm
To Adjust
(Softkeys are shown in Bold)
Select Character Group
Select Character
To go to next Character NEXT
f (double chevrons)
f (single chevrons)
f
f or OFF
f or OFF
f or OFF
f
f or OFF
f or OFF
f or OFF
f or OFF
f
f or OFF
A
Warning -
When entering a drug name the character "%" should not be used as it may cause the pump to lock up and the safety
processor alarm to sound. The word "percent" or an abbreviation is recommended for use. Only the Models GH and
CC are affected by this anomaly.
1000SM00001 Iss. 18
12/86
General options
Option Description
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).
NEOI WARNING Sets the Near End Of Infusion (NEOI) warning time.
EOI POINT Sets the End Of Infusion volume.
KVO AT EOI Enables pump to run at the Keep Vein Open (KVO) rate when End Of
Infusion (EOI) is reached.
KVO RATE Sets the Keep Vein Open (KVO) rate.
BACK OFF Motor will reverse to relieve line pressure when an occlusion occurs.
AUTO SAVE When disabled, the patient information is cleared on power up.
RATE LOCK When enabled, the rate can be locked to prevent unwanted changes of
the set infusion rate.
QUIET MODE When enabled, the button beeps are muted.
AC FAIL When enabled, the AC Power Failure Alarm will sound if AC power is
disconnected.
RATE TITRATION When enabled, the rate can be changed whilst the pump is infusing.
PRESSURE DISPLAY Enables / disables the Pressure Icon on the main display.
AUTO PRESSURE Enables / disables the automatic pressure alarm level option.
AUTO SET PRESSURE Automatically sets the line occlusion pressure alarm level to a specified
amount above the current pressure.
AUTO OFFSET Adjusts the automatic offset value used by auto pressure and auto set
pressure.
HANDS FREE BOLUS Enables / disables hands-free bolus.
CAP PRESSURE Sets the maximum pressure limit.
PRESSURE DEFAULT Sets the default occlusion alarm level.
DEFAULT BOLUS VOLUME Sets the default hands-free bolus volume for No Drug mode only.
MAX PRESSURE Sets the maximum pressure limit.
WEIGHT Sets the default patient weight in kg.
CAP RATE Sets the maximum value for infusion rate.
PURGE RATE Sets the purge rate.
PURGE VOLUME LIMIT Sets the maximum permissible purge volume.
PURGE SYRINGE Prompt to purge syringe after confirmation.
BOLUS Enables / disables the bolus feature.
DEFAULT BOLUS Sets the default bolus rate.
CAP BOLUS RATE Sets the maximum value for bolus rate.
BOLUS VOL LIMIT Sets the maximum permissible bolus volume.
MANUAL BOLUS Volume infused will be increased if plunger is manually moved in and
syringe remains confirmed.
CALL BACK TIME Adjusts the time for the pump to sound the call back alarm.
VTBI CLEAR RATE Rate will be set to zero when VTBI has been set-up with stop as the end
rate.
EVENT LOG DISPLAY Enables / disables the event log display.
BATTERY ICON Enables / Disable the Battery Icon on the main display.**
AUDIO VOLUME Sets the alarm volume of the pump at high, medium or low.
AUTO NIGHT MODE Sets Backlight to dim between 21:00 and 06:00hrs.
* For Guardrails® Software enabled pumps, pumps with Plus software and the Alaris® PK Syringe Pump
Key:
= available option
= unavailable option
these options may vary or will not be available, with only the first three options listed in table above
adjustable in the General Options on the pump. Please refer to the relevant Pump or PC Software
Directions For Use for comprehensive information.
** For Alaris® GS Syringe Pump the battery icon can be seen via the Options menu by pressing the
key.
Alaris® Syringe Pump
Configuration and Calibration
Models
GS GH* CC* TIVA
d
1000SM00001 Iss. 18
13/86
Teach Learn
Teach Learn Procedure (Software versions V1.4.13 and above)
Alaris® Syringe Pump
Configuration and Calibration
For the teacher pump only (not required for learn pumps), in General Options 251, switch off 1.
RS232 before commencing Teach Learn procedure.
Turn the teacher pump on in normal operation.2.
Enter the access code 167 on learn pump.3.
Align the two IrDA ports on the pumps (optimum distance is 5cm).4.
Press OK and then Yes to confirm.5.
A progress bar will travel across the learn pump.6.
When completed, select No to cancel retry.7.
Note: For multiple
Teach Learn procedures,
to avoid call-back alarm
every 2 minutes, turn
teacher pump on in
access code mode.
Possible reasons for failure:
RS232 is not switched off.•
If software versions are different, confirm Teach Learn procedure on learner pump to continue. Verify settings after completion of •
learn.
The pump models are different. For example, an Alaris® GS Syringe Pump can only teach an Alaris® GS Syringe Pump.•
The line of sight between the IrDA windows was obstructed during data transfer.•
Important: During the Teach Learn procedure a note should be taken of any parameters that fail. These should then be adjusted •
manually in the relevant option setting. The final screen will show “Incomplete Data Transfer” if any commands have failed. Verify
learn pump configuration prior to returning the pump to clinical use.
Check protocols are correct on learn pump after Teach Learn procedure, before returning pump to use.
A
After a Teach Learn procedure it is necessary to clear the previous patient setup in order to update the syringe
information. On power-up after Teach Learn procedure and when prompted with CLEAR SETUP, select YES.
1000SM00001 Iss. 18
14/86
Alaris® Syringe Pump
Configuration and Calibration
Data Set Transfer
Data Set Upload and Download (401 and 499)
Upload Data Set to an Alaris® Syringe Pump with Guardrails® Safety Software or an Alaris® PK Syringe Pump (401)
Using the Guardrails® Editor Transfer Tool or Alaris® PK Editor Software Transfer Tool allows a released Data Set to be uploaded to an
Alaris® Syringe Pump.
Download Data Set from an Alaris® Syringe Pump with Guardrails® Safety Software or an Alaris® PK Syringe Pump (499)
Using the Verification Tool allows an uploaded Data Set in an Alaris® Syringe Pump to be downloaded to a PC for comparison and
verification.
Note: After data
set upload the new
parameters will not take
effect until the pump
has been powered up in
normal operation mode
and a new profile has
been selected.
Download CQI Event Log (402)
Download CQI Event Log from an Alaris® Syringe Pump with Guardrails® Safety Software (402)
Using the CQI Event Log Downloader allows the CQI Event Log to be downloaded from an Alaris® Syringe Pump to a PC for use with the
Guardrails® CQI Reporter. The Guardrails® CQI Reporter is a program for querying and reporting on the collective event data allowing the
user to analyse trends in medication administration and track medication errors.
Warning -
A
Note: For more
information relating to
the Guardrails® Editor, the
Alaris® PK Editor Software
and the Guardrails® CQI
Reporter refer to the
relevant Directions For
Use supplied with the
software.
At no time should the Guardrails® Safety Software or the Alaris® PK Editor Software be used to upload to or download
from an Alaris®
Syringe Pump while the pump is connected to a patient.
1000SM00001 Iss. 18
15/86
Calibration procedures (243)
Enter access code 243 to display the Calibration Selection menu (see Access Codes).
SYRINGE CLAMP calibration
Fit calibration tool into position on pump as shown in Steps 1-2 and close the •
clamp.
At each step, • CAL is displayed if value is within tolerances.
Press • CAL button to store calibration point.
Note: If CAL is not displayed,
check for correct positioning of
calibration tool.
If calibration cannot be
performed, repairs to pump may
be necessary.
Note: The calibration values
shown on the displays are for
illustrative use only and may
vary.
Note: The pump should be
power cycled after entering any
new calibration or configuration
information prior to performing
any validation tests.
Alaris® Syringe Pump
Configuration and Calibration
Calibration tool required: 1000TG00095
Step 1
Step 2
Step 3
1000SM00001 Iss. 18
16/86
PLUNGER POS (position) calibration
Fit calibration tool into position on pump as shown in Steps 1-3. •
At each step, • CAL is displayed if value is within tolerances.
Press • CAL button to store calibration point.
Alaris® Syringe Pump
Configuration and Calibration
Note: If CAL is not displayed,
check for correct positioning of
calibration tool.
If calibration cannot be
performed, repairs to pump may
be necessary.
Note: The calibration values
shown on the displays are for
illustrative use only and may
vary.
Step 1
Channel for locking clip
Step 2
Close-up of calibration tool,
showing locking clip in position.
Calibration tool required: 1000TG00095
Step 3
Step 4
1000SM00001 Iss. 18
Locking clip
17/86
SYRINGE FORCE calibration
Precondition:
This preconditions the mechanism and should only be done if motorplate or chassis
has been replaced. Fit Calibration tool as shown, zero the gauge, run until gauge
registers 10kgf and then carefully declutch mechanism and withdraw plunger. Do
not press any button during this procedure.
Note: To convert Kilograms
of Force (kgf) to Newtons
(N) multiply by 9.806650. For
example 10kgf = 98.07N.
Note: The calibration values
shown on the displays are for
illustrative use only and may
vary.
Excessive force will damage the plunger mechanism. Do not apply more than 10 kgf ±0.05kgf to the plunger
A
mechanism at any time.
Alaris® Syringe Pump
Configuration and Calibration
Calibration tool required:
0000TG00200 (top) or
0000TG00020 (bottom)
10kgf ±0.05kgf
Zero Gauge Syringe Force Calibration Tool Plunger
Fit Calibration tool and position plunger as shown in Steps 1 to 3, zero the gauge. At each step press CAL when required calibration
force is reached.
Note: If CAL is not
displayed, check for
correct positioning of
tool.
If calibration cannot
be performed, repairs
to pump may be
necessary.
Allow 30 seconds for pressure to stabilise following any preconditioning calibration.
Step 1
0kgf ±0.05kgf
1000SM00001 Iss. 18
18/86
Step 2
3kgf ±0.05kgf
Step 3
10kgf ±0.05kgf
Alaris® Syringe Pump
Configuration and Calibration
Step 4
A
Use of the 0000TG00200 Digital Occlusion Testgear.
The 0000TG00200 Occlusion testgear uses a digital force gauge to register applied forces.
Please refer to the MecMesin Compact Gauge Operation Instructions supplied for detailed operational information
and power options and requirements.
To prepare the testgear for use, load into the syringe pump.
Ensure there is nothing touching the testgear plunger (such as the syringe plunger drive).•
Turn on the Compact Gauge using the ‘On/Zero’ key.•
Select ‘kg’ force units, and ‘MAX’ reading option.•
If the display indicates other than 0.00kg, zero the system using the ‘On/Zero’ key.•
Operate the system as required for performing the calibration activity.
Before the next use, ensure the ‘MAX’ reading is cleared using the ‘On/Zero’ key.
1000SM00001 Iss. 18
19/86
LINE PRESSURE calibration – Alaris® CC Syringe Pump only
Tools required:
Pressure gauge (range 0-1400 mmHg) (Tolerance +/- 0.1% Full Scale Accuracy)•
Dedicated pressure sensing disc extension set (i.e. G30402M)•
50ml Luer-lock syringe•
Dedicated pressure sensing disc extension set
Alaris® Syringe Pump
Configuration and Calibration
Pressure Transducer
Load pressure disc infusion set into transducer. Connect infusion set to syringe and gauge. Using syringe, apply pressure required as
shown at steps 1-3. At each step press CAL when required calibration pressure is displayed on pressure gauge.
The calibration values shown on the displays are for illustrative use only and may vary.
Note:
Pressure gauge50ml Luer-lock syringe
Step 1
25mmHg ± 1mmHg
Step 2
500mmHg ± 1mmHg
Step 3
1000mmHg ± 1mmHg
Step 4
1000SM00001 Iss. 18
20/86
Alaris® Syringe Pump
BATTERY STATE
FINISH
OK
CAP 2488 mAh 00:09
CHR 2362 mAh 05:28
VOL 8.21 V 02:05
Configuration and Calibration
BATTERY calibration
Connect the Pump to AC mains.1.
Select BATTERY CALIBRATION from menu and press OK.2.
The pump will automatically run the battery calibration. Battery calibration cycles the battery through a charge, discharge and re-3.
charge sequence during which the gas gauge within the battery pack will be updated with a measurement of the current capacity
of the cells.
Battery compartment should be ventilated during calibration (open battery cover). Pump may fail calibration if too
A
hot, so care should be taken not to calibrate too many pumps in close proximity (in a docking station, for example).
Ensure that the battery is supported as you open the battery compartment.
Disconnecting the AC mains at any time during calibration will cause battery calibration to fail.
A
When calibration is complete, the following is shown on the display:4.
2
1
3
Value Description Pass Criteria
1 Battery Capacity Pack capacity value updated after measured
2 Current Battery Charge Level Current charge in pack. n/a
3 Battery Voltage Current pack voltage. n/a
4 Initial Charge Time Time taken during initial charge phase. Initial charge
5 Discharge Time Time taken during measured discharge phase. Pack
6 Final Charge Time Time taken during final charge phase. Pack is fully
4
6
5
discharge phase (if changed).
phase checks pack is fully charged and if not it is
charged.
is discharged to determine how much charge is
available from the pack.
recharged ready for use.
Greater than 2100mAh
Lower than 2 hours 59 minutes
Between 4 hours 15 minutes and 10
hours
Lower than 2 hours 59 minutes
All pass criteria (see table above) should be met and the pump should display FINISH at the end of the calibration otherwise 5.
calibration has failed. If calibration has failed retry calibration or replace battery.
Press 6. OK to exit.
Note: The plunger drive
will move automatically
during the discharge
phase, so ensure that
the plunger drive is
not obstructed during
calibration (remove
syringes etc).
1000SM00001 Iss. 18
21/86
Alaris® Syringe Pump
Preventative Maintenance
Preventative Maintenance 3
Preventative Maintenance
To ensure the pump remains in good operating condition, routine and preventative maintenance inspections are required. Routine
maintenance inspections should be performed by hospital/facility before each use, see Directions For Use for details.
Preventative maintenance inspections should be performed at least every three years.
For the preventative maintenance inspection the following should be performed:
Full visual inspection of the pump, internal and external•
Fitting of all updates required•
Battery test and/or replacement•
Clean the pump•
Performance Verification Procedure•
Following all spare part replacement and repair activities, testing must be performed in accordance with the
A
Performance Verification Procedure (PVP). Additional testing and calibration may be required after certain repairs
are completed, see table in Chapter 6 Corrective Maintenance for more information.
Visual Inspection
Open the pump, as per Chapter 6 Corrective Maintenance and visually inspect the interior of the pump.
Visually inspect the exterior of the pump checking the following:
Labels should be replaced as required if not flat, legible or fully adhered.•
Check Keypad for any sign of wear and replace as required. •
Case components must be checked for damage and replaced if necessary. •
Check the pole clamp is not damaged and that it functions correctly.•
Inspect the AC power supply plug and cable for damage.•
The case should be clean and free from IV solution residue, especially near moving parts. •
Check for dried solution deposits on accessible areas of pressure transducer and plunger mechanism.•
1000SM00001 Iss. 18
22/86
Alaris® Syringe Pump
Preventative Maintenance
Recommended Cleaning
To ensure this pump remains in good operating condition, it is important to keep it clean and carry out the routine procedures
described below. All servicing should only be performed by a qualified service engineer.
Thoroughly clean external surfaces of the pump, by wiping over with a lint-free cloth, lightly dampened with warm water and a
standard disinfectant/detergent solution.
Do not use the following disinfectant types:
NaDcc (such as PRESEPT)•
Hypochlorites (such as CHLORASOL)•
Aldehydes (such as CIDEX)•
Cationic Surfactants (such as Benzalkonium Chloride)•
Iodine (such as Betadine)•
Recommended cleaners are:
Brand Concentration
Hibiscrub 20% (v/v)
Virkon 1% (w/v)
The following products were tested and are acceptable for use on the Alaris® Syringe Pump range if used in accordance with the
specified manufacturer’s guidelines.
Warm soapy water•
Mild detergent in water (e.g. Young’s Hospec)•
70% Isopropyl Alcohol in water•
Chlor-Clean•
Clinell Sporicidal wipes•
Hibiscrub•
TriGene Advance•
Tristel Fuse sachets•
Tristel Trio wipes system•
Tuffie 5 wipe•
Virkon Disinfectant•
Virusolve+ (Ready To Use)•
Virusolve+ (Wipes) •
Before cleaning always switch OFF and disconnect from the AC power supply. Never allow fluid to enter the casing
A
and avoid excess fluid build up on the pump.
Do not use aggressive cleaning agents as these may damage the exterior surface of the pump.
Do not steam autoclave, ethylene oxide sterilise or immerse this pump in any fluid.
Use an appropriate cleaning method that does not allow an excess of fluid to accumulate around the keypads.
Aggressive cleaning can potentially create a fluid ingress path into the shelf keypad which can result in keypad
failure.
In case of failure, usually resulting in a KY1 error code, the shelf keypad must be replaced. As a preventive
measure, shelf keypads manufactured after week number 15, 2003 should be used since they offer more
protection to excessive cleaning. The week number may be found on the keypad connection tail.
We recommend that all pumps within the following serial numbers -
Alaris® GS Syringe Pump 08510 - 09976
Alaris® GH Syringe Pump 16437 - 22286
Alaris® CC Syringe Pump 03471 - 06632
Alaris® TIVA Syringe Pump 01310 - 02369
(or pumps outside of this range which had their shelf keypad replaced between 2nd July 2002 and 30th April
2003) have their shelf keypad replaced at the next routine service. All other pumps have a shelf keypad that does
not exhibit this potential risk.
1000SM00001 Iss. 18
23/86
Updates
Upgrading software
Recommended at the next service: If the pump has software versions V1.9.3 (MK1/2) or V2.3.5 (MK3) and below,
then upgrade to software version V1.9.4 (MK1/2) or V2.3.6 (MK3) or greater.
Strongly recommended: If the pump has software version V1.5.9 and below then upgrade the Alaris® Syringe
Pump (except the Alaris® TIVA Syringe Pump) software to the latest software versions, as this will address a
potential issue that may result in a condition where the running LED is flashing, the infusion status shows
"INFUSING" but the volume infused display will not increment and no drug will be infused into the patient.
This potential issue may occur under the following remote circumstances :-
If the pump is subsequently stopped and restarted, the infusion will start normally.
Mandatory: If the Alaris® PK Syringe Pump software is below V3.2.16 then upgrade to software version V3.2.16
or greater. This will provide an additional advice screen for the Propofol Schnider model usage, alerting the user
that a Tpeak of 1.6 minutes is used.
When upgrading a pump from one software version to another where the first or middle digit changes, cold start
will be required before and after software upgrade, unless otherwise stated in a Technical Information Notice.
Calibration will also be required after software upgrade and cold start.
Alaris® Syringe Pump
Preventative Maintenance
A new syringe was recently fitted into the drive mechanism and•
An infusion is started, very quickly stopped and then restarted. (The pump must be stopped between •
0.375 secs and 0.435 secs after starting - a window of 0.06 secs.)
Complete and return the 'Software Upgrade Record' in the 'Appendix' section after performing any software
A
Tools required
upgrade.
The Software Distribution Disk (See table below) •
IrDA port on PC or Comms Port•
Programming kit 1000SP00172 (Includes Programme Header and IrDA cable)•
RS232 cable 1000SP00336•
Ver. 3 Software Maintenance Utility (SMU) 1000CD00028•
IrDA power-down test
To check PC is set up correctly for communication with Alaris® Syringe Pumps the Power Down Test needs to be performed on one
Alaris® Syringe Pump only as follows:
Load the IrDA Power Down Test program on your PC.1.
Select GO on the PC software program.2.
Align the IrDA converter with the pump IrDA window (optimum distance is 5cm). 3.
Connect to serial port.4.
Enter access code 5. 166.
Press 6. Yes to continue Bootstrap.
Select IrDA interface.7.
Select a Baud rate of 115200.8.
The pump will then display Bootstrap in progress.9.
Press the 10. c button to silence the alarm.
Select Transmit on PC. Check progress bar moves on PC and pump powers down.11.
1000SM00001 Iss. 18
24/86
Software Versions available
Alaris® Syringe Pump
Preventative Maintenance
Syringe Pump Model
Alaris® GS Syringe Pump
Alaris® GH Syringe Pump
Alaris® CC Syringe Pump
Alaris® TIVA Syringe Pump
Alaris® PK Syringe Pump
Key: MP = Main Processor. Mk1/Mk2/Mk3 are the released versions of the Control PCB.
Syringe Pump Model with Plus Software
Alaris® GH Syringe Pump
Alaris® GH Guardrails® Syringe Pump
Mk1/Mk2 Mk3 Mk1/Mk2 Mk3 Mk3
1000SP01221
(MP v1 5.10)
1000SP01221
(MP v1 5.10)
1000SP01221
(MP v1 5.10)
1000SP01221
(MP v1.6.2)
Software Enhanced Software Guardrails® Safety Software
1000SP01225
(MP v2.0.0)
1000SP01226
(MP v2.0.0)
1000SP01227
(MP v2.0.0)
1000SP01228
(MP v2.1.0)
1000SP01469
(MP v4.1.4)
1000SP01469
(MP v4.1.4)
1000SP01270
(MP v1.9.4)
1000SP01270
(MP v1.9.4)
1000SP01270
(MP v1.9.4)
1000SP01270
(MP v1.9.4)
1000SP01276
(MP v2.3.6)
1000SP01268
(MP v2.3.6)
1000SP01267
(MP v2.3.6)
1000SP01269
(MP v2.3.6)
1000SP01454
(MP v3.2.16)
MP v3.1.4
(Installed by CareFusion
Personnel)
MP v3.1.4
(Installed by CareFusion
Personnel)
Alaris® CC Syringe Pump
Alaris® CC Guardrails® Syringe Pump
Soft bootstrap
Load the software program onto your PC. Start the ‘MP Only’ version of relevant pump software. Check the correct pump type is 1.
displayed.
Select GO.2.
Align the IrDA converter pump with the IrDA window (optimum distance is 5cm), or connect RS232 cable. 3.
Connect to serial port.4.
Enter access code 166.5.
Press Yes to continue Bootstrap.6.
Select IrDA interface or RS232 interface.7.
Select a Baud rate of 115200.8.
The pump will then display Bootstrap in progress.9.
Press the c button to silence the alarm.10.
Select Start on PC. Monitor progress of all selected channels11.
Power down pump.12.
1000SP01476
(MP v4.1.4)
1000SP01476
(MP v4.1.4)
1000SM00001 Iss. 18
25/86
Alaris® Syringe Pump
Preventative Maintenance
Hard bootstrap
Load the software program onto your PC. Start the relevant pump software (not the ‘MP Only’ version).1.
Disconnect the battery and separate the pump.2.
Fit the Programme header onto the control board.3.
Reconnect the battery. The pump will alarm, press the c button to silence.4.
Align the IrDA converter pump with the IrDA window (optimum distance is 5cm), or connect RS232 cable. 5.
Connect to serial port.6.
Switch the Programme header to the correct position either RS232 or IrDA.7.
Switch on the Programme header.8.
Select GO on the PC software program.9.
Select Start on PC. Monitor progress of all selected channels10.
Power down pump.11.
Cold start
It may be necessary to carry out a cold start if the pump has changed between certain software. Refer to documentation supplied with
the software disk to see if cold start is required.
Enter access code 611, then power down when prompted.1.
Perform a full calibration.2.
Caution - Potential Erasure of Data:
A
Cold Start erases ALL information from the pump. This feature should only be used when changing between
incompatible software versions. Full recalibration and reconfiguration will be required. CareFusion technicians
should not re-instate drug information (this MUST be left to the customer).
Power Failure
Failures may occur when using laptops when communicating with Alaris® Syringe Pumps, due to power
requirements.
External power supply may be used in conjunction with IrDA or RS232 cable to compensate for lack of power
from laptop.
Please Note IrDA data transfer can be affected by bright sunlight or fluorescent lighting.
1000SM00001 Iss. 18
26/86
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