Alaris
Alaris Syringe Pump MK3 Technical Service Manual Issue 34
Technical Service Manual
92 Pages
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Page 1
Alaris™ Syringe Pump MK3
Contents General Information... 5 Introduction... 5 Product Familiarity... 5 Purpose of this manual... 5 Conventions Used in this Manual... 6 General precautions... 6 Front panel and main display... 7
Configuration and Calibration... 8 Access codes... 8 Dedication options (301/302)... 9 Data Set Activation (612)... 9 Handsfree Bolus (175)... 9 Power Lock (711)... 9 Configuration options (251)... 10 Teach Learn... 13 Teach Learn Procedure (Software versions V1.4.13 and above)... 14 Data Set Transfer... 15 Data Set Upload and Download (401 and 499)... 15 Download CQI Event Log (402)... 15 Calibration procedures (243)... 16 SYRINGE CLAMP calibration... 16 PLUNGER POS (position) calibration... 17 SYRINGE FORCE calibration... 18 LINE PRESSURE calibration – Alaris CC Syringe Pump only... 20 BATTERY calibration... 21
Preventative Maintenance... 22 Preventative Maintenance... 22 Visual Inspection... 22 Recommended Cleaning... 23 Updates... 24 Upgrading software... 24 Pole Clamp Arm Update... 26 Motor Plate Strain Beam Update... 26 Transmission Buffer Pad Update... 26 Linear (PL3) Update...27 Plunger Backplate Replacement... 28 Battery Test and Replacement... 29 Replace the Main Battery... 29 Self-test Procedure (123)... 30 Self-tests included in full test... 30 Self-tests not included in full test... 31 Comms Test (123)...31 Calibration Verification Mode (240)... 32 1000SM00001 Issue 34
2/92
Alaris™ Syringe Pump MK3
Performance Verification Procedure... 33
Troubleshooting... 34 Review logs... 34 Event Log download... 34 Information Logs (376)... 34 Software fault codes... 35 PL3 Error or PL8 / PL9 Error (for pumps with Plus Software)... 39 Introduction... 39 Failure causes... 39 Diagnosis... 39 Actions... 39 Exception error handling... 42 General fault diagnosis... 42
Circuit Descriptions... 43 Functional module block diagram... 43 Module overview functional description... 44 Control PCB... 44 Pressure Transducer (Model CC)... 44 Power Supply Unit PCB... 44 Display PCB... 44 Battery... 45 Transmission... 45
Corrective Maintenance... 46 Corrective Maintenance... 46 Access to pump... 47 Rear case and subassemblies... 49 Power Supply Unit and Speaker... 49 Mains inlet, PE stud and magnet... 50 Pole clamp and RS232... 51 Rail cam... 52 Front case and subassemblies... 53 Control PCB and RS232 (if option fitted)... 53 Display PCB... 55 Chassis PCB and Plunger assembly... 56 Chassis assembly and Pressure Transducer (Model CC only)... 57 Syringe Sizing assembly... 58 Chassis assembly breakdown... 60 Plunger assembly breakdown... 62 Pressure Transducer Assembly (Model CC only)... 64 Keypads and labels... 65
1000SM00001 Issue 34
3/92
Alaris™ Syringe Pump MK3
Two Layer Keypad... 66
Appendix... 70 Electromagnetic Compatibility... 70 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions... 70 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity... 71 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 Syringe Pump... 73 Disposal... 74 Information on Disposal for Users of Waste Electrical and Electronic Equipment... 74 Information on Disposal in Countries outside the European Union... 74 Battery Removal... 74 Spare Parts Listing... 75 Electrical Parts Listing... 75 Front Case Parts Listing... 76 Rear Case Parts Listing... 77 Keypads and Labels... 78 Transmission Parts Listings... 79 Software... 80 Test Equipment...81 Fitting and Replacement Guidelines... 82 General assembly information... 82 Torque guide... 82 Lockbox Accessory... 84 Lockbox Cleaning Instructions... 84 Pump Battery Replacement... 86 Lockbox Parts Replacement... 87 Service Contacts... 88 Document History... 89 Software Upgrade Record... 91
1000SM00001 Issue 34
4/92
Alaris™ Syringe Pump MK3 General Information
1 General Information 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.
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Please refer to the Alaris Syringe Pump MK4 Technical Service Manual (1000SM00024) for all servicing information for the MK4 versions.
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) MK3
• Alaris GH Syringe Pump
• Alaris GH Guardrails™ Syringe Pump (with Plus software) MK3
• Alaris TIVA Syringe Pump
• Alaris CC Syringe Pump (with Plus software) MK3
• Alaris Enteral Syringe Pump
• Alaris CC Guardrails Syringe Pump (with Plus software) MK3
• 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. This manual has been prepared for use by Qualified Service Personnel only. CareFusion recommends that all servicing should only be carried out by CareFusion certified Qualified Service Personnel. Note: Throughout this manual the pump software terminology, syringes used and disposables used vary for the Alaris Enteral Syringe Pump, e.g. Infusion is Delivery, extension set is feeding tube, etc. See the relevant DFU for complete information. However all tests and procedures will remain the same, unless otherwise stated.
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It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service Manual for your CareFusion products. These documents are referenced on www.carefusion.com. Copies can be obtained by contacting your local CareFusion representative.
1000SM00001 Issue 34
5/92
Alaris™ Syringe Pump MK3 General Information
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... 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.
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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.
General precautions
Y
Please read the general Operating Precautions described in the Directions for Use carefully prior to using the pump. 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.
A
An electrical shock hazard exists if the pumps casing is opened or removed. Refer all servicing to Qualified Service Personnel.
M
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 remove the source of the interference or regulate the infusion by another appropriate means.
L
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. 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.
1000SM00001 Issue 34
6/92
Alaris™ Syringe Pump MK3 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. Time Remaining Icon Syringe Type Fitted / Drug Name / Profile* Pressure Information** / Pressure Icon (if enabled)
Infusion Status
Infusion Rate
Volume Infused Blank Softkeys
Pressure button
* “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
ON/OFF button - Press once to switch the pump on. Press and hold down for 3 seconds to switch the pump off.
b
RUN button - Press to start the infusion. The Green LED will flash during infusion.
h
HOLD button - Press to put the infusion on hold. The amber LED will be lit while on hold.
c i
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
d
OPTION button - Press to access optional features.
e
PRESSURE button - Press to display the pumping pressure and alarm level.
g
BLANK SOFTKEYS - Use in conjunction with the prompts shown on the display.
f
CHEVRON keys - Double or single for faster/slower, increase or decrease of values shown on main display.
j
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.
k
AC POWER indicator - When illuminated, indicates that the pump is connected to an AC power supply and the battery is being charged.
1000SM00001 Issue 34
7/92
Alaris™ Syringe Pump MK3 Configuration and Calibration
2 Configuration and Calibration 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 (Not available for Guardrails Software enabled Pumps and the Alaris PK Syringe Pump)
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) and the Alaris Enteral Syringe Pump: Code
Description
123
Self Test Procedure
166
External Reprogramming
240
Calibration Verification Mode
243
Calibration Selection Menu
251
User Configuration Menu
301
Fully Dedicated (Not available for the Alaris Enteral Syringe Pump)
302
Semi-dedicated (Not available for the Alaris Enteral Syringe Pump)
376
Service Access Menu
401
Upload Data Set to Pump (Not available for the Alaris Enteral Syringe 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. Hold down b and turn the pump on. 2. Enter the required access code using the f keys and the NEXT softkey. 3. When the required code shows on screen, press OK to confirm. 1000SM00001 Issue 34
8/92
Alaris™ Syringe Pump MK3 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 i 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 Issue 34
9/92
Alaris™ Syringe Pump MK3 Configuration and Calibration
Configuration options (251) Enter access code 251 to display the User Configuration menu: 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
Set the current date and time. To set the clock, use f and NEXT to adjust and OK to store.
Hospital Name*
Enables establishment name (max 20 characters) to be displayed during the power-up sequence. To set the hospital name, use f and NEXT to adjust and OK to store.
Enable Syringes*
Configure the type and size of syringes permitted for use. To enable syringes, use f and SELECT, to enable/disable and OK to store.
Language
Configure the language used for messages shown on display. Select language required using f and SELECT to store.
Contrast
Set the display panel contrast. Use f to adjust contrast and OK to store.
Enable Units*
Select the type of units permitted for use on the pump. To enable units, use f and MODIFY, to enable/disable and OK to store.
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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.
*Note: For Guardrails Software enabled pumps, pumps with Plus software, the Alaris Enteral Syringe Pump 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 Issue 34
10/92
Alaris™ Syringe Pump MK3 Configuration and Calibration
Alaris TIVA Syringe Pump drug protocol setup 1. Select Drug Library from Configuration Options (251). 2. Use f to select drug and press MODIFY to modify selected drug or NEW to create new drug name. 3. QUIT will return to 251 main menu. 4. When modifying a drug protocol, pressing BACK at any time will take you to the previous step. 5. Modify - Existing drug a) ENABLE/DISABLE - Enables or disables the drug being available. b) DELETE - Select Yes to delete from drug library. c) EDIT - See table below. 6. Edit Drug Protocol - New or existing drug a) Press OK softkey to confirm each step. Drug Option
To Adjust (Softkeys are shown in Bold) Select Character Group f (double chevrons)
Drug Name
Select Character f (single chevrons) To go to next Character NEXT
Concentration Units
f
Minimum Concentration
f or OFF
Default Concentration
f or OFF
Maximum Concentration
f or OFF
Dose Rate Units
f
Induction Dose
f or OFF
Induction Time
f
Pause After Induction
MODIFY
Maintenance Rate
f
Bolus Dose
f
Bolus Rate
RATE
Hands Free Bolus
MODIFY
1000SM00001 Issue 34
11/92
Alaris™ Syringe Pump MK3 Configuration and Calibration
Alaris CC Syringe Pump* drug protocol setup 1. Select Drug Library from Configuration Options (251). 2. Use f to select drug and press MODIFY to modify selected drug or NEW to create new drug name. 3. QUIT will return to 251 main menu. 4. When modifying a drug protocol, pressing BACK at any time will take you to the previous step. 5. Modify - Existing drug a) ENABLE/DISABLE - Enables or disables the drug being available. b) DELETE - Select Yes to delete from drug library. c) EDIT - See table below. 6. Edit Drug Protocol - New or existing drug a) Press 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
To Adjust (Softkeys are shown in Bold) Select Character Group f (double chevrons)
Drug Name
Select Character f (single chevrons) To go to next Character NEXT
Dose Rate Units
f
Maximum Dose
f or OFF
Default Dose
f or OFF
Minimum Dose
f or OFF
Concentration Units
f
Minimum Concentration
f or OFF
Default Concentration
f or OFF
Maximum Concentration
f or OFF
Maximum Bolus
f or OFF
Bolus Rate
f
Pressure Alarm
f or OFF
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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 Issue 34
12/92
Alaris™ Syringe Pump MK3 Configuration and Calibration
General options Option
Description
GH
CC
TIVA
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.
Key:
* For Guardrails Software enabled pumps, pumps with Plus software, the Alaris Enteral Syringe Pump and the Alaris PK Syringe Pump only these options are adjustable in the General Options on the pump.
= available option = unavailable option
** For the Alaris Enteral Syringe Pump, software version v4.2.1 and above, Quiet Mode is adjustable in the General Options on the pump.. Please refer to the relevant Pump or PC Software Directions For Use for comprehensive information.
Teach Learn 1000SM00001 Issue 34
13/92
Alaris™ Syringe Pump MK3 Configuration and Calibration
Teach Learn Procedure (Software versions V1.4.13 and above) 1. For the teacher pump only (not required for learn pumps), in General Options 251, switch off RS232 before commencing Teach Learn procedure. 2. Turn the teacher pump on in normal operation. 3. Enter the access code 167 on learn pump. 4. Align the two IrDA ports on the pumps (optimum distance is 5cm).
Note: For multiple Teach Learn procedures, to avoid call-back alarm every 2 minutes, turn teacher pump on in access code mode.
5. Press OK and then Yes to confirm. 6. A progress bar will travel across the learn pump. 7. When completed, select No to cancel retry.
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 GH Syringe Pump can only teach an Alaris GH 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.
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Check protocols are correct on learn pump after Teach Learn procedure, before returning pump to use. 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 Issue 34
14/92
Alaris™ Syringe Pump MK3 Configuration and Calibration
Data Set Transfer Data Set Upload and Download (401 and 499) Upload Data Set to an Alaris Syringe Pump with Plus Sofware, Alaris Guardrails Syringe Pump or an Alaris PK Syringe Pump (401) Using the Alaris Plus Editor Transfer Tool, 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 Plus Sofware, Alaris Guardrails Syringe Pump 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, where applicable. Note: After data set upload it is advisable to switch the pump off and then wait 10 seconds before powering on again. Also 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 Plus Sofware or Alaris Guardrails Syringe Pump (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.
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Warning At no time should the Alaris Plus Editor Transfer Tool, Guardrails Safety Software, CQI Event Log Downloader 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.
Note: For more information relating to the Alaris Plus Editor, Guardrails Editor, the Alaris PK Editor Software and the Guardrails CQI Reporter refer to the relevant Directions For Use supplied with the software.
1000SM00001 Issue 34
15/92
Alaris™ Syringe Pump MK3 Configuration and Calibration
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 softkey to store calibration point. Calibration tool required: 1000TG00095 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 pump should be power cycled after entering any new calibration or configuration information prior to performing any validation tests.
Note: The calibration values shown on the displays are for illustrative use only and may vary.
Step 1
Step 2
Step 3
1000SM00001 Issue 34
16/92
Alaris™ Syringe Pump MK3 Configuration and Calibration
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 softkey 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.
Calibration tool required: 1000TG00095
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.
Step 3
Locking clip
Step 4
1000SM00001 Issue 34
17/92
Alaris™ Syringe Pump MK3 Configuration and Calibration
SYRINGE FORCE calibration 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.
Calibration tool required: 0000TG00200 (top) or 0000TG00020 (bottom)
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Excessive force will damage the plunger mechanism. Do not apply more than 10kgf ±0.05kgf to the plunger mechanism at any time.
Fit Calibration tool and position plunger as shown in Steps 1 to 3, zero the gauge. At each step press CAL softkey 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.
Step 1 0kgf ±0.05kgf
1000SM00001 Issue 34
18/92
Alaris™ Syringe Pump MK3 Configuration and Calibration
Step 2 3kgf ±0.05kgf
Step 3 10kgf ±0.05kgf
Step 4
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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 Issue 34
19/92
Alaris™ Syringe Pump MK3 Configuration and Calibration
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
50ml Luer-lock syringe
Pressure Transducer
Pressure gauge
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 softkey when required calibration pressure is displayed on pressure gauge. Note: The calibration values shown on the displays are for illustrative use only and may vary.
Step 1 25mmHg ± 1mmHg
Step 2 500mmHg ± 1mmHg
Step 3 1000mmHg ± 1mmHg
Step 4
1000SM00001 Issue 34
20/92
Alaris™ Syringe Pump MK3 Configuration and Calibration
BATTERY calibration 1. Connect the Pump to AC power. 2. Select BATTERY CALIBRATION from menu and press OK. 3. The pump will automatically run the battery calibration. Battery calibration cycles the battery through a charge, discharge and recharge sequence during which the gas gauge within the battery pack will be updated with a measurement of the current capacity of the cells.
A
Battery compartment should be ventilated during calibration (open battery cover). Pump may fail calibration if too 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.
A
Disconnecting the AC power at any time during calibration will cause battery calibration to fail.
4. When calibration is complete, the following is shown on the display: 1
2
3
4
6
5
Value
Description
Pass Criteria
1
Battery Capacity
Pack capacity value updated after measured discharge phase (if changed).
Greater than 2100mAh
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 phase checks pack is fully charged and if not it is charged.
Lower than 2 hours 59 minutes
5
Discharge Time
Time taken during measured discharge phase. Pack is discharged to determine how much charge is available from the pack.
Between 4 hours 15 minutes and 10 hours
6
Final Charge Time
Time taken during final charge phase. Pack is fully recharged ready for use.
Lower than 2 hours 59 minutes
5. All pass criteria (see table above) should be met and the pump should display FINISH at the end of the calibration otherwise calibration has failed. If calibration has failed retry calibration or replace battery.
A
A new battery or battery that has been in storage may fail its initial calibration run, from these states most batteries require conditioning with at least 3 charge discharge cycles to achieve their maximum capacity. Therefore batteries faulty an initial calibration run should not immediately be considered defective, once cycled most initial failures will show improvement and pass on a second calibration attempt.
6. Press OK to exit. Note: The plunger drive will move automatically during the discharge phase. The plunger drive must be positioned away from the end of travel, at least the middle of the travel, and not be obstructed during calibration (remove syringes etc).
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