Alaris VP Plus Guardrails Technical Training Course Manual Issue 1

Alaris® VP Plus Guardrails® Volumetric Pump

Technical Training Course Manual

Contents Introduction...

3

General Precautions...

3

Main Display Features... 4 Display... 4 Screen Icons... 4

Controls and Indicators...

5

Set Up and Operation...

6

Infusion Setup... 6 Priming the Infusion Set, if required... 6 Start Infusion... 6

Service Mode...

7

CQI Events Download... 7 Factory Defaults... 7 Configuration... 8 Data Set Transfer... 10 Calibration... 11

Preventative Maintenance... 14 Visual Inspection... 14 Battery Test and Replacement... 14 Test Verification/PVP... 15

Performance Verification Procedure... 19 Upgrading Firmware... 20 Requirements... 20 Preparation... 20 Software Download... 20

Event Log Download... 22 Notes:... 23

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Introduction The Alaris® VP Plus Guardrails® Volumetric Pump, hereinafter referred to as the Pump, is a volumetric infusion Pump that provides accurate and reliable infusions over a range of rates. The Pump has enhanced pressure monitoring capability allowing the clinician to monitor patient specific in-line pressure changes with high precision. This technical training course manual shows how to set up, test and calibrate the Alaris® VP Plus Guardrails® Volumetric Pump. It is intended for use by personnel experienced in medical equipment testing and maintenance procedures­. For more in-depth information on operation and servicing please refer to the relevant Directions For Use (DFU) and the Technical Service Manual (TSM). To view the TSM visit our web site http://www.carefusion.co.uk/alaris-technical/.

General Precautions Attention consult accompanying documents: Prior to using this pump, carefully read the Operating Precautions described in the Directions for Use (DFU). 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.

Ala

GP ris®

A M 

Dangerous Voltage. An electrical shock hazard exists if the casing of the pump is opened or removed. Refer all servicing to qualified service personnel. This pump is protected against the effects of high energy radio frequency emissions and is designed to be 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. 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.

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Main Display Features Display

NORADrenaline

Infusion Status/Drug Name/Profile Name/Primary or Secondary

RATE

Infusion Rate Dose Rate

25.0 ml/h 1.2 mcg/kg/min

45.0 ml VOLUME 50 .0 ml 1 h 48 m 00 s VTBI

Volume to be Infused Volume Infused Time remaining

VOLUME

Softkey Identifiers

VTBI

mmHg

28

Line Pressure

60

Downstream Occlusion Alarm Limit

Softkeys

Clear Volume Infused Set VTBI Option

Screen Icons Symbol

Description Time icon - Indicates time remaining before VTBI will be completed. If the time is greater than 24 hours then 24+ will be displayed. Also indicates pressure sample time on the Pressure Trend screen.

N

Battery icon - Indicates battery charge level to highlight when the battery will require recharging.

Line Pressure icon - Shows the current in-line pressure value in mmHg.

Downstream Occlusion Alarm Limit icon - Shows the downstream occlusion alarm limit in mmHg.

? !

Indicates that the value entered is outside of the Guardrails® soft limits. When the warning is overridden this indicates Guardrails® safety protocols are in use. Indicates that the value entered is outside of the Guardrails® hard limits. This warning cannot be overridden. This symbol is also used to prompt the user to set the rate. Indicates that the Pump is running at a rate below a Guardrails® soft limit. Indicates that the Pump is running at a rate above a Guardrails® soft limit.

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Controls and Indicators Symbol

Description

a b h c i

ON/OFF button - Press once to switch the Pump on. Press and hold down for approximately three 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. MUTE button - Press to silence active alarm, warning or prompt for approximately 2 minutes. The audio from the active alarm, warning or prompt will continue to sound every 2 minutes until the condition has been resolved. To silence the active audio for an extended interval of 15 minutes; press CANCEL, then press and hold the MUTE button until 3 rapid beeps are heard. Once the 15 minute interval has timed out the mute interval returns to 2 minutes. PRIME/BOLUS button - Press to access PRIME or BOLUS softkey. Press and hold down softkey to operate. PRIME - primes the infusion set with fluid when setting up an infusion for the first time. • Pump is on hold. • Infusion set is not connected to a patient. • Volume infused (VI) is not added to the total volume infused displayed. BOLUS - delivers fluid or drug at an accelerated rate. • Pump is infusing. • Infusion set is connected to patient. • Volume infused (VI) is added to the total volume infused displayed.

d e f g S j

OPTION button - Press to access optional features. PRESSURE button - Use this button to display the line pressure, trend display, and adjust the downstream occlusion alarm limit. CHEVRON keys - Double or single for faster/slower increase/decrease of values shown on display. BLANK SOFTKEYS - Use in conjunction with the prompts shown on the display. AC POWER indicator - When illuminated the Pump is connected to an AC power supply and the battery is being charged. BATTERY indicator - When illuminated the Pump is running on the internal battery. When flashing, the remaining battery run time is limited.

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Set Up and Operation Infusion Setup 1. Connect the pump to an AC power supply using the AC power cable. 2. Load the primed infusion set or prime using steps below. 3. Connect flow sensor, if required. 4. Press the a key. • The pump will run a short self-test. Check two beeps are activated during this test. • Check the displayed date and time are correct. Check display shows the data set name and version number. 5. CLEAR SETUP? - Selecting NO will retain all previous rate and volume settings, go to step 7. Selecting YES will automatically reset the rate and volume settings to zero and the CONFIRM PROFILE? screen will be displayed. 6. CONFIRM PROFILE? screen will show the data set name, version number and profile name: a) Press YES softkey to confirm current profile and go to next step. b) Selecting NO will display the profile selection screen, select correct profile using f keys and press OK softkey to confirm. Confirm profile screen will display again, press YES softkey and SELECT screen will be displayed. NOTE: The CONFIRM PROFILE screen is only shown if more than one profile is available in the data set. If a profile has been filtered, then the option to select ALL will be displayed in the profile selection screen. Selecting ALL will show the filtered profiles. 7. Select either ml/h, DOSING ONLY or DRUGS (A-Z) and press OK to confirm. Then follow the prompts as required. a) ml/h 1. Select ml/h from the list using the f keys.

SELECT

2. Press OK to confirm.

ml/h DOSING ONLY DRUGS A B C D E FGHIJ KLMNO PQRST UVWXYZ SELECT WITH OK

3. Enter the ml/h rate as prompted on the display in the next screen.

QUIT

b) Dosing Only - see Directions For Use for details. c) Drugs - see Directions For Use for details. 8. Clear VOLUME infused, if required. 9. Enter VTBI, if required, by selecting VTBI softkey on main display. Set VTBI by using the BAGS option and/or f keys and press OK to confirm. Select the END RATE using the f keys to scroll through the on-screen choices and press the OK softkey to confirm. 10. Enter or adjust the RATE, if necessary, using the f keys.

Priming the Infusion Set, if required

A

• Always prime the infusion set prior to connecting to the patient. • The prime rate and prime volume limit are configured in the data set via the Alaris® Editor. • The pump will not prime if rate lock has been activated. • During PRIME, the pressure alarm limit is temporarily increased to the maximum level.

The i button allows the delivery of a limited volume of fluid in order to prime the infusion set. 11. Press i button to display the PRIME screen. 12. Press and hold the flashing PRIME softkey until the fluid flows and the priming of the infusion set is complete. The volume used during priming will be displayed, but it is not added to the volume infused. 13. When priming is complete release the PRIME softkey.

Start Infusion 14. Connect the infusion set to the test equipment as required. 15. Press b key to start the infusion. INFUSING will be displayed. 1000CM00020 Issue 1

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Service Mode

A

Warning At no time should an access code be entered while the pump is connected to a patient. Service Mode should only be accessed by Qualified and Trained personnel.

The Service Mode menu comprises of a list of options, which are user selectable. To enter the menu:Turn the pump off. Hold down b and turn the pump on a. Enter the access code 212 using the f keys and the NEXT softkey. When the code shows on screen, press OK to confirm. Select the required option using the f keys and the OK softkey. The options are as follows: CQI Events Download

Download CQI Events from the Pump.

Data Set Transfer

Upload a data set to pump.

Configuration

This menu comprises a list of options which are configurable by the user.

Calibration

This menu comprises a list of calibrations which can be performed by the user.

Test Verification/PVP

Performance Verification Procedure Tests.

Factory Defaults

Load a default data set. Confirm to perform a cold start.

CQI Events Download The CQI Event log is downloaded via the Alaris® Transfer Tool (1000SP01535), refer to the relevant Directions For Use for further details. 1. Open the Alaris® Transfer Tool software on the PC. 2. Select the CQI Download button. The CQI Event Log Download Wizard is displayed. Click Next to continue. 3. Select the serial port(s) required to transfer the CQI event log data from the Pump(s). Click Next to continue. 4. Select the file option for saving the CQI event log. Select the existing zip file or enter a filename and location to create a new file. Click Next to continue. 5. Connect the Pump(s) to the PC. 6. Switch the Pump on in Tech Mode (code 212), select CQI Events Download and OK softkey to confirm. Click Finish on the wizard and Start softkey on the Pump. The Transfer Tool status is shown as CQI log downloading. 7. The CQI event logs will be downloaded to the selected file and the Alaris® Transfer Tool status is shown as CQI log download complete. The file information is updated to show the File Name and File Size.

A

Warning At no time should the CQI Event Log be downloaded while the Pump is connected to a patient.

Factory Defaults Select the required option using the f keys and the OK softkey. Default Data Set

Replace the current data set with a default data set. 1. Press OK to confirm loading the default data set.

Clear CQI Log File

Confirm clearing all pump history and resetting the data set to the factory default. 1. Press OK to confirm clearing the CQI Log File.

Cold Start Confirm

Confirm clearing and resetting to defaults the data set and calibration data. 1. Press OK to confirm performing a cold start.

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Configuration Select the required option using the f keys and the OK softkey. Date/Time

Sets the current date and time used for event logging. 1. Set the correct date and time using the f keys. 2. Press NEXT to continue to next item to change. 3. Press OK to confirm.

Software Versions

Displays the pump software versions. 1. Press OK to exit after verifying Software Version fitted.

Serial number

Configure the displayed serial number. 1. Set the serial number required (maximum 10 characters) using the f keys. 2. Press NEXT to continue to next item to change. 3. Press OK to confirm.

Pump Reference

Pump specific text to be displayed in user mode at start up. (20 characters max.) 1. Set the Pump Reference required using the f keys. 2. Press NEXT to continue to next item to change. 3. Press OK to confirm.

Language

Configure the Language used for display messages. 1. Select the required Language using the f keys. 2. Press OK to confirm.

Backlight & Contrast

Adjust the Backlight and Contrast values 1. Use the f keys to adjust Backlight and Contrast to required setting. 2. Press PARAM to change between Backlight and Contrast. 3. Press OK to confirm. Note: Select the Dimming parameter to see what the display would look like when dimmed.

Current Data Set File

Displays the current data set file details. 1. Press OK to exit after verifying current data set information.

Additional configuration options available through the Editor: Feature

Description

Range

AC Fail Warning

Controls whether, when main power has been disconnected, a warning is generated to inform the user that the pump is operating solely on battery power.

Enabled / Disabled

Audio Volume

Controls the audio volume used for alarms, warnings and prompts.

Low / Medium / High

Audio Volume Adjustable

Controls whether the user is able to adjust the audio volume setting.

Enabled / Disabled

Auto Night Mode

Controls whether, between defined times, the pump makes changes consistent with usage at night, e.g. dimmed backlight.

Enabled / Disabled

Auto save

Controls whether, when the pump is powered down, the active infusion settings are preserved for restoration at the next power-up.

Enabled / Disabled

Battery Icon

Controls whether or not the battery icon, which indicates state of charge, is displayed.

Enabled / Disabled

Callback Time

The time that is allowed to elapse between the user’s last recorded interaction with the pump and generation of a callback alarm.

0.1 to 15 minutes

Drug Override Mode

Always - Any changes made to the dose rate that are outside of the Guardrails® Soft Alerts will require confirmation before starting infusion.

Always / Smart

Smart – Confirmation of setting will be required on first dose rate set outside of the Guardrails® Soft Alert. Any subsequent changes will not require confirmation until after the dose rate has been confirmed inside the Guardrails® Soft Alert limits.

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Feature

Description

Range

Event Log

Controls whether or not it is possible for the user to inspect the contents of the event log using the pump’s display and keypad.

Enabled / Disabled

Quiet Mode

Controls whether or not the pump operates in a mode whereby generation of sound is minimised.

Enabled / Disabled

Rate Lock

Controls whether the Rate Lock feature is available for use.

Enabled / Disabled

Rate Titration

Allows the adjustment of the infusion rate while the pump is infusing, without putting the pump on hold.

Enabled / Disabled

Standby Mode

Controls whether or not standby mode is available on the pump.

Enabled / Disabled

VTBI Clear Rate

Controls whether or not the pump forces the user to define a new rate following completion of delivery of a previous VTBI.

Enabled / Disabled

Weight Default

The default patient weight.

Weight Soft Min to Weight Soft Max (Between 0.01kg and 250kg)

Weight Soft Min

The minimum patient weight for weight-based drug dosing calculations before alerting the user.

0.01kg to Weight Default

Weight Soft Max

The maximum patient weight for weight-based drug dosing calculations before alerting the user.

Weight Default to 250kg

AIL Limit

The single bubble Air-in-line alarm setting.

50 / 100 / 250 / 500 µl

Bolus Mode

Controls whether or not the pump allows bolus delivery method.

Enabled / Disabled

Bolus Rate Default

The default value for bolus rates.

10ml/h to Bolus Rate Max

Bolus Rate Max

The maximum permissible bolus rate.

Bolus Rate Default to 1200ml/h

Bolus Volume Max

The maximum permissible bolus volume.

1 to 100ml

Infusion Rate Max

The maximum permissible infusion rate.

1 to 1200ml/h

KVO Rate

The maximum infusion rate when performing KVO delivery.

0.1 to 20ml/h

Near End of Infusion Point

The point defined in terms of remaining time at which the infusion is deemed to be Near end i.e. nearly complete.

1 to 15 minutes

Primary VTBI Max

The maximum VTBI for primary infusions.

1 to 9999ml

Prime Rate

The rate at which priming is performed.

100 to 1200ml/h

Prime Volume Max

The maximum volume that can be purged as part of a given prime operation.

5 to 50ml

Secondary Infusion

Allows the use of a secondary infusion in the same channel.

Enabled / Disabled

Sec. Infusion Rate Max

The maximum permissible infusion rate for secondary infusions.

1 to 1200ml/h

Sec. VTBI Max

The maximum permissible setting for the Volume To Be Infused for secondary infusions.

1 to 9999ml

Downstream Occlusion Alarm Pressure

The default downstream occlusion pressure value.

1 to 800mmHg

Downstream Pressure Maximum

The maximum permitted downstream occlusion pressure value.

1 to 800mmHg

Auto Pressure

Controls the setting of the downstream occlusion limit offset above the measured pressure at that moment.

Enabled / Disabled

Auto Set Pressure

Controls whether the downstream occlusion limit can be set automatically.

Enabled / Disabled

Auto Offset

When the downstream occlusion limit is set automatically, this value is the amount added to the stable running downstream pressure to set the limit.

15 to 100mmHg

Alarm Volume Ramping

Controls whether the alarm volume ramping feature is enabled, which controls whether the alarm, warning or prompt volume increases over time.

Enabled / Disabled

Disable Near End Of Infusion

Controls whether the Near End of Infusion alarm is disabled.

Enabled / Disabled

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Data Set Transfer Upload data set to a pump Equipment required: • Alaris® Editor V4.4 Software Kit (1000SP01534) or Alaris® Transfer Tool Software Kit (1000SP01535) • RS232 cable (1000SP01183) • USB to RS232 Converter cable (1000EL00979) • USB to RS232 converter 4 way hub (1000EL00980) - optional • PC - for requirements see Upgrading Firmware PC requirements Using the Alaris® Transfer Tool allows an approved data set to be uploaded to a Pump.

A

Warning At no time should the Alaris® Transfer Tool be used to upload to a Pump while the Pump is connected to a patient.

1. Open the Alaris® Transfer Tool software on the PC. 2. Select the Data Set Upload button (Ctrl+U). The Data Set Upload Wizard is displayed. Click Next to continue. 3. Select the serial port(s) required to transfer the data set to the Pump(s). Click Next to continue. 4. Click the Select Dataset button and Open the required data set. The selected data set and path are displayed. Click Next to continue. 5. Enter the data set ID and click Validate. If the data set ID entered matches the ID of the selected data set the Next button will become available. Click Next to continue. 6. The data set selection is now complete. Click Finish. The file information is updated to show the File Name used, Data Set Name and Supported Pump Types. 7. Connect the Pump to PC. 8. Switch the Pump on in Tech Mode (code 212), select Data Set Transfer and press OK softkey to confirm. 9. Press the START softkey to begin transfer. 10. When the transfer is complete, the Pump will validate the data then display Transfer Complete. The transfer status will be shown as Data Set Deployed to the Pump. Note: Please ensure the data set ID shown on the Pump is identical to the one transferred. 11. Press ACCEPT softkey to confirm correct transfer and exit. The transfer status will be shown as Deployed. 12. Switch off the Pump by holding the power button for 3 seconds and disconnect from the PC. 13. If multiple uploads are required, connect the next Pump and repeat from step 5. 14. When all uploads are complete, click Menu > Exit to close the Transfer Tool.

A

Caution: Loading the Transfer Tool software is considered a non-clinical service activity. Interconnecting the Pump with a PC may cause the safety or electromagnetic environment to change while the connection exists. The threat of higher leakage currents or EMI disturbances may be present. Disconnect the IrDA or RS232 cable connection at both ends following software upload activities.

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Calibration Select the required option using the f keys and the OK softkey.

Up Pressure Calibration

Performs upstream pressure system verification and calibration. Equipment required: • Up Pressure Calibration Kit, part number: 1000JG00386, contains: -- one x 100gF weight -- two x 350gF weight -- VP support jig -- fixture block with bubble level Select the required option using the f keys and the OK softkey. 1. Press START softkey to begin calibration. 2. Enter the sensor information for GAP SIZE using the f keys. NOTE: The GAP SIZE parameter value can be found in any one of two places. Inside the pump adhered to the force sensor circuit board or in the battery compartment. 3. Press the ACCEPT softkey. 4. Lay the pump on its back and place onto the Supporting Jig.

5. Place the Fixture Block onto the four tolerance pads. 6. Ensure the Supporting Jig is level by checking that the bubble is within the inner black circle of the Bubble Level. If the bubble is not central, turn the adjustable feet of the jig until it is central.

7. Install 100gF weight into the bearing hole of the Fixture Block. Slowly lower the weight onto the pressure sensor button. 8. Wait for 15 seconds countdown. Press NEXT softkey to store.

9. Carefully apply both 350gF weights to make 800gF weight. 10. Wait for 15 seconds countdown. Press NEXT softkey to store. 11. Press NEXT softkey to continue. 12. Press ACCEPT softkey to validate, GAP SIZE, OFFSET (CALC), GAIN (CALC).

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Validation Procedure: 13. Remove the weights from the Fixture Block so that 0gF is applied to the pressure sensor. Press the NEXT softkey. NOTE: Leave the Fixture Block in place on the tolerance pads for 0gF application during verification. NOTE: A check mark or X will appear on the display to confirm or fail the sensor readings.

14. Install 100gF weight into the bearing hole of the Fixture Block. Slowly lower the weight onto the pressure sensor button.

15. Carefully apply the 350gF weight onto the 100gF weight. 16. With weight of 450gF applied, press the NEXT softkey. NOTE: A check mark or X will appear on the display to confirm or fail the sensor readings. 17. When Calibration Pass is displayed press the PASS softkey, or if Calibration Fail is displayed press REPEAT softkey to start calibration again.

Down Pressure Calibration

Performs downstream pressure system verification and calibration. 1. Install infusion set, 70593. Close upstream roller clamp to ensure no leakage occurs. 2. Set up equipment as per Figure 1. Close door with set open to atmosphere. Pressure source capable of generating the required pressure Pressure Gauge

Vent to atmosphere

Figure 1 3. Press the START softkey. 4. Test will run for 30 seconds and establish the mV at 0mmHg. 5. Press the ACCEPT softkey. 6. Turn 3-way tap to close from atmosphere. 7. Apply a pressure of 100mmHg and Pump will count down for 15 seconds. 8. Press the ACCEPT softkey. 9. Apply a pressure of 800mmHg and Pump will count down for 15 seconds. 10. Press the ACCEPT softkey.

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11. Turn 3-way tap to vent to atmosphere. 12. Turn 3-way tap to close from atmosphere. 13. Press the NEXT softkey to proceed to Verification Procedure.

Verification Procedure 14. Apply a pressure of 50mmHg and wait for 5 seconds. 15. Press the NEXT softkey. 16. Apply a pressure of 450mmHg and wait for 5 seconds. 17. Press the NEXT softkey. 18. Press the PASS softkey if acceptable. 19. Press the REPEAT softkey to perform calibration again, if required.

Volumetric Cal

Performs Pump volumetric verification and calibration. 1. Load the primed infusion set into the Pump and set-up as shown in Figure 2. If burette is dry, wet burette with fluid until meniscus is visible on volumetric graduations. Adjust the fluid level so the meniscus is level with the selected burette volume mark and the middle pump finger. Record the initial level.

450mm ± 20mm

Figure 2 2. Press START softkey to begin the test. Selecting the DETAILS softkey will display additional calibration test information with respect to volumes and motor position. Test will run and fluid will be delivered into the burette. Pump will flash VOLUMETRIC CALIBRATION and Performing test will be displayed on the bottom of the screen. Depressing the SUSPEND softkey will pause the test, QUIT will return to CALIBRATION menu. 3. Read the final level reached in the burette after the target volume of 10ml is delivered. Subtract this amount from the initial level to find the actual amount delivered. 4. When Enter the actual value collected with f is displayed, check accumulated air in line value is less than 100µl. Enter the volume delivered into the burette using the keys and the OK softkey. If accumulated air in line value is greater than 100µl, repeat the test. 5. If no calibration is required No CAL required! is displayed. Volume delivered is within ±3% of the target (9.7ml to 10.3ml), press PASS to confirm and exit. 6. Calibration is changed automatically to a numerically greater Cal value to compensate for negative volume delivered (less than 9.7) and to a lower Cal value for positive volume delivered (greater than 10.3 ml). If the Cal value is changed automatically, screen will display CAL changed Verification required, press VERIFY and repeat steps 1 to 5. Depressing QUIT soft key will return to CALIBRATION menu. 7. If the pump still fails replace the platen and / or fingers and repeat the calibration procedure. Battery Cal

Perform battery calibration. 1. Connect AC Mains to the Pump and press CAL to begin. 2. When calibration is complete it will display CALIBRATION SUCCESS or CALIBRATION FAILURE. Press PASS to confirm successful calibration or REPEAT to perform calibration again.

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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 year. For the preventative maintenance inspection the following should be performed: • Full visual inspection of the pump, internal and external • Fitting of all updates required (see TSM for details) • Battery test and/or replacement • Clean the pump (see TSM for details) • Performance Verification Procedures

Visual Inspection When the pump is open 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 pumping mechanism.

Battery Test and Replacement To test the battery perform the battery calibration. 1. Connect AC Mains to the Pump, hold down b and turn the pump on a. 2. Enter the access code 212 using the f keys and the NEXT softkey. 3. When the code shows on screen, press OK to confirm. 4. Select the CALIBRATION using the f keys and the OK softkey. 5. Select the BATTERY CAL using the f keys and the OK softkey. 6. Press CAL to begin. 7. When calibration is complete it will display CALIBRATION SUCCESS or CALIBRATION FAILURE. Press PASS to confirm successful calibration or REPEAT to perform calibration again. 8. If battery continues to fail replace the battery and repeat procedure.

A

The battery pack used in this Alaris® Volumetric Pump is manufactured by CareFusion and includes a proprietary PCB (printed circuit board) designed specifically for the Alaris® Volumetric Pump, and in conjunction with Alaris® Volumetric Pump software, controls battery use, charge and temperature. Any use of battery packs that are not manufactured by CareFusion in the Alaris® Volumetric Pump is at your sole risk, and CareFusion does not provide any warranty for or endorsement on any battery packs that are not manufactured by CareFusion. CareFusion’s product warranty shall not apply in the event the Alaris® Volumetric Pump has suffered damage or premature wear, or malfunctions or otherwise operates incorrectly, as a result of use with a battery pack that is not manufactured by CareFusion.

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Test Verification/PVP In Test Verification/PVP menu select required test/menu using the f keys and the OK softkey. PVP Work Flow

Performance Verification Procedure (PVP) tests. This test is used to confirm that the Pump is functioning correctly. Press the START softkey to begin. The PVP workflow will iterate through the following tests: • Software Versions • Date/Time (read only) • Serial Number (read only) • Safety Clamp • Sear • Audio Test • Chequerboard • LED’s • Keypad • Nurse Call • RS232 Loop Back • Pumping Efficiency Test • Downstream Occlusion Pressure Test • Alarms Functionality • Volumetric (Accuracy Test) Calibration See individual test details in this course manual for instructions.

Downstream Occlusion Pressure Test

This test is used to confirm that the pressure sensor is correctly calibrated and able to detect an occlusion at the correct line pressure. Use the infusion set ten times only and then replace. Record the number of times the infusion set has been used. NOTE: The Occlusion Pressure Test is carried out with fluid in the infusion set. The test set up is shown in Figure 3.

450 mm ± 20 mm Pressure Gauge 3-way tap

150 mm ± 5 mm Container

Figure 3 1. Install a primed infusion set into the pump. Connect to 3-way tap on pressure gauge and place container to collect fluid below 3-way tap. Ensure system is primed to the pressure gauge . 2. Enter the PVP Work Flow and proceed to the Occlusion Pressure Test. 3. Rate is set to 25ml/h, VTBI should be 100ml. Alarm Levels can be selected according to the Table below. Pressure Setting mmHg

% of FSD

mmHg of FSD

Acceptable pressure range mmHg

25

±4%

±32

-7 ~ 57

500

±5%

±40

460 ~ 540

800

±6%

±48

752 ~ 848

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4. Configure the pressure gauge in mmHg to hold the peak maximum reading. 5. Turn the 3 way tap to open to atmosphere and press START to begin. 6. Allow the pump to run for 15-20 seconds then turn the 3-way tap to the pressure gauge. 7. The pump will continue to infuse until a high pressure alarm is triggered. Press CANCEL to stop the alarm, screen will display ALARM Triggered! 8. Confirm the measured pressure is within the limits listed in table shown above. To confirm the pressure is within the limits press the PASS softkey. Press the STOP softkey to end test any time. 9. Press the REPEAT softkey to run the test from the beginning. Open the tap to relieve the pressure before repeating the test.

A Alarms Functionality

If the pressure is outside of tolerance pressure calibration is required. Calibration should be performed as per procedure. If the pump continues to fail the occlusion test then the pressure sensor should be replaced and perform the calibration procedure again.

Test the Alarms function correctly. Note: A fluid filled Infusion Set is required for this test. 1. Press the START softkey to begin. 2. Pump starts an infusion. 3. Check all alarms sound and display correctly. 4. Alarms to test are: • AC Mains Disconnect • Door Open • Upstream occlusion • Air In Line 5. When all the alarms have been tested press the PASS softkey if all the alarms worked correctly or REPEAT softkey if alarms still need to be checked.

User Interface

Display, Keypad, LEDs and Audio Tests.

Chequerboard

Display Chequerboard Test. 1. Check pattern is displayed correctly and

P to pass. If pattern is incorrect then press O to fail.

2. Press PASS softkey to confirm pass and exit. Keypad Tests

Perform Keypad Test to check all keys work when pressed. 1. Press the START softkey to begin. 2. Press all the keys and a

P will indicate each key to pass.

3. Press PASS softkey to confirm pass and exit. LED Tests

Check all LEDs display in correct order. 1. Press the START softkey to begin. 2. Check LEDs are displayed correctly and

P to pass. If an LED is not displayed then press O to fail.

3. Press PASS softkey to confirm pass and exit. Audio Tests

Check Primary and Secondary Audio sounders sound. 1. Press the START softkey to begin. 2. Check Audio sounds are correct and

P to pass. If Audio sounds are not correct then press O to fail.

3. Press PASS softkey to confirm pass and exit. Power Supplies

Test AC Mains and Battery operation.

AC Mains Test

Tests the AC mains removal detection. 1. Press the START softkey to begin. 2. Check AC Mains connected/disconnected is correctly indicated and press softkey if not correctly detected. 3. Press PASS softkey to confirm pass and exit.

Battery

Review the battery information. 1. Press the DETAILS softkey to see further battery details. 2. Press QUIT softkey to exit. 1000CM00020 Issue 1

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P softkey or press O

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Sensor Tests

Perform tests on the pump sensors.

Flow Sensor Test

Check Flow Sensor is connected and drops count. 1. Plug flow sensor into connector on rear of the pump. 2. Press the START softkey to begin. 3. Check Flow sensor operation is correct and press

P softkey if drops are displayed correctly or press

O softkey if drops are not detected. 4. Press PASS softkey to confirm pass and exit. Safety Clamp Test

Check Safety clamp detection registers clamp enabled or disabled. 1. Press the START softkey to begin. 2. Check Clamp enabled/disabled is correctly indicated and press correctly detected.

P softkey or press O softkey if not

3. Press PASS softkey to confirm pass and exit. Sear Test

Check Sear detection registers sear enabled or disabled. 1. Press the START softkey to begin. 2. Check Sear in/out is correctly indicated and press detected.

P softkey or press O softkey if not correctly

3. Press PASS softkey to confirm pass and exit. Air In Line Test

Check Air In Line sensor detects fluid and air correctly. 1. Press the START softkey to begin. 2. Insert a fluid filled Infusion Set and an air filled Infusion Set. 3. Confirm pump detects fluid and air correctly and press detected.

P softkey or press O softkey if not correctly

4. Press PASS softkey to confirm pass and exit. Note: Upstream is always INVALID. Run-In Mode

Performs a continuous infusion for burn in testing. 1. Load an Infusion Set. 2. Set the rate required using the f keys and press the START softkey to begin test. 3. Press STOP softkey when test is completed. 4. Press PASS softkey to confirm pass and exit.

Pumping Efficiency Test

This test is used to confirm that the Pump is able to generate sufficient pressure. The test set-up is as per Figure 4.

450 mm ± 20 mm Pressure Gauge 3-way tap

150 mm ± 5 mm Container

Figure 4 1. Insert the Infusion Set (70593) and the in-line roller clamp closed to prevent fluid flow. 2. Close the door and open the roller clamp on the set. Ensure that the 3-way tap to the transducer is closed to the atmosphere.

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3. From the Sensor Test menu screen, highlight Pumping Effic’y Test and press OK softkey. 4. Press the RATE softkey to select a rate of 50ml/h. 5. Press the START softkey and start the timer. 6. When 1000mmHg is reached, stop the timer and then press the STOP softkey and open the 3-way tap to atmosphere. 7. Record that the time taken to reach 1000mmHg was 1 minute 52 seconds or less. 8. Press the PASS softkey to confirm pass and exit. Pump Finger Height / Parking Test

Allows the mechanism to be parked. 1. Press the START softkey to begin. 2. Mechanism will run and park. 3. Press DONE softkey to confirm and exit.

Comms Tests

RS232, IrDA and Nurse Call Tests.

IrDA Test

Check IrDA operates correctly. IrDA Test requires specialist equipment. For further details please contact CareFusion.

RS232 Loop Back

Check RS232 operates correctly. 1. Link pins 2 and 3 of the RS232 connector on rear of the pump. 2. Press the START softkey to begin. 3. Check RS232 operation is correct and

P for pass are shown after each item. If RS232 Test fails a

O is displayed to indicate the failure. 4. Press PASS softkey to confirm pass and exit. Nurse Call Test

Check Nurse Call operates correctly. 1. Press the START softkey to begin. 2. Check Nurse Call operation is correct and

P for pass are shown after each item. If Nurse Call fails a

O is displayed to indicate the failure. 3. Press PASS softkey to confirm pass and exit.

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Performance Verification Procedure Model / Serial Number:

Service Order / Inventory Number:

Hospital Name / Reference:

Inspection

Software Version:

Physical inspection and cleanCH3 Check all functions in PVP Work Flow Enter access code 212 and go to PVP Work Flow • Software Versions • Date/Time • Serial Number • Safety Clamp • Sear

Self TestCH3

• Audio Test • Chequerboard • LED’s • Keypad • Nurse Call • RS232 Loop Back • Pumping Efficiency Test -- Time taken = 1 minute 52 seconds or less

_____ minutes _____seconds

• Downstream Occlusion Pressure Test -- Occlusion alarm = 500mmHg ± 40mmHg

______________mmHg

• Alarms Functionality • Volumetric (Accuracy Test) Calibration -- Delivery = 10ml ± 0.3ml (3%) Setup

Set rate to zero (or lowest value possible), clear Volume Infused and VTBI Class I Type CF

Electrical Safety TestS

______________ml

Test in accordance with the standard EN 60601-1 and test equipment operation manual.

Test results are stored: • Electronically

¨

• Print-out

¨

• Other

¨

PASS / FAIL

___________________ Verification Performed

___________________________

_________________________

_____________________

By

Sign

Print

Date

CHX indicates the chapter number in the Technical Service Manual (TSM) - 1000SM00022. E.G. CH2 = Refer to TSM Chapter 2.

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Alaris® VP Plus Guardrails® Volumetric Pump

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Upgrading Firmware Requirements • PC Minimum hardware system requirements:

Software requirements:

• 1GHz Pentium processor

• 512MB RAM

• 1GB of free space on the system hard drive

• CD ROM drive

• Available configurable RS232 9 pin serial or USB communications ports

• Keyboard

• Video resolution of 1024 X 768 pixels and 16 bit colour depth

• Mouse

• Microsoft Windows 2000 (service pack 4), or XP (service pack 2)

• The Software Maintenance Utility (SMU) (1000SP01537) • RS232 cable (1000SP01183) • USB to RS232 Converter cable (1000EL00979) - optional • USB to RS232 converter 4 way hub (1000EL00980) - optional • Firmware CD

Preparation • Load the SMU software onto the PC • Connect RS232 connector (using USB to RS232 converter if required) to each Pump being updated • Disconnect the Battery • Remove the Battery Compartment Plug

Battery Compartment Plug

Software Download 1. Through the Rear Case, there is a set of three dip switches on the bottom of the Control PCB. Switch 1 should be ON and switches 2 and 3 should be OFF. 2. Turn the Dip/Rocker Switches, using a small flat blade screwdriver or round ended tweezers, to: • Switch 1 = OFF • Switch 2 = ON • Switch 3 = ON

3. Start the SMU facility to upload the software. 4. Select the Firmware zip file. 5. Select the Comm settings - Comm Port and Baud rate of 460800 (USB to RS232 converter) or 115200 (RS232). 6. Connect the Battery to the Battery Cable and connect the mains cable, if required. 7. Press Start on the SMU.

A

Switch 1 turns the safety battery circuit on but is not required for programming. Switch 2 forces the pump to turn on. Switch 3 turns the pump into ‘Boot Mode’, this is only used for programming.

8. The firmware upload has finished successfully when the flashing green light, on the SMU, changes to a steady green light. 9. Disconnect the RS232 connector. 1000CM00020 Issue 1

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