Annual Certification Test

 

Annual Certification Overview

The annual certification process includes a sequence of maintenance checks that need to be performed annually on the Sapphire infusion pump. The annual certification procedures are briefly described in the following table.

 

  Maintenance Check   

Visual inspection (including mechanical and electrical inspections)

Checking for pump integrity: cracks, loose parts, connectors, touch screen and other tests, as defined in the Service Manual.

Safety features testing

Checking speaker, LEDs, door sensor and bolus handle.

Calibration verification

Performing tests that determine whether calibration is necessary.

The current chapter explains the annual certification process, with special emphasis on the calibration verification tests. The annual process is supported by Q Core’s Annual Certification Kit and Software. The kit includes tools for performing the tests, as well as a PC program that provides trained technicians with step-by-step instructions for how to perform the tests.

 

Certification due date counting

 

Sapphire and SapphireH100

The starting condition for counting the certification date is the shorter of the two options:

10 working hours or 180 days from pump shipment day from Q Core warehouse. The date one of these conditions is met is defined as the start date.

·         After the condition is met, the next certification date will be the start date + 380 days.

·         Before the condition is met, the next certification date will be the release date (pump shipment date from Q-Core) + 380 days.

After preforming the certification process, the next certification due date will be the date of the PC that performed the test (start user usage date at pump’s Eeprom)+ 380 days.

Tolerance = ±7 days. 

 

Sapphire Plus

The starting condition of counting certification date is the shorter of the two options:

10 working hours or 2 years from pump shipment day from Q Core warehouse (set as the certification date during Q Core FTP Lab process in EEPROM).

·         After the condition is met, the next certification date is a dynamic value that will be calculated according to calibration days left from current date (calibration days = certification date + 380 – current date):

o    10 hours condition: certification date is due after 10 working hours.

o    2 years condition: certification date is set to the original certification date + 2 years

·         Before the condition is met, the calibration days will be calculated as follows: Certification date + 2 years + 380 days – current date. The next certification date in view system will be calculated according to the calibration days that were left from the current date.

After preforming the certification process, the next certification due date in EEPROM is set to the date of the PC that performed the test.

  

Testing Rationale of the Annual Certification Process

 

The annual certification process involves visual and safety inspection and performing a series of tests on the pump, to determine whether or not the pump requires calibration. The tests need to be performed once a year by a trained technician.

The Sapphire pump saves the date of the last certification process, and automatically displays the following messages on the pump’s Main Display as the next required testing date approaches:

·         Annual certification due in 2 weeks. Please contact trained technician.

·         Annual certification due in 2 days. Please contact trained technician.

·         Annual certification date is overdue. Please contact trained technician.

 

The Calibration Verification Process

 

The heart of the annual certification process is the calibration verification which is made up of the following set of tests:

·         Occlusion Sensor

·         Air Detector

·         Flow Accuracy

To facilitate the testing process, Q Core has developed a special testing kit referred to as “Annual Certification Kit” which supplies special tools necessary for testing 5 pumps. The kit is used with the Annual Certification Software. It enables you to perform testing with the pump connected to your PC and to receive immediate testing feedback via the Q Core server.

The software application provides step-by-step testing instructions with a summary version of the same instructions inscribed on the pump itself. The application allows you to test simultaneously 1-8 pumps, using a USB to 4-port serial RS232 adapter which can be purchased separately from Q Core.

A test can be simultaneously performed on up to 8 pumps.

The tools provided in Annual Certification Kit can be used for 5 pumps, and only one pump at a time.

To test multiple pumps simultaneously, prepare number of kits as the number of pumps that will be tested.

 

Annual Certification Test

 

Figure 1-1: Visual inspection for cracks


Figure 1-2: Visual inspection of safety door


3. Check the cassette chamber, pumping mechanism and cassette locking mechanism for functionality and cleanness (Figure 1-3):

·         The door latch should move to “cassette unlock position” freely and spring back to “lock position” without any resistance, otherwise return the pump for servicing.

·         The internal white panel should be free of foreign materials and dirt. If necessary, use standard detergent solution to clean the connector or the Dispatch® (Caltech) ready-to-use towels. Pay particular attention to the area around the 4 fingers roots.

·         The Bubble Detector (BD) must be inspected for possible cracks, scratches or dirt. If the BD plastic shell is damaged, return the pump for servicing. A dirty BD cover can lead to improper functioning of the BD, creating false alarms. Verify that the BD plastic cover is clean of grease or other foreign materials.

Figure 1-3: Visual inspection of cassette chamber


4. A properly functioning safety door must “click” itself into the open position, and must snap itself to a secure closed position. The door has an internal protrusion to assure correct locking of the cassette when the door is closed. Verify that the protrusion is not broken.

Figure 1-4: Visual inspection of safety door


5. Check that the power-communication connector is free of foreign materials and dirt. If necessary, clean and dry with a dry cloth.

Figure 1-5: Visual inspection of power-communication connector

6. The pump has flat golden connectors (P2C) on the back of its plastic housing. Make sure that the connectors are not loose, broken, dirty or corroded. When cleaning the pads, take special care not to scratch its golden surfaces.


Figure 1-6: Visual inspection of connectors


7. The pump pressure sensor is located on the 3rd fingertip. This fingertip should move freely and the gap between the tip and the finger should befree of dirt, grease or foreign materials. Gently press the tip to verify that it is moving freely.

Figure 1-7: Visual inspection of pressure sensor


Pump must be serviced:

·         In any case of cracked, broken or deformed parts of the pump housing, the pump must be serviced. This includes the pump housing, cassette chamber door and battery door.

·         In case of a cracked, broken or deformed BD plastic housing.

·         Pumps suspected of being damaged must be tested for proper performance before being returned to patient use. This includes pumps that have been physically damaged, or those that have fluid intrusion.

 

Testing System Functions

 

The Test system menu enables you to test basic system functionalities. Only users with authorization levels of High or Technician have access to this menu.
> To access the Test system menu:

·         From the toolbar of the Start Up screen, select Options. Then, select Pump configuration > Test system.

 

Speaker High

• On: High volume auditory signal sounds. • Off: No auditory signal.

Speaker Low

• On: Low volume auditory signal sounds. • Off: No auditory signal.

Alarm LED

• On: The red (Alarm) LED is lit. • Off: The red (Alarm) LED is not lit.

Charge LED

• On: The yellow (Charge) LED is lit. • Off: The yellow (Charge) LED is not lit.

Running LED

• On: The green (Run) LED is lit. • Off: The green (Run) LED is not lit.

Door Sensor

• Closed: The safety door is closed. • Opened: The safety door is open.

Bolus Handle

• Released: The handle is not pressed. • Pressed: The handle is pressed.

To test bolus handle functionality first connect the bolus handle to the Sapphire infusion pump. Do NOT connect bolus handle to mini cradle splitter.

 

The administration set used in the Annual Certification Process is not for human use. Do not use this Administration Set for any other purpose.

 

Annual Certification Kit

The Annual Certification Kit is a pre-packaged kit provided by Q Core that contains all the special equipment necessary for performing certification testing. One kit can be used for testing 5 pumps. The Annual Certification Kit is designed to be used in conjunction with Q Core’s Annual Certification Software. Testing with the software application is initiated by scanning the barcode of the Kit (found on the Directions for Use).

 

Q Core Medical has access to Event Log information and may use it for purposes such as back up, research, and statistical analysis. However, Q Core Medical does not collect, save, or disclose any personally identifiable information.

 

Kit Components

 

The components of the Annual Certification Kit are shown in the following illustrations. All components of the kit are listed and described in the table preceding the figures.

Administration set

1800 mm tubing, with (i) spike, (ii) Syringe (iii) back check valve (iv) Y-connector (v) T-connector (vi) administration cassette, (vii) slide clamp, (viii) Sleeve, (ix) Fluid bag cap (See Figure 1)

All tests

Fluid bag

Plastic bag that can hold up to 500 mL (See Figure 2).

All tests

 

  Description  

  Component  

  Used for  


Figure 1: Administration set


Figure 2: Extension set


Figure 3: Syringe


Figure 4: Flow Accuracy Container


Figure 5: Flow Accuracy Container: cap


Figure 6: Hydrophobic cap (6)

 

Annual Certification Software

Q Core’s Annual Certification Software streamlines the Annual Certification process by enabling you to test the pump while communicating with the Q Core server. Step-by-step instructions are provided onscreen (PC and Pump screens), and results are printed immediately following the testing process.

 

Requirements

 

Before installing the software, verify that the following requirements are met:

·         Operating System: Windows 7, Windows XP

·         Screen Resolution: 1024:768 (minimum), 96 DPI

·         Memory: 4 GB

·         Internet Access

Verify with your facility IT team that the internet connection has an open port TCP 5100 to host name: applicationsserver.qcore.com for communicating with Q Core server, and is not restricted by firewall.

 

Acquiring the Software

The Annual Certification Kit software can be obtained from Q Core FTP site (https://qcore.smartfile.com). 

Please note that only trained technicians registered with the company will be cleared to receive the software.

 

Logging In

The user is requested to insert the username and password provided by Q Core Medical.  Contact Q Core for a new password or username if forgotten.

Figure 7: Login screen

 

Station Setup

This section describes how to connect the pumps to the PC via COM ports. Each pump adequately connected, will immediately be presented as a station on the left pane of the screen. There might be a lag between the pump and computer screen, please wait for the PC and pump to synchronize and follow the instructions on the screen.

You can connect a single pump via serial port; for configuring additional COM ports to your PC, use the USB to 4-port serial RS232 adapter, see the explanation below.


Figure 8: Stations Dialog Box

   3. Choose a free COM for each station needed.

   4. Confirm selection by clicking the OK button. Your selection will be saved for the next use of the software.

 

> To use the Q Core USB to 4-port serial RS232 adapter (for enabling additional COM ports):

The USB to 4-port serial RS232 adapter provides 4 external COM ports to your computer (P/N 15077-000-0001). Follow the DFU instructions for installation.

 

The Testing Screen

 

This section provides an overview of the structure and features of the Annual Certification Software screen.

> To connect via serial:

1.     Open the Annual Certification program, log into the program.

2.     Choose the Setup link at the upper right corner. The following window appears:

It is recommended to configure all COM ports to the PC application before starting a test. Configuring an additional COM port while a test is running is not possible.


Figure 9: Testing Screen

The main portion of each page of the application consists of a “main screen” which provides step-by-step instructions for performing the current stage of testing. The header of each page provides the number of the currently selected Station, the name of the test and the specific test-step being conducted (for example, Occlusion Sensor (Station 2): Prime).

 

The Station pane, at the left side of each page, provides information about the testing status of each Station.

The following links are available at the upper right corner of each page:

  Function/Notes  

  Name of Link  

 

Refresh active pump

Refreshes the display of the pump that connected to the active station

Help

Provides more detailed information/instructions about certification testing.

About

Provides information about the software version and corresponding pump versions.

Login/Logout

Enters/exits the application.

Setup

Configures stations to available COM ports.

Close

Provides option to close the current/all tests, and to exit the program

 

Working with the Station Pane

 

After the pumps are connected to the computer and turned on, the Station Pane becomes active. Each Station corresponds to a pump that is connected to the computer. Stations that have no pump connected to them (such as Station 3 in Figure 10) are disabled.

The Station pane provides a snapshot of the status of each pump throughout the testing process. Each Station has five numbered circles, corresponding to the stages of testing. The circle that is highlighted represents the stage that the pump is currently in. To help differentiate between the pumps, the numbers of each Station are coded in a different color. To help associate between the pump tested and its depiction on the screen, the pump’s display is marked with a rectangle colored with the color code on the computer screen.


Figure 10: Station Panel

The five stages of testing (listed 1-5 on the pane) are:

  Name of Testing Stage  

  Number of Testing Stage  

 

Getting Started

Prime

Air Detector & Accuracy

Occlusion Sensor

Results

 

Performing the Annual Certification Tests

 

The following sections explain how to perform the required Annual Certification tests using Q Core’s software application.

The annual certification tests are designed in a way that each action is required in order to set the pump to a specific condition required for the tests. Follow each instruction fully in order to perform the tests adequately.

The descriptions in this section elaborate on the directions in the software application.

 

Getting Started

The following sections describe how to prepare the testing environment and begin the testing process.

Required Materials

The following equipment is required for certification testing:

·         Q Core Annual Certification Kit(s).

·         An infusion bag that is filled with at least 200 mL fluid – the bag should be a collapsible bag of water.

·         RS232 COM ports, or Serial on USB (optional).

·         Motorola LS2008 barcode reader (optional); you may use the barcode key manually instead.

·         RS232 communication cable between pump and computer.

Before beginning the tests, make sure that the Annual Certification Kits contain all the original parts supplied by Q Core

 

Testing Conditions

The following environmental conditions should be met during testing to help ensure accurate results. Deviation from the environmental conditions might affect the accuracy of the tests.

·         Approximate time of the test (per pump) is 15 minutes; verify that your computer has adequate power supply to last for the duration of the test.

·         Room temperature: 20º C ± 5º C

·         Relative humidity: up to 70%

·         Pump position: straight and vertical

·         The required distance between the center of the pump and the bottom of the bag is 50 cm (Figure 11).

·         The required distance between the center of the pump and the bottom of the container cap is 0 ±10 cm (Figure 11).


Figure 11: Station Setup

 

Launching the Annual Certification Process

> To perform the Setup Sequence:

Carry out the following setup sequence for all the devices prior to connecting the pumps to the PC and starting the Annual Certification test.

If the pumps were already connected to the PC, disconnect all the devices from the COM ports and wait for 30 seconds before performing the setup sequence.

The Annual Certification software uses Continuous delivery mode for the tests, even if this mode is not configured on the Sapphire pump. When the certification tests are finished, make sure that the pump is at an allowed delivery mode.

1. From the Options menu, select Pump configuration > General settings. Select Authorization level. Then, using the keypad, enter the High level password > OK.

2. Change the Occlusion Pressure to 1.2 BAR (17.4 PSI, 900 mmHg). Press Options from the Start screen > Pump Configuration > Alarms > Occlusion Pressure.

3. Programming a treatment:

    3.1 The following instructions are for pumps without a Drug Library installed.

Multi Therapy pumps:

a. Select Continuous delivery mode

b. Configure treatment: Rate= 100ml/h, VTBI=100 ml

c. Confirm the treatment by pressing OK

d. Exit the treatment by pressing Exit

e. Verify that the option Repeat Last Infusion is available (don’t select it). If not, repeat steps b-d.

 

Proceed to the section to perform the Preliminary Inspections below.

 

Epidural only pumps:

a. Select PCEA delivery mode

b. Configure treatment: VTBI=100 ml, Rate=10 ml/h, Demand bolus=0mL, No loading Dose

c. Confirm the treatment by pressing OK

d. Exit the treatment by pressing Exit

e. Verify that the option Repeat Last Infusion is available (don’t select it). If not, repeat steps b-d.

 

Proceed to the section To perform the Preliminary Inspections below.

   3.2 The following instructions are for pumps with a Drug Library installed.

For pumps with Continuous delivery mode available:

a. Select Continuous delivery mode

b. Configure a treatment with Drug Name=”General”

c. Configure treatment: Rate=100ml/h, VTBI=100ml

d. Confirm treatment by pressing OK

e. Exit the treatment by pressing Exit

f. Verify that the option Repeat Last Infusion is available (don’t select it). If not, repeat steps b-e

 

Proceed to the section To perform the Preliminary Inspections below.

 

For pumps without Continuous delivery mode:

The Drug Library should be removed prior to the Annual Certification Test; For removing the Drug Library use the Pump Cleanup tool available at Q Core’s FTP site (under the folder “Pump Cleanup Tool for Maintenance”). 

 

The “Pump Cleanup Tool for Maintenance” FTP folder contains the Pump Cleanup tool, work instructions, and self-declaration training record. In order to receive credentials to use the Pump Cleanup Tool the following should be followed:

a. Download and read the work instructions and the self-declaration training record

b. Fill and sign the self-declaration training record

c. Send a scanned copy of the signed self-declaration training record to: 

d. Username and password will be sent to your e-mail by Q Core’s service department.

Change the pump’s settings back to factory default after the test is completed.

> To perform the Preliminary Inspections:

1. Perform Thorough Visual Inspection. Check Pass or Fail in the box next to Visual inspections according to findings.

2. Perform Functional Tests. Check Pass or Fail on applicable boxes next to Functional Inspections according to findings.

The Preliminary Inspections verify that the pump is in a proper condition before starting the certification.

A pump that failed one of the inspections tests is considered as Failed and should be serviced. A Failed pump cannot proceed to the certification process.

A pump that passed all of the inspections tests is marked as Pass and can continue to the Calibration Verification process.

By clicking Next, the user who is logged in confirm to be the one who performed the inspections tests.

If this is the first time you run this program, you need to configure your stations and COM ports first. Verify that the driver installed successfully. The ACK software automatically recognizes the ports that successfully connected to the pumps.

2. Using the RS232 connector cable, connect each pump to the computer, and turn the pump(s) on.

3. Select a station by double clicking on its slot on the Navigation Pane.

 

> To perform the Kit Selection:

1. Using the barcode reader (or the keyboard), enter the barcode number of the Annual Certification Kit and verify the following:

    a. The barcode number has 28 characters

    b. The barcode number starts with “+M8261…”

    c. The PC language is set to English (some characters, such as “/” will be translated and won’t reflect the actual serial number of the kit).

The barcode reader can be found on the top left of the Directions for Use, found within the kit.

After entering (or scanning), the barcode number will appear in the Kit Serial Number field.

2. Click Check. The Q Core server checks the validity of the kit.

The kit is limited to 5 uses. Save the DFU for further eligible uses of the kit.

Ensure that all parts of an old kit are disposed of before using a new kit. Parts from an old kit should not be used under another kit number.

If the kit has not been fully used, a message appears listing the number of uses remaining. If the number of uses is exhausted or the kit is otherwise invalid, an appropriate error message appears.

Use of the kit is deducted from the eligible uses once the results of the tests are sent to Q Core.

Exiting the tests in the middle of the process will not deduct the number of uses remaining. However, you will have to start the process from the beginning. Results are not saved if you exit the process in the middle.

3. To start the first test (Occlusion Sensor), click Start certification.

 

Performing the Occlusion Sensor Test

This test involves creating pressure in the system by introducing specific amounts of air into the administration set, against a check valve. The air is inserted in a 3-step process.

 

> To perform the Occlusion Sensor test:

1. Prepare the infusion bag and the administration set:

    a. Fill the bag with at least 200 mL of tap water, and attach the administration set to the bag.

    b. Attach the administration set to the pump, and close the safety door.

2. Perform automatic priming on the pump, press Prime.

For this test, automatic priming is required. Do not prime the administration set manually.

During the Occlusion Sensor Test (Prime, Setup and Test), do not remove the administration cassette from the pump.

3. Verify effectiveness of the prime by visually inspecting the administration set and checking for air.

If any air is present, on the pump, press Prime. Repeat automatic priming until the set is completely free of air.

4. When the administration set is fully primed, on the pump, press Next.

5. Attach the extension set to the administration set, with the check valve at the free end (Figure 2 above). Then, fill the syringe with air.

6. On the pump, press Next.

Steps 7-9 need to be completed within 30 seconds.

Be exact in applying air!

To start the test over for any reason, on the toolbar of the pump, press Restart.

7. Using the syringe, insert air into the administration set until the air reaches the first mark on the tubing (Figure 1 above). Then, on the pump, press Mark 1.

8. Insert more air into the administration set, until the air reaches the second mark on the tubing. Then, on the pump, press Mark 2.

9. Insert more air into the administration set, until the air reaches the third mark on the tubing. Then, on the pump, press Mark 3.

10. To proceed to the next test (Air Detector), on the pump, press Next.

 

Performing the Air Detector Test

This test involves introducing air into the administration set from above the administration cassette and checking whether the pump detects air in the system.

 

> To perform the Air Detector test:

1. Remove the extension set from the administration set.

2. Using the syringe, insert 1 mL of air into the administration set, via the Y-connector (Figure 1 above), and disconnect the syringe. Then, on the pump, press Start.

Infusion of fluid starts, and then (when the air is recognized) stops.

3. To proceed to the next test (Flow Accuracy), on the pump, press Next.

 

Performing the Flow Accuracy Test

This test involves infusing a specific amount of fluid into a container and checking whether the pump measures the correct volume infused.

 

Prior to starting the test verify fluid container is completely dry. The kit is provided with two bottles in order to ensure that at least one of the bottles is dry at any given time.

Starting the test with all components dry is critical to the success of the certification testing.

> To perform the Flow Accuracy test:

1. With the cap removed from the Flow Accuracy Container, attach a new hydrophobic filter to the male luer fitting on the cap of the Flow Accuracy Container. Do not reuse hydrophobic filters. Then, attach the end of the administration set to the female luer fitting. When finished, press Next on the pump.

2. Prime the administration set manually, as follows:

·         Remove the administration cassette from the pump and perform manual priming by opening the AFFV on the cassette.

·         Verify the set and the leading tube of the cap are flushed.

·         Avoid getting the hydrophobic filter wet.

3. Verify effectiveness of the prime by visually inspecting the administration set and checking for air.

If any air is present, repeat priming until the set is completely free of air.

4. When the administration set is fully primed, reinsert the cassette to the pump and close the door. Verify that all connections are tight. On the toolbar of the pump, press Next.

·         Keep the positioning of the fluid container vertical during the test period.

·         Once the flow accuracy container is full, the device detects the occlusion and stops the test. Drops may seem coming from the filter as the water in the container reaches the top, this is normal.

5. Make sure the cap and the Flow Accuracy Container are completely dry. Attach a completely dry container to the cap. A container from a different kit maybe used.

To ensure the container is completely dry, hang it upside down for at least 10 minutes prior to use.

You may verify the container dryness by weighing the container with a balance: the weight of a dry bottle should not exceed 13g. Weight above this value indicates that some water is present in the container.

Ensure the cap is dry by wiping it with a dry cloth. Verify there is no residual fluid in the inner areas of the bottle cap.

6. Make sure the connectors on the top are fully screwed into place prior to starting the test.

Figure 12: Flow Accuracy Container Cap

7. Make sure the container is positioned upright and in the same height of the pump. Use the hanger on the cap if necessary.

10cm difference between the two is acceptable. Larger difference can cause back pressure that will jeopardize the credibility of the results.

8. Make sure the collapsible bag of water holds at least 150 mL of water. Then, press Start on the pump.

9. To complete the certification testing process and generate results, press Finish.

10. If the pump failed the Flow Accuracy test, perform the manual prime again as described in step 2 before repeating the Flow Accuracy test. This will not deduct from the number of kits available.

 

Viewing Results

When certification testing is finished, a PDF report is automatically generated and displayed on the computer monitor. The report includes the following information:

·         Document number

·         Pump serial number

·         Kit serial number

·         Testing results (successful or unsuccessful)

 

For the certification process to be successful, you must have the Preliminary Inspections confirmed and the pump passed all 3 tests. The report can be printed for further records. After printing, close the test’s screen on the PC.

At the end of the ACK test, turn the pump off and disconnect the pump from power supply and communication cable. Change Occlusion pressure back to original settings.

 

After the Test

After the device passes the ACK test, verify the following:

·         The date and time are set to local date and time. Adjust as necessary.

·         The new ACK date is more than 1 year from present date. The annual certification record can be printed if required before clicking “close” on the PC window. Once the window is closed, printing is unavailable.

Disconnect the pump from the Annual Certification software and change the pump’s settings to “Factory Settings”.

From the toolbar of the Start Up screen, press Options > Technician options > Pump settings > Reset system > Factory defaults

 

Troubleshooting Certification Testing

The following sections explain how to troubleshoot common problems that may arise while performing certification testing.

 

Communication

The following issues can arise due to communication problems:

  Management  

  Problem  

 

The cable is connected and COM port is selected but the pump does not appear

There may be a delay, please wait until the pump appears.

Username and password were entered, yet the application couldn’t connect to the Q Core server. An error message appears: “Failed to connect to the server”

Check that: (1) The PC is connected to the internet (2) The firewall allows communication to outer servers. Consult your IT department regarding security instructions in your facility before changing the firewall settings. (3) If the error message keeps appearing, contact service@qcore.com or a local Hospira service center.

The following error message appears: “Connection with the pump has lost (no samples in 4 seconds)”.

(1) Verify the communication cable is properly attached to the pump and the PC. (2) Restart the certification process. If problem persists, replace communication cable

Login and Kit Entry

The following issues can arise due to login and kit entry problems:

Username was entered, and the following error message appears: “Username should contain only letters and digits”

(1) Make sure to enter the correct username you were given. (2) To retrieve the username or to acquire a new one, contact service@qcore.com or a local Hospira service center.

Password was entered, and the following error message appears: “Password should contain only letters and digits”

(1) Make sure to enter the correct password you were given. (2) To retrieve the password or to acquire a new one, contact service@qcore.com or a local Hospira service center.

Username and password were entered, and the following error message appears: “Unknown User”

(1) Make sure to enter the correct username and password you were given. (2) To retrieve the username and password or to acquire new ones, contact service@qcore.com or a local Hospira service center.

A kit number that was not approved by Q Core Server was entered, the following error message appears: “Invalid Kit Number”.

Check that: (1) The correct kit Serial number was entered. (2) The serial number matches the barcode number that is located on the kit DFU.

  Management  

  Problem  

 

Occlusion Sensor Test

The following issues can arise during the Occlusion Sensor test:

Reset of the Test

For any reason that the test needs to be restarted, you must disconnect the Extension Set first. After confirmation, the pump performs automatically priming. Repeat the test, starting from the Setup screen.

Test was not completed within 30 seconds after pressing Mark 1 on the pump. An error message appears.

Perform Reset of the Test.

Test was performed incorrectly and needs to be restarted.

On the toolbar of the pump, press Restart. Then, to confirm, press Yes. Perform Reset of the Test.

The pump does not detect rising pressure between marks. An error message appears.

Check that: (1) The administration set is not damaged (2) The Extension Set is connected correctly (3) Air was inserted If one of the conditions is not met, correct it, and then press Restart. Perform reset of the test. If the set is undamaged, and the test was performed properly, press Confirm. The program proceeds to the Air Detector test.

Management  

  Problem  

 

Air Detector Test

The following issue can arise during the Air Detector test:

Air could not be detected within 30 seconds of pressing Start. An error message appears.

If air was not inserted into the administration set, press Restart. Then, repeat the test, starting at the Test screen. If air was inserted into the administration set, press Confirm. The program proceeds to the Flow Accuracy test.

Error message appears indicating “Cannot Start Pump”

Close the test software, reopen and ensure to carry out the “Setup” sequence, as described in

Logging In above.

  Management  

  Problem  

 

Flow Accuracy Test

The following issues can arise during the Flow Accuracy test:

Test is completed too quickly. An error message appears.

Verify that: (1) The Flow Accuracy Container is in an upright position. (2) The hydrophobic filter is dry. (3) The container is full. If the conditions are not met, press Restart. Empty the Flow Accuracy Container and replace the filter. Position the Container upright, using the hanger. Then, press Start. The test begins again. If the conditions are met, press Confirm. The program proceeds to the Finish screen.

Test is not completed within the expected amount of time. An error message appears.

Verify that: (1) The administration set is connected to the Flow Accuracy Container. (2) All connections are tight. (3) There are no leaks in the Container or the cap. If the conditions are not met, correct them, and then press Restart. Empty the Flow Accuracy Container and replace the filter. Position the Container upright, using the hanger. Then, press Start. The test begins again. If the conditions are met, press Confirm. The program proceeds to the Finish screen.

Pump has stopped even though no pressure was built. The test aborted and the pump switched to prime state.

Repeat the Flow Accuracy test

  Management  

  Problem  

 

General

The following are general issues that can arise during certification testing:

The ACK software stops during the test

Re-start the ACK software and begin the test from the start.

The ACK test failed

Repeat the ACK test only if you suspect that an incorrect technique may have been used, or there was faulty test equipment (e.g. loose cap on bottle, not enough back pressure introduced etc.)

Some of the graphic information was not transferred and is missing from the pump screen (title, text, and buttons).

On the PC, activate the station that the pump is connected to. Click the “Refresh active pump” link on the Status and Links bar. The display is reloaded into the pump screen.

The certificate printing process failed; information is printed without the certificate image background.

Perform one of the following options: (1) Use the “print screen” option and copy the certificate image to a suitable application to print. (2) Provide the pump S/N and certification date to service@qcore.com and the certificate will be emailed to you.

Station appears inactive although being properly configured

Verify there are no other active PC programs that use the same configured COM port

The user double-clicked a station that has no live pump attached to it, the following error message appears: “There is no pump attached to this station. Action Canceled”

Check that: (1) The pump is connected to the matching COM port. (2) The pump is turned on or attached to a power supply

The user double clicked a station, but no user is logged in, the following error message appears: “No User Logged In. Login first, and then start the certification process”

Log into the software

An alarm was triggered in the pump that is not related for the specific stage, the following error message appears: “Critical Alarm Occurred. Check pump. Certification is aborted”

(1) Refer to Alarms and Troubleshooting in the Sapphire Service Manual and attend the alarm as instructed. (2) Restart the certification process.

Some of the graphic information was not transferred and is missing from the pump screen (title, text, buttons).

(1) If text or title is missing, they will appear on the PC screen. (2) If a button is missing, try to press its location. If only the image is missing, the function will work. If pressing on the button location doesn’t work, close the current test and restart.