FasTest PM Test

Table of Contents

• FasTest PM Overview
• Getting Started: Preliminary Inspections
• FasTest PM Kit
• FasTest PM Software
• Performing the FasTest PM Tests
• Troubleshooting FasTest PM Testing

FasTest PM Test

1. FasTest PM Overview

The FasTest PM (Preventive Maintenance) process includes a sequence of maintenance checks that need to be performed annually on the Sapphire infusion pump. The FasTest PM procedures are briefly described in the following table:

Each station in the navigation pane corresponds to a pump.

• Stations that are not configured are disabled and appear in gray.
• Stations that are configured but have no pump connected to them appear in blue.
• Stations that are configured and have a pump connected to them appear in blue with the icon “Connected” next to them.

FasTest PM Calibration Verification Process

The heart of the FasTest PM process is the calibration verification, which is made up of the following set of tests:

• Air Detector
• Flow Accuracy
• Occlusion Sensor

To facilitate the testing process, Eitan Medical has developed a special testing special testing application. The software application provides step-by-step testing instructions with a summarized version of the same instructions displayed on the pump itself. The application allows you to simultaneously test up to eight pumps, using a USB to 4-port serial RS232 adapter, which can be purchased separately from Eitan Medical.

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

The tools provided in FasTest PM Kit can be used for 30 pumps, and only one pump at a time.

FasTest PM Kit

The FasTest PM Kit is a pre-packaged kit provided by Eitan Medical that contains all the special equipment necessary for performing certification testing. One kit can be used for testing up to 30 pumps. The FasTest PM Kit is designed to be used in conjunction with Eitan Medical’s FasTest PM Software. Testing with the software application is initiated by scanning the barcode of the Kit (found on the Directions for Use).

FasTest PM Software

Eitan Medical’s FasTest PM Software streamlines the FasTest PM process by enabling you to test the pump while communicating with the Eitan Medical 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 10 or Windows 11
• .NET Framework 4.0
• FasTest PM setup file: an “.msi” or “.exe” file
• 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 443 to host name: alphaapplicationserver.eitanmedical.com or *.eitanmedical.com for communicating with Eitan Medical server and is not restricted by firewall or proxy.

The Testing Screen

This section provides an overview of the structure and features of the FasTest PM Software screen.

> To connect via serial:

1. Open the FasTest PM program; log into the program.
2. Choose the Setup link at the upper right corner.
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.

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 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.

Performing the FasTest PM Tests

The following sections explain how to perform the required FasTest PM tests using Eitan Medical’s software application.

The FasTest PM 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 FasTest PM testing:

• Eitan Medical FasTest PM Kit(s).
• At least 100 mL water for each kit (the infusion bag is supplied with the kit).
• RS232 COM ports, or Serial on USB (optional).
• Motorola LS2008 barcode reader (optional); you may use the barcode key manually instead.
• Communication cable between pump and computer.

Before beginning the tests, make sure that the FasTest PM Kits contain all the original parts supplied by Eitan Medical

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.

• 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.
• The required distance between the center of the pump and the bottom of water level in the bag is 50 cm above the pump

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 FasTest PM test.

1. Set pump authorization level to High.
2. From the Optionsmenu, select Pump configuration > General settings. Select Authorization level. Then, using the keypad, enter the High level password > OK

> To perform the Kit Selection:

1. Using the barcode reader (or the keyboard), enter the barcode number of the FasTest Kit
2. Click Check. The Eitan Medical server checks the validity of the kit.

The kit is limited to 30 uses. Save the DFU for further eligible uses of the kit.

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 Eitan Medical.

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.

> To perform the Visual Inspection: 

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. 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.

1. Prepare the infusion bag and the administration set:
   • Fill the bag with at least 100 mL of tap water, and attach the administration set to the bag.
   • Adjust the bag height, so that the water level in the bag is 50 cm above the pump.
   • Attach the administration set to the pump and close the safety door.
2. If required, press Prime. If not required, press Next. Wait for the pump and software to synchronize.
3. Press Next to proceed to the Air Detector & Accuracy test.

Performing the Air Detector & Accuracy Process

This test involves introducing a pre-specified amount of air into the

administration set.

The application checks if the pump detected air in the system, and whether

the measured infused volume is correct (checks it versus the expected

volume).

> To perform the Air Detector & Accuracy test:

1. Continuing from the previous stage, without disconnecting the syringe, pull the plunger back all the way to the 1.5 mL stopper; then, slowly for at least two seconds, push in all the way to the Y-connector.
2. This inserts 1.5 mL of air into the administration set, via the Y-connector; then, on the pump, press Start. The pump starts delivering the water. When the stage is completed, the pump stops.
3. To proceed to the next test (Occlusion Sensor), on the pump, press Next.

Performing the Occlusion Sensor Test

This test involves delivering a known volume of fluid; then, creating pressure

in the system – caused by introducing a specific amount of air into the

administration set against a closed clamp.

> To perform the Occlusion Sensor test:

1. Set the administration clamp to CLOSED (clamp the administration set).
2. On the pump, press Start.
3. When the test is completed, set the administration clamp to OPEN (unclamp the administration set); then, on the pump, press Next.
4. On the pump, press Next.

Viewing Results

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

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

• The field Device SW version displays the pump software version.
• The Occlusion sensor test and Accuracy test results are displayed on scales.
• Pump serial number
• Kit serial number

Troubleshooting FasTest PM Testing

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