Bill of Health – HELP

1 Sapphire Bill of Health Overview

Bill of Health is a software tool that provides an effective test for basic functionalities (listed in section 1.2 below) of the family of Sapphire infusion pumps. The Bill of Health process includes a sequence of pump functionality checks that should be performed as part of the pump’s service process and generally when indication of pump basic functionality is needed.

The Bill of Health (BOH) is a tool to determine that the pump mechanism, hardware components, and software function correctly. It will provide the user with documentation about the pump basic functionality status at that time.

The Bill of Health is intended to be used by trained technicians. It provides the technicians with step-by-step instructions on how to perform the BOH.      

1.1 References

• Access to Eitan Medical’s FTP (File Transfer Protocol) Website 10050-049-0001-SRV
• Group Training Record, ADMN-4007

1.2 Personnel Training

        Personnel performing this procedure for the first time will be trained as follows:

• Review of procedure
• Implementation of procedure
• The training will be documented on the Group Training Form located in the FTP site. Training forms must be submitted to Eitan Medical otherwise access to the FTP site will be denied.
• Fill out the Group Training Form, scan and email to service@eitanmedical.com.
• Hospira employee trained on this procedure will be documented on Group Training Record, ADMN-4007 located in the FTP site.  Follow good documentation practices.  Distributor may use ISO Train to document training if available.
• For more information see “Access to Eitan Medical’s FTP (File Transfer Protocol) Website 10050-049-0001-SRV”.

The Bill of Health software serves as part of the service process, and provides a short checkup for basic functionalities of the Sapphire infusion pump.

The following provides an explanation (rationale) as to why a pump which has passed the Bill of Health tests is considered as “healthy” and can remain in service:

• Air detector test
  • Verifies the functionality of the air sensor
• Occlusion sensor reading with and without an administration cassette
  • Verifies the functionality of the force sensor
• The Alarm System test simulates a treatment at various rates and delivery modes.
  • Verifies no alarms are initiated during a simulated treatment.
• Battery function test
  • Verifies the pump can run on battery power
• Charging test
  • Verifies the pump can be charged using a Eitan Medical Mini cradle attached to a power supply

Important Note:  The Bill of Health tool is not intended to provide certification for pump accuracy, or replace the pump annual certification.

Note: Other than performance, the tests described above cover all sensors, hardware and software components, and possible mechanism malfunctions. These tests are identical in nature to those that are applied during final testing procedures, as part of the production process.

1.3 The Bill of Health Testing Process

The Bill of health process is made up of the following set of tests:

• Air Detector
• Occlusion Sensor
• Alarm System
• Occlusion Sensor (With Cassette)
• Battery Function
• Charging

The application allows you to test 1-8 pumps simultaneously, using a USB to 4-port serial RS232 adapter.

2 Bill of Health Software

Eitan Medical’s Bill of Health Software enables testing of pumps while communicating with the Eitan Medical server. Instructions are provided on PC screen, and results are presented immediately following the testing process.

The following topics are covered:

2.1 Requirements

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

• Operating System: Windows 7, Windows XP
• Screen Resolution: 1024:768 (minimum)
• Memory: 4 GB
• Internet Access

2.2 Acquiring the Software

The Sapphire Bill of Health SW can be obtained from the Eitan Medical FTP site (https://eitanmedical.smartfile.com/). For information regarding the FTP site, see FTP Protocol 10050-049-0001-SRV. Please note that only Authorized Technicians registered with the company will be cleared to receive the software.

2.3 Logging In

The user is requested to insert the username and password provided by Eitan Medical. Contact Eitan Medical for password or username if forgotten.

Figure 1 – Login Screen

2.4 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 an active station on the left pane of the screen (See stations Figure 4). To configure additional COM ports to your PC, use the USB to 4-port serial RS232 adapter.

• COM port configuration

1. Open the Bill of Health program; log into the program.
2. Choose the Setup link at the upper right corner. The following window appears:

Figure 2 – Stations dialog box

3. Choose a free COM (one or more) for each station needed.
4. Confirm selection by pressing the OK button

• To use the Eitan Medical 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). Ensure correct driver installation is applied to

           computer configuration prior to running BOH.

2.5 The Bill of Health Screen

This section provides an overview of the structure and features of the Bill of Health screen.

Figure 3 – Getting Started Screen

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

The Station pane, at the left side of each page, provides information about the testing status of each Station. For details, refer to Working with the Station Pane on page 8.

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

2.6 Working with the Station Pane

After the pumps are connected to the computer and turned on (Performing the Bill of Health Test on page 10), 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 3) are disabled.

The Station pane provides a snapshot of the status of each pump throughout the testing process. Each Station has three 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 stripes colored with the color code on the computer screen.

Figure 4 – Station panel

The three stages of testing (listed 1-3 on the pane) are:

• Getting Started
• Running Test  
• Results

3 Performing the Bill of Health Tests

The following sections explain how to perform the Bill of Health tests using Eitan Medical’s software application:

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

WARNING: Pump alarms are turned off for the Bill of Health process.

Abrupt termination of the process (such as miscommunication, power shutdown etc.)

can lead to a case in which the pump remains in such hazardous state.

Make sure to enable all alarms before returning pump to use

(See troubleshooting section 4.1)

3.1 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 testing:

• An infusion bag that is filled with at least 200 ml fluid
• Eitan Medical macrobore infusion set AP404 or AP206. Do not use sets with drip-chambers or back check valves of any kind.
• Eian Medical Mini Cradle with splitter
• RS232 communication cable between pump and computer

NOTE: It is important to perform each test with the administration set completely primed, with no air bubbles. Performing testing with the set not fully primed will lead to test failure.

3.2 Performing the Bill of Health Test

Starting the testing process involves attaching the pump(s) to the computer and setting up the delivery system.

Note: The Bill of Health software uses Continuous delivery mode for the tests, even if this mode is not configured on the Sapphire pump. When the tests are finished, make sure that the pump is at allowed delivery mode.

• To begin the testing process:
  • Log into the Eitan Medical Bill of Health Software (See Logging In on page 5).
  • Mount each pump onto a mini-cradle device with splitter
  • Connect each pump to power supply via the mini-cradle splitter
  • Using the RS232 connector cable, connect each pump to the computer, and turn the pump(s) on.
  • Select a station by double clicking on its slot on the Navigation Pane. The Getting Started page (See Figure 3) appears, with relevant info of the pump displayed.
• To Start Bill of Health test:
  • Setup the administration set and reservoir containers so that each administration set output is put back inside the reservoir, creating a loop for each station.
  • Do not insert the administration cassette yet.
  • Verify pump door is closed.
  • Verify all clamps are open and there are no occlusions.
  • Verify there is no air in line. If air is visible, prime the set.
  • Mount the pump on the mini-cradle and verify power supply is connected
  • After all above steps are verified, mark the checkbox on the screen as checked and click Start. A message reminding to verify that the administration cassette is removed and the power supply is connected will appear (see figure 5). Verify and click OK.

Figure 5 – System setup after attaching cassette

• Later in the tests, when the message appears, attach the administration cassette to the pump and close the pump’spump door. Verify again the system is setup correctly (See Figure 6) and click OK.

Figure 6 – System setup after attaching cassette

3.3 Viewing Results

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

• Document number
• Pump serial number
• Username
• Test date
• Testing results (Passed or Failed)

For the process to Pass, all tests must pass successfully. The report can be printed for further records.

Note: At the end of the Bill of Health test, turn the pump off and disconnect the pump from power supply and communication cable.

4 Troubleshooting

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

4.1 Communication

The following issues can arise due to communication problems:

4.2 Login

The following issues can arise due to login problems:

4.3 General

The following are general issues that can arise during testing: