Pump Cleanup Tool Work Instructions

1. General

The Pump Cleanup Tool is used for deleting the Sapphire pump’s Drug Library, Preset Programs and Event Log. Additionally, it can be used for resetting the pump to the factory defaults.  

2. Scope

This document describes the work instructions for using the Pump Cleanup Tool.

3. Terms and Abbreviations

CCA  Clinical Care Area

FTP   File Transfer Protocol

PC     Personal Computer

ACK   Annual Certification Kit

COM  Communication

SW    Software

4. Applicable Documents

4.1  Group Training Record, ADMN- 4007

4.2  Access to Eitan Medical’s FTP Website, 10050-049-0001-SRV

5. Authority and Responsibilities

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

• Review of the procedure
• Implementation of the procedure
• The training will be documented in the Group Training Record form, ADMN-4007, located in the FTP site. The training records must be submitted to Eitan Medical. Fill in the form, scan it and send it to service@eitanmedical.com. Otherwise access to the FTP site will be denied.
• Distributor may use ISO training records as an equivalent mean of documenting the training. 

6. Required equipment

PC requirements:

• Operating system: Windows 7 / Windows XP
• .NET framework 4.0
• Screen resolution: 1024:768 (minimum), 96 dpi
• Memory: 4 GB
• Internet access

 Additional equipment:

• RS232 communication cable
• Optional- USB to 4 port serial RS232 adapter (P/N 15077-000-0001) (to perform the procedure on 4 pumps simultaneously)

7. Obtaining the SW

The Pump Cleanup Tool SW can be obtained from Eitan Medical’s FTP site (https://eitamedical.smartfile.com). For more information regarding the FTP site see document: Access to Eitan Medical’s FTP Website (see Ref. 4.2). Only authorized technicians registered with the company will be cleared to receive the SW.

Download the SW from the FTP site. Run the installation file by double clicking it. Press Next to start the installation. A shortcut to the installed SW will be automatically created on the PC’s desktop. 

8. Annual certification confirmation

In case you wish to use the Pump Cleanup Tool SW for deleting the pump event log, it is required to confirm the pump annual certification status by performing an Annual Certification Test (ACT) prior to initiating the Pump Cleanup Tool Software. The test is performed by using an annual certification kit (ACK 15075-020-0001, sold separately)

Warning: Performing the cleanup process without confirming the

annual certification status may result in loss of data from the pump’s

event log.

9. Getting started

9.1 Open the Pump Cleanup Tool SW.

9.2 Turn the pump on and connect it to the computer, using the RS232 communication cable. To enable additional COM ports use Eitan Medical’s USB to 4 port serial RS232 adapter. This adapter provides 4 external COM ports to the PC. Ensure correct driver installation prior to using the adapter.

9.3 Insert the username and password provided by Eitan Medical.

9.4 Select the Setup link at the upper right corner. Select a free COM for the required station and press OK.

9.5 Each station in the navigation pane corresponds to a pump. Stations that have no pump connected to them are disabled. Stations that have a pump connected to them appear with the icon “Connected” besides them (See figure 1).

Figure 1: Navigation Pane + Welcome screen

9.6 The navigation pane provides a snapshot of the status of each pump throughout the Cleanup process. Each station has 3 numbered circles, corresponding to the stages of the process. The highlighted circle 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.

10. The Cleanup process

10.1 Select a connected station by double clicking on its slot in the navigation pane. Pay attention that the “Connected” icon is not shown when the station is in process (see figure 2)

10.2 Select the items you would like to clean from the pump.

Warning: Do not abort the process or disconnect the pump while the Pump Cleanup Tool is working.

Warning: The Cleanup process is irreversible. Deleted items cannot be recovered.

The basic options are (See figure 2):

• Clean all- Remove the Drug Library and the Preset Programs from the pump
• Drug Library- Remove all CCA settings and drug profiles (included in the “Clean all” option)
• Preset programs- remove all Preset Programs from all delivery modes (included in the “Clean all” option)
• Reset pump- Reset the pump to factory defaults

Figure 2: Select Items              

10.3 In order to see the advanced options click on the small arrow at the right side of the screen (see figure 2). The advanced options enable cleaning the pump’s event log by selecting the “Clean Event Log” option on screen.

Warning: Deleting all events significantly hinders optimal pump service

10.4 In order to send the Event Log to Eian Medical prior to deleting it, check the box at the bottom of the screen (see figure 2) (this option is chosen by default). Sending the Event Log to Eitan Medical may take up to 10 minutes. After selecting the required items press Next.

10.5 After pressing Next, the Cleanup process will start. The actions performed will appear one after another on screen with the corresponding status bar. If the action was executed successfully the status will be marked as “Completed”. If the action failed the status will be marked as “Failed”. In this case refer to section 11 of this document – Troubleshooting. 

10.6 After completing the Cleanup process, the results will be displayed on screen. There are two possible results:

• Process Completed Successfully
• Unable to complete process

11. Troubleshooting

This section explains how to solve common problems that may arise while using the Pump Cleanup Tool.  

11.1 Communication issues:

11.2 Login issues:

11.3 General issues: