Directions for Use
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CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
BodyComm™ V3.3 Directions For Use
DFUBODYCOMM3.3 Rev. 00
CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
Caesarea Medical Electronics Ltd. 16 Shacham Street Industrial Park Caesarea North P.O.BOX 3009 Caesarea 3088900, Israel
BD.com BD, the BD Logo, BodyComm, BodyGuard and T34 are trademarks of Becton, Dickinson and Company or its affiliates. All other trademarks are property of their respective owners. © 2021 BD. All rights reserved.
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DFUBODYCOMM3.3 Rev. 00
BD BodyComm™ V3.3 Directions For Use - Rev. 00
CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
Table of Contents 1. General Information 1.1. Overview 1.2. Applicable Products 1.3. Required Equipment 1.4. Minimum Hardware Requirements 1.5. Minimum Software Requirements 1.6. Application 1.7. Terms Used In Manual 1.8. Document History 2. BD BodyComm™ Installation and Configuration 2.1. Connect Pump to BD BodyComm™ 3. Home Page / Current State Screen 4. Pump Settings 4.1. View/Print Settings 4.2. Adjust Settings 4.3. Update Date 4.3.1. BD BodyGuard™ T Syringe Pumps 4.4. Adjust Technician Setting 4.4.1. BD BodyGuard™, BD BodyGuard™ Epidural and BD BodyGuard™ Pain Manager Pumps 4.4.2. BD BodyGuard™ T Syringe Pump 4.5. Syringe Data 4.6. Record Macro 4.7. Load Macro 4.8. Play Macro 4.9. Error Message on Exit 4.10. Global Macro 5. View Events 5.1. Save Events to Export Files 5.2. Print Graphs 5.3. Save Graphs to PDF File 5.4. Print All Events 5.5. Print Events Between Specific Dates 5.6. Print From Specific Event 5.7. Error Message on Exit 5.8. Confirmation Message to Load Events 6. Protocol 6.1. Upload Drug Library 6.2. Update Protocol 6.2.1. Record Macro 6.2.2. Load Macro 6.2.3. Play Macro 6.2.4. Enter Protocol Code to Change Pre-set Protocol Data 6.2.5. Print Protocol Data 7. Actual State and Current State Screens 7.1. Actual State BD BodyComm™ V3.3 Directions For Use - Rev. 00
DFUBODYCOMM3.3 Rev. 00
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7.2. Current State 8. MacroCreator 8.1. Overview 8.2. Applicable Products 8.3. Create Drug Library 8.4. Create Drug Protocol 8.4.1. Pump Settings 8.4.2. Protocol Data 8.5. MacroCreator Commands 8.5.1. Back Button 8.5.2. Cancel Last Changes button 8.5.3. Delete Drug button 8.5.4. Ok and Next and Add Drug buttons 8.5.5. Next Drug button 8.5.6. Previous Drug button 8.5.7. Open Macro in progress 8.5.8. Open button (On Create/Open Macro screen) 8.5.9. Print Macro Data button (on Create/Open Macro screen) 8.5.10. Print Macro by Departments button (on Create/Open Macro screen) 8.6. Clinician Approval 8.7. Save Macro 9. Software Update Configuration 9.1. Procedure 10. Troubleshoot 10.1. Connecting BD BodyGuard™ Infusion Pump to BD BodyComm™ 10.1.1. Procedure 10.2. Connecting BD BodyGuard™ T Pump to BD BodyComm™ 10.2.1. Procedure 10.3. Printer Configuration 10.3.1. Procedure for Windows 7 environment 10.3.2. Procedure for Windows 10 environment 10.4. Connection Configuration 10.5. Troubleshooting 10.6. BD BodyComm™ Uninstallation Procedure 10.6.1. Procedure 11. Access Codes
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BD BodyComm™ V3.3 Directions For Use - Rev. 00
CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
1. General Information 1.1. Overview BD BodyComm™ is a software utility tool. It permits qualified and trained personnel only to configure BD BodyGuard™ infusion and syringe pumps and upload the clinician-approved protocols to supported pumps. Previous infusion records may be viewed as part of the device history. The BD BodyComm™ installation includes an automatic installation of the MacroCreator application used to create drug library and drug protocol files offline. MacroCreator is a desktop-based PC application. It helps technicians to create, save, print, and approve protocol drug library - files with clinician off-line, and upload drug library and drug protocol files to pumps via BD BodyComm™ application. Once the Drug Library or pump settings and protocols are defined, clinician needs to sign off the protocol with the Clinician Code (refer to section 11. Access Codes on page 70) to be able to save it.
1.2. Applicable Products NOTE: CME pumps in this document are referred to as their BD rebranded names throughout. . See comparison table below.
Comparison Table: CME
BD Rebranded Name
BodyGuard™ 323 ColorVision
BD BodyGuard™
BodyGuard™ 545 ColorVision
BD BodyGuard™ Epidural
BodyGuard™ 595 ColorVision
BD BodyGuard™ Pain Manager
N/A
BD BodyGuard™ Duo
T34™
BD BodyGuard™ T
Software Versions: BD BodyGuard™ BGCV_CFN_24** (CME pumps), BGCV_CFN_25** (BD branded). BD BodyGuard™ Epidural BGCV545_060** (CME pumps), BGCV545_061** (BD branded). BD BodyGuard™ Pain Manager BGCV595_060** (CME pumps), BGCV595_061** (BD branded). BD BodyGuard™ Duo TWINCV_TPN_030*** (BD branded). TWINCV_TPN_031***(BD branded). BD BodyGuard™ T T34**3.07* (CME pumps), T3.2A-** (BD branded, including CME branded pumps with updated software)
1.3. Required Equipment BD BodyGuard™ Volumetric Pumps: l l
l l
PC with an USB port BD BodyGuard™ Charger with RS232 Communication port (PCG00020 for single channel, PCG00011TCV for Dual channels) USB-Serial Cable (197-100X) BD BodyGuard™ Duo: USB-Serial Cable 197-100X + Adapter Cable CAB00013
BD BodyComm™ V3.3 Directions For Use - Rev. 00
DFUBODYCOMM3.3 Rev. 00
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CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
BD BodyGuard™ T Syringe Pump: l l l l
PC with a USB port BD BodyComm™ T34™ Communication Station (150-312S) USB-Serial Cable (197-100X) 9v Alkaline battery
1.4. Minimum Hardware Requirements l l l
Minimum processor and memory configuration as specified by the OS USB port Printer (optional)
1.5. Minimum Software Requirements l l
Windows 7 and Windows 10 PDF reader (Optional)
1.6. Application l l
BD BodyComm™ software works with Microsoft Windows 7 and Windows 10 Operating system. No network is required to operate BD BodyComm™ software.
1.7. Terms Used In Manual NOTE: Indicates that the information that follows is additional important information that helps to operate BD BodyComm™.
1.8. Document History Revision
Date
Software Version
Description
00
June 2021
3.3
First release. Changes from previous software version 3.2: • Added support for BD Bodyguard™ Duo software version TWINCV_TPN_031*** • Clarification on required equipment and general instructions throughout the document • Extra instruction that vigilance is required to ensure the complete transfer of Macro
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DFUBODYCOMM3.3 Rev. 00
BD BodyComm™ V3.3 Directions For Use - Rev. 00
CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
2. BD BodyComm™ Installation and Configuration Follow the below steps to install and configure BD BodyComm™. Warning: These products interact with medical device systems, so the protection of these products from outside altercation or access falls to the security of the desktop where these applications are loaded. It is recommended that customers implement desktop policies that will lock down access to the directories where this software is loaded, and the use of antivirus and antimalware products to ensure those system are protected from viruses. And for networked systems, network login authentication should be implemented so event logging on the device can be traced back to the audit logs of the desktop, which can be used to troubleshoot access to these applications and provide some security to protecting the integrity of these systems. BD BodyComm™ installer shall install MsComm, which is a pre-requisite, the latest BD BodyComm™ and MacroCreator application in the local drive. Uninstall existing BD BodyComm™ application, when installing a new version. Logs and Macro files shall be retained for reference even after the uninstallation of the BD BodyComm™ application. 1. By clicking the “BD BodyComm v3.3.exe” installer file shall display the License agreement of BD to the user to inform about the terms and conditions to agree.
2. The user must read the terms and conditions, check the I agree to the terms and conditions box, and then click the Install button to install the BD BodyComm™ application.
BD BodyComm™ V3.3 Directions For Use - Rev. 00
DFUBODYCOMM3.3 Rev. 00
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CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
3. Click OK to start the MsComm installation.
4. To begin the installation, click the 5. Click Continue.
button.
NOTE: The MsComm component MSCOMM32.OCX is placed under C:Windows on the local drive.
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DFUBODYCOMM3.3 Rev. 00
BD BodyComm™ V3.3 Directions For Use - Rev. 00
CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
6. Click OK to confirm.
7. Once the BD BodyComm™ and MacroCreator application has been placed in the local drive the installation shall be completed. Confirm that the MSCOMM32.OCX component is placed under the C:Windows folder.
8. On opening the C: drive user shall be able to see the BD BodyComm™ v3.3 folder created with BD BodyComm™ and MacroCreator application in it.
BD BodyComm™ V3.3 Directions For Use - Rev. 00
DFUBODYCOMM3.3 Rev. 00
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CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
9. Shortcuts are created and placed in desktop for easy access.
10. Shortcuts are created under Program Menu under BD BodyComm™ v3.3 folder for user access.
2.1. Connect Pump to BD BodyComm™ Applicable models: BD BodyGuard™, BD BodyGuard™ Epidural, BD BodyGuard™ Pain Manager, BD BodyGuard™ Duo infusion pumps, and BD BodyGuard™ T Syringe Pump. Connect the pump with RS232 port. Switch on the pump and start the BD BodyComm™ application. . The below screens are visible. Follow the on-screen prompts to see Pump Current State Screen. If not, restart the pump and ensure correct configuration/settings. 1. Double click the BD BodyComm™ application icon, the below screen appears with the message BD BodyComm™ Waiting for Connection.
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DFUBODYCOMM3.3 Rev. 00
BD BodyComm™ V3.3 Directions For Use - Rev. 00
CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
NOTE: If there is a problem with the connection to BD BodyComm™ while AC Power is ON, unplug the pump from the power supply and connect again. 2. When connected, Pump ON-LINE screen appears. Pump ON- LINE screen is displayed based on the model of the connected pump as shown below.
BD BodyComm™ V3.3 Directions For Use - Rev. 00
DFUBODYCOMM3.3 Rev. 00
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CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
3. The below screen appears with a message for detected COM Port. Click Ok and restart the pump.
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DFUBODYCOMM3.3 Rev. 00
BD BodyComm™ V3.3 Directions For Use - Rev. 00
CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
4. After restart, Pump Current State screens appear on the screen. Please find example screenshots in the below points. 5. The below screen appears when BD BodyGuard™ Infusion Pump is connected. Appropriate screen is shown when BD BodyGuard™ Epidural and BD BodyGuard™ Pain Manager infusion pumps are connected.
6. The below screen appears when BD BodyGuard™ T Syringe pump is connected.
BD BodyComm™ V3.3 Directions For Use - Rev. 00
DFUBODYCOMM3.3 Rev. 00
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CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
3. Home Page / Current State Screen Applicable models: BD BodyGuard™, BD BodyGuard™ Epidural, BD BodyGuard™ Pain Manager, BD BodyGuard™ Duo infusion pumps, and BD BodyGuard™ T Syringe Pump. 1. Insert the pump into a charger with RS232 port and switch on the pump. If configured with appropriate settings, Pump Current State screen appears on the screen. If not, restart the pump with the factory default settings. 2. When BD BodyComm™ is connected to the BD BodyGuard™ Infusion Pump, the following command options are available. l View/Adjust Settings l View Events l Protocol l Exit l Software Update (If s19 and .Cor files are available in installer path)
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DFUBODYCOMM3.3 Rev. 00
BD BodyComm™ V3.3 Directions For Use - Rev. 00
CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
3. When BD BodyComm™ is connected to the BodyGuard™ Epidural or BD BodyGuard™ Pain Manager infusion pumps, the following command options are available. l View/Adjust Settings l View Events l Upload Protocol l Exit l Software Update (If s19 and .Cor files are available in installer path)
BD BodyComm™ V3.3 Directions For Use - Rev. 00
DFUBODYCOMM3.3 Rev. 00
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CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
4. BD BodyComm™ has below command options when connected to BD BodyGuard™ Duo Infusion Pump, click on the required command listed below. l Pump Setting l Upload Protocol l Event Log l Print Pump Settings l Software Update (If s19 and .Cor files are available in installer path)
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DFUBODYCOMM3.3 Rev. 00
BD BodyComm™ V3.3 Directions For Use - Rev. 00
CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
5. BD BodyComm™ has seven command options when connected to BD BodyGuard™ T Syringe Pump, click on the required command listed below. l Syringe Data l Technician l Global Macro l Event Log l Pump Settings l Print Pump Settings l Actual State
NOTE: This screen shows the pump serial number and software options. The picture shows which model of pump is connected.
BD BodyComm™ V3.3 Directions For Use - Rev. 00
DFUBODYCOMM3.3 Rev. 00
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4. Pump Settings 4.1. View/Print Settings BD BodyComm™ allows the user to view and print settings for the below pumps. Applicable models: BD BodyGuard™ Epidural, BD BodyGuard™Pain Manager, BD BodyGuard™ Duo infusion pumps, BD BodyGuard™ T Syringe Pump, and BD BodyGuard™ Pump. 1. Click View/Adjust Settings button, this option shows all settings stored in the pump including calibration settings.
2. There are three further options. a. Back returns to the previous page. b. Print Pump Setting prints all the displayed settings. c. In BD BodyGuard™ T Syringe Pump, Print Pump Settings button is available in the landing screen, which is used to print all the settings related to the BD BodyGuard™ T Syringe Pump.
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DFUBODYCOMM3.3 Rev. 00
BD BodyComm™ V3.3 Directions For Use - Rev. 00
CONFIDENTIAL AND PROPRIETARY – NOT TO BE DISTRIBUTED WITHOUT BD’s PRIOR WRITTEN CONSENT
3. Refer to the below View/Adjust Settings screens.
BD BodyGuard™ Infusion Pump
BD BodyGuard™ Epidural and BD BodyGuard™ Pain Manager Infusion Pumps
BD BodyComm™ V3.3 Directions For Use - Rev. 00
DFUBODYCOMM3.3 Rev. 00
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BD BodyGuard™ Duo Infusion Pump
NOTE: Settings cannot be changed on the BD BodyGuard™ Duo Infusion Pump.
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DFUBODYCOMM3.3 Rev. 00
BD BodyComm™ V3.3 Directions For Use - Rev. 00