SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 1of 18 UMW02 ASSEMBLY & TEST SPECIFICATION 910-00059-01 Copyright © 2003-2004 FitSense Technology Proprietary Information Revision History DATE VERSION DESCRIPTION 05/21/08 01 Initial release of document 05/22/08 02 Added details to Functional Verification process 06/09/08 03 Added FCC labeling details 06/24/08 04 Updated rework instructions to reflect UWM in location of best performance 7/16/
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 Table of Contents 1 INTRODUCTION.............................................................3 2 INCOMING INSPECTION................................................4 3 INCOMING TEST............................................................4 4 BP MONITOR REWORK INSTRUCTIONS...................10 5 FUNCTIONAL TEST.....................................................11 6 PACKAGING.............
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY 1 1.1 DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 3of 18 INTRODUCTION Purpose of this document The purpose of this document is to specify the assembly and functional test requirements for the A & D Medical Digital Blood Pressure Monitor with the Universal Wireless Module (UWM). This device complies with Part 15 of the FCC Rules.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 4of 18 A ID Number label along with the FCC label is to be adhered to the blood pressure monitor as described in the BP Monitor Rework Instructions. The second ID Number label can be used on the product carton, packaging or as the manufacturer deems appropriate. The bar coded serial number label contains alpha and numerical characters.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 5of 18 A known good ActiLink must be installed in the USB port of the test PC prior to starting the application. If no ActiLink is present, or the ActiLink is not functioning properly, an error message “Check Link Connection, Program will close” will be displayed and the program will exit when the operator clicks on the “OK” tab as shown below.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY ● DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 6of 18 Blood pressure test_Pulse - Disabled with a No in the Ena column. Once the test limits have been correctly set as described above for Incoming Test of the UWM PCB, select the “OK” tab. This will save the Test Configuration limit settings, which will now be utilized each time the test application is started.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 7of 18 The ActiLink label should be facing opposite the direction of the UWM PCB under test, as shown in the photograph below. The Incoming Test fixture containing the UWM PCB under test should be placed at a distance of 100 feet (30.5 meters) at one end of a non-metallic table top, at a height of 36 inches (0.914 meters) off the floor, with the tip of the antenna facing the ActiLink.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 8of 18 All wireless devices should be removed from the test area, and the PC or laptop wireless capability should be turned off or disabled. No obstacles should be between the ActiLink and the UWM PCB under test. 3.4 UWM Incoming Test Process The following test process can be used to verify the UWM PCB functionality prior to being reworked into Digital Blood Pressure Monitor.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 9of 18 If the ID Number of a UWM PCB other than that to be tested appears in the upper right of the test screen, selecting the [NO] tab will enable a filter preventing the application from detecting the unwanted sensor. This allows the operator to filter out all other UWM PCBs other than the specific UWM to be tested.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 10of 18 3.4.4 Once all 4 sub-test have completed, a status message of PASS ALL Tests or FAIL, and the ID Number of the UWM PCB that was tested will be displayed across the top of the test screen as shown below for ID Number FJHN-00256-00038. 3.4.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 11of 18 4.3 Assemble BP monitor per manufacturing assembly process. 4.4 Clean the location for the ID Number and FCC label with 90% Isopropyl Alcohol and allow to dry. Place labels per the manufacturing assembly process. 4.5 Test the functionality of the BP monitor per Section 5 of this document. 5 5.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 12of 18 The System Test portion of the ActiBPMfgTest Manufacturing Test application should be used for Incoming Test of the wireless BP monitor. When the application is started, Select the tab for System Test. The application (ActiBPMfgTest.exe) is installed in the C:\Program Files\ActiBP Manufacturing Test. The application can be setup as a shortcut on the desktop.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 13of 18 ● Blood pressure test_Diastolic - Min and Max values should be set to plus/minus 10 percent of the Dastolic value being used by manufacturing to test the BP Monitor. At the time this document was created, the value of 80 was used.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 14of 18 displayed across the top of the test screen, as shown below for ID Number FJHC00256-00030. All results, pass or fail, are captured in a log file located in C:\Program Files\ActiBP Manufacturing Test folder. The log file will also contain information regarding the Mfg. Plant and test Station Number.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 15of 18 The BP monitor under test should be placed at a distance of 100 feet (30.5 meters) at one end of a non-metallic table top, at a height of 36 (0.914 meters) inches off the floor, and with the front of the BP monitor facing the ActiLink. Refer to the photograph below.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY 5.4 DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 16of 18 Functional Test Process Two (2) operators are required to Functionally Test the BP monitor at a distance of 100 ft (30.50 meters). The first operator will control the test application on the laptop or PC. The second operator will operate the BP monitor. With an ActiLink installed in the PCs USB port, start the ActiBPMfgTest.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 17of 18 If the ID Number of any BP monitor other than that to be tested is displayed by the application, the operator selects the [NO] tab for each device detected until the UUT is detected. The [NO] tab will place the ID Number in a reject list, and the rejected device will not be displayed again by the application until the operator selects “Sensors”, then selects “Clear Rejected List”. 5.4.
SUBJECT: A&D MEDICAL DIGITAL BLOOD PRESSURE MONITOR ASSEMBLY 5.4.4 6 DOCUMENT NUMBER: 910-00059-01 REVISION: 08 PAGE: 18of 18 Once all 7 sub-test have completed, a status message of PASS ALL Tests or FAIL, and the ID Number of the BP monitor tested will be displayed across the top of the test screen as shown below. PACKAGING Packaging of the A&D Medical Wireless Digital Blood Pressure Monitor is TBD.
