NOVA BIOMEDICAL StatStrip 55848 - Page 8

StatStrip Glucose Hospital Meter
Table of Contents
toc-2
4 Docking/Charging Station 4-1
5 Linearity Test 5-1
5.1 Running a Linearity Test ..........................................5-1
6 Maintenance 6-1
6.1 Charging the Meter ..................................................6-1
6.2 Changing the Battery ...............................................6-2
6.3 Cleaning and Disinfecting the Meter ........................6-4
7 Troubleshooting 7-1
7.1 Meter Screen Alerts .................................................7-1
A Appendix A-1
A.1 StatStripGlucoseHospitalMeterSpecications .... A-1
A.2 Controls/Linearity Solutions .................................... A-2
A.3 Barcode Scanner .................................................... A-3
A.4 Normal Glucose Adult Values Non-diabetic ............ A-4
A.5 Ordering Information ............................................... A-4
A.6 Theory ..................................................................... A-5
A.6.1 Glucose ....................................................... A-5
A.7 Results of Multi-Center Clinical Study .................... A-5
A.7.1 Clinical Study Performance ......................... A-9
A.7.2 Medical Condition Analysis Summary Tables A-12
A.7.3 Parent Drug Class Summary Tables ........... A-24
A.8 Results of Multi-Center Capillary Critical Care Study: A-35
A.8.1 Prospective Clinical Study ......................... A-35
A.8.2 Real World Evidence Studies .................... A-36
A.8.3 Clinical Study Performance ....................... A-37
A.9 Wireless Meter Use .............................................. A-38
A.9.1 Newtwork Unauthorized Access Protection A-38
A.9.2 Wireless Network Connections.................. A-39
A.9.3 Radio Frequency & Radiation Exposure Info A-40
A.9.4 WiFi Radio Option Operation..................... A-42
A.9.5 Enabling/Disabling the WiFi Radio ............ A-43
A.9.6 WiFi Usage Considerations ....................... A-45
A.9.7 WiFi Technical Considerations .................. A-46
A.9.8 WiFi Function and Performance ................ A-47
A.9.9 Meter Wi-Fi Settings, Range, Options ....... A-49
A.10 Warranty ............................................................... A-53
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 8 9/13/18 8:29 AM