A-1
Appendix A
Instructions for Use Manual Appendix A
A Appendix
AppendixAincludesanalyzerspecications,solutionsand
reagents, consumable lists, reference information, and war-
ranty for the StatStrip Glucose Hospital Meter.
A.1 StatStrip Glucose Hospital Meter Specifications
Measurement Range: Glu 10-600 mg/dL or 0.6-33.3 mmol/L
Acceptable Samples: •Capillarywholeblood(ngerstick),
Venous whole blood, arterial whole
blood, neonatal heel stick, and
neonatal arterial whole bloodsam-
ples throughout all hospital and all
professional healthcare settings,
including critical care settings
• Sample size 1.2 µL
Measuring Technology:
Enzyme, Amperometric Glucose Enzyme
(Aspergillus sp., >1.0 IU)
Analysis Time: 6 seconds
Meter Memory: 1000 patient tests
200 QC tests
4000 Operators
Docking/Charging Station: Desk mount
Input 100-240 VAC , 50-60 Hz,
0.25 A single; 1.5 A dual and quad
Output +5 VDC ,
2 A single; 7 A dual and quad
Data Output Port: RJ-45 Ethernet (10 Mbit)
Connectivity: Protocol TCP/IP Ethernet
Standard POCT1-A Compliant
Battery: Rechargeble Li-polymer 3.7 V 1250 mAh
Electrical Compliance: Conforms to UL and CSA Standards:
IEC 61010-1:2010 and IEC 61010-2-101:2015
Dimensions: 146 mm (5.8 in) x 79 mm (3.1 in)
x 30 mm (1.18 in)
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 1 9/13/18 8:29 AM
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