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Mack Information Systems, Inc.

15 Hershey Court, Newtown PA 18940

sales@mackinfo.com

215-884-8123

Plexxium II

Compliant with:

21 CFR 11 Requirements for Electronic Signatures

21 CFR 211.25 Requirements for Training

21 CFR Part 606.140, 606.160 Blood Bank Regulations

21 CFR 806, 820 Quality System Requirements

FDA Docket No. 93-394 - Guidelines for Quality Assurance in Blood Banks

Accuracy, Resolution, and Range Requirements of National Committee for Clinical Laboratories (NCCLS) per 116 - T

Approvals:

Safety Certificates - UL 3121 - 1, EN 61011, IEC 61010 - 1

EMC - FCC Part 15 - A, EN 61326, EN 55011

CE-EN 61326 - 1: 1997 A1: 1988

CAN/CSA-C22.2 No.1010.1 - 92, ”Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements.”

Plexxium II (CAMS) Plexxium II Plexxium II Specifications Plexxium II Specifications TMS II (Temperature Monitor/Alarm) Universal BacT/Alert 3D Interpreter Stop/Motion Sensor TMS 4-20 mA Temperature Transmitter

Plexxium II Toolkit Sensors Remote Alarm