epoc System Manual - English

1 51011600 Rev.: 00 Distributed by Alere North America, LLC 30 S. Keller Road, Suite 100, Orlando, FL 32810 USA Tel (US): (877) 441-7440 Tel (outside US): (321) 441-7200 System Manual 2016 Alere. All rights reserved. The Alere Logo, Alere, epoc, and Care-Fill are trademarks of the Alere group of companies. All other trademarks referenced are trademarks of their respective owners. Epocal Inc. 2060 Walkley Road Ottawa, ON K1G 3P5 Canada Tel: (613) 738-6192 Fax: (613) 738-6195 Emergo Europe Molenstraat 15, 2513 BH The Hague, Netherlands Tel: + Fax: + Email: IVD 51011600 Rev.: 00 Patents US D639956; US 6845327; US 6896778; US 7094330; US 7767068; US 7824529; US 7842234; US 8506778; additional patents pending. 51011600 Rev.: 00 Table of Contents Page 1 of 5 Section Title Page 1 Introduction epoc System Manual .

2 1-1 Cautions .. 1-1 Warranty .. 1-1 Warranty Limitations .. 1-2 WEEE Compliance .. 1-3 2 epoc Blood Analysis System System Overview .. 2-1 Operation Overview .. 2-2 3 epoc System Operation System Operation Overview .. 3-1 Turning ON the epoc Reader .. 3-1 Turning ON the epoc Host .. 3-2 Logging in to epoc Host Software Application .. 3-2 Running a Test on a Dedicated Reader .. 3-2 Alternate Means to Run a Test .. 3-2 Reader Electronic Internal QC Test .. 3-3 Reader Screen .. 3-3 Obtaining the Test Card .. 3-4 Inserting the Test Card .. 3-5 Calibration Sequence .. 3-5 Entering Patient Information (or Lot Number) and Test Selection .. 3-6 Using Barcode Scanner to Enter Patient ID .. 3-7 Collecting a Blood Sample .. 3-7 Timing of Sample Introduction .. 3-7 Sample Introduction .. 3-8 Test Completion .. 3-9 Running Another Test .. 3-9 3. 19 Closing the Test and Disconnecting the Reader.

3 3-10 3. 20 EDM Synchronization .. 3-10 3. 21 Logging Out and Turning the Power OFF .. 3-10 Multiple Reader Testing .. 3-11 4 epoc Test Cards General Test Card Information .. 4-1 Test Card Physical Characteristics .. 4-1 Test Card Packaging, Storage, and Shelf 4-2 Table of Contents 51011600 Rev.: 00 Table of Contents Page 2 of 5 Section Title Page 5 epoc Reader Overview .. 5-1 Power Requirements .. 5-2 Rechargeable Battery .. 5-3 Reader Status and Firmware Version .. 5-3 Test Status .. 5-4 Audible Signals .. 5-4 Card Insertion Slot .. 5-5 Docking Pivot .. 5-5 USB Maintenance Port .. 5-6 Motorized Mechanism .. 5-6 Wireless Module .. 5-6 Barcode Scanner .. 5-6 Thermal System .. 5-7 Operating Environment .. 5-7 6 epoc Host Overview .. 6-1 Rechargeable Battery .. 6-1 Barcode Scanner .. 6-1 6. 4 Soft (Warm) and Hard (Cold) Reset.

4 6-2 6. 5 Navigation .. 6-2 6. 6 Entering Text .. 6-3 6. 7 Date/Time Clock .. 6-4 6. 8 Status Indicators .. 6-4 6. 9 User Accounts .. 6-5 6. 10 epoc Host Application User Interface .. 6-5 6. 11 Startup Screen .. 6-6 6. 12 Login Screen .. 6-6 6. 13 Operational Modes .. 6-7 6. 14 Testing Mode .. 6-7 6. 15 Main Reader Screen .. 6-8 6. 16 Reader Screen .. 6-9 6. 17 Reader Screen Pages .. 6-9 6. 18 Test Results Page .. 6-10 6. 19 Critical Values Actions .. 6-12 6. 20 Test Information Page .. 6-13 6. 21 Test Selection Page .. 6-13 6. 22 Respiratory Therapy Parameters .. 6-14 Age and Gender .. 6-17 6. 24 EDM Synchronization .. 6-17 6. 25 Viewing Tests Mode .. 6-18 6. 26 Viewing Electronic QC Mode .. 6-20 Viewing Thermal QA 6-21 6. 28 Personal Options Page .. 6-22 Positive Patient ID Lookup .. 6-23 51011600 Rev.: 00 Table of Contents Page 3 of 5 Section Title Page 7 epoc Host Administration General.

5 7-1 First Time Administrator Login .. 7-1 Limitations for Use .. 7-1 Administrator Access .. 7-2 Windows Mobile Operating 7-2 Administrator User Interface .. 7-3 Administrator Options .. 7-4 Barcode Options Page .. 7-10 EDM Options Page .. 7-11 Card Options 1 .. 7-12 Card Options 2 .. 7-15 7. 12 Personal Options Page .. 7-16 Software Upgrades .. 7-16 Set Date, Time, and Time Zone .. 7-20 Reader Identifiers .. 7-20 Reader Configuration and Reader Software Upgrade .. 7-21 Dedicating Readers .. 7-22 Test Record Administration .. 7-23 8 epoc Enterprise Data Manager Introduction .. 8-1 Deployment .. 8-1 Hardware and Software Requirements .. 8-1 Installation .. 8-1 epoc Database .. 8-2 epoc Link 8-2 Using EDM Web Application .. 8-3 Blood Tests Page .. 8-4 Blood Tests: Filtering Results .. 8-6 Blood Tests: Printing Results .. 8-6 Blood Tests: Exporting List of Tests to CSV File .. 8-8 QA Tests.

6 8-8 Reports: Electronic QC .. 8-9 Reports: Thermal QA .. 8-10 Reports: Usage Statistics .. 8-10 Reports: Patients List (ADT) .. 8-11 Inventory: Hosts .. 8-11 Inventory: Readers .. 8-12 Inventory: Card Lots .. 8-14 Inventory: Printers .. 8-15 8. 21 Users Page .. 8-16 8. 22 Groups Page .. 8-18 8. 23 Host Settings .. 8-19 8. 24 Host Settings: Units .. 8-19 8. 25 Host Settings: Ranges .. 8-19 Host Settings: Software Update .. 8-22 Host Settings: eVAD Update .. 8-22 Departments .. 8-23 51011600 Rev.: 00 Table of Contents Page 4 of 5 Section Title Page 8 epoc Enterprise Data Manager Configurations .. 8-25 QA 8-26 8. 31 EDM Settings .. 8-26 9 Quality Assurance Overview .. 9-1 Recommended Quality Control for epoc System .. 9-1 Optional Quality Control for epoc System .. 9-3 Aqueous Fluid Handling .. 9-4 Value Assignment Datasheets.

7 9-6 10 Care and Maintenance of epoc System General Information .. 10-1 Care of the epoc System .. 10-1 Cleaning .. 10-1 Maintenance .. 10-2 11 Theory of Operation epoc Host .. 11-1 epoc Reader .. 11-1 epoc Test Card .. 11-2 Sensor Module .. 11-3 Sensor Electrodes .. 11-5 Quality Control and epoc System .. 11-10 References .. 11-14 12 BGEM Test Card Specifications General BGEM Test Card Specifications .. 12-1 Test Card Configuration and Use .. 12-2 pH .. 12-8 pCO2 .. 12-12 pO2 .. 12-16 Sodium (Na+) .. 12-20 Potassium (K+) .. 12-25 Ionized Calcium (Ca++) .. 12-29 Chloride (Cl-) .. 12-34 Glucose (Glu) .. 12-38 Lactate (Lac) .. 12-47 Creatinine (Crea) .. 12-52 Hematocrit (Hct) .. 12-57 Calculated Values .. 12-61 13 epoc Reader and Host Specifications epoc Reader .. 13-1 epoc Reader Components .. 13-2 epoc Host (Socket) .. 13-3 epoc Host Accessories (for Socket).

8 13-4 epoc Host2 (Zebra) .. 13-5 epoc System Accessories .. 13-7 epoc System Compliance .. 13-8 51011600 Rev.: 00 Table of Contents Page 5 of 5 Section Title Page 14 Troubleshooting and Error Messages General .. 14-1 Out-of -Range Results on the Test Card for Liquid Quality Control or Calibration Verification .. 14-1 Failed Reader Electronic QC .. 14-1 Failed Thermal QA .. 14-2 epoc Host Application Messages .. 14-2 epoc Host Screen Alignment .. 14-20 15 Glossary Symbols .. 15-1 Terminology and Abbreviations .. 15-2 Appendix A. Ref: 51001684 epoc Host Quick Start Guide (Socket SoMo 650) Appendix B. Ref: 51005527 epoc Host2 Quick Start Guide (Zebra MC55A0) Appendix C. Ref: 51000848 epoc Reader Quick Start Guide Appendix D. Ref: 51003903 epoc Care-Fill Capillary Tube Package Insert Appendix E. Ref: 51011873 User Guide: Enhanced QA Features for the epoc System 51011600 Rev.

9 : 00 Introduction 1-1 General The epoc System Manual describes the proper use and operation of the epoc Blood Analysis System . System operators and the System administrator should familiarize themselves with the applicable sections in the Manual prior to conducting testing. All operators and the System administrator require training by Epocal Inc. ( Epocal ) authorized personnel prior to conducting patient testing. This training is based upon the information contained in this Manual . The System Manual should be made available to the administrator and operators at all times while the epoc Blood Analysis System is in use. Cautions Cautions are identified throughout the Manual using the Caution, risk of danger or Caution, consult accompanying documents symbol. The operator and administrator need to pay special attention to the instructions accompanying this symbol to ensure that the epoc Blood Analysis System is used properly, reliably and safely.

10 The Biological risks symbol is used in the Manual to identify potential biological risks associated with the handling of blood samples. Precautions, as stipulated by the facility where the epoc System is utilized, must be taken to ensure that the risk of transmitting blood borne pathogens is minimized. Other symbols may also be used in the System Manual . The correct interpretation of these symbols is located in the Glossary Section. Warranty Epocal warrants to the original customer that the medical equipment manufactured by Epocal is free from defects in materials and workmanship, and under normal and proper use conditions, for a period of one (1) full year from the date of shipment. Upon receiving notice from the customer of any defects within this warranty period, Epocal shall, at its option and sole discretion, either repair, replace or modify this medical equipment or part thereof, which proves to be defective. Epocal shall repair or replace software media and firmware which does not execute as intended due to such defects.