Siemens PFA-100 System Manual de usuario

PFA-100 System

Instruction Manual (US)

– Instructions for Use –

11210658

Manual Version: 1.0.1

Date of Issue: 2017-12

We reserve the right to make changes in the course of technical development without previous notice.

Emil-von-Behring-Str. 76

35041 Marburg

Germany

Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written approval

of Siemens Healthcare Diagnostics Products GmbH.

Updating 1.

Trademarks PFA-100 and Dade are trademarks of Siemens Healthcare Diagnostics Inc.

Mikrozid is a trademark of Schülke & Mayr GmbH.

Littelfuse is a trademark of Littelfuse Inc.

Software Copyrights Software of Siemens Healthcare Diagnostics Products GmbH is the

Siemens. You are entitled to use this software as well as the printed

documentation relating to it on one single, non-transferable workstation.

Disclaimer Siemens Healthcare Diagnostics has validated the provided instructions,

reagents, instrument, software and customizable features for this system to

optimize product performance and meet product specifications. User

defined modifications are not supported by Siemens as they may affect

performance of the system and test results.

Version Date Changes

Manual Software

1.0 2.20 2016-11 First version

1.0.1 2.20 2017-12 Update

Siemens Healthcare Diagnostics Products GmbH

Emil-von-Behring-Str. 76

35041 Marburg

Germany

www.siemens.com/diagnostics

Chapter overview

PFA-100 System – Instruction Manual (US) – Version 1.0.1

Chapter overview

1 About this document

2 Safe handling

3 Delivery and installation

4 Quick reference guide

5 Service and warranty

6 Description of the analyzer

7 Setup and changing configuration

8 Performing tests

9 QC procedures

10 Cleaning and disinfection

11 Maintenance

12 Diagnostics and troubleshooting

Index

PFA-100 System – Instruction Manual (US) – Version 1.0.1

Chapter overview

Table of contents

PFA-100 System – Instruction Manual (US) – Version 1.0.1 1TOC

Table of contents

1 About this document 1-1

1.1 Orientation tips 1-1

1.2 Abbreviations 1-2

2 Safe handling 2-1

2.1 Intended use 2-1

2.2 General safety information 2-2

2.2.1 Operator qualification 2-2

2.2.2 Electrical safety 2-2

2.2.3 Mechanical safety 2-3

2.2.4 Operational safety 2-4

2.2.5 Safe handling of samples, PFA test cartridges, and consumables 2-5

2.2.6 Correct functionality of the analyzer 2-6

2.3 Safety messages 2-6

2.3.1 Signal words in safety messages 2-6

2.3.2 Structure of safety messages 2-6

2.4 Meaning of the warning and information symbols on the analyzer 2-7

2.5 Statutory requirements 2-7

2.6 Obligations of the system owner 2-7

3 Delivery and installation 3-1

3.1 Delivery 3-1

3.1.1 Transporting the analyzer 3-1

3.1.2 Scope of delivery 3-1

3.1.2.1 Accepting delivery 3-2

3.1.2.2 Unpacking 3-2

3.1.2.3 Inventory analyzer accessories 3-4

PFA-100 System – Instruction Manual (US) – Version 1.0.1

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Table of contents

3.2 Installation 3-7

3.2.1 Operating conditions 3-8

3.2.1.1 Ambient conditions for storage 3-8

3.2.1.2 Ambient conditions for operation 3-8

3.2.2 Requirements of worktop 3-9

3.2.3 Connecting the analyzer 3-10

3.2.3.1 Installing fuses 3-11

3.2.3.2 Connecting the analyzer to the power source 3-13

3.2.3.3 Loading printer paper 3-14

3.2.3.4 Threading printer paper 3-16

3.2.3.5 Loading trigger solution 3-17

3.2.3.6 Checking for correct installation 3-19

3.3 Preparing the analyzer for longer periods of non-operation 3-20

4 Quick reference guide 4-1

5 Service and warranty 5-1

5.1 Siemens service 5-1

5.2 Warranty 5-1

5.3 Ordering information 5-2

5.4 Disposal of the analyzer 5-3

6 Description of the analyzer 6-1

6.1 Analyzer 6-1

6.1.1 Carousel 6-2

6.1.2 Trigger solution compartment 6-3

6.1.3 LCD display 6-3

6.1.4 Keyboard 6-4

6.1.5 Printer 6-4

6.2 Consumables 6-5

6.2.1 Consumables’ labels 6-5

6.2.2 Consumables/parts list 6-6

6.2.3 PFA test cartridges 6-7

Table of contents

PFA-100 System – Instruction Manual (US) – Version 1.0.1 3TOC

6.3 Technical specifications 6-7

6.3.1 Physical 6-7

6.3.2 Electrical 6-7

6.3.3 Environmental 6-8

6.3.4 General 6-8

6.3.5 Printer 6-9

6.3.6 Software 6-9

6.4 Data connections 6-9

6.5 Laboratory information system (LIS) 6-11

6.6 Principle of operation 6-12

7 Setup and changing configuration 7-1

7.1 Priming the analyzer 7-1

7.2 Setup of the software 7-3

7.2.1 Selecting language 7-3

7.2.2 Setting the time format 7-4

7.2.3 Setting the date format 7-6

7.2.4 Patient identification request 7-7

7.2.5 Analyzer initialization 7-8

7.3 Configuration 7-8

7.3.1 Low/high flag ranges 7-9

7.3.2 Audible keys 7-11

7.3.3 Laboratory information system (LIS) 7-12

8 Performing tests 8-1

8.1 Test request with patient ID number option disabled 8-4

8.1.1 Single test 8-4

8.1.2 Duplicate test or two test types, same patient ID 8-4

8.1.3 Two different test types, different patient ID 8-5

8.2 Test request with patient ID number option enabled 8-6

8.2.1 Single test 8-6

8.2.2 Duplicate test or two test types, same patient ID 8-7

8.2.3 Two test types, different patient ID 8-8

PFA-100 System – Instruction Manual (US) – Version 1.0.1

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Table of contents

8.3 Canceling tests 8-9

8.4 Printing results 8-10

8.4.1 Automatic printing after test 8-10

8.4.2 Printing the results of the last run 8-10

8.4.3 Printing stored test results 8-11

8.4.4 Printing usage history 8-12

9 QC procedures 9-1

9.1 Self test and daily alignment check for trigger solution dispensing 9-2

9.2 Run control 9-6

9.3 Printing control results 9-9

10 Cleaning and disinfection 10-1

10.1 Cleaning the analyzer 10-1

10.2 Disinfecting the analyzer 10-1

11 Maintenance 11-1

11.1 Replacing trigger solution 11-2

11.2 Priming the system 11-4

11.3 O-Ring maintenance 11-6

11.3.1 Maintaining and inspecting the O-Ring 11-6

11.3.2 Removing the O-Ring 11-7

11.3.3 Installing the O-Ring 11-9

11.3.4 Cleaning O-Ring using cleaning pads 11-10

11.4 Replacing printer paper 11-13

11.5 Replacing printer ribbon 11-15

11.6 Replacing fuses 11-16

Table of contents

PFA-100 System – Instruction Manual (US) – Version 1.0.1 5TOC

12 Diagnostics and troubleshooting 12-1

12.1 Power on diagnostics 12-1

12.2 Self test 12-1

12.3 Printing error log 12-2

12.4 Displaying test results 12-3

12.5 Common status messages 12-5

12.5.1 Maximum Test Time Exceeded 12-6

12.5.2 Test Terminated Due To Air Leak 12-7

12.5.3 Test Terminated Due To Flow Obstruction 12-8

12.5.4 Test Terminated Due To Insufficient Sample 12-9

12.5.5 Test Terminated Due To Maximum Syringe Travel 12-10

12.6 Other status messages 12-11

Index IX-1

PFA-100 System – Instruction Manual (US) – Version 1.0.1

6TOC

Table of contents

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