Bayer Rapidpoint 400 Service manual

Service Manual

105953 Rev. C, 2003-02

No part of this manual or the products it describes may be reproduced by any means or in any form without prior consent in writing from Bayer Corporation.

The Rapidpoint 400 system is for In Vitro Diagnostic Use.

Rapidpoint, Rapidlink, RapidQC, Quick, and CompleNet are trademarks of Bayer Corporation.

Intel and Pentium are trademarks of Intel Corporation.

Northbridge is a trademark of Hyundai.

Panellink is a trademark of Silicon Image, Inc.

Sharp is a trademark of Sharp Corporation.

Sound Blaser is a trademark of Creative Technology Ltd.

Velcro is a trademark of Velcro Industries B.V.

Origin: UK

The information in this manual was correct at the time of printing. However, Bayer Corporation continues to improve products and reserves the right to change specifications, equipment, and maintenance procedures at any time without notice.

If the system is used in a manner differently than specified by Bayer Corporation, the protection provided by the equipment may be impaired. See warning and hazard statements.

Table of Contents

Preface 19

Conventions Used in this Manual 19 Understanding the Symbols 20 Understanding Result Symbols 22

Mechanical Descriptions 23

Overview 25

The Base Model 26

Measurement Cartridge 31

Measurement Cartridge Fluidics 33

Sample Entry 33 Sliding Valve 33 Tubing 35 Reagent System 35 Sensor Module 36 KCl Reservoir 40

Wash/Waste Cartridge 41

Cartridge Interface Module 43

AutomaticQC Cartridge 46

AutomaticQC Cartridge Fluidic Components 47

Rev. C 3

AutomaticQC Cartridge Interface 49 Mechanical Components 51 Electronic Components 51

Pumps 52

Display 53

Display Module 53 Liquid Crystal Display 53 Touch Screen 53 Printer 54 Display Board 54 Display Support 54

CO-oximeter Components 55

CO-ox Measurement Components 56 Illumination Housing Assembly 57 Neon Board Assembly 57 Fiber Bundle Assembly 58 Sample Chamber Interface Assembly 58 Co-ox Sample Chamber 60 Polychromator Module 60

Electronic System Overview 63

Overview 67

Electronic System 68

4 Rev. C

Contact PC Board 69

Digital Signals 69

Digital Input Signals 69 Digital Output Signals 69 Analog and Other Input Signals 70 Analog and Other Output Signals 72

Circuit Description 74

Amperometric Circuits 74 Potentiometric Circuits 75 Hematocrit/Fluid Detector Circuits 75

Display PC Board 77

Digital Signals 77

Digital Input Signals 77 Digital Output Signals 78

Analog Signals 79

Analog and Other Input Signals 79 Analog and Other Output Signals 80

Circuit Description 80

Microcontroller and Peripheral Circuitry 80 Touch Screen Switches 81 DC-DC Converter Circuit 81 LCD Backlight Inverter Circuit 81

Dualopto PC Board 82

Sensor Circuit 82

Main PC Board 83

Real-Time Processor (RTP) 83

RTP 68332 Processor Circuitry 83 RTP 68332 Address and Data Bus Circuitry 83 RTP EPROM and PSRAM Circuitry 84

Rev. C 5

RTP Address Bus Decoder and Memory Controller Complex Programmable Logic Device Circuitry

RTP Data Bus I/O Latch CPLD Circuitry 85

Data Acquisition System (DAS) Front End Circuitry 85

DAS Analog-to-Digital Converter Circuitry 86 DAS Fluid Detector Circuitry 86 RTP/UIP First In First Out (FIFO) Memory

Communications Circuitry UIP Main Interconnect Board ISA Interface Circuitry 87 UIP Display Module, COM1, COM2/LPT1, and

Utility Circuitry UIP COM3 Circuitry 87 UIP ISA Address Bus Decoder, Data Bus I/O

Latch CPLD, and Communications Circuitry Control Micro-stepper Processor, and Sample

and Wash Pump Driver Circuitry Control Heater DAC, Driver Circuitry, and Valve

Driver Circuitry

Power System Status Circuitry, Diagnostic LEDs, and Switches

Control Automatic Quality Control (AQC) Valve Stepper Circuitry

Power System Protection and Input Circuitry 90

UIP Main Interconnect Board ISA Interface 92

Digital Input Signals 92 Digital Output Signals 92 Digital Bi-directional Signals 93

UIP COM1 Interface 94

Digital Input Signals 94 Digital Output Signals 94

UIP COM2/LPT1 Interface 95

Digital Input Signals 95 Digital Output Signals 95

Flat Panel Interface 96

Digital Output Signals 96

6 Rev. C

UIP Utility Interface 96

Digital Output Signals 96

Display Board Interface 97

Digital Input Signals 97 Digital Output Signals 97

Multiplexer Board Interface 98

Digital Input Signals 98 Digital Output Signals 98 Analog and Other Output Signals 99

Main Interconnect PC Board 100

ISA Connectors 100

Multiplexer PC Board 101

Digital Signals 102

Digital Input Signals 102 Digital Output Signals 102

Analog Signals 103

Analog and Other Input Signals 103 Analog and Other Output Signals 104

Circuit Descriptions 105

Amperometric Isolation Circuits 105 Digital Control Circuit 106 Temperature Circuits 106 Programmable Gain Amplifier Circuitry 106

User Interface Processor PC Board 107

Miscellaneous Functions 108

Keyboard Controller 108 Battery 108 Miscellaneous Function Connector 108

Peripheral Interfaces 109

Serial Ports 109

Rev. C 7

Parallel Port 109 Floppy Disk Controller 109

Co-oximeter OMZ Heater PC Board 110

Analog Signals 111

Analog and Other Input Signals 111 Analog and Other Output Signals 111

System Diagrams and Cable Drawings 113

System Diagrams 115

Cable Drawings 130

Calibrations 141

Calibrating the System 143

Calibrating the Touch Screen 145

Emergency Calibration of the Touch Screen 147

Troubleshooting 149

Troubleshooting Problems 155

Button and Parameter Status 155 Symbols on Screens and Reports 162 No Results on Screens and Reports 164

8 Rev. C

Unexpected Sodium and Potassium Results 166 Replacing the Measurement Cartridge 167 Replacing the AutomaticQC Cartridge 168 Bar Codes 169

Scanning Technique 172 Bar Code Quality 172 Resetting the Bar Code Scanner 172

Printer 173 Touch Screen 174 Communication 175

Viewing the Events Log 176

System Messages 177

AQC Cartridge Expired 177 AQC Cartridge Not Valid 177 AQC Connector is Open 177 AQC Pending 177 Additional Cal Required 177 Additional Wash Required 178 Analysis is turned off by a remote computer. 178 Bubbles in the Sample. The system cannot

complete analysis. Touch Continue to begin the sequence to clear the system. Replace the sample port when prompted. 178

Cal Overdue 179 Cal Not Done 179 Cal Pending 179 COox Chamber Temp Error 179 COox Sample Temp Out of Range 180 D2 Excessive Drift Qualifiers: pH, pO2,

pCO2, Na+, K+, Ca++, Cl-, Glu 181 D2 Excessive Drift: Hct 181

Rev. C 9

D2 Excessive Drift: tHb 182 D3 Slope Error: pH, pO2, pCO2, Na+,

K+, Ca++, Cl-, Glu 184 D3 Slope Error: Hct 184 D3 Slope Error: tHb 185 D4 Offset Error: pH, pCO2, Na+, K+,

Ca++, Cl-, Hct 186 D4 Offset Error: Glu, pO2, 186 D21 Processing Error 188 D23 Reagent Error: 1-8 or 10-13 189 D23 Reagent Error: 9 190 D24 AQC Material Error 192 D33 Valve Error: 1 193 D33 Valve Error: 2 194 D35 Electronics Error: 1-13 196 D35 Electronics Error: 14 196 D38 Temp Error: 1 198 D38 Temp Error: 2–13 198 D39 Obstruction 200 D40 Wash Not Detected 201 D41 No AQC Material Detected 202 D60 Communications Error 204 D70 Optics Error: 2 205 D70 Optics Error: 3, 4, 7, 11 205 D70 Optics Error: 9, 12 206 D73 COox Chamber Position Error 209 D75 Lamp Failure 210 D76 COox Electronics Error: 211 D77 Coox Temperature Error 212 Door Error 214 Excessive Bubbles in COox Sample. 214 Incorrect M Cartridge 215 Installation error. Unable to complete

the installation. Try again. 215

10 Rev. C

Insufficient Sample Volume. The system cannot complete analysis. Touch

Continue

to begin the sequence to clear the system. Replace the sample port when prompted. 216

M Cartridge Expired 216 M Cartridge Not Valid 216 No AQC Cartridge 217 No M Cartridge 217 No Paper in Printer 218 No W Cartridge 219 Out of Reporting Range 219 QC Lot Not Defined 219 QC Material Expired 219 Question Result: 219 Required QC Due 220 Sensors Unavailable For QC 220 SulfHb > 1.5% 220 System Error. Please wait. The system is

trying to recover from the error. 220 System Error. Turn the power switch off.

Wait 10 seconds then turn the switch on. 221 System requires operator attention. 221 Temp Not Ready 222 Temp Out of Range 223 Temp Warning 225 The language cannot be selected because

the current version is not installed. Install the latest language version to select the language. 226

The system detected an obstruction and cannot complete analysis. Touch

Continue

to begin the sequence to clear the obstruction. Replace the sample port when prompted. 227

The system did not detect a sample. Remove the sample device if present and touch

Continue.

Replace the sample port when prompted 227 This password is about to expire. Renew the

password before access to the system is denied. 228

Rev. C 11

This password is expired. Renew the password to access the system. 228

Uncorrected: 228 Unrecoverable System Error.

Call your service representative for assistance. 228 Unsuccessful Connection. Review the setup

values. Ensure that the cables are connected and that the network is operating. 229

W Cartridge Expired 229

Diagnostics 230

Printing Diagnostic Reports 231 Testing the Printer 233

Definitions for a Printed Temperature Report 235

Testing the Measurement Valve in Diagnostics 235

Testing the AutomaticQC Cartridge Valve in Diagnostics

237

Testing the Pumps 238 Using the Measurement Cartridge Simulator 240

Testing the Measurement Channels 240 Testing the Pump Flow 242

Testing the Measurement Cartridge Valve Alignment

244

Using the AutomaticQC Cartridge Simulator 246

Testing the Valve Alignment 247 Testing the IDEE ROM and Cartridge

Connector Switch.

251

Lamp Calibration Test 252 Wavelength Calibration Test 253 Lamp On/Off Test 254 Sample Chamber Test 255 Shutting Down the System 256

12 Rev. C

Recovering from a Power Loss 256

Illustrated Parts Lists 259

Main Assembly Illustrations 261

Main Assembly Parts List 278

Cartridge Interface Assembly Illustrations 281

Cartridge Interface Assembly Parts List 286

Power Module Assembly Illustrations 287

Power Module Assembly Parts List 293

CO-ox Module Components Illustrations 294

Replacing Components 299

Replacing the Sample Port 303

Replacing the Fuses 306

Replacing the CO-ox Lamp 308

Replacing the Cartridge Interface Assembly 309

Rev. C 13

Replacing the Connector Block Assembly 313

Removing the AutomaticQC Cartridge 318

Replacing the AutomaticQC Frame Assembly 320

Replacing the Diskette Drive Assembly 323

Replacing the Display/Printer Assembly 326

Replacing the Paper Cover 330

Replacing the Door Lock Module 333

Replacing the Hard Drive 334

Replacing the Power Supply Module 337

Replacing the Fan 339

Replacing the Power Entry Module With Switch 340

Replacing the Rear Interconnect Board 343

Replacing the Pump Roller Cages 345

14 Rev. C

Replacing the Pump Motors 349

Replacing the Wash/Waste Switch 354

Replacing the Fiber Bundle Assembly 356

Replacing the Neon Board Assembly 358

Replacing the Illumination Housing Assembly 360

Replacing the Polychromator Module 362

Replacing the Sample Chamber Interface Assembly 365

Replacing the Main Board 367

Replacing the UIP Board 370

Replacing the Main Interconnect Board 372

Removing the Rear Cover and Power Module Assembly 375

Installing the Rear Cover, Cartridge Interface Assembly, and Power Module Assembly 378

Rev. C 15

Spare Parts 381

Spare Parts Listing 383

Biohazards and Warnings 387

Protecting Yourself from Biohazards 387

Protecting Yourself from Electrical Shock Hazards 389

References 390

Installing and Relocating the Rapidpoint 400 Series

Installing the System 391 Installing the AutomaticQC Cartridge 394 Relocating the System 396 Shipping or Storing the System 397

System 391

Connecting to a Computer System 401

Connecting to a Rapidlink System 401

Using a CompleNet Network Connection 401 Entering IP Addresses 402 Using DHCP 403 Using a Serial (RS-232) Connection 405

Connecting to a Laboratory Information System 407

16 Rev. C

Connecting the Bar Code Scanner 409

Swapping Out a Rapidpoint 400 Series System 411

Removing the Current Rapidpoint 400 Series System

Installing the New Rapidpoint 400 Series System 414 Restore Setup and Correct the Date and Time 415 Rapidlink Setup 415

Setting Up RapidQC Complete in the Rapidlink Database

Setting Up RapidQC Hct in the Rapidlink System 417

Finishing the Rapidpoint Setup 417

411

416

Rapidpoint 400 Series Cartridge Usage 419

Overview 419

Verifying Modes of Operation 420

Setting the Rapidpoint 400 Series System to the FOR DEMONSTRATION ONLY Mode

What Can Go Wrong? 423

Setting the Rapidpoint 400 Series System to the USER Mode

What Can Go Wrong? 425 Using Simulator Cartridges in the USER Mode 425

421

423

About Rapidpoint 400 Series Calibrations 427

Rev. C 17

Overview 427

Calibration Types 427 Retrospective Calibration (Retrocal) 428 Calibration Schedule 429

Interruptible and Uninterruptible Calibrations 429

Cartridge Initialization (Init) 430

Initialization Calibration Timeline 431

Remote Access Setup to the Rapidlink System 433

Installing and Configuring Remote Access Setup (RAS) 434

Configuring RAS To Start Automatically 435 Adding Rapidpoint to Users and Groups 435 Adding Upload and Download Directories 436

Index 439

18 Rev. C

Preface

This manual is to be used with the Bayer Diagnostics Rapidpoint® 400 series system. It provides the information and procedures necessary to service the Rapidpoint 400 series system. Related documents include the following:

• Rapidpoint 400 Series Operator’s Manual

• Rapidpoint 400 Series Reference Guide

• Rapidpoint 400 Series Interface Specification Manual

This manual is designed to meet the needs of Bayer Diagnostics Service Representatives and biomedical engineers who perform installation, replace parts, and troubleshoot the Rapidpoint 400 series system.

Conventions Used in this Manual

This manual uses the following text and symbol conventions.

Convention Description

Bold Bold type indicates a button on the screen. For example, if the word

“setup” appears as Setup, it refers to the button labeled Setup.

Buttons that you use frequently are represented on the screen with a symbol instead of text. In this manual, these button names appear in bold with the word button after them. For example, “the

Continue button” refers to the button in the lower right corner of the

screen that you touch to advance to the next screen. You can refer to the Rapidpoint 400 Series Reference Guide on the

system or to Buttons in Section 5 of the Rapidpoint 400 Series Operator’s Manual to identify the buttons that are represented by symbols.

italic

Italic type refers to the title of a document or a section title in this manual. For example, Mechanical Descriptions refers to the first section of this manual.

Information appropriate for Rapidpoint 405 systems.

Biohazard statements alert you to potentially biohazardous

conditions.

(Continued)

Rev. C Preface 19

Convention Description

Warning statements provide information about a condition that may cause personal injury.

Caution statements provide information about conditions that may cause product damage or loss of data.

NOTE

Note statements alert you to important information that requires your attention.

Understanding the Symbols

This section describes the symbols that may appear on the exterior of the system. The symbols provide you with the location of certain components and with warnings for proper operation.

Symbol Description

This symbol reminds you to push the measurement cartridge firmly to lock it in place.

This symbol identifies the area on the wash/waste cartridge where you push to install the cartridge correctly.

This symbol identifies the ampule breaker where you insert ampules to break off the top.

This symbol indicates where you insert the sample device (syringe, capillary, or ampule) to perform analysis.

This symbol cautions you about the risk of exposure to biohazards.

This symbol indicates a hazard or danger is associated with the product.

This symbol cautions you about the risk of exposure to potential electrical hazards.

This symbol indicates that the input electricity is alternating current.

This symbol alerts you to important information about the fuses.

(Continued)

20 Rev. C

Symbol Description

This symbol identifies that the system is type B equipment, which provides a particular degree of protection against electric shock.

Class 1 This symbol indicates that the system is class 1 type

This symbol indicates that the main power supply is on.

This symbol indicates that the main power supply is off.

equipment, which has basic insulation and additional safety grounding precautions. Reference Underwriters Laboratories Document for Medical Electrical Equipment, Part 1: General Requirements for Safety, UL 2601-1.

This symbol indicates that the system is approved by UL as meeting U.S. requirements for safety.

This symbol indicates that the system meets the requirements of the European Union.

This symbol indicates that the system is approved by CSA as meeting the U.S. and Canadian requirements for safety.

This symbol indicates the type of measurement cartridge that can be installed on the system.

This symbol indicates the area to write the date the cartridge is installed on the system, if required.

This symbol cautions you not to spray this area with cleaning solutions or other fluids that may damage sensitive parts of the system.

In vitro diagnostic device

Consult instructions for use

Temperature limitation (2°C - 8°C)

Contains sufficient for (n) tests (250 tests)

Catalog number

(Continued)

Rev. C Preface 21

Symbol Description

Serial number

Batch code

Manufactured by

Authorized Representative

Understanding Result Symbols

The following symbols identify results that are out of range or that need your attention. These symbols and results appear in red on the screen. They also appear on the report. The ranges can appear on the printed report, if this option is selected in Setup.

This symbol . . . Indicates that . . .

the result is above range.

the result is below range.

– – – – –

– – – – – the result is below the reporting range.

? the system has an atypical response when measuring this

u the hematocrit (Hct) result was not corrected for sodium (Na+)

the result is above the reporting range.

parameter. The system does not report results for other parameters that use the affected parameter. For example, if ? appears with the chloride (Cl-) result, the system does not report a result for anion gap (AnGap).

When this symbol appears with the hematocrit (Hct) result, it may indicate that the result was not corrected for sodium (Na+) because sodium failed Required QC analysis.

Analyze the sample again, if possible.

because the sodium sensor is out of calibration or because the sodium measurement is beyond the reporting range.

22 Rev. C

Mechanical Descriptions

Overview 25

The Base Model 26

Measurement Cartridge 31

Measurement Cartridge Fluidics 33

Sample Entry 33 Sliding Valve 33 Tubing 35 Reagent System 35 Sensor Module 36 KCl Reservoir 40

Wash/Waste Cartridge 41

Cartridge Interface Module 43

AutomaticQC Cartridge 46

AutomaticQC Cartridge Fluidic Components 47

AutomaticQC Cartridge Interface 49

Mechanical Components 51

Electronic Components 51

Pumps 52

Display 53

Display Module 53

Rev. C Mechanical Descriptions 23

Liquid Crystal Display 53

Touch Screen 53

Printer 54

Display Board 54

Display Support 54

CO-oximeter Components 55

CO-ox Measurement Components 56

Illumination Housing Assembly 57

Neon Board Assembly 57

Fiber Bundle Assembly 58

Sample Chamber Interface Assembly 58

Co-ox Sample Chamber 60

Polychromator Module 60

24 Rev. C

Overview

This section describes the mechanical components of the Rapidpoint 400 series systems. Each component contains individual modules that perform a series of related functions. The Rapidpoint 400 series systems consists of the following components:

• Measurement cartridge

• Wash/waste cartridge

• AutomaticQC cartridge

•Pumps

• Display

• CO-oximeter

Rev. C Mechanical Descriptions 25

The Base Model

The base model refers to the 400 system model.

Rapidpoint 400 Series System (door open)

1 Measurement cartridge 7 Paper advance knob

2 Door 8 Ampule breaker

3 Door latch 9 Air filter carrier

4 Cartridge handle 10 Sample port

5 Display 11 Support bracket for AutomaticQC cartridge

6 Printer 12 Wash/waste cartridge

26 Rev. C

Rapidpoint 405 System (door open)

1 Optic Head Assembly: Delivers and collects light from the CO-ox sample

chamber.

2 Drive Wheel: Opens and closes the CO-ox sample chamber.

3Pumps: Move samples and reagents through the measurement and wash/waste

cartridges.

4 Valve Actuator: Moves the valve that controls flow of the sample and reagents.

Rev. C Mechanical Descriptions 27

Rapidpoint 400 Series System with AutomaticQC Cartridge Installed

1 AutomaticQC cartridge

2 Cartridge connector

Rapidpoint 400 Series System with Bar Code Scanner Holder

28 Rev. C

Rapidpoint 400 Series System (left side)

1 Diskette drive

Rev. C Mechanical Descriptions 29

Rapidpoint 400 Series System (rear view)

1 Serial Port: Allows serial connection to a Rapidlink data management system or

an LIS.

2 Network Port: Allows network connection to a Rapidlink data management system.

3 Screen Latch: Allows you to adjust the viewing angle of the screen.

4 Handle: Helps you to move the system.

5 Co-ox Lamp: Appears only in Rapidpoint 405 systems.

6 Power Switch

7 Fuse Compartment

8 Power Input

9 Bar Code Port: Allows you to connect the optional bar code scanner to the system.

The scanner allows you to identify patient and QC samples by scanning their bar codes.

10 Air Filter

30 Rev. C

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