Bayer RapidPoint 400 User manual

2

Rapidpoint'400	Series

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Machine τόσον

HST

Service Manual

5 n

Bayer HealthCare

ASS :

R

.

105953 Rev. D, 2004-06

Pat a

© 1998 Bayer HealthCare LLC. All rights reserved.

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 HealthCare LLC.

The Rapidpoint 400 system is for In Vitro Diagnostic Use.

Rapidpoint, Rapidlink, RapidQC, Quick, and CompleNetare trademarks of Bayer HealthCare LLC.

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 Blaster is a trademark of Creative Technology Ltd. Velcro is a trademark of Velcro Industries. B.V: mes

Origin: UK	Ur
Bayer HealthCare LLC	О	th
Subsidiary of Bayer Corporation		`
East Walpole, MA 02032-1597 USA
Bayer Diagnostics Mig (Sudbury) Ltd
Sudbury, CO10 2XQ, UK	|

The information in this manual was correct at the time of printing. However, Bayer HealthCare 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 HealthCare, the protection provided by the equipment may be impaired. See warning and hazard statements.

A

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		|		os		33
		Tubing .					и		35
		Reagent System			o		EE		35
		Sensor	Module					<	36
		KCI Reservoir							40
	Wash/Waste Cartridge								41
и	‘Cartridge’ Interface				Module		o		AS
a	Automatic			¢Cartridge i			NE		46
	AutomaticQC			Cartridge		Fluidic	Components		47
Rev. D									3

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

. Rev. D

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. D

D2	Excessive				Drift:		tHb			182
D3	Slope Error: pH, pO2, pCO2, Na+,
K+,	Ca++, Cl-, Glu									184
D3	Slope		Error:			Het				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

Rev. D

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. D

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. D

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. D

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		340
With	Switch
Replacing		the	Rear	Interconnect			Board	343
Replacing		the	Pump	Roller		Cages		345

14	Rev.	D

Replacing		the	Pump Motors
Replacing		the	Wash/Waste Switch
Replacing the Fiber Bundle Assembly
Replacing the Neon Board Assembly
Replacing		the	Illumination
Housing	Assembly
Replacing		the	Polychromator Module
Replacing		the	Sample Chamber
Interface		Assembly
Replacing		the	Main	Board
Replacing		the	UIP	Board
Replacing the Main Interconnect Board
Removing the Rear Cover and Power
Module	Assembly

349

354 356 358

360 362

365 367 370 372

375

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

Rev. D

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

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. D

Connecting the Bar Code Scanner	409
NÝ

Swapping Out a	Rapidpoint		400	Series
System						411
Removing the Current Rapidpoint 400 Series
System						411
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						416
Setting	Up	RapidQC Het	in the	Rapidlink System		417
Finishing	the	Rapidpoint	Setup			417

U	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								421
	What Can			Go Wrong?					423
	Setting		the	Rapidpoint 400		Series	System	to
	the	USER		Mode					423
	What Can			Go Wrong?					425
	Using		Simulator		Cartridges	inthe	USER	Mode	425

About Rapidpoint 400 Series Calibrations	427
NY
Rev. D	17

Overview				427
Calibration	Types			427	M
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	434
Setup (RAS)
Configuring RAS To Start Automatically	435
Adding Rapidpoint to Users and Groups	435	my
Adding Upload and Download Directories	436
Index	439

18

Rev. D

Preface

This manual is	to	be used	with	the Bayer	HealthCare Rapidpoint® 400
series system.	It	provides	the	information	and procedures necessary to

service the Rapidpoint 400 series system. Related documents include the following:

e Rapidpoint 400 Series Operator's Manual

‚ Rapidpoint 400 Series Reference Guide

*Rapidpoint400 Series interface Specification Manual

This manual	is designed to meet	the	needs	of Bayer		HealthCare 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,

ifthe

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.

(0)

Information

appropriate

for

Rapidpoint

405

systems.

A

Biohazard

statements

alert

you

to

potentially

biohazardous

conditions.

(Continued)

Rev. D

Preface

19

Convention	Description
	Warning statements		provide			information about a condition that	(A
	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 dangeris 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. D

Symbol

Class 7

14250554 REF

Description

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

This symbol indicates that the main power supply is on.

This symbol indicates that the main power supply is off.

This symbol indicates that the system is class 1 type 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. D

Preface

21

Symbol			Description
SN			Serial		number
LOT			Batch		code
mal			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	above	the	reporting	range.
	the	result	is	below	the	reporting	range.

the system has an atypical response when measuring this 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.

the hematocrit (Hct) result was not corrected for sodium (Na*) because the sodium sensor is out of calibration or because the sodium measurement is beyond the reporting range.

22

Rev. D

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
	KCI Reservoir				40
Wash/Waste			Cartridge		41
Cartridge		Interface Module			43
AutomaticQC			Cartridge		46
AutomaticAC			Cartridge	Fluidic Components	47
AutomaticAC			Cartridge	Interface	49
Mechanical Components					51
Electronic		Components			51
Pumps					52
Display					53
Display Module					53
Rev. D				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. D

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. D

Mechanical Descriptions

25

The Base Model

The base model refers to the 400 system model.

Rapidpoint 400 Series System (door open)

10

11

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. D

Rapidpoint 405 System (door open)

1Optic 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.

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

Rev. D

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

5 cm (2 in)

28

Rev. D

Rapidpoint 400 Series System (left side)

^

^

1 Diskette drive

Rev. D

Mechanical Descriptions

29

Rapidpoint 400 Series System (rear view) 3

10 9

— O0BGNNO

6

O

	Serial Port: Allows serial connection to a		Rapidlink data	management system or
	an LIS.
	Network	Port: Allows network connection	to a Rapidlink	data	management system.	CY)
	Screen	Latch: Allows you to adjust the viewing angle of		the	screen.
	Handle:	Helps you to move the system.

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

Power Switch

Fuse Compartment

Power Input

Bar	Code Port: Allows you to connect the optional	bar code scanner to the system.
The	scanner allows you to identify patient and OC	samples by scanning their bar
codes.

10 Air Filter

30

Rev. D

Measurement	Cartridge
The self-contained measurement cartridge is non-serviceable.		It consists
of the fluidic components, reagents, and sensors that measure		patient and
QC samples.
Measurement	Cartridge

ada

NO REN =

Internal	fluidic		components and reagents
Sensor	module
Sample	port
Input to	waste		bag
Primary	alignment			pin
Output	from	wash		bag
Secondary		alignment pin

a

In addition, the measurement cartridge contains the mechanical components that interface with the following components:

the reagent system with the peristaltic pumps

* the sensor module with the electronic componentsthe wash/waste cartridge

the thermal control

The external area of the cartridge consists of the platen area which

contains the	pump tubing.	When	the	measurement			cartridge	is installed
and locked	into place, the	roller	cage	of	the	base unit	is positioned		against
the pump tubing to move		the reagents,			the	samples,	and the	wash	fluids
through the	system.

Rev. D

Mechanical Descriptions

31

The measurement cartridge is protected by	a door	that	locks in place. The
door provides an electrostatic shield for the	measurement			system. A
mechanical microswitch senses when the	door is	open	or	closed.

5	Pump	tubing
6	Sliding valve
7	CO-ox Sample chamber
8	Drive	wheel interface

Measurement

cartridges

can

analyze a

total

of

750

patient

and/or

QC samples, and measure blood gases, electrolytes, glucose, total

hemoglobin, and hemoglobin derivatives in arterial,

venous

and capillary

whole

blood samples.

Each

cartridge

is

stable for 28

days after

installation

on the

system

when

the

cartridge

is

installed

by

the

date on the label. The

Instal-by date indicates the last date on which the cartridge can be

installed and still have 28 days of use before expiration.

System

Parameters

Determined

and

Reported

400

pH,

pCO,,

pO,, Na”,

K*,

Ca**,

Cr,

glucose,

Het

405

pH, pCO,, pO,, Na”, K*, Ca**,

Cr,

glucose,

tHb,

FO2Hb,

FHHb,

FMetHb,

FCOHb

If a cartridge

is

installed

after the Install-by

date,

it is

stable

for

the

number

of days remaining before expiration, that

is,

28

days

minus

the

number

of

days past the Install-by date. View the Status

screen

to see the number of

days

remaining

and

the

expiration

date.

You

cannot

install

a

cartridge

if

only 1

day

of

use is remaining. The system prompts

you

when

you

need

to

replace the

cartridge.

Store cartridges refrigerated at 2 to 8°C. Cartridges

can also be stored at

room

temperature,

not to exceed

25°C,

for up to 14

days.

32

Rev. D