Vitalcare 506N3 Series Manual de usuario

Cat. No. 1446

Date 08/07 Part No. 39178B101

Revision 1

VitalCareTM

506N3 Series

Patient Monitor

Service Manual

Page ii VitalCareTM 506N3 Series Service Manual Criticare Systems, Inc.

CRITICARE SYSTEMS, INC. (Criticare) owns all rights to this unpublished work

and intends to maintain this work as confidential. Criticare may also seek to

maintain this work as an unpublished copyright. This publication is to be used solely for

the purposes of reference, operation, maintenance, or repair of Criticare equipment.

No part of this publication may be reproduced in any manner or disseminated for

other purposes.

In the event of inadvertent or deliberate publication, Criticare intends to enforce its

rights to this work under copyright laws as a published work. Those having access

to this work may not copy, use, or disclose the information in this work unless

expressly authorized by Criticare to do so.

All product specifications, as well as information contained in this publication, are

subject to change without notice.

All information contained in this publication is believed to be correct. Criticare

Systems, Inc., shall not be liable for errors contained herein nor for incidental or

consequential damages in connection with the furnishing, performance, or use of

this material.

This publication may refer to information and products protected by copyrights or

patents and does not convey any license under the patent rights of Criticare

Systems, Inc., nor the rights of others. Criticare Systems, Inc., does not assume

any liability arising out of any infringements of patents or other rights of third

parties.

PROPERTY OF CRITICARE SYSTEMS, INC.

DOX™ oximetry and ComfortCuff™ NIBP technology are trademarks of Criticare

Systems, Inc.

OxiMax®SpO2technology is a registered trademark of Nellcor Puritan Bennett Inc.

FILAC®and FasTemp®are registered trademarks of TYCO Healthcare.

TurboTemp®is a registered trademark of Cardinal Health, Inc.

Criticare Systems, Inc. VitalCareTM 506N3 Series Service Manual Page iii

Contents.............................................................................................. iii

Warranty..............................................................................................ix

Service Return Policy...........................................................................x

EC Declaration .................................................................................... xi

Section 1 — Introduction

Description ........................................................................................1-1

Intended Use.....................................................................................1-2

About this Manual..............................................................................1-2

Non-Invasive Blood Pressure (NIBP)................................................1-3

Comfort Cuff Technology..........................................................1-3

Description of NIBP Measurement ...........................................1-3

Cuff Inflation and Pressure Protection......................................1-4

Heart Rate.........................................................................................1-5

DOX Pulse Oximetry Measurement (SpO2)......................................1-5

Definition...................................................................................1-5

DOX Digital Oximetry................................................................1-5

Method......................................................................................1-6

SpO2Clinical Testing and Accuracy.........................................1-6

Nellcor Pulse Oximetry Measurement (SpO2)...................................1-7

Definition...................................................................................1-7

Method......................................................................................1-7

Automatic Calibration................................................................1-8

Accuracy of OxiMax Sensors....................................................1-8

Functional versus Fractional Saturation ...................................1-8

Measured versus Calculated Saturation...................................1-9

Temperature....................................................................................1-10

Predictive Mode......................................................................1-10

Continuous Mode....................................................................1-11

Axillary Measurements ...........................................................1-11

Clinical Testing and Accuracy.................................................1-11

Specifications ..................................................................................1-12

Symbols...........................................................................................1-16

Safety ..............................................................................................1-18

Software Error Related Hazard Mediation..............................1-19

Potential Interference..............................................................1-19

Leakage Current.....................................................................1-19

Voltage Fluctuations...............................................................1-20

Defibrillation, HF, and Electronic Device Protection...............1-20

Biocompatibility.......................................................................1-20

Latex Content .........................................................................1-20

DEHP Content ........................................................................1-20

Contents

Page iv VitalCareTM 506N3 Series Service Manual Criticare Systems, Inc.

Section 2 — Service Menus

Introduction....................................................................................... 2-1

Service Mode.................................................................................... 2-1

Service Menus ......................................................................... 2-1

Primary Service Displays......................................................... 2-1

Secondary Service Displays .................................................... 2-2

Service Display List.................................................................. 2-2

Self Tests................................................................................. 2-4

NIBP Calibration Mode..................................................................... 2-6

LCD Text Display.............................................................................. 2-7

Using the Menus...................................................................... 2-7

Exit the Menu........................................................................... 2-7

Factory Defaults................................................................................ 2-8

Alarm Menu.............................................................................. 2-8

Parameter Setup...................................................................... 2-8

Printer Setup............................................................................ 2-9

Configuration Menu.................................................................. 2-9

NIBP Cycle Menu..................................................................... 2-9

Trend Menu............................................................................ 2-10

Patient Menu.......................................................................... 2-10

User Defaults.................................................................................. 2-10

Setting User Defaults............................................................. 2-10

Power Up in Service Mode..................................................... 2-11

Saving Unit Defaults............................................................... 2-11

Alarm Menu .................................................................................... 2-13

Alarm Volume......................................................................... 2-13

Pulse Volume......................................................................... 2-13

High Pulse.............................................................................. 2-14

Low Pulse............................................................................... 2-14

High SpO2.............................................................................. 2-14

Low SpO2 .............................................................................. 2-14

High Systolic .......................................................................... 2-14

Low Systolic........................................................................... 2-14

High Diastolic......................................................................... 2-14

Low Diastolic.......................................................................... 2-14

High MAP............................................................................... 2-14

Low MAP................................................................................ 2-14

High Temperature.................................................................. 2-15

Low Temperature................................................................... 2-15

Parameter Setup Menu................................................................... 2-15

Temperature Mode................................................................. 2-15

Degrees F/C........................................................................... 2-15

SpO2 Search.......................................................................... 2-15

NIBP Tone.............................................................................. 2-15

SpO2Average........................................................................ 2-15

Printer Setup Menu......................................................................... 2-16

On NIBP................................................................................. 2-16

On Alarm................................................................................ 2-16

Interval ................................................................................... 2-16

Print To................................................................................... 2-16

Serial...................................................................................... 2-16

Baud Rate.............................................................................. 2-16

Criticare Systems, Inc. VitalCareTM 506N3 Series Service Manual Page v

Configuration Menu.........................................................................2-17

Date........................................................................................2-17

Time........................................................................................2-17

Hour........................................................................................2-17

Minute.....................................................................................2-17

Day .........................................................................................2-17

Month......................................................................................2-17

Year........................................................................................2-17

Contrast ..................................................................................2-17

Temperature...........................................................................2-17

SpO2.......................................................................................2-17

NIBP .......................................................................................2-17

Enable MAP............................................................................2-17

International Configuration Settings ................................................2-18

Language................................................................................2-18

Trend Button Settings......................................................................2-18

Interval....................................................................................2-18

Format ....................................................................................2-18

Span .......................................................................................2-18

Patient Button Settings....................................................................2-18

Section 3 — Theory of Operation

System Architecture..........................................................................3-1

Module Architecture ..........................................................................3-2

Main Board ...............................................................................3-2

Display Board ...........................................................................3-2

NIBP Module.............................................................................3-3

DOX Module .............................................................................3-3

Nellcor Module..........................................................................3-3

Nellcor Carrier Board................................................................3-3

Temperature Modules...............................................................3-4

FasTemp Isolation Board..........................................................3-4

Printer Module ..........................................................................3-4

Block Diagram...................................................................................3-5

Section 4 — Cleaning and Disinfecting

Cleaning and Disinfecting..................................................................4-1

Blood Pressure Cuffs................................................................4-1

DOX Pulse Oximeter Sensors ..................................................4-2

OxiMax Pulse Oximeter Sensors..............................................4-2

Temperature Probes.................................................................4-4

Accidental Wetting.............................................................................4-5

Page vi VitalCareTM 506N3 Series Service Manual Criticare Systems, Inc.

Section 5 — Preventative Maintenance

Incoming Inspection.......................................................................... 5-1

Maintenance Schedule..................................................................... 5-1

Long-Term Storage........................................................................... 5-1

Service Checks................................................................................. 5-1

Calibration......................................................................................... 5-1

Serviceable Components.................................................................. 5-2

Battery Removal/Replacement ................................................ 5-2

Fuse Removal/Replacement.................................................... 5-4

Annual Testing.................................................................................. 5-5

Accessory Testing.................................................................... 5-5

Functional and Safety Testing.................................................. 5-5

Equipment and Tools............................................................... 5-6

Test Fixtures ............................................................................ 5-7

Electrical Safety Tests .................................................................... 5-10

Withstanding Voltage Test (Hi-Pot)........................................ 5-10

Equipment Needed ................................................................ 5-10

Setup Hi-Pot Tester................................................................ 5-10

Hi-Pot Performance Test........................................................ 5-11

Leakage Testing..................................................................... 5-13

Setup Procedure (Self-Test) .................................................. 5-13

Leakage Procedure................................................................ 5-14

Functional Tests ............................................................................. 5-16

System Check........................................................................ 5-16

Speaker Performance, Alarms Verification............................ 5-17

Power Supply Performance ................................................... 5-18

Printer Performance............................................................... 5-18

Monitoring Module Verification ....................................................... 5-19

NIBP Verification.................................................................... 5-19

NIBP Seal Test....................................................................... 5-20

SpO2Verification: CSI DOX Only .......................................... 5-21

SpO2Verification: Nellcor Only.............................................. 5-21

Temperature Verification........................................................ 5-23

Functional and Safety Testing Checklist......................................... 5-25

Section 6 — Service Testing & Calibration

Monitor Testing................................................................................. 6-1

Service Checks........................................................................ 6-1

Field Service Testing........................................................................ 6-1

Equipment and Tools............................................................... 6-2

Communication Testing.................................................................... 6-3

Equipment Required ................................................................ 6-3

Pinout Chart............................................................................. 6-3

Procedure................................................................................. 6-3

DOX SpO2Performance Testing...................................................... 6-4

Programming the SmartSat Analyzer....................................... 6-4

Test Procedure......................................................................... 6-4

Nellcor SpO2Performance Testing .................................................. 6-5

Programming the SmartSat Analyzer....................................... 6-5

Test Procedure......................................................................... 6-5

Criticare Systems, Inc. VitalCareTM 506N3 Series Service Manual Page vii

NIBP Calibration................................................................................6-6

Equipment Required.................................................................6-6

Installing the PC Service Program............................................6-6

Configuring the Ports................................................................6-6

Setup ........................................................................................6-7

Calibrate ...................................................................................6-8

Safety Test..............................................................................6-11

Speed Test .............................................................................6-14

Leak Test................................................................................6-16

Accuracy Test.........................................................................6-20

Other Module Testing and Calibration.............................................6-22

Section 7 — Disassembly

Before You Begin ..............................................................................7-1

Service Safety...........................................................................7-1

Electrostatic Discharge Protection............................................7-2

Tools Needed ...........................................................................7-2

Replace the Printer............................................................................7-3

Replace the Temperature Boards .....................................................7-5

Replacing the FasTemp Isolation Board...................................7-6

Replacing the FasTemp Board.................................................7-8

Replacing the TurboTemp Board............................................7-12

Replace the SpO2Board.................................................................7-13

DOX SpO2with TurboTemp or without Temperature.............7-14

DOX SpO2with FasTemp.......................................................7-15

Nellcor SpO2PCB/Carrier Board with TurboTemp or

without Temperature...............................................................7-18

Nellcor SpO2with FasTemp...................................................7-19

Front Bezel Service.........................................................................7-22

Disassemble Front Bezel from Rear Housing.........................7-22

Replace Main Board...............................................................7-24

Replace Speaker....................................................................7-29

Replace LCD and LED Display Boards ..................................7-31

Replace Membrane ................................................................7-35

Chassis Service/Pump Disassembly...............................................7-39

Replace ComfortCuff NIBP Module........................................7-41

Replace Power Supply ...........................................................7-42

Completion of Service.....................................................................7-43

Section 8 — Troubleshooting

Troubleshooting Guide......................................................................8-1

Page viii VitalCareTM 506N3 Series Service Manual Criticare Systems, Inc.

Section 9 — Drawings and Schematics

List of Drawings................................................................................ 9-1

Assembly Parts Lists................................................................ 9-1

PCB Drawing List.............................................................................. 9-2

Final Assemblies............................................................................... 9-3

506DN3.................................................................................... 9-3

506DNP3.................................................................................. 9-3

506DNT3.................................................................................. 9-4

506DNTP3 ............................................................................... 9-5

506LN3..................................................................................... 9-5

506LNP3.................................................................................. 9-6

506LNT3 .................................................................................. 9-7

506LNTP3................................................................................ 9-8

506DNV3.................................................................................. 9-9

506DNVP3............................................................................... 9-9

506LNV3................................................................................ 9-10

506LNVP3.............................................................................. 9-10

506N3..................................................................................... 9-11

506NP3.................................................................................. 9-11

506NT3 .................................................................................. 9-12

506NTP3................................................................................ 9-12

506NV3.................................................................................. 9-13

506NVP3................................................................................ 9-13

Base Assemblies ............................................................................ 9-14

Without Temperature ............................................................. 9-14

With Temperature .................................................................. 9-14

NIBP Only .............................................................................. 9-15

NIBP/TEMP............................................................................ 9-15

Front Bezel ..................................................................................... 9-16

Non-Temperature................................................................... 9-16

Temperature........................................................................... 9-16

NIBP Only .............................................................................. 9-17

NIBP/TEMP............................................................................ 9-17

Rear Housing Assembly................................................................. 9-18

Chassis Assembly .......................................................................... 9-18

NIBP ............................................................................................... 9-19

Module ................................................................................... 9-19

Pneumatic.............................................................................. 9-19

PCB Assembly................................................................................ 9-20

Printer Assembly............................................................................. 9-20

Appendix A — Main Board Upgrades

Overview...........................................................................................A-1

Battery Disconnect Warning Inducator.....................................A-1

Backward Compatability...................................................................A-1

Upgrading the Main Board................................................................A-2

Removing the old Main Board..................................................A-2

Installing the new Main Board..................................................A-4

Criticare Systems, Inc. VitalCareTM 506N3 Series Service Manual Page ix

Warranty

Workmanship &

Materials

Criticare Systems, Inc. (CSI) warranties the 506N3 Series monitor to

be free from defects in workmanship and materials for a period of one

(1) year from date of shipment under normal use and service. The

monitor warranty does not include batteries, sensors, probes, cables,

cuffs, and hoses. CSI’s obligation under this warranty is limited to

repairing or replacing, at CSI’s option, any part which upon CSI’s

examination proves defective.

Nellcor accessories carry a 90 day warranty.

EXCEPT AS DESCRIBED IN THE PARAGRAPH ABOVE, CSI

MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING

ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A

PARTICULAR PURPOSE.

Exemptions

CSI’s obligation or liability under this warranty does not include any

transportation or other charges or liability for direct, indirect or

consequential damages or delay resulting from the improper use or

application of the product or the substitution upon it of parts or

accessories not approved by CSI or repair by anyone other than a

CSI authorized representative.

This warranty shall not extend to any instrument which has been

subjected to misuse, negligence or accident; any instrument from

which CSI’s original serial number tag or product identification

markings have been altered or removed; or any product of any other

manufacturer.

Safety, Reliability &

Performance

Criticare Systems, Inc. is not responsible for the effects on safety,

reliability and performance of the 506N3 Series patient monitors if:

assembly operations, extensions, readjustments, modifications or

repairs are carried out by persons other than those authorized by

Criticare Systems, Inc., or

the 506N3 Series monitors are not used in accordance with the

instructions for use, or

the electrical installation of the relevant room does not comply with

NFPA 70: National Electric Code or NFPA 99: Standard for Health

Care Facilities (Outside the United States, the relevant room must

comply with all electrical installation regulations mandated by the

local and regional bodies of government).

In Case of Emergency

Contact

CRITICARE SYSTEMS, INC. Telephone: (262) 798-8282

20925 Crossroads Circle Tech Support: (800) 458-2697

Waukesha, WI 53186 Orders: (800) 458-4615

USA Fax: (262) 798-8290

Internet: www.csiusa.com

Page x VitalCareTM 506N3 Series Service Manual Criticare Systems, Inc.

Service Return Policy

Return Procedure

In the event that it becomes necessary to return a unit to Criticare

Systems, Inc., the following procedure should be followed:

Obtain return authorization. Contact the CSI Service Department

at 800-458-2697 to obtain a Customer Service Authorization (CSA)

number. (Outside the US, call 001-262-798-8282.) The CSA number

must appear on the outside of the shipping container. Return

shipments will not be accepted if the CSA number is not clearly

visible. Please provide the model number, serial number, and a brief

description of the reason for return.

Freight policy. The customer is responsible for freight charges when

equipment is shipped to CSI for service (this includes customs

charges).

Loaner service. In the U.S. If it is necessary to provide a loaner

system, CSI will ship a loaner by overnight courier. The loaner system

must be returned to CSI at the customer’s expense within one week

after receipt of the repaired goods. If the unit is not returned to CSI

within that time, the customer will be invoiced for the full purchase

price of the equipment.

Outside the U.S. No loaners are available from CSI internationally.

Contact your local CSI representative.

Incoming Inspection

The following incoming inspection is required whether it is a first time

arrival or a return from service. Prior to clinical use, the instrument

should be inspected for the following.

1. The quality inspection seal on the instrument should be

unbroken. This seal indicates that the instrument has been

tested according to manufacturers specifications.

2. No physical damage is observed.

3. The instrument's battery is to be charged by connecting the

instrument to a power outlet for a minimum of 6 hours prior to

clinical use.

4. When connecting the instrument to a power outlet and then

turning the instrument on, all displays appear to function

correctly and no system errors occur.

If a discrepancy to these inspection items is observed, do not use the

instrument and immediately report the discrepancy to the CSI

Service Department.

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