Welch Allyn Medical Diagnostic Equipment 300 Series User Manual

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Vital Signs Monitor

300 Series

Service Manual

ii

Welch Allyn Vital Signs Monitor 300 Series

© 2011 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual.

Welch Allyn and Flexible Monitoring are registered trademarks of Welch Allyn. POEM and FlexNet are trademarks of Welch Allyn.

Nellcor and Oximax are registered trademarks of Nellcor Puritan Bennett.

SET, LNCS, and Masimo are registered trademarks of Masimo Corporation. Possession or purchase of a Masimo SpO2- equipped monitor does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone or in combination with this device, fall within the scope of one or more of the patents relating to this device.

Software in this product is copyright by Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title and ownership of the software remain with Welch Allyn or its vendors.

For information about any Welch Allyn product, call Welch Allyn Technical Support:

USA

+ 1 315 685 4560

Australia

+ 61

2 9638 3000

 

800 535 6663

 

 

 

Canada

800 561 8797

China

+ 86

216 327 9631

European Call Center

+ 35 3 46 906 7790

France

+ 33

1 55 69 58 49

Germany

+ 49 7477 92 71 86

Japan

+81

42 703 6084

Latin America

+ 1 305 669 9003

Netherlands

+ 31

202 061 360

Singapore

+ 65 6419 8100

South Africa

+ 27

11 777 7555

United Kingdom

+ 44 20 7365 6780

Sweden

+ 46

8 58 53 65 51

This device complies with Part 15 of the FCC rules and with the rules of the Canadian ICES-003. Operation is subject to the following two conditions: (1) This device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation.

Caution! Changes or modifications not expressly approved by Welch Allyn could void the purchaser’s authority to operate the equipment.

810-2811-02 (CD)

Manual Part Number 810-1651-04 Rev A, 09/2011

Welch Allyn, Inc.

Regulatory Affairs Representative

8500 SW Creekside Plac

Welch Allyn Limited

Beaverton, OR 97008-7107 USA

Navan Business Park

 

Dublin Road, Navan

 

County Meath, Republic of Ireland

www.welchallyn.com

Printed in USA

Service Manual

iii

Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

General safety considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Electrostatic discharge (ESD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Service overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Purpose and scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Technical support services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Returning products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Product configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Recommended service intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Service options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Related documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Service menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Functional verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Functional verification overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Equipment required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Functional verification procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Checklist and test results report form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Troubleshooting and repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Troubleshooting chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Requirements for module-level repair and replacement. . . . . . . . . . . . . . . . . . . . . . . . . 36 NIBP characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Welch Allyn monitor service utility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Disassembly procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Procedures overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Remove and disconnect the battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Separate the front and rear chassis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Disassemble the front chassis assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Remove the LCD display from the main board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Disassemble the rear chassis assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Remove the main board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Disassemble and remove the NIBP assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Remove and replace the speaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Remove and disassemble the printer assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Disassemble the temperature module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Disassemble the Nellcor SpO2 assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Disassemble the Masimo SpO2 assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Replacement parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Updates and service bulletins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

DC power cable clamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

iv

Welch Allyn Vital Signs Monitor 300 Series

1

1 Safety

All personnel must read and understand all safety information presented in this manual before using or repairing the monitor.

Caution Use only the Welch Allyn Monitor Service Utility (810-1784-XX) with this monitor.

Software service tools, such as the “Custom Repair Software” (part number 130S29E), distributed for use with previous models of the Vital Signs Monitor, must not be used with the Model 300 Series. Use of any tool other than the Welch Allyn Monitor Service Utility (810-1784-XX) may set the monitor in an undefined and unrecoverable state.

United States federal law restricts this device to sale, distribution, or use by or on the order of a licensed medical practitioner.

General safety considerations

Always consider the following safety points when using the monitor:

Place the monitor and accessories in locations where they cannot harm the patient should they fall from a shelf or mount.

Do not connect more than one patient to a monitor.

Do not connect more than one monitor to a patient.

Do not use the monitor in an MRI suite or hyperbaric chamber.

Do not autoclave the monitor.

Accessories can be autoclaved only if the manufacturer’s instructions clearly approve it. Many accessories can be severely damaged by autoclaving.

Inspect the power adapter cord periodically for fraying or other damage. Replace the adapter as needed. Do not operate the monitor from mains power if the adapter, the adapter cord, or the cord plug is damaged.

Frequently check all cables, both electrically and visually.

To avoid explosion, do not operate the monitor in the presence of flammable anesthetics.

WARNING Use only accessories approved by Welch Allyn. Visit www.welchallyn.com. The use of any other accessories can result in inaccurate patient data, can damage the equipment, and can void your product warranty.

WARNING Always use accessories according to the standards of your facility and according to the manufacturer's directions for use.

2

Safety

Welch Allyn Vital Signs Monitor 300 Series

A monitor that has been dropped or otherwise damaged or abused must not be used until it has been tested and verified by qualified service personnel for proper operation.

If the monitor detects an unrecoverable problem, an error code and a brief message appear in the message display. Report all such errors to Welch Allyn.

While under warranty, the monitor must be serviced only by a Welch Allyn service technician.

Electrostatic discharge (ESD)

CAUTION

SENSITIVE ELECTRONIC DEVICES

DO NOT SHIP OR STORE NEAR STRONG ELECTROSTATIC, ELECTROMAGNETIC, MAGNETIC OR RADIOACTIVE FIELDS.

ATTENTION

OBSERVE PRECAUTIONS

FOR HANDLING

ELECTROSTATIC

SENSITIVE DEVICES

WARNING Electrostatic discharge (ESD) can damage or destroy electronic components. Handle static-sensitive components only at static-safe workstation.

WARNING Consider all electrical and electronic components of the monitor as static-sensitive.

Electrostatic discharge is a sudden current flowing from a charged object to another object or to ground. Electrostatic charges can accumulate on common items such as foam drinking cups, cellophane tape, synthetic clothing, untreated foam packaging material, untreated plastic bags, and work folders, to name only a few.

Electronic components and assemblies, if not properly protected against ESD, can be permanently damaged or destroyed when near or in contact with electrostatically charged objects. When you handle components or assemblies that are not in protective bags and you are not sure whether they are static-sensitive, assume that they are static-sensitive and handle them accordingly.

Perform all service procedures in a static-protected environment. Always use techniques and equipment designed to protect personnel and equipment from electrostatic discharge.

Remove static-sensitive components and assemblies from their static-shielding bags only at static-safe workstations—a properly grounded table and grounded floor mat— and only when you are wearing a grounded wrist strap (with a resistor of at least 1 megohm in series) or other grounding device.

Use only grounded tools when inserting, adjusting, or removing static-sensitive components and assemblies.

Remove or insert static-sensitive components and assemblies only with monitor power turned off.

Insert and seal static-sensitive components and assemblies into their original staticshielding bags before removing them from static-protected areas.

Always test your ground strap, bench mat, conductive work surface, and ground cord before removing components and assemblies from their protective bags and before beginning any disassembly or assembly procedures.

Service manual

Safety

3

Symbols

The symbols illustrated on the following pages appear on the monitor or in this document.

Documentation symbols

WARNING Indicates conditions that could lead to illness, injury, or death.

Caution In this manual, indicates conditions that could damage equipment or other property.

Caution On the product, means “Consult accompanying documentation.”

Certification and operation labels

This device has been tested and certified by the Canadian Standards Association International to comply with applicable U.S. and Canadian medical safety standards.

Urgent alarm notification (output to Nurse Call system)

 

 

 

 

Patient connections are Type BF, and protected

 

Recycle used batteries properly and in accordance

 

 

 

 

 

 

 

against defibrillation.

 

with local regulations.

 

 

 

 

 

 

 

 

Do not dispose of batteries in refuse containers.

 

 

 

 

Australian Registered Importer

 

Sealed lead-acid battery, 6V 4 Ah

 

 

 

 

 

 

 

 

 

 

 

 

Shipping, storing, and environment labels

Keep this end of the package or shipping crate up.

Protect the monitor from exposure to rain.

Do not expose the monitor to relative humidity above this limit.

Do not subject the monitor to altitudes outside these limits.

Fragile contents—handle with care.

 

Limit stacking to this number of units.

 

 

 

 

 

 

Do not expose the monitor to temperatures

outside these limits.

Monitor connector labels

Temperature Probe Cable Connector

SpO2

SpO2 Sensor Cable Connector

RS232 Cable Connector

 

AC Power Adapter Cable Connector

Nurse Call Cable Connector

 

NIBP Hose Connector

4

Safety

Welch Allyn Vital Signs Monitor 300 Series

Printer door label

Press to open the printer door

Load paper this direction

The monitor front panel controls are described in more detail throughout this document.

Front panel controls

Set alarm limits

Power on/off

Silence alarms

Print patient data

Scroll up/down, Scroll forward/back,

Review patient data

Increase/decrease value

 

(The scroll icon appears as these two arrows in the documentation.)

Set an NIBP automatic measurement interval

Cycle to the next menu selections

Start/stop an NIBP cycle (AUTO button)

Front panel displays and indicators

SYS

Systolic pressure

 

Temperature

DIA

Diastolic pressure

 

 

SpO2

Arterial hemoglobin oxygen saturation

 

 

 

Pulse rate

pulse

Pulse strength

 

 

amplitude

 

 

 

indicator

 

message

MAP (mean arterial pressure)

 

Neonatal

window

 

 

 

ºC

Degrees Celsius

 

Pediatric

ºF

Degrees Fahrenheit

 

Adult

 

 

 

M

Monitored temperature

 

AC power

 

 

Battery charging (flashing)

 

 

Battery charged (steady)

 

Battery low

 

 

 

Battery fully discharged

 

 

5

2 Service overview

Purpose and scope

This service manual is a reference for periodic preventive maintenance and corrective service procedures for the Vital Signs Monitor 300 Series.

Corrective service is supported to the level of field-replaceable units. These include some circuit-board assemblies and some subassemblies, case parts, and other parts. (See “Replacement parts” on page 87 for a complete list of user-replaceable service parts.)

Note Repair and replacement of the main board is not supported. All service work on the main board must be performed by certified and qualified service personnel at an authorized Welch Allyn service center.

Caution No component-level repair of circuit boards and subassemblies is supported. Use only the repair procedures described in this manual.

WARNING When performing a service procedure, follow the instructions exactly as presented in this manual. Failure to do so could damage the monitor, invalidate the product warranty, and lead to serious personal injury.

This guide provides troubleshooting information, assembly procedures, and instructions for functional testing and performance verification. It is intended for use only by technically qualified service personnel.

This guide applies only to the Vital Signs Model 300 Series. For servicing the previous (52000-series) version of the Vital Signs Monitor, refer to Welch Allyn service manual 95P445E, which is available on the TechView CD (900298-1).

Technical support services

Welch Allyn offers the following technical support services:

Telephone support

Loaner equipment

Service agreements

Service training

Replacement service parts

Factory Service

For information on any of these services, contact Welch Allyn at the Technical Support: numbers listed on page ii.

6

Service overview

Welch Allyn VSM 300 Series

Returning products

To return a product for service, contact Welch Allyn Technical Support and request a Return Material Authorization (RMA) number.

Note Welch Allyn does not accept returned products without an RMA.

When requesting an RMA, please have the following information available:

Product name, model number, and serial number

A complete return shipping address, including a contact name and phone number; include any special shipping instructions

A purchase-order number or credit-card number if the product is not covered by warranty or service agreement

A full description of the problem or service request

To ship the monitor, please observe these packing guidelines:

Remove from the package all hoses, connectors, cables, sensors, power cords, and other ancillary products and equipment, except those items that might be associated with the problem.

Use the original shipping carton and packing materials, or as close an approximation as possible.

Include a packing list.

Write the Welch Allyn RMA number with the Welch Allyn address on the outside of the shipping carton.

United States federal regulations require that any unit received by Factory Service must be free from blood-borne pathogens before processing. All incoming products are cleaned as well as possible, but products that cannot be effectively cleaned cannot be accepted for repair. Please thoroughly clean all organic residues from the product before shipment. This will ensure safe receipt, processing and repair, and will help expedite the return of your monitor.

Product configurations

Model numbers for the configurations are as follows:

Model

Features

Model

Features

 

 

 

 

 

 

53000

Standard (NIBP, Pulse Rate, and MAP)

530T0

Standard + Temperature

 

5300P

Standard + Printer

530TP

Standard + Temperature + Printer

53N00

Standard + Nellcor® SpO

53S00

Standard + Masimo® SpO

 

2

 

 

2

53NT0

Standard + Nellcor SpO2 + Temperature

53ST0

Standard + Masimo SpO2 + Temperature

53N0P

Standard + Nellcor SpO2 + Printer

53S0P

Standard + Masimo SpO2

+ Printer

53NTP

Standard + Nellcor SpO2 + Temperature + Printer

53STP

Standard + Masimo SpO2

+ Temperature + Printer

 

 

 

 

 

Service manual Service overview 7

Recommended service intervals

Interval or Condition

Action Recommended

Procedure

Page

 

 

 

 

Every 6 - 24 months

Complete functional test

Functional verification

9

(per hospital protocols)

 

 

 

Battery does not hold a charge

Check battery capacity

Functional verification

9

 

Replace battery

Disassembly procedure

55

Monitor has been dropped or

Complete functional test

Functional verification

9

otherwise damaged

 

 

 

Monitor malfunctioning

Complete functional test

Functional verification

9

Monitor does not pass

Troubleshooting and repair followed by

Troubleshooting and repair

33

Functional Verification

functional test; if necessary, return to

Disassembly procedure

55

 

authorized service center

Functional verification

9

 

 

 

 

Service options

Warranty service

All repairs on products under warranty must be performed or approved by Welch Allyn. Refer all warranty service to Welch Allyn Factory Service or another authorized Welch Allyn Service Center. Obtain an RMA number for all returns to Welch Allyn Factory Service – see “Returning products” on page 6.

Caution Unauthorized repairs will void the product warranty.

Non-warranty service

Welch Allyn Factory Service and authorized Service Centers support non-warranty repairs. Contact any Welch Allyn regional service center for pricing and service options.

Welch Allyn offers modular repair parts for sale to support non-warranty service. This service must be performed only by qualified end-user biomedical/clinical engineers using this service manual.

The Welch Allyn Monitor Service Utility supports certain service functions. For information, see “Welch Allyn monitor service utility” on page 37.

Related documents

Title

 

Reorder number

Vital Signs Monitor 300

Series Directions for Use (Masimo, multilanguage)

810-2250-XX

Vital Signs Monitor 300

Series Directions for Use (Nellcor, multilanguage)

810-2252-XX

Service menu

To see the service menu, first power the monitor off. Press and hold for 3 seconds. While is depressed, press until the monitor displays the message Service Mode.

8

Service overview

Welch Allyn VSM 300 Series

The monitor runs a self-test and then displays the main software version number (M: X.XX.XX). Press repeatedly to cycle to the menu selection of interest.

/min

SYS

SpO2 %

DIA (mmHg)

3 seconds SERVICE MODE

Power-up Self-test

RESET TO DEFAULT

Main SW version

 

M: X.XX.XX

YES

NO

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BP CYCLES:XXXXXX

 

 

 

 

NIBP SW version

 

 

 

 

 

 

 

 

 

 

 

 

N:XX.XX.XX

 

 

RUN TIME:XXXXX

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

POWER OFF

Exit Service Mode

 

 

 

 

 

 

 

 

 

 

BATTERY:X.XX V

 

 

 

SpO2 SW version

 

 

 

 

 

 

 

 

 

 

S:X.X.X.X

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NIBP TEST

Temperature SW version

T:X.X

9

3 Functional verification

Functional verification overview

This section describes the procedure for a complete functional test to support recommended preventive-maintenance schedules.

The verification includes tests for a monitor configured with the printer, temperature, and SpO2 options. Perform only the tests applicable to the actual configuration.

A checklist of the functional tests is provided on “Checklist and test results report form” on page 31. It is recommended that you print a copy of the checklist each time you perform the functional verification procedure, so that you can record and save the test results. If the monitor ever requires service, the records of test results can often facilitate troubleshooting.

Functional verification does not require opening the monitor case.

Equipment required

This equipment is required for functional verification of a fully configured monitor.

Commercially available general-purpose/medical test equipment

Item

Manufacturer part number/specification

 

 

Power supply

Variable, 0-8 VDC, 0.75 amperes (minimum), with voltage and current

 

indicators (for 1mA current measurement)

Digital pressure meter

Netech Digimano 1000 or equivalent

AC withstand voltage (hi-pot) tester

Associated Research 3605 or equivalent

SpO2 functional tester (Nellcor, for testing

Nellcor SRC-MAX

the monitor only)

 

SpO2 functional tester (Masimo, for testing

Masimo Tester REF 1593

the monitor only)

 

SpO2 extension cable (required for SRC-

Nellcor DEC-8

MAX)

 

SpO2 simulator (for testing the monitor and

Fluke (Biotek) Index2 XL/XLFE or equivalent

the SpO2 sensor)

 

Syringe, 60 mL, Slip tip, Luer

BD (Becton, Dickinson) 309654 or equivalent

Hi-pot cable connectors

See “Test connections” on page 29.

Timer (to display elapsed time, in seconds)

 

 

 

10

Functional verification

Welch Allyn VSM 300 Series

 

Welch Allyn accessories and test equipment

 

 

Order number

Description

06138-000

Temperature test key

 

(for testing the monitor only)

01802-110, 110 V

9600 Plus Calibration Tester

01802-220, 220 V

(for testing the monitor and the temperature probe)

008-0265-XX

Neonatal cuff hose, 96-inch

008-0620-XX

Neonatal #1 cuff, disposable, box of 10

020-0702-XX

Cuff simulator (or equivalent 500 cc test volume)

5200-101A

DC power adapter

407590

Battery substitution connector

810-1784-XX

Welch Allyn Monitor Service Utility

 

(required for NIBP repair or replacement;

 

not required for functional testing)

008-0842-XX

Service Serial Cable (for use with the Welch Allyn Monitor

 

Service Utility 810-1784-XX)

WA 5088-01

Tycos air release valve and small bulb

600-0021-XX

NIBP tubing connector, threaded

600-0179-XX

Tubing, 1’

600-0043-XX

Tee, plastic

Service manual

Functional verification

11

Functional verification procedure

Reference illustration

 

 

 

 

 

Fahrenheit

Systolic

 

 

 

 

Celsius

 

 

 

 

 

window

 

 

 

 

Print patient data

Diastolic

 

 

 

/min

Change settings

window

SYS

SpO2 %

 

 

 

 

 

 

 

Adult

 

 

 

 

Monitored

DIA

 

 

 

temperature

Pediatric

 

 

 

 

Increase/Decrease

Neonatal

 

 

 

 

 

 

 

 

Forward/Back

 

 

 

 

 

Message

 

 

 

 

Battery charged

window

 

 

 

 

Battery charging

 

 

 

 

 

Battery low

Power

Review

Set

Start/

Set

Silence

On/Off

patient

NIBP

stop

alarm

alarms

 

data

interval

NIBP

limits

 

System/power

Note Other than the optional NIBP overpressure test (page 18), the tests described here must be performed as part of a complete functional verification procedure.

Setup

If the monitor is configured with the temperature option, connect the temperature probe and insert it into the probe well.

If you are using an optional Welch Allyn Model Calibration Tester, plug it in and set it to the values that match your tester model:

Model

Temperature

 

 

 

 

9600

96.4 °F

(35.8 °C)

9600 Plus

96.8 °F

(36.0 °C)

 

 

 

If the monitor is configured with the SpO2 option, connect the SpO2 sensor.

Battery charge and beeper

1.With the monitor turned off, disconnect the power adapter from the monitor.

2.Verify that the charge LED is off.

3.Connect the power adapter. The monitor emits a single beep tone.

4.Verify that the charge LED is on.

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Note Depending on the charge level of the battery, the charge LED may be either flashing or steady.

flashing indicates that the monitor is running on AC, the battery is charging, and the battery is charged to less than 90% capacity.

steady indicates that the monitor is running on AC, the battery may or may not be charging, and the battery is charged to at least 90% capacity.

Battery substitution cable setup

1.Disconnect the power adapter.

2.Remove the battery cover and remove and disconnect the battery.

3.Connect the open-ended red (+) and black (–) wires of the battery substitution cable (407590) to the variable DC power supply.

4.Set the power supply to 6.0 V ± 0.25 V.

WARNING Do not exceed 8.0 V.

5. Connect the test power cable to the battery connector on the monitor.

Monitor-off current

With the monitor powered down, verify that the current draw from the power supply is less than 1 mA.

Power-on self-test

1. Power the monitor on.

Note If the monitor displays error E38, power the monitor off and then power it on again.

2.Verify that the start-up tone (double beep) is audible.

3.Verify that all front-panel lights (background indicators, LCD pixels, and LED segments and periods) come on in the proper order: left, center, and right.

Initialization/idle mode current

Note If your monitor is configured without the temperature option and without the SpO2 option, skip these steps and proceed to “Baseline current draw” on page 13.

1.If the temperature option is present:

a.Verify that the temperature probe is in the probe well.

b.Set the temperature mode to MONITOR.

c.Remove the temperature probe from the probe well.

d.Verify that the temperature reading appears within 4 seconds.

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e.Do not return the probe to the probe well.

2.If the SpO2 option is present:

a.Verify that the SpO2 sensor cable is connected to the monitor.

b.Verify that the current draw from the bench power supply is less than 800 mA.

3.Disconnect the SpO2 sensor (if equipped).

4.Insert the temperature probe (if the monitor is so equipped) into the probe well.

Baseline current draw

1.With the monitor powered on, wait for the monitor LEDs to blank. In this state, the SpO2 % reads - -, the time of day is displayed in the message window, and the rest of the displays are blank.

2.Note and record the exact current from the power supply. (This value will be used in the NIBP and printer tests.)

Battery voltage

1.Power the monitor off.

2.Simultaneously press and hold and to bring up the monitor in SERVICE MODE. (When the monitor completes the power-on self-test in service mode, the main software version number appears in the message display.)

3.Press repeatedly until BATTERY VOLTAGE appears in the message display.

4.Verify that the displayed battery voltage is within 0.1 volt of the DC power supply input.

5.Exit Service Mode by turning off the monitor and then turning it on again.

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NIBP

Note The tests described in this section are to be performed only as part of a complete functional verification procedure.

Characterization test

1.Attach a neonate hose (part 008-0265-01) to the NIBP fitting on the monitor.

2.Prepare the 60-mL syringe as follows, with reference to the illustration below:

a.Move the syringe plunger to the 35 mL line.

b.Drill a small hole (for example, 9/64 inch) through the syringe and the plunger shaft, at a location between the plunger and the top of the syringe.

c.Insert a rod or bolt (for example, a 6-32 screw) through the hole so that the plunger cannot move, creating a constant volume in the syringe of 35 mL ± 2 mL. Secure the rod or bolt so that it cannot fall out of the hole.

--

--

--

--

--

--

--

--

--

--

--

--

60

 

50

 

40

 

30

 

20

 

10

 

ml

 

 

 

 

 

 

 

 

 

 

 

3.Insert the tip of the syringe into the open end of the neonate hose. Verify that the fit is tight and secure.

4.Set the monitor patient type to Adult, as follows:

a. Press once.

b. If the monitor is not already in Adult mode, press once or twice until Adult appears in the message display.

c. Press .

5. Press .

6. Verify that the error code C03 appears in the message display within a few seconds.

WARNING If the error code C03 does not appear, characterize NIBP according to the instructions presented on page 36, and then repeat the NIBP characterization test.

WARNING Do not use the monitor if it does not pass the NIBP characterization test. If the NIBP module is not properly characterized, the monitor could overinflate a neonatal cuff, which could create a hazard for neonatal patients.

WARNING If you cannot characterize the NIBP module, remove the monitor from service immediately and return it to Welch Allyn for service. (See “Returning products” on page 6.)

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Leak test

This tests the NIBP system for abnormal leakage.

If the NIBP system is leaking, check for leaks in the external plumbing before opening the case to look for internal leaks.

If you determine that any NIBP module component is causing abnormal leakage, you must replace the NIBP module before returning the monitor to clinical use.

Caution Do not attempt component-level repair of the NIBP module. Any change to the NIBP module requires that the monitor be returned to the factory for NIBP module calibration.

1.Put the monitor in Service mode:

a.Power the monitor off.

b.Power the monitor on while pressing.

WARNING Do not connect the monitor to a patient while the monitor is in Service mode. Overpressure detection is disabled while the monitor is in NIBP test mode.

2.Attach a #1 neonatal cuff and hose to the monitor

Wrap the cuff securely around a solid cylindrical object of circumference between 1.6 and 1.9 inches (4.1 and 4.8 cm).

3.Press repeatedly until NIBP TEST appears in the message window and 0 is displayed in the SYS and DIA windows.

Note When you first enter the NIBP test mode, give the monitor about a minute to initialize NIBP before you change the target test pressure.

When switching from one target pressure to the next, give the monitor time to fully inflate and stop before you select the next target pressure.

In the NIBP test mode, press repeatedly to select the target NIBP test pressure. The target pressure is displayed on the DIA LEDs. The measured instantaneous pressure determined by the monitor is displayed on the SYS LEDs.

4.Press once to select 80 mmHg (10.7 kPa). The cuff inflates to approximately 115 mmHg (15.3 kPa).

Note In the NIBP test mode, and especially at small test volumes, the pressure achieved can vary significantly (30-40 mmHg or 4-5.3 kPa) from the target pressure.

5.Wait 15 seconds, and note the current pressure.

6.Wait another 10 seconds and verify that the pressure has not dropped more than 8 mmHg (1.1 kPa) below the pressure noted in step 5.

If the pressure drop is greater than 8 mmHg (1.1 kPa), check the cuff, the hose, and all external connections for leaks, and then repeat from step 3.

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7.Press several times to select 0 mmHg (0 kPa). The valve opens to release pressure.

8.Disconnect the neonate cuff.

Pressure calibration verification

This tests pressure readings on the monitor against a calibrated external pressure meter.

1.Put the monitor in Service mode:

a.Power the monitor off.

b.Power the monitor on while pressing.

WARNING Do not connect the monitor to a patient while the monitor is in Service mode. Overpressure detection is disabled while the monitor is in NIBP test mode.

2.Connect the monitor to an adult cuff or a 500 cc test volume, a pressure meter or a manometer, and a pump bulb, as shown.

3.Press repeatedly until NIBP TEST appears in the message window and 0 is displayed in the SYS and DIA windows.

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4.Press once to select 80 mmHg (10.7 kPa). The cuff quickly inflates to approximately 80 mmHg (10.7 kPa), and then settles at a slightly lower pressure level. Wait a few seconds for the pressure to stabilize.

5.Verify that the value displayed in SYS is within 3 mmHg (0.4 kPa) of the value displayed on the digital pressure meter.

6.Press to select 150 mmHg (20 kPa) target pressure. The cuff quickly inflates to approximately 150 mmHg (20 kPa), and then settles at a slightly lower pressure level. Wait a few seconds for the pressure to stabilize.

7.Verify that the value displayed in SYS is within 3 mmHg (0.4 kPa) of the value on the digital pressure meter.

8.Press to select 300 mmHg (40 kPa). The cuff quickly inflates to approximately 300 mmHg (40 kPa), and then settles at a slightly lower pressure level. Wait a few seconds for the pressure to stabilize.

9.Verify that the value displayed in SYS is within 6 mmHg (0.8 kPa) of the value on the digital pressure meter.

Valve and pump current, inflation, and deflation tests

Note Replace the internal battery with an external power supply. (See “Battery substitution cable setup” on page 12.)

To test pump current

1.Put the monitor in Service mode:

a.Power the monitor off.

b.Power the monitor on while pressing.

WARNING Do not connect the monitor to a patient while the monitor is in Service mode. Overpressure detection is disabled while the monitor is in NIBP test mode.

2.Press repeatedly until NIBP TEST appears in the message window and 0 is displayed in the SYS and DIA windows.

3.Press to select 0 mmHg (0 kPa) target pressure.

4.While watching the current meter, press to select 80 mmHg (10.7 kPa) target pressure.

5.Note the highest current reading during inflation.

6.While the pump is running, verify that the reading on the current meter is not more than 750 mA above the current level noted in step 2 of the verification test (“Baseline current draw” on page 13).

7.Press three times to select 0 mmHg (0 kPa) target pressure.

To test inflation

1.Press repeatedly until NIBP TEST appears in the message window and 0 is displayed in the SYS and DIA windows.

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2.Press once to select 80 mmHg (10.7 kPa).

3.Wait for the pump to start and stop.

4.Press once to select 150 mmHg (20 kPa).

5.Wait for the pump to start and stop.

6.Bleed the pressure to 0 by opening the relief valve on the bulb.

7.Close the relief valve on the bulb.

8.Have a timer ready.

9.Press once to select 300 mmHg (40 kPa), and immediately observe the manometer.

10.As soon as the manometer reads 5 mmHg (0.67 kPa), start the timer.

11.When the manometer reaches 250 mmHg (33.3 kPa), stop the timer.

12.Verify that the elapsed time (step 11 minus step 10) is less than 8 seconds.

To test deflation

1.If the pressure has dropped more than 10 mmHg, use the pump bulb to raise it to 300 mmHg ± 5 mmHg.

2.While the pressure is still at approximately 300 mmHg (as shown by the manometer and the SYS window), press once to select 0 mmHg, and immediately start the timer.

3.After 10 seconds, verify that the manometer reads less than 15 mmHg.

If you are doing the NIBP overpressure test, skip to “Overpressure tests (optional)” on page 18.

4.Disconnect the hose from the monitor.

Overpressure tests (optional)

Note Redundant circuitry in the VSM 300 series monitor guarantees that the bloodpressure cuff cannot overinflate.

The allowable cuff pressure and the overpressure cutoff are controlled by software. A software failure (a defective PROM) would generate a checksum error, disabling monitor operation and setting it in a safe mode.

These tests demonstrate that:

the monitor cannot exceed the maximum allowable cuff pressure for adults (280 mmHg), pediatrics (200 mmHg), and neonates (141 mmHg)

the overpressure cutoff feature shuts down the pump and dumps pressure before the pressure reaches 330 mmHg (44 kPa)

To verify maximum allowable cuff pressure for NIBP version 3.20.00

1.Assemble one of the test setups illustrated on page 16, using an adult cuff or cuff simulator.

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2.Turn on the monitor.

3.Set the monitor to ADULT mode.

a.Press once.

b.Press repeatedly until ADULT appears.

4.Set the inflation target pressure to 270 mmHg (36 kPa).

a.Press repeatedly until TARGET PRESSURE appears in the display window.

b.Press repeatedly as needed to set the target pressure (displayed in the SYS window) to 270 mmHg (36 kPa).

5.Press to start the pump.

The pressure reaches approximately 270 mmHg (36 kPa), the pump shuts off, and the pressure begins stepping down.

6.Carefully squeeze the pump bulb to raise the pressure to 280 mmHg (37.3 kPa).

• The dump valve opens and quickly drops the pressure to approximately 0.

• The monitor displays C10 to indicate that an overpressure event has occurred.

7.Set the monitor to PEDIATRIC mode.

8.Set the inflation target pressure to 170 mmHg (22.7 kPa).

9.Raise the pressure to 200 mmHg (26.7 kPa).

a.Press and wait for the pressure to reach 170 mmHg (22.7 kPa). The pump shuts off and the pressure reading starts stepping down.

b.Carefully squeeze the pump bulb to raise the pressure to 200 mmHg (26.7 kPa).

The dump valve opens and quickly drops the pressure to approximately 0.

The monitor displays C10 to indicate that an overpressure event has occurred.

10.Replace the adult cuff with a #1 neonate cuff, and wrap the neonate cuff securely around a solid cylindrical object with circumference between 1.6 and 1.9 inches (4.1 and 4.8 cm).

11.Set the monitor to NEONATE mode.

12.Set the inflation target pressure to 132 mmHg (17.6 kPa).

13.Raise the pressure to 141 mmHg.

a.Press and wait for the pressure to reach 132 mmHg (17.6 kPa). The pump shuts off and the pressure reading starts stepping down.

b.Carefully squeeze the pump bulb to raise the pressure to 141 mmHg (18.8 kPa).

The dump valve opens and quickly drops the pressure to approximately 0.

The monitor displays C10 to indicate that an overpressure event has occurred.

To verify overpressure cutoff for NIBP versions 4.20.00 and later

This test demonstrates that the overpressure cutoff feature prevents pressure from rising fast enough to exceed the cutoff pressure (295 to 330 mmHg, or 39.3 to 44.0 kPa) before the pump stops and the dump valve and the bleed valve open.

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Welch Allyn VSM 300 Series

When the overpressure cutoff triggers, the pump stops, the dump and bleed valves open, and the monitor displays E40. Any subsequent button press shuts off the monitor.

Note Due to NIBP implementation differences, this test does not verify overpressure cutoff in earlier NIBP versions.

In those versions, due to a longer software delay in activating the cutoff function, the normal overpressure cuff pressure is exceeded before the overpressure cutoff safety triggers. If the normal overpressure-detection algorithm were to fail, the overpressure cutoff safety function would trigger immediately.

1.Restart the monitor.

2.Set the monitor to ADULT mode.

3.Set the inflation target pressure to 270 mmHg (36.0 kPa).

4.Increase the inflation rate, causing the overpressure cutoff to stop the pump and open the bleed and dump valves.

a.Start the pump.

b.When the pressure (SYS window) reaches approximately 230 mmHg (32.4 kPa), very rapidly squeeze the pump bulb while observing the digital pressure meter.

Assuming that you squeeze the bulb rapidly enough to reach the trigger threshold and activate the overpressure cutoff:

The pressure does not exceed 280 mmHg.

The dump valve and bleed valve open, dropping the pressure to approximately 0.

E40 appears in the Sys window.

Pressing any button causes the monitor to shut down.

5.Disconnect the test setup from the monitor.

If you executed this test as part of the functional verification procedure, proceed to...

“Printer” on page 21.

If the monitor has no printer, “SpO2” on page 23.

If the monitor has no SpO2 option, “Temperature” on page 25.

If the monitor has no temperature option, “Nurse call” on page 27.

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Printer

Note This test is to be performed only as part of a complete functional verification procedure.

1.Put the monitor into Service Mode.

2.Verify that the printer has paper.

3.Press . Verify that a settings report prints, and that it contains no printed anomalies and no missing or faded sections.

Note With a new roll of paper, the first line might be faded. This does not indicate a problem.

Note The settings report (as shown in the example below) contains a calibration record, user record, hardware status record, and software versions record.

The calibration record includes manufacturing configuration data: monitor serial number, set parameters, and language.

The user record includes user-configurable settings: alarm limits, patient type, parameter modes/units, auto interval, tone volume, and others.

The hardware status record shows the hardware revision number, the battery voltage level, the total number of NIBP monitoring cycles completed on the monitor, and the total number of hours of operation of the monitor.

The software versions record indicates the software version numbers of the main board, SpO2 and Temperature options (if present), and NIBP.

4.After 2 seconds of printing, verify that the current draw is no more than 2.5A above the baseline current recorded in step 2 of the verification test “Baseline current draw” on page 13.

5.Exit the Service Mode.

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SpO2

Note The tests described in this section are to be performed only as part of a complete functional verification procedure.

Perform one of the following three SpO2 tests.

Testing the monitor only (Nellcor SpO2)

Use this procedure to test only the monitor SpO2 function.

1.Power the monitor off.

2.Connect the Nellcor SRC-MAX SpO2 functional tester to the SpO2 input connector through a Nellcor DEC-8 extension cable.

3.Power the monitor on.

Note In the following tests, if the SRC-MAX defaults are outside the monitor alarm limits, readjust the limits or silence the alarms.

4.Verify the following on the SRC-MAX:

All of the monitor LEDs flash: left panel, center panel, right panel.

SRC-MAX initializes to a default condition where the four test parameter LEDs are lit closest to their selector buttons

The default pulse rate is 60 bpm and the default SpO2 is 75%

5.Give the monitor up to 30 seconds to stabilize, and verify a displayed pulse rate of 60 ± 3 bpm and a displayed SpO2 of 75 ± 3%.

6.Set the SRC-MAX pulse rate to 200 bpm.

7.Give the monitor up to 30 seconds to stabilize, and verify a displayed pulse rate of 200 ± 3 bpm.

8.Switch the SRC-MAX SpO2 saturation percentage to 90.

9.Give the monitor up to 30 seconds to stabilize, and verify a displayed SpO2 saturation level of 90 ± 3%.

10.Disconnect the SRC-MAX.

Testing the monitor only (Masimo SpO2)

Use this procedure to test only the monitor SpO2 function.

1.Power the monitor off.

2.Connect the Masimo Tester REF 1593.

3.Power the monitor on.

4.Give the monitor up to 30 seconds to stabilize, and then verify a displayed pulse rate (from SpO2) of 61 bpm ± 1 bpm and a displayed saturation of 81% ± 3%.

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Welch Allyn VSM 300 Series

Testing the sensor with the monitor

Use this procedure to test the monitor SpO2 function while verifying a sensor.

1.Connect an SpO2 sensor to the simulator optical finger and to the monitor.

2.Set the BioTek Index2 SpO2 simulator as follows:

SpO2 manufacturer type

Nellcor (MP-506A or Nell-3A)

 

Masimo (MS-11)

 

 

% SpO2

94

Rate

60 (Motion Artifact not selected)

 

 

3.Wait for the monitor display to stabilize.

4.Verify an SpO2 saturation level of 94 ± 4.

5.Verify that the monitor displays a pulse rate of 60 ± 4.

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Temperature

Note The tests described in this section are to be performed only as part of a complete functional verification procedure.

Perform one of the following temperature tests.

Testing the monitor only

Use this procedure to test only the temperature function.

1.With monitor power on and with the temperature probe in the well, disconnect the probe cable from the temperature input connector on the rear of the unit.

2.Connect the Welch Allyn Sure Temp Plus temperature test key (06138-000) to the temperature input connector.

3.Remove the probe from the well.

4.Verify that the displayed temperature is 97.3 ± 0.2 F (36.3 ± 0.1 C).

Testing the probe with the monitor

Use this procedure to test the temperature function while verifying the temperature probe.

1.If the Welch Allyn Calibration Tester is not already warmed up, warm it up as follows: a. Set the tester temperature to the following temperature:

Model

Temperature

 

 

 

 

9600

96.4 °F

(35.8 °C)

9600 Plus

96.8 °F

(36.0 °C)

 

 

 

b.Plug the power adapter into the tester; wait (up to 15 minutes) until the tester ‘ready’ indicator light is on continuously.

2.Set the monitor temperature mode to Monitored.

3.Insert the temperature probe (without probe cover) into the small thermometer hole on the dry-heat well of the tester.

4.Wait two minutes and verify that the reading displayed on the monitor is as follows:

Model

Temperature

 

 

 

 

9600

96.4 °F ±0.4 °F

(35.8 °C ±0.2 °C)

9600 Plus

96.8 °F ±0.4 °F

(36.0 °C ±0.2 °C)

 

 

 

5.Switch the tester to the following temperature and wait about five minutes for the ‘ready’ indicator to light.

Model

Temperature

 

 

 

 

9600

106.0 °F

(41.1 °C)

9600 Plus

105.8 °F

(41.0 °C)

 

 

 

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6. Verify that the reading displayed on the monitor is as follows:

Model

Temperature

 

 

 

 

9600

106.0 °F ±0.4 °F

(41.1 °C ±0.2 °C)

9600 Plus

105.8 °F ±0.4 °F

(41.0 °C ±0.2 °C)

 

 

 

7.Remove the probe from the tester and replace it in the probe well.

8.Disconnect the tester.

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Nurse call

Note The tests described in this section are to be performed only as part of a complete functional verification procedure.

Relay verification

With reference to the drawing and table below, use an ohmmeter to check the contact resistance at the output pins of the Nurse Call connector, while the monitor is in the alarm state and while the monitor is out of the alarm state.

When the Nurse Call verification is done, disconnect the Nurse Call cable and turn off the monitor.

1 (Black)

4 (not connected)

 

Normally Open

 

2 (Red) Arm

3 (Green) Normally Closed

 

.

30V

, 1A Max

Pins

Resistance

Resistance

 

(Alarm OFF)

(Alarm ON)

1-2

> 1 M

< 1

2-3

< 1

> 1 M

Putting the monitor into the alarm state

To create an alarm condition for testing the Nurse Call relay, follow these steps.

1. Press repeatedly until INTERVAL ST appears in the message display.

2.Wait for the pump to charge twice (about 10 seconds), and verify that error code C04 appears in the SYS display.

3.Verify that the Nurse Call circuit is shorted. (Refer to the table shown above.)

4.Press .

5.Verify that the Nurse Call circuit is open. (Refer to the table shown above.)

6.To exit the alarm state, press repeatedly until INTERVAL 15 appears in the message display, and then press .

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Battery

Note This test is to be performed only as part of a complete functional verification procedure.

1.With the monitor power off, disconnect the battery substitution-cable connector.

2.Install and connect the battery.

3.Connect the AC power adapter to the monitor.

4.Verify that the AC mains indicator is illuminated on the monitor front panel.

The indicator could be flashing or steady, depending on the state of the battery. flashing indicates that the battery is charging; steady indicates that the battery is charged to at least 90% capacity.

5.Charge the battery for a minimum of 12 hours (until stops flashing).

6.Disconnect the AC power adapter.

7.Turn the monitor on and set it up as follows:

NIBP Auto Interval

OFF

 

 

Printer, if present

OFF (not printing)

 

 

SpO2 sensor

Disconnected

(if SpO2 option is present)

 

Temperature probe

Either connected or disconnected

(if temperature option is present)

 

 

 

8.Note the time and let the monitor run until low battery ( flashing) is indicated. (Run time for a new, fully charged battery is at least 12 hours.)

9.Charge the battery for a minimum of 12 hours (until stops flashing).

10.Disconnect the ac power adapter.

11.Start the monitor in Service Mode.

12.Press repeatedly until “Battery: X.XXV appears in the message window.

13.Verify that the voltage is 6.10 V.

Patient isolation test

Note This test is to be performed only as part of a complete functional verification procedure.

Patient isolation test - overview

To verify proper patient isolation, it is important to run this test following any procedure in which the monitor is opened.

WARNING Failure to run the dielectric test when indicated could cause serious injury to patients, and could lead to damage to the monitor.

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