Connex Spot Monitor Service Manual sw 1.X Ver F Sept 2015

© 2015 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, Connex, SureTemp, FlexiPort, and SureBP are registered trademarks of Welch Allyn. Eco Cuff is a trademark of Welch Allyn. LNCS, ReSposable , and Rainbow are trademarks of, and SET, LNOP, and Masimo are registered trademarks of Masimo Corporation. Possession or purchase of a Masimo SpO2-equipped device 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. For Masimo patent information, please visit www.masimo.com/patents.htm. Nellcor™ SpO2 Patient Monitoring System with OxiMax™ Technology and Nellcor™ SpO2 OxiMax™ Technology are registered trademarks of COVIDIEN LP Covidien Holdings Inc. Braun and ThermoScan are registered trademarks of Braun GmbH. Nonin is a registered trademark of Nonin Medical, Inc. The Bluetooth® word mark and logos are registered trademarks owned by BluetoothSIG, Inc. and any use of such marks by Welch Allyn is under license. Software in this product is Copyright 2014 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, reverseengineered, 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. This product may contain software known as “free” or “open source” software (FOSS). Welch Allyn uses and supports the use of FOSS. We believe that FOSS makes our products more robust and secure, and gives us and our customers greater flexibility. To learn more about FOSS that may be used in this product, please visit our FOSS website at www.welchallyn.com/opensource.html. Where required, a copy of FOSS source code is available on our FOSS website. For patent information, please visit www.welchallyn.com/patents. For information about any Welch Allyn product, contact Welch Allyn Technical Support: www.welchallyn.com/about/ company/locations.htm. DIR 80019225 Ver. F Revision date: 2015-09

This manual applies to

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220 USA www.welchallyn.com

901058 Vital Signs Monitor Core.

Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Dublin Road Navan, County Meath Republic of Ireland

iii

Contents Symbols and definitions ... 1 Safety ... 5

Warnings and cautions ... 5 General safety considerations ... 6 Electrostatic discharge (ESD) ... 6

Overview ... 9

Purpose and scope ... 9 Technical support services ... 10 Recommended service intervals ... 14 The Welch Allyn Service Tool ... 15 Battery performance ... 16

Controls, indicators, and connectors ... 19 Advanced settings ... 23

Access Advanced settings ... 23 General tab ... 24 Parameters tab ... 24 Network tab ... 26 Service tab ... 29

Power-up sequence ... 33 Bluetooth® wireless technology ... 35

Enable Bluetooth pairing ... 35 Pair devices with Bluetooth wireless technology ... 35 Connect Bluetooth devices and download data ... 36 Rename a laptop ... 36

Disassembly and repair ... 37

Required tools and equipment ... 38 Torque value table ... 38 Connector types ... 39 Disassembly overview ... 42 Power down the monitor ... 43 Remove the monitor from the stand ... 44 Exploded view diagram ... 45 Remove the battery ... 46 Remove the back housing ... 47 Remove the temperature module or housing ... 48

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Connex® Spot Monitor

Disassemble the main PCA board ... 51 Remove the speaker ... 51 Separate the main PCA board from the front housing ... 52 Remove the SpO2 insert ... 53 Remove the SpO2 board ... 57 Remove the communications board ... 60 Remove the LCD from the main PCA board ... 62 Remove the pump assembly ... 67 Replace the main PCA board ... 68 Disassemble the front housing ... 69 Remove the bezel from the front housing ... 69 Remove the power switch ... 70 Accessory Power Management (APM) work surface ... 73 Remove the APM work surface from the stand ... 73 Remove the APM work surface battery ... 74 MS3 ... 77

Field replaceable units ... 79

Service kits overview ... 79

Cleaning requirements ... 83

Prepare to clean the equipment ... 84 Remove liquid spills from the monitor ... 85 Clean the equipment ... 85 Dry the equipment ... 85 Store the device ... 86 Cleaning accessories ... 86 Clean the Braun ThermoScan PRO 6000 contacts ... 86 Decontamination and cleaning requirements for returns ... 87

Device configuration and setup ... 89 Configuration overview ... 89

Functional verification and calibration overview ... 93

Functional verification tests ... 93 Basic functional verification ... 97 Full functional verification and calibration ... 110

Options and upgrades ... 115

Available options ... 116 Install options ... 116 Upgrading software with the Welch Allyn Service Tool ... 116 Partners in Care service and support agreements ... 118 Service and repair training ... 118

Appendix ... 121

Specifications ... 121 Factory defaults ... 126 Install the Nurse Call cable ... 134 Troubleshooting ... 135 Identifying the monitor and subsystems ... 189 Interconnect diagram ... 192

Service manual

Contents v

Service and maintenance toolset ... 193 Service software IT setup ... 195

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Connex® Spot Monitor

1

Symbols and definitions Documentation symbols WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. Warning statements appear with a grey background in a black and white document. CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. This definition applies to both yellow and black and white symbols. Follow instructions/directions for use (DFU) -- mandatory action. A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days.

Power symbols Power button

Equipotential ground

(on the display) Power plug

Battery absent or faulty

(on the monitor, green indicator) Alternating Current power present, battery fully charged

Battery charge level

(on the monitor, amber indicator) Alternating Current power present, battery is charging

Battery

Alternating Current (AC)

Rechargeable battery

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Connex® Spot Monitor

Symbols and definitions

Rated power input, DC

Rated power input, AC

Lithium-ion battery

Direct current (DC)

Connectivity symbols Bluetooth®

Ethernet RJ-45

USB

Nurse call

Wireless signal strength • Best (4 bars) • Good (3 bars) • Fair (2 bars) • Weak (1 bar) • No signal (no bars) • No connection (blank)

Miscellaneous symbols Manufacturer

Defibrillation-proof Type BF applied parts

Product Identifier

Serial number

Reorder number

China RoHS markings for control of pollution caused by electronic information products. XX indicates Environmentally Friendly Use Period in years.

Do not reuse

Recycle the product separate from other disposables

Nonionizing electromagnetic radiation

Call for maintenance

Service manual

Symbols and definitions 3

Light below

FCC ID

IPX1

Prescription only

The identification number assigned by the Federal Trade Commission

IC ID

Industry Canada identification number. The equivalent governing body to the FCC in the United States

This end up

Fragile

European Community Representative

Meets essential requirements of European Medical Device Directive 93/42/EEC

IP = International Protection Marking X = No object ingress rating

Australian Regulatory Compliance Mark

1 = Protected against vertically dripping water Intertek ETL Listed Mark indicating successful independent safety testing

Recycle

Temperature range

Global Trade Identification Number

Stacking limit by number

Keep dry

Humidity range

Screen symbol Process indicator for activities like acquiring measurements and connecting to a laptop

4

Symbols and definitions

Connex® Spot Monitor

5

Safety All users of the monitor must read and understand all safety information presented in this manual before using or repairing the monitor. United States federal law restricts this device to sale, distribution, or use by or on the order of a licensed medical practitioner.

Warnings and cautions WARNING Safety risk. Make frequent electrical and visual checks on cables, sensors, and electrode wires. All cables, sensors, and electrode wires must be inspected and properly maintained and in proper working order to allow the equipment to function properly and to protect patients. WARNING Safety risk. Place the monitor and accessories in locations where they cannot harm the patient should they fall from a shelf or mount. WARNING Fire and explosion hazard. Do not operate the monitor in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide; in oxygen-enriched environments; or in any other potentially explosive environment. WARNING Inaccurate measurement risk. Dust and particle ingress can affect the accuracy of blood pressure measurements. Use the monitor in clean environments to ensure measurement accuracy. If you notice dust or lint build-up on the monitor’s vent openings, have the monitor inspected and cleaned by a qualified service technician. WARNING Defective batteries can damage the monitor. If the battery shows any signs of damage or cracking, it must be replaced immediately and only with a battery approved by Welch Allyn. CAUTION Before disassembling the device or installing options, disconnect the patient from the monitor, power down the device, and disconnect the AC power cord and any attached accessories (for example, SpO2 sensors, blood pressure hoses and cuffs, and temperature probes) from the device. CAUTION To ensure that the monitor meets its performance specifications, store and use the monitor in an environment that maintains the specified temperature and humidity ranges.

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Connex® Spot Monitor

Safety

CAUTION The monitor may not function properly if dropped or damaged. Protect it from severe impact and shock. Do not use the monitor if you notice any signs of damage. CAUTION Do not connect more than one patient to a monitor or connect more than one monitor to a patient. CAUTION Do not operate the monitor in the presence of magnetic resonance imaging (MRI) or hyperbaric chambers.

General safety considerations •

If the monitor detects an unrecoverable problem, it displays an error message. For more information, see “Troubleshooting.”

•

To ensure patient safety, use only accessories recommended or supplied by Welch Allyn. (See the accessories list in the Appendix of the Directions for use or http:// www.welchallyn.com/en/products/categories/patient-monitoring/vital-signsdevices.html.) Always use accessories according to your facility’s standards and according to the manufacturer’s recommendations and instructions. Always follow the manufacturer’s directions for use.

•

Welch Allyn recommends that only Welch Allyn service personnel or an authorized repair center perform warranty service. Performing unauthorized service on a device that is within warranty may void the warranty.

Electrostatic discharge (ESD)

CAUTION Electrostatic discharge (ESD) can damage or destroy electronic components. Handle static-sensitive components only at static-safe workstation. CAUTION Assume that all electrical and electronic components of the monitor are 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, and 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 staticsensitive 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.

Service manual

Safety

7

•

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.

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Safety

Connex® Spot Monitor

9

Overview Purpose and scope This service manual is a reference for periodic preventive maintenance and corrective service procedures for the Welch Allyn Connex Spot Monitor. It is intended for use only by trained and qualified service personnel. Corrective service is supported to the level of field-replaceable units. These include circuit-board assemblies and some subassemblies, case parts, and other parts. 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. CAUTION No component-level repair of circuit boards and subassemblies is supported. Use only the repair procedures described in this manual. Find instructions for functional testing and performance verification in the Welch Allyn Service Tool help files. This manual applies only to this device. For servicing of any other vital signs monitor, see the service manual for the specific device. Service work not described in this manual must be performed by qualified service personnel at the factory or at an authorized Welch Allyn service center.

Related documents When using this manual, refer to the following: •

Connex® Spot Monitor Directions for use (on the user documentation CD)

•

Welch Allyn Service Tool: http://www.welchallyn.com/en/service-support/service-center/service-tool.html

•

Welch Allyn Service Tool Installation and configuration guide: http://www.welchallyn.com/en/service-support/service-center/service-tool.html

•

Welch Allyn Braun ThermoScan® PRO 6000 Themometer Directions for use CD

•

Welch Allyn Braun ThermoScan® PRO 6000 Charging Station Directions for use CD

•

Welch Allyn 9600 Plus Calibration Tester Directions for use

•

Welch Allyn website: http://www.welchallyn.com

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Connex® Spot Monitor

Overview

Technical support services Welch Allyn offers the following technical support services: •

Telephone support

•

Loaner equipment

•

Service agreements

•

Service training

•

Replacement service parts

•

Product service

For information on any of these services, go to this site: http:// www.welchallyn.com/en/service-support.html.

Service loaners For warranty or non-warranty repairs not covered under a support agreement, loaners are available for a nominal charge, subject to availability. Payment is required prior to shipment for all loaners not covered under a support agreement. The loaner fee can be found on the Welch Allyn loaner price list. Welch Allyn Service Centers that provide repair service for this product can, on request, loan a device for use while the device is being repaired. Loaned devices are provided free of charge for products repaired while under a support agreement that includes a free loaner provision.

Service options Partners in Care service agreements While product warranties provide basic assurance of Welch Allyn hardware quality, they may not include the full range of services and support you need. Welch Allyn offers premium service and support through our Partners in Care program. Whether you service your own devices and require a minimum of support or rely on us to service your device, Welch Allyn provides a program that will meet your needs. For more information visit our web site at http://www.welchallyn.com/en/service-support.html or call your sales representative.

Warranty service All repairs on products under warranty must be performed or approved by Welch Allyn. Refer all warranty service to Welch Allyn Product Service or another authorized Welch Allyn Service Center. Obtain a Return Material Authorization (RMA) number for all returns to Welch Allyn Product Service from our website: http://www.welchallyn.com/en/service-support/submit-a-repair.html. CAUTION Unauthorized repairs will void the product warranty.

Service manual

Overview

11

Non-warranty service Welch Allyn Product Service Centers and Authorized Service Providers support nonwarranty 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. Service training is available from Welch Allyn for biomedical/clinical engineers. For information, go to this site: http://www.welchallyn.com/en/service-support/partners-in-care/education-services/ technical-training.html.

Repairs A Welch Allyn Service Center or Authorized Service Provider must perform all repairs on products under warranty unless you are a properly certified technician that has successfully completed a Welch Allyn Technical Training course. More information on Technical Training can be obtained from your sales representative or by visiting http:// www.welchallyn.com/en/service-support/partners-in-care/education-services/technicaltraining.html. CAUTION Unauthorized repairs will void the product warranty. Qualified service personnel or a Welch Allyn Service Center should repair products out of warranty. If you are advised to return a product to Welch Allyn for repair or routine maintenance, schedule the repair with the service center nearest you. Welch Allyn Technical Support If you have a problem with the device that you cannot resolve, call the Welch Allyn Technical Support Center nearest you for assistance. A representative will assist you in troubleshooting the problem and will make every effort to solve the problem over the phone, potentially avoiding an unnecessary return. If your product requires warranty, extended warranty, or non-warranty repair service, a Welch Allyn Technical Support representative will record all necessary information to issue an RMA number. The support representative will provide you with the address of the Welch Allyn Service Center to send your device to. Technical support is available during local business hours.

Returning products When returning a product to Welch Allyn for service, ensure that you have the following information: •

Product name, model number, and serial number. This information may be found on the product and serial number labels on the back housing.

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Connex® Spot Monitor

Overview

•

A complete return shipping address.

•

A contact name and phone number.

•

Any special shipping instructions.

•

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

•

A full description of the problem or service request.

1. Obtain an RMA number. Either contact Welch Allyn and request an RMA number or visit us on the web: http://www.welchallyn.com/en/service-support/submit-a-repair.html. Welch Allyn does not accept returned products without an RMA.

Note

2. Ship the device to Welch Allyn, observing these packing guidelines: a.

Remove from the package the battery, all hoses, connectors, cables, sensors, power cords, and other ancillary products and equipment, except those items that might be associated with the problem. Recommendations for returning Lithium-ion batteries •

Use ground transportation to return batteries.

•

If returning multiple batteries, package each battery individually.

•

Do not consolidate multiple batteries in a single package.

•

Use packaging provided by Welch Allyn or the battery manufacturer.

•

Do not pack a defective battery in checked or carry-on baggage if traveling by air.

Packaging •

If you return the battery with the device, remove the battery, seal the battery in an antistatic plastic bag, and place the battery in the position reserved for the battery near the device in the original shipping carton.

•

If you return the battery separately, package the battery in the replacement battery’s plastic bag and shipping box.

Service manual

Overview

13

If the original shipping carton or replacement battery shipping box is unavailable, consult the manufacturer website for information about shipping Lithium-ion batteries: http://www.iccnexergy.com/regulatory-updates/lithium-shipping WARNING Safety risk. Do not ship any battery that has been physically damaged or shows signs of leakage unless you receive specific instructions which meet the requirements for the shipment of Lithium-ion batteries. Dispose of damaged or leaking batteries in an environmentally safe manner consistent with local regulations. Note

In the United States, the applicable regulations can be found in the Code of Federal Regulations (CFR). Refer to 49 CFR 173.185 for shipping Lithium-ion batteries by air or ground. Use 49 CFR 172.102 sections A54 and A101 to find the special provisions for shipping Lithium-ion batteries.

b. Clean the device. Note

c.

To ensure safe receipt of your device by the service center and to expedite processing and return of the device to you, thoroughly clean all residues from the device before you ship it to Welch Allyn. For decontamination and cleaning requirements, see the appendices. If a returned device is found to be contaminated with bodily fluids, it will be returned at the owner’s expense. United States federal regulations prohibit the processing of any device contaminated with blood-borne pathogens. Welch Allyn thoroughly cleans all returned devices on receipt, but any device that cannot be adequately cleaned cannot be repaired.

Put the device, enclosed in a plastic bag with a packing list, into the original shipping carton with the original packing materials or into another appropriate shipping carton.

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

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Connex® Spot Monitor

Overview

Recommended service intervals To confirm that the device is functioning within the design specifications, perform periodic service as indicated in the following table. Customers who have the Standard unlicensed edition of the Welch Allyn Service Tool can perform the basic functional verification and calibration procedures referenced in the table by following the instructions in this manual. Component

Service interval

Service procedure

NIBP module

Annually

Basic functional verification

SpO2 module

Annually

Basic functional verification

SureTemp Plus

Annually

Basic functional verification

Braun ThermoScan PRO 6000

Annually1

Basic functional verification

Battery

2 years2

Replace the battery

1 In addition to this annual service interval, Welch Allyn recommends cleaning the contacts of the Braun thermometer

and dock every 4 months because debris that accumulates in the contacts can interfere with data transmission. See "Clean the Braun ThermoScan PRO 6000 contacts" later in this manual.

2 Battery performance is a function of clinical use and charge/discharge patterns. Welch Allyn recommends replacing

the battery after 2 years or when its remaining capacity no longer meets workflow requirements

If you have the Gold edition of the service tool, use the tool to perform a complete functional verification and calibration of the device in lieu of performing the basic tests. Perform a complete functional verification and calibration of the device whenever any of the following conditions exist: •

The device does not meet specifications (based on the basic functional verification)

•

The device has been dropped or otherwise damaged

•

The device is malfunctioning

•

The case has been opened

•

An internal part has been replaced (battery excluded)

Note

For instructions on using the Gold edition, see the Service Tool help files.

Maintenance For device maintenance information, see “Maintenance and service” in the device’s directions for use. This section covers the following topics: •

Perform periodic checks

•

Replace the monitor battery

•

Replace the APM work surface battery

•

Cleaning requirements

Note

Service-related cleaning is addressed in the service manual as well.