WelchAllyn Vital Signs Monitor Series 6000 Service Manual Software Version 2.0X - 2.2X

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Contents Symbols ... 1 Safety ... 5

Warnings and cautions ... 5 General safety considerations ... 7 Electrostatic discharge (ESD) ... 7

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 Service menu ... 23

Access the Service screens ... 23 General tab ... 23 Self-tests tab ... 26 Logs tab ... 26 Device tab ... 27 Licensing tab ... 28

Power-up sequence ... 29 Troubleshooting ... 31

Symptoms and solutions ... 31 Technical alarm messages ... 43

Disassembly and repair ... 59

Required tools and equipment ... 60 Power down the monitor ... 60 Remove the battery ... 62 Remove the rear housing ... 63 Disassemble the rear housing ... 66 Disassemble the main chassis ... 74

Functional verification and calibration ... 111 Functional verification tests ... 111 Basic functional verification checks ... 114

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Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Electrical safety testing ... 129 Ground stud connector ... 129

Options, upgrades, and licenses ... 131

Available options, upgrades, and licenses ... 132 Install options ... 133 Masimo parameter upgrades ... 134 Configure options ... 135

Field replaceable units ... 137

Rear housing ... 137 Bottom housing ... 142 Extended bottom housing ... 144 Extended top housing ... 145 Top housing ... 146 Side panels ... 147 Front housing and midsection ... 148 Miscellaneous parts ... 150 Service tools ... 151 Options ... 152 Service parts for Braun PRO 4000 and dock ... 159 Licenses ... 160 Partners in Care service and support agreements ... 161 Service and repair training ... 163

Appendices ... 165 Decontamination and cleaning requirements for returns ... 165 Clean the CO2 input connector ... 167 Identifying the monitor and subsystems ... 167 Factory defaults ... 171 Disassembly and repair reference ... 185 Interconnect diagram ... 197

1

Symbols Documentation symbols WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death.

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. WARNING Hot surface. Do not touch.

Follow the operating 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 days.

Power symbols Power on/Display power-saving

Equipotential terminal

(on the display) monitor is plugged into Alternating Current power

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 cover

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Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Symbols

Alternating Current (AC)

Rechargeable battery

Connectivity symbols USB

Ethernet RJ-45

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

Nurse call

Connected to central station

Disconnected from central station

Miscellaneous symbols CO2 sampling input

CO2 sampling output/exhaust

Manufacturer

Limited rotation/Turn completely to right

Reorder number

Serial number

Do not reuse

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

Nonionizing electromagnetic radiation

Recycle the product separate from other disposables

Restrictions for use of wireless device in Europe. European Community's Class 2 radio equipment.

Call for maintenance

Defibrillation-proof Type BF applied parts

Do not expose to open flame

Service manual

Symbols

Altitude range

Not for injection

Transport and storage temperature range

Authorized Representative of the European Community

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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. 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. 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.

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Safety

Welch Allyn Connex® Vital Signs Monitor 6000 Series™

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.

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Safety 7

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 on the user documentation CD or www.welchallyn.com.) 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.

•

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.

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Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Safety

•

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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Overview Purpose and scope This service manual is a reference for periodic preventive maintenance and corrective service procedures for the Welch Allyn Connex Vital Signs Monitor 6000 Series, firmware version 2.0X–2.1X. 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. 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. 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: •

Welch Allyn Connex Vital Signs Monitor 6000 Series Directions for use, software version 2.0X–2.1X (on the user documentation CD, part number 105534)

•

Welch Allyn Service Tool CD (part number 103521)

•

Welch Allyn Service Tool Installation and configuration guide (part number 103820)

•

Welch Allyn Braun PRO 4000 Service manual (part number 701627)

•

Welch Allyn 9600 Plus Calibration Tester Directions for use (part number 701754)

•

Welch Allyn Radio Configuration guide: click here to download the PDF

•

Welch Allyn website: www.welchallyn.com

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Welch Allyn Connex® Vital Signs Monitor 6000 Series™

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 www.welchallyn.com.

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. Loaner equipment for the individual component modules is not available.

Overview

Service manual

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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 www.welchallyn.com 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. CAUTION Unauthorized repairs will void the product warranty.

Non-warranty service Welch Allyn product 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. Service training is available from Welch Allyn for biomedical/clinical engineers. For information, go to www.welchallyn.com/support/technical/ monitoring_suppt_training.htm.

Repairs A Welch Allyn Service Center must perform all repairs on products under warranty, unless you have purchased a Welch Allyn Partners in Care Biomed agreement allowing you to service the device while under warranty. 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

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Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Overview

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 bottom of the device.

•

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. Visit us on the web to obtain an RMA: www.welchallyn.com/customer-selfservice.htm or contact Welch Allyn and request an RMA number. 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 the Lithium Ion battery •

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 in the original shipping carton near the device.

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Overview

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

If the original shipping carton or replacement battery shipping box is unavailable, consult the manufacturer website for information regarding shipping lithium ion batteries: 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 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 batteries by air or ground. Use 49 CFR 172.102 sections 29, 188, 189, A54, A55, A100, A101, A103, and A104 to find the special provisions for shipping lithium 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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Welch Allyn Connex® Vital Signs Monitor 6000 Series™

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 Silver 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. 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. Component

Service interval

Service procedure

NIBP module

Annually

Basic functional verification

SpO2 module

Annually

Basic functional verification

SpHb parameter

Annually

Basic functional verification

EarlySense module

N/A

N/A

RRa parameter

N/A

N/A

CO2 module 1

Annually or 1200 hours (whichever Calibration (first time only) comes first) Annually or 4000 hours (whichever Calibration comes first) 30,000 hours

Replace the module

SureTemp Plus

Annually

Basic functional verification

Braun ThermoScan PRO 4000

Annually

Basic functional verification

Battery

300 charge cycles

Replace the battery

1Initially calibrate the module after 1200 operating hours, then once a year or after 4000 operating hours, whichever comes first. The initial calibration should not occur before 720 hours of use. If the initial calibration is done before 720 hours of use, the module will reset to require its next calibration after 1200 hours, instead of after 4000 hours.

Use the service tool, Gold edition, to perform a complete functional verification and calibration of the device whenever any of the following conditions exist: •

Based on the basic functional verification, the device does not meet specifications

•

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.

Service manual

Overview

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

Replacing the printer paper

•

Inspecting and cleaning the device and accessories

•

Changing the battery

The Welch Allyn Service Tool The Welch Allyn Service Tool is available in the following editions: •

Silver: Accompanies your device.

•

Gold: Required to perform complete functional verification and calibration. This edition requires an additional license. For more information about acquiring this license, contact Welch Allyn. Note

To qualify for the Gold license, you must attend the Welch Allyn technical training course or complete online training for the device.

Clinicians and technical service personnel can use the service tool to manage and maintain supported Welch Allyn products. You can use the service tool to do the following: •

Review device information. When connected to the device, the service tool lists installed modules, installed firmware and hardware versions, warranty and repair information, status, and usage history.

•

Receive notifications when periodic maintenance is needed. The service tool can help you manage and maintain your entire inventory of supported Welch Allyn products. Through the remote service function, the service tool can connect to Welch Allyn Customer Service. With this functionality you can automatically receive firmware updates and feature upgrades for your supported products, including software upgrades for the service tool.

•

Install updates and upgrades. The service tool can read the firmware version for each module and check for available updates or upgrades.

•

Create a work list. The work list provides information about service actions- referred to as work orders-that are waiting for you to perform on your maintained devices. Work orders may include periodic calibrations, upgrades, or license installations.

•

Schedule periodic maintenance. You can use the service tool to set the service interval for each maintained device.

•

View and save logs. You can download and save log files from the device for analysis to help diagnose and identify reported issues.

•

Create user accounts. Administrators can create user accounts and set permission levels to control access to the features, allowing one group to perform administrative tasks and another to perform service tasks. Restricting access prevents the service tool from being used to make unauthorized changes on a connected device.

•

Perform functional verification and calibration. The service tool can check any device requiring calibration and, if necessary, calibrate the device to match the design specifications. This feature is not supported for all products and requires the service tool, Gold edition, for each supported product.

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Welch Allyn Connex® Vital Signs Monitor 6000 Series™

Overview

•

Recover devices. In the rare case where a device can no longer boot because of corrupted firmware, the service tool can connect the device to Welch Allyn Technical Support to reinstall the firmware.

•

Extensible. The service tool software accepts new plug-ins to support future Welch Allyn products.

Some of these features are enabled for any user (Silver edition). Others require special user account privileges or a Welch Allyn service contract (Gold edition). If you require gold-level support for a Welch Allyn product, please contact Welch Allyn technical support.

Battery performance About the battery The device uses a rechargeable lithium ion smart battery. Internal circuitry enables the battery to report its condition to the device. The device displays the battery status via the LED power indicator, icons on the screen, and status messages appearing in the Device Status area of the display. Battery information may be collected using the service tool. New batteries are shipped from the manufacturer with a 30 percent charge to extend shelf life. When installing a new battery in the device, you must plug the device into AC power to wake up the battery. If the AC power is not applied to the device, the new battery will appear discharged. The Device Status area displays a low-battery status message when 30 minutes of power remain and again when 5 minutes remain. Battery charging is provided by the device’s internal power supply. For a complete list of battery specifications, see the device’s directions for use.

Best practices The following practices help to extend the life of the battery and the device. WARNING Safety risk. When handling and storing Lithium batteries: Avoid mechanical or electrical abuse. Batteries may explode or cause burns, if disassembled, crushed or exposed to fire or high temperatures. Do not short or install with incorrect polarity. •

Whenever possible, keep the monitor plugged in to charge the battery.

•

Remove the battery when storing the device for an extended amount of time.

•

Replace batteries that trigger a low battery status message when fully charged.

•

Do not use damaged or leaking batteries.

•

Store batteries with a 30 to 50 percent charge.

•

Store batteries within the temperature range indicated for each period: ○ For storage less than 30 days: Maintain temperature between –4 °F and 122 °F (–20 °C and 50 °C). ○ For storage between 30 days and 90 days: Maintain temperature between –4 °F and 104 °F (–20 °C and 40 °C).

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Overview

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For storage more than 90 days up to 2 years: Maintain temperature between –4 °F and 95 °F (–20 °C and 35 °C).

•

Recycle batteries where ever possible. In the United States call 1-800-8-BATTERY for information about recycling your Lithium Ion battery or go to the RBRC website at www.rbrc.org for additional information.

•

When recycling is not an option dispose of batteries in an environmentally safe manner consistent with local regulations.

Factors affecting battery operating time The following settings and conditions affect the battery operating time. •

The display brightness setting

•

The display power-saver setting

•

The device power-down setting

•

Frequency and duration of alarms and alerts

•

Amount of motion artifact during NIBP measurements

•

Radio searching for an access point

19

Controls, indicators, and connectors The following diagrams show a full-featured monitor. Your monitor, based on size or configuration, might not contain all of these features. Top-Left-Front view

No. Feature

Description

1

Printer

Printer provides a printout of patient and device information.

2

Light bar

Provides a visual alarm with red and amber LEDs.

3

Thermometry

Temperature probe cover box.

4

Thermometry

Temperature probe.

5

Thermometry (connector behind cover)

Secures the probe connection to the monitor.

6

LCD screen

1024 x 600 pixels color touchscreen provides a graphical user interface.

7

Battery compartment (behind cover)

Houses the lithium-ion battery.