Connex ProBP 3400 Service Manual Ver C April 2021

© 2021 Hillrom. 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 Hillrom. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Hillrom. Hillrom 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, SureBP Technology, and Welch Allyn FlexiPort are registered trademarks of Welch Allyn. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Welch Allyn is under license. Software in this product is Copyright 2021 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, contact Hill-Rom Technical Support http://www.hillrom.com/en/ about-us/locations.html.

80016499 Ver. C, Revision date: 2021-04

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA hillrom.com Welch Allyn, Inc. is a subsidiary of Hillrom Holdings, Inc. PATENTS hillrom.com/patents May be covered by one or more patents. See above Internet address. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications.

AND EU IMPORTER Welch Allyn Limited Navan Business Park, Dublin Road, Navan, County Meath, C15 AW22 Ireland

Authorized Australian Sponsor Welch Allyn Australia Pty. Ltd. Unit 4.01, 2-4 Lyonpark Road Macquarie Park, NSW 2113 Phone 1800 650 083

iii

Contents Symbols ... 1 Safety ... 5 Warnings and cautions ... 5 General safety considerations ... 6 Electrostatic discharge (ESD) ... 7

Overview ... 9 Purpose and scope ... 9 Technical support services ... 9 Recommended service intervals ... 12 Configuration options ... 13 The Welch Allyn Service Tool ... 14

Controls and indicators ... 17 Connections ... 19 Power-up sequence ... 21 Troubleshooting ... 23 Power ... 23 Display ... 24 Communication ... 24 NIBP ... 25 System errors ... 26

Disassembly and repair ... 27 Required tools and equipment ... 28 Disassemble the external housing ... 28 Separate the chassis assembly from the circuit board assembly ... 31 Disassemble the chassis assembly ... 33 Disassemble the circuit board assembly ... 36

Reassembly ... 39 Functional verification tests ... 43 About the Welch Allyn Service Tool ... 43 Required equipment ... 44 Test Bluetooth radio functionality ... 45 Service record ... 46

iv Contents

Welch Allyn® Connex® ProBP™ 3400 digital blood pressure device

Upgrades and licenses ... 47 Available upgrades and licenses ... 47

Field-replaceable units ... 49 External housing ... 49 Chassis and manifold assemblies ... 50 Circuit board assembly ... 52 Miscellaneous parts ... 53 Service tool ... 53 Licenses ... 53 Partners in Care service and support agreements ... 53 Service and repair training ... 54

Appendices ... 55 Clean the device ... 55 Factory defaults ... 56 Disassembly and repair reference ... 56

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.

Consult operating instructions.

Power symbols (green indicator) External power present, battery charged

Battery charging

(amber indicator) External power present, battery is charging

Rechargeable battery

No external power present

Battery charge level

Button symbols Power on/standby

Return to previous screen

Blood Pressure Start/Stop

Select

2

Symbols

Welch Allyn® Connex® ProBP™ 3400 digital blood pressure device

Navigation (Up, Down, Left, Right)

Shipping, storing, and environment symbols Fragile; handle with care

Temperature limits

IPXØ

Relative humidity limits

Lithium-ion battery

Recovery/Recyclable

Recycle the product separate from other disposables

This end up

Keep dry

Equipment is not protected against the ingress of liquid

Connectivity symbols Bluetooth® wireless technology enabled

USB connection

Devices are connected via Bluetooth wireless technology

Bluetooth radio is disabled or not paired

Miscellaneous symbols Wireless radio alert in Europe. European Communities Class 1 radio equipment.

EMC Framework of Australia

Intertek ETL listed

Type BF applied parts

Service Manual

Symbols

Class II equipment

Available for sale only upon order of a physician or licensed health care provider

Serial number

Manufacturer

Reorder number

Call for maintenance

Non-ionizing electromagnetic radiation

Regulatory Affairs Representative

3

4

Symbols

Welch Allyn® Connex® ProBP™ 3400 digital blood pressure device

5

Safety All users of this device must read and understand all safety information presented in this manual before using or repairing the device. 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 Fire and explosion hazard. Do not operate the device in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide; in oxygenenriched environments; or in any other potentially explosive environment. WARNING The device might not function properly if dropped or damaged. Do not use the device if you notice any signs of damage. Qualified service personnel must check any device that is dropped or damaged for proper operation before putting the device back into use. WARNING For proper patient electrical isolation and battery charging, use only the provided external power supply to charge the device. WARNING Electric shock hazard. Use the USB connector only to connect to devices complying with IEC 60601-1 or other IEC standards as appropriate to the device. The user is responsible for verifying that the system complies with the requirements of the system standard IEC 60601-1-1 if additional devices are connected to the ProBP 3400. WARNING Inaccurate measurement risk. Dust and particle ingress can affect the accuracy of blood pressure measurements. Use the device in clean environments to ensure measurement accuracy. If you notice dust or lint accumulation on the blood pressure port, have the device inspected and cleaned by a qualified service technician. WARNING Electric shock hazard. Before cleaning the device, disconnect the power cord from the power source and the device. Ensure power transformer and wall plug assembly are dry before plugging into an outlet. WARNING Take care to prevent water or other fluid from entering any connectors on the device, power transformer, and wall plug. Should this occur, dry the connectors with warm air. Check the accuracy of all operating functions.

6

Safety

Welch Allyn® Connex® ProBP™ 3400 digital blood pressure device

WARNING Defective batteries can damage the device. If the battery shows any signs of damage, leakage, or cracking, it must be replaced immediately, and only with a battery recommended for or supplied with the device. WARNING Improper disposal of batteries can create an explosion or contamination hazard. Never dispose of batteries in refuse containers. Do not dispose of the battery in fire. Always recycle batteries according to local regulations. WARNING Improper handling of the battery can lead to heat generation, smoke, bursting, or fire. WARNING Do not remove the label from the battery. WARNING Do not disassemble, modify, or solder the battery. WARNING Do not directly connect or short-circuit the positive (+) and negative (-) battery terminals. WARNING To avoid short circuits, keep battery terminals away from metal objects. WARNING Do not expose the battery to temperatures higher than 80 °C/176 °F. WARNING Safety risk. When handling and storing lithium batteries, avoid mechanical or electrical abuse. Batteries might explode or cause burns if disassembled, crushed or exposed to fire or high temperatures. Do not short. Always install with correct polarity. CAUTION The device is not heat-resistant. Do not autoclave. CAUTION To ensure that the device meets performance specifications, store and use the device in an environment that maintains the specified temperature and humidity ranges. CAUTION Do not operate the device in the presence of magnetic resonance imaging (MRI) or hyperbaric chambers.

General safety considerations •

If the device 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. 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, unless otherwise specified in a service agreement. Performing unauthorized service on a device that is within warranty will void the warranty.

Safety 7

Service Manual

Electrostatic discharge (ESD)

CAUTION Electrostatic discharge (ESD) can damage or destroy electronic components. Handle static-sensitive components only at a static-safe workstation. CAUTION Assume that all electrical and electronic components of the device 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 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 device power turned off.

•

Insert and seal static-sensitive components and assemblies into their original static-shielding 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.

8

Safety

Welch Allyn® Connex® ProBP™ 3400 digital blood pressure device

9

Overview Purpose and scope This service manual is a reference for periodic preventive maintenance and corrective service procedures for the device. 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 device, 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. 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. For information about servicing any other product, see the service manual for that product.

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

Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device Directions for Use (part number 103701)

•

Welch Allyn Service Tool CD (part number 103521)

•

Welch Allyn Service Tool Installation and Configuration Guide (part number 103820)

•

Welch Allyn website: www.welchallyn.com

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

Telephone support

•

Advance replacement equipment

•

Service agreements

•

Service training

10

Overview

Welch Allyn® Connex® ProBP™ 3400 digital blood pressure device

•

Replacement service parts

•

Product service

For information on any of these services, call the Welch Allyn Service Center nearest you.

Advance replacement When a device requires service by a Welch Allyn Service Center, Welch Allyn can provide an advance replacement device to minimize downtime. The replacement device will be shipped to you as soon as you request one and is yours to keep. After you receive it, you return your original device to Welch Allyn. Replacement devices are available at no cost for warranty repairs or as defined by a service agreement. NOTE Welch Allyn reserves the right to charge for advance replacement if the repair is not covered under warranty or if the original device is not returned.

Service options Partners in Care service agreements While product warranties provide basic assurance of Welch Allyn hardware quality, they might 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 level 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 website 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 an authorized Welch Allyn Service Center. Obtain a Return Material Authorization (RMA) number for all returns to Welch Allyn. CAUTION Unauthorized repairs will void the product warranty.

Non-warranty service Welch Allyn Service Centers support non-warranty repairs. Contact Welch Allyn Technical Support 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 for this product is available from Welch Allyn for biomedical/clinical engineers. For information, go to www.welchallyn.com/support/technical/monitoring_suppt_training.htm.

Overview 11

Service Manual

Repairs A Welch Allyn Service Center must perform all repairs on products under warranty, unless you have purchased a Welch Allyn support 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 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, provide the following information: •

Product reference number and serial number. This information can be found on the product and serial number label 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 or service agreement.

•

A full description of the problem or service request.

1.

Contact Welch Allyn and request an RMA number. NOTE Welch Allyn does not accept returned products without an RMA.

2.

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

Remove from the package the battery, all hoses, connectors, cables, 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.

12

Overview

Welch Allyn® Connex® ProBP™ 3400 digital blood pressure device

•

Use packaging provided by Welch Allyn or the battery manufacturer.

•

If traveling by air, do not pack a defective battery in checked or carry-on baggage.

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.

•

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

c.

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.

Put a copy of the Welch Allyn RMA in the shipping carton.

e.

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

Recommended service intervals To confirm that the device is functioning within the design specifications, perform periodic service using the Welch Allyn Service Tool as indicated in the following table.

Overview 13

Service Manual

Component

Service interval

Service procedure

Device

Annually

Calibration check using the Silver-level Welch Allyn Service Tool

Use the Gold-level Welch Allyn Service Tool to perform a complete functional verification and calibration of the device whenever any of the following conditions exist: •

Based on the calibration check, the device does not meet specifications

•

The device has been dropped or otherwise damaged

•

The device is malfunctioning

•

The case has been opened

•

A part has been replaced

For details on performing the functional verification, see the section on functional verification.

Maintenance For device maintenance information, see the directions for use. Covered topics include the following: •

Changing the battery

•

Inspecting and cleaning the device and accessories

Configuration options The device is available in the configurations shown in the table below. The model-number suffix, denoted by an asterisk (*), indicates the power cord packaged with the device. Available suffixes are listed after the configuration table. NOTE For more configuration options, including approved accessories, see the directions for use. Model

Standard BP

SureBP

Bluetooth

Mounting configuration

34BFHT-*

Handheld

34BFWT-*

Wall mounted

34BFST-*

Mobile stand

34XFHT-*

Handheld

34XFWT-*

Wall mounted

34XFST-*

Mobile stand

34BXHT-*

Handheld

14

Overview

Welch Allyn® Connex® ProBP™ 3400 digital blood pressure device

Model

Standard BP

SureBP

Bluetooth

Mounting configuration

34BXWT-*

Wall mounted

34BXST-*

Mobile stand

34XXHT-*

Handheld

34XXWT-*

Wall mounted

34XXST-*

Mobile stand

Region codes, as indicated by the asterisk (*), include the following: Code

Region

6

Australia/New Zealand

C

China

2

Europe

J

Japan (mobile stand version only)

B

North America

7

South Africa

4

United Kingdom

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

Silver: Accompanies your device.

•

Gold: Required to perform 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 product.

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

Overview 15

Service Manual

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 calibration check. You can use the service tool to test the system to ensure that its performance meets calibration specifications. A calibration check is required to meet the periodic maintenance requirements.

•

Perform functional verification and calibration. The service tool can check any system 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.

•

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 device 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, contact Welch Allyn Technical Support.

16

Overview

Welch Allyn® Connex® ProBP™ 3400 digital blood pressure device