ProBP 3400 Instructions for Use Sw ver 1.04.XX

© 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 Hillrom Technical Support http://www.hillrom.com/en/ about-us/locations.html.

80028319 Ver. A Revision date: 2021-04

This manual applies to DEVICE

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA hillrom.com Welch Allyn, Inc. is a subsidiary of Hillrom Holdings, Inc.

901055 DIGITAL BLOOD PRESSURE

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

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.

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 Initial device setup ... 1 Introduction ... 3 Intended use ... 3

Symbols ... 5 General warnings and cautions ... 9 NIBP warnings and cautions ... 13 Contents checklist ... 15 Controls and indicators ... 17 Screen elements ... 19 Connections ... 21 Blood pressure hose and cuff ... 23 Blood pressure cuff selection ... 23

Power transformer ... 25 Power transformer and wall plug ... 25 Charge the device ... 26

Setup ... 27 Insert the battery ... 27 Assemble power cord and wall plug/line cord assembly ... 28 Charge the ProBP 3400 ... 28 Mount the device ... 29 Initial startup ... 29

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Contents

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

Battery ... 31 Startup ... 33 Blood pressure procedure ... 35 Blood pressure measurement ... 35 Obtain blood pressure measurement ... 36

Settings ... 37 Settings matrix ... 37 Unit of measure ... 37 Pressure presets ... 38 Bluetooth wireless technology ... 38 Advanced settings ... 39

Data review ... 43 Review data ... 43 Delete data ... 43

Maintenance and service ... 45 Inspection ... 45 Calibrate the device ... 45 Change the battery ... 45 Clean the device ... 46

Specifications ... 49 Physical specifications ... 49 Mechanical specifications ... 49 Electrical specifications ... 50 Environmental specifications ... 50 Product disposal ... 52

Standards and compliance ... 53 General safety compliance ... 53 General radio compliance ... 53

Guidance and manufacturer's declaration ... 55 EMC compliance ... 55 Emissions and immunity information ... 56

Warranty ... 63 Troubleshooting ... 65 Inaccurate blood pressure readings ... 65 Cuff inflation and deflation with no blood pressure reading displayed ... 66 No cuff inflation ... 67 Cuff pops off ... 67 Cuff deflating too slowly ... 67 Device does not turn on ... 68 Bluetooth troubleshooting ... 68

Instructions for use

Contents

v

Appendix ... 71 ProBP 3400 approved accessories ... 71 Configuration options ... 73

vi

Contents

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

1

Initial device setup Before using ProBP 3400 digital blood pressure device (ProBP 3400) for the first time, you must configure the device for use. See Setup for additional information.

2

Initial device setup

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

3

Introduction This Instructions for use manual is a comprehensive guide designed to help you understand the capabilities and operation of the ProBP 3400 non-invasive blood pressure device. The information in this manual includes all options available with the device. Read this manual thoroughly before attempting to setup, configure, use, troubleshoot, or maintain the device.

Intended use The ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP). The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider. This device is not intended for use on neonates, infants, or children under the age of 3 years. The effectiveness of this device has not been established in pregnant, including pre-eclamptic, patients.

4

Introduction

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

5

Symbols For information on the origin of these symbols, see the Welch Allyn symbols glossary: welchallyn.com/symbolsglossary

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.

Follow instructions for use (IFU) -- mandatory action. A copy of the IFU is available on this website. A printed copy of the IFU can be ordered from Welch Allyn for delivery within 7 calendar days.

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

6

Symbols

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

Blood Pressure Start/Stop

Select

Navigation (Up, Down, Left, Right)

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

Temperature limits

IPXØ

Humidity limitation

Lithium-ion battery

Recovery/Recyclable

Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted municipal waste.

This end up

Keep dry

Equipment is not protected against the ingress of liquid

Global Trade Item Number

Connectivity symbols Bluetooth® wireless technology enabled

USB connection

Devices are connected via Bluetooth wireless technology

Bluetooth radio is disabled or not paired

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

Authorized Representative in the European Community.

Instructions for use

Symbols

Product Identifier

Medical device

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

Australian Communications and Media Authority (ACMA) Radio Compliance Mark (RCM).

Intertek ETL listed

Type BF applied parts

Class II equipment

For Use by or on the order of a licensed medical professional.

Serial number

Manufacturer

Reorder number

Call for maintenance

Non-ionizing electromagnetic radiation

Mass in kilograms (kg)

7

8

Symbols

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

9

General warnings and cautions WARNING The information in this instructions for use is a comprehensive guide to the operation of ProBP 3400. For best results, read this instructions for use thoroughly before using the device. WARNING The device is designed for medical clinician use. Although this instructions for use may illustrate medical spot-check techniques, only a trained clinician who knows how to take and interpret a patient's vital signs should use this device. WARNING The device is intended for use only in environments with clinician supervision. WARNING The device is not intended for continuous monitoring. Do not leave the device unattended while taking measurements on a patient. WARNING The device is not intended for use during patient transport. 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 Use only Welch Allyn approved accessories. Use of unapproved accessories with the device can affect patient and operator safety, and can reduce product performance and accuracy. To ensure patient safety and optimal product performance, use only accessories and supplies recommended for or supplied with the device, and use according to the accessory manufacturer's instructions for use. WARNING Every three months, inspect the blood pressure cuff and other accessories for fraying or other damage. Replace as necessary. WARNING Inaccurate measurement risk. Do not use the device on patients who are connected to heart/lung machines. WARNING Electric shock hazard. Do not open the device or attempt repairs. There are no user-serviceable parts inside ProBP 3400 other than battery replacement. Only perform routine cleaning and maintenance procedures specifically described in this instructions for use. Inspection and servicing of internal parts shall only be performed by qualified service personnel.

10

General warnings and cautions

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

WARNING The device complies with applicable domestic and international standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices. As a precaution, avoid using the device in close proximity to other equipment. WARNING Welch Allyn is not responsible for the integrity of any mounting installation. Welch Allyn recommends that customers contact their Biomedical Engineering Department or maintenance service to ensure professional installation for safety and reliability of any mounting accessory. WARNING The device is not defibrillator proof. WARNING The device may 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 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 may 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 If the accuracy of any measurement is in question, check the patient's vital sign(s) with an alternate method and then check to verify the device is functioning properly. 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.

Instructions for use

General warnings and cautions

11

WARNING Electric shock hazard. Before cleaning the device, disconnect the power cord from the power source and the device. Ensure that the power transformer and wall plug assembly are dry before plugging into an outlet. WARNING Electric Shock Hazard. If you clean the power transformer, take the following precautions: •

Ensure the power transformer is unplugged from the outlet.

•

Ensure that the cleaning cloth is not dripping or over saturated.

•

Apply minimal pressure on the wipe or cloth when cleaning; avoid wiping the gap or connection areas on the power transformer and wall plug.

•

Ensure the power transformer, wall plug, and cord 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. CAUTION The device is not heat-resistant. Do not autoclave. CAUTION Use the device within stated operating temperature ranges. The device will not meet performance specifications if used outside these temperatures ranges. CAUTION Always unplug the external power source from the outlet before moving the device to a new location. Notice to users and/or patients in EU Any serious incident that has occurred in relation to the device, should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

12

General warnings and cautions

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

13

NIBP warnings and cautions WARNING ProBP 3400 is not intended to measure blood pressure on neonatal patients. The AAMI SP10:2002 standard defines neonates as children 28 days or less of age if born at term (37 weeks gestation or more); otherwise up to 44 gestational weeks. WARNING This device is not intended for use on neonates, infants, or children under the age of 3 years. The effectiveness of this device has not been established in pregnant, including pre-eclamptic, patients. WARNING To ensure pediatric blood pressure accuracy and safety, the Small Child Reusable Cuff (REUSE-08) is the smallest cuff approved for use with young children. WARNING Do not compress the blood pressure hose or cuff. This may cause system errors or patient safety risks to occur. WARNING NIBP readings may be inaccurate for patients experiencing moderate to severe arrhythmia. WARNING Inaccurate measurement risk. Do not use the device on patients who are experiencing convulsions or tremors. WARNING Use only blood pressure cuffs and hoses listed as approved accessories to ensure safe and accurate NIBP measurements. WARNING Patient injury risk. When several blood pressure measurements are taken on the same patient, regularly check the cuff site and extremity for possible ischemia, purpura, and/or neuropathy. WARNING Do not allow a blood pressure cuff to remain on the patient more than 3 minutes when inflated above 15 mmHg. Excessive cuff tightness may cause venous congestion, peripheral nerve injury, discoloration of the limb, and patient distress. WARNING Inaccurate measurement risk. Do not place the cuff where it can disturb proper circulation. Do not place the cuff on any area where circulation is compromised or on any extremity used for intravenous infusions. WARNING The blood pressure cuff must be properly positioned to ensure blood pressure accuracy and patient safety. Wrapping the cuff too loosely (preventing proper inflation) may result in inaccurate NIBP readings.

14 NIBP warnings and cautions

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

WARNING Patient injury risk. Never install Luer Lock connectors on Welch Allyn blood pressure tubing. Using these connectors on blood pressure cuff tubing creates the risk of mistakenly connecting this tubing to a patient's intravenous line and introducing air into the patient's circulatory system. WARNING NIBP measurements may be inaccurate in the presence of excessive motion artifact. Minimize extremity and cuff motion during blood pressure readings. WARNING The position and physiologic condition of the subject can affect a blood pressure reading. WARNING If the blood pressure cuff is not at heart level, note the difference in reading due to the hydrostatic effect. Add the value of .2 kPa (1.80 mmHg) to the displayed reading for every 2.5 cm (inch) above heart level. Subtract the value of .2 kPa (1.80 mmHg) from the displayed reading for every 2.5 cm (inch) below heart level. WARNING Proper blood pressure cuff size and placement is essential to the accuracy of the blood pressure determination. See Blood pressure cuff selection for sizing information. WARNING Continuous cuff pressure due to connection tubing kinking may result in blood flow interference and harmful injury may occur to the patient. WARNING Frequent measurements can cause injury to the patient due to blood flow interference. WARNING Do not place the cuff over a wound as this can cause further injury. WARNING Blood flow interference may result if the application of the cuff and its pressurization on any limb where intravascular access or therapy, or an arteriovenous (A-V) shunt is present and could result in injury to the patient. WARNING Avoid pressurizing a cuff on the arm side of a mastectomy. WARNING Pressurization of the cuff may result in temporary loss of function of simultaneous used monitoring equipment applied on the same limb as the cuff. WARNING The automated sphygmomanometer needs to be checked to ensure that its operation does not result in prolonged impairment of blood circulation of the patient.