ProBP 3400 Directions for Use Ver B

© 2010 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 byWelch 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, 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 2010 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 Welch Allyn Technical Support (www.welchallyn.com/ support) or call: USA +1 800 535 6663 +1 315 685 4560 Canada +1 800 561 8797 European Call Center +353 46 90 67790 Germany +49 695 098 5132 Japan +81 3 6383 0852 Malaysia +603 7875 3341 Singapore +65 6419 8100 Spain +34 917 499 357 United Kingdom +44 207 365 6780

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103701 (CD) DIR 80016085 Ver. A

European Community Representative Welch Allyn, Inc. 4341 State Street Road

Welch Allyn Ltd

Skaneateles Falls, NY 13153-0220 USA

Dublin Road, Navan

www.welchallyn.com

County Meath, Republic of Ireland

Navan Business Park

Tel.: +353 46 90 67700 Fax: +353 46 90 67755

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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, indicators, and connectors ... 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/line cord assembly ... 25 Charge the device ... 25

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

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Contents

ProBP 3400

Battery ... 31 Startup ... 33 Standby mode ... 35 Blood pressure measurement ... 37 Settings ... 39 Settings matrix ... 39 Unit of measure ... 39 Pressure presets ... 40 Bluetooth wireless technology ... 40 Advanced settings ... 41

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

Maintenance and service ... 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 ... 50

Standards and compliance ... 51 General radio compliance ... 51

Guidance and manufacturer's declaration ... 53 Emissions and immunity information ... 53

Warranty ... 57 Troubleshooting ... 59 Inaccurate blood pressure readings ... 59 Cuff inflation and deflation with no blood pressure reading displayed ... 60 No cuff inflation ... 60 Cuff pops off ... 61 Cuff deflating too slowly ... 61 Device does not turn on ... 61 Bluetooth troubleshooting ... 62

Directions for use

Contents

v

Appendix ... 65 ProBP 3400 approved accessories ... 65 Configuration options ... 68

vi

Contents

ProBP 3400

1

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

2

Initial device setup

ProBP 3400

3

Introduction This Directions 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.

4

Introduction

ProBP 3400

5

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/power off

Return to previous screen

Blood Pressure Start/Stop

Select

6

Symbols

ProBP 3400

Navigation (Up, Down, Left, Right)

Shipping, storing, and environment symbols

IPXØ

Fragile; handle with care

Relative humidity limits

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

European Community Representative

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

EMC Framework of Australia

Intertek ETL listed

Type BF applied parts

Directions for use

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

7

8

Symbols

ProBP 3400

9

General warnings and cautions WARNING The information in this directions for use is a comprehensive guide to the operation of ProBP 3400. For best results, read this directions for use thoroughly before using the device. WARNING The device is designed for medical clinician use. Although this directions 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 oxygen-enriched 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 directions 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 directions for use. Inspection and servicing of internal parts shall only be performed by qualified service personnel. 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.

10 General warnings and cautions

ProBP 3400

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. WARNING Electric shock hazard. Before cleaning the device, disconnect the power cord from the power source and the device. Caution Take care to prevent water or other fluid from entering any connectors on the device. 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.

Directions for use

General warnings and cautions

11

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.

12

General warnings and cautions

ProBP 3400

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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 To ensure pediatric blood pressure accuracy and safety, the Small Child Reusable Cuff (REUSE-08) and the Small Child Disposable Cuff (SOFT-08) are the smallest cuffs approved for use with young children. The child's arm must fit within the range markings on the cuff. 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. 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.

14 NIBP warnings and cautions

ProBP 3400

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.