Hillrom Welch Allyn 4400 Instructions For Use Manual
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Hillrom Welch Allyn 4400 Instructions For Use Manual

Hillrom Welch Allyn 4400 Instructions For Use Manual

Spot vital signs
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Instructions for use
Software version 1.X
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© 2022 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.
Legal Statement. Welch Allyn, Inc. ("Welch Allyn") assumes no responsibility for any injury to anyone that may result from (I) failure to properly use
the product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual, or (ii) any illegal or
improper use of the product.
Welch Allyn, SureTemp, FlexiPort, and SureBP are registered trademarks of Welch Allyn. EcoCuff is a trademark of Welch Allyn.
Nonin is a registered trademark of Nonin Medical, Inc.
Software in this product is Copyright 2022 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.
This product may contain software known as "free" or "open source" software (FOSS). Hill-Rom 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 hillrom.com/opensource. Where required, a copy of FOSS source code is available on our FOSS
website.
PATENTS / PATENT 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.
For information about any product, contact Hillrom Technical Support: hillrom.com/en-us/about-us/locations/.
107241, 80029786 Ver. A
Revision date: 2022-06
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
hillrom.com
Welch Allyn, Inc. is a subsidiary of Hill-
Rom Holdings, Inc.
This manual applies to
901057 Vital Signs Device.
Authorized Australian Sponsor
and EU IMPORTER
Welch Allyn Australia Pty. Ltd.
Welch Allyn Limited
1 Baxter Drive
Navan Business Park
Old Toongabbie NSW 2146
Dublin Road
Australia
Navan, Co. Meath
C15 AW22
Ireland
Authorized Representative for
Kazakhstan
TOO Orthodox Pharm
Uly Dala Avenue 7/4, apt 136
Nur-Sultan 010000 Kazakhstan

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Summary of Contents for Hillrom Welch Allyn 4400

  • Page 1 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 hillrom.com/opensource. Where required, a copy of FOSS source code is available on our FOSS website.

  • Page 2: Table Of Contents

    iv Contents Welch Allyn® Spot Vital Signs 4400 Troubleshooting ........................49 NIBP messages ..................................49 SpO2 messages .................................. 55 Temperature messages ..............................56 Patient data messages ..............................62 System messages ................................62 Contents Power messages ................................64 Software update messages ............................65 Specifications ..........................

  • Page 3: Intended Use

    2 Introduction Welch Allyn® Spot Vital Signs 4400 Introduction   This manual describes the capabilities and operation of the Welch Allyn® Spot Vital Signs 4400 (device). The information, including the illustrations, pertains to a device configured with noninvasive blood pressure (NIBP), body temperature, pulse oximetry (SpO2), and pulse rate. If your device configuration lacks any of these options, some information in this manual might not apply.

  • Page 4: Symbols And Definitions

    Documentation symbols For information on the origin of these symbols, see the Welch Allyn symbols glossary: https:// www.hillrom.com/content/dam/hillrom-aem/us/en/sap-documents/LIT/80022/ 80022945LITPDF.pdf. 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 Miscellaneous symbols background in a black and white document.

  • Page 5: Screen Symbol

    Symbols and definitions 5 6 Symbols and definitions Instructions for use Welch Allyn® Spot Vital Signs 4400 Authorized Representative in This device has no alarms. the European Community Temperature limit Global Trade Item Number Stacking limit by number Keep dry Humidity limitation Atmospheric pressure limitation...

  • Page 6: About Warnings And Cautions

    8 About warnings and cautions Welch Allyn® Spot Vital Signs 4400 WARNING Patient injury risk. Wash hands to reduce the risk of cross- contamination and nosocomial infection. WARNING Patient injury risk. Do not place the device in any position that might cause it to fall on the patient.
  • Page 7 Instructions for use About warnings and cautions 9 10 About warnings and cautions Welch Allyn® Spot Vital Signs 4400 WARNING Electric shock hazard. All signal input and output (I/O) connectors are WARNING Defective batteries can damage the device. If the battery shows any intended for connection of only devices complying with IEC 60601-1, or other IEC signs of damage or cracking, it must be replaced immediately and only with a standards (for example, IEC 60950), as applicable to the device.
  • Page 8 About warnings and cautions 11 12 About warnings and cautions Instructions for use Welch Allyn® Spot Vital Signs 4400 Residual risk information WARNING Verify the patient vitals data for each entry on the Spot Vital Signs 4400 device before transferring patient records. This product complies with relevant electro-magnetic interference, mechanical safety, CAUTION This device is not intended for use in the home healthcare performance, and biocompatibility standards.

  • Page 9: Controls, Indicators, And Connectors

    14 Controls, indicators, and connectors Welch Allyn® Spot Vital Signs 4400 No. Feature Description Power button Blue button on lower-left corner of the device: • Powers on the device • Provides power options for the device • Wakes up the device from Sleep mode Controls, indicators, and connectors Back-Bottom-Left view  ...

  • Page 10: Supplies And Accessories

    16 Setup Welch Allyn® Spot Vital Signs 4400 Locate the battery cover, indicated by on the back of the device. Using a double-slotted screwdriver, loosen the captive screw at the base of the battery cover, and then remove the cover. Remove the battery to access the battery connection port on the device.

  • Page 11: Disconnect The Nibp Hose

    Setup 17 18 Setup Instructions for use Welch Allyn® Spot Vital Signs 4400 Connect the NIBP hose Place your thumb and forefinger on the hose connector spring tabs and squeeze firmly. Align the hose connector with the hose connector port on the bottom of the device. Insert the hose connector, pressing firmly until both of the spring tabs click into place.

  • Page 12: Power Down The Device

    WARNING Always observe the device during power-up. If any display fails to memory. illuminate properly, or if a system fault code or message displays, inform qualified service personnel immediately, or call your nearest Hillrom Customer Service or Press to power up the device.

  • Page 13: Common Screen Functionality

    Instructions for use Startup 21 22 Startup Welch Allyn® Spot Vital Signs 4400 Two actions wake the device from sleep mode: • The power button is pressed. • The screen is tapped. Enter Sleep mode Press If there is no system message, a dialog box appears with options to Power down, Sleep, and Cancel.

  • Page 14: Pop-Up Screens

    Startup 23 24 Startup Instructions for use Welch Allyn® Spot Vital Signs 4400 Primary tabs Bars Description The primary tabs at the bottom of the screen enable you to switch between tabs and change the Running on battery, battery charge is very low; 0% - 10% Display time remaining (HH:MM) controls in the content area on the device.

  • Page 15: Settings Tab

    Startup 25 26 Startup Instructions for use Welch Allyn® Spot Vital Signs 4400 Settings tab The Settings tab enables you to edit certain device functions. It contains vertical navigation tabs: • Averaging • Date / Time • Device • Advanced Adjust screen brightness The screen can be adjusted to 10 levels of brightness.

  • Page 16: Nibp Measurements

    28 Patient vitals Welch Allyn® Spot Vital Signs 4400 WARNING Patient injury risk. Inaccurate measurement risk. Do not use an SpO2 finger clip sensor and a blood pressure cuff simultaneously on the same limb. Doing so may cause a temporary loss of pulsatile flow, resulting in either no reading or an inaccurate SpO2 or pulse rate until the flow returns.

  • Page 17: Position The Cuff

    Large adult 32.0 – 43.0 12.6 – 16.9 measurements, see Tips for Taking Accurate Blood Pressure Readings on the Hillrom website. Thigh 40.0 – 55.0 15.7 – 21.7 Obtain a single NIBP measurement Position the cuff CAUTION Correct sizing of the blood pressure cuff is important for accurate blood pressure readings.

  • Page 18: Temperature Frame

    Patient vitals 31 32 Patient vitals Instructions for use Welch Allyn® Spot Vital Signs 4400 Averaging WARNING Patient injury risk. Do not exceed the recommended temperature measurement durations in Direct mode. Continuous measurement durations of 3 The Averaging program enables you to record the patient's average NIBP readings over a set minutes at the oral and rectal sites and 5 minutes at the axillary site are period of time.

  • Page 19: Temperature Buttons

    Instructions for use Patient vitals 33 34 Patient vitals Welch Allyn® Spot Vital Signs 4400 Icon Description WARNING Patient injury risk. Always take a temperature measurement with a Welch Allyn single-use probe cover securely attached. Failure to use a probe cover Oral can cause patient discomfort from a heated probe, patient cross-contamination, and inaccurate temperature readings.

  • Page 20: Take A Temperature In The Predictive Mode

    Patient vitals 35 36 Patient vitals Instructions for use Welch Allyn® Spot Vital Signs 4400 • If you have a patient whose body temperature is below the normal temperature range and CAUTION The device does not retain Direct mode temperatures in memory. For you follow the previous step, the probe sensor identifies this condition and turns off the probe temperature measurements that are within normal range, it is important to note preheater in order to accommodate the lower body temperature measurement.

  • Page 21: Spo2 Numeric View

    Patient vitals 37 38 Patient vitals Instructions for use Welch Allyn® Spot Vital Signs 4400 The frame provides a numeric view and a waveform view of SpO2 data. You can toggle between WARNING Patient injury risk. Do not use tape to secure the finger clip sensor to views by touching the left side of the frame.

  • Page 22: Additional Parameters

    Instructions for use Patient vitals 39 40 Patient vitals Welch Allyn® Spot Vital Signs 4400 Enter vitals measurements manually CAUTION If the Low Perfusion message is frequently displayed, find a better perfused measuring site. In the interim, assess the patient and, if indicated, verify oxygenation status through other means.

  • Page 23: Advanced Settings

    Patient vitals 41 42 Patient vitals Instructions for use Welch Allyn® Spot Vital Signs 4400 NOTE Patient data will be deleted after 24 hours, or after the device is reset. Advanced settings Consult the Spot Vital Signs 4400 Service manual for Advanced settings.

  • Page 24: Maintenance And Service

    44 Maintenance and service Welch Allyn® Spot Vital Signs 4400 Component Service interval Service procedure SureTemp Plus Annually Basic functional verification Battery Replace the battery Semi-annually Battery performance is a function of clinical use and charge/discharge patterns. Welch Allyn recommends replacing the battery after six months or when its remaining capacity no longer meets workflow requirements.

  • Page 25: Cleaning Requirements

    Instructions for use Maintenance and service 45 46 Maintenance and service Welch Allyn® Spot Vital Signs 4400 Cleaning agent Additional information NOTE Do not overtighten the screw. Accel INTERVention Cleaning requirements Accel TB CaviWipes This section presents procedures for cleaning the device (including the device, stand, accessories, and accessory basket and bins).

  • Page 26: Clean The Equipment

    Maintenance and service 47 48 Maintenance and service Instructions for use Welch Allyn® Spot Vital Signs 4400 Remove battery pack from the device. For cleaning the wallboard and VESA mount use only 70 percent isopropyl alcohol solution applied to a clean cloth. Dry excess liquid from the device.

  • Page 27: Troubleshooting

    50 Troubleshooting Welch Allyn® Spot Vital Signs 4400 Message Possible cause Suggested action Unable to determine NIBP; check The blood pressure measurement Make sure the NIBP settings/patient connections; limit patient dumped too soon mode is appropriate. If the problem movement. 050007 persists, have the device inspected by a qualified service technician.
  • Page 28 Instructions for use Troubleshooting 51 52 Troubleshooting Welch Allyn® Spot Vital Signs 4400 Message Possible cause Suggested action Message Possible cause Suggested action allowable range for the specified Ambient temperature out of range. Ambient temp out of range on Restore device to normal message Clear error and retry.
  • Page 29 Troubleshooting 53 54 Troubleshooting Instructions for use Welch Allyn® Spot Vital Signs 4400 Message Possible cause Suggested action Message Possible cause Suggested action device inspected by a qualified NIBP not functional. 050618 Invalid NIBP target pressure Internal malfunction. If the problem service technician.

  • Page 30: Spo2 Messages

    Troubleshooting 55 56 Troubleshooting Instructions for use Welch Allyn® Spot Vital Signs 4400 Message Possible cause Suggested action Message Possible cause Suggested action NIBP not functional. 05FF0F The NIBP sensor firmware failed to Internal malfunction. If the problem SpO2 interference The SpO2 interference detected.
  • Page 31 Instructions for use Troubleshooting 57 58 Troubleshooting Welch Allyn® Spot Vital Signs 4400 Message Possible cause Suggested action Message Possible cause Suggested action under voltage or Temperature not functional. 030207 The temperature module Internal malfunction. If the problem persists, unstable. message requires an have the device inspected by a qualified object, but did not...
  • Page 32 Troubleshooting 59 60 Troubleshooting Instructions for use Welch Allyn® Spot Vital Signs 4400 Message Possible cause Suggested action Message Possible cause Suggested action Temperature not functional. 03080B The temperature module Internal malfunction. If the problem persists, Temperature not functional. 030817 EEPROM not initialized Internal malfunction.

  • Page 33: Patient Data Messages

    Troubleshooting 61 62 Troubleshooting Instructions for use Welch Allyn® Spot Vital Signs 4400 Message Possible cause Suggested action Message Possible cause Suggested action Temperature not functional. 030824 The temperature module Internal malfunction. If the problem persists, Temperature not functional. 03CE00 Unable to read PIM file Retry the device update.

  • Page 34: Power Messages

    Instructions for use Troubleshooting 63 64 Troubleshooting Welch Allyn® Spot Vital Signs 4400 Message Possible cause Suggested action Message Possible cause Suggested action 000002 System failure Restart the device Input voltage too low. Power supply issue. The PMIC input Check the operating environment Device will shut down.

  • Page 35: Software Update Messages

    Troubleshooting 65 66 Troubleshooting Instructions for use Welch Allyn® Spot Vital Signs 4400 Software update messages Message Possible cause Suggested action Software Update: The manifest file transfer timed out Verify the connection and retry. Manifest transfer timed or connection was lost during out.

  • Page 36: Specifications

    68 Specifications Welch Allyn® Spot Vital Signs 4400 Protection classifications, all device configurations Active area 6.1 in. (W) x 3.4 in. (H) (154.08 mm [W] x 85.92 mm [H]) Resolution 800 x 480 pixels Pixel arrangement RGB (red, green, blue) Pixel size 63.2 µm (W) x 179 µm (H) Specifications...

  • Page 37: Spo2 Specifications

    (±5 mmHg mean error, 8 mmHg standard deviation) Thermometry clinical accuracy validation For a copy of our Clinical Validation Study, please contact Hillrom Customer Care. Mean Arterial Pressure (MAP) range Adult: 23 to 230 mmHg (StepBP, SureBP)

  • Page 38: Environmental Specifications

    Specifications 71 72 Specifications Instructions for use Welch Allyn® Spot Vital Signs 4400 See the Welch Allyn Spot Vitals Signs 400 Service manual for recommended service intervals. Accuracy SpO2 specifications checks and calibration are only recommended if the device case is opened or if issues are suspected.

  • Page 39: General Compliance And Standards

    If in doubt, the user of the device shall first contact Hillrom Technical Support for guidance on safe disposal protocols. For more specific disposal or compliance information, see www.welchallyn.com/weee, or contact Hillrom Technical Support:...

  • Page 40: Emissions And Immunity Information

    Emissions and immunity information For information about electromagnetic compatibility (EMC), see the Hillrom website: https://www.hillrom.com/content/dam/hillrom-aem/us/en/sap-documents/LIT/80025/ 80025125LITPDF.pdf You can order a printed copy of the Emissions and immunity information from Hillrom for delivery within 7 calendar days. Guidance and manufacturer's declaration  ...

  • Page 41: Appendix

    78 Appendix Welch Allyn® Spot Vital Signs 4400 Part number Description 02895-100 Rectal probe and well kit (9ft. / 2.7M) 02894-0000 Oral probe well (blue) 02894-1000 Rectal probe well (red) 05031-110 SureTemp Plus Disposable probe covers (10,000 covers, packaged 25/box) Appendix  ...

  • Page 42: Applied Parts

    NOTE Some model numbers and product features described in this publication might not be available in your country. For the latest information about products and features, please contact Hillrom Customer Care. SmartCare protection plus plans SmartCare protection plus plans include onsite repair.

  • Page 43: Suretemp Plus Thermometry

    Instructions for use Appendix 81 82 Appendix Welch Allyn® Spot Vital Signs 4400 Part number Model Description Part number Description REUSE-06-ML Reusable Cuff, Welch Allyn, reusable, small infant, ML 0740-000 8008J Nonin infant flex sensor with 25 wraps REUSE-07-ML Reusable Cuff, Welch Allyn, reusable, infant, ML 0741-000 8000J Nonin adult flex sensor with 25 wraps...

  • Page 44: Warranty

    Instructions for use Appendix 83 Warranty Welch Allyn warrants the product to be free of defects in material and workmanship and to perform in accordance with manufacturer's specifications for the period of two years from the date of purchase from Welch Allyn or its authorized distributors or agents. The warranty period shall start on the date of purchase.

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