Welch Allyn Spot Vital Signs 4400 Instructions For Use Manual
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Welch Allyn Spot Vital Signs 4400 Instructions For Use Manual

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Software version 1.X

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Summary of Contents for Welch Allyn Spot Vital Signs 4400

  • Page 1 Instructions for use Software version 1.X...
  • Page 2 © 2019 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.

  • Page 3: Table Of Contents

    Contents Introduction ..................... 1 Intended use ......................1 Contraindications ....................1 Symbols and definitions ................. 3 About warnings and cautions ..............7 General warnings and cautions ................7 Controls, indicators, and connectors ........... 13 Setup ...................... 15 Supplies and accessories ................... 15 Connect the battery ...................
  • Page 4 ® 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 Power messages ....................64 Software update messages ................64 Specifications ..................

  • Page 5: Introduction

    Intended use ® The Welch Allyn Spot Vital Signs 4400 (device) is intended to be used by clinicians and medically qualified personnel for operator initiated spot-check/single measurement of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in oral, rectal and axillary modes of adult and pediatric patients down to 29 days of age.
  • Page 6 ® 2 Introduction Welch Allyn Spot Vital Signs 4400...

  • Page 7: Symbols And Definitions

    Follow instructions/directions 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...
  • Page 8 ® 4 Symbols and definitions Welch Allyn Spot Vital Signs 4400 Rated power input, DC Rated power input, AC Lithium-ion battery Connectivity symbols Miscellaneous symbols Manufacturer Defibrillation-proof Type BF applied parts Product Identifier Serial Number Reorder Number Recyclable Do not reuse, Single use device Separate collection of Electrical and Electronic Equipment.
  • Page 9 Instructions for use Symbols and definitions 5 Stacking limit by number Keep dry Humidity limitation Mass in kilograms (kg) Maximum safe working load Non-ionizing electromagnetic limits radiation Screen symbol Process indicator for activities like acquiring measurements and connecting to a laptop...
  • Page 10 ® 6 Symbols and definitions Welch Allyn Spot Vital Signs 4400...

  • Page 11: About Warnings And Cautions

    About warnings and cautions Warning and caution statements can appear on the device, on the packaging, on the shipping container, or in this document. The device is safe for patients and clinicians when used in accordance with the instructions and the warning and caution statements presented in this manual. Before using the device, familiarize yourself with the sections of this instructions for use that pertain to your use of the device.
  • Page 12 WARNING Equipment damage and personal injury risk. No modifications to the device are allowed by anyone other than a qualified Welch Allyn service representative. Modification of the device could be hazardous to patients and personnel.
  • Page 13 Instructions for use About warnings and cautions 9 WARNING Electric shock hazard. Do not open the device or attempt repairs. The device has no user-serviceable internal parts. Only perform routine cleaning and maintenance procedures specifically described in this manual while the device is not in use on a patient. Inspection and servicing of internal parts shall only be performed by qualified service personnel.
  • Page 14 WARNING The use of the Spot Vital Signs 4400 device adjacent to or stacked with other equipment or medical electrical systems should be avoided because it could result in improper operation.
  • Page 15 Welch Allyn may affect the EMC emissions or immunity. WARNING Maintain minimum separation distance of 12 inches (30 cm) between any part of the Spot Vital Signs 4400 device and portable RF communication equipment (including peripherals such as antenna cables and external antennas).
  • Page 16 CAUTION Use only the Welch Allyn USB client cable to connect a laptop computer to the USB client port. Any laptop connected to the device must be running on a battery, a 60601-1 compliant power supply, or a 60601-1 compliant isolation transformer.

  • Page 17: Controls, Indicators, And Connectors

    Controls, indicators, and connectors Note Your model might not contain all of these features. Front-Left view No. Feature Description LCD screen 7" color touchscreen provides a graphical user interface. Thermometry probe well Houses the SureTemp probe on the device Battery charge and power-up status indicator The LED indicates the charging and power-up status when connected to AC power: •...
  • Page 18 ® 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 Back-Bottom-Left view No.

  • Page 19: Setup

    Always recycle batteries according to national or local regulations. WARNING Use only Welch Allyn approved accessories, and use them according to the manufacturer’s directions for use. Using unapproved accessories with the device can affect patient and operator safety and can compromise product performance and accuracy, and void the product warranty.

  • Page 20: Mount The Device

    Note Do not over-tighten the screw. Mount the device The Spot Vital Signs 4400 device can be mounted on either the mobile stand, desk stand, or wall mount. Follow the assembly instructions or instructions for use included with your device.

  • Page 21: Connect The Nibp Hose

    Instructions for use Setup 17 4. In the compartment to the left of the probe well, insert a Welch Allyn probe cover carton. Connect the NIBP hose 1. Place your thumb and forefinger on the hose connector spring tabs and squeeze firmly.

  • Page 22: Disconnect Ac Power

    ® 18 Setup Welch Allyn Spot Vital Signs 4400 Disconnect AC power CAUTION Never move the device or mobile stand by pulling on any of the cords. This may cause the device to tip over or damage the cord. Never pull on the power cord when disconnecting the cord from the mains outlet.

  • Page 23: Startup

    Startup Power The Power button, located on the lower-left corner of the device, performs multiple functions. • Powers up the device • Wakes the device from Sleep mode • Opens a pop-up dialog with controls to power down, enter Sleep mode, or cancel CAUTION Do not use a long press of the Power button to power down the device when it is functioning normally.
  • Page 24 ® 20 Startup Welch Allyn Spot Vital Signs 4400 The power LED flashes until the device displays the brand logo and a power-up tone sounds. On initial power-up, the device prompts you to set the language, date, and time. Set the date and time 1.

  • Page 25: Common Screen Functionality

    Instructions for use Startup 21 Sleep mode The device enters sleep mode after a period of inactivity. You can also manually put the device into sleep mode. Different types of inactivity have different time delays. • When a configurable amount of time has passed since the last screen press •...
  • Page 26 ® 22 Startup Welch Allyn Spot Vital Signs 4400 The primary screens have three sections: Item Description 1 Status Status area appears at the top of the screen and includes information regarding system-wide features. 2 Content The Content area displays information determined by the primary — or global — navigation tab chosen at the bottom of the screen.

  • Page 27: Pop-Up Screens

    Instructions for use Startup 23 Bars Description Running on battery, battery charge is very low; 11% - 25%; display time remaining (HH:MM) Running on battery, battery charge is very low; 0% - 10% Display time remaining (HH:MM) When the battery is not being recharged and power becomes low, a notification appears in the Status area.
  • Page 28 ® 24 Startup Welch Allyn Spot Vital Signs 4400 Primary tabs The primary tabs at the bottom of the screen enable you to switch between tabs and change the controls in the content area on the device. The tab you choose determines what information appears on the screen.
  • Page 29 Instructions for use Startup 25 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. Adjust screen brightness in the Device tab in Settings.
  • Page 30 ® 26 Startup Welch Allyn Spot Vital Signs 4400...

  • Page 31: Patient Vitals

    Patient vitals NIBP Located in the upper-left corner of the Home tab, the NIBP frame contains data and features relevant to noninvasive blood pressure measurement. WARNING Patient injury risk. Do not install luer connectors on blood pressure tubing. Using luer connectors in manual or automated blood pressure systems creates the risk of inadvertent connection to intravenous (IV) tubing, which can introduce air into the patient’s circulatory system.
  • Page 32 If necessary, use the femoral artery in the thigh to take a measurement. WARNING Possible measurement error. Use only Welch Allyn blood pressure cuffs and accessories; substitution may result in measurement error.
  • Page 33 Instructions for use Patient vitals 29 NIBP measurement display When the measurement is complete, the NIBP frame displays the measurement until you save it, or until you start another NIBP measurement. If any NIBP measurement is out of range or cannot be determined, the NIBP frame shows a “++” or “- -” in front of the measurement.
  • Page 34 ® 30 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 35 Instructions for use Patient vitals 31 uncrossed, feet are flat on the floor, back and arm are supported, and the cuff is level with the patient's heart. To obtain an accurate resting blood pressure reading, wait 5 minutes to begin this procedure.

  • Page 36: Temperature

    ® 32 Patient vitals Welch Allyn Spot Vital Signs 4400 Temperature General temperature warnings and cautions WARNING Patient injury risk: The decision to use this device with children, or pregnant or nursing women is at the discretion of the trained clinician using the equipment.
  • Page 37 Instructions for use Patient vitals 33 Icon Description Pediatric axillary Adult axillary Oral Rectal. Devices configured with the temperature module and the red rectal probe well and probe default to the rectal mode. Temperature buttons The button on the right side of the frame enables you to use Direct mode. Icon Button name Description...
  • Page 38 Carefully place the probe in the axilla, avoiding contact with other objects or material. 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 can cause patient discomfort from a heated probe, patient cross-contamination, and inaccurate temperature readings.
  • Page 39 Instructions for use Patient vitals 35 Predictive mode Predictive mode is a one-time measurement that takes a temperature in approximately 6-15 seconds. Removing the probe from the probe well, loading a probe cover, and holding the probe tip in place at the measurement site initiates a Predictive mode measurement.
  • Page 40 ® 36 Patient vitals Welch Allyn Spot Vital Signs 4400 Take a temperature in the Direct mode Direct mode displays the temperature of the probe as long as the probe tip remains in place at the measurement site and remains within the operating patient temperature range.

  • Page 41: Spo2

    Instructions for use Patient vitals 37 The device does not retain Direct mode temperatures in Note memory. Therefore, it is important to note the temperature before removing the probe from the measurement site and then manually record it in the patient record. 6.
  • Page 42 ® 38 Patient vitals Welch Allyn Spot Vital Signs 4400 WARNING Inaccurate measurement risk. Severe anemia may cause erroneous SpO2 readings. WARNING Inaccurate measurement risk. The pulse oximeter can be used during defibrillation, but the readings may be inaccurate for up to 20 seconds.
  • Page 43 Instructions for use Patient vitals 39 WARNING The accuracy of SpO2 measurements can be affected by any of the following: • excessive ambient light • excessive motion • electrosurgical interference • arterial catheters, blood pressure cuffs, infusion lines, etc. • moisture in the sensor •...

  • Page 44: Enter Vitals Measurements Manually

    ® 40 Patient vitals Welch Allyn Spot Vital Signs 4400 Do not use flex sensors on patients who have allergic reactions to the Note adhesive. To take an SpO2 measurement: 1. Verify that the sensor cable is connected to the device.

  • Page 45: Save Patient Data

    The patient data appears on a row with the date and time at which you saved the data. 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 46 ® 42 Patient vitals Welch Allyn Spot Vital Signs 4400...

  • Page 47: Maintenance And Service

    The device may remain in service until repair is required or operation indicates that it is out of calibration. Customers who have the Standard unlicensed edition of the Welch Allyn Service Tool can perform the basic functional verification procedures referenced in the table. Refer to...

  • Page 48: Replace The Device 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. Customers who have the Standard unlicensed 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.

  • Page 49: Cleaning Requirements

    This section presents procedures for cleaning the device (including the device, stand, accessories, and accessory basket and bins). Welch Allyn has validated these instructions to be capable of preparing your device and above accessories for re-use. Clean on a routine basis according to your facility's protocols and standards or local regulations.
  • Page 50 ® 46 Maintenance and service Welch Allyn Spot Vital Signs 4400 1. Power down the device. 2. Disconnect the power cord from the mains outlet and the power source. 3. Remove battery pack from the device. 4. Dry off excess liquid from the device.
  • Page 51 Instructions for use Maintenance and service 47 Section 2. Not approved for cleaning the display Cleaning agent Additional information 10 percent bleach solution (.5% - 1% sodium hypochlorite) applied to a clean cloth Clorox HealthCare Bleach Germicidal Cleaner ® Sani-Cloth Bleach Remove liquid spills from the device Liquids can damage electronics inside the device.
  • Page 52 ® 48 Maintenance and service Welch Allyn Spot Vital Signs 4400 7. Wipe the AC power cord. 8. Wipe the stand from top to bottom. Dry the equipment 1. Allow all components except the LCD screen to air dry. 2. Wipe the LCD screen dry with a clean cloth.

  • Page 53: Troubleshooting

    Troubleshooting This section presents tables of notification and error messages to help you troubleshoot issues on the device. To use these tables, locate the message that displays on the device in the left column of the table. The remainder of the row explains possible causes and suggests actions that can resolve the issue.
  • Page 54 ® 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 movement. dumped too soon mode is appropriate. If the problem...
  • Page 55 Instructions for use Troubleshooting 51 Message Possible cause Suggested action NIBP not functional. 050207 The NIBP module message requires an Internal malfunction. If the problem object, but did not contain one persists, have the device inspected by a qualified service technician. NIBP not functional.
  • Page 56 ® 52 Troubleshooting Welch Allyn Spot Vital Signs 4400 Message Possible cause Suggested action Low battery. Plug into outlet. 050518 The NIBP module power rail is too low Plug device into an AC outlet to charge the battery. Battery overcharged. Disconnect from The NIBP module power rail is too high.
  • Page 57 Instructions for use Troubleshooting 53 Message Possible cause Suggested action NIBP not functional. 05060C NIBP command not implemented Internal malfunction. If the problem persists, have the device inspected by a qualified service technician. NIBP not functional. 05060D NIBP wrong data count Internal malfunction.
  • Page 58 ® 54 Troubleshooting Welch Allyn Spot Vital Signs 4400 Message Possible cause Suggested action NIBP not functional. 05FF01 Unrecognized WACP parameter Internal malfunction. If the problem received from sensor persists, have the device inspected by a qualified service technician. NIBP not functional. 05FF02 Timeout waiting for sensor response Internal malfunction.

  • Page 59: Spo2 Messages

    Instructions for use Troubleshooting 55 SpO2 messages General SpO2 messages Message Possible cause Suggested action SpO2 not functional. 044800 SpO2 not functional Internal hardware malfunction in SpO2 module. If the problem persists, have the device inspected by a qualified service technician.

  • Page 60: Temperature Messages

    ® 56 Troubleshooting Welch Allyn Spot Vital Signs 4400 Message Possible cause Suggested action Low perfusion index. Clear to SpO2 marginal pulse quality or artifact Reapply the sensor to the patient. If the retry. 040500 problem is still present, replace the SpO2 sensor.
  • Page 61 Instructions for use Troubleshooting 57 Message Possible cause Suggested action Temperature not functional. 3020A The temperature module Internal malfunction. If the problem persists, have message is performing a the device inspected by a qualified service request/action when the technician. module state prohibits the request/action.
  • Page 62 ® 58 Troubleshooting Welch Allyn Spot Vital Signs 4400 Message Possible cause Suggested action Temperature not functional. 30803 The temperature module Internal malfunction. If the problem persists, have internal calibration resistor the device inspected by a qualified service (RCAL) on the board is technician.
  • Page 63 Instructions for use Troubleshooting 59 Message Possible cause Suggested action Connect temperature probe. 3080F The temperature module Probe malfunction. Replace probe. If the problem detected no probe persists, have the device inspected by a qualified connected service technician. Replace temperature probe. 30810 The temperature module Probe malfunction.
  • Page 64 ® 60 Troubleshooting Welch Allyn Spot Vital Signs 4400 Message Possible cause Suggested action Temperature not functional. 3081C The temperature module Internal malfunction. If the problem persists, have turned Q&C on and the the device inspected by a qualified service heater voltage is not high technician.
  • Page 65 Instructions for use Troubleshooting 61 Message Possible cause Suggested action Replace temperature probe. 30829 The temperature module Probe malfunction. Replace probe. If the problem has a non-responsive probe. persists, have the device inspected by a qualified The thermistor has pulled service technician.

  • Page 66: Patient Data Messages

    ® 62 Troubleshooting Welch Allyn Spot Vital Signs 4400 Patient data messages Message Possible cause Suggested action Database schema out of The database was cleared due to a Information status message; press OK button to data; recreating. schema update dismiss.
  • Page 67 Instructions for use Troubleshooting 63 Message Possible cause Suggested action Low battery 30 minutes or The battery power is low Connect the power supply to AC power to charge less remaining. 1C1005 the device. Low battery 5 minutes or The battery power is extremely low Connect the power supply to AC power to charge less remaining.

  • Page 68: Power Messages

    ® 64 Troubleshooting Welch Allyn Spot Vital Signs 4400 Message Possible cause Suggested action Save successful. The device configuration or logs were Information status message; press OK button to saved to the USB device dismiss Send successful. Data was successfully sent over USB.
  • Page 69 Instructions for use Troubleshooting 65 Message Possible cause Suggested action Software Update: At least one of the sub systems failed Restart the device. Installation failed. Reboot to install and retry. Software Update: Upgrade The partition is running out of space Free up adequate space needed to perform the unsuccessful.
  • Page 70 ® 66 Troubleshooting Welch Allyn Spot Vital Signs 4400...

  • Page 71: Specifications

    Specifications Physical specifications Protection classifications, all device configurations Characteristic Specification Electrical rating 100 – 240 V AC, 50 – 60 Hz, 0.8A – 0.5 A Duty cycle Continuous operation Type of protection against electric shock Class I internally powered Type BF defibrillator proof Degree of protection against electric shock, for parts applied to patients IEC EN 60601-1, 2nd and 3rd Editions...
  • Page 72 ® 68 Specifications Welch Allyn Spot Vital Signs 4400 Protection classifications, all device configurations Pixel arrangement RGB (red, green, blue) Pixel size 63.2 µm (W) x 179 µm (H) Luminance 530 cd/m2 Battery specifications 2 Cell battery specifications Hours of use...
  • Page 73 Instructions for use Specifications 69 NIBP specifications Overpressure cutoff Adult: 300 mmHg ±15 mmHg Pediatric: 300 mmHg ±15 mmHg SureTemp Plus temperature module specifications SureTemp Plus temperature module specifications Temperature range (all 80°F to 110°F (26.7°C to 43.3°C) measurement sites) Calibration accuracy ±0.2°F (±0.1°C) (Direct mode) Laboratory accuracy...
  • Page 74 ® 70 Specifications Welch Allyn Spot Vital Signs 4400 SpO2 specifications Refer to sensor manufacturer's directions for use for additional information. WARNING Functional testers cannot be used to assess the accuracy of a pulse oximeter device. While functional testers may be useful for verifying that the pulse oximeter sensor, cabling, and device are functional, they are incapable of providing the data required to properly evaluate the accuracy of a system's SpO2 measurements.

  • Page 75: Environmental Specifications

    Instructions for use Specifications 71 SpO2 specifications All Sensors: ± 2 digits Environmental specifications Operating temperature 50°F to 104°F (10°C to 40°C) Storage/Transport temperature -4°F to 122°F (-20°C to 50°C) Operating altitude -1250 to 10,000 ft. (-381 m to 3,048 m) Operating humidity 15% to 90% noncondensing Storage/Transport humidity...
  • Page 76 ® 72 Specifications Welch Allyn Spot Vital Signs 4400...

  • Page 77: Standards And Compliance

    European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply. For more specific disposal or compliance information, see www.welchallyn.com/weee, or contact Welch Allyn Customer Service at +44 207 365 6780.
  • Page 78 ® 74 Standards and compliance Welch Allyn Spot Vital Signs 4400...

  • Page 79: Guidance And Manufacturer's Declaration

    Welch Allyn may affect the EMC emissions or immunity. WARNING Maintain minimum separation distance of 12 inches (30 cm) between any part of the Spot Vital Signs 4400 device and portable RF communication equipment (including peripherals such as antenna cables and external antennas).

  • Page 80: Emissions And Immunity Information

    Welch Allyn Spot Vital Signs 4400 Emissions and immunity information For information about electromagnetic compatibility (EMC), see the Welch Allyn website: http://www.welchallyn.com/emc-SPOT4400 You can order a printed copy of the Emissions and immunity information from Welch Allyn for delivery within 7 calendar days.

  • Page 81: Appendices

    The following tables list approved device accessories and applied parts. For information about options, upgrades, and licenses, refer to the service manual. WARNING Use only Welch Allyn approved accessories and applied parts, and use them according to the manufacturer’s directions for use. Using...
  • Page 82 Line cord 6, Australia/New Zealand PWCD-66 Line cord 6, Australia/New Zealand —Orange PWCD-3 Line cord 3, Israel PWCD-Y Line cord Y, Italy 4400-PS Spot Vital Signs 4400 35 watt power supply BATT22 Spot Vital Signs 4400 2 cell lithium-ion battery...
  • Page 83 S1-4400 4400, Comprehensive partnership program, 1 year S1-4400-2 4400, Comprehensive partnership program, 2 years Literature/Documentation Part number Description Spot Vital Signs 4400 CD Kit (Instructions for use and Quick reference) 419833 Applied parts FlexiPort cuffs Part number Model Description Reusable...
  • Page 84 Spot Vital Signs 4400 Part number Model Description Disposable Soft-12 CUFF, Welch Allyn, LG ADULT Disposable Soft-12L CUFF, Welch Allyn, LG ADULT LONG Disposable Soft-13 CUFF, Welch Allyn, THIGH Disposable ECOCUFF-09 EcoCuff, Child, 1521 cm Disposable ECOCUFF-10 EcoCuff, Small Adult, 2028 cm...

  • Page 85: Warranty

    Appendices 81 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.

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