Hillrom Welch Allyn Spot Vital Signs 4400 User manual

Welch Allyn®
Spot Vital Signs 4400
Instructions for use – Addendum
Hillrom Extended Care Solution
Software version 1.X

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Revision date: 2020-07
This manual applies to 901057 Vital Signs Device.
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Contents
Introduction ................................................................................................................................. 1
Modifications to FDA cleared Intended use (modifications are underlined) ................................. 1
Contraindications ............................................................................................................................................................... 1
FDA guidance ......................................................................................................................................................................... 2
Device performance .......................................................................................................................................................... 2
Potential risks .......................................................................................................................................................................... 2
Symbols and definitions .......................................................................................................... 3
About warnings and cautions ............................................................................................... 7
General warnings and cautions .................................................................................................................................. 7
Device setup and basic operation ....................................................................................... 9
Connect the Bluetooth Low Energy dongle ....................................................................................................... 9
Power ........................................................................................................................................................................................ 10
Primary screens .................................................................................................................................................................. 11
Caring for the Spot 4400 and accessories ......................................................................................................... 13
Troubleshooting ...................................................................................................................... 15
Communications messages ....................................................................................................................................... 15
Specifications ............................................................................................................................ 17
Physical specifications .................................................................................................................................................... 17
Environmental specifications .................................................................................................................................... 18
Configuration options .................................................................................................................................................... 18
Standards and compliance .................................................................................................. 19
General compliance and standards ....................................................................................................................... 19
Guidance and manufacturer's declaration ..................................................................... 21
EMC compliance ................................................................................................................................................................ 21
Emissions and immunity information .................................................................................................................. 22
Accessories ................................................................................................................................ 27
iii

iv Contents Welch Allyn® Spot Vital Signs 4400

Introduction
The purpose of this Instructions for use (IFU) addendum is to describe features of the Welch Allyn®
Spot Vital Signs 4400 (device) configured for home use. A more complete description of the Spot
4400 is available on the CD accompanying the device, part number 419833. The addendum does
not repeat details already presented in that IFU but focuses narrowly on the at-home
configuration--on the amendments and modifications that pertain to at-home use. It describes
how an at-home configuration and setup is different from Spot 4400 devices used inside medical
facilities. It also includes many warnings and cautions targeting home users, informing them how
best to protect themselves, members of their household, and also the device.
This addendum complements the Quick Reference, a pamphlet patients receive and review with a
clinician before taking the device home. The Hillrom Connected Care resource page also provides
access to videos and other literature related this at-home platform. Scan the code below to go to
that site.
Modifications to FDA cleared Intended use
(modifications are underlined)
The Welch Allyn® Spot Vital Signs 4400 (device) is intended to be used by patients to initiate spot-
check/single measurement of noninvasive blood pressure, pulse rate, noninvasive functional
oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in oral and axillary
modes of adult and pediatric patients greater than 12 years of age under the direction of clinicians
or other medical professionals. The intended use locations for patients to be measured are in the
home environment. Patient vitals captured on the device will be sent to a software designed to
collect and transmit health information.
The Hillrom Connected Care Platform solution is not intended for use in the diagnosis, cure,
treatment, or prevention of disease. It is not intended as a substitute for medical care by a
healthcare provider. It is not intended for emergency use or real-time monitoring.
Contraindications
• The device is not intended for use on neonates.
1

• The device is not intended for unattended monitoring.
• The device is not intended for patient transport.
• The device is not intended to be used in a carrying case.
For contraindications of SpO2 sensors, consult the sensor manufacturer's directions for use.
FDA guidance
The FDA issued Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support
Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
During this emergency and while the policy is in effect, the FDA does not intend to object to
limited modifications to indications, claims, functionality, hardware, or software of cleared non-
invasive remote monitoring devices that are used to support patient monitoring without prior
submission of a 510(K) where the modifications do not create an undue risk. Based on this
guidance, Hillrom has released the Welch Allyn Spot Vital Signs 4400 Device for use in the home
with Hillrom Connex software.
When the device is used in the home, it is not intended for use in the diagnosis, cure, treatment or
prevention of disease on its own. It is not intended as a substitute for medical care by a healthcare
provider. It is not intended for emergency use or real-time monitoring.
Device performance
Validation of the integration of the Bluetooth radio, the home user screen and power cord into the
Welch Allyn® Spot Vital Signs 4400 device was completed through software verification testing and
design validation of the changes to the user interface, power cord and Bluetooth® radio, and IFU.
The Spot 4400 device has been tested and shown to comply with IEC 60601-1 Edition 3.1, IEC
60601-1-2 4th Edition and IEC 60601-1-11 2nd edition. A Risk assessment has been performed
according to ISO 14971. Any identified hazards have been found to be acceptable.
Potential risks
See the Instructions for use included on the enclosed CD, this Addendum, and the Quick reference
for a complete list of Warnings and Cautions.
For further information on the Hillrom Welch Allyn® Spot 4400 Home, including the
Instructions for use, this Addendum, and the Quick reference, visit hillrom.com.
2Introduction Welch Allyn® Spot Vital Signs 4400

Symbols and definitions
Documentation symbols
For information on the origin of these symbols, see the Welch Allyn symbols glossary: http://
www.welchallyn.com/symbolsglossary.
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
background in a black and white document.
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. This
definition applies to both yellow and black and white symbols.
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
Stand-by Direct current (DC)
Power plug Battery absent or faulty
Alternating Current power
present, battery fully
charged
Battery charge level
Alternating Current power
present, battery is charging Battery
3

Alternating current (AC) Rechargeable battery
Rated power input, DC Rated power input, AC
Lithium-ion battery
Connectivity symbols
USB Bluetooth Low Energy
technology
Miscellaneous symbols
Manufacturer Defibrillation-proof Type BF
applied parts
Reorder Number Serial Number
Product Identifier Recyclable
Do not reuse, Single use
device Separate collection of
Electrical and Electronic
Equipment. Do not dispose
as unsorted municipal waste.
IP22 IP = International Protection
Marking
2 = Ingress against solid
foreign objects
2 = Protected against
vertically falling water drops
when enclosure tilted up to
15°
Call for maintenance
This way up Fragile
4Symbols and definitions Welch Allyn® Spot Vital Signs 4400

Stacking limit by number This device has no alarms.
Temperature limit Global Trade Item Number
Humidity limitation Keep dry
Maximum safe working load
limits Mass in kilograms (kg)
Atmospheric pressure
limitation Non-ionizing
electromagnetic radiation
Time required to complete a
process, like charging a
battery (2 hours)
Intertek Testing Laboratories
Approved (ETL)
Screen symbol
Process indicator for activities
like acquiring measurements
and connecting to a laptop
or an iPhone
NIBP (blood pressure) or Start
BP
Instructions for use – Addendum Hillrom Extended Care Solution Symbols and definitions 5

6Symbols and definitions Welch Allyn® Spot Vital Signs 4400

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.
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 patient
data.
General warnings and cautions
NOTE This section presents only new warnings and cautions or those that have
been modified from the most recently released Instructions for use (IFU) to address
the at-home user. See the IFU on the enclosed CD for a full listing of warnings and
cautions for clinical versus at-home users.
WARNING Safety and inaccurate measurement risk. Use and store the device in
an environment that avoid hazards and prevents device damage.
• Do not place or operate the device in direct sunlight.
• Do not operate the device outdoors.
• If the device gets wet during transport, allow it to dry before use.
• Keep the device away from pets and children.
• Keep the device away from heat sources (fireplaces, ovens, etc.).
• Keep the device away from sources of dust or lint (clothes dryers, home fans, etc.).
• Keep the device away from moisture-producing devices (humidifiers, nebulizers,
vaporizers, etc.).
WARNING Safety risk. The device does not have a protective earth (grounded)
terminal. Stop using the device if you observe arcing or sparks at the outlet.
WARNING Strangulation risk. Do not allow children or pets to touch or play with
device cords, cables, or tubing that could get wrapped around their necks.
7

WARNING Choking risk. An oral probe cover enters your mouth when taking oral
temperatures. When inserting the probe tip inside the mouth, ensure that the
probe cover remains on the probe tip to avoid the risk of choking on the probe
cover. When using on children or vulnerable people, the Spot 4400 device must
only be used with special care and under permanent supervision. When used on
adults, caution should be taken.
WARNING Choking risk. The Bluetooth dongle should never be placed in the
mouth as it poses a choking risk.
WARNING Patient injury risk. Wash your hands frequently, and especially before
and after touching the device, to reduce cross-contamination and the spread of
infection.
WARNING Personal injury risk. Do not place the device anywhere that it might fall
on you and hurt you.
WARNING Patient injury and inaccurate measurement risk. Do not operate the
device while it is being carried or transported.
WARNING Patient injury and inaccurate measurement risk. Do not modify or alter
the device in any way. Modification may affect performance, safety, and accuracy.
WARNING Patient injury and inaccurate measurement risk. Use only the App and
device software provided with the Extended Care Solution. Using any other
software violates the safety, effectiveness, and design controls of this medical
device.
WARNING Personal injury risk. The power cord plug is the disconnect device used
to isolate this equipment from supply mains. Position the equipment so that it is
not difficult to reach or disconnect the plug.
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 build-up on the
device's vent openings, have the device inspected and cleaned by a qualified
service technician.
WARNING Welch Allyn is not responsible for the integrity of a facility's power. If
the integrity of a facility's power is in doubt, always operate the device on battery
power alone when it is attached to a patient.
CAUTION Use only a Class II AC power cord to charge the power source for the
device.
CAUTION To ensure that the system meets its performance specifications, store
and use the system in an environment that maintains the specified temperature
and humidity ranges (see Environmental specifications).
8About warnings and cautions Welch Allyn® Spot Vital Signs 4400

Device setup and basic operation
The medical facility is responsible for assembling the device before the patient takes it home. If any
connectors or cables come loose and the patient needs help to reconnect them, consult the Setup
section of the complete IFU (on CD) for instructions. The health care provider or medical facility is
the point of contact for technical problems.
Pictured below are the Spot 4400 device, the stand plus hardware, and most accessories that
comprise the 4400-RPMKIT: power supply and power cord, thermometer probe and probe well,
probe covers, Nonin SpO2 sensor and cable, Bluetooth Low Energy dongle, and blood pressure
hose. Missing from this illustration is the EcoCuff blood pressure cuff, which appears on the cover of
this IFU Addendum next to the fully assembled device.
Connect the Bluetooth Low Energy dongle
1. On the rear of the device, align the Bluetooth Low Energy dongle with the USB port.
2. Insert the dongle, pressing firmly until the dongle is seated.
9

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. You will lose configuration settings. Touch
the Settings > Device tab to power down the device.
The LED in the center of the power plug symbol indicates the battery charging status.
• Green indicates that AC power is present and that the battery is fully charged.
• Amber indicates that AC power is present and that the battery is charging.
NOTE You may operate the device while the battery is charging.
NOTE The time from powering on the device until it is ready for use is
approximately 40 seconds.
Device warm up and cool down
If the device has been stored below -4°F (-20°C) or above 122°F (50°C), allow the device to
warm up or cool down in a room temperature environment of 50°F– 90°F for 4 hours before
powering on the device.
Power up the device
The device runs a brief diagnostic self-test each time it powers up. If an issue occurs, the error
message appears in the Status area.
WARNING To ensure patient safety, listen for an audible indicator and watch for
visual messages at power-up at least once daily. Correct any system errors before
using the device. In addition to the audible indicator, the screen Status area
displays icons and messages that help you to distinguish any actions, if needed.
10 Device setup and basic operation Welch Allyn® Spot Vital Signs 4400

WARNING Always observe the device during power-up. If any display fails to
illuminate properly, or if a system fault code or message displays, inform qualified
service personnel immediately, or call your nearest Hillrom Customer Service or
Technical Support facility. Do not use the device until the problem is corrected.
CAUTION Always use the device with an adequately charged and properly
functioning battery.
Press to power up the device.
The power LED flashes until the device displays the brand logo and a power-up tone sounds.
This process takes about 40 seconds. On initial power-up, the device prompts you to set the
language, date, and time.
Primary screens
The device has primary screens and pop-up screens.
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. The content area also might have
vertical tabs on the left side of the screen that relate to the primary navigation tab
chosen. It also can display summary information on current vital signs.
3 Primary
navigation The primary navigation tabs appear at the bottom of the screen.
Battery status
The battery status indicator displays the state of the battery.
Instructions for use – Addendum Hillrom Extended Care Solution Device setup and basic operation 11

The battery status is represented by icons in the upper-right corner of the device display. The status
represents several possible situations.
• The device is connected to a power source and the battery is charging or is fully charged. The
estimated charge rate is displayed as a percentage of capacity.
• The device is not connected to a power source and is running on battery power. The
estimated charge time remaining is shown by a series of 0–4 bars and hours/minutes:
• The device is connected to a power source but the battery does not maintain a charge (or has
been removed).
Icon Description
4 bars: Running on battery, battery charge is high; 76% - 100%; display time remaining
(HH:MM)
3 bars: Running on battery, battery charge is medium; 51% - 75%; display time remaining
(HH:MM)
2 bars: Running on battery, battery charge is low; 26% - 50%; display time remaining (HH:MM)
1 bar: Running on battery, battery charge is very low; 11% - 25%; display time remaining
(HH:MM)
0 bars: 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.
NOTE Monitor the remaining battery charge in the battery status indicator and
plug the device into a power outlet as soon as you are able.
If the notification is dismissed or if you take no action to charge the battery, a non-dismissible
notification appears and sounds when battery power is critically low. Plug the device into a power
outlet immediately to prevent the device from powering down.
Information and error messages
NOTE This device has no alarms.
When the device detects certain events, a notification appears in the Device Status area at the top
of the screen. Below are the notification types.
• Information messages, which appear on a blue background.
• Error messages, which appear on a white background.
You can dismiss a notification by touching the message on the screen or, for some notifications,
you can wait for the notification to time out. Some notifications are not dismissable and will persist
as long as the applicable condition remains.
Refer to the Troubleshooting section for a complete list of information and error messages.
12 Device setup and basic operation Welch Allyn® Spot Vital Signs 4400

Caring for the Spot 4400 and accessories
While the Spot 4400 is in a patient's home, the patient is responsible for protecting the device from
damage and for completing cleaning and disinfection tasks.
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
disinfection specifically described in the Quick Reference.
Protecting the equipment
• Make sure the Spot 4400 is on a level surface where it won't be knocked over or damaged.
• Make sure the hoses, cables, and power cord do not cause a trip hazard.
• Keep the Spot 4400 and iPhone away from pets and children who may damage the
equipment.
Cleaning and disinfection
Hillrom recommends you clean and disinfect the unit with Clorox disinfecting wipes when visibly
soiled, prior to use on another person, and as instructed per facility protocol.
WARNING Electric shock hazard. Before cleaning and disinfecting the device,
disconnect the AC power cord from the mains outlet and the power source.
WARNING Electric shock hazard. DO NOT immerse the device or accessories. The
device and the accessories are not heat-resistant.
WARNING Liquids can damage electronics inside the device. Prevent liquids from
spilling on the device.
Cleaning refers to the removal of germs, dirt, and impurities from surfaces. It does not kill germs,
but by removing them, it lowers their numbers and the risk of spreading infection.
Disinfecting refers to using chemicals, for example, EPA registered disinfectants, to kill germs on
surfaces. This process does not necessarily clean dirty surfaces or remove germs, but by killing
germs on a surface after cleaning, it can further lower the risk of spreading infection.1
NOTE See the device Instructions for use for additional approved cleaning
products.
Prepare the Spot 4400 for cleaning and disinfection
1. Unplug the device from the electrical mains outlet.
2. Use as many Clorox disinfecting wipes as necessary to ensure the wipe remains wet, but not
dripping during both the cleaning and disinfection steps.
3. Follow the directions on the Clorox disinfecting wipes manufacturing label.
4. Do not clean or disinfect the EcoCuff blood pressure cuff. Replace it if soiled.
5. Remove the oximetry finger sensor for separate cleaning instructions according to the
manufacturer’s Instructions for use, which are provided.
1 Disinfection for Households. Interim Recommendations for U.S. Households with Suspected or Confirmed
Coronavirus Disease 2019 (COVID-19).
Instructions for use – Addendum Hillrom Extended Care Solution Device setup and basic operation 13

Step 1: Cleaning
1. Remove the wipe from the Clorox disinfecting wipes container.
2. Wipe all surfaces of the device, including the top, sides, front, rear, and bottom of the device.
Use as many wipes as needed to wipe all surfaces.
3. Remove the thermometer probe and then wipe the entire probe.
4. Wipe cords, cables, and stand.
5. Discard any used wipe(s).
6. Wash your hands thoroughly.
Step 2: Disinfection
1. Using a new Clorox disinfecting wipe, wipe down all surfaces of the device, including the top,
sides, front, thermometer probe, rear, and bottom of the device.
2. Use enough wipes for all treated surfaces to remain visible wet for 4 minutes. Reapply
disinfectant as needed to keep the area visibly wet.
3. Wipe cords, cables, and stand. Make sure all wiped surfaces remain visibly wet for 4 minutes.
4. Discard any used wipe(s).
5. Wash your hands thoroughly.
14 Device setup and basic operation Welch Allyn® Spot Vital Signs 4400

Troubleshooting
This section presents tables of notification and error messages to help you troubleshoot issues on
the device. Only the new content related to the at-home configuration is presented here.
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.
NOTE Instructions to "Call for service" in troubleshooting tables mean that you
should contact qualified service personnel in your facility to investigate the issue.
For issues with the device and its operation, contact Hillrom Technical Support at
hillrom.com/en-us/about-us/locations/.
Communications messages
Bluetooth LE (BLE)
Bluetooth messages apply to Home Mode only.
Message Possible cause Suggested action
Bluetooth hardware error.
074010 Device detected a Bluetooth hardware and is not functional Reboot device. If problem persists replace Bluetooth radio. If problem still present,
replace main PCBA.
Bluetooth power on check
failure. 074020 Device cannot detect a functional Bluetooth module. Replace Bluetooth radio. If problem still present, replace main PCBA.
Bluetooth device
successfully connected.
074030
Bluetooth connected No action required.
Bluetooth device
disconnected. 074040 Bluetooth not connected Bluetooth client dropped the connection.
Bluetooth device not
detected on startup in
Home Mode. 074050
Bluetooth LE adapter not found on
startup Insert or replace the Bluetooth LE adapter.
15

16 Troubleshooting Welch Allyn® Spot Vital Signs 4400