Hillrom Extended Care Solution Quick Reference
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Hillrom Extended Care Solution Quick Reference

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Overview
This Quick Reference guides patients through the vitals capture
process after initial setup and training in the hospital or clinic.
Welch Allyn
Spot Vital Signs
4400 Device
Modifications to FDA cleared Intended use (Spot 4400)
(modifications are underlined)
Intended use (Spot 4400)
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.
Modifications to Hillrom Connex App Intended use
(modifications are underlined)
Intended use (Hillrom Connex App)
The Hillrom™ Connex® software is designed to collect, track,
trend, and retrospectively transmit health information (e.g.,
blood pressure, SpO2, temperature, and pulse rate) from
commercially available wireless FDA cleared medical in-home
devices, and health and wellness devices, to an online (cloud)
database. With user's consent, this information will be shared
with a health care provider.
The Hillrom Connex software 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 health care provider.
It is not intended for emergency use or real-time monitoring.
Hillrom
FDA guidance
Connex
The FDA issued Enforcement Policy for Non-Invasive Remote
Portal
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
Hillrom
that are used to support patient monitoring without prior
Connex App
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, the
Addendum, and this 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, Addendum,
and this Quick reference, visit hillrom.com.
Extended Care Solution
Attention health care providers
To help patients with first-time setup of their iPhones,
including pairing the iPhone with the Welch Allyn Spot
Vital Signs 4400, go to page 15 of this Quick Reference.
Hillrom™
Quick Reference
1

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Summary of Contents for Hillrom Extended Care Solution

  • Page 1 Quick Reference Overview with a health care provider. The Hillrom Connex software is not intended for use in the This Quick Reference guides patients through the vitals capture diagnosis, cure, treatment, or prevention of disease. It is not process after initial setup and training in the hospital or clinic.

  • Page 2: Controls, Indicators, And Connectors

    Set up the Spot Vital Signs 4400 device and accessories • Make sure the Spot 4400 is on a level surface where it won't be knocked over or damaged. • Plug the Spot 4400 into an AC outlet. A green indicator light on the front of the unit and on the power brick light up.
  • Page 3 Launch the Hillrom Connex App on your phone the device into a power outlet immediately to prevent the device from powering down. 1. Tap the Hillrom Connex app on your phone Symbols in the Connex App 2. Tap New Vitals to begin capturing your health information.
  • Page 4 SpO2 sensor. Remove anything, such as NOTE Your phone must have an internet connection nail polish, that could interfere with sensor operation. Hillrom Connex and the App must be open to transmit your vitals to your health care provider.
  • Page 5 Delete 3. Tap the button. Set up reminders 1. If you are not already logged in, open the Hillrom Connex App. 2. On the Home screen, tap the in the upper right corner. 2. On your phone, tap Save to transmit your vitals to your health The Settings screen appears.

  • Page 6: Cleaning And Disinfection Instructions

    This long list covers general use of the device, actions Hillrom recommends you clean and disinfect the unit with you should take, and actions you should avoid to protect Clorox disinfecting wipes when visibly soiled, prior to use on yourself and get accurate vitals measurements.
  • Page 7 Patient injury risk. Do not place the device measurement risk. Use only the App and device anywhere that it might fall on you and hurt you. software provided with the Extended Care Solution. WARNING Equipment failure and patient injury risk.
  • Page 8 CAUTION Patient safety risk. Inaccurate United States Federal law restricts this measurement risk. Use only Hillrom- or Welch Allyn- device to sale, distribution, or use by or on the order approved accessories, and use them according to the of a physician or licensed health care professional.

  • Page 9: Spo2 Warnings And Cautions

    WARNING WARNING NIBP readings may be inaccurate for Patient injury risk. Inaccurate patients with certain conditions, such as moderate to measurement risk. Do not use the thermometer if severe arrhythmia, arterial sclerosis, poor perfusion, you notice any signs of damage to the probe or the diabetes, pregnancy, pre-eclampsia, and renal instrument.

  • Page 10: Troubleshooting

    A "Connection failed" phone using the the phone using the Hillrom CAUTION message appears Do not modify or alter the SpO2 sensor phone's Bluetooth Connex App.
  • Page 11 No patient email not stay on the screen Direct mode (indicated probe well and try again. addresses can be edited in the Hillrom Connex system. when I return the by a snail icon on the The thermometer is too probe to the probe screen).
  • Page 12 WITH THEM. BY CLICKING THE "AGREE" BUTTON BELOW YOU: For more information (I) HAVE READ AND UNDERSTAND THESE TERMS OF USE; (II) Scan the following code to go to the Hillrom Extended Care ACCEPT THESE TERMS OF USE AND AGREE THAT YOU ARE Solution resource page.
  • Page 13 App requires submission of login and password reference. Our Global Privacy Notice may be viewed at https:// information and/or other authentication tokens or codes to hillrom.com/en-us/global-privacy-notice/. create a user account (collectively and individually “Login and Geographic Restrictions. The App is provided for access Password”).
  • Page 14 WARRANTY OF ANY KIND WHATSOEVER, EITHER EXPRESS OR objections to the exercise of jurisdiction over You by such courts IMPLIED. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE and to venue in such courts. LAW, WE SPECIFICALLY DISCLAIM AND EXCLUDE ANY AND Limitation of Time to File Claims.
  • Page 15 Assembly Instructions). appears. 2. Set up the patient in the Hillrom Connex Portal (see 800267324, Hillrom Connex Portal Instructions for Use) on the Hillrom Extended Care Solution resource page. 3. Send an email to the patient with the temporary password.
  • Page 16 Hillrom™ Extended Care Solution 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. Hillrom Technical Support hillrom.com/en-us/about-us/locations/ Welch Allyn, Inc. is a subsidiary of Hill-Rom Holdings, Inc.

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