FLC-4400-RPMKIT-BASE
Welch Allyn<sup>®</sup>
Hillrom™ Extended Care Solution
Learn more about Hillrom Extended Care Solution. Explore Hillrom's products and medical technologies across the health care industry.
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Welch Allyn®

Hillrom™ Extended Care Solution

Extend your care. Extend your connection.

 

Extend care capabilities beyond the walls of your facility with Hillrom’s Extended Care Solution — a new way to manage and monitor patient vital signs. Help recovering and at-risk patients feel confident, connected, and comfortable, while allowing medical staff to get the critical information they need, quickly and accurately. Patients can capture their vital signs at home with the Welch Allyn® Spot® 4400 Vital Signs Extended Care Device. Patient measurements will automatically transfer to the Hillrom Connex® App via Bluetooth®, and can be sent right to their care team by pressing the "send" button. Clinicians can then access patient vitals on the web-based Hillrom Connex Clinical Portal to monitor patients for any signs of change. Help reduce your hospital's patient load and patient exposure risk, while preserving critical protective gear. Get the vital signs data you need to make informed care decisions—from a distance. And because high-quality remote care has become an urgent priority, reimbursements and CPT codes are available to support remote monitoring devices and services—including the Hillrom Extended Care Solution.

 

Overview

The Hillrom Extended Care Solution, part of the Hillrom Connected Care Platform, combines a clinical-grade, all-in-one vital signs device with a patient app and clinician review portal, so you can extend patient care beyond the walls of your facility.

Distance doesn’t mean disconnected.

  • Seamlessly send vital signs measurements to the Hillrom Connex App with Bluetooth® (BLE)
  • SureBP® technology can provide BP in only 15 seconds
  • Easy-to-use Blood Pressure Averaging program
  • SureTemp® Plus Oral/Axillary Thermometry
  • Nonin® SpO2 technology measures blood oxygen saturation
  • 7" color touchscreen for a simple, user-friendly workflow
  • Each device ships with four FlexiPort® EcoCuff® single-patient blood pressure cuffs
  • 8-hour Lithium ion battery to maximize time before recharging
  • Patient-entered weight parameter
  • iOS and Android compatibility
  • Clinician notification email messages
Male clinician confidently looks at the camera while wearing PPE.

SIMPLE

Patients' vitals are sent to the clinical portal with the push of a button.

SAFE

Help reduce hospital patient load, exposure and use of protective gear.

CONNECTED

Get the vitals data you need to help make informed care decisions.

SECURE

The secure, web-based portal provides streamlined access to patient data.

Learn more about the Hillrom™ Extended Care Solution and see how you can extend care beyond the walls of your facility. play_circle_outline

Hillrom™ Extended Care Solution

Introducing the Hillrom™ Extended Care Solution: Essential remote care at the most vital time. Technology and care tactics may evolve, but some things stay the same: Data-driven decision-making is at the heart of good healthcare.

Monitor with Confidence

Get the vital data you need to help make informed care decisions — from a distance.

Through our Extended Care Solution, the Welch Allyn® Spot® 4400 Vital Signs Extended Care Device enables patients to take their vital signs at home. Then, with the push of a button, patients can send their readings to a secure, web-based clinical portal for your review and assessment. Consider it a house call without the close quarters.

Welch Allyn® Spot® 4400 Vital Signs Extended Care Device

Take Your Temperature

Hillrom™ Connex® Clinical Portal

Hillrom™ Connex® Patient App

Measure SpO2 & Pulse Rate

Capture a BP Reading

Education & Documentation

Get in the know to get the most value out of your solution.

Product Documentation

Frequently Asked Questions

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.

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, 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.