Hillrom Welch Allyn Spot Vital Signs 4400 Instructions For Use Manual
Hillrom extended care solution
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Summary of Contents for Hillrom Welch Allyn Spot Vital Signs 4400
- Page 1 Welch Allyn ® Spot Vital Signs 4400 Instructions for use – Addendum Hillrom Extended Care Solution Software version 1.X...
- Page 2 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.
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Page 3: Table Of Contents
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 .......................... - Page 4 iv Contents Welch Allyn® Spot Vital Signs 4400...
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Page 5: Introduction
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. -
Page 6: Fda Guidance
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. -
Page 7: Symbols And Definitions
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. - Page 8 4 Symbols and definitions Welch Allyn® Spot Vital Signs 4400 Alternating current (AC) Rechargeable battery Rated power input, DC Rated power input, AC Lithium-ion battery Connectivity symbols Bluetooth Low Energy technology Miscellaneous symbols Manufacturer Defibrillation-proof Type BF applied parts Reorder Number Serial Number Product Identifier Recyclable...
- Page 9 Symbols and definitions 5 Instructions for use – Addendum Hillrom Extended Care Solution Stacking limit by number This device has no alarms. Temperature limit Global Trade Item Number Humidity limitation Keep dry Maximum safe working load Mass in kilograms (kg)
- Page 10 6 Symbols and definitions Welch Allyn® Spot Vital Signs 4400...
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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. - Page 12 8 About warnings and cautions Welch Allyn® Spot Vital Signs 4400 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.
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Page 13: Device Setup And Basic Operation
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. -
Page 14: Power
10 Device setup and basic operation Welch Allyn® Spot Vital Signs 4400 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 •... -
Page 15: Primary Screens
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. - Page 16 12 Device setup and basic operation Welch Allyn® Spot Vital Signs 4400 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.
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Page 17: Caring For The Spot 4400 And Accessories
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. - Page 18 14 Device setup and basic operation Welch Allyn® Spot Vital Signs 4400 Step 1: Cleaning Remove the wipe from the Clorox disinfecting wipes container. 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.
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Page 19: Troubleshooting
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. - Page 20 16 Troubleshooting Welch Allyn® Spot Vital Signs 4400...
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Page 21: Specifications
Specifications Physical specifications Protection classifications, all device configurations Characteristic Specification Electrical rating 100 – 240 V AC, 50 – 60 Hz, 1.2A – 0.5 A Duty cycle Continuous operation Design life Spot 4400 device 5 years (maintaining safety and performance) Battery 300 full charge / discharge cycles Nonin SpO2 sensor... -
Page 22: Environmental Specifications
18 Specifications Welch Allyn® Spot Vital Signs 4400 Protection classifications, all device configurations Flammable anesthetics WARNING Not suitable for use with flammable anesthetics. IP22 Protected from ingress against solid foreign Degree of protection provided by the enclosure with respect to harmful ingress of liquids objects and against vertically falling water drops when enclosure tilted up to 15°... -
Page 23: Standards And Compliance
Standards and compliance General compliance and standards The device complies with the following standards: 21 CFR Subchapter H – Medical Devices – US Food and Drug Administration IATA DGR – International Air Transport Association Dangerous Goods Regulation United Nations ST/SG/AC.10/11 – Manual of Tests and Criteria, Part III, Sub-Section 38.3 AAMI TIR69: 2017 –... - Page 24 Users must adhere to all federal, state, regional, and/or local laws and regulations as it pertain to the safe disposal of medical devices and accessories. 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...
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Page 25: Guidance And Manufacturer's Declaration
Guidance and manufacturer's declaration EMC compliance Special precautions concerning electromagnetic compatibility (EMC) must be taken for all medical electrical equipment. This device complies with IEC 60601-1-2:2014/EN 60601-2-1:2015. • All medical electrical equipment must be installed and put into service in accordance with the EMC information provided in these tables and in the Instructions for use. -
Page 26: Emissions And Immunity Information
22 Guidance and manufacturer's declaration Welch Allyn® Spot Vital Signs 4400 Emissions and immunity information Electromagnetic emissions The Spot 4400 device is intended for use in the electromagnetic environment specified below. The customer or user of the Spot 4400 device should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance... - Page 27 Guidance and manufacturer's declaration 23 Instructions for use – Addendum Hillrom Extended Care Solution Electromagnetic immunity voltage variations on environment. If the user of the Spot 4400 power supply input At 0°, 45°, 90°, 135°, device requires continued operation lines 180°, 225°, 270°...
- Page 28 24 Guidance and manufacturer's declaration Welch Allyn® Spot Vital Signs 4400 Electromagnetic immunity where P is the maximum output power rating of the transmitter in watts (W) and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey , should be...
- Page 29 Guidance and manufacturer's declaration 25 Instructions for use – Addendum Hillrom Extended Care Solution Recommended separation distances between portable and mobile RF communications equipment and the Spot 4400 device 11.67 20.00 12.00 23.00 For transmitters rated at a maximum output power not listed above, the recommended separation distanced in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
- Page 30 26 Guidance and manufacturer's declaration Welch Allyn® Spot Vital Signs 4400 Test specifications for enclosure port immunity to RF wireless communications equipment 217 Hz 5500 5785 For some services, only the uplink frequencies are included. The carrier shall be modulated using a 50 percent duty cycle square wave signal. As an alternative to FM modulation, 50 percent pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.
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Page 31: Accessories
Cord; Blue 20500-251N-NCE SureTemp probe covers (250 covers/25 box) Service protection plans Part number Description 4400 SmartCare Protection BPI 1YR S1-4400-BPI-1 4400 SmartCare Protection BPI 3YR S1-4400-BPI-3 Literature/Documentation Part number Description Hillrom Connected Care Platform Quick Reference 772265... - Page 32 Material No. 772263...
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