VitalConnect Platform Instructions For Use & Information Manual
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VitalConnect Platform Instructions For Use & Information Manual

Wireless physiological monitoring system
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Instructions-For-Use (IFU)
& Information Guide
IFU-01
IFU-01, Rev. A
Page 1 of 20

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Summary of Contents for VitalConnect VitalConnect Platform

  • Page 1 Instructions-For-Use (IFU) & Information Guide IFU-01 IFU-01, Rev. A Page 1 of 20...

  • Page 2: User Assistance Information

    Device Description The VitalConnect Platform consists of the VitalConnect Sensor, Relay Software Library, and Server Software Library. The VitalConnect Platform is accessible via an application program interface (API) that allows authorized persons to receive data and notifications generated by the system.

  • Page 3: Antenna Description

     The VitalConnect Platform is intended for use on general care patients which are at least 18 years of age. It is not intended for use on critical care in-patients. It is not intended as a diagnostic or alarm device.

  • Page 4: Information Guide

     Do not wear VitalConnect Sensor if you are Pregnant or breastfeeding  If you are wearing a VitalConnect Sensor and plan on traveling on an airplane, contact your service provider for instruction.  All components of VitalConnect Sensor should be kept out of the reach of children, pets, or anyone who may swallow components or otherwise be at risk of being harmed by components.
  • Page 5 VitalConnect Sensor while undergoing any medical imaging procedures such as MRI, CT, X-ray, PET, etc.  If any component of your VitalConnect System fails to operate after attempting all suggested troubleshooting methods, contact your product provider immediately.  Do not dispose the patch and battery in a household trash bin. Dispose per local laws, care facility laws or hospital laws.

  • Page 6: General Information

    General Information:  VitalConnect Sensor is tested by UL for electrical safety in accordance with IEC 60601-1-1  VitalConnect Sensor is tested by UL for electromagnetic compatibility in accordance with IEC 60601-1-2  Vital Connect Sensor complies with the Essential Performance defined in 60601-1, amendment 1: “performance of a clinical function, other than that related to BASIC...

  • Page 7: Data Accuracy

    Recommendations:  For a good connection and proper operation, the VitalConnect Sensor should NOT be worm over areas with a high concentration of body hair in the torso area. Removal of body hair on the torso area is recommended before placing the VitalConnect Sensor.
  • Page 8  In the event the Internet is interrupted, Service Provider should notify the end-user (patient) that patient vital data is not being transmitted.  Provide detail use instruction and information on the user interface application. FCC: FCC ID : SPO-VCI-Module IC: 11013A-VCIMODULE ...

  • Page 9: Electromagnetic Compatibility (Emc)

    Electromagnetic Compatibility (EMC):  Vital Connect Sensor may need special precautions regarding EMC and should be used according to the EMC information provided in the “Warning” and “Caution” sections of this document.  Portable and mobile RF communications equipment can affect Vital Connect Sensor. See Medical Electrical Equipment user manual for RF communication precautions.
  • Page 10 Guidance and declaration – electromagnetic immunity (For ME equipment ME system that are not life-supporting) Vital Connect Sensor is intended for use in the electromagnetic environment specified below. The end user of the Vital Connect Platform (including Vital Connect Sensor) should assure that it is used in such an environment.
  • Page 11 Guidance and declaration – electromagnetic immunity (For ME equipment ME system that are not life-supporting) Vital Connect Sensor is intended for use in the electromagnetic environment specified below. The end user of the Vital Connect Platform (including Vital Connect Sensor) should assure that it is used in such an environment.
  • Page 12 Recommended separation distance between portable and mobile RF communications equipment and Vital Connect Platform (For ME equipment ME system that are not life-supporting) Vital Connect Sensor is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The end user of the Vital Connect Platform (including Vital Connect Sensor) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Vital Connect Platform Sensor as recommended below, according to the maximum output...
  • Page 13 The following marking information will be placed on the package: Description: IP24 VitalConnect Sensor Patch, (Patch IP27 Model No.: 545-00006-00, Sensor Model No.: 600-00001-00) CAUTION: - Do not place device on broken skin. If irritation develops, Underwriters Laboratories discontinue use - For individual use only MEDICAL —...
  • Page 14 Configure user parameters as required (relay software library and server library). d) Prepare and provide user with additional user instruction as applicable. 2. Ensure that VitalConnect Relay intended to collect end user vital data is functional. Instruction for use for the end-user 1.

  • Page 15: Start-Up Process

    2. Follow the assembly instruction provided in the VitalConnect Sensor box. 3. If the VitalConnect Sensor is assembled and placed on the torso per the IFU, physiologic data should be automatically collected and transmitted to the server designated by the Service Provider.
  • Page 16 VitalConnect Sensor - Assembly Instruction (bottom entry): Sensor Module Module Connector Figure 1: Front logo side Figure 2: Back side Patch Blue outline shown on Figure-3 below is for visualization and may not be indicated on the patch * Battery side...

  • Page 17: Please Read Before Use

    Please read before use: 1. Please ensure hand is clean, dry, and non- greasy before handling patch and sensor. 2. It is recommended for men with long chest hair to trim or shave at least several hours before application. 3. It is recommended that you stand or sit upright and use a mirror when applying patch to chest. Back Flap (1) Peel paper liner (5) Adhesive...
  • Page 18 Removing Module from Patch Figure 9: Hold patch securely by the wing Figure 7: Hold patch in one hand with side with 1 hand (pulling upward position). adhesive side facing you. With the other hand, place thumb on top edge of the module side. Position 1 Position 2 Position 3...

  • Page 19: Troubleshooting

    Tips for Best Use Connection  Check module to ensure logo is facing up before connecting to the patch.  Ensure that sensor module is firmly connected  Green LED light will blink several times if module is properly connected AND patch has sufficient battery life to operate.
  • Page 20 General symbols Symbol Title Protected against splashing water IP24 Protected against submerging in water (up to 1 meter for 30 minutes) IP27 Do not reuse Operating instruction Follow operating instruction Non-ionizing radiation Defibrillation proof type CF applied part Underwriters Laboratories MEDICAL —...

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