THE VITLS PLATFORM INSTRUCTIONS FOR USE Vitls Platform, User Manual, version 3.
Copyright © This publication is provided for informational purposes only and Vitls Inc. makes no warranties, either express or implied, in this document. Information in this document is subject to change without notice. The entire risk of the use or the results of the use of this document remains with the user.
Contents Introduction ............................................................................................... 4 The Vitls Platform Introduction ..................................................................4 The Tego VSS Sensor Description ............................................................... 4 Indications for Use ..................................................................................... 5 Contraindications.....................................................................
Introduction The Vitls Platform user manual is intended to provide information for the correct operation of the Tego VSS Sensor, the BaseStation and the Vitls App. Do not operate these products before reading the instructions. The Vitls Platform was developed for intended use by clinicians and medically qualified personnel. The Vitls Platform is not intended to be a replacement for good clinical judgment. The Vitls Platform is for prescription use only.
continuous data transmission. The continuous wireless transmission of the data occurs with a delay or latency of seconds between continuous data collection and transmission1. The recorded data can be stored and downloaded from the BaseStation. Recorded data can continue to be transferred to the Secure Server Library if there is an active server connection.
• • is not intended for use on users on cardio-pulmonary bypass, and is not intended during an MRI scan or in a location where it will be exposed to strong electromagnetic forces. Warnings • • • • • • • • • • • Depending on wireless connectivity, a temporary interruption of data transmission is possible, which may impact continuous or real-time monitoring. Data will be stored on the Tego VSS Sensor for transfer once connectivity is reestablished.
• • • • • • • • • • • • • • continuous data monitoring is necessary for patient safety, treatment in the home setting may not be appropriate. If considered medically necessary, additional measures may be taken to ensure appropriate care and monitoring is provided to meet the clinical need. If connected to other devices/system through the same user interface (i.e.
Platform Description The Vitls Platform consists of the Tego VSS Sensor, the BaseStation Software Library, the BaseStation, and the Secure Server Library. The Secure Server Library is accessible via an application program interface (API) that allows authorized persons to receive data and notifications generated by the system.
platform to fully functional capability without consent from Vitls. The following describes the cybersecurity vulnerability procedure if an incident report is received: • • • • Confirmation letter on receiving a report will be provided to the Provider within 24hours from the date of the incident report. Suggested actions will be provided to the Provider within 15-days from the date of incident report.
Vitls Platform Operating Instructions Tego VSS Sensor Overview Top View Bottom View Skin Preparation and Application 1. Prepare the skin: The Sensor can be applied to the Left or Right chest. Select a side for the sensor placement. Shave the area where the sensor will be applied if necessary (armpit and chest). Use a sterile prep pad to clean the skin and allow the area to dry. 2. Remove from packaging: Tear the packaging open along the indicated line and remove the Tego VSS Sensor carefully. 3.
4. Placement of the Sensor: Pull the adhesive backing off (retain backing containing QR Code), first on the Temperature Image side and place firmly under the arm, directly in the armpit (axilla) on the mid-axilary line. Now ask the patient to lower their arm, pull off the adhesive on the Vitls Logo side and place comfortably (not too loose and not too tight) on the chest. Press down on both ends of the patch to ensure it is well adhered to the skin.
Indicator Lights Indicator Blue LED Red LED Low Battery Description Indicates the device is connected to the BaseStation. Two flashes of the light indicate pairing with App is successful. • Three flashes of the Red light indicates the device has been switched on. • 2 Flashes, every 8 seconds, indicates the device is disconnected from the BaseStation. • Shining for 2 seconds indicates battery low. Low battery indicator on the Vitls App indicates the battery level is low and power will soon be lost.
Troubleshooting Basic troubleshooting includes the following: • Make sure that the “Tego VSS Operating Instructions” have been followed. • If the Tego VSS Sensor is lifting from the skin’s surface, press down firmly on the areas of the sensor that lifted in order to reattach it to the skin. If the problem persists, use a new sensor.
App Overview 1. 2. 3. 4. The Vitls App will be pre-loaded on the display device (i.e. smartphone, tablet etc.). Open the Vitls App from the home screen of the tablet. Follow the below instructions to add a patient, pair a device and view patient data. Tap “Add Patient” at the top of the screen. Add a Patient Vitls Platform, User Manual, version 3.
5. Complete all required (*) fields. Tap “Save & Continue”. Patient On-boarding 6. Scan the QR Code found on the adhesive backing and wait for a green tick ( ) indicating pairing successful. Device Pairing Vitls Platform, User Manual, version 3.
7. Select the bed that the patient has been allocated to. Tap “Save & Finish”. Setting Patient Location 8. The Dashboard will display the status of all the patients wearing a Tego VSS Sensor that has been paired with the App. Patient Dashboard 9. Tap on the patient’s name in the Patient Dashboard Screen to view the Individual Vitls Platform, User Manual, version 3.
Patient Screen displaying all the vital signs, graphs and notes. 10. Tap on a specific vital sign to view the graph (bottom left). Individual Patient Screen Vitls Contact Information For questions or comments about the device and its application, or other issues related to the Vitls platform requiring assistance, please contact your local representative using the information provided below. USA Vitls Inc.
Product Specifications Measurements PPG Specifications Wavelength 525nm to 950nm (Infrared, Red and Green emitter with detector) Heart Rate (stationary and 30 - 200 Beats per Minute (<±5 or 10% Beats per Minute, ambulatory) whichever is greater) Heart rate variability (HRV) 20 - 200 Milliseconds (Measured by the variation in the beat-to-beat interval.
Fall or No Fall Fall Detection (> 90% Sensitivity and > 98% Specificity) < 5% Absolute Error Compared to Manual Count. Step Count Step count is reset to 0 after step 65535 is reached. System Specifications Communications Bluetooth (BT4.1) Max. 15 Meters (50 Feet Line of Sight) Radio Modulation FSK (Frequency-shift Keying) Radio Frequency 2.
Technical Description Summary of test methods to establish SpO2 accuracy, reference method for pulse rate accuracy SpO2 and pulse rate accuracy were determined in accordance with Medical electrical equipment — IEC 80601:Part 2-61:2017 Particular requirements for basic safety and essential performance of pulse oximeter equipment. A clinical trial was conducted in accordance with ISO 14155:2011 Clinical investigation of medical devices for human subjects — Good clinical Practice.
Clinical Study Summary of clinical study reports used to assess SpO2 accuracy, patient information (whether test subjects were sick/healthy, describe skin color, age, gender, etc) Vitls Platform, User Manual, version 3.
Electromagnetic Emission Declaration The Tego VSS Sensor is intended for use in the electromagnetic environment specified below. The end user of the Tego VSS Sensor should ensure that it is used in such an environment. Emission test Compliance Electromagnetic environment RF emissions Group 1 CISPR 11 The Tego VSS Sensor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
FCC Compliance FCC ID: 2ASYD-VT-F-010 • This Tego VSS Sensor components comply with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This sensor may not cause harmful interference, and (2) This sensor must accept any interference received, including interference that may cause undesired operation (FCC Title 47, Subpart A, Part 15.19(3)).
Guidance and declaration – electromagnetic immunity (For ME equipment ME system that are not life-supporting) The Tego VSS Sensor is intended for use in the electromagnetic environment specified below. The end user of the Vitls Platform (including the Tego VSS Sensor) should ensure that it is used in such an environment.
Guidance and declaration – electromagnetic immunity (For ME equipment ME system that are not life-supporting) The Tego VSS Sensor is intended for use in the electromagnetic environment specified below. The end user of the Vitls Platform (including the Tego VSS Sensor) should ensure that it is used in such an environment.
Recommended separation distance between portable and mobile RF communications equipment and the Vitls Platform (For ME equipment ME system that are not life-supporting) The Tego VSS Sensor is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
General Symbols Symbol Title IP Rating: • IP24 - protected against splashing water • IP27 - protected against submerging in water (up to 1 meter for 15 minutes) Do not re-use Consult instructions for use Properly dispose of EEE (Electrical and Electronic Equipment) Non-ionizing radiation Defibrillation proof type CF applied part MR Unsafe Manufacturer Caution Do not use if package is damaged Authorized Representative in the European Community Serial number Vitls Platform, User Manual, version 3.
General Symbols Symbol Title Batch code Use by date Pressure limits (Storage) Temperature limits (Storage) Humidity limits (Storage) Non-sterile Radio Emission Direct Current Thermometer Bluetooth Avoid Prolonged Exposure to Sunlight Vitls Platform, User Manual, version 3.
