THE VITLS PLATFORM INSTRUCTIONS FOR USE Vitls Platform, IFU, 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 ...............................................................................................3 The Vitls Platform Introduction ..................................................................4 The Tego VSS Sensor Description ...............................................................4 Indications for Use .....................................................................................5 Contraindications........................................................................
The Vitls Platform user manual is intended to provide information for the correct operation of the Tego VSS Sensor 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.
collection and transmission1. The recorded data can be stored and downloaded from the hospital system or hospital supplied equipment. Recorded data can continue to be transferred to the Secure Server Library if there is an active server connection. Should the BaseStation lose the connection to the Secure Server Library, data will be stored on the BaseStation until the connection with the Secure Server Library has been restored.
x x x x x x x x x x x The nature of Long Wear (Acrylic) adhesive may cause adverse skin reactions. Clinicians and medically qualified personnel should advise patients to seek medical attention should an allergic reaction occur and persist beyond 2-3 days. There is an increased probability of occurrence of skin reactions the longer the duration of contact the device has with the skin. Histories of skin irritations should be considered before placing the Tego VSS Sensor on a patient.
x x x x x x x x x x x x this affect, steer clear of interfering devices. Do not use the Tego VSS Sensor if the packaging has been opened, or appears used, damaged, or expired. Do not attach the Tego VSS Sensor over body hair on the chest/under arm area. Excessive body hair should be removed before application. The Tego VSS Sensor will remain intact in moist environments. It will not be damaged or compromised during bathing or showering.
transmits the data via bi-directional communication to a central server controlled by the Secure Server Library, where the data is stored for analysis by clinicians, medically qualified personnel and researchers. The Vitls Platform is made up of the following: 1. Tego VSS Sensor a. The Sensor is designed as a low-cost disposable self-adhesive interface to the body. The enclosure is constructed of a froth able foam with a PU film coating.
Storage and Handling Storage temperature range: 5℃ - 41℃ Storage relative humidity range: 10 - 93% RH Storage barometric pressure range: 70 - 102 kPa Ensure your hands are clean and dry before handling the Tego VSS Sensor. Gloves are recommended for clinicians and medically qualified personnel when handling the Sensor. Vitls Platform Operating Instructions Tego VSS Sensor Overview Top View Bottom View Skin Preparation and Application 1.
2. Remove from packaging: Open the sealed bag along the perforated line and remove the Device carefully. 3. Placement of the Sensor: Ask the patient to extend their arm out to the side at a 90-degree angle with their torso. Pull the adhesive backing off, first on the small side and place firmly under the arm, directly in the middle of the armpit (mid-axilliary line).
5. Pairing the Tego VSS Sensor with the Vitls App: Complete Patient Onboarding and add the Device ID to the patient profile in the Vitls App. A blue light on the Tego VSS Sensor will flash 2 consecutive times, every 10 seconds, when pairing has been successful. For further guidance, please refer to the Vitls App Overview on page 16. 6. Once the Sensor has been paired with the Vitls App, retain the adhesive backing in the patient’s file. 7.
Please observe local laws for disposal of battery-operated electronic products. Dispose of all Tego VSS Sensors as per local laws, care facility laws or hospital laws for routine/nonhazardous electronic waste. Troubleshooting Basic troubleshooting includes the following: x Make sure that the “Tego VSS Operating Instructions” have been followed. x 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.
5. Complete Patient Onboarding and add the Device ID to the patient profile in the Vitls App. Tap “Save & Continue”. Patient On-boarding Vitls Platform, IFU, version 3.
6. Tap on the patient’s name in the Patient Dashboard Screen to view the Individual Patient Screen displaying all the vital signs, graphs and notes. 7. Tap on a specific vital sign to view the graph (bottom left). Individual Patient Screen Vitls Platform, IFU, version 3.
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. Texas Medical Centre Innovation Institute 2450 Holcombe Boulevard Houston, TX 77021 USA Phone: +1 (415) 949-9963 www.vitlsinc.com Vitls Platform, IFU, version 3.
Product Specifications Measurements PPG Specifications Wavelength 525 nm to 950 nm (Infrared, Red and Green emitter with detector) Heart Rate (stationary and 30 - 200 Beats per Minute (root-mean-square difference ambulatory) <±5 or 10% Beats per Minute, whichever is greater) 10-30 Breaths per Minute with a mean absolute error of less than 2 Breaths per Minute, validated by clinical studies Respiration Rate 4-42 Breaths per Minute with a mean absolute error of less than 1.
Minimum Measurement Time 60 seconds System Specifications Communications Bluetooth (BT4.1) Max. 15 Meters (50 Feet Line of Sight) Radio Modulation FSK (Frequency-shift Keying)͒ Radio Frequency 2.4GHz Transmit power -20 to +4 dBm AES-ECB 128 Bit Encryption or Security AES-CCM 128 Bit Encryption (Advanced Encryption Standard) Battery Battery Type Lithium Battery Voltage 3V Battery Life 144 Hours Operating Conditions Thermometer Operating Mode Ambient Temperature Direct 5.0℃ – 41.0℃ 41.
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 80601-2-61:2017 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.
FCC Compliance FCC ID: 2ASYD-VT-A-030 x 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, and͒(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. Immunity test IEC 60601 Test Level Compliance level Radiated RF 3 V/m 3 V/m IEC 61000-4- 3 80 MHz to 2.
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: x IP27 - protected against submerging in water (up to 1 meter for 30 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, IFU, 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 Refer to Manual Vitls Platform, IFU, version 3.
General Symbols Symbol Title No SpO2 Alarm Potentially Incorrect indicator on the VItls App, which indicates that a vitals measurement may be incorrect. Vitls Platform, IFU, version 3.
