HFVi monitor

GUDID 03760232460177

HFVI Monitor is intended for use in a medical environment and under the direct supervision of a licensed healthcare practitioner or by personnel specifically trained for its use. The system is intended for use on adult and pediatric patients, in a facility providing patient care by monitoring heart rate variability. The High Frequency Variability Index (HFVI) is a complex monitoring technology intended for use as an adjunct to clinical judgment. Clinical judgment should always be used when interpreting the HFVI in conjunction with other available clinical signs. As with any monitored parameter, artifacts and poor signal quality may lead to inappropriate HFVI values. Potential artifacts may be caused by muscle activity or rigidity, patient motion, improper sensor placement or electrical interference.

MDOLORIS MEDICAL SYSTEMS

Electrocardiograph, professional, single-channel

• Primary Device ID: 03760232460177
• NIH Device Record Key: dc24db38-a54a-45a5-a786-4112344808d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HFVi monitor
• Version Model Number: V1
• Company DUNS: 262207287
• Company Name: MDOLORIS MEDICAL SYSTEMS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33362092080
• Email: contact@mdoloris.com
• Phone: +33362092080
• Email: contact@mdoloris.com
• Phone: +33362092080
• Email: contact@mdoloris.com
• Phone: +33362092080
• Email: contact@mdoloris.com
• Phone: +33362092080
• Email: contact@mdoloris.com
• Phone: +33362092080
• Email: contact@mdoloris.com
• Phone: +33362092080
• Email: contact@mdoloris.com
• Phone: +33362092080
• Email: contact@mdoloris.com
• Phone: +33362092080
• Email: contact@mdoloris.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 360 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 360 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 360 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 360 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 360 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 360 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 360 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 360 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 360 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760232460177 [Primary]

FDA Product Code

• DPS: Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-03-10
• Device Publish Date: 2016-12-21

Devices Manufactured by MDOLORIS MEDICAL SYSTEMS

• 03760232460283 - HFVI-SC-V1: 2024-06-06 The patient cable is used to connect the HFVI Sensor (UDI number 03760232460245) to the acquisition box BA-HFVI-V1 (UDI number 0
• 03760232460177 - HFVi monitor: 2021-03-10HFVI Monitor is intended for use in a medical environment and under the direct supervision of a licensed healthcare practitioner or by personnel specifically trained for its use. The system is intended for use on adult and pediatric patients, in a facility providing patient care by monitoring heart rate variability. The High Frequency Variability Index (HFVI) is a complex monitoring technology intended for use as an adjunct to clinical judgment. Clinical judgment should always be used when interpreting the HFVI in conjunction with other available clinical signs. As with any monitored parameter, artifacts and poor signal quality may lead to inappropriate HFVI values. Potential artifacts may be caused by muscle activity or rigidity, patient motion, improper sensor placement or electrical interference.
• 03760232460177 - HFVi monitor: 2021-03-10 HFVI Monitor is intended for use in a medical environment and under the direct supervision of a licensed healthcare practitioner
• 03760232460184 - BA-HFVI-V1: 2021-03-10 The acquisiton box BA-HFVI-V1 is to be used with the MDoloris HVFI Monitor (UDI number : 03760232460177)