VibroSense Meter II

VibroSense Meter II

The VibroSense Meter II is built on advanced technology to measure and analyse the neurological function in hands or feet by examining and quantifying  the ability to perceive fine-tuned vibrations, at multiple frequencies, applied on the skin.

The evolution of the VibroSense Meter II is based on more than four decades of experimental and clinical research addressing peripheral sensory neuropathy of the hand and foot.

The VibroSense Meter II can detect changes in the vibration sensitivity before it is developed into permanent nerve damage.

Typical applications

VSM II is intended for primary and specialist care, researchers and occupational health care that work with surveillance, treatment, diagnosis or rehabilitation of peripheral neuropathy in the feet or hands.

Support for diagnosis of peripheral sensory neuropathy, which may be caused by diabetes or cancer treatment with chemotherapy

Research for quantification of neuropathy in various diseases or due to medical treament

Medical controls of workers exposed to vibration in risk groups according to the "EU-directive 2002/44/EG"

Characteristics

• Unique and proven method based on Multi Frequency Vibrometry
• Non-invasive and objective examinations, easy to implement
• Quantitative and excellent repeatability of measurement results
• Subclinical and pre-symptomatic discovery
• Automatic comparison with gender and age-matched reference data from 1100 healthy individuals from age 8-85 years
• Wireless measurement of skin temperature
• Meets the standard ISO 13091-1 for measuring of Vibration Perception Thresholds

Measuring Device

• Size: (L x W x H) 40 x 27 x 16 cm
• Total weight: 4.8 kg
• Operating temperature: 0 – 50 ºC
• Power supply: Power adapter, 120 – 240 V AC , 85 W
• Device Input Power: 24V DC, 2.5 A
• PC interface: USB
• Psychophysical algorithm: Method of Limit, modified von Békésy up/down (QST)
• Measurement compliance: ISO13091-1
• Medical Device: Class I, IEC60601-1
• EMC compatibility: IEC/EN 60601-1-2 ed. 4
• Frequencies: 4 Hz – 500 Hz, sinusoidal
• Amplitude: 80 dB – 170 dB (0.01 – 316 m/s2)
• Ramp speed: +/- 3 dB/s
• Skin temp. accuracy: +/- 0.5 ºC
• Calibration: Self-calibration at start up. Calibration check is recommended every second year
• Intended purpose: The VibroSense Meter® II is a non-invasive medical device intended for transient use with the purpose of measuring vibration perception thresholds of the intact skin on the hand or foot in humans by Quantitative Sensory Testing (QST).

Accessories included

• Measuring device
• Response button
• Power adapter

The VibroSense Meter® II software (VSM II) under licence on requested application area.

The VibroSense Meter® II software requirements Standard PC

• Operating system: Windows 7 or later
• Free hard disk space: Min. 20 MB
• EU MDR Directive 2017/745 EG
• The VibroSense Meter® II is specially designed to be a useful tool for the assessment and health surveillance required by the EU directive 2017/745/EG.

System description

The VibroSense Meter® II consists of a Measuring device, a Response button and a PC software.

The finger or the foot is placed on a probe which vibrates at different frequencies and intensities.

The patient presses the Response button and a Vibrogram is recorded according to a modified von Békésy up/down psychophysical algorithm.

The examination method is called Multi Frequency Vibrometry.

Different types of mechano-receptors in the skin are stimulated at different frequencies. The vibration perception capacity of the patient is recorded, analogously to a hearing test by

audiometry.

Vibrogram

The VibroSense Meter® II quantifies Vibration Perception Thresholds (VPTs) of the hand or foot at seven frequencies between 4 Hz and 500 Hz. The examination result is presented as a Vibrogram, which shows the recorded VPTs versus the employed frequencies.

Characteristics

• Multi Frequency Vibrometry

• Pre-symptomatic and subclinical detection

of sensory neuropathy

• Includes screening or full examination

• Quantitative and objective

• Built-in reference, based on 1100 healthy individuals aged 8-80 years

• Control of applied skin force

• Non-invasive and painless

• Remote skin temperature measurement

• Integrated patient record system

• Small and portable

Medical applications

Sensory neuropathy of the hand or foot often manifests

as impaired vibration perception thresholds. This is a

characteristic finding in:

• Diabetic Peripheral Neuropathy (DPN),

– diagnosis support and prevention of foot ulcers

• Chemotherapy Induced Peripheral Neuropathy (CIPN)

– individualisation of therapy

• Hand Arm Vibration Syndrome (HAVS)

– early detection and prevention

• Carpal Tunnel Syndrome (CTS) and other Compression

nerve entrapments

– diagnosis support and follow up

• Other neurological disorders, e.g., Multiple Sclerosis (MS)

– diagnosis support and follow up

VibroSense Meter® II system

The VibroSense Meter® II PC-software controls the Measuring device and stores recorded Vibrograms in a database.

The VSM software may be used for diagnosis support, e.g. by showing neuropathy development over time. All results can be exported directly to MS Excel for further analysis