Omnisense 8000S: Portable Assessment of Bone Health & Early Detection of Osteoporosis

Osteoporosis Management - Anytime, Anywhere
Sunlight Omnisense® 8000S is a high-end mobile bone assessment device that delivers high precision and accuracy along with user-friendly, radiation-free measurement at multiple skeletal sites. Omnisense 8000S offers complete portability, providing the ideal mobile bone assessment solution for the clinics and physicians that require it.

Setting a New Standard in Bone Strength Assessment
Omnisense 8000S is the only portable bone assessment device on the market today with measurement at multiple skeletal sites. Measurement with Omnisense 8000S is based on Omnipath®, a patented technology developed for diagnosing and monitoring osteoporosis. With its convenience in portability, quick-set-up, and compactness, Omnisense 8000S can also be used as a shared resource or a mobile service.

 Point-of-Care Solution
Omnisense 8000S is a compact self-contained device based on a familiar Windows user interface. The Omnisense concept embodies unique patient history and scheduling features which enable you to easily track measurement history and monitor treatment.

Performance. Portability. Perfection.

• Compact and portable
• Measurement at multiple skeletal sites
• Ethnicity-based male and female reference databases
• Fits WHO criteria for osteoporosis diagnosis
• FDA and CE approved
• Cost-effective

Measurements at Multiple Skeletal Sites

Multi-Site Advantage
Omnisense's unique probe technology is the only one of its kind. By enabling measurement at multiple skeletal sites, the Omnisense probe system provides you with greater diagnostic ability and enhanced measurement flexibility.

Getting The Whole Picture
Due to the systemic nature of osteoporosis, having a multiple site option provides an overall picture of the skeleton and offers many advantages to the physician:

Combining measurement results of different skeletal sites can optimize fracture risk assessment.

Using multiple measurement sites enables the physician to overcome the dilemma of how to asses patients who have a clinical indication of osteoporosis but whose measurement results do not support this.

Exclusive Reference Database

The Omnisense includes a unique reference curve for each of the recommended skeletal sites:
the distal 1/3 radius, the mid-shaft tibia, the proximal third phalanx, and the fifth metatarsal.

Reference databases were collected in representative geographical regions. All subjects were between the ages of 20 - 90 and met strict eligibility criteria. Each skeletal site was measured in accordance with Omnisense's strict measurement methodology. Omnisense reference databases currently support the following populations:

• Caucasian - Male and Female
• North American - Male and Female
• Latin American - Female
• Asian - Male and Female

Peak Bone Strength
Data was collected and analyzed to establish the Omnisense reference curve and peak speed of sound (SOS) for each site.

The graph depicts SOS results as a function of age for the Caucasian female distal 1/3 radius. Note that the SOS increases to a peak of 4158 m/sec at the age of 41 with a population standard deviation of 102 m/sec, and declines thereafter.

When comparing Omnisense SOS to bone density assessment devices such as DXA, SOS measurements peak at a later age, demonstrating that Omnisense SOS measurements reflect various bone properties. In addition to mineral density, SOS measurements take into consideration such bone properties as elasticity, cortical thickness, and micro-architecture.

WHO Compliant
The Omnisense reference curve meets the WHO criteria for osteoporosis, defined as the proportion of subjects with measurement results of 2.5 standard deviations or more below the norm for healthy young adults. When measured by Omnisense, the prevalence of osteoporosis among Caucasian post-menopausal women aged 60-90 is similar to that identified by the WHO Study Group that defined the criteria for osteoporosis*.

Proven
Much discussion has been devoted to the appropriate sample size needed to establish a statistically significant reference database. Sunlight researchers have taken the initiative to gather measurement data from over 6000 subjects measured at 14 different centres from around the world. These subjects were not pre-selected nor were there any special qualification criteria applied to them. Both the system curve and the new curve were then compared by their mean and standard deviation. No statistical differences were found to exist, reinforcing the validity of the Omnisense reference curve.

*"Assessment of Fracture Risk and its Application to Screening for Postmenopausal Osteoporosis," Report of a WHO Study Group, WHO Technical Report Series #843, World Health Organization, Geneva 1994

The Omnipath® Advantage
Omnipath®, Sunlight Omnisense's unique, patented axial transmission technology, also know as A-QUS (axial quantitative ultrasound), provides comprehensive and accurate bone strength assessment.

Omnisense's innovative technology is based on the measurement of the speed of ultrasonic waves propagating along the bone's maximal strength axis, eliminating soft tissue effects and providing an accurate diagnosis. Axially transmitted speed of sound (SOS) is independent of bone size and body size (that is, the height and weight of the patient).

 Speed of Sound
Omnisense generates inaudible high-frequency pulsed acoustic waves. Ultrasonic
waves are successively transmitted and received by transducers embedded in the hand-held ultrasound probe. By measuring the propagation time along the different trajectories (Time of Flight), the SOS of the bone is determined.

 Bone Strength Assessment You Can Rely On
As ultrasound waves pass through bone, the speed, dispersion, and attenuation of the signals are strongly influenced by density, elasticity and cohesiveness. The higher the density of the bone, the greater its modulus of elasticity, and the more cohesive its microstructure, the faster the speed of propagation. Therefore, the faster the speed of propagation, the stronger the bone.

Omnisense is designed to perform measurements along bones such as the distal 1/3 radius, the phalanx, the tibia, and the metatarsal. Results, when used in conjunction with clinical risk factors, aid the physician in the management, diagnosis, and monitoring of osteoporosis.

US PATENT # 6221019 (International patents pending)

 Sunlight Omnisense® 8000S Ultrasound Bone Sonometer Technical Specifications