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1 English Cover 10:10 Page 1 New Revolutionary Body Shaped Design Advanced Patient Positioning Relieves Pressure, Friction & Moisture Cuts Risk of Decubitus Ulcers Burst & Tear Resistant Easily Cleaned Just as the gel and foam devices of yesteryear represented an important evolutionary transition away from sand filled positioners, the EVOLUTION range of patient positioning devices represents the next important technological leap forward. View our Evolution Product Video at
2 English Cover 10:11 Page 2 2 New Revolutionary Innovative Advanced Design Ergonomic Shape ADDING A NEW DIMENSION TO PATIENT POSITIONING Style 2 Style 1 Medium Large Small Large Enhanced Head Stability and Patient Safety Redistributes pressure over a greater area of the patients head and neck Allows ease of Endotracheal Intubation Helps prevent the formation of Decubitus Ulcers Zero Pressure on the Occipital area helps to prevent Decubitus Ulcers, Pressure Alopecia and Fluid Pooling Fingered Lateral Supports provide excellent pressure redistribution and stable head support with comfortable fit Smooth contoured surfaces allow maximum patient immersion Raised neck area supporting cervical vertebrae and trapezoid muscle Ease of cleaning Air Ventilation through the base maintains normothermia at the occipital bone Product Information permanently engraved into coating for regulatory and traceability requirements Concave base aids self adjusting motion and allows air ventilation Non-Slip base grips to operating table mattress Recessed handles for patient manipulation, helps eliminate risk of injury DISPOSABLE COVERS AVAILABLE FOR EACH SIZE EVOLUTION PATIENT POSITIONERS COME WITH A 2 YEAR WARRANTY VISIT OUR WEB SITE TO VIEW THE EVOLUTION PRODUCT VIDEO
3 Booklet 09:40 Page 1 3 Excellent and Functional Patient Stability Features Better Patient Immersion Disposable Cover for Hygiene Control Breathable Patient held in a Natural Position Breathable Fabric Cover absorbs moisture. Helps in keeping the patient skin dry and free from excess fluids. ViscoElastic Foam Positioner distributes pressure evenly over larger area Excellent Neck Support Occipital Air Bone with Zero Ventilation Pressure Channels Helps eliminate the possibility of facet subluxation Vertebral neutrality is achieved by covering an area from C2 to C6, eliminating the possibility for cervical arterial occlusion. Moisture / Fluids can escape from contact with the patients skin allowing air movement and circulation, helping to reduce the risk of skin maceration and promoting normothermia. Style 2 allows ease of Endotracheal Intubation Better Patient Manipulation Style 2 has an opening at the top to allow access for the Anaesthetist s hand to achieve ease of endotracheal intubation. The patients head still has a large area of support and stability. The atlanto-occipital joint allows for a nodding motion and the atlanto-axial joint allows for half of the full rotation in the cervical spine. Low Pressure Mapping Values Head Stability 265lb Person on Evolution Patient Positioner Large Head Style 1 SHP14 Shown with Disposable Cover Redistributes pressure over a greater area of the patients head and neck Occipital Bone with Zero Pressure Pressures distributed over a greater area The closing in action cups the head, holding it in a natural position and eliminating the risk of shear and frictional force.
4 4 Interface Pressure Mapping Test Evolution Patient Positioners produce zero pressure on the occipital bone. The Gels and the Pillow show much higher values from 75mmHg to 225mmHg Comparison Between Market Equivalents Versus VascoCare Medical Limited Evolution Supine Head Positioner Style 1 (SHP14) on the Occipital Area (130lb Person) (60 kg Person) VascoCare Medical Supine Head Positioner Style 1 (SHP14) Zero IP Gel Head Ring Gel Contoured Head Pad Standard Pillow Interface Pressure (mm Hg) Time Elapsed (minutes) Support Area Test Results show that the Evolution Patient Positioner offers more than twice the area of support than the Gels or Pillow. Comparison Between Market Equivalents Versus VascoCare Medical Limited Evolution Supine Head Positioner Style 1, (SHP14) (130lb Person) (60 kg Person) 300 VascoCare Medical Supine Head Positioner Style 1 (SHP14) Gel Head Ring Gel Contoured Head Pad Standard Pillow 250 Support Area (cm2) Time Elapsed (minutes)
5 5 Pressure Mapping Comparison 130lb Person on Evolution Patient Positioner Large Head Style 1 (SHP14) mmhg 130lb Person on Evolution Patient Positioner Large Head Style 2 (SHP24) mmhg 130lb Person on Standard Pillow mmhg 130lb Person on Gel Contoured Head Pad mmhg 130lb Person on Gel Head Ring mmhg mmhg
6 Booklet 09:42 Page 4 6 Tissue Viability Test Full Field Perfusion Imager (FLPI) Analysis1 As a result of occlusion, both blood concentration and tissue volume increase above normal levels. The resulting lack of oxygen (anoxia) causes the blood vessels in the tissue to widen (vasodilation) and consequently, a reddening of the skin occurs. Upon release, blood returns to the previously occluded region at a higher than normal average velocity and concentration to nourish the oxygen-starved region. Comparison Between Market Equivalents Versus VascoCare Medical Supine Head Positioner Style 2, (SHP24) (60 kg Person) 10 minute baseline VascoCare Medical Supine Head Positioner Style 2 (SHP24) Gel Head Ring Gel Contoured Head Pad Standard Pillow 1200 FLPI Perfusion Units (P.U.) Time (minutes) Figure 1 Graph illustrating the different perfusion rates between each product over a 30 minute time period. The rate of blood perfusion (units of perfusion, p.u.) resulting after use of each product, within the given test area is illustrated in the graph above. As there was no increase in trends beyond the 30 minute imaging test period there was no justification to extend it. The VascoCare Evolution Patient Positioner Style 2 was the only product to achieve a similar readout to the baseline reading. Using either the gel contoured head pad or head ring resulted in post analysis perfusion units between P.U. only decreasing to normal baseline levels after a 20 minute time period. Using a standard pillow, Occipital Area perfusion levels took less than 10 minutes to equilibrate back to baseline levels after an initial peak of 600 P.U. However only the VascoCare Evolution Patient Positioner Style 2 readout correlates with baseline level perfusion levels from beginning to end, where a perfusion level of less than 200 P.U. was maintained throughout the entire trial period. Conclusion: This was an Independent Study conducted at the University of Limerick, Ireland. The studies concluded that the Evolution product produced minimal perfusion in the Occipital Area producing a readout similar to the base line. The gel took a full 20 minutes and the standard pillow took 10 minutes to achieve a baseline readout. 1 This trial was carried out at the Biophotonics Research Group headquarters at the University of Limerick and performed over the course of a 10 hour period by a group of expert researchers in the field of biophotonics and imaging. 30
7 7 Thermal Analysis Test The Temperature Sensor Test performed on the Market Equivalents compared to the VascoCare Medical EVOLUTION Supine Head Positioner illustrates the difference in thermal properties between the products. The temperature is measured at the skin on the Occipital Area. Temperature Differential Between Market Equivalents and VascoCare Medical Limited Evolution Supine Head Positioner Style 1, (SHP14) (60 kg Person) Skin Temperature at Occipital Bone VascoCare Medical Supine Head Positioner Style 1 (SHP14) Zero IP Gel Head Ring Gel Contoured Head Pad Standard Pillow Elapsed Time (Minutes) Conclusion: The market equivalents are slower to warm up if used under the same room temperature conditions as EVOLUTION Patient Positioner. The pillow does not allow air ventilation hence increasing the skin temperature at the occipital bone. As the Evolution Patient Positioners were specifically designed to prevent skin maceration around the bony prominence of the head, this area is exposed to normal room temperature so high levels of moisture do not accumulate causing skin damage.
8 English Cover 10:12 Page 4 EVOLUTION PATIENT POSITIONERS COME WITH A 2 YEAR WARRANTY Head Positioners currently available Covers: Supine Head Positioners: REF CSHP12 SHP12 Small Style 1 REF CSHP14 SHP14 Large Style 1 REF CSHP23 SHP23 Medium Style 2 REF CSHP24 SHP24 Large Style 2 FULL RANGE OF EVOLUTION SUPINE POSITIONERS Head Torso Arm Knee Foot Active Ingredients Recommended Disinfectant to Use Size Specifications Dimensions common to style 1 & 2 Patent Pending Technology Small 200mm Medium 250mm Large 273mm Dimension tolerance ± 5mm Authorised Distributor: View our Evolution Product Video at Design & Print by Modern Printers: Small 192mm Medium 210mm Large 230mm Sodium Hypochloride Sodium Chloride 100mm 116mm Propan-1-ol (Alcohol Wipes) 126mm Sodium Dichloroisocyanurate Vascocare Medical Limited Enterprise and Research Incubation Centre Institute of Technology Carlow, Kilkenny Road, Carlow, Ireland T: (0) E: customercare@vascocare.com Copyright VascoCare Medical Ltd 2/2012 REF: DB-SHPEU-002 BS EN ISO &2 (Smouldering Cigarette Test) BS EN ISO &4 (Match Flame Test) ISO 13485:2003 (Medical devices - Quality management systems) Approved
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