1. GentleHeel, Heel Incision System www. crossbaymedicalinc.com Bringing Medical Innovation to the World

2. Newborn Screening: Heel Incisions Neonatal screening testHeel sampleHeel incision system- GentleHeelCompetitor analysisComparison table

3. Neonatal screening test ESSENTIAL FOR: 1.The search for harmful or potentially fatal disorders that are not evident at birth Metabolic disorders, often called "inborn errors of metabolism" may interfere with the use of nutrients to the body to maintain healthy tissue and produce energy Other disorders that can be detected through screening include problems or hormonal blood 2.Evidence of disturbances that can interfere with normal physical and mental development of a newborn 3.Evidence of disturbances that can interfere with normal physical and mental development of a newborn

4. All regions perform screening (Guthrie test) for: 1.PKU 2.congenital hypothyroidism - Thyroid hormone deficiency leads to retarded growth and brain development - If detected early a child can be treated with oral doses of thyroid hormone to permit normal development - Incidence: 1 in 4,000 Robert Guthrie (June 28, 1916 - Seattle, June 24, 1995) was an American microbiologist. He is remembered for being the first to test using whole blood dried on paper in the 60 Neonatal screening test

5. Metabolic disorder Children with PKU lack an enzyme needed to process the amino acid phenylalanine. This amino acid is necessary for normal growth in infants and young children and for the normal use of the protein throughout life. high can damage brain tissue and can cause mental retardation. Treatment of PKU Following an early system of special diet can often prevent mental retardation and with certain restrictions in diet, these children can lead a normal life Since the development of the PKU test in the '60s, researchers have identified additional blood tests to screen newborns for other disorders, which if not detected and treated early, can cause physical problems, mental retardation and in some cases death

6. Neonatal screening test Technology able to detect blood components that are elevated in certain disorders, and able to screening for more than 20 metabolic diseases with a single sample.

7. Newborn Screening: Heel Incisions Neonatal screening testHeel sampleHeel incision system- GentleHeelCompetitor analysisComparison table

8. Heel sample: When and why? To obtain a blood sample from the infant /child up to 2 years For screening for congenital disorders (Guthrie test) Levied on the outside of the heel: More secure than a venipuncture The baby's fingers are too small to obtain an adequate sample Avoid phlebotomy or peripheral vascular plants, risk of bleeding Collection of metabolic screening: The sample must be sent to the Regional Collection Center

9. Heel sample: Issues/Complications 1.Excessive squeezing: May cause hemolysis of the sample Force accumulation of debris in the sample site Inhibits the natural flow of blood Can cause coagulation Jeopardizes future withdrawals due to trauma 2.Osteomielitis : If the incision is too deep, can cause inflammation of bone and bone marrow 3.infection: If a sterility is not maintained (device / heel) 4.Insufficient sample or compromise: Consequent need to perform a second puncture

10. Newborn Screening: Heel Incisions Neonatal screening testHeel sampleHeel incision system- GentleHeelCompetitor analysisComparison table

11. GentleHeel The GentleHeel, unique in its kind, combines the precision of the mechanism activated by a calibrated steel spring and a surgical cutting blade with very sharp grinding. The quality of the cutting blade associated to a arc incision ensures less traumatic withdrawals, compared to the “puncture” systems consequently, a significant reduction of the vasoconstriction caused by pain, which is also due to insufficient sample of blood.

12. GentleHeel The sharp steel surgical blade allows a painless incision of the capillary and quicker healing. Blood flow from the capillary sampling is abundant and requires no painful "squeezing" of the heel which can alter the chemical values ​​ of blood sampling. The blood sample obtained with GentleHeel is comparable to a sample of arterial blood. This enables multiple analyses (blood gases, laboratory tests with micro-method, etc..) without having to resort to traditional methods of sampling.

13. GentleHeel The packaging of each individual device is sterile for maximum control of infections. In this regard, the use of the right size of the GentleHeel ensures adequate sampling of blood with a single incision and minimizes the recall of infants to repeat the Guthrie test. The right measure of GentleHeel is easy recognized thanks to the color codes: depth. 0.65 mm - length. 1.40 mm (for children weighing between 0.6 and 1.0 kg.) GentleHeel micro preemie: depth. 0.85 mm - length. 1.75 mm (for babies weighing < 1.5 kg.) GentleHeel preemie: depth. 1.0 mm - length. 2.5 mm (for normal weight children) GentleHeel newborn: depth. 2.0 mm - length. 3.0 mm (for children weighing > 5 kg.) GentleHeel Toddler:

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