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G-15/1 Ultrasound transmission gel

G-15/1 Ultrasound transmission gel

G-15/1 Ultrasound transmission gel

Product catalog summary
Product Description: Ultrasound transmission gel is used as a medium for acoustically coupling a transducer to the human body during ultrasound imaging procedures. It is applied to the patient's skin or the transducer before the examination.
Product Characteristics: The gel is non-irritating, non-greasy, hydrosoluble, salt-free, and does not damage the transducer. It is high density, spreads easily, and is free from natural latex, phthalates, and animal or biological compounds.
Technical Specifications: The gel contains ingredients such as Aqua, Glycerin, and Carbomer. It is available in various packaging materials like PEHD and HDPE. The gel is blue, transparent, viscous, with a density of 1.00-1.02 g/mL, pH of 5.5-6.5, and viscosity over 1,000,000 mPa:s. It has an acoustic impedance of 1.63 MRayls and efficiency over 99.5% from 0.5 MHz.
Microbiological Properties: The gel contains less than 10 UFC/mL of total aerobes, moulds, and yeasts, and is free from pathogens like Staphylococcus aureus and Escherichia coli.
Biocompatibility: The product is biocompatible, non-cytotoxic, non-sensitizing, and does not cause intracutaneous irritation, complying with ISO 10993 standards.
Sterilization and Expiry Date: The gel is non-sterile with a shelf life of 3 years. After opening, 250 mL to 1L bottles should be used within one day, but are secure for 30 days if stored properly. 5L containers are secure for one month with proper practices.
Storage and Maintenance: Store in a dry place, away from direct sunlight, at temperatures between 5-40°C. It is a single-use product with no maintenance required.
Packaging: Available in various sizes, including 250 mL, 500 mL, 1L, and 5L containers, with specific service box quantities.
Instructions for Use: Apply the gel on the selected area and remove with a disposable towel.
Regulatory Information: The product complies with Regulation (EU) 2017/745 and UK MDR Regulation 2002 on Medical Devices, certified under ISO 13485. It is classified as a Class I product with GMDN code 15321 and EMDN code 711040185.
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Catalog excerpts

G-15/1 Ultrasound transmission gel-1

TECHNICAL DATA SHEET TELIC GROUP Ultrasound transmission gel Transonic > Product description Ultrasound gel are intended are intended for general use as a transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient’s skin or on the transducer prior to initiating an ultrasound examination. Product characteristics « Does not irritate skin. ¢ Non greasy. « Hydrosoluble. « Does not contain salt. Does not damage the transducer. « High density. It spreads out easily and uniformly. « This product is free to natural latex, phthalatos and animal or biological origin compounds. Technical specifications Ingredients Aqua (Water), Glycerin, Carbomer, Propylene Glycol, Sodium Hydroxide , Diazolidinyl Urea, Methylparaben, Disodium EDTA, Propylparaben, Cl 42051. Materials ¢ 250 mL white bottle: PEHD ¢ 500 mL white bottle: HDPE o 1L white bottle: PEHD o 5L flexible container: LLDPE ¢ 5L rigid container: HDPE 5L rigid container: HDPE This document is property of Telic, $.A.U. Is not allow their transmission to third parts or not authorized copies. 1-3

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G-15/1 Ultrasound transmission gel-2

TECHNICAL DATA SHEET Tube: Polyethylene PE BD Push-button: PP Bagel: PP Physio-chemical propierties « Colour, Odour, Appearance: Blue gel, transparent, viscous. Odour to its raw materials (it doesn’t contain perfume) « Density: 1.00 — 1.02 g/mL (202C) e pH: 55-65 Viscosidad (222C): >1.000.000 mPa:s ¢ Acoustic impedance: 1.63 MRayls « Efficiency (from 0.5 MHz): > 99.5% Microbiological properties « Total aerobes: <10 UFC/mL » Moulds and yeasts: <10 UFC/mL « Pathogens (Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa, Escherichia coli): Absence Biocompatibility ¢ ISO 10993-5: No cytotoxic....

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G-15/1 Ultrasound transmission gel-3

DATA SHEET « 5L containers: Security guaranteed for one month, always if good practices are maintained: refill working bottles and put the cap on immediately. Store in a cool and dry place. Keep away from direct sunlight. Disinfect any compound (cannule, dosing pump) before putting in contact with gel. Storage and maintenance + Keep protected from direct sunlight / the outside « Keep ina dry place ¢ Temperature range: 5-402C « Single use product. No maintenance required 250 mL bottle: Service box of 25 units. 1L bottle: Service box of 20 units. Flacon blanc de 500 ml. Carton d’emballage de 20...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.