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AOS Interstitial Templates, Needles, and Accessories are indicated for use in adults where Brachytherapy of the cervix or prostate is an accepted clinical practice.

AOS Interstitial Templates, Needles, and Accessories are designed for interstitial Brachytherapy treatments of the cervix and prostate. The Templates are designed to be sutured to the perineal area in order to fix the geometry of the Template Need into the cervix or prostate. AOS Templates are made of silicone, with holes in a circular pattern, typically spaced 1 cm (Center-to center). AOS Templates are supplied in two configurations to accommodate a prostate or GYN treatment. The Template is sutured in place and Template Needles are inserted into the Template. The number and type of Template Needles is dependent on the model of Afterloader. Additional accessories are required in vaginal cases. The AOS GYN Templates have a large hole with a quide strip. The matching AOS Vaginal Guide Tube is inserted in this hole, lining up the guide groove. The Vaginal Guide is pushed to the desired depth and the large O-Ring is slipped over the Vaginal Guide. The AOS Collar is then used to push the Vaginal Guide until it can be slipped over and on to the Template. The O-Ring's elasticity tightens down and provides sufficient tension to hold the Vaqinal Guide in place. Each Vaginal Guide has six (6) Needle grooves for the insertion of additional Template Needles as required. Where an Afterloader is used, the Template Needles are connected to the Afterloader via an appropriate connector. If the Template Needle has a female Luer Adaptor on the proximal end, connection to the AOS Universal Connecting Guide Tube, P/N SGJ0007, provides an unobstructed pathway for the source wire or cable from the Afterloader to the appropriate distance as determined by the Afterloader. Some Afterloaders provide a transfer tube, which is connected to the other end slips over the plain end of the Template Needle and is tightened down to hold and connect the Template Needle.

AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site in adults.

AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site.

The AOS Orion Ir-192 Source Cable is a sealed radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. This device is the replaceable Ir-192 source for the Nucletron Corp. MicroSelectron HDR V2 and V3 Afterloaders.

The AOS Orion Ir-192 Source Cable (Model No. CSO0012-192) is a nominal 12 Curie Iridium-192 source cable for use in the Nucletron microSelectron HDR Version 2 (Model No. 105.99) and the Nucletron microSelectron V3 (Model No. 106.990) Remote Afterloaders.

The purpose of the AOS Universal Connecting Guide Tube is to provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply radionuclide source into the body or to the surface of the body for radiation therapy.

Alpha-Omega Services (AOS) Universal Connecting Guide Tube is used to connect any Alpha-Omega applicator accessory with Luer Lock fittings to a High Dose Rate (HDR) Afterloader. The Alpha-Omega universal Connecting Guide Tube is supplied in the nominal length of 100cm. The distal end is a female luer lock, which is used to connect to the male end of the Luer Lock applicator/accessory or to the Extension Adaptor and Needle combination, providing an un obstructed pathway for the source wire or cable from the Afterloader to the tip of the applicator/accessory.

The purpose of AOS Interstitial Templates, Needles and Accessories is to provide and enclosed pathway for application of radioactive source(s) into the body or surface of the body for radiation therapy (brachytherapy).

Alpha-Omega Services (AOS) Templates, Template Needles and Accessories provide a fixed array of needles, via the template. AOS Templates are made of silicone, with holes in a circular pattern, typically spaced 1 cm (center-to center). AOS templates are supplies in various sizes to accommodate treatment sites as prostate, rectum, or vagina. The Template is sutured in place and Template Needles are inserted into the holes of the Template. The number and type of Template needles is dependant on the model of Afterloader or if the manual LDR method is used, which consists of strands or ribbons of discrete sources. Additional accessories are required in vaginal cases. The AOS GYN Templates have a large hole, with a guide strip. The matching AOS Vaginal Guide Tube is inserted in this hole, lining up the guide strip with the guide grove. The Vaginal Guide is pushed do the desired depth and the large O-Ring is slipped over the Vaginal Guide. The AOS collar is then used to push the O-Ring along the Vaginal Guide until it can be slipped over and on to the grooved ring on the Template. The O-Ring's elasticity tightens down and provides sufficient tension to hold the Vaginal Guide in place. Each Vaginal Guide has six (6) Needle grooves for the insertion of additional Template Needles as required. Template Needles may have a plain end or some sort of attachment device, such as a female luer adaptor if an Afterloader is to be used. If the Manual LDR method is used, typically a Template Needles with or without a collar is chosen. Where an Afterloader is used, the Template Needles are connected to the HDR Afterloader via an appropriate connector. If the Template Needle has a female Luer Adaptor on the proximal end, connection to the AOS Universal Connecting Guide Tube (K964910) provides an unobstructed pathway for the source wire or cable from the Afterloader to the appropriate distance as determined by the Afterloader. Some Afterloaders provide a transfer tube, which is connected, to the Afterloader while the other end slips over the plain end of the Template Needles and is tightened down to hold and connect the Template Needle.

AOS Marker Seeds are used to provide reference positions around a proposed treatment site in order to re-apply a radionuclide source into the body or to the surface of the body for multiple sessions of radiation therapy.

AOS Marker Seeds are small, cylindrical pieces of 24k gold or silver, which are easily visible with radiography imaging systems.

The Mega Pure Cart ( MPC1), is intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate, and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection. The MPC is A portable unit and is designed for single patient use only within a Hospital or Clinic setting.

The Mega Pure Cart ( MPC1), is intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate, and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection. The MPC is a portable unit and is designed for single patient use only within a Hospital or Clinic setting. The Mega Pure Cart purifies potable feed water through deionization. Deionization is used to remove 99.99+% of ions from water. Deionization alone does not remove particulates, organics, bacteria, viruses or endotoxins. The system is designed for hemodialysis application to treat carbon filtered potable water. Inappropriate use can result in the formation of Nitrosamines in the effluent of the deionizer. The purpose of the pretreatment section of the system is to condition the feed water supplying the deionizers. Conditioning the feed water will include: check valves to prevent backflow into the potable water source, one carbon tank and one carbon cartridge equipped with a test port between them to test for water conductivity, pH and chlorine/chloramines residual. This carbon is granular activated carbon with 12 x 40 mesh size and a iodine number of greater than 900. The purpose of the post treatment is to remove bacteria and endotoxins or lower them to within acceptable limits allowed by AAMI standards. The post treatment section of the system will include: sub micron/ ultra filter after the deionizer. The alarm system will consist of two temperature compensated audible/visual alarms. The first alarm located after DI cartridge #1 and #2 is a 1meg ohm alarm and the second alarm is a temperature compensated audible/visual alarm and is pre set a 1 Meg ohm for final water quality. Routine monitoring of the test port #1 is necessary to detect any chlorine/chloramines breakthrough. Should any of the alarms sound during the treatment, the treatment should stop immediately and follow the DI cartridge exchange procedure listed in the operator's manual.

A high specific activity radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. Device is the active source for a Nucletron Microselection Device.

The source is made of a stainless steel capsule with an outer diameter of approximately 1.1mm. A hole is drilled through the center of the capsule to a depth of the ir 192 seed. The closed end of the capsule is welded to a 1.1 mm diameter 7 X 7 stranded stainless steel cable. On the opposite end, a solid connector is welded in the same manner to the free end of the cable A Ir 192 seed is inserted into the open end of the capsule. The Ir 192 seed is secured by welding the open end of the capsule. The post-weld length of capsule is approximately 4.5 mm in length and overall length of the finished source cable assembly is approximately 2000 mm. These physical specifications are the source for the Nucletron Microselection HDR device.

To provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply a radionuclide source into the body or to the surface of the body for radiation therapy. Single Use Device. Do not re-clean, re-sterilize device. Any reprocessing may result in changes in the physical characteristics of the device. Do not counter accepted clinical practice or institution guidelines.

The AOS Universal Connecting Guide Tube coupling catheters are substantial equivalence to Varian Coupling catheter (K952913), and Omnitron International Coupling catheter (K881665). Construction and materials are the same for all referenced devices. All devices are listed as single use, provided as non sterile.