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The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate the conversion of measurement data by the Profile-ESP software to mm units, and facilitates stitching of spinal x-rays as part of the Image Processing service.
The marker is placed around the neck of the patient by the medical imaging professional during x-ray imaging. It is shipped by Company personnel to the customer site and includes a user manual in the device package. No additional training or installation is required.
Length – approximately 36” / Weight – approximately 5 oz.
ORTHO KINEMATICS, INC.
3.0
In Commercial Distribution
- 00868579000278 ()
- Radiographic image marker, manual
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended use in licensed practitioner’s office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by practitioner.
LD TECHNOLOGY, LLC
D001
In Commercial Distribution
- B322D0011 ()
- Pulse oximeter, line-powered
The quanTtest red Total Protein Assay System is intended for the quantitative determination of protein in cerebrospinal fluid and urine for both manual and automated systems. The quanTtest red Total Protein Assay System provides a simple method of protein quantitation using microliter samples of urine or cerebrospinal fluid. Total Protein is measured by the dye binding method using a complex of pyrogallol red and molybdenum acid (Mo+6). At low pH the dye is red and changes to blue when complexed with protein.The kit consists of reagent, controls for both CSF and urine chemistry, and four reagent standards: Level 2 (25 mg/dL), Level 3 (50 mg/dL), Level 4 (100 mg/dL), and Level 5 (200 mg/dL).
QUANTIMETRIX CORPORATION
2210-02
In Commercial Distribution
- M0512210021 ()
2210-02
- Total protein IVD, kit, enzyme spectrophotometry
The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection.
NIDEK CO.,LTD.
CEM-530
In Commercial Distribution
- 04987669100530 ()
- Optical pachymeter
- Direct ophthalmoscope, line-powered
New Easy-to-Use Disk Format. Hardy Diagnostics now offers a convenient way of testing ß-lactamase activity in bacteria. The rapid Nitrocef test consists of a disk that is impregnated with the Nitrocefin reagent, which is a chromogenic cephalosporin. This rapid test can yield clinically relevant information earlier than an MIC test. A positive ß-lactamase test can predict resistance to such antibiotics as penicillin, ampicillin, amoxicillin, and other ß-lactamase containing drugs for the following organisms:
• Neisseria gonorrhoeae
• Haemophilus spp.
• Moraxella (Branhamella) catarrhalis
• Staphylococcus spp.
• Enterococcus spp.
• Anaerobes (such as some species of Bacteroides, Porphyromonas, Clostridium, Fusobacterium, Prevotella)
The rapid Nitrocef Disk test can be used for all of the above organisms with results in 5 minutes or less, with the exception of some Staphylococcus spp. that may take up to one hour. The ß-lactamase test is preferred to disk diffusion and agar dilution for the detection of plasmid-mediated beta-lactamase resistance in gonococci. These HardyDisks™ are packages loose in a glass vial.
HARDY DIAGNOSTICS
Z7301
In Commercial Distribution
- 00816576028887 ()
- 00816576028894 ()
Z7301
- Beta-lactamase production microbial reagent IVD
AlbiQuick™, for Candida albicans differentiation, 5 minute test, 25 tests per kit
The new Hardy AlbiQuick™ utilizes two enzyme color reactions to produce an accurate result that’s easy to read out. AlbiQuick is performed on a convenient card with two reaction wells. Only Candida albicans possesses the enzymes that will hydrolyze the PRO and NAG compounds on the card. Incubation time is only five minutes at room temperature!
Requires the use of a handheld 366nm ultra violet lamp(see Cat. no. UVL56).
The old germ tube method of C. albicans identification requires several hours of incubation and tedious microscopy to produce a result. The AlbiQuick™ eliminates the need for this and other lengthy procedures.
A recent study, which compared the above NAG and PRO methods to the traditional germ tube test, showed a sensitivity of 99% and a specificity of 99-100% (the germ tube test showed a sensitivity of 95% and a specificity of 99%; all isolates confirmed by API 20C). Ref: Crist, et al, J. Clin. Microbiol. 34:2616-2618. Accurate, fast, and convenient...that’s AlbiQuick™!
Contains:
Albiquick Test Cards (25) 00819398027298
Albiquick Reagent A (1) 00816576029051
Developer Reagent (1) 00819398028585
HARDY DIAGNOSTICS
Z121
In Commercial Distribution
- 00819398028608 ()
Z121
- Candida albicans/C. glabrata antigen IVD, kit, agglutination, rapid
The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model LN and L. The device description of the Dental Low-speed Handpiece is as following:
The gear ratios of handpieces have various gear ratios (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 1:5 (speed increase));
The handpieces have maximum Forward rotation speed 19000 rpm and maximum Reverse rotation speed of 18000 rpm.
The air motors are capable of running up to a speed of 22000 rpm, but different at different pressure of air supply; refer to section 2.3 for details.
The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).
Guangdong JINME Medical Technology Co., Ltd.
LN, L
In Commercial Distribution
- 06971119540029 ()
- Dental power tool system handpiece, pneumatic
The Saccadometer Plus system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Plus is equipped with three red laser projectors with 10º separation, and 6 experiments are included in embedded software.
The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage.
Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
PLUS
In Commercial Distribution
- 05906874392010 ()
- Eye movement analysis system
The Saccadometer Adavnced system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Advanced is equipped with three red laser projectors with 10º separation and green laser located centrally over the red. Eighteen experiments are included in embedded software.
The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage.
Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
ADVANCED
In Commercial Distribution
- 05906874392027 ()
- Eye movement analysis system
Reusable
INTENDED USE/ CONTRAINDICATIONS
PrernierPro'" Air Transfer Mats are indicated for patients
• Who are unable to transfer or turn by their own effort. both assisted and unassisted
• Whose size and weight present possible risks to caregivers involved in the transfer of the patient
PRECAUTIONS & WARNINGS
• Use two or more caregivers during patient transfers
• Do not use transfer mat until user manual is reviewed.
• Do not leave patient unattended on inflated transfer mat
• Do not attempt to move patient on uninflated transfer mat.
• The maximum safe working load for all PremierPro"' Air Transfer Mats is 1,000Ibs (450kg)
AIR SUPPLY
Air supply units may be compatible with PremierPro' " Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit’s operating Instructions, observing all precautions and warnings. All safety guidelines within the air supply unit' s operating Instructions should be followed.
INSTRUCTIONS FOR USE
1. Transfer surfaces should be close together and equal height or a slightly lower destination surface.
2. Air inlet pockets are located at the foot end of pad. Locate and insert air supply hose.
3. Avoid having obstructions in path of transfer including lines and hoses
4. Hold onto handles during inflation.
5. Move patient in a diagonal direction. head or feet end first until patient reaches destination and is centered.
6. Raise side rails, disconnect t air hose and undo safety straps.
7. Use appropriate turning and rolling technique to remove transfer mat from underneath patient.
SVS LLC
3722
In Commercial Distribution
- 00818566019240 ()
- Length: 39 Inch
3722
- Patient transfer system, powered