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BP-BT Kiosk is designed to measure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 6.7 inches (17.0 cm) to 16.5 inches (42.0 cm). Indication: Prescription use in medical or clinic environment only.Rx only.

BP-BT Kiosk has the same design as the predicated device with an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is first adapted to the arm size and then, inflated automatically by an internal pump. The systolic and diastolic blood pressures are also determined by oscillometric method. The deflation rate is controlled by an internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300 mmHg. BP-BT Kiosk will not inflate the cuff higher than 300 mmHg. BP-BT Kiosk will turn on an irregular heartbeat if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and transmitted via Bluetooth wireless module. The cuff is also deflated automatically to 0 mmHg at the same time.

Oxi-W system is intended for use: To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoplethysmography or PTG) provided by the oximeter. It only provides mathematical analysis of the input of the PTG using the first and second derivatives of the PTG values related to the microvascular condition. To analyze the basic rhythms of the NN or RR intert rate from the PTG, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate to the autonomic nervous system function. The system only provides mathematical analysis of input PTG values. It is practitioner to make proper judgement based on these values. The software provides a visual alarm for 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 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 for 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 for use in support life and not for continuously monitoring The system will be used by practitioner.

The Oxi-W System is a programmable electro medical system (PEMS) including: - Pulse oximeter with data transmission via Bluetooth. - - -Software installed on a computer Hardware : - collects SpO2%, pulse rate value and vertical bar graph pulse amplitude - (photoplethysmography) and sends the encrypted numbers to the Software. Software: - Display SP02%, and photoplethysmography. - - Mathematical analysis of the pulse waveform (Photoplethysmography) using the first and second derivative of the wave to provide values related to the microvascular condition. - Mathematical analysis of the pulse waveform (Photoplethysmography) to detect the heart rate and provides values of the heart rate variability related to the autonomic nervous system function.

The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is intended for rapid measurement of ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) in adults and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy. TBL-ABI can be used on patients with unilateral lower limb amputation. The TBL-ABI System is intended to be used to spot-check patients. The TBL-ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.

TBL-ABI System comprises: - 3 Bluetooth blood pressure devices with attached cuffs. - Software installed on a computer It is intended to measure a patient's Ankle Brachial Index (ABI) and provide Pulse Volume Recording (PVR) / volume plethysmography. This is done through an automated process. The operator places the three devices with different color-coded electronic boxes on the right or left arm, and on each leg as described in the instructions for use, and the devices connect to the computer via Bluetooth. Once the devices are connected, the operator clicks start on the software to start the measurement. The devices will then automatically control the inflation of the cuffs and monitor the variations in individual pressures to determine values to be used for the calculation of the ABI values for both the left and right of the patient. TBL-ABI uses pneumo-plethysmography in order to obtain physiologic measurements from the patient's limbs. Measurements are conducted as a single occurrence on the three limbs, thus eliminating any requirement to rest the patient between measurements. The test period takes approximately 3 minutes. ABI values, as well as the Pulse Volume recording (PVR), are displayed on the software installed in a computer. The results are saved in a backup file and can also be printed.

LD-Oxi system is intended for use: 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 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.

The LD-Oxi System is a programmable electro medical system (PEMS) including: 2 USB plug and play Pulse oximeter device including an electronic circuit and reusable Adult SpO2 probe 2 Software installed on a computer Description of the features Displays SpO2%, pulse rate value and vertical bar graph pulse amplitude (photoplethysmography). Mathematical analysis of the pulse waveform (photoelectrical Plethysmography feature). Mathematical analysis of the Heart Rate Variability (HRV feature).

SudoC device is a medical device for the measurement of galvanic skin response related to the sweat glands. The SudoC provides values. It is the physician's responsibility to make proper judgments based on these numbers. The device is indicated for use in general adult population. Prescription Use: Federal law restricts this device to sale by or on the order of a physician.

The SudoC is a programmable electro medical system including: - USB plug and play hardware device including an electronic box, 2 reusable cables to connect . the box to electrodes and 2 tactile electrodes placed on the sole of each foot. - Software installed on a computer. ● As a galvanic skin response measurement device, it measures the skin resistance (i.e., conductance).

The TM-ABI system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TM-ABI system is intended for the rapid measurement of ankle-brachial pressure index (ABP), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy. TM-ABI system can be used on patients with unilateral lower limb amputation. The TM-ABI System is intended to be used to spot-check patients. The TM-ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.

TM-ABI System is a programmable electro medical system (PEMS). The system comprises: - Σ USB plug and play hardware. - Software installed on a computer It is intended to measure a patient's Ankle Brachial Pressure Index (ABPI) and Ankle brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography. This is done through an automated process. The operator places the three color coded cuffs on the right or left arm, and on each ankle as described in the instructions for use, and connects to the device. When connected, the operator clicks start on the software to begin measurement. The device will then automatically control the inflation of the cuffs and monitor variations in individual pressures to determine values to be used for the calculation of the ABI values for both the left and right of the patient. TM-ABI uses pneumo-plethysmography in order to obtain physiologic measurements from patient's limbs. Measurements are conducted as a single occurrence on the three liminating any requirement to rest the patient between measurements. The test period takes approximately 3 minutes. The ABPI or ABI are calculated using the conventional algorithm: The device measures systolic pressures on arm and 2 ankles and then calculates the ABIs as follows: Left ABI = Left ankle pressure / Arm pressure Right ABI = Right ankle pressure / Arm pressure ABPI values, as well as the Pulse Volume recording (PVR), are displayed on the LCD, and on a software installed in a computer. The results are saved in a backup and can also be printed.

ANS 1 Software is an optional software accessory for use with the following models with data management capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer) When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS 1 software uploads the data of the devices, analyzes the data, and then displays the data in a computer for enhanced data management. The ANS 1 software is intended for use in clinical settings as an aid for health care professionals to review, analyze, and evaluate the historical tests results. The device provides values. It is the physician responsibility to make proper judgment based on these numbers. The ANS 1 software data are stored in back up files located on the PC. The software is intended for use only with adult subjects. Prescription Use X

ANS 1 Software is an optional software accessory for use with the following models with data management capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer). When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS1 software uploads the data of the devices, analyzes the data, and then displays the data in a computer for enhanced data management. The ANS 1 software is intended for use in clinical settings as an aid for health care professionals to review, analyze, and evaluate the historical tests results. The device provides values. It is the physician responsibility to make proper judgment based on these numbers. The ANS 1 software data are stored in back up files located on the PC. The software is intended for use only with adult subjects.

SudoPath is a Galvanic skin response measurement device. The SudoPath provides values. It is the physician's responsibility to make proper judgments based on these numbers. The device is indicated for use in general adult population Prescription Use: Federal law restricts this device to sale by or on the order of a physician.

SudoPath is a programmable electro medical system including: USB plug and play hardware device including an electronic box, 2 reusable cables to connect the box to electrodes and 4 tactile electrodes placed on the sole of the feet and on the palm of the hands. Software installed on a computer. As a galvanic skin response measurement device, it measures the skin resistance (i.e., conductance).

The TM-Oxi device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Non-invasive measurement of blood pressure (NIBP) of adult patients. The TM-Oxi software uploads the data of the device and displays the data into a computer for enhanced data management. The TM-Oxi software is intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate the historical tests results. TheTM-Oxi device is intended for spot-checking of patients. The TM-Oxi system does not report any diagnosis but provides values. It is the physician's responsibility to make proper judgments based on these numbers. Prescription Use: Federal law restricts this device to sale by or on the order of a physician.

The TM-Oxi is a programmable electro medical system using one oximeter and one noninvasive blood pressure device (NIBP). The system comprises: a. Hardware: Non- invasive blood pressure, pump and valve boards and connections, tube, bladder and cuff 510k cleared (K093013) not modified. USB HUB DC converter with 3 features. Power supply of NIBP board via USB hub connected to USB port of the PC and microchip converter 5V to 6 V. microchip converter 510k cleared (K090671) not modified via USB hub > connected to USB port of the PC. connected to USB port of the connected to USB port of the PC. > b. Software: The used software are ESO software 510k K102442 for data analysis and ES Complex software 510k number k 113264 for data management. software 310k humber K 115204 for addinations of the data from oximeter (ESO) and blood pressure device (Contec 08A K110774). pressure device (Contect 687 ATT 10777). Therefore the TM-Oxi system will be a combination of the 2 separate devices.

ES Complex Software is an optional software accessory for use with the following models with data management capabilities: a) Contec 08A, blood pressure device b) ESO, oximeter c) EIS-GS, galvanic skin response device and d) ES-BC. Analyzer body composition When use Contec 08A and ESO and/or EIS-GS and/or ES-BC, the ES Complex software uploads the data of the devices and displays the data into a computer for enhanced data management. The ES Complex software is intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate the historical tests results.

ES Complex Software is an optional software accessory for use with the following models with management capabilities: a) Contec 08A, blood pressure device b) ESO, oximeter c) EIS-GS, galvanic skin response device and d) ES-BC. Analyzer body composition When use combination Contec 08A and ESO, and/or EIS-GS and/or ES-BC, the ES Complex software uploads the data of the 4 devices and displays the data into a computer for enhanced data management.