(87 days)
The ELI 230 Electrocardiograph is a non-invasive prescription device.
- The Mortara ELI 230 Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms.
- The device is indicated for use for patients of any age, diseased or non-diseased.
- The device is indicated for use to provide interpretation of the data for consideration by a physician.
- The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
- The device is indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis.
- The device is not intended to be used as a vital signs physiological monitor.
- The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
The ELI 230 is a multi-channel diagnostic electrocardiograph intended for acquiring and printing ECG's of adult and pediatric patients. The ELI 230 utilizes previously cleared predicate Mortara technology and design features from the Mortara electrocardiograph device family, together with other current industry techn allo dest to achieve a highly reliable electrocardiograph. The device is not intended to be used as a vital signs nhysiological monitor. The ELI 230 is intended to be used by a licensed health care practitioner in a hospital or clinical setting.
The ELI 230 is a standard 12-lead, electrocardiograph that is intended to be used with the Mortara Wireless Acquisition Module (WAM) or Mortara Acquisition Module (AM12) patient cables. The ELI 230 acquires ECG waveforms from the WAM or AM12 patient cables.
The ELI 230 incorporates a similar user interface to that of the Mortara ELI 250 Electrocardiograph (K031182), The LCD on the ELI 230 is a QVGA color (320 x 240), 2.4" active matrix, TFT. Although sightly smaller than the ELI 250, the LCD displays waveforms as well as menus and configuration screens. As in the ELI 250, the user will use soft-keys to select functions displayed on screen. a group of five keys are available on the ELI 230 keyboard and they are located underneath the LCD. The ELI 230 implements the latest VERITAS™ Resting Interpretation criteria (adult/pediatric) (cleared in ELI 350 K082946).
The ELI 230 has a custom keyboard which includes symbol, cursor control and special function keys. The ELI 230 has a Main Configuration menu, divided in multiple pages, that includes all the default settings and user preferences (print speed, filters, etc.) The ELI 230 user will use soft-keys to select functions displayed on the LCD screen. A group of five keys and an On/Off key are available on the keyboard, and they are located near the LCD.
The ELI 230 prints on thermal roll paper oriented in the "landscape" mode. The printer is entirely controlled by software. When a print job is started the printer voltage is enabled, the 20 KHz chopper is enabled and the target speed is set. The 1 msec timer will step the motor phases every millisecond until the target speed is reached. ECG printout speed choices allowed are 5, 10, 25 and 50 mm/s. The outer dimensions of the ELI 230 are approximately 8 inches (width, left-to-right) x 12 inches (depth, front-to-back) x 3 inches (height, top-tobottom). The housing of the ELI 230 is ABS polycarbonate. Provisions for mounting the EU (230 to, a cre will be made.
The ELI 230 operates from a standard AC connection and also has the capability of being operated directly from a sealed lead-acid battery. The battery is only removable / replaceable through disassembly of the united when operating from the battery, remaining charge will be monitored. When the battery charge is low, an indication will be made to the operator. When the battery charge is depleted to its lowest allowed level, the unit will automatically power down. The battery is charged by an internal power supply when connected to the AC line. The unit will indicate when the battery is being charged and when it has reached full charge. When the blite has been discharged to a pre-defined, low-voltage limit, the internal power supply will be capable of re-dataging. the battery to 90% of its full charge level within 8 hours.
The provided document is a 510(k) premarket notification for the Mortara ELI 230 Electrocardiograph. It describes the device, its intended use, and indications for use, and claims substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study that proves the device meets such criteria.
The document states: "The ELI 230 implements the latest VERITAS™ Resting Interpretation criteria (adult/pediatric) (cleared in ELI 350 K082946)." This implies that the device is leveraging previously cleared interpretation criteria, rather than presenting new performance data for interpretation within this specific 510(k). To find the detailed acceptance criteria and performance study for the VERITAS™ Resting Interpretation criteria, one would need to refer to the 510(k) notification K082946 for the ELI 350.
Therefore, based solely on the provided text for K100127, I cannot complete the requested tables and information. The document focuses on showing substantial equivalence based on previously cleared technology and design features, and does not include new clinical performance data for the interpretation algorithm.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).