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myPatch®sl is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. The myPatch®sl is intended for use by Adults and all Pediatric subgroups

The myPatch®sl (model # 3000sl) ambulatory electrocardiograph (ECG) recorder is a small, lightweight ambulatory ECG recorder that records ECG continuously. The unit records 1 or 2 channels of ECG up to 14 days and 3 channels up to 9 days. The device is composed of a large ECG electrode and an ECG recorder. The ECG recorder snaps onto the electrode and records until the recorder is turned off or the battery is drained. At the end of the recording, the recorder can be plugged into a PC via a USB cable. The ECG recording can be transferred to a pc where processing software can transfer the data to a format that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers. Only the recorder is part of this 510(k) application. The myPatch®sI recorder also incorporates an Event feature where the patient double taps on the recorder when they feel a symptom. The myPatch®sI recorder has a power button on the recorder. Once depressed for 1 second, the green LED flashes. The LED will flash for 30 seconds as a "start-up" period. This gives the user time to apply the electrode to the patient's sternum without recording artifact during the hookup period. To power off the recorder, the button is held down 2 seconds. A red light will flash and the recording period ends. As the mvPatch®sl is worn continuously up to 14 davs it will be worn (used) in homes. healthcare facilities, hospitals, and where ever the patient may go. The associated accessories that are part of the myPatch®-sl recorder are a lead wire, USB cable and the mvPatch®-sI electrode. Per the Class II Special Controls Guidance Document: Electrocardiograph Electrodes, issued on July 21, 2011 "the FDA has determined that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of this generic type of device if the manufacturer follows the recommendations in this special controls guidance to address the issues identified in this guidance." The scope of the guidance includes "bare ECG electrodes or ECG electrodes that incorporate as part of their design, a conductive gel, an adhesive system or a lead wire". Per this guidance, we have the device specifications, composition, formulation, component specifications, engineering drawings with dimensions & composition, written description of how the electrode connects to the myPatch®sI and a list of features and specifications in tabular format. The lead wire has been tested by the manufacturer to EN 55024:1998 +A1:2001 +A2:2003 and EN 55022:1998+A1:2000+A2:2003 standards. The copy of the Certificate of Conformity is in our files. The myPatch®sI records ECG in accordance to the standard IEC 60601-2-47:2012 for ambulatory ECG Recorders. During the recording the patient wears the myPatch®sI connected to an electrode on the upper sternum. The myPatch®sI consists of a microprocessor, recording circuit, memory, data storage, light-emitting diode (trans-illuminates the power button), and snap contacts to the electrode. In addition to that, myPatch®sI contains firmware to control the recording of the ECG data and software to transfer the recorded ECG file to the pc. The battery is a rechargeable lithium polymer battery with a built-in protection circuit. The charge of the myPatch®sI is by use of a USB cable with a proprietary connector which can only be connected to myPatch®sl when it is not connected to the electrode. The myPatch®sI has a serial number and product number in a bar code format and numbers to secure the traceability of the equipment and the data during and after the studies. mvPatch®sI is reusable. The electrode (accessory to myPatch®sl) is the passive part. The electrode consists of one laver of one-sided adhesive tape that runs the full length of the electrode. This adhesive tape allows the electrode to be placed on the upper sternum. The electrode gel is placed on the underneath side of the adhesive tape. Through this electrode qel the ECG of the patient is recorded. The top side of the electrode has 4 snaps that will connect in only one way to the myPatch®sl and one snap for an optional lead wire. The conductor paths are flex strips that run between the connector and the electrode gel. A release liner is placed on the underside of the electrode. The release liner covers the adhesive tape and the electrode gel. This liner is torn off when placing the myPatch®sl on the upper sternum. The electrode must be connected to the myPatch®sI to have any practical use. The electrode is a single use device and is disposed of after the one single use. When recording a 3 channel ECG, a standard lead wire is attached to the snap on the front, bottom of the electrode. This lead wire attaches to any standard ECG electrode. The normal placement of this electrode is the V5 position. The case of the myPatch®sI recorder is a Sabic/Lexan HP1 high flow polycarbonate for medical device applications and has the following certifications: ISO10993 or USP Class VI.

myPatch®s is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizht headedness, pre-syncope, fatigue, chest pain and/or anxiety. The myPatch®s is intended for use by Adults and all Pediatric subgroups.

The myPatch®s ambulatory electrocardiograph (ECG) recorder is a small, lightweight monitor that records EG continuously. The unit records 1, 2 or 3 channels of ECG up to 7 days. The device is composed of a large EGG electrode and an ECG recorder. The ECG recorder snaps onto the electrode and records until the recorder is removed from the electrode. At the end of the recorder can be plugged into a PC via a USB cable. The ECG recording can be transferred in an available file format that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers.

The myPatch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, presyncope, syncope, fatigue, chest pain and/or anxiety.

The myPatch ambulatory electrocardiograph(ECG) recorder is a small, lightweight monitor that records ECG continuously. The unit records 2 channel of ECG data up to 3 days. The device is composed of a large ECG electrode and ECG recorder. The ECG recorder clips onto the electrode and records until the recorder is removed from the electrode. At the end of the recorder can be plugged into a PC via the USB connection. The ECG recording can be transferred in an available file that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers. The myPatch records ECG in accordance to the standard IEC 60601-2-47:2012 for ambulatory ECG recorders. During the recording the patient wears the myPatch connected to an electrode on the sternym. The myPatch consists of a plastic casing containing a battery and electronics consisting of a microprocessor, measuring circult, memory, data storage, light-emitting dlode (transilluminates the plastic casing), and contact to the electrode. In addition to that, myPatch contains firmware to control the collection of the ECG-data and software to transfer to processing software. The battery is a rechargeable lithium polymer battery with a built-in protection circuit. The charging of the myPatch is by use of a USB cable, which can only be connected to myPatch when it is not connected to the electrode. At the bottom of myPatch is an electrical and click-on connection for the electrode. myPatch must be connected to the electrode to turn on and to acquire data. myPatch has a serial number to secure the traceability of the equipment and the data during and after the investigation. myPatch is reusable. The electrode ( accessory to myPatch, ) is the passive part. The electrode consists of one layer of onesided adhesive tape that runs the full length of the electrode. This adhesive tape allows the electrode to be placed on the sternum. The electrode gel is placed on the underneath side of the adhesive tape. Through this electrode gel, the ECG of the patient is measured. The top side of the electrode has an electrical and click-on connection to myPatch. The conductor paths are printed on the adhesive tape. These conductor paths make the connection between the electrode gel on the underside and the connection to myPatch on the top side of the electrode. Release liners are placed on the underside and on the top side of the electrode. These release liners cover the adhesive tape and the electrode gel and are torn off when placing the myPatch on the sternum. The electrode has to be connected to myPatch to have any practical use. The electrode is a single- use device and is disposed of after one single use.