PocketECG IV DUAL CHANNEL Instructions For Use MEDICALGORITHMICS S.A. Aleje Jerozolimskie 81, 02-001 Warsaw, Poland e-mail: technical@medicalgorithmics.com web: www.medicalgorithmics.
January 10, 2019 | v. 3.0 INTENDED USE The PocketECG transmitter is intended to acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The results of arrhythmia and ST elevation detection are displayed, stored or/and transmitted along with the ECG signals. The acceleration signals are analyzed in order to determine the physical activity of the patient.
• ECG electrodes. FCC REQUIREMENTS FCC ID: 2AB2MP4TRA The device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications of any kind not expressly approved by Medicalgorithmics S.A. could void the user's authority to use ECG.
the device. Damaged ECG cable can be replaced only by the manufacturer. • The conductive parts of ECG cables are intended to be connected only to the ECG electrodes. They should not be connected to any conductive parts of any objects including earth. • The capacity of the PocketECG Li-Ion battery decreases with normal use over time. The manufacturer recommends replacing the battery with a new one after 300 charging cycles or after 2 years of use.
• Place the electrodes on the patient’s body and connect the ECG cables of the PocketECG transmitter as shown. 4. Reporting symptoms in a patient view • Press the ‘Report Symptoms’ button. • Select observed symptom from the list. RED YELLOW GREEN WHITE BLACK RED • Indicate when symptoms occurred and then confirm your choice. • If you select wrong symptom, you can always modify it. Otherwise, the selected symptom is confirmed automatically after 5 seconds.
• When the main battery is being removed during an ongoing session, the transmitter operates continuously powered from the backup battery up to 1 minute. • When the battery gets damaged or is worn out, follow standard disposal procedure for Lithium-ion batteries. CAUTION: If the main battery charge level is low, replace it with fully charged one, immediately.
TECHNICAL PARAMETERS Model Type Powered by Wireless communication Power consumption Working time Input impedance CMRR Sampling rate Registered signal band Input dynamic range PocketECG IV P4TR-AA-ADS (LTE version for Verizon), or P4TR-BA-ADS (LTE version for AT&T) A Lithium-ion battery 3.7 V type: PECGB-III (1700 mAh) Verizon version: AT&T version: B4(AWS1700) B13(700) B2 B4(AWS1700) B12(700) <2.5 A (in transmission mode) at least 24 hours >10 MΩ >60 dB 300 Sa/s 0.
WARNINGS Warning statements alert to situations which, if not avoided, could result in illness or injury of the patient. Specific warnings can also be found in other sections of this instructions for use. All of them should be obeyed. • DO remove electrodes, patient lead wires, and the PocketECG transmitter from the patient before defibrillation. • DO maintain a minimum distance of 6 inches between the transmitter and pacemaker for patients with a pacemaker.
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NOTIFICATIONS NOTIFICATION DESCRIPTION ACTION The device was turned off for over 12 hours. Would you like to continue monitoring? The PocketECG transmitter was turned off for over 12 hours. Make sure, that you have to stop or continue session, call a service provider. ECG Module Error The ECG module malfunction. Turn off and then turn on the device. If the module still does not operate correctly, call a service provider. Replace Battery Battery state of charge is less than or equal to 10 %.
ELECTROMAGNETIC & OTHER INTERFERENCES It is recommended to keep the PocketECG transmitter as far as possible from all equipment combining RF transmitters. Try to reorient or/and relocate PocketECG transmitter when the ECG signal displayed on the screen of is partially masked by disturbing signal despite the ECG electrodes are properly placed on the patient skin.
WARNING: Sources of electromagnetic radiation like: battery cover in the warm room for at least 24 hours). • portable and mobile radio frequency (RF) communications equipment (e.g. cellular phones, mobile radio), • Remove the battery from either the transmitter or charger before storing them. This prevents the battery from accidental discharge and reduces the risk of its damage.
SYMBOLS USED ON POCKETECG TRANSMITTER CASING MEDICAL INCIDENT, SERVICE, DECLARATION OF CONFORMITY CE mark (Council Directive 93/42/EEC) • In the event of a medical incident, please notify the manufacturer immediately. Type BF applied part • If you would like to receive the declaration of conformity, please contact the manufacturer. 0197 Manufacturer’s name and address Date of manufacture Consult instructions for use Warning • Service is provided only by Medicalgorithmics S.A.
