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.com 0197 January 10, 2019 | v. 3.0 1/11 INTENDED USE FCC REQUIREMENTS The PocketECG transmitter is intended to acquire, analyze, visualize, record or/and transmit the ECG 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. It is assumed that the device can further transmit the and acceleration signals along with analysis results using available wireless technologies. The PocketECG IV is intended for use under the supervision of a physician or those knowledgeable all aspects of ECG morphology, rhythm, and arrhythmias. Having fulfilled the working conditions specified in the manual, the device may be used when the patient is in the following places: clinic, hospital, outpatient cardiology clinic, house, business establishment, etc. CONTRAINDICATIONS The PocketECG IV is not intended to be used by patients who have been diagnosed with threatening require spitalization or patients who require inpatient arrhythmias and monitoring using a life-saving device. The Pocket ECG III is not intended for use in surgical rooms, intensive care units, intermediate or step-down units, emergency vehicles. The PocketECG IV is MR unsafe and should not be used in any magnetic resonance environment. COMPLIANCE The Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG IV complies with the following regulations:
the essential requirements of the Council Directive 93/42/EEC, the requirements of the United States Food and Drugs Administration, the requirements of the Health Canada Medical Devices Regulations. US Federal Law restricts this device to sale by or on the order of a physician. is subject FCC ID: 2AB2MP4TRAA The device complies with part 15 of the FCC Rules. Operation 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. following the to Changes or modifications of any kind not expressly approved by Medicalgorithmics S.A. could void the user's authority to use ECG. COMPONENTS & ACCESSORIES SYMBOLS USED ON POCKETECG TRANSMITTER CASING CE mark (Council Directive 93/42/EEC) 0197 Type BF applied part Manufacturers name and address Date of manufacture Consult instructions for use 1 PocketECG transmitter includes radio wave transmitters COPYRIGHTS 2 3 Warning Caution Keep dry IP20 Protection against solid particles up to 12.5 mm (fingers or similar objects), lack of protection against ingress of water Dispose the device in compliance with appropriate regulations MR unsafe Serial number Brazilian National Institute of Metrology, Quality and Technology
(Inmetro) certification mark Australian Communications and Media Authority (RCM) certification mark SIM card (GSM) MicroSD memory card 1 2 3 PocketECG The transmitter, model:
PocketECG IV, type: P4TR-AA-ADS (LTE version for Verizon), P4TR-BA-ADS (LTE version for AT&T) A Lithium-ion battery, type: PECGB-III, rated 3,7 VDC, 1700 mAh charging An AC plug-in charger type PECGC-III suitable for PECGB-III, manufactured by Medicalgorithmics S.A., rated 100 VAC 240 VAC, 0.2 A, 50/60 Hz battery type MicroSD memory card PocketECG pouch Holster (optional, for indoor use only) Accessories which are needed to the proper operation but are not included in the PocketECG IV package:
SIM card, ECG electrodes. 2/11 MEDICAL INCIDENT, SERVICE, DECLARATION OF CONFORMITY In the event of a medical incident, please notify the manufacturer immediately. If you would like to receive the declaration of conformity, please contact the manufacturer. Service is provided only by Medicalgorithmics S.A. In case of any product malfunction it shall be returned to the following address:
to manufacturer directly MEDICALGORITHMICS S.A. Aleje Jerozolimskie 81 02-001 Warsaw, Poland e-mail: technical@medicalgorithmics.com Copyright 2018 Medicalgorithmics S.A. No one is permitted to reproduce or duplicate, in any form, this instructions for use or any part thereof without permission from Medicalgorithmics S.A. Medicalgorithmics S.A assumes no responsibility for any injury or for any illegal or improper use of the product that may result from failure to use this product instructions, cautions, warnings, or statement of intended use published in this manual. in accordance with the 11/11 WARNING: Sources of electromagnetic radiation like:
portable and mobile radio frequency equipment
(RF)
(e.g. cellular phones, mobile radio), communications radio frequency identification systems
(RFID) devices using one or more of the following wireless technologies:
o Wi-Fi (IEEE 802.11), o Bluetooth (IEEE 802.15), o ZigBee (IEEE 802.15.4), o WiMAX (IEEE 802.16), o Ant, etc., base for radio stations
(cellular/cordless) telephones and land mobile radios, amateur radio, AM, and FM radio broadcast and TV broadcast, metal detectors, diathermy, lithotripsy, electrocautery, radiofrequency identification (RFID), near
(NFC), electronic article surveillance (EAS) can affect the PocketECG transmitter. field communication 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 ACCESSORIES Recyclable materials Indoor use only Direct current Alternating current Date of manufacture Class II equipment Serial number IP02 Minimum Ingress Protection class provided by protective pouch FCC Logo (Declaration of Conformity) MAINTENANCE The PocketECG transmitter type: P4TR-AA-ADS, and P4-TR-BA-ADS and battery charger type:
PECGC-III, manufactured by Medicalgorithmics S.A. are designed for 5 years continuous use if properly operated. Then the device should be recycled according to the local recycling program or refurbished by the manufacturer. CLEANING & STORING The outer surface of the transmitter, ECG lead wires and transmitter accessories (charger, batteries) can be wiped with a wet soft cloth and soft soap dissolved in water or an alcohol-based disinfecting agent
(70 % ethanol or 70 %
isopropyl alcohol). When cleaning or using the equipment, never get the cables and the connectors wet. Neither the device nor the accessories are waterproof. Should its transmitter or accessories get accidentally wet, dry it immediately (leave the device with removed battery cover in the warm room for at least 24 hours). the PocketECG USING POCKETECG IV 1. Safety precautions One device is intended to monitor only one patient at a time. It is recommended for the device to work at room temperature (working temperature is: from 0 C to +43 C (from 32 F to 109 F)). Air in rooms where the device works should be free of caustic gasses, steam, and dust. Although the device is powered from 3.7 VDC and does not allow for power intake larger than 3 A it is not guaranteed that it cannot produce a spark which could initiate the explosion. The patient should check with the appropriate airline carrier to confirm that the PocketECG transmitter which is similar to a regular mobile phone may be used on the airplane during take-off, flight, and landing. During handling the device, it is necessary to avoid excessive stretching and sudden jerking of cables connecting the PocketECG transmitter with electrodes placed on the patients body. The ECG cables should not be bent, pulled and wrapped around the device. Parts that wear out and are intended for single use should be used in accordance with binding regulations and cannot be re-used. The electrodes placed on the patients body should be replaced with new ones after no longer than 24 hours if the diagnostic session is to be continued. The manufacturer is not liable for damage caused by improper use of the device or neglecting guidelines included in the instructions for use. The manufacturer accepts liability only when the device is used as intended and in accordance with the instructions for use. The ECG cable is permanently attached to the PocketECG transmitter. In case of damage, do not repair or replace it, because it may negatively influence the electromagnetic compatibility of 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. Recycle or dispose of used batteries according to the local regulations. 2. Starting the device Slide the battery into its compartment, until it will snap. The device turns on automatically, and it is ready for starting a new recording session about 30 seconds after the battery is placed in its compartment. A fully charged battery makes it possible to continuously monitor the patient's ECG and acceleration the PocketECG transmitter for at least 24 hours. signals using CAUTION: Prior to starting a diagnostic session IV instructions for use carefully. PocketECG read the CAUTION: A patient should be trained by qualified personnel before using the PocketECG transmitter. CAUTION: The batteries should be charged before the first usage. CAUTION: If no image is displayed within 30 seconds after placing the battery in the compartment, the battery is fully discharged or the device does not operate correctly due to the abnormal temperature or humidity conditions. 3. Connecting the ECG electrodes Remove hair from the place where the electrode will be attached. Wipe the chosen site with a damp cloth/wet wipes (do not use high-proof alcohol as it may dry up the epidermis and distort the ECG signal). 10/11 3/11 Place the electrodes on the patients body and connect the ECG cables of the PocketECG transmitter as shown. RED YELLOW WHITE BLACK confirm your choice. GREEN RED cable clips colors complying with the EU requirements left, the US requirements right Use only high-quality electrodes with fast conducting gel. Always obey instructions for use provided by the electrodes manufacturer. It is recommended to use electrodes designed for Holter monitoring. Secure each lead wire. Cables of the PocketECG transmitter should be attached to the electrodes a way that reduces movements causing signal artifact. WARNING: Discard electrodes after each use. intended WARNING: The snaps of the ECG lead wires are made of metal conducting the current and are to be connected with electrodes placed on a patients body. Never connect the lead wire snaps with any source of electric power power outlets, power supplies, and batteries. such as CAUTION: Always make sure that the electrodes are placed correctly. CAUTION: Verify the use-by dates on applied electrodes to make sure they have not expired. CAUTION: ECG electrodes can cause skin irritation. Examine the skin for signs of irritation or inflammation and avoid placing of the electrode in those areas. 4. Reporting symptoms in a patient view Press the Report Symptoms button. Select observed symptom from the list. Indicate when symptoms occurred and then If you select wrong symptom, you can always modify it. Otherwise, the selected symptom is confirmed automatically after 5 seconds. 1 2 3 Button for patients to report symptom 1 2 3 Battery level indicator Signal strength indicator 5. Stopping the device To switch the transmitter off ensure that the recording session is finished. Then you can remove the battery from its compartment. WARNING: Never ship the PocketECG transmitter/charger with the main battery inserted into its compartment. 6. Replacing the main battery The discharged battery should be charged immediately if the diagnostic session is intended to be performed for a period longer than 24 hours. Slide the battery lock to release the battery. Remove the battery. Place fully charged battery into compartment and push it until the lock clicks. The PocketECG transmitter is equipped with backup battery that is intended to supply the device when the main battery is being replaced. 4/11 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. The PocketECG IV device and any of its components should not be used for patient monitoring during any diagnostic treatment performed using:
tests or medical computed tomography (CT) systems, positron emission technology (PET), diathermy, lithotripsy, electrocautery systems. If the patient is going to be examined/treated using any of the listed diagnostic systems while being monitored with the PocketECG IV device, it is recommended to:
contact your medical service provider or medical professional supervising your recording session to inform that you are going to remove the PocketECG transmitter for some time due to the medical examination/treatment;
disconnect the ECG lead wires of the PocketECG transmitter from the electrodes placed on your body;
leave the PocketECG transmitter in a place where it will not be exposed to any disturbing radiation generated by the medical system that is going to be used. Do not stop the recording session;
when the examination/treatment is finished, replace the electrodes if necessary and connect the lead wires of the PocketECG transmitter to the electrodes. EFFECTIVE RADIATED POWER (ERP) Frequency
(MHz) Mode ERP (dBm) WARNING: The PocketECG transmitter is MR unsafe and should not be used in any magnetic resonance environment. by recommended WARNING: Use of accessories other than those the manufacturer, with the exception of the accessories sold by the manufacturer as internal replacement for components, may result in increased emission or decreased immunity of the device. parts of Sources WARNING:
strong electromagnetic radiation such as radio transmitters, personal transmitters working in the 80-2500 MHz frequency band may disturb the ECG signal and the automated ECG signal analysis. wireless 9/11 In order to resolve and prevent interference issues, above table presents the operating frequencies of the PocketECG CRS transmitter and the associated Effective Radiated Power (ERP). Commented [KW1]: Above table will be filled after completion of the measurements. 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. Replace Battery Battery state of charge is less than or equal to 10 %. The data are not transmitted to the remote server. Turn off and then turn on the device. If the module still does not operate correctly, call a service provider. Replace the battery with the fully charged. Insert Battery The PocketECG transmitter cannot find the battery. Insert the battery to the PocketECG transmitter Connect Electrodes No Memory Card No Network Electrodes contact loss. The ECG signal data are not transmitted to the remote server. The microSD card is not installed in its compartment and the session cannot be initialized. Put on the electrodes to your body. Install microSD card or replace damaged one. The PocketECG transmitter cannot connect to the mobile phone network -
data cannot be transmitted. Keep the PocketECG transmitter in the area where the mobile network is accessible. Critically low battery level. The device will shut down. Replace battery before update Battery state of charge is 2 %, the device will shut down. Battery state of charge is less than or equal to 29 %, the update will not be initiated. Replace the battery with the fully charged. Replace the battery with the fully charged. Software update in progress Transmitter software is being updated. Do not remove the battery when the message is visible. Data synchronization is required. Make sure that this device has 3G network coverage. Data need to be transmitted to the remote server. Ensure that 3G network coverage is available. When the main battery is being removed during an ongoing session, the transmitter operates continuously powered from the backup battery up to 1 minute. If the charging process starts within 5 minutes, the battery tends to operate properly. Otherwise, remove the battery from the charger because it is damaged and should be no longer used. WARNING: Do not use other chargers than those intended for use with the battery dedicated for the PocketECG transmitter to prevent the danger of battery explosion. CAUTION: The charging process does not start if the battery is damaged or has been deeply discharged (e.g. kept in the turned off PocketECG transmitter for a long period of time). CAUTION: The battery charger can be supplied only by the AC voltage specified on the charger label. CAUTION: The backup battery is activated only when a recording session is ongoing. 8. Charging the backup battery The backup battery inside the PocketECG transmitter and cannot be removed. installed is The charging of the backup battery is started automatically. The charging of the backup battery is initiated when the charge level falls below the predefined minimum level and the main battery powering the device is fully charged. When the battery gets damaged or is worn out, for standard disposal procedure follow Lithium-ion batteries. CAUTION: If the main battery charge level is low, replace it with fully charged one, immediately. If the main battery remains removed from its compartment for a period longer than 1 minute, the transmitter will switch off and the transmission will be suspended. 7. Charging the main battery Plug the charger into the AC mains. light Check whether all indicators blink simultaneously with orange light (the sound is generated if the battery is not inserted into the charger within 15 seconds from the charger powers on). Put the battery into the charger and verify indicator flashes orange in progress whether the indicating that the charging is
(the sound is no longer generated). light Wait until all light indicators of the charger change color from orange to green indicating that the battery is fully charged. The battery requires ca. 4 hours to be fully charged. If the device is not going to be used for a longer time period, remove the battery. The battery reliability may be degraded when left in the turned off device for a long period of time. If the charger generates the sound when the battery has been already inserted into its cradle, the battery may be damaged or deeply discharged. To verify whether the deeply discharged battery may be safely used, keep it in the charger for 5 minutes. 8/11 5/11 TECHNICAL PARAMETERS Model PocketECG IV Type P4TR-AA-ADS (LTE version for Verizon) Powered by A Lithium-ion battery 3.7 V type: PECGB-III (1700 mAh) Verizon version:
AT&T version:
Wireless communication B4(AWS1700) B13(700) B2 B4(AWS1700) B12(700) Power consumption
<2.5 A (in transmission mode) Working time at least 24 hours Input impedance
>10 M CMRR
>60 dB Sampling rate 300 Sa/s Registered signal band 0.05 Hz to 60 Hz Input dynamic range 5 mV Acceptable constant component 300 mV Dimensions 167x79x14.5 mm (without cable) Weight 161 g operating conditions 0 C to 43 C (32 F to 109 F) Temperature transport and storage conditions
-20 C to 60 C (-4 F to 140 F) operating conditions 15 % to 93 %, non-condensing Relative humidity Atmospheric pressure transport and storage conditions operating conditions transport and storage conditions up to 93 %, non-condensing 700 hPa to 1060 hPa 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. Turn the transmitter off immediately and provide appropriate patient care if you suspect the transmitter affected the peacemaker. DO the keep transmitter in the protective pouch with protection class at least IP02 in all outdoor applications. PocketECG DO keep the device and its accessories in dry conditions when showering, bathing or washing. Product is not watertight. DO keep the device and its accessories away from to avoid danger of infants and children swallowing. DO NOT use the device in infants weighing less than 10 kg. DO NOT use the device in intensive care units. It should not be used with high-frequency surgical devices or directly on the heart. DO NOT use accessories other than those recommended by the manufacturer. It may be dangerous to the user and may affect the electromagnetic compatibility of the PocketECG transmitter. DO NOT plug the device to a different source of power than intended by the manufacturer. Using a different power source is hazardous and may impair the functioning of the equipment or result in serious injury to the user. DO NOT use the device in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide. DO NOT position PocketECG battery charger so that it is difficult to operate the detachable power supply cord. DO NOT service the device while in use with a patient, excluding main battery replacement. DO NOT attempt to open or service neither the battery pack nor the transmitter. DO NOT disassemble, crush, puncture the battery, and do not short external contacts or circuits, dispose of in fire or water or expose to temperatures higher than 60 C (140 F). Replace a Lithium-ion battery only with batteries specified by the device manufacturer. Recycle or dispose of used batteries according to the local regulations or reference guide supplied with your product. DO NOT use the device at gas stations, fuel depots, chemical plants or where blasting operations are in progress, or in potentially explosive atmospheres such as fueling areas, fuel storehouses, below deck on boats, fuel or chemical transfer or storage facilities, and areas where the air contains chemicals or particles, such as grain, dust, or metal powders. The user should observe restrictions on the use of radio equipment in such places. Please be aware that sparks in such areas could cause an explosion or fire resulting in bodily injury or even death. DO NOT use the device in a manner such that it is in direct contact with the body. The device needs to be worn in such a way that display is facing away from patient body. PocketECG IV has been tested and meets FCC RF exposure guidelines when used with an accessory that contains no metal and that positions the device in a minimum of 1.0 cm from the body. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. 6/11 7/11