Related Manuals for TZ Medical Aera CT 3G
Summary of Contents for TZ Medical Aera CT 3G
- Page 1 Aera CT 3G Mobile Cardiac Monitor Operator Manual Revision 1.2 Document No. 14480 Page 1...
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Page 2: Table Of Contents
Testing ....................................26 Troubleshooting ..............................27 Error Messages.................................. 27 Server Errors ..................................28 Wireless Compliance ..............................29 Specifications ................................30 TZ Medical Warranty ..............................32 Limited Warranty ................................32 Obtaining Warranty Service .............................. 32 Accessories ................................33 Revision 1.2 Document No. 14480... -
Page 3: Device Overview
Device Overview Description Caution: US Federal law restricts this device to sale by or on the order of a physician. The Aera CT is a battery operated ambulatory electrocardiograph recorder for use in mobile cardiovascular telemetry. It is capable of storing 3 channels of patient ECG data acquired from three or five surface electrodes adhered to the body for over 28 days of continuous recording. -
Page 4: Indications For Use
Device Overview Indications for Use The Aera CT is intended for acquiring ambulatory ECG signals from patients who either are at risk of having cardiac disease or have intermittent symptoms indicative of cardiac disease and who have demonstrated a need to be monitored on a continuing basis. Indications for conducting ambulatory recording include: ... -
Page 5: Recorder Components
Device Overview Recorder Components Figure 1 1. Color Display 2. Patient Event Button 3. Up Key 4. Left Key 5. Select Key 6. Right Key 7. Down Key Front view of the Aera CT. Figure 2 1. Battery Compartment 2. microSD Card Holder 3. - Page 6 Device Overview Recorder Components (continued) Figure 3 1. Patient Cable Receptacle 2. Power Cable Receptacle 3. Power Receptacle Plug Side view of the Aera CT. Revision 1.2 Document No. 14480 Page 6...
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Page 7: Equipment Symbols
Device Overview Equipment Symbols Consult the Directions For Use Type B device Electrically Isolated Manufacturer Info Emits Non-ionizing Radiation RX Only Prescription Only Revision 1.2 Document No. 14480 Page 7... -
Page 8: Precautions
Use only a TZ Medical, Inc. certified microSD memory card for recording. Do not connect anything other than the battery charger provided by TZ Medical, Inc. to the charge port on the Aera CT. Use only patient cables provided by TZ Medical, Inc. with the Aera CT. -
Page 9: Operation
Operation Battery Installation Instructions 1. Align slots in battery with tabs in device. 2. Push battery down on side opposite the tabs. Figure 4 Battery Insertion. Revision 1.2 Document No. 14480 Page 9... -
Page 10: Initial Device Setup
Operation Initial Device Setup When you first receive your Aera CT device, the wireless system must be configured to communicate with your receiving software. To achieve this, follow the instructions from your software provider to load the necessary wireless settings onto the provided microSD card. Insert the configured microSD card into the card holder, located in the battery compartment, of the Aera CT. -
Page 11: User Interface
Operation User Interface The Aera CT employs a graphical user interface consisting of a color LCD and 5 touch-sensitive keys for configuration and patient hookup procedures. The only touch-sensitive areas of the device are the 5 keys. The LCD is NOT a touch screen. Note: Aggressive attempts to use the LCD as a touch-screen can result in irreparable damage to the LCD. -
Page 12: Starting A Study
Operation Starting a Study To begin a new patient study, the receiving software must first be configured. Follow the instructions from your software provider to set all of the relevant parameters and prepare the server for the new patient study. If it is anticipated that the patient hookup procedure will be performed in a location that does not have reliable wireless connectivity, this process should include loading the settings for the study onto the microSD card in the device, according to the instructions from your software provider. - Page 13 Operation Starting a Study (continued) Figure 10 Figure 11 This device needs to erase the SD card The device will double check to make sure before it can continue with a new study. that you want to erase all the data. When there is no data on the microSD card, you will be prompted to update the device’s clock.
- Page 14 Operation Starting a Study (continued) Once the device time has been verified, the Aera CT must load the proper settings for the new study. If the settings were previously loaded onto the microSD card, select the KEEP CURRENT option to continue. This could be used when poor wireless reception is expected.
- Page 15 Operation Starting a Study (continued) Once the device has successfully downloaded the latest settings, it will automatically prompt you to connect the patient to the device by displaying the selected electrode configuration on the display. It will also silently report the successful settings download action to the server in the background.
- Page 16 Operation Starting a Study (continued) On the “ECG Quality” screen, the Aera CT will draw the ECG trace from one of its three input channels in real time. Toggle which channel is being drawn by highlighting the LEAD option and pressing SELECT. If necessary, highlight the SCALE option and press SELECT to change the dynamic range of the display.
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Page 17: Monitoring A Study
Operation Monitoring a Study Once a study has been started, the Aera CT will silently record and transmit ECG data with no intervention from the patient. The patient can wake the display by briefly pressing the patient event button to view a status screen with instructions on how to mark an event. - Page 18 Operation Monitoring a Study (continued) For the duration of the study, the Aera CT will periodically upload files to the receiving server. These event files provide information on the status of the device, (such as battery life, recording state, and electrode connection status), as well as information on detected arrhythmias and patient activated events.
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Page 19: Ending A Study
Operation Ending a Study The Aera CT provides 2 automated methods and 2 manual methods for ending a study. When the Aera CT is configured at the beginning of the study, it can be programmed to automatically end the study after a specific length of data has been recorded, or to end the study at a specific date and time. - Page 20 Operation Ending a Study (continued) It is also possible to end the study from the device itself using the early-out procedure: 1. Make sure the recording is suspended by disconnecting the patient cable from the device. 2. Simultaneously hold the left key on the keypad while briefly pressing the patient event button to access the “security code screen”.
- Page 21 Operation Ending a Study (continued) After entering the first 4 digits of the device’s serial number, the Aera CT will prompt you one last time to make sure that you wish to end the study. Select the STOP option to end the study and transmit any remaining pending data to the server.
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Page 22: Electrode Application
Operation Electrode Application Employ the following procedure when applying electrodes to a patient and connecting them to the Aera CT: 1. Select electrode sites to match the configured electrode configuration shown in the following figures or as instructed by the physician. Select areas over bone, avoiding muscle areas and breast tissue. 2. - Page 23 Operation Electrode Application (Continued) Figure 30 Electrode Configuration #2 (5 electrodes) Figure 31 Electrode Configuration #3 (3 electrodes) Revision 1.2 Document No. 14480 Page 23...
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Page 24: Patient Use Precautions
Operation Patient Use Precautions The Aera CT contains sensitive electronic circuitry. Please observe the following precautions while using the Aera CT. Failure to do so may result in serious damage to the device. Avoid Exposure to Moisture The Aera CT should not be used while swimming, showering, bathing, or participating in any aquatic activities. -
Page 25: Maintenance
Maintenance Charging The Aera CT employs a rechargeable lithium-ion battery to meet the demanding power requirements of cellular data transmissions. This battery can be recharged in the device without interrupting the data recording. To charge the battery, connect the battery charger to the charge port on the device. The Aera CT will indicate that the battery is charging by replacing the battery status indicator on the screen with a charging indicator. -
Page 26: Cleaning
7. In case of a failure, the Aera CT will generally attempt the test again, rather than displaying a failure message. Note: If an Aera CT device repeatedly fails any of the device tests, the device will need to be returned to TZ Medical for servicing. Revision 1.2 Document No. 14480... -
Page 27: Troubleshooting
These errors can often be resolved by removing the battery and mircoSD card, formatting the card, and then re- inserting the card and battery. If the error message persists, the device will need to be returned to TZ Medical Inc. for servicing. See the Warranty section of this manual for instructions on returning a device for service. -
Page 28: Server Errors
Troubleshooting Server Errors The Aera CT may also display an error message when attempting to download settings from the server. In this case, the error message is typically not indicative of a failure with the device; it is generally an indication of a server error that is preventing the Aera CT from operating properly. -
Page 29: Wireless Compliance
This device has been tested and meets FCC RF exposure guidelines when worn on the body using using the Aera CT Leather Carrying Case (PN: 7110-02) or Aera CT Plastic Holster (PN: 7214-08) available from TZ Medical. In cases other than the above carrying accessories is used it should not contain any metal parts and provide a minimum distance of 2 cm from the body. -
Page 30: Specifications
Specifications Functional ECG Channels Sample Rate 256 or 512 Samples per Second User Interface Color graphic display with direction pad and select Memory Total Recording Time 28 Days Maximum Event Duration 11 minutes Media microSDHC card* Data Retention 10 years * Use only TZ-supplied memory cards or the recorder will not function properly Physical Case Dimensions... - Page 31 Mode of Operation – Continuous Conformance to Regulatory Standards TZ Medical, Inc. declares that his device complies with the essential requirements of Article 3 of the R&TTE 199/5/EC Directive, if used for its intended use and that the following standards have been applied: BS EN 62209-2: 2010 ETSI EN 301 489-1 V1.8.1...
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Page 32: Tz Medical Warranty
TZ Medical Warranty Limited Warranty This TZ Medical product is warranted to be free from manufacturing and material defects for a period of one (1) year from the date of shipment from TZ Medical to the original purchaser (“Warranty Period”). If a hardware defect arises and a valid claim is received within the Warranty Period, TZ Medical will either repair or replace the defective product free of charge for parts or labor. -
Page 33: Accessories
Accessories The following accessories are available for use with the Aera CT. Part Number Description Aera CT Rechargeable Li-Ion Battery 3500-02 Aera CT 4GB microSDHC Card 5500-29 Aera CT 5-Electrode Patient Cable 6111-02 Aera CT 3-Electrode Patient Cable 6111-03 Aera CT Shortened 3-Electrode Patient Cable 6111-04 Aera CT 4-Electrode Patient Cable 6111-05...