Generic / Preliminary Sirona USER MANUAL Caution: FEDERAL LAW RESTRICTS THIS DEVICE FOR SALE TO OR ON THE ORDER OF A PHYSICIAN. Carefully read all instructions prior to use. Observe all warnings and precautions noted in these directions. Failure to do so may result in patient complications.
Table of Contents Notices ................................................................................................................................ 3 User Safety Information...................................................................................................... 4 Warnings ............................................................................................................... 4 Cautions ...............................................................................................
Notices Conventions Used in this Manual NOTE WARNING Warning statements describe conditions or actions that can result in personal injury or loss of life. CAUTION Caution statements describe conditions or actions that can result in damage to the equipment or loss of data. Notes contain additional information on usage. Manufacturer’s Responsibility IntriCon Datrix considers itself responsible for effects on safety and performance only if: 1.
User Safety Information Intended Use The SIRONA APETS recorder is a small, portable, digital Holter/Event recorder intended for use by medical professionals to acquire ECG data from a single patient in a clinical, point of care or outpatient setting. ECG data is first recorded to a Secure Digital (SD) card and then transferred to a Holter/Event analysis system for review by a physician or other qualified professional.
2. Use of accessories other than those recommended by IntriCon Datrix may compromise product performance. 3. To maintain designed operator and patient safety, any peripheral equipment and accessories that can come in direct patient contact must be in compliance with IEC 60601-1. 4. Hardware is designed to meet or exceed IEC 60601-1-2, however some environmental electrical interference may cause an artifact in the ECG.
Section 1: Introduction This manual is written for clinical professionals. It is assumed that the reader has a working knowledge of medical terminology and procedures as required for monitoring cardiac patients. Purpose of the User Manual The User Manual describes how to safely operate the SIRONA Holter/Event recorder, Smart Dock and linkStream.
Front Panel LED Button The Sirona front panel contains two buttons and five LED lights (Light Emitting Diodes) as follows: Record Button Send Button Record Green or Red LED Lead-off Red LED Battery Green or Red LED Sirona User Manual Rev D02 -7-
Section 3: Initial Device Setup Setting Parameters One of the advantages of this device is that it can easily be configured to work in different modes, and with different operational parameters. In order to enable this, the device has an internal nonvolatile microSD card where it will store configuration parameters. These parameters are retrieved from microSD card upon device start-up. Device ID is set by the manufacturer . The device ID is secured from accidental modification.
Section 4: Connecting Devices Deleted: Attaching Recorder to Patient 4.1 Attaching Recorder to Patient Patient Cable The Patient cable connects to the Walta connector on the side of the SIRONA recorder. The cable is keyed for proper alignment. Be sure to align the key. Do not force a cable into position. Use only IntriCon Datrix cable part numbers listed in table 1.
3-Lead 1-Channel Electrode Placement Read and follow instructions included with the electrodes. 1. Check the patient cable for damage or wear. Replace if necessary. Use Silver Chloride disposable electrodes designed for 24 hour Holter/Event monitoring. 2. Place the electrodes onto the ECG leads. 3. Remove the backing from the pre-gelled disposable electrode. 4. Firmly place an electrode on each of the prepared skin surface sites. Dispose of any electrode that does not properly adhere to the skin.
4.3 Connecting the linkStream to a PC The linkStream is connected to a PC through a mini-USB to USB cable. The mini-USB end plugs into the linkStream and the USB end plugs into the PC Section 5: Instructions for Use Deleted: Page Break Deleted: Patient 5.1 Instructions for Patient Before the patient leaves the office inform the patient about: a) Proper use of the Record button and patient diary. b) Transmitting ECG by TTM. c) Light message displays Deleted: ¶ Formatted: Bullets and Numbering 5.
Smart Dock Operation When Sirona is placed on the dock Smart Dock will charge battery. The charging status is indicated by the battery LED on Sirona. The table in charging section below explains the battery LED behavior. To extract data from the SD card in the Sirona. Put the Sirona in “dock mode” by pressing “Send+Record” together for 5 seconds. Place the Sirona on the Smart Dock. Open the Sirona Viewer application on the PC and hit the “Save Holter Data” tab to save the data as a bin file.
SIRON A Patient Interface Light Signals There are several messages that could appear to alert you that action may be required, or simply to alert you that an error has occurred.
Section 6: Device Maintenance Inspection and Cleaning Routine inspection will help maintain the safety and performance of your SIRONA Holter/Event recorder, Smart Dock and linkStream. Before operating the device perform a visual inspection to identify any damage or excessive wear. The outside surfaces can be cleaned with a cloth dampened with a mild soap and water solution. Do not dispose of the unit in trash.
Charging The Sirona should only be charged with equipment supplied by Intricon Datrix (Model Number – RX 92446-0009 and Model Number – RX92598) intended for that purpose.
Sirona Accessory List Description Part Number 3 Wire 1-Channel Event Cable 20" RX92368-001 5 Wire 2-Channel Holter Cable 20" RX92368-003 5 Wire 5-Channel Event Cable 20" RX92368-004 7 Wire 3-Channel Holter Cable 20" RX92368-005 3 Wire 1-Channel Event Cable 39" RX92368-006 5 Wire 2-Channel Holter Cable 39" RX92368-008 5 Wire 2-Channel Event Cable 39" RX92368-009 7 Wire 3-Channel Holter Cable 39" RX92368-010 5 Wire 3-Channel Holter Cable 20" RX92368-011 5 Wire 3-Channel Holter Cable 39" R
SIRONA DATASHEET General Specifications: Input impedance: ≥ 10 MΩ CMRR: > 60 dB AC signal range: ± 5mV DC signal range: ± 300mV Bandwidth: 0.05 –40 Hz. Sampling rate: 250 samples/sec. Resolution: 10 bits Battery: Lithium-Polymer rechargeable Memory type: Flash Waterproof rating: IP54 and brief immersion to 6” (when patient cable attached) Lead status: Automatic lead-off detection User alerts: LED indicators and audible alerts. Wireless link option: 2.
Service/Technical Support: IntriCon Datrix 340 State Place Escondido, CA 92029 Tel: 760-480-8874 Fax: 760-480-9474 Warning: THE SIRONA SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT. IF ADJACENT OR STACKED USE IS NECESSARY, THE SIRONA SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION IN THE CONFIGURATION IN WHICH IT WILL BE USED.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Sirona, including cables, than the recommended separation distance calculated for the equation applicable to the frequency of the transmitter. Recommended separation distance. Conducted RF 3 Vrms N/A d 1 . 17 P d 1 . 17 P 80 MHz d 2 .
Guidance and manufacturer's declaration - electromagnetic immunity The Sirona is intended for use in the electromagnetic environment specified below. The customer or user of the Sirona should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 IEC 60601 level test Compliance level +/- 6 kV contact +/- 6 kV contact +/- 8 kV air +/- 8 kV air Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile.
The Sirona is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Sirona can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Sirona as recommended below, according to the maximum output power of the communications equipment.
Page 13: [1] Deleted Record LED flashes green Nidhi Panday Number of flashes corresponds to the number of stored recordings[NP1] 7/24/2012 12:38:00 PM None
