SpiderView Digital Holter Recorder USER MANUAL
TABLE OF CONTENTS 1. INTRODUCTION ........................................................................................................ 5 1.1. Use in the United States............................................................................................. 5 2. SPIDERVIEW PRESENTATION................................................................................ 6 2.1. Intended use...............................................................................................................
11.1. Voltage screen ......................................................................................................... 28 11.2. Impedance screen.................................................................................................... 28 11.3. Time and date screen............................................................................................... 29 11.4. About screen ............................................................................................................
1. INTRODUCTION 1. INTRODUCTION This icon is used to draw your attention to a particularly important point. This icon alerts you to a hazard that may result in equipment damage or personal injury. Carefully read the instructions provided with this icon. USE IN THE UNITED STATES USA only 1.1. SpiderView – UA10709B [CAUTION: Federal law restricts the sale of this device by or on the order of a physician.
2. SPIDERVIEW PRESENTATION 2. SPIDERVIEW PRESENTATION 2.1. INTENDED USE SpiderView is a digital ECG Holter recorder intended for long-term ambulatory ECG recordings, multi-channel, and High-Resolution ECG recordings. WARNING: The holter analyzing SyneScope software is needed to download and analyze the recordings. 2.2. SPECIFIC FEATURES OF SPIDERVIEW SpiderView uses flash cards: MMC cards (Multi Media Cards), SD cards (Secured Data) or MicroSD cards.
3. USER PROFILE 3. USER PROFILE 3.1. TRAINING Any person who has followed the training required by the local regulatory authority. Training completion and effectiveness are under his/her medical supervisor’s responsibility. NOTE: Any serious incident that has occurred in relation to the device must be reported to MicroPort CRM S.r.l. and your competent authority.
4. PRECAUTIONS FOR USE AND MAINTENANCE 4. PRECAUTIONS FOR USE AND MAINTENANCE 4.1. TRANSPORTATION SpiderView is packaged for delivery as outlined in the packaging chapter. If you want to repack and carry or deliver the SpiderView after its first usage, we recommend putting all the parts back into their initial positions. Please take care putting the flash card case into the appropriate place. Flash cards can be sent by postal service. They are light and extremely strong.
4. PRECAUTIONS FOR USE AND MAINTENANCE WARNING: SpiderView does not start if a MicroPort flash card is not inserted. SpiderView is only guaranteed to work properly if flash cards supplied by MicroPort are used. Furthermore, flash cards designed for use in MicroPort recorders should not be used for other applications. WARNING: SpiderView shall not be used in environments with flammable anesthetic mixtures containing oxygen or nitrous oxide. 4.4.
5. WARRANTY 5. WARRANTY SpiderView and flash cards are guaranteed for parts and work for two years from the date of delivery. After-sales service is available after the warranty has expired. WARNING: The warranty is only valid under the condition that no attempts have been made to open or repair the device. The warranty will be void if the device or the cards have been used contrary to this user manual’s recommendations.
6. GENERAL DESCRIPTION 6. GENERAL DESCRIPTION 6.1.
6. GENERAL DESCRIPTION 6.2. (8) Flash card insertion slot (9) Battery compartment (10) Service connector (reserved for maintenance) (12) Reset button DESCRIPTION OF SYMBOLS ON THE CASE AND PACKAGING The following symbols are displayed on the SpiderView case and packaging: Device classified as BF (IEC 60601-1). Refer to the SpiderView user manual before handling the part of the device with this symbol.
6. GENERAL DESCRIPTION 6.3. OPENING THE BATTERY COVER In order to open the battery cover, users need a thin tool such as a pencil. This tool is to be inserted into the hole while sliding the cover with the thumb as shown below: 6.4. CABLE INSERTION AND EXTRACTION The insertion (first A then B) and extraction (first C then D) of the patient cable should be done as indicated in the picture below.
7. USE OF BATTERIES 7. USE OF BATTERIES Open the recorder. Insert the battery in the battery compartment (9), respecting the polarity as marked in the compartment. 7.1. BATTERIES SpiderView is powered by one AA 1.5 V battery (lithium or alkaline). A new lithium battery will last between one and seven consecutive days of recording, depending on the brand of battery, the recording quality mode, and the number of channels.
8. POSITIONING THE ELECTRODES 8. POSITIONING THE ELECTRODES WARNING: Connect the patient to the SpiderView only when the back of the SpiderView is in place. Electrodes supplied with SpiderView have been designed to withstand long-term ambulatory recording while ensuring patient comfort. Nevertheless, other ECG electrodes may be used. To ensure a good quality ECG recording, special care must be taken when preparing the patient’s skin, positioning the electrodes and connecting the leads.
8. POSITIONING THE ELECTRODES Cable length: 122 cm 8.1.2. ELECTRODE PLACEMENT This electrode configuration allows you to obtain the maximal number of independent ECG channels with the smallest possible number of electrodes. Place the red electrode (+) over a rib at V5, the brown electrode (+) on the xiphoid muscle at the bottom of the sternum and the white electrode (common – pole) on the sternum over the manubrium. Positioning of electrodes for this configuration is shown in the figure below.
8. POSITIONING THE ELECTRODES 3 1 4 2 5 8.3. THREE CHANNEL RECORDING (7 ELECTRODES) 8.3.1. ELECTRODES Channel: + pole Common – pole A 1: white 2: red B 3: black 4: brown C 5: blue 6: orange Ground 7: green 7: green Cable length: 152 cm 8.3.2. ELECTRODE PLACEMENT Generally, it is recommended that a completely different lead be used in addition to the two leads used for a two-channel recording.
8. POSITIONING THE ELECTRODES 8.4. XYZ CHANNEL RECORDING (7 ELECTRODES) 8.4.1. ELECTRODES This electrode configuration is suggested for: ― Derived 12 channel ambulatory recordings*. ― High Resolution 20min recordings for late potential analysis; for this application a shielded cable is recommended to reduce noise level.
8. POSITIONING THE ELECTRODES 5 Purple V2 V2 position 6 Purple V3 V3 position 7 Purple V4 V4 position 8 Purple V5 V5 position 9 Purple V6 V6 position Cable length: 150 cm * Available with SyneScope Holter Software. 8.5.2.
9. USING THE PROGRAMMING BUTTONS 9. USING THE PROGRAMMING BUTTONS 9.1. USER INTERFACE STRUCTURE The user interface is structured as a sequence of several screens, which allow you to set the parameters of the device and of the recording. The programming keypad contains 7 buttons (the numbers refer to the “general description” section): These buttons (2) are used to move from one screen to another. These buttons (3) are used to move the cursor inside one screen and to modify the parameters of the screen.
9. USING THE PROGRAMMING BUTTONS A beep indicates the start-up of the recorder. The LCD screen lights up and the device performs a number of automatic tests to check that all of its components are functioning properly and carries out various initialization procedures. If the display remains blocked on an AUTOTEST number, this indicates that a problem has been detected. Contact MicroPort After-Sales Service. If all tests are normal, the message INSERT CARD is displayed.
10. STARTING THE HOLTER RECORDING 10. STARTING THE HOLTER RECORDING 10.1. PROGRAMMING USING THE BUTTONS 10.1.1. ECG screen This screen allows you to: ― Visually check the quality of the ECG leads ― Program the type of pacemaker to record ECG’s amplitude and scrolling speed can be changed for a better visualization on the screen. This will not be taken into account during the recording.
10. STARTING THE HOLTER RECORDING NOTE: If the type of pacemaker is unknown, it is suggested to select bipolar mode. A high sensitivity mode is available. It can be used to detect very low amplitude PM spikes. Because of the high sensibility, it is likely that noise and muscular or movement artifacts are detected as stimulation spikes. A shielded cable is suggested in order to reduce false pacing spike detections. 10.1.3.
10. STARTING THE HOLTER RECORDING ― Holter recording ― High Resolution recording (HR) ― Holter recording + HR recording The Holter mode is always available if any flash card and cable is inserted into the device. The High Resolution mode is only available if a 3-channel cable is inserted (XYZ shielded, XYZ non shielded or standard 3 channels). The duration of the HR recording depends on the size of the card.
10. STARTING THE HOLTER RECORDING 10.1.7. High resolution mode If this mode has been selected in the mode choice screen, the device will now display the high resolution ECG. The high scrolling speed (25mm/s) and amplitude (2 cm/mV) grant a high quality visualization of the ECG and allow you to check if the recording is affected by undesired muscle noise or electromagnetic interference (transformers, neon lights, mobile phones and other devices can affect the ECG with baseline noise).
10. STARTING THE HOLTER RECORDING Move to “REC” and press the "E" button to start the high resolution recording. During the high resolution recording the LED will blink fast. At the end of the high resolution mode the device will beep and switch to Holter mode. The LED will blink slowly. 10.1.9.
10.
11. DEVICE PARAMETERS 11. DEVICE PARAMETERS 11.1. VOLTAGE SCREEN This screen allows the user to check the voltage of the external battery (AA 1.5 V) in order to evaluate if there is sufficient power to perform a 1 to 7-day recording. The voltage of the internal battery (VL 3V) is also displayed so that the user can estimate the autonomy of the configuration of the device (date, time, contrast, recording mode). 11.2.
11. DEVICE PARAMETERS This image can be seen from every screen on the device (except the final Summary screen) by pressing the “E” button. 11.3. TIME AND DATE SCREEN The device’s time and date can be modified in the Time screen and Date screen. Use the buttons to select hours/minutes/seconds or day/month/year and use the buttons to modify the value. European and US date and time systems are available.
12. SPECIAL FUNCTIONING MODES AND ERROR MESSAGES 12. SPECIAL FUNCTIONING MODES AND ERROR MESSAGES If an error has been generated that can be easily corrected by the user or if it is an error of use, the screen displays a message followed by a recommendation. The following messages may appear: Initialization impossible, use another card Displayed when an error appears during the flash card initialization phase. Use another flash card, this one is defective.
12. SPECIAL FUNCTIONING MODES AND ERROR MESSAGES 0105 Opening error during init. of recording 0205 Attempt to open a read only file or a special (directory) 0106 Closing error during init. of recording 0206 Seek to negative file pointer attempted 0107 Media access error during recording 0207 Write failed.
13. TECHNICAL SPECIFICATIONS 13. TECHNICAL SPECIFICATIONS 13.1. TYPE USA only SpiderView digital Holter ECG and high resolution ECG recorder. 13.2. This device is a AECG device type 1. NUMBER OF LEADS Depending on the cable used, the device records the following leads: ― 2 or 3 bipolar leads ― 12 leads* (6 peripheral leads + 6 precordial leads) ― 3 leads XYZ to calculate 12 leads according to Dower matrix* * Available with SyneScope Holter software. 13.3. 13.4.
13. TECHNICAL SPECIFICATIONS The recorded signal, sampled at 1000 Hz, is averaged every 5 ms and is compressed for storage. In standard recording mode (STD), the ECG signal is filtered with a low pass 50 Hz filter to have a good signal/noise ratio and to optimize the size of recorded files (5MB/channel/24h). In enhanced recording mode (ENH), there is no 50 Hz filter and the signal has an excellent quality as long as there is not much noise (10MB/channel/24h).
14. ACCESSORIES 14. ACCESSORIES The following products, items and accessories listed in the table below are available for SpiderView: 34 Code Description Available on AA Catalogue LA456T SpiderView Pack ✓ LA456T SP SpiderView N/A LK600C, LK601C, LK602C SyneScope Software v3.
15. APPENDIX 15. APPENDIX 15.1. GUIDANCE AND MANUFACTURER'S DECLARATION: ELECTROMAGNETIC EMISSIONS All information below is based on the normative requirements to which the manufacturers of electro-medical devices are subject, in the sense of IEC60601-1-2.
15. APPENDIX 15.3. 15.4. GUIDANCE AND MANUFACTURER'S DECLARATION: ELECTROMAGNETIC EMISSIONS Emissions test Compliance Electromagnetic environment - guidance Electromagnetic radiation disturbance (radiated EMISSIONS) CISPR 11 Group 1 The SpiderView uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
15. APPENDIX Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Voltage dips 0% UT (IEC 61000-4-11) For 0.5 cycle Non applicable Mains power quality should be that of a Home health care environment or professional health care establishment. If operation of the system requires continued use during power cuts, it is recommended that the medical device be powered by a separate power source (UPS, etc.).
15. APPENDIX Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Proximity fields emitted by RF wireless communication devices IEC61000-4-3 (provisional method) 9 V/m 9 V/m 710 MHz, 745 MHz, 780 710 MHz, 745 MHz, 780 Home health care environment and professional health care establishment.
15. APPENDIX 15.5. SPIDERVIEW AND MOBILES (RECOMMENDATIONS) The SpiderView is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Portable RF communication devices (including peripherals such as antenna cables and external antennae) should not be used closer than 30 cm (12 inches) to any part of SpiderView, including the specified cables. Otherwise, the performance of this device may be impaired. 15.6.
15. APPENDIX 1. this device may not cause harmful interference, and 2. this device must accept any interference received, including interference that may cause undesired operation of the device. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
MicroPort CRM S.r.l. Via Crescentino S.N. 13040 Saluggia (VC) Italy Tel: +39 0161 487095 www.microport.
