Revison 0.8.6
Document No. 01424
Mobile Cardiac Monitor
Operator Manual
Страница 1: ...Revison 0 8 6 Document No 01424 Mobile Cardiac Monitor Operator Manual ...
Страница 2: ...G lead cable to the monitor 12 7 Using the Monitor 12 7 1 Powering on the monitor 12 7 2 Checking ECG signal quality 14 7 3 Recording a cardiac event 15 7 4 Entering symptoms and activity level associated with the cardiac event 16 7 5 Recharging the battery 17 8 Maintenance and Service 18 8 1 Cleaning 18 8 2 Service 18 8 3 Troubleshooting 19 8 4 Disposal of Battery 20 9 Medical Device Symbols and ...
Страница 3: ...ar device consists of a monitor a patient ECG lead cable an externally rechargeable battery and a wall battery charger The RhythmStar device is intended to be used with 3rd party lead electrodes supplied to a patient by a physician or a monitoring enter High quality FDA approved lead electrodes should be used The RhythmStar system supports USB connectivity that can be used to send and receive data...
Страница 4: ...e reviewed by a medical professional The data received from RhythmStar device can be used by another device for arrhythmia analysis reporting and signal measurements The RhythmStar system is not intended to sound any alarms The device does not deliver any therapy administer any drugs provide interpretive or diagnostic statements or provide for any life support RhythmStar is for prescription use on...
Страница 5: ...leave the battery in RhythmStar when it is not in use To receive the best recording results instruct patients to stay away from heavy electrical equipment or other sources of electromagnetic interference Equipment such as electric blankets and heating pads are included in this group Avoid exposing RhythmStar or RhythmStar battery to water or excessive moisture Do not expose RhythmStar or RhythmSta...
Страница 6: ...ar monitor is a small lightweight portable battery powered device which is typically worn on a patient s belt or waistband by placing the monitor in a cell phone type pouch not supplied by RhythMedix Monitor Components Letter Description A LCD display B Record Button C Menu Selection Buttons A C B Front view of the RhythmStar Monitor ...
Страница 7: ...8 6 Document No 01424 Page 7 Monitor Components continued Letter Description D Battery Compartment E Serial Number F Battery Door Back view of the RhythmStar Monitor battery door removed no battery inserted D E F ...
Страница 8: ...pplied by the manufacturer With RhythmStar you can choose between a 3 or a 5 lead ECG cable 5 3 Batteries RhythmStar uses an external rechargeable Lithium Ion Li Ion battery This easily removable battery must be recharged with the supplied battery charger Only IEC 62133 certified Li Ion batteries supplied by RhythMedix are to be used with RhythmStar 3 lead ECG Cable 5 lead ECG Cable ...
Страница 9: ...A Proper preparation of the patient s skin is required for obtaining a quality ECG recording It is best to refer to your electrode manufacturer for instructions on proper skin preparation techniques However the following points can assist in obtaining quality ECG recordings If necessary shave hair from the areas on the chest where the electrodes are to be placed At each location where an electrode...
Страница 10: ... Figures 1 or 2 in this manual or as instructed by the physician 6 1 1 3 lead configuration Three color coded lead wires are used to create two channels of ECG re cording This is a typical electrode placement Figure 1 3 Lead Electrode Placement Color Location RA White Upper right portion of chest 2 to 3 inches below collarbone LL Red Below left breast over lower ribcage LA Black Upper left portion...
Страница 11: ... electrode placement Figure 2 5 Lead Electrode Placement Color Location RA White Upper right portion of chest 2 to 3 inches below collarbone LL Red Below left breast over lower rib cage LA Black Upper left portion of chest 2 to 3 inches below collarbone RL Green Lower right rib margin over bone V1 Brown Fourth intercostal space at the right boarder of the sternum ...
Страница 12: ...eceptacle opening on the top portion of the RhythmStar monitor Once aligned firmly insert the cable connector into the cable receptacle as pictured below 7 Using the monitor 7 1 Powering on the monitor RhythmStar does not contain a separate On Off power button When you are ready to begin using RhythmStar insert a charged battery into the monitor as pictured on the following page ...
Страница 13: ...he polarity instructions on the battery to on the wall of the battery compartment and on the battery to on the wall of the battery compartment Step 3 Replace battery cover on the back of monitor by gently aligning it as pictured and use your thumb to push up and toward the top of the monitor to slide the battery cover on Step 4 If the battery was successfully installed after a few seconds the scre...
Страница 14: ...operly connected to the patient and the patient ECG lead wire connector is properly connected to RhythmStar the patient s ECG signal will display as pictured Use the Menu Selection buttons to select Ch1 Ch2 and Ch3 Ch3 only available when using the 5 lead ECG cable Step 5 When you are satisfied with the ECG quality press the Record Button to exit the ECG signal display and begin Monitoring the pat...
Страница 15: ...provided by the medical technician or physician and are capable of pressing the necessary buttons RhythmStar will also be automatically recording and transmitting asymptomatic cardiac events as they occur without the patient needing to press the Record Button or interface with RhythmStar in any way Follow the below instructions to record a cardiac event Step 1 Instruct the patient to press the Rec...
Страница 16: ... that best represent the reason for the event By pressing the Record Button of a highlighted symptom the empty circle next to the selection will fill The patient can repeat this step to select more than one symptom if appropriate Once symptom s are properly selected the patient should highlight the NEXT selection and then press the Record But ton to move on to the next screen Step 2 RhythmStar wil...
Страница 17: ... in the RhythmStar monitor the other battery is being charged We recommend replacing the battery being used in the RhythmStar monitor with a fully charged battery every 24 hours to avoid any power outage on the monitor while RhythmStar is monitoring the patient To charge the battery place the rechargeable Lithium Ion battery into the charger Next plug the charger into the wall outlet 110 or 220V O...
Страница 18: ...rgent NOTE Do not use alcohol or acetone to clean the lead wires as this can cause the wires to stiffen and the insulating plastic to crack Do not immerse the monitor in water or any other cleaning solution Store the patient ECG lead cables suspended when possible Avoid kinking the patient ECG lead cables 8 2 Service If there is a problem with the monitor review the Troubleshooting section for a l...
Страница 19: ...Revison 0 8 6 Document No 01424 Page 19 8 3 Troubleshooting ...
Страница 20: ...s charge the battery should no longer be used and should be recycled To locate a Rechargeable Battery Recycling Corporation RBRC collection point within the US visit the website listed below and type in your postal or zip code The closest drop off points in many stores such as Wal Mar Home Depot Radio Shack Best Buy will display http www call2recycle org locator Place the batteries that you wish t...
Страница 21: ...Revison 0 8 6 Document No 01424 Page 21 9 Medical Device Symbols and Safety Signs ...
Страница 22: ...DPA 850 1900 MHz GSM GPRS EDGE 850 900 1800 1900 Time Slot Class 12 n a Output Power WCDMA Band II V 0 302 GSM850 2 13 W PCS1900 1 74 Electrical CMRR 90 105 dB AC Range 6 mV DC Range 300 mV Input Impedance 10 MOhm Frequency Response 0 05 to 40 Hz Recovery Time 1 33 sec ADC Resolution 12 12 16 Bits ADC Sample Rate 125 250 1000 Hz Battery Type Replicable externally re chargeable Li Ion 3 7 V Life Fr...
Страница 23: ...or the express warranties stated above RhythMedix disclaims all warranties including implied warranties of merchantability and fitness The stated express warranties are in lieu of all obligations of liabilities on the part of RhythMedix for damages including but not limited to special indirect or consequential arising out of or in connection with the use or performance of RhythMedix products Any w...
Страница 24: ... standard for wireless mobile devices employs a unit of measurement known as the Specific Absorption Rate or SAR The SAR limit set by the FCC is 1 6W kg Tests for SAR are conducted using standard operating positions accepted by the FCC with the device transmitting at its highest certified power level in all tested frequency bands Although the SAR is determined at the highest certified power level ...
Страница 25: ...t generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment...
Страница 26: ... toutes les exigences du Réglement sur le matériel brouilleur du Canada This device complies with Industry Canada license exempt RSS standard s Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Cet appareil est conforme aux normes CNR ex...
Страница 27: ...n and length of the QRS complexes atrial activity analysis and template matching for AF detection Rhythmedix conducted algorithm performance testing according to the ANSI AAMI EC57 standard The MIT BIH AHA and NST databases were used to verify performance of the algorithm The algorithm performance testing summary is provided in the tables below QRS Detection Performance AF Detection Performance Da...
Страница 28: ...nt ECG lead cable PC 10005 RhythmStar three channel patient ECG lead cable BP 10006 RhythmStar Rechargeable Li Ion battery BC 10007 RhythmStar Li Ion wall charger for battery PA 10008 RhythmStar replaceable battery door Part Number Description PC 10003 RhythmStar two channel patient ECG lead cable BP 10006 RhythmStar Rechargeable Li Ion battery BC 10007 RhythmStar Li Ion wall charger for battery P...
Страница 29: ...pment In the case the battery is connected in reverse it is charged reversely during charge and causes an excessive current during discharge and may cause heat generation explosion or fire due to an abnormal chemical reaction Do not let the battery terminals and contact a wire or any metal like a metal necklace or a hairpin with which it carried or stored together In such a case the battery is sho...
Страница 30: ...temperature sources Such a high temperature may cause acid leakage If you find the battery rusty bad odor heating or any other defective before using the battery for the first time after purchase do not use it Take it back to the dealer instead In case young children use the battery instruct them on the contents of the instructions and ensure the battery is correctly used by them at all times If t...
Страница 31: ...eaters or high temperature sources Such a high temperature may cause heat generation explosion or fire Do not use the battery with any equipment other than specified Any such practice may expose some types of equipment to an abnormal current which may result in heat generation explosion or fire WARNING Discontinue charging after specified charging time even if the charge is not complete Otherwise ...
Страница 32: ...Revison 0 8 6 Document No 01424 RhythMedix LLC Horizon Corporate Center 5000 Atrium Way Ste 1 Mt Laurel NJ 08054 Tel 856 282 1080 Fax856 282 1333 www rhythmedix com ...
