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User Documentation

Document 40212 Revision G Page 1 of 17

AUDICOR RT 4.0 AM (Holter) Quick Reference Guide, Addendum

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Intended Use.................................................................................................................................... 2 Notations in This Addendum............................................................................................................ 3 AUDICOR RT+AM Warnings and Cautions .................................................................................... 3 User Capabilities .............................................................................................................................. 6 Patient Instructions........................................................................................................................... 6 Getting Started ................................................................................................................................. 8 Troubleshooting the Wireless Preview Mode .................................................................................. 8 Troubleshooting Signal Quality – Adjust Leads, Patient and Environment if Necessary ................ 9 Troubleshooting Data Management: ............................................................................................... 9 AUDICOR RT+AM components suitable for use within the patient environment:......................... 11 Prepare ECG Electrode and AUDICOR Sensor Sites................................................................... 11 Contact Information........................................................................................................................ 12 Data Analysis Methods: ................................................................................................................. 12 Symbols ......................................................................................................................................... 13 Federal Communications Commission (FCC) Statement.............................................................. 14 Field Replaceable Units: ................................................................................................................ 14 Customer Acceptance/Verification Procedure: .............................................................................. 15 R&TTE Statement of Conformity ................................................................................................... 16 SPECIFICATIONS ......................................................................................................................... 17

Proprietary and confidential: This document may not be copied, disclosed or used in whole or in part without the consent of Inovise Medical, Inc. © Copyright, Inovise Medical, Inc., 8770 SW Nimbus Ave, Suite. D, Beaverton, OR 97008-7196 USA (503) 431-3800

c. electrocardiography (ECG) and similar tests. The AUDICOR system accepts and analyzes downloads of up to 48 hours of patient data from the ambulatory ECG/heart sounds collection device. The AUDICOR interpretive statements and graphics are designed to enhance the diagnostic process. Holter monitoring. third heart sound (S3) strength. This documentation is intended for use by medical practitioners who perform computer-aided phonocardiography. Precautions: AUDICOR RT may not be suitable for patients with extremely fragile skin or patients with open wounds/lesions at or immediately adjacent to electrode and sensor positions. Suite D. See warnings and cautions for additional important precautions. reporting and interpretation of advanced parameters such as Electro-Mechanical Activation Time (EMAT). history and other relevant factors. disclosed or used in whole or in part without the consent of Inovise Medical. including shortness of breath. AUDICOR RT may not be appropriate for patients that have skin allergies or are otherwise sensitive to the disposable electrodes and or the AUDICOR sensor used with the system. Related Publications: Publication AUDICOR RT 4. © Copyright.. Audicor systems allow detection. when used with AUDICOR Sensors on the chest wall. d. Federal law restricts the sale of the device identified in this manual to.0 AM (Holter) Quick Reference Guide. Contraindications: AUDICOR RT analyses are not valid for patients under 18 years of age. 8770 SW Nimbus Ave. h. a licensed medical practitioner. analyzing and reporting heart sound data and to provide interpretation of the data in an integrated ACG (acoustic cardiograph) report for consideration by physicians. always give consideration to patient symptoms.0 AM Quick Reference Guide Part number 40211 Proprietary and confidential: This document may not be copied. i. and the Systolic Dysfunction Index (SDI). fourth heart sound (S4) strength. The AUDICOR System. Beaverton. Inc. e. and for patients who are at risk for heart disease. Addendum Page 2 of 17 1 Intended Use a. With any diagnostic test. Left Ventricular Systolic Time (LVST). or on the order of. is intended for use in acquiring. Inc. b. They are no substitute for the qualified judgment of a properly trained. supervised clinician.40212_G AUDICOR RT 4. Selected parameters are typically reported in a trended report format where multiple data points are trended over time.. Inovise Medical. ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read. OR 97008-7196 USA (503) 431-3800 . AUDICOR testing is indicated for patients 18 years of age and older who present with cardiac symptoms. g. f. It is also intended for physicians who interpret heart sounds and ECG data.

Inc. Suite D. Contact could cause unacceptable levels of electrical current to flow to the patient. 3 AUDICOR RT+AM Warnings and Cautions Warning Warning AUDICOR analyses are not valid for patients under 18 years of age. Beaverton.. Addendum Page 3 of 17 2 Notations in This Addendum Warning statements identify conditions or practices that could result in injury to patients or users. Inc. Once the AUDICOR sensors or one or more ECG electrodes are connected to the patient cable. Sensors or electrodes trapped under defibrillator pads or paddles during defibrillation or sensors or electrodes in contact with high frequency electrosurgical equipment can cause patient burns. Battery may explode or catch fire if mishandled: • Do not disassemble or incinerate • • • • • Do not charge except as specified in the instructions Do not heat above 60oC (140oF) Do not crush Do not immerse in water/liquids or cleaning fluids Do not abuse or mistreat the battery Warning Warning Warning Warning Warning Warning Warning Proprietary and confidential: This document may not be copied. Other types of electrodes can result in a leads off condition and incomplete AUDICOR or ECG data and/or reports. Damaged. blood born pathogens and contamination..40212_G AUDICOR RT 4. do not allow any un-terminated patient cable leads or the un-terminated patient cable connector to meet with grounded or live parts. ECG electrodes and patient cable from the chest area.0 AM (Holter) Quick Reference Guide. abuse or mishandling of this device could result in delays in diagnosis and treatment as well as electrical shorts and could create a fire hazard. Tips convey helpful information about how to use the AUDICOR TS system. Before performing defibrillation or applying any high frequency surgical equipment to a patient. Use only Ag/AgCL-type ECG electrodes with AUDICOR sensors. disclosed or used in whole or in part without the consent of Inovise Medical. AUDICOR Sensor 4. Caution statements identify conditions or practices that could result in damage to equipment or other property. OR 97008-7196 USA (503) 431-3800 .0 is a single use device. Do not use in the presence of flammable gasses. Inovise Medical. © Copyright. The quality of ECG and sound signals reported by the AUDICOR RT system may be adversely affected by electromagnetic interference from environmental sources resulting in non-physiological waveforms with the potential for misinterpretation. remove AUDICOR sensors. 8770 SW Nimbus Ave. Do not reuse single use devices due to risk of spreading infection.

To avoid damaging AUDICOR components. including water Do not perform any type of sterilization procedure on AUDICOR AM components Do not abuse or drop the AUDICOR AM device Caution To avoid damaging the AUDICOR AM/Holter device. Do not immerse AUDICOR AM components in any type of liquid. Once you are receiving patient waveform data from a particular AUDICOR AM. insure the AUDICOR RT preview data is from the patient you are working with and not a second or third patient in the waiting room. In this case the patient may experience notable discomfort.40212_G AUDICOR RT 4. disclosed or used in whole or in part without the consent of Inovise Medical. Addendum • Do not attempt to use a corroded or damaged battery Page 4 of 17 Warning AUDICOR may not be suitable for patients with extremely fragile skin or patients with open wounds/lesions at or immediately adjacent to electrode and sensor positions. Inovise Medical. Suite D. be very careful not to allow fluid into the seams of the AM device. The AUDICOR AM meets requirements for “recording ECG signals in the presence of implanted pacemaker pulses”. securely and properly connect all cables to the AUDICOR Holter device before you attach lead wires to the patient. discontinue use immediately. The AUDICOR RT+AM warranty does not cover damage from fluids applied to the AM device. AUDICOR sensors are not designed to function with other adapters.0 AM (Holter) Quick Reference Guide. You should observe artifact on the preview display that corresponds with each tap to verify that the preview waveforms are from the recording device currently being set up. use a pencil to tap on the back of the Audicor sensor being displayed.D and RF Channel information (See back of AM device) in the Configure Holter Front-End screen. Simultaneously attaching patient leads for another device to the same patient can cause the ECG signals to be corrupted. pain or burning sensation or a skin rash in and around the sensor area.. especially at any point around the battery door/ compartment. First check that you have entered the correct Sensor I. swim or engage in other activity that may immerse the Audicor AM device or lead set or get them wet. 8770 SW Nimbus Ave. © Copyright. For ECG electrodes check manufacturer’s information for instructions. Should a mild or severe skin reaction to the sensor adhesive occur. OR 97008-7196 USA (503) 431-3800 . Clean the affected area of all adhesive residue and apply topical relief as prescribed by the patient’s physician. AUDICOR may not be appropriate for patients that have skin allergies or are otherwise sensitive to the disposable electrodes and or the AUDICOR sensors used with the system. Beaverton. Do not use organic solvents on any parts of the patient cable or on the AUDICOR AM/Holter device. Inc. To ensure proper patient isolation and signal quality. Inc. take the following precautions: • • • • • Warning Warning Warning Caution Caution Caution Caution Do not shower. It does NOT meet requirements for “being capable of recording the activity of an implanted pacemaker”. Attach only AUDICOR adapters to AUDICOR sensors. Note: Failure to detect the pacemaker could result in incorrect ElectroMechanical Activation Time (EMAT) measurements. Proprietary and confidential: This document may not be copied. bathe. During preview..

or incinerate. forcing the card in at an angle may irreparably damage the card latching mechanism. To release the card. insure the card slides evenly and symmetrically into the storage card slot. charging temperature range must be maintained between (+10 and +45) degrees C or (50-113) degrees F.0 AM (Holter) Quick Reference Guide.40212_G AUDICOR RT 4.. Inc. Maintain discharge temperature within 0 to +45) degrees C or (32113) degrees F. The battery used in this device may present a risk of fire or chemical burn if mistreated. after a recording session has been initiated. Beaverton. Do not force the card into the slot. If the card is released it will protrude enough from the storage card slot to allow capturing it between your thumbnail and index finger for removal. Look for Inovise Medical and or the AUDICOR brand as an initial measure of compatibility for both the battery and the charger. Use of another battery may present a risk of fire or explosion. be careful not to touch or contaminate the metal battery terminals. Addendum Page 5 of 17 Caution Except for the battery and storage card. © Copyright. Suite D. a fully charged AUDICOR battery is installed. When inserting the storage card into the Audicor AM storage card slot expect to feel a spring like action. DO NOT attempt to start a recording sessions unless the data storage card with adequate storage space is properly installed in the AUDICOR AM. Replace battery with (Inovise Medical. Inovise Medical. Inc. disclosed or used in whole or in part without the consent of Inovise Medical. 8770 SW Nimbus Ave. there are no serviceable parts inside the AUDICOR AM/Holter device. Part # 20213) only.. heat above 60°C (140°F). Doing so voids the warranty. Caution Caution Caution Caution Caution Caution Caution Proprietary and confidential: This document may not be copied. opening the battery door will terminate the recording session. Do not attempt to open the AUDICOR Holter device other than to remove the battery cover to access and replace the battery and or the memory/storage card. For AUDICOR AM battery. and the battery door cover is completely closed and locked in place. When handling the battery. Inc. These devices contain hydrogel that can be very corrosive and may damage both the battery terminals and the Audicor AM battery contacts. Do not disassemble. Only use Inovise supplied AC cords and country specific AC/Mains adapters. Also. if the card catches because it is misaligned pull the card out and realign so that it is square and even in the card slot. Be careful to first release the storage card from the Audicor AM storage card slot before attempting to remove the card. Note: Even a small gap between the battery cover door and the AM device will prevent a recording session from starting. This is especially true after handling ECG electrodes or Audicor Sensors. OR 97008-7196 USA (503) 431-3800 .. Be careful to match the battery to the correct charging device before applying AC/Mains power. gently push in with your thumbnail until you feel and or hear a slight click.

no storage card installed or corrupt data file. it is important to orient and inform the patient about the operation and use of the device. Inc. © Copyright. The battery charger is not a medical device and therefore keep at least 1. The Audicor RT+ AM System is equipped with wireless telecommunication features.. Inc. If the LED is flashing twice per second (double flash ). OR 97008-7196 USA (503) 431-3800 . Inc. Beaverton. For those systems equipped with a roll stand. including insufficient data storage. If the LED is flashing once per second (single flash ) data is being stored and no further action is required. check the rate at which the LED is flashing on the front of the device. the Quick Reference Guide (part # 40211) and the Quick Reference Guide Addendum (part # 40212) before applying Audicor to the patient. ensure that the wheels are locked after the system is oriented adjacent to the test subject and also locked when charging and not in use. If it appears Audicor RT + AM interferes with the use or operation of other business or medical equipment within the immediate proximity of the device. (productsupport@inovise. Caution Caution Caution Caution Caution Caution 4 User Capabilities The medical personnel performing the Audicor AM test (User) need to have the ability to follow the instructions and guidelines in the User Documentation set which include the Quick Reference guide and associated Addendum. The User should first read in their entirety.40212_G AUDICOR RT 4. Keep away from children. There will be no indication on the AUDICOR AM device that leads are off or data is noisy. Do not disassemble and do not dispose of in fire. Addendum Page 6 of 17 Caution After starting a recording. 8770 SW Nimbus Ave. Once recording has started double flashing indicates a fault condition. Suite D. The AUDICOR RT + AM System is not equipped with antivirus software. The User should at a minimum train the patient how to: Proprietary and confidential: This document may not be copied. files already exist on the card.0 AM (Holter) Quick Reference Guide. discontinue use immediately and notify Inovise Medical. 5 Patient Instructions While setting up Audicor and applying the recording device to the patient. Users also need to have sufficient dexterity to hold and manipulate small objects such as the Audicor AM memory card. Inovise Medical. disclosed or used in whole or in part without the consent of Inovise Medical.com) The AUDICOR RT+ AM System is not equipped to detect the presence of a pacemaker and/or mark the presence of a pacemaker spikes.. to prevent damage or injury. Adding antivirus software may compromise the performance of this medical application and therefore void any remaining warranty. no data is being stored and the RECORDING WILL FAIL! The normal and abnormal flashing patterns after recording has started are illustrated below: Normal Operation After Starting Fault Condition = = Flash Flash/Flash Pause Pause Flash Flash/Flash Pause Pause Flash… Flash/Flash… NOTE: Double flashing is normal in waveform preview mode only. Caution Dispose of used batteries properly and according to local standards for Lithium-polymer batteries. This medical system should not be networked or Internet connected for this reason.5 meters from patient care areas.

Proprietary and confidential: This document may not be copied.40212_G AUDICOR RT 4. disclosed or used in whole or in part without the consent of Inovise Medical. Suite D. The patient should be instructed not to shower. overpatch and the Holter device itself should they detach. © Copyright... Inovise Medical. Beaverton. How to interpret the flashing LED color code. OR 97008-7196 USA (503) 431-3800 .0 AM (Holter) Quick Reference Guide. swim or engage in other activity that may immerse the AM recording device. For example orange is expected and does not indicate a problem with the Audicor AM. electrodes. sensors or electrodes. sensors. Inc. 8770 SW Nimbus Ave. bathe. Inc. the patient cable. Addendum Page 7 of 17 • • • • Locate the Audicor AM Event button and describe the proper use. How to reconnect the patient lead wires.

OR 97008-7196 USA (503) 431-3800 . 6. b Steps 7 . © Copyright. 2Gb Storage Card c. Audicor AM recording device b. Inc. Inc. Proprietary and confidential: This document may not be copied. exit the preview mode and close the RT application then remove the antenna for ten seconds and reconnect to allow the PC to establish a new hardware connection. 5-Wire Audicor Patient Cable e. 7. Slide the assembled Audicor AM into the Holster.D.. Battery Charger & Power Supply Place the Audicor AM recording device face down to expose the battery cover.Charging the Battery 5. To view traces in preview the Audicor AM device must also be powered and connected to the patient via the patient cable and appropriate electrodes/sensors. Slide the battery cover into place. Locate the following items a. 8770 SW Nimbus Ave.. Align contacts with battery charger terminals 7 Troubleshooting the Wireless Preview Mode The wireless preview mode is used to verify the signal quality and patient connection. Addendum Page 8 of 17 6 Getting Started Getting Started: Preparing the Audicor AM Recording Device with Accessories for Use Step 1 – Locate the parts that make up the Audicor AM Device a 1.0 AM (Holter) Quick Reference Guide. a a c Storage Card Slot d 4. Note: Do not force the card should it catch due to misalignment. Use your thumbnail to carefully push the card into the slot until it locks into place.7 Volt battery. b Storage Card c d e 2. The battery contacts should align with the gold contacts. Place the fully charged battery in the battery compartment. Launch the RT application and re-enter I.7 Volt Lipoly battery d. Charge for approximately 4 hours. Ensure the cover is firmly seated and flush with the AM housing. If you are having difficulty follow these steps: • Is the antenna connected/powered? If the USB antenna is properly connected and installed on the PC via the USB extension cable. Locate the storage card slot and insert the 2Gb storage card.Applying the AM Holster Steps 8 . c e f 8. Inovise Medical. Audicor AM Holster f. Beaverton. the antenna LED light should be on or flashing while in the wireless preview mode. Suite D. carefully realign and insert until latched into place. 3. Affix the 5-Wire Patient Cable to the AM device. If the antenna LED is not on or flashing. Use your thumb to slide the battery cover off. disclosed or used in whole or in part without the consent of Inovise Medical. Affix snap electrodes only when ready to mount on patients abdomen. Charging the Lipoly 3.40212_G AUDICOR RT 4. and channel information as required to preview the data. Steps 2-6 Assembling the Audicor AM recording device 3.

The order of the files is determined by the file extension: RAW. and click the Check Now …button. use the end time of the previous file. Choose the Tools tab. Inc.. © Copyright. ECG electrodes and all ECG and sensor adapters. analyze the files.0 AM (Holter) Quick Reference Guide. When practical.002. Re-enter the ID and Channel information and proceed with the preview mode. Check that the ECG electrodes and AUDICOR sensorsare securely affixed to the skin surface by running your fingers around the edge of the device. The patient should also avoid loud noisy settings that could compromise heart sound data for extended periods (hours). slide the Audicor AM battery cover open and remove the battery for 60 seconds then reinstall the battery and close the battery cover. right click on the SD drive (with Vista. Audicor AM is a low power device therefore some local wireless systems may interfere with the Audicor AM wireless preview feature. This procedure will reset the AM device. If the patient cannot provide the start time.40212_G AUDICOR RT 4. • Proprietary and confidential: This document may not be copied. check the following: • Ensure good contact between the patient’s skin. Verify the AUDICOR AM patient cable is well seated with the AUDICOR AM/Holter device. Follow the instructions in the Audicor RT with AM Quick Reference Guide entitled “Starting and Stopping the AM recording session without Audicor RT.. This message is generally a result of the recorded file having a file size of zero bytes. Start the RT application. OR 97008-7196 USA (503) 431-3800 . If problems continue replace any suspect AUDICOR sensor or ECG electrode. step 1 of “Prepare the AM System for Use”. Suite D. Does the preview display indicate “Waiting for Data” or “Buffering …” but no data appears? Position the USB antenna to obtain line of sight with the Audicor AM recording device? It’s best to mount the antenna approximately 5-6 feet above the floor to allow for line of site with the AM device (within 10 feet) of the patient preparation area. In order to determine the start time of the next file. 001. In this case you will need to start the AM recorder manually. In Windows Explorer. See antenna wall mounting instructions in Audicor RT with AM Quick Reference Guide. Addendum • Page 9 of 17 If the problem persists shut down the RT application. Select both check boxes and click Start. Inovise Medical. the USB antenna and the RT application. the patient should refrain from strenuous or vigorous exercising while the recording session is underway to avoid excessive motion artifact. If the ECG or sound quality is still poor disconnect and reconnect ECG and Sensor snap adapters. 8770 SW Nimbus Ave. • • 9 Troubleshooting Data Management: • What if there are multiple files on the Audicor AM memory card? Multiple files are usually the result of patient restart. Beaverton. • • 8 Troubleshooting Signal Quality – Adjust Leads. one at a time.One or more files on the memory card are invalid. Now reconnect the USB antenna. remove the USB antenna from the PC. Patient and Environment if Necessary If you need to improve the signal quality. Inc. etc. disclosed or used in whole or in part without the consent of Inovise Medical. probably “Removable Disk”) and select Properties. What if I see the message ‘Possible Memory Card Problem .

8770 SW Nimbus Ave. not FAT32.. If possible. consider reformatting the Micro SD card: o o Insert the Micro SD card into the Micro SD card adapter and then insert into the PC. [Cancel] [Try Again] [Continue] to resume analysis of the data files. OR 97008-7196 USA (503) 431-3800 . Printers and other accessory devices that have been added to your PC may have these slots for flash cards (photo accessories etc. Inc. disclosed or used in whole or in part without the consent of Inovise Medical. Suite D. Click Computer in the Windows Explorer list of folders and then right click on the Micro SD drive letter noted above and select the Format option. If the AutoPlay popup is displayed. If there is no memory card or memory card adapter inserted in the slots this error may appear. © Copyright. Addendum Page 10 of 17 • What if I continue to have problems with the Micro SD card? Save the files if possible and replace the card. If this message is not displayed. Note: This is a very fast process and should take only seconds to complete. o o o o o o • What if there is a “No Disk” error & unhandled exception after clicking “ Analyze New Holter”? This is typically due to a printer or other PC peripheral device that has an empty memory card slot.0 AM (Holter) Quick Reference Guide. and not NTFS. Inovise Medical.). navigate to Micro SD drive just inserted. remove/save any files still remaining on the drive as reformatting will erase them. click “Open folder to view files using Windows Explorer”.40212_G AUDICOR RT 4. note the drive letter of Micro SD card for reference later. Check the “Quick Format” option located at the bottom of the window. Important. bottom intray and remove the Micro SD card with adapter from the PC port. Click Start and OK when the warning popup telling you that all data on the selected drive will be erased. CAUTION: Selecting the incorrect drive and formatting will erase all files on selected drive therefore. Inc. Beaverton. be careful to first verify the drive letter is correct for the Micro SD card before formatting the drive. Note: Installing a memory Proprietary and confidential: This document may not be copied. Ensure the selected file system is “FAT”. If this is not possible.. not exFAT. Safely remove the Micro SD adapter by clicking the appropriate icon in the right. You can work around this problem by clicking any of the three options presented.

If the Audicor RT notebook PC free disk space drops below 20 GB (20000 MB) free up disk space to insure the application can run properly. patient cable and holster AUDICOR Sensor 4. OR 97008-7196 USA (503) 431-3800 . disclosed or used in whole or in part without the consent of Inovise Medical. Inovise Medical.. memory card. Suite D.0 AUDICOR USB Wireless Adapter AUDICOR Software enabled PC 11 Prepare ECG Electrode and AUDICOR Sensor Sites Prepare the ECG sites for a 5-lead recording session. Beaverton. 5-Lead Placement Diagram Place V3 between fourth intercostal RA LA Space at left sternal border and V4 V3 AUDICOR Sensors ® V4 LL Place tab electrodes and AUDICOR Sensors in these traditional lead positions. Inc. Use an AUDICOR sensor here Proprietary and confidential: This document may not be copied. Tip – The Audicor RT welcome screen displays “Disk Free Space” in (MB). 10  AUDICOR RT+AM components suitable for use within the patient environment:  AUDICOR AM recording device with battery. 8770 SW Nimbus Ave. Use an AUDICOR sensor here Fifth intercostal space left of midclavicular line.0 AM (Holter) Quick Reference Guide. Addendum Page 11 of 17 card or a memory card adapter will prevent this error from reoccurring when clicking “Analyze New Holter”.40212_G AUDICOR RT 4. © Copyright.. Inc. RA – LA – LL – V3 – V4 – Right arm at clavicle Left arm at clavicle Left leg at hip Midway between V2 and V4.

audicor.com Authorized Representative for CE Marked Devices: Priory Analysts The Atrium. United Kingdom Tel: +44 (0) 1908 319295 Fax: +44 (0) 1908 320776 www. Tip .priory-analysts..When applying the Audicor AM recording device to the patient. consider lowering the sensor position slightly to reduce discomfort and interference with undergarments. Inc. LU1 3BE. Proprietary and confidential: This document may not be copied.. 12 Contact Information Inovise Medical. 8770 SW Nimbus Ave. Measurements are provided for each 12-second interval in the analysis period. This will reduce the risk of something hooking the wire and pulling it off the snap electrode. For patients with oily skin consider using extra adhesive fasteners to secure the AM in place. To avoid uncomfortable pushing and probing to engage the snaps on the patients abdomen. disclosed or used in whole or in part without the consent of Inovise Medical. install the Audicor AM mounting snap electrodes on the holster prior to affixing to the patient. Removing the extra adhesive dressings from the patient due to a poor or defective electrode or patient cable is uncomfortable and can be avoided if you check the signal quality via preview first.com 13 Data Analysis Methods: Methods for HR and ST Measurement: Heart rate is calculated by computing the average R-R interval in the 12-second interval being analyzed. OR 97008-7196 USA (503) 431-3800 . Suite D. Addendum Page 12 of 17 Tip . 8770 SW Nimbus Avenue Suite D Beaverton. The snap electrodes may not be enough for extended recording sessions.0 AM (Holter) Quick Reference Guide. That quantity is then divided into 60000 to convert to beats/minute. PREVIEW the waveform/signal quality before adding additional adhesive fasteners to secure the lead wires.The ideal mounting location for the Audicor AM device is on the abdomen above the waste line so as not to interfere with clothing. Inc. Beaverton. © Copyright. Audicor AM and Sensors for extended recording periods (hours). The Audicor AM device is mounted using two standard snap ECG electrodes. so: Heart Rate = 60000 / (average R-R interval) ST segments are measured for each ECG lead by computing a median beat and determining the J point and measuring its value from the isoelectric. Inc.40212_G AUDICOR RT 4. Only measurements are calculated and no determination of “depression” or “elevation” is made. Oregon 97008-7196 Tel: 503-431-3800 Fax: 503-431-3801 www. Inovise Medical. Tip – Consider taping the ECG lead wires to the body near the electrode. Tip – When the sensor position for V3 and V4 are directly in-line with or adjacent to the female bra line. Park Street West Luton.

Inovise Medical. OR 97008-7196 USA (503) 431-3800 . a physician Date of manufacture (yymmdd) Manufacturer Authorized Representative for the CE Mark Not Defibrillator-proof type of CS equipment Cardiac Protected Equipment..40212_G AUDICOR RT 4. Part number/catalog item Serial number Lot number For use by.0 AM (Holter) Quick Reference Guide. or on the order of. © Copyright. Inc. (Type CF . 8770 SW Nimbus Ave. Beaverton.. Inc. Suite D. the AUDICOR AM and on the AUDICOR accessories. Addendum Page 13 of 17 14 Symbols The following symbols may appear on the AUDICOR RT. disclosed or used in whole or in part without the consent of Inovise Medical.Not a defibrillator protected device) Consult accompanying documents Reset External Power Serial Port USB port Headphones Do Not Re-use – “Use Only Once” Contains no Latex Use by YYYY-MM-DD AUDICOR Sensor Sensor Pouch Sensor Box Proprietary and confidential: This document may not be copied.

. the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. This equipment generates. there is no guarantee that interference will not occur in a particular installation. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This device complies with Part 15 of the FCC Rules-Operation is subject to the following two conditions: 1) This device may not cause harmful interference and 2) This device must accept any interference received. © Copyright. • Increase the separation between the equipment and receiver. there are no serviceable parts associated with AUDICOR AM. Addendum Page 14 of 17 15 Federal Communications Commission (FCC) Statement Clause 15. including interference that may cause undesired operation of the device. End users must follow the specific operating instructions for satisfying RF exposure compliance.You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment. OR 97008-7196 USA (503) 431-3800 . If this equipment does cause harmful interference to radio or television reception. pursuant to part 15 of the FCC rules. These parts may be replaced or exchanged per the terms of the then current product warranty and/or as part of a fee for service contract after the warranty terms have expired..com/Forms/Support_Req. FCC RF Radiation Exposure Statement: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.audicor. disclosed or used in whole or in part without the consent of Inovise Medical. Clause 15.html . Beaverton. Suite D. 16 Field Replaceable Units: Other than the battery and memory/storage card. Should your product fail to operate in the manner described in the accompanying documentation contact Inovise Service and Support at http://www. may cause harmful interference to radio communications. Inc.40212_G AUDICOR RT 4. uses and can radiate radio frequency energy and. • Consult the dealer or an experienced radio/TV technician for help. Proprietary and confidential: This document may not be copied. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.0 AM (Holter) Quick Reference Guide. Inc.105(b) -This equipment has been tested and found to comply with the limits for a Class B digital device. if not installed and used in accordance with the instructions. Inovise Medical. 8770 SW Nimbus Ave. However. which can be determined by turning the equipment off and on.21 . See Specification Table at the end of this document for a list of Field Replaceable Units.

Micro SD. 2GB..40212_G AUDICOR RT 4.7 V Li-Poly battery g. AUDICOR® AM For AM mounting. AUDICOR® AM. Beaverton.) 20213* Battery Pack. Suite D.) 12266 Holster. requires 2 Snap ECG electrodes f. Inc.AUDICOR PC with AUDICOR RT with AM SW installed PC Power Supply PC Power Supply AC Power Cord PC Rechargeable Battery P/N 20214 .7 Volt Li-Poly Installed in AM battery compartment d.0 AM (5-Wire) Includes 3 ECG and 2 Sound/ECG leads e.) 20215 Charger Assembly.) 11131* Storage card. 8770 SW Nimbus Ave.) 11135 6’ A->A USB extension cable Interfaces USB Antenna to Audicor RT Notebook * AUDICOR® AM user serviceable parts Verify that all AUDICOR RT with AM system components are present: P/N 20218 . with Adapter Installed in AM battery compartment c. AUDICOR® AM Replacement battery cover for AM Recorder i. AUDICOR® AM Requires 11135 A->A USB extension cable to PC h. AUDICOR® 4. Extension 6 Ft. © Copyright.Cable USB data. disclosed or used in whole or in part without the consent of Inovise Medical. battery cover.) 20214 USB Wireless Adapter. Inc. Inovise Medical.) 20222 Patient Cable..USB Wireless Adapter (antenna) P/N 11135 . AUDICOR® AM Stand alone battery charger for 3. (For mounting antenna) Proprietary and confidential: This document may not be copied.0 AM (Holter) Quick Reference Guide.) 10380* Case. OR 97008-7196 USA (503) 431-3800 . Addendum Page 15 of 17 17 Customer Acceptance/Verification Procedure: Locate the Field Replaceable Units (FRU) that make up the Audicor AM Device a b c d e • f g h i Field Replaceable Units (FRU) that make up the Audicor AM Device a. 3.0 Ambulatory Monitor-AM Mounts on patients abdomen need items b-e b.) 20223 Audicor® 4.

Follow Quick Reference Guide P/N 40211 instructions steps 2-4 under “Preparing the Audicor AM device for Use”.0 AM Quick Reference Guide P/N 40212 . Power on the laptop and wait until the desktop is fully loaded. storage card. The product conforms to the described standards and/or other normative documents.(AM) with accessories Audicor Ambulatory Monitory (Includes battery cover) 3. Addendum Page 16 of 17 P/N 20225 .0 AM Quick Reference Guide Addendum P/N 40032 . © Copyright.AUDICOR RT 4.0 AM (Holter) Quick Reference Guide.AUDICOR 4. Beaverton.AUDICOR RT 4. 8770 SW Nimbus Ave.40212_G AUDICOR RT 4.0 AM Quick Ref. Is the Audicor RT+AM application screen displayed? (See Audicor RT 4. Does the AC LED light? 2. w/adapter Holster. Double click the Audicor RT icon to launch the application.. disclosed or used in whole or in part without the consent of Inovise Medical.AUDICOR Systems General Warranty Statement Customer acceptance criteria: Acceptance Criteria 1. Proprietary and confidential: This document may not be copied. conduct any appropriate local testing and place the Audicor RT 4.7 Volt 550 mAh Lithium-Polymer Rechargeable Battery (2-Each) 2Gb Micro SD. Inovise Medical.0 Ambulatory Monitor . Inc.. Audicor AM Battery Charger with power supply 5-Wire Audicor AM Patient Cable P/N 40211 . Install the laptop battery in the AUDICOR enabled laptop. OR 97008-7196 USA (503) 431-3800 . Does the AM LED light when the Event Mark button is pressed? * If the acceptance criteria indicates Pass. 1) 3. *Pass/Fail 18 R&TTE Statement of Conformity Model Name – PC1C ® Product Name – Audicor® AM Product Name –USB Receiver (for Audicor AM)Model Name – TD1J The listed AUDICOR® products herewith conform with the essential requirements and other relevant requirements of the R&TTE Directive (1999/5/EC). Inc. connect the power supply and AC power cord to AC mains power. and carries the CE-mark accordingly.0 with AM into service. Suite D. Guide 40211 Fig.

0 is manufactured in USA by Katecho Inc. Configured (Without Accessories) 20223 AUDICOR® 4. Micro SD. AUDICOR® AM 20214 USB Wireless Adapter. Beaverton. Inovise Medical.40212_G AUDICOR RT 4. Suite D. © Copyright. all rights reserved 0843 Proprietary and confidential: This document may not be copied. disclosed or used in whole or in part without the consent of Inovise Medical. A->A. Inc.0 AM replaceable parts Not supplied with Audicor RT 4.. Addendum Page 17 of 17 19 SPECIFICATIONS Feature AUDICOR® AM dimensions Battery in Audicor AM Specification (H) 76.0 Ambulatory Monitor . The AUDICOR RT application software is manufactured in the USA by Inovise Medical.. 3. and 60601-2-47 SGS certified IEC 60601-2-47.48in) Lithium Polymer. AUDICOR® AM 20222 Patient Cable.0 AM (Holter) Quick Reference Guide.7V 550 mAh rechargeable battery Replace after ~12 months Up to 48 hours on a single charge Recharge time < 4 hours 0 to 45 degrees C (32 to 113 degrees F) 10 to 95% relative humidity (non-condensing) -20 to 60 degrees C (-40 to 140 degrees F) 10 to 95% relative humidity (non-condensing) Complies with IEC 60601-1. AUDICOR® AM 11131 Storage card. AUDICOR 4. Inc.0 AM (5-Wire) 10380 Case. The AUDICOR RT application software runs on a notebook PC manufactured in China. 8770 SW Nimbus Ave. Inc. Laptop.78in).0 AM System is assembled in the USA by Inovise Medical. The AUDICOR Sensor 4. The AUDICOR 4. Inc. Inc. OR 97008-7196 USA (503) 431-3800 .3mm (1. Extension 6' Environmental operating conditions Storage and Transport Safety Performance standards Notebook PC Country of Origin: The AUDICOR RT 4.6mm (3.01in). (D) 12. (W) 45.0 AM device with accessories is manufactured in Taiwan by YI-Phone Inc. © July 2012 Inovise Medical. AUDICOR® AM (USB Antenna) 20213 Battery Pack.AM 20215 Charger Assembly.0 AM 20219 Computer. 2GB. 12266 Holster. with Adapter 30105 Sensor 4.0. ANSI/AAMI EC38 Intel® Notebook PC Microsoft® Windows® Vista Printer AUDICOR RT 4.1mm (. battery cover. Box of 100 Each 11135 USB Cable.