POMRX92369Sirona ECG Recorder

Sirona User Manual Rev D02 -1- 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. IntriCon Datrix 340 State Place Escondido, CA 92029 Sirona User Manual Rev D02 -2- Table of Contents Notices ................................................................................................................................ 3 User Safety Information...................................................................................................... 4 Warnings ............................................................................................................... 4 Cautions ................................................................................................................ 5 Notes: .............................................................................................................................. 5 Section 1: Introduction.......................................................................................................6 Section 2: Getting Started .................................................................................................. 6 Front Panel .......................................................................................................................... 7 Section 3: Initial Device Setup ........................................................................................... 8 Section 4: Attaching Recorder to Patient............................................................................ 8 Patient Cable ...................................................................................................................9 Patient Preparation .......................................................................................................... 9 Patient Hookup................................................................................................................ 9 Section 5: Instructions for Patient.................................................................................... 10 RECORD Button .......................................................................................................... 11 SEND Button ................................................................................................................ 11 SIRONA Patient Interface Light Signals ...................................................................... 13 Section 6: Device Maintenance ....................................................................................... 14 Inspection and Cleaning................................................................................................ 14 Testing........................................................................................................................... 14 SIRONA DATASHEET ................................................................................................... 17 Service/Technical Support: ............................................................................................... 18 Sirona User Manual Rev D02 -3- Notices Conventions Used in this Manual 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. NOTE Notes contain additional information on usage. Manufacturer’s Responsibility IntriCon Datrix considers itself responsible for effects on safety and performance only if: 1. Readjustments, modifications or repairs to the IntriCon Datrix Holter/Event recorders are carried out only by IntriCon Datrix authorized personnel. AND 2. The IntriCon Datrix SIRONA is used as presented in this manual. The warranty is only valid if you use IntriCon Datrix approved replacement parts and accessories. User Responsibility The user of this product is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards. Equipment Identification IntriCon Datrix equipment is identified by a serial number on the back of the device. Take care not to deface these numbers. Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced or translated to another language without prior written consent of IntriCon Datrix. Other Important Information IntriCon Datrix reserves the right to change or amend this manual at anytime without notice. IntriCon Datrix makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. IntriCon Datrix shall not be liable for errors or omissions that may appear in this document. IntriCon Datrix makes no commitment to update or to keep current the information contained in this document. Before using the IntriCon Datrix SIRONA Holter/Event recorder read this manual in its entirety and become thoroughly familiar with the contents. Sirona User Manual Rev D02 -4- 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. Explanation of Symbols Warnings 1. This device captures and presents data reflecting a patient’s physiological condition that when reviewed by a trained medical professional can be useful in determining a diagnosis. However, the data should not be used as sole means fo…

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TEST REPORT Report Number: 100658121MIN-005B Project Number: G100658121 Testing performed on the Sirona / ECG Monitor FCC ID: POMRX92369 To 47 CFR Part 15. 249:2010 RSS- 210, Issue 8, 2010 47 CFR, Part 15:2009, §15.107 and §15.109, Class B For IntriCon Corporation Test Performed by: Test Authorized by: Intertek Testing Services NA, Inc. 7250 Hudson Blvd., Suite 100 Oakdale, MN 55128 USA IntriCon Corporation 1260 Red Fox Road Arden Hills, MN 55112-6944, USA Prepared by: Date: September 4, 2012 Simon Khazon Reviewed by: Date: September 4, 2012 Uri Specotr This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to copy or distribute this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. This report must not be used to claim product endorsement by A2LA, NIST nor any other agency of the U.S. Government. EMC Report No: 100658121MIN-005B FCC ID: POMRX92369 Page 2 of 42 TABLE OF CONTENTS 1.0 GENERAL DESCRIPTION.......................................................................................................... 3 1.1 Product Description; Test Facility ....................................................................................... 4 1.3 Environmental conditions.................................................................................................... 5 1.4 Measurement uncertainty ................................................................................................... 6 1.5 Field Strength Calculation................................................................................................... 6 2.0 TEST SUMMARY.......................................................................................................................... 7 3.0 TEST CONDITIONS AND RESULTS........................................................................................ 8 3.1 Field strength of fundamental ............................................................................................. 8 3.2 Field strength of harmonics and spurious emissions ....................................................... 10 3.3 Bandwidth of Emissions.................................................................................................... 25 3.4 Transmitter power line conducted emissions ................................................................... 32 3.5 Receiver/digital device radiated emissions....................................................................... 33 3.6 Digital device conducted emissions.................................................................................. 41 4.0 TEST EQUIPMENT..................................................................................................................... 42 EMC Report No: 100658121MIN-005B FCC ID: POMRX92369 Page 3 of 42 1.0 GENERAL DESCRIPTION Model: Sirona Type of EUT: ECG Monitor FCC ID: POMRX92369 Related Submittal(s) Grants: None Company: IntriCon Corporation. Customer: Mr. Vijay Sundermurthy Address: 1260 Red Fox Road Arden Hills, MN 55112-6944, USA Phone: (651) 604-9534 Fax: (612) 636-8944 e-mail: [email protected] Test Standards: 47 CFR, Part 15:2010, §15.249 RSS–210, Issue 8, 20010 RSS-Gen, Issue 3, 2010 47 CFR, Part 15:2010, §15.107 and §15.109, Class B ICES-003, Issue 4:2004 Other Type of radio: Stand -alone Module Hybrid Date Sample Submitted: March 2, 2012 Test Work Started: March 2, 2012 Test Work Completed: March 19, 2012 Test Sample Conditions: Damaged Poor (Usable) Good EMC Report No: 100658121MIN-005B FCC ID: POMRX92369 Page 4 of 42 1.1 Product Description; Test Facility Product Description: Transceiver Operating Frequency 2400-2483.5 MHz Modulation: FSK Antenna(s) Info: Type Integral Gain 2.0dBi Antenna Installation: User Professional Factory Transmitter Power Configuration: Internal battery External power source 120VAC 230VAC 400VAC VDC Other: Amp. 50Hz 60Hz Special Test Arrangement: Testing was performed on the EUT with fully charged internal battery. Test Facility Accreditation: A2LA (Certificate No. 1427.01) Test Methodology: Measurements performed according to the procedures in ANSI C63.10- 2009 EMC Report No: 100658121MIN-005B FCC ID: POMRX92369 Page 5 of 42 1.2 EUT Configuration The equipment under test was operated during the measurement under the following conditions: - Standby - Continuous - Test program (customer specific) - Operating modes of the EUT: No. Description 1 The device was pre-programmed to transmit continuously in three separate frequency channels, low, middle, and upper frequency channel, one channel being transmitted at a given time. 2 Standby/Receiving mode Cables: No. Type Length Designation Note None Support equipment/Services: No. Item Description None 1.3 Environmental conditions During the measurement the environmental conditions were within the listed ranges: Normal Temperature: 15-35 ° C Humidity: 30-60 % Atmospheric pressure: 86-106 kPa EMC Report No: 100658121MIN-005B FCC ID: POMRX92369 Page 6 of 42 1.4 Measurement uncertainty The expanded uncertainty (k = 2) for radiated emissions from 30 to 1000 MHz has been determined to be: ±4 dB at 10m and ±5.4 dB at 3m The expanded uncertainty (k = 2) for conducted emissions from 150 kHz to 30 MHz has been determined to be: ±2.6 dB 1.5 Field Strength Calculat…

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Test Setup Photos