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Operation Manual MA 1

8100216 Rev. 5

09/03/2023

6.6 Electrical Safety, EMC and Associated Standards

1. IEC 60601-1:2012/ ANSI/AAMI ES 60601-1: 2005 / A2:2010: Medical Electrical

Equipment, Part 1 General Requirements for Safety

2. IEC 60601-1-2:2014: Medical Electrical Equipment - Part 1-2: General

Requirements for Basic Safety and Essential Performance - Collateral Standard:
Electromagnetic Compatibility - Requirements and tests

3. DIN/EN/ISO 14971:2012 - Application of risk management to medical devices

4. General Safety and Performance Requirements of the current REGULATION (EU)

2017/745

5. DIRECTIVE 2011/65/EU on the restriction of the use of certain hazardous

substances in electrical and electronic equipment (RoHS 2)

6. Directive 2002/96/EC on waste electrical and electronic equipment (WEEE)

Содержание MA 1

Страница 1: ...Operation Manual MA 1...

Страница 2: ......

Страница 3: ...ng and Disinfection Recommendations 8 3 4 Disposables 9 3 5 Components Replacement Parts 9 3 6 Recycling and Disposal 9 4 Unpacking and Installation 10 4 1 Unpacking the System 10 4 2 Hardware Orienta...

Страница 4: ...www maico diagnostics com german support resources International https www maico diagnostics com support resources Copyright 2023 MAICO Diagnostics All rights reserved No part of this publication may...

Страница 5: ...ENTs hearing healthcare professionals or other trained technicians in a hospital clinic or healthcare facility 1 3 Contraindications of Use The patient is too young sick or uncooperative to perform th...

Страница 6: ...ystem including safety information as well as maintenance and cleaning recommendations READ THIS ENTIRE OPERATION MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM Use this device only as described in this...

Страница 7: ...is manual accompanying labels and or inserts A defective product should not be used Make sure all connections to external accessories are snug and secured properly Parts which may be broken or missing...

Страница 8: ...tion consult accompanying documents Warning consult accompanying documents Return to authorized representative special disposal required Reference number Medical Device Global Trade Item Number Patien...

Страница 9: ...calibration Do not use the device if any damage is suspected Calibration of the device The device and the transducers complement each other and share the same serial number i e MA7663252 Therefore the...

Страница 10: ...device adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this device and the other equipment should be observed to v...

Страница 11: ...t of repair during the guarantee period please enclose evidence of purchase with the device 3 2 Maintenance In order to ensure that the device works properly it has to be checked and calibrated at lea...

Страница 12: ...lies that are supplied with your device Ear cushion covers are intended for single use only These should be discarded after use They cannot be cleaned In case of re use of the single use disposables y...

Страница 13: ...onent appears to be damaged in shipment contact your distributor immediately to report it Do not attempt to use any component or device that appears to be damaged Reporting Imperfections Notify the ca...

Страница 14: ...iometric Headset 2x AA Batteries Carrying Case Operation Manual Quick Guide Audiogram Pad Applied parts according to IEC 60601 1 As download from the download center see accompanying leaflet Table 3 R...

Страница 15: ...attery life The device will power off after 90 s of inactivity When batteries get too low to produce the proper signal remaining battery power of 2 1 V or lower the device will shut off and will not t...

Страница 16: ...condensation by storing the device in its original packaging If the device is stored under warmer conditions than the use conditions no special precaution are required before use Always ensure proper...

Страница 17: ...r Conduction Testing 5 4 1 Screening A hearing screening utilizes a Pass or Refer result and is used to determine if further testing is required as a hearing problem may exist Patients are typically s...

Страница 18: ...ither ear would result in a Refer Note When presenting tones be sure to vary the timing of the tone presentation This is to prevent the patient from routinely raising his her hand instead of respondin...

Страница 19: ...e disposal of authorized service companies STANDARDS Safety Standards IEC 60601 1 2005 Cor 2006 Cor 2007 A1 2012 Internally powered Type B Applied Parts EMC Standard IEC 60601 1 2 2014 The MA 1 is not...

Страница 20: ...ansducers Headband tension DD45 Headband Static Force 4 5 N 0 5 N DD65 v2 Headband Static Force 10 0 N 0 7 N Inputs Tone Accuracy Level 4 dB Precision 5 dB level steps Outputs Left Right Stimuli Prese...

Страница 21: ...al MA 1 8100216 Rev 5 18 09 03 2023 6 2 Connections Figure 5 CONNECTIONS No Connection socket Specification 1 Phone ZA 10 UA 7 Veff 6 3 Pin Assignment SOCKET CONNECTOR PIN 1 PIN 2 Phone 3 5 mm Mono Gr...

Страница 22: ...lent threshold sound pressure level RETSPL dB re 20 Pa DD45 DD65 v2 500 7 0 26 1 1000 15 0 32 4 2000 26 0 43 6 4000 32 0 43 8 Table 7 Reference Values for Stimulus Calibration REFERENCE VALUES FOR STI...

Страница 23: ...o cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The MA 1 is suitable for use in all commercial industrial business and residential environments Harmonic emissions...

Страница 24: ...the electromagnetic environment specified below The customer or the user of the MA 1 should assure that it is used in such an environment Immunity test IEC EN 60601 test level Compliance level Electr...

Страница 25: ...equirements for Basic Safety and Essential Performance Collateral Standard Electromagnetic Compatibility Requirements and tests 3 DIN EN ISO 14971 2012 Application of risk management to medical device...

Страница 26: ...Operation Manual MA 1 8100216 Rev 5 23 09 03 2023 6 7 Checklist for Subjective Device Check...

Страница 27: ...ecifications are subject to change without notice MAICO Diagnostics GmbH Sickingenstr 70 71 10553 Berlin Germany Tel 49 30 70 71 46 50 Fax 49 30 70 71 46 99 E mail sales maico biz Internet www maico b...

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