SA 200 series Instructions for Use May 2020

Audiometers SA 201/202/203/204 Instructions for Use

Warranty We, Auditdata A/S warrant that this product is free from defects in material and workmanship and, when properly installed and used, will perform in accordance with applicable specifications. If within one year after original shipment, it is found not to meet this standard, then it will be repaired, or at our option, replaced at no charge except for transportation costs, when returned to an authorised Auditdata - Service facility. If field service is requested, there will be no charge for labour or material; however, there will be a charge for shipping/travel expense at the service centre’s current rate.

Note Changes in the product not approved in writing by Auditdata shall void this warranty. Auditdata shall not be responsible for any indirect, special or consequential damages, even if notice has been given in advance of the possibility of such damages. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

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Audiometers SA 201/202/203/204 Instructions for Use

Package and unpacking External Inspection

Although your audiometer system parts were carefully tested, inspected and packed for shipping, immediately examine the outside of the container after receiving the instrument for any signs of damage. Notify your carrier if you observe any damage.

Unpacking

Carefully remove your audiometer system parts from its shipping container. If you observe any mechanical damage, notify the carrier immediately so that a proper claim can be made. Be certain to save all packing material so that the claim adjuster can inspect it as well. As soon as the carrier has completed the inspection, notify your Auditdata representative. If the instrument must be returned to the supplier, repack it carefully (in the original container, if possible) and return it prepaid to the supplier for the necessary adjustment.

Package contents

Check carefully that you have got all system parts according to the delivery note. If any system part is missing or the delivery is not according to your order, notify your Auditdata representative immediately.

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Audiometers SA 201/202/203/204 Instructions for Use

Manufacturer The audiometer is manufactured and sold in the EU by: Auditdata A/S Dalbergstroeget 5-7 DK-2630 Taastrup Denmark Phone: +45 70203124 www.auditdata.com

Intended Use/Indications for Use The system is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained clinicians. Audiometric testing should take place in a sound treated quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing. • The device is intended for hearing test. • The device with stated accessories is indicated for non-continuous, non-invasive air and optionally bone conduction and speech audiometric testing in quiet office and sound treated environments. • The device is indicated for use with both pediatric and adult age groups. • The device is not indicated as a sole means of diagnostics.

Principles of Operation Presentation of pure tone sine wave and speech stimuli for threshold determination and supra-threshold testing within the range of 125 Hz to 8 kHz and varying intensity levels to assess client hearing levels.

Warnings and cautions To ensure safe operation of this instrument, you must follow the instructions and precautions contained in this manual. Before attempting to connect, operate or adjust this product, please read these instructions completely. User skill

Users of this instrument are expected to have the appropriate training in audiometry.

Cover

The cover of the audiometer must be on during operation. Only qualified service personnel should remove the cover.

Defective parts

Do not use defective equipment. If you suspect a malfunction, contact a service representative authorized by manufacturer for inspection of the equipment. On a regular basis, inspect the system for visible damage. Do not use damaged headphones or accessories with the device. A defective system part must be immediately replaced by qualified service personnel. A defective part can cause testing errors and put your test subject, yourself or your equipment at risk.

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Audiometers SA 201/202/203/204 Instructions for Use Electromagnetic Compatibility (EMC)

The Entomed SA20x family is suitable for use in all establishments other than domestic, but it can be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, if the following warning is taken in account: WARNING: This device is intended for use in professional healthcare environment only and might interfere or be disturbed by nearby equipment, therefore, it may be necessary to take mitigation measures, such as reorienting, relocating or shielding the location. Install and operate the SA20x audiometer according the EMC information, warnings and recommendations to prevent adverse events to the patient and operator due to electromagnetic disturbances for the expected service life time. WARNING: Failure to comply the precautions listed in this section may cause presenting of unwanted hearable noise or a wrong output on patients headset and therefore the possibility of wrong client response. WARNING: Do not place the system on or near equipment that generates a strong magnetic or electrical field, as this may cause improper operation and interfere with the intended use of the device. RECOMMENDATION: To reduce the frequency of electrical shocks through ESD, the floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. RECOMMONDATION: The quality of the mains power should be that of a typical commercial or hospital environment. WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the SA20x audiometer including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

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Audiometers SA 201/202/203/204 Instructions for Use

Interconnection with other equipment

External equipment intended for connection to signal input, signal output or other connectors, shall comply with relevant IEC standard (e.g. IEC 60950 for IT equipment and the IEC 60601 series for medical electrical equipment). In addition, all such combinations – systems – shall comply with the standard IEC/EN 60601-1, Safety requirements for medical electrical systems. Equipment not complying with IEC 60601 shall be kept outside the test subject environment, as defined in the standard (at least 1.5 m from the test subject or the test subject support). Any person who connects external equipment to signal input, signal output or other connectors has formed a system and is therefore responsible for the system to comply with the requirements of IEC/EN 60601-1. If in doubt, contact qualified technician or your local representative.

Maintenance and calibration

The Auditdata audiometers are all designed for providing a trouble-free service for a long time period. The devices should be contained in an environment according to the operational specifications, so that the temperature and humidity does not rise above dangerous measures. As correct calibration, however, is highly important for reliable test results, recommendations for maintenance and calibration schemes have been specified by international standards and, in some cases, superseded by national recommendations and/or legislation. On a regular basis, inspect the system for visible damage. Do not use damaged headphones or accessories with the device. The headset and transducers are NOT intended for calibration by users. Contact your local distributor for your annual service and calibration. For further information, please refer to chapter Maintenance and calibration. If in doubt, contact your local representative.

Headsets to be handled with care

Please note, although headsets are of robust design, they should be handled with care, as their calibrated performance could be jeopardized if dropped into the floor. Do not place the device in any position that may cause it, or the connected headphones, to fall on the client or operator.

Measurement Accuracy

Excessive moments should be avoided during the test, as it may interfere with the measurement and can result in wrong measurement results.

Power supply/Cables/ Transducers

•

If the PC complies with IEC 60950 or with IEC 60601-1 3rd, use the USB cord to connect to the system.

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Audiometers SA 201/202/203/204 Instructions for Use

Explosion hazard/ Electric shock hazard

•

If the PC is in use and not compliant with IEC 60950 or IEC 60601-1, use optical USB connection Type OPTICIS M2-100-03 with power supply that is supplied with the system - Protek Power PMP6016-B1.

•

Do not touch the USB connector from the PC and the patient at the same time, when the IEC 60950 approved PC is used.

•

The main power supply should be easily accessible for plugging/unplugging.

•

Cables should be changed by properly qualified personnel only.

•

Do not pull the headphone cable. To disconnect the headphones or other accessories from the device, pull the plug. Do not lift or carry the device by any of the connected cables.

•

Carefully route all the cables to reduce the possibility of entanglement or strangulation.

•

Do not connect non-medical equipment unless it forms part of the medical system. There is a danger that the leakage currents may exceed their valid limits and consequently be a hazard to the client and the examiner.

•

Do not use the device in the presence of flammable substances.

•

Do not attempt to disassemble the device. The device contains no user-serviceable items inside. The operator may only perform maintenance procedures specifically described in this document.

•

The operator should take care never to touch non-medical parts of the system and the client at the same time.

•

The operator must not touch the RS 232, IN2 or IN3 connectors and the patient at the same time.

Barriers

Remove any barriers before placing the headphones or insert phones on the patient, such as jewellery or the patient’s hair during the test.

High sound pressure

•

Do not use talk forward microphone in areas where there is risk of acoustical feedback.

•

Avoid exposing the client or other persons to unnecessarily high sound pressures, as these may be damaging to hearing.

Inspection of client

Before applying the headphones or insert phone, inspect the patient’s ear drum, ear canal, pinna and surrounding areas for lesions or other types of infection. Do not use the headphones or insert phones if any contraindications exist.

Mobile multi-outlet

If mobile multi-outlet power strips for mains power supply are in use: •

they must comply with MEDICAL ELECTRICAL SYSTEM in IEC 60601-1

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Audiometers SA 201/202/203/204 Instructions for Use • Moisture

their rated current must not be exceeded

Do not expose the device to moisture. Extreme moisture can cause the device to fail or perform inaccurately.

Non-medical equipment Do not connect non-medical equipment unless it forms part of the medical system. There is a danger that the leakage currents may exceed their valid limits and consequently be a hazard to the client and the examiner. Mechanical damage

Conductors and wiring between the system components must be protected against mechanical damage.

Usage

The devices must only be used for their intended purpose. The device is intended only as an adjunct in client assessment. It must be used in conjunction with assessment of clinical indicators and symptoms.

Modifications

Do not modify the equipment without authorization of the manufacturer.

Waterproof

The headphones, probe microphone set, cables, connectors and other electrical accessories are not waterproof. See the Cleaning instructions for safe handling.

Skin contact/ Client contact

The headsets / patient switch are only to be used with uninjured skin of the test person. The time of usage is short duration and less than 24 hours.

Ambient noise

All tests must be conducted in a sound treated or sound proof room with low ambient noise.

Disposal

•

•

In the event of irreparable damage to the device, dispose of it through an approved hazardous materials disposal facility in accordance with the RoHS (Restriction of the Use of Certain Hazardous Substances) and WEEE (Waste Electrical and Electronic Equipment) regulations, or return it to manufacturer. When using the device with insert phones or probe-tube set, note that the used foam ear tips or probe tubes are not intended for reuse and should be disposed in a manner consistent with normal infection control procedures.

Disinfection

Parts that come into contact with the client (that is, transducers, the handheld push-button, and the probe microphone set) should be disinfected before use.

Incidents

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. page 8

Audiometers SA 201/202/203/204 Instructions for Use

Symbols on the rear panel of the audiometer This symbol indicates the audiometer conforms to the provisions noted in 93/42/EEC Medical Devices Directive. 0123

This symbol indicates that applied parts are classified Type B according IEC 60601-1.

IEC 60645-1 Type 3(4)

IEC 60601-1

Type 3 audiometer according IEC 60645-1

The audiometer is in compliance with IEC 60601-1

This symbol indicates “Caution, consult accompanying documents”. This symbol indicates care should be taken to the environment when discarding all electronic equipment. Contact your dealer for further information concerning recycling.

This symbol indicates the switch to turn power On/Off to the audiometer. This symbol indicates direct current. Note. Only AC/DC Adapters marked REF EN 560 128 (suffix A, B, etc., can exist, depending on second source) may be connected to the audiometer! Follow operating instructions.

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Audiometers SA 201/202/203/204 Instructions for Use

CONTENTS

SPECIFICATIONS

13

Standards and directives

13

Applied Parts

15

Function Testing Modes Pure Tone – Frequency Range, Format and Length Hearing Level Range Hearing level - Accuracy and Control Increments Narrow band masking noise Speech Channel L and R Communication Operator/Test subject

15 15 15 16 18 18 18 19

Transducer Information Transducers TDH-39 Earphone Cushion Attenuation DD45 Earphone Cushion Attenuation DD65v2 Ambient Noise Attenuation

19 19 19 20 20

Special Functions

21

Environment Transport and Storage Operating requirements fully in accordance to IEC 60645-1 Audiological equipment Warm-up-time

21 21 21 21

Power and Power Consumption AC/DC Adapter Audiometer Unit Power Consumption

22 22 22 22

Dimensions and Weight

22

Cable length of Transducers and Accessories

22

GET TO KNOW THE PANELS OF THE AUDIOMETER

23

SA 201 Rear Panel SA 201 Front Panel SA 201

23 23 24

SA 202 Rear Panel SA 202 Front Panel SA 202

26 26 27

SA 203 Rear Panel SA 203 Front Panel SA 203

29 29 30

SA 204 Rear Panel SA 204 Front Panel SA 204

32 32 33

START UP THE AUDIOMETER

35

Initial installation

35

Power On

35

Stand by mode

36

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Audiometers SA 201/202/203/204 Instructions for Use MANUAL TESTING – PURE TONE

40

Selections to be done in manual testing

40

Air conduction testing

41

Air conduction testing with masking noise SA 203/204

43

Bone conduction testing SA 203/204

44

Bone conduction testing with masking noise SA 203/204

44

DISPLAY STORED HEARING THRESHOLDS

45

PRINT AUDIOGRAM SA 201*/202/203/204

47

Connecting the audiometer to a printer

47

Select printer mode

47

Print audiogram

47

TRANSFER AUDIOGRAM TO COMPUTER SA 201*/202/203/204

49

Summary

49

Connecting the audiometer to a computer

49

Select transfer to computer mode

49

Transfer audiogram to the computer

50

MANUAL TESTING – SPEECH SA 204

52

Air conduction testing SA 204

52

Bone conduction testing SA 204

56

Bone conduction testing with masking noise SA 204

56

MANUAL TESTING – FREE FIELD SA 203/204

57

AUTOMATIC TESTING – PURE TONE SA 202/203/204

58

Selections to be done in automatic testing

58

Air conduction testing SA 202/203/204

59

Air conduction testing with masking noise SA 203/204

62

Bone conduction testing SA 203/204

63

PROPOSALS FOR ROUTINE AIR CONDUCTION TESTING

64

Initial installation

64

Test subject care and instruction

65

Manual testing

66

Automatic testing SA 202/203/204

68

INTERNAL MEMORY FOR STORING AUDIOGRAMS

68

SET UP

70

FACTORY SETTINGS

75

MAINTENANCE AND CALIBRATION

76 page 11

Audiometers SA 201/202/203/204 Instructions for Use General

76

Intervals between checks – as stipulated by ISO 8253-1

76

Stage A - Routine checking and subjective tests

76

Fuse Replacement

77

PIN ASSIGNMENTS TABLE

78

PERIODIC OBJECTIVE CHECKS – LOG

79

AUDIOGRAM – EXAMPLES

80

Printout SA 202

80

Printout SA 203

81

Printout SA 204

82

Printout audiogram transferred to computer

83

Screen dump audiogram transferred to computer

84

ACCESSORIES

85

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Audiometers SA 201/202/203/204 Instructions for Use

SPECIFICATIONS Standards and directives Classification according Annex IX of EU Medical Device Directive (MDD) 93/42/EEC: Device SA201, SA202, SA203, SA204

Class IIa

Rule 10

CE CE0123

Classification according Annex VIII of EU Medical Device Regulation MDR (EU) 2017/745:

Device SA201, SA202, SA203, SA204

Class IIa

Rule 10

CE CE0123

All Auditdata Audiometers SA 201/202/203/204 covered in this manual including the below listed accessories respective applied parts, do comply with the Council Directive RoHS-II/2011/65/EU.

SA 201

IEC 60601-1/A1:2012

202 203 204

IEC 60645-1:2017

Medical Electrical Equipment – Part 1: General requirements for safety Electroacoustics - Audiometric equipment Part 1: Equipment for pure-tone and speech audiometry

IEC 60645-1 Classification

Type 3

IEC 60645-1 Classification

Type 4

X

X

IEC 60601-1-2:2014

Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. EN 55011 / CISPR11, Group 1, Class B

X

X

X

X

X

X

X

X

X

X

X

X

Harmonic Current Emission:

Test levels for professional healthcare environment. IEC 61000-3-2:2018, Class A

X

X

X

X

Voltage Fluct. and Flicker:

IEC 61000-3-3:2013

X

X

X

X

Enclosure Port:

Immunity Test Level:

IEC 61000-4-2 (ESD)

± 8 kV contact, ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

IEC 61000-4-3 (rad Fields)

3 V/m, 80 MHz – 2,7 GHz, 80 % AM at 1 kHz & Test points / frequencies according table 9 of IEC/EN 60601-12:2014/:2015 (RF wireless communications equipment): 385 MHz; Pulse Modulation: 18 Hz; 27 V/m 450 MHz, FM + 5Hz deviation: 1 kHz sine; 28 V/m

EMC Emission: EMC Immunity:

page 13

X

X

X

X

X

X

X

X

X

X

Audiometers SA 201/202/203/204 Instructions for Use

IEC 61000-4-8 (magn. Fields)

710, 745, 780 MHz; Pulse Modulation: 217 Hz; 9 V/m 810, 870, 930 MHz; Pulse Modulation: 18 Hz; 28 V/m 1720, 1845, 1970 MHz; Pulse Mod.: 217 Hz; 28 V/m 2450 MHz; Pulse Modulation: 217 Hz; 28 V/m; 5240, 5500, 5785 MHz; Pulse Mod.: 217 Hz; 9 V/m 30 A/m, 50 Hz & 60 Hz

Input a.c. power port:

Immunity Test Level:

IEC 61000-4-4 (bursts)

± 2 kV, 100 kHz repetition frequency

IEC 61000-4-5 (surges)

± 0,5 kV, ± 1 kV, line to line

IEC 61000-4-6 (cond. RF)

IEC 61000-4-11 (volt. inter.)

3 V/m, 0,15 MHz – 80 MHz, 80 % AM at 1 kHz 6 V/m in ISM bands between 0,15 MHz and 80 MHz 0 % UT; 0,5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°. 0 % UT; 1 cycle and 70 % UT; 25/30 cycles at 0° 0 % UT; 250/300 cycle

Patient Coupling Port:

Device has no patient coupling port (see SIP / SOP)

Signal Input / Output Port:

Immunity Test Level:

IEC 61000-4-2 (ESD)

± 8 kV contact, ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

IEC 61000-4-4 (bursts)

Only applicable for patient headsets, patient client switch and speaker cables because cable length might be > 3m. N/A; cable not directly connected to outdoor cables.

IEC 61000-4-11 (volt. dips)

IEC 61000-4-5 (surges) IEC 61000-4-6 (cond. RF)

Only applicable for patient headsets, patient client switch and speaker cables because cable length might be > 3m.

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Audiometers SA 201/202/203/204 Instructions for Use

Applied Parts Note: These parts must only be replaced by identical parts delivered by the manufacturer.

SA 201 202 203 204 DD45

Supra-aural phones and phones w Audiocups noise attn. cups.

X

X

X

X

DD65v2

Circumaural audiometric headset equipped with noise attenuation Peltor cups.

X

X

X

X

EA-5A

Insert phones

X

X

X

X

TDH 39

Supra-aural phones

X

X

X

X

B-71

Bone Vibrator

N/A N/A

X

X

Subject response switch

X

X

X

Monitor headset

N/A N/A N/A

X

X

*) Note: The list of Parts and Accessories is subject to change without notice. An updated list will always be available from our homepage: www.auditdata.com.

Function Testing Modes

SA 201 202 203 204 Manual hearing threshold level determination X X X X Automatic hearing threshold level determination N/A X X X Air Conduction X X X X Bone Conduction N/A N/A X X Narrow Band Masking - manual level adjust or synchronous level N/A N/A X X Free Field - manual testing mode N/A N/A X X Speech audiometry - manual testing mode with recorded speech N/A N/A N/A X or live speech, with or without speech noise

Pure Tone – Frequency Range, Format and Length Frequency range Air Conduction Bone Conduction Accuracy Total Harmonic Distortion Tone Format Continuous Pulses Frequency modulation

SA

201 202 203 204

125 – 250 – 500 – 750 – 1000 – 1500 – 2000 X X – 3000 – 4000 – 6000 – 8000 Hz 250 – 500 – 750 – 1000 – 1500 – 2000 – 3000 N/A N/A – 4000 – 6000 – 8000 Hz +/- 1% X X X X  2.5% earphones

X

X

X

X

X X

X X

 5.5% bone vibrator

N/A N/A

X

X

X X X

X X X

X X X

2.5 pulses/sec. Warble: ± 5 %, triangular 10 Hz at 8 kHz, 8 Hz at 6 kHz and 5 Hz at 125 Hz – 4 kHz.

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X X X

Audiometers SA 201/202/203/204 Instructions for Use

Tone Length Manual testing

Automatic testing

Two alternatives, selected in the SET UP. X 1. Steady Tone as long as the Present key is pressed. 2. Steady Tone as long as the Present key is pressed, but at least 1.3 sec even if the key is pressed a shorter time. 1.3 sec N/A

X

X

X

X

X

X

Hearing Level Range Air Conduction (Measured in accordance to ISO 389-1-2) Manual mode

Frequency Hz 125 250 500-4000 6000-8000

Automatic mode

SA 201 -10 to 80 -10 to 100 -10 to 110 -10 to 100

Hearing Level Range dB HL SA 202 SA 203 -10 to 80 -10 to 80 -10 to 100 -10 to 100 -10 to 110 -10 to 120 -10 to 100 -10 to 110

SA 204 -10 to 80 -10 to 100 -10 to 120 -10 to 110

SA 201 N/A N/A N/A N/A

Hearing Level Range dB HL SA 202 SA 203 -10 to 80 -10 to 80 -10 to 100 -10 to 100 -10 to 110 -10 to 110 -10 to 100 -10 to 100

SA 204 -10 to 80 -10 to 100 -10 to 110 -10 to 100

Hearing Level Range dB HL SA 202 SA 203 N/A -10 to 45 N/A -10 to 60 N/A -10 to 60 N/A -10 to 70 N/A -10 to 70 N/A -10 to 60 N/A -10 to 60

SA 204 -10 to 45 -10 to 60 -10 to 60 -10 to 70 -10 to 70 -10 to 60 -10 to 60

Frequency Hz 125 250 500-6000 8000

Bone Conduction (Measured in accordance to ISO 389-3) Manual/Automatic mode

Frequency Hz 250 500 750 1000 1500-4000 6000 8000

SA 201 N/A N/A N/A N/A N/A N/A N/A

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Audiometers SA 201/202/203/204 Instructions for Use Narrow Band Noise (Measured in accordance to ISO 389-4) Manual mode

Frequency Hz 125 250 500-6000 8000

SA 201 N/A N/A N/A N/A

Hearing Level Range dB HL SA 202 SA 203 N/A 0 to 80 N/A 0 to 80 N/A 0 to 100 N/A 0 to 90

SA 204 0 to 80 0 to 80 0 to 100 0 to 90

Free Field - Pure tone at 1 meter (Measured in accordance to ISO 389-7) Manual mode

Frequency Hz 125 250 500-4000 6000-8000

SA 201 N/A N/A N/A N/A

Hearing Level Range dB HL SA 202 SA 203 N/A -10 to 80 N/A -10 to 100 N/A -10 to 120 N/A -10 to 110

SA 204 -10 to 80 -10 to 100 -10 to 120 -10 to 110

Note. Specified range is audiometer calibrated output level range. Max.level obtained is depending on the free field system specification in combination with the characteristics of the test environment.

Free Field – Narrow Band Masking Noise at 1 meter (Measured in accordance to ISO 389-7) Manual mode

Frequency Hz 125 250 500-6000 8000

SA 201 N/A N/A N/A N/A

Hearing Level Range dB HL SA 202 SA 203 N/A 0 to 70 N/A 0 to 80 N/A 0 to 100 N/A 0 to 90

SA 204 0 to 70 0 to 80 0 to 100 0 to 90

Note. Specified range is audiometer calibrated output level range. Max.level obtained is depending on the free field system specification in combination with the characteristics of the test environment.

Speech Audiometry Manual mode

Air conduction Bone conduction Speech noise

SA 201 N/A N/A N/A

page 17

Hearing Level Range dB HL SA 202 SA 203 N/A N/A N/A N/A N/A N/A

SA 204 -10 to 120 -10 to 80 -10 to 100

Audiometers SA 201/202/203/204 Instructions for Use Hearing level - Accuracy and Control Increments Accuracy

125 - 4000 Hz 6000 and 8000 Hz

+/- 1,0 dB +/- 1,0 dB 5 dB

Control increments

Narrow band masking noise Band limits according to IEC 60645-1

Min roll off

Centre Freq. (Hz)

SA 201 202 203 204 X

X

12 dB/octave

N/A N/A

X

X

More than 40 dB

N/A N/A

X

X

N/A N/A

X

X

Lower cut-off Frequency (Hz)

Upper cut-off Frequency (Hz)

Min

Max

Min

Max

125

105

111

140

149

250

210

223

281

297

500

420

445

561

595

750

631

668

842

892

1000

841

891

1120

1190

1500

1260

1340

1680

1780

2000

1680

1780

2240

2380

3000

2520

2670

3370

3570

4000

3360

3560

4490

4760

6000

5050

5350

6730

7140

8000

6730

7130

8980

9510

Both sides

Stop band Synchronous masking

N/A N/A

The level of masking noise can be selected to automatically track the stimulus level.

SA 201 202 203 204

Speech Channel L and R Microphone

Input for live speech testing

N/A N/A N/A

X

IN1 and IN2

Inputs for recorded speech material from external stereo CD/tape player.

N/A N/A N/A

X

White noise filtered to a low and middle frequency band, simulating the average spectrum of conversational speech.

N/A N/A N/A

X

Air conduction

-10 to 120 dB HL

N/A N/A N/A

X

Bone conduction

-10 to 80 dB HL

N/A N/A N/A

X

Speech noise

-10 to 100 dB HL

N/A N/A N/A

X

Nominal 0.40 to 5 V RMS. Noise

Intensity range

page 18

Audiometers SA 201/202/203/204 Instructions for Use Communication Operator/Test subject

SA 201 202 203 204

Talk forward

Built in talk forward microphone for operator talk to the test subject during testing.

X

X

X

X

Talk back

Test subject talk back microphone to talk to the operator during speech test.

N/A N/A N/A

X

Monitor / Live speech monitor headset

Operator monitor headset to listen to Speech N/A N/A N/A Channel L, Speech Channel R and Talk back signal and talk to the test subject.

X

Transducer Information Transducers

SA 201 202 203 204

DD45 Headset

Pair of DD45 earphones, 10ohm, w / DD51 cushions, headband and cords

X

X

X

X

TDH 39 Headset

Pair of Telephonics TDH-39 earphones,

X

X

X

X

10 ohm, w/ MX 41 AR Cushions, headband and cords. DD65v2 Headphone

Circumaural Headphone in Peltor Cups with cushions, headband and cord. Imp.: 10 ohms

X

X

X

X

Insert Earphones

Pair of matched E-A-RTONE 5A insert earphones, 10 ohm, w/ cords.

X

X

X

X

Bone conductor assembly

Radioear B-71 bone vibrator, 10 ohm, w/ headband and cord.

N/A N/A

X

X

Free Field System

The sound field system is comprised of a pair of speakers with an integrated amplifier.

N/A N/A

X

X

TDH-39 Earphone Cushion Attenuation Frequency (Hz) 125 250 500 750 1000 1500 2000 3000 4000 6000 8000

page 19

Attenuation (dB) 6.5 4.5 7.0 10.0 15.5 18.5 26.0 30.5 33.0 27.0 24.5

Audiometers SA 201/202/203/204 Instructions for Use DD45 Earphone Cushion Attenuation Frequency (Hz) 125 250 500 800 1000 1600 2000 3150 4000 6300 8000

Attenuation (dB) 3.0 5.0 7.0 11.0 15.0 21.0 26.0 31.0 32.0 26.0 24.0

Frequency (Hz) 125 250 500 800 1000 1600 2000 3150 4000 6300 8000

Attenuation (dB) 8.3 15.5 26.1 28.2 32.4 33.7 43.6 41.4 43.8 46.7 45.6

DD65v2 Ambient Noise Attenuation

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