GSI 17 Instruction Manual Rev10 May 2009

Electromagnetic compatibility (EMC)

CE Mark per Medical Device Directive (93/42/EEC) 2

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European authority representative VIASYS Healthcare GmbH Leibnizstrasse 7 97204 Hoechberg Germany Tel: (49) 931-4972 - 308 Fax: (49) 931-4972 - 62308 Email address: [email protected] First printing: September 1991, Rev. 1 Revised: September 1992, Rev. 2 November 1993, Rev. 3 October 1996, Rev. 4 July 1999, Rev. 5 September 2002, Rev. 6 February 2003, Rev. 7 September 2003, Rev 8 February 2005, Rev 9 January 2008, Rev 10

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Table of contents Electromagnetic compatibility (EMC) European authority representative Table of contents Warranty Specifications Standards

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Chapter 1

Introduction Unpacking and inspection Accessories supplied Connectors, Controls, Indicators Front panel controls and indicators (see Figure 1) Rear panel connectors and indicators (see Figure 1) Installation Pretest procedure Pretest noise recovery period Elimination of ambient noise Permissible noise levels Recycling / disposal

12 12 13 13 15 16 17 17 18 18 19

Chapter 2

Battery Option NiCad BATTERY OPERATION Recharging NiCad batteries Replacing NiCad batteries Alkaline battery installation/operation

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Chapter 3

Operation Preliminary check Instructing the subject Placing the earphones Response handswitch Audiogram form Routine calibration check Routine test administration HL control (F3) Range Extension pushbutton (F2) 3.7.3 Tone Type Selector (F9) Typical testing session Pretest Review Familiarization Determining the threshold (Pure Tone) Testing procedure

28 29 29 30 30 31 32 32 32 32 33 33 33 34 34

Chapter 4

Routine Maintenance Calibration Earphone cords Hum and random noise Distortion and frequency shift Special messages CAL Exx Bibliography

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Warranty We, Grason-Stadler, Inc. 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, it will be repaired, or at our option, replaced at no charge except for transportation costs, when returned to an authorized Grason-Stadler service facility. If field service is requested, there will be no charge for labor or material; however, there will be a charge for travel expense at the service center’s current rate. NOTE: Changes in the product not approved in writing by Grason-Stadler shall void this warranty. Grason-Stadler shall not be liable 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, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OF FITNESS FOR A PARTICULAR PURPOSE.

! WARNING The GSI 17 is designed to be used with a hospital grade outlet. Injury to personnel or damage to equipment can result when a three-prong or two-prong adapter is connected between the GSI 17 power plug and an AC outlet or extension cord. Additionally, the GSI 17 is equipped with a specific power transformer which should not be interchanged with any other transformer or supply. This symbol

indicates the location of a service adjustment part and

is intended for service personnel only. The GSI 17 is a specifically calibrated audiometer and the periodic service and adjustments for the instrument that may be required should be done only by an authorized Grason-Stadler service technician.

! CAUTION The GSI 17 is designed to comply with the EMC requirements according to IEC 60601-1-2. Radio transmitting equipment, cellular phones, etc. shall not be used in the close proximity of the device since this could influence the performance of the device. Particular precaution must be considered during use of strong emission sources such as High Frequency surgical equipment and similar device so that e.g., the HF-cables are not routed on or near the device. If in doubt, contact a qualified technician or your local representative. Refer to the Electromagnetic Compatibility (EMC) Guide on CD 482-638702. 01-05-09

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Specifications Standards The GSI 17 meets ANSI S3.6 and IEC 645 Type 4 Audiometer Standards. UL 60601-1 Medical Electrical Equipment Requirements for Safety IEC/EN 60601-1 General Requirements CSA C22.2 No.601-1-M90 Protective Classification This system is intended for continuous operation and has a protective classification of Class II, Type B. Class II

Type B

equipment symbols

Degree of protection against harmful ingress of water: Ordinary (no protection) Frequency Range Discrete Frequencies: 125, 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, 8000 Hz Accuracy: ±3% Total Harmonic Distortion: <2% Intensity Ranges: 125 Hz, 500 to 6000 Hz, 250 and 8000 Hz,

-10 to 50 dB HL -10 to 90 dB HL -10 to 70 dB HL (Increments of 5 dB steps)

Note: A “+10” dB switch extends maximum at all frequencies by 10 dB. Accuracy: 125 to 4000 Hz, ±3 dB 6000 to 8000 Hz, ±5 dB Signal to Noise Ratio: >70 dB

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Tone Type Rise/Fall Time: Continuous: Pulsed: FM:

20-50 msec Steady when present bar depressed 2.5 pulse/sec 5 Hz, ±5%

Head set Telephones TDH39 Earphones with MX41AR Cushions (60 ohm impedance). Power Line Voltage: Range: Consumption: Battery Types: Capacity:

Environmental Temperature: Operating: Powerline Storage: Battery Storage: Humidity: Warm-up Time: Mechanical Dimensions: Weight

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100-240 V (±10%) Note: Desktop power supply 50-60 Hz (± 5%) 9 Watts

Rechargeable (NiCad) or Non-Rechargeable (Alkaline) Range: 7.0 V - 9.0 V NiCad: - 22 hours continuous operations Alkaline: - 45 hours continuous operations

60° F to 105° F (15° C to 40° C) -40° F to 140 ° F (-40° C to 60° C) -40° F to 105° F (-40° C to 40° C) 5% to 90% 10 minutes for instruments stored at room temperature

13.25" W x 14" D x 3.75" H (33.66 cm x 35.56 cm x 9.53 cm) 5.6 lb (2.53 kg) net 8 lb (3.64 kg) shipping 10 lb (4.55 kg) shipping with battery included

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Supplied Accessories Catalog Numbers Test headset (TDH39) 8000-0175 Audiogram Forms (1 pad of 50) 1717-9600 Instruction Manual 1717-0100 Battery Pack Assembly (used with 1717-9710, 1717-9715 models only) 1717-2010 AC Power Module 8000-0246 120V (US) Power Cord 4204-0251 220V (Euro plug) Power Cord 4204-0271 Contact GSI for complete list of available power cords GSI 17’s with serial numbers below # 0856 require a different power module. Contact GSI for correct catalog replacement number. Optional Accessories Response Handswitch 7874-0156 Patch Cord, 2 Conductor 4204-0505 Audiocups 8000-0155 Battery 8410-0060 Battery Pack Assembly 1717-2010 Battery Pack includes GSI supplied NiCad battery. May also be used with six (6), Size C, Alkaline batteries (not included) Replacement NiCad Catalog Listings GSI 17 Audiometer, AC Power (USA) GSI 17 Audiometer, AC Power and Battery (USA) GSI 17 Audiometer , AC Power (Export) GSI 17 Audiometer, AC Power and Battery (Export)

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1717-9700 1717-9710 1717-9705 1717-9715

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Chapter 1

Introduction The GSI 17 Audiometer is a single-channel, pure tone, air conduction, portable instrument designed to provide basic audiometric screening capability for physicians’ offices, schools and industry. The lightweight design allows easy transport to a variety of testing locations, and the built-in storage cavity and case provide enough room to contain all instrument accessories. The clearly labeled front panel controls and full frequency range make accurate, reliable testing a simple matter for any user. The GSI 17 is a precisely designed and calibrated instrument. With proper care it will deliver accurate sound-pressure levels to subject ears for your hearing screening program. Note: The GSI 17 should be recalibrated yearly (or sooner if a problem develops). See Chapter 4.

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Unpacking and inspection Although your GSI 17 was carefully tested, inspected and packed for shipping, it is good practice after receiving the instrument to immediately examine the exterior of the container for any signs of damage. Notify your carrier if any damage is noted. Carefully remove your GSI 17 from its shipping container. If the instrument appears to have suffered mechanical damage, notify the carrier immediately so that a proper claim can be made. Be certain to save all packing materials so that the claim adjuster can inspect it as well. As soon as the carrier has completed the inspection, notify your Grason-Stadler representative. If the instrument must be returned to the factory, repack it carefully (in the original container if possible) and return it prepaid to the factory for necessary adjustments. Check that all accessories itemized in Accessories supplied below are received in good condition. If any accessories are missing, contact Grason-Stadler immediately. See the Specifications section for the catalog numbers of accessories and also for a listing of optional accessories.

Accessories supplied Test Headset Assembly (TDH39) Audiogram Pad (1 pad of 50) Battery Pack Assembly (used with 1717-9710 and 1717-9715 models only) AC power cord

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Connectors, Controls, Indicators

Figure 1: Front and rear panel.

Front panel controls and indicators (see Figure 1) F1 - Power switch and indicator for ON and OFF. F2 - Range extension pushbutton allows you to increase the stimulus intensity 10 dB above the standard maximum HL at any frequency. When in use, a “+” appears on the LCD. F3 - HL control for setting stimulus intensity level. Level is indicated on LCD. F4 - Present bar for stimulus presentation. F5 - Stimulus being presented via an earphone. Presentation indicated by illuminated green LED. F6 - Subject response indicator shows you when the test subject has pressed the handswitch button by an illuminated green LED (with optional handswitch only). F7 - Control for setting stimulus frequency. Frequency is indicated in the window adjacent to the control. 01-05-09

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F8 - Routing switch for stimulus presentation to the earphone. Left or right indicated by illustration of subject. F9 - Switch for setting the stimulus tone type. FM = warble tone __ = steady tone - - - = pulsed tone F10 - Low battery indicator to alert you of a limited operating time. Recharge or replace batteries (dependent on whether NiCad or Alkaline batteries are used).

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Rear panel connectors and indicators (see Figure 1) R1 - Power input jack (5-pin DIN Connector) with front panel illustration showing its location and a rear panel label giving the input power specifications. R2 -

! Attention, consult accompanying document for instructions or warnings pertaining to these parts.

R3 - Earphone output jacks (standard phone jacks). Front panel illustration shows left and right phone. R4 - Response handswitch input jack (standard phone jack) with front panel illustration showing location. R5 -

Entry by qualified service personnel only.

Note: The above symbol is located inside the storage compartment. It denotes a Type B, Class II product per IEC 878 as referenced in IEC 60601-1.

Note: There is a symbol on the bottom panel (marked B1 in Figure 2) that indicates entry by qualified service personnel only.

B1 Figure 2 : Bottom panel.

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Installation 1. Plug the power cord into the appropriate jack (R1) on the back panel of the instrument. 2. Plug the other end into a line power (mains) outlet. 3. Plug the earphones into the earphone jacks (R3) on the rear panel. Note the symbol along the top of the front panel, which indicates which is right (RED) and which is left (BLUE). 4. Turn the power switch to ON. Note: For battery operation, please refer to Chapter 2.

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Pretest procedure Note: The GSI 17 is a versatile audiometer designed for use in doctor offices, schools, industrial settings, the military, etc. The generic term “subject” used in this manual is used to identify the person whose hearing is being evaluated. Any program aimed at obtaining reliable records of hearing thresholds should be staffed and supervised by appropriately-trained individuals. Training courses leading to certification are available for audiometric technicians in most urban areas. Two prerequisites are of particular importance to the procurement of reliable audiograms: • Prior to testing, allow adequate time for the subject to recover from the effects of a previous exposure to high-level sound. • Tests should be performed in a quiet area.

Pretest noise recovery period Exposure to high levels of sound (unmuffled lawn mowers, power tools, loud music, gunfire, etc.) tends to create a temporary threshold shift (TTS), which diminishes with time after exposure. Any subject tested soon after such exposure may manifest a hearing loss that does not reflect the subject’s normal hearing threshold. It is, therefore, important that the testing procedure prescribe some time interval - usually at least 16 hours - between the last exposure to high-level sound and the administration of any hearing test.

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Elimination of ambient noise Excessive noise in the test environment such as that produced by conversation, typewriters, or other machines also reduces test validity because it tends to mask the test signals particularly at the lower frequencies where earphone cushions provide less effective attenuation. An acoustically tested room may be required if ambient noise at the subject’s ears reaches objectionable levels - i.e., sufficient to cause apparent hearing loss at the low frequencies. Also, Audiocups are available from GSI as an optional accessory. If the test subject is in the same room as the audiometer, it is recommended that the subject be seated about 1 meter (-3 ft) away from the instrument. Maximum permissible test environment sound-pressure levels are specified by American National Standard Criteria for Permissible Background Noise during Audiometric Testing, S3.1-1977 (revised). Table 2 shows the maximum background levels that can be present inside the room while a valid hearing test is being conducted. For more comprehensive information about hearing testing and hearing conservation, refer to the Bibliography.

Permissible noise levels Test Tone Frequency (Hz)

125

250

500

750

1000

1500

2000

3000

4000

6000

8000

* Test Room**

34.0

22.5

19.5

21.5

26.5

26.5

28.0

33.5

34.5

38.0

43.5

29.0

17.5

14.5

16.5

21.5

21.5

23.0

28.5

29.5

33.0

38.5

Test Room

*Ears covered maximum permissible octave band levels. **Ears covered maximum permissible one-third octave band levels.

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Recycling / disposal

!

CAUTION Many local laws and regulations consider electric equipment-related waste as hazardous or requiring special procedures to recycle or dispose of. This includes batteries, printed circuit boards, electronic components, wiring and other elements of electronic devices. Follow all of your respective local laws and regulations for the proper disposal of batteries and any other parts of your system such as monitors, amplifiers, keyboards, electrodes, etc. Check the Cardinal Health website for recommended instructions and addresses for proper return or disposal of electronic wastes relating to Cardinal Health products in Europe and other localities. The contact information for the WEEE - In Europe Cardinal Health GmbH NeuroCare Group D-97204 Hoechberg Germany Tel: +49 (0) 931-4972-309 Fax: +49 (0) 931-4972-318

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