GSI 18 User Guide Rev 00 September 2008

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Safety summary In this manual, two labels identify potentially dangerous or destructive conditions and procedures:

! WARNING The WARNING label identifies conditions or practices that may present danger to the patient and/or user.

! CAUTION The CAUTION label identifies conditions or practices that could result in damage to the equipment. NOTE: Notes help you identify areas of possible confusion and avoid potential problems during system operation.

Safety notes

! WARNING The GSI 18 is designed for compliance to IEC and UL 60601-1 when used in the patient vicinity. To achieve this compliance, use of hospital grade plug and receptacles is required. For patient and operator safety, the GSI 18 must be used with properly grounded plug and receptacles at all times. The GSI 18 is equipped with a specific power transformer (ref: 113-405900), which should not be interchanged with any other transformer or supply. Any program aimed at obtaining reliable records of hearing thresholds should be staffed and supervised by appropriately-trained individuals. Latex is not used any where in the manufacturing process. The base material for the earphone cushions is made from natural and synthetic rubber.

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! WARNING This symbol indicates the location of a service adjustment part and is intended for service personnel only. The GSI 18 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 GSI service technician. Please read the entire manual prior to using the GSI 18 to familiarize yourself with the test functions and proper accessory connections. Accessory equipment connected to the analog and digital interfaces must be certified to the respective IEC standards (IEC950 for data processing or IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Everybody who connects additional equipment to the signal input or signal output port configures a medical system, and is therefore responsible that the system complies with the requirements of the system standard IEC60601-1-1. If in doubt, consult the technical service department or your local representative.

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Warranty We, Cardinal Health 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 Cardinal Health/GSI product 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 Cardinal Health shall void this warranty. Cardinal Health 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.

Printing history 1st printing: September 2008

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European authority representative Cardinal Health Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg Germany Tel: (49) 931-4972 - 308 Fax: (49) 931-4972 - 62308 Email address: [email protected]

Specifications The GSI 18 meets: ANSI S3.6 (2004)

Specification for Audiometers (Type 4)

IEC 60645-1 (2002)

Electroacoustics - Audiological Equipment Pure Tone Audiometers (Type 4) It is Class 1, internally powered with Type B applied parts.

IEC 60601-1 (2003)

Medical Electrical Equipment Part 1 - General Requirements for Safety

UL 60601

Medical Electrical Equipment, Part 1 -General Requirements for Safety

CAN/CSA-C22.2 No. 601.1-M90 (2003)

Medical Electrical Equipment - Part 1: General Requirements for Safety

IEC/EN 60601-1-2 (2001)

Medical Electrical Equipment Part 1 Electromagnetic compatibility requirements

0344

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

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Frequency Range Discrete Frequencies:

125, 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, 8000 Hz

Accuracy:

±2%

Total Harmonic Distortion:

<2.5% measured acoustically at the maximum Hz for frequencies below 5000 Hz and measured electrically above 5000 Hz.

Intensity Ranges

In increments of 5 dB steps

125 Hz

-10 to 50 dB HL

500 to 6000 Hz

-10 to 90 dB HL

250 and 8000 Hz

-10 to 70 dB HL

The above intensity ranges apply to the TDH 39 earphones. NOTE:The maximum output values in dB HL are reduced by 10 dB when insert phones (EAR 3A/5A) are used, except for 6 kHz where the maximum dB HL is reduced by 20 dB. NOTE:A “+10” dB button extends the 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

Tone Type Rise/Fall Time:

20-50 msec

Continuous:

Steady when present bar depressed

Pulsed:

2.5 pulse/sec

FM:

±5%, 5 Hz, Triangular modulation

Head set Telephonics TDH 39 Earphones with MX41AR Cushions (60 ohm impedance). Headband

Revised 9/2/08

Exerts a force between 4 and 5 N when the earphones are separated by 145mm.

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Power Line Voltage:

The AC-DC adapter is a universal auto-ranging with an input voltage range of 90 - 264V at 47 - 63 Hz.

Consumption:

1.5 Watts

Battery Types:

5 each: Alkaline AA 1.5V 5 each: Rechargeable Nicad or NIMH AA 1.2V. NOTE: The instrument does not provide a recharging circuit for these batteries.

Capacity:

Minimum of 10 hours of power for either battery type. A Low Battery icon will display when there is approximately 1 hour left of power.

Environmental Temperature Operating:

59° F to 104° F (15° C to 40° C) NOTE: Warm-up time is required if storage temperature is different from room temperature.

Ambient Pressure:

98 kPa to 104 kPa

Warm-up Time:

10 minutes for instruments stored at room temperature

Storage/Shipping:

-30° F to 149° F (-34° C to 65° C)

Battery Storage:

-4° F to 105° F (-20° C to 40° C)

Humidity:

15% to 95%

Mechanical Dimensions:

12.59” W x 8.76” D x 3.18” H (32 cm W x 22.3 cm D x 8.1 cm H)

Weight

2.55 lbs (1.16 Kg) with 5 AA batteries

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Supplied Accessories

Catalog Numbers

Test headset (TDH39) (with Headband)

8000-0178

Audiogram Forms (1 pad of 50)

1717-9600

Instruction Manual

1718-0100

Bag, Carrying

143-414700

AC Power Module (1718-9700 or 1718-9701 only) Power Supply

113-405900

5 each, AA Alkaline Batteries (1718-9705 or 1718-9706 only) Quick Reference Guide - Threshold Audiometry

1717-0140

Optional Accessories Response Handswitch

7874-0156

Patch Cord, 2 Conductor

4204-0505

Audiocups

8000-0155

Insert Phone Assembly 3A (50 ohm impedance)

1700-0441

Insert Phone Assembly 5A (50 ohm impedance)

1700-0882

! WARNING Use only Cardinal Health supplied components and accessories.

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Table of Contents

Safety summary ...0-i Safety notes

0-i

Warranty ... 0-iii Printing history ... 0-iii European authority representative...0-iv Specifications ...0-iv

1 Introduction Customer responsibility...1-2 Unpacking and inspection ...1-3 Accessories supplied

1-3

Recycling / disposal...1-4 Installation ...1-5 Rear panel connectors...1-5 Bottom panel ...1-7 Controls and indicators...1-8 LCD display...1-10 AC power...1-12 Connecting the AC power Disconnecting the AC power

1-12 1-12

Battery operation ...1-13 Sleep mode ...1-13 Low battery indicator ...1-13 Replacing the batteries ...1-14 Removing batteries Placing new batteries

1-15 1-16

2 Operation Preliminary check...2-1 Pretest noise recovery period...2-2 Test environment ...2-3 Providing patient instructions...2-4 Placing the earphones ...2-5 Response handswitch GSI Audiogram Form

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2-6 2-6

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GSI 18 Routine test administration ... 2-7 Transducer selection HL knob (F12) Range Extension pushbutton (F1) Tone Type selector (F3, F4, F5)

2-7 2-7 2-8 2-8

Typical testing session ... 2-9 Pretest review Familiarization Determining the threshold (Pure Tone) Testing procedure

2-9 2-9 2-10 2-10

3 Routine Maintenance Preventive maintenance ... 3-1 Recommended cleaning solutions Cleaning the system Cleaning patient contact reusable devices

3-1 3-2 3-2

Routine calibration check ... 3-3 Calibration check ... 3-4 Earphone cords ... 3-4 Hum and random noise... 3-5 Distortion and frequency shift ... 3-5 Special messages ... 3-6 Cal... 3-6 Exx... 3-7

4 Electromagnetic Compatibility (EMC) 5 Bibliography Appendix A - GSI Country Kit Appendix B - Reference Threshold Values

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1 Introduction The GSI 18 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. The clearly labeled front panel controls and full frequency range make accurate, reliable testing a simple matter for any user. The GSI 18 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 18 should be calibrated yearly (or sooner if a problem develops) by a Cardinal Health/GSI certified technician. See Chapter 3.

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GSI 18 Customer responsibility

! WARNING This product and its components will perform reliably only when operated and maintained in accordance with the instructions contained in this 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 or are plainly worn, distorted or contaminated should be replaced immediately with clean, genuine replacement parts manufactured by or available from Cardinal Health/GSI. This product should not be used in the presence of fluid that can come into contact with any of the electronic components or wiring. Should the user suspect fluids have contacted the system components or accessories, the unit should not be used until deemed safe by a Cardinal Health/GSI certified service technician. Do NOT use in the presence of flammable gaseous mixtures. Users should consider the possibility of explosions or fire when using this device in close proximity to flammable anesthetic gases. Periodically have a service technician perform electrical safety checks on the unit in order to show continued compliance to IEC and UL 60601-1.

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General Information

Unpacking and inspection Although your GSI 18 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 18 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 GSI 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 GSI immediately. See the Specifications section for the catalog numbers of accessories and also for a listing of optional accessories.

Accessories supplied • Carrying Case • Test Headset Assembly (TDH39) • Audiogram Pad (1 pad of 50) • AC Power Module and Cord • GSI 18 Audiometer Instruction Manual • How to Conduct Threshold Audiogram Quick Card

! WARNING Only use Cardinal Health/GSI approved parts and accessories. The use of parts or materials that are not recognized to be used with the device can degrade minimum safety.

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GSI 18 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.D-9 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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General Information

Installation 1. Plug the power cord into the appropriate jack (R5) on the rear panel. 2. Plug the power cord from the Power Module into a line power (mains) outlet. 3. Plug the earphones into the earphone jacks on the rear panel. R3 is for the right and R4 is for the left earphone/insert phone. 4. Turn the power switch to ON (R6).

Rear panel connectors R1

R2

R3

R4

R5

R6

Figure 1: Rear panel connectors. R1 - Covered by a sticker and intended for service personnel only. R2 - Patient Hand Switch input jack (standard phone jack). R3 - Right ear phone output jacks (standard phone plug). You can insert either Headphone or Insert Earphone jacks. R4 - Left earphone output jacks (standard phone jack). You can insert either Headphones or Insert Earphone plugs. R5 - Power Input jack (2.1 mm pin). R6 - Power switch. Press the switch to the left to turn the power on.

Table of symbols on the GSI 18 No.

1

Symbol

!

Description Attention, consult accompanyinig documents.

2

Date of manufacture.

3

CE Marked in accordance with the European Council Directive 93/42/EEC concerning medical devices.

4

Medical device listing mark for U.S. and Canada by Intertek Tesing Service.

5

Special Recycling Required. Do not dispose in landfill.

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GSI 18

No.

Symbol

6 7

Description Type B equipment.

REF

8

Symbol for “CATALOG NUMBER.” Stand-by.

9

Right Ear. R

10

Left Ear. L

11

Patient Response Button.

12

AC Power

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General Information

! WARNING Do not turn on/off system power while a patient is wearing the headsets or insert earphones. Use only the Cardinal Health/GSI provided power supply. The GSI 18 provided power supply should only be connected to a power source meeting the following range 90246VAC, 47-63Hz. In North America the power source should be a maximum of 120VAC.

Bottom panel

B1

B2 Figure 2

B1 - Serial number of system. B2 -Battery compartment See Replacing the Batteries for detailed instructions.

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GSI 18 Controls and indicators F1

F2

F3

F4

F5

FM +10dB

R

L

dB HL

Hz Ref / ANSI S3.6 / ISO 389

F12

F11

F10

F9

F8

F7

F6

Figure 3: Front panel controls and indicators. F1 -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. F2 -Liquid Crystal Display (LCD). F3 -Selects steady stimulus tone type. The symbol corner of the display if selected.

is shown in the upper right hand

F4 -Selects pulsed stimulus tone type. The symbol corner of the display if selected.

is shown in the upper right hand

F5 -Selects frequency modulated stimulus tone type. FM is shown in the upper right hand corner of the display if selected.

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