GSI TympStar User manual Versions 1

5 (1)

Grason-Stadler

GSI® TympStar Versions 1 and 2

Middle-Ear Analyzer

Service Manual

Reference Instruction Manual 2000-0110, Rev3.0

Printed October, 2002

GSI

 

 

 

 

 

Grason-Stadler - A Division of VIASYS Healthcare

 

 

Grason-Stadler

 

 

 

 

5225 Verona Road, Building 2, Madison, WI 53711

 

 

 

 

TEL:608-441-2323,800-700-2282,FAX:608-441-2234

 

 

 

 

 

 

 

 

Title: GSI TympStar Versions 1 and 2

Middle-Ear Analyzer

Service Manual

Date:

October, 2002

Copyright © 2001 Grason-Stadler. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of Grason-Stadler. The information in this publication is proprietary to Grason-Stadler.

Part number:

2000-0110

 

 

Printing history:

November, 2001

First printing

Rev 1.0

 

June, 2002

Second printing

Rev 2.0

 

October, 2002

Thirdprinting

Rev 3.0

Warranty for the GSI TympStar Versions 1 & 2

Grason-Stadler warrants the GSI TympStar Versions 1 and 2 to be free of original defects in material and workmanship and to perform in accordance with manufacturer’s specifications for a period of one year from the date of purchase. If this instrument or any component thereof is found to be defective or at variance from the manufacturer’s specifications during the warranty period, Grason-Stadler will repair, replace, or recalibrate the instrument or component at no cost to the purchaser.

This warranty only applies to instruments purchased new from Grason-Stadler or its authorized distributors or representatives. The purchaser must return the instrument directly to Grason-Stadler or an authorized GSI TympStar distributor or representative and bear the costs of shipping.

This warranty does not cover breakage or failure due to tampering, misuse, neglect, accidents, modification, or shipping, and is void if the instrument is not used in accordance with manufacturer’s recommendations or if repaired or serviced by other than Grason-Stadler or a Grason-Stadler authorized representative.

WARNING

The GSI TympStar Versions 1 and 2 are designed to be used with a hospital grade outlets. Injury to personnel or damage to equipment can result when a three-prong adapter is connected between the instruments’s power plug and an A/C outlet or extension cord.

Accessory Hazard Warning

This IEC 601-l/CSA C22.2 No. 601.1M90 listed medical instrument should be interconnected with accessories that have proper electrical compatibility and which are listed as conforming to Part 1: General Requirements for Safety of the UL Medical Electrical Equipment Standard UL2601-1. Connection of accessories not meeting these requirements may result in electrical leakage currents in excess of those allowed by the standard and present a potential electrical shock hazard to the person being tested.

User manuals

Installation, setup and

operating information can be found in the Reference

 

Instruction Manuals:

 

 

TympStar Version 1:

2000-0100

 

TympStar Version 2:

2000-0120

Service personnel

Repair and/or bench testing of the GSI TympStar Version 1 and Version 2

 

instruments should be performed only by trained personnel. The following

 

instructions are provided primarily for use by persons who are skilled in the

 

repair of electronic equipment.

Electrical safety

CAUTION

 

The GSI TympStar Version 1 and Version 2 instruments are

 

IEC 601-1/CSA approved; consequently if any parts are re-

 

placed during the repair of these units, only exact replace-

 

ments should be made. Any alterations of the present elec-

 

trical or mechanical construction or components will void

 

these safety approvals.

CMOS handling

Many of the integrated circuits on the PC Boards are constructed of CMOS

 

and NMOS materials. Please observe the following precautions:

CAUTION

Failure to observe the following precautions whenever a circuit board or an integrated circuit package is handled can result in damage to the GSI TympStar Version 1 or Version 2 instrument. Please observe these precautions:

1) Place the instrument and parts on a grounded, conductive work surface.

2) Ground yourself (with a strap having about 1 Meg-Ohm resistance) to discharge or prevent static charges.

3) Ground the frame of any test instrument or soldering iron to be used. 4) If any circuit boards are to be stored or transported, enclose them in

conductive (antistatic) envelopes.

Contents

Introduction ..................................

1-1

General .....................................................................................................................

1-1

Version 1 ...................................................................................................................

1-2

Version 1 equipment connections and options .....................................................

1-2

Version 2 ...................................................................................................................

1-3

Version 2 equipment connections and options .....................................................

1-3

The probe .................................................................................................................

1-4

Instrument controls .................................................................................................

1-5

Hardkeys and softkeys .........................................................................................

1-5

Rotary pressure control .......................................................................................

1-5

Test modes and menu navigation ..........................................................................

1-5

Changing parameter settings..................................................................................

1-7

Menu diagrams ........................................................................................................

1-7

GSI default parameter settings ...............................................................................

1-7

Specifications ...............................

2-1

Introduction ..............................................................................................................

2-1

Standards .................................................................................................................

2-1

Version 1 Specifications ...................................................

2-1

Sensitivity ranges ....................................................................................................

2-2

Probe signal .............................................................................................................

2-2

Pneumatic System ...................................................................................................

2-3

Acoustic Reflex Activating (Stimulus) Signal .........................................................

2-3

Stimulus Presentation Control ................................................................................

2-5

Temporal Specifications of Stimulus Presentation ...............................................

2-5

Environmental ..........................................................................................................

2-6

Warm-Up Time..........................................................................................................

2-6

Calibration Stability ..................................................................................................

2-7

Connectors ...............................................................................................................

2-7

Electrical ...................................................................................................................

2-8

Supplied Accessories ..............................................................................................

2-9

Mechanical ...............................................................................................................

2-9

Materials of manufacture ........................................................................................

2-9

GSI TympStar Version 1 and Version 2 Service Manual

Contents - 1

Table of Contents

 

Calibration requirements .........................................................................................

2-9

Version 2 Specifications .................................................

2-10

Standards ...............................................................................................................

2-10

Sensitivity ranges ..................................................................................................

2-11

Temporal Latency in ARLT Mode ..........................................................................

2-12

Multi Frequency .....................................................................................................

2-12

Probe Signal (Sinusoidal) ......................................................................................

2-12

Pneumatic System .................................................................................................

2-13

Acoustic Reflex Activating (Stimulus) Signal .......................................................

2-13

Click Stimulus ........................................................................................................

2-16

Stimulus ..................................................................................................................

2-16

Presentation Control..............................................................................................

2-16

Temporal Specifications Of Stimulus Presentation ............................................

2-17

Environmental ........................................................................................................

2-17

Warm-Up Time........................................................................................................

2-17

Calibration Stability................................................................................................

2-18

Connectors .............................................................................................................

2-18

Electrical .................................................................................................................

2-19

Supplied Accessories ............................................................................................

2-20

Mechanical .............................................................................................................

2-20

Materials of manufacture ......................................................................................

2-20

Calibration requirements .......................................................................................

2-20

Operation summary......................

3-1

Front panel controls .........................................................

3-1

Hardkeys...................................................................................................................

3-2

Tymp ....................................................................................................................

3-2

Reflex ...................................................................................................................

3-2

Etf .........................................................................................................................

3-2

Special .................................................................................................................

3-2

Page .....................................................................................................................

3-2

Print ......................................................................................................................

3-2

Remote .................................................................................................................

3-2

Data Transfer .......................................................................................................

3-2

Pressure control ...................................................................................................

3-2

Manual .................................................................................................................

3-2

Hold ......................................................................................................................

3-2

Stop ......................................................................................................................

3-2

Start ......................................................................................................................

3-3

Stimulus ...............................................................................................................

3-3

Intensity ................................................................................................................

3-3

Contents - 2

Grason-Stadler

Table of Contents

 

Present .................................................................................................................

3-3

LCD hardkeys...........................................................................................................

3-3

Clear ....................................................................................................................

3-3

Erase ....................................................................................................................

3-3

Return...................................................................................................................

3-3

Softkeys ....................................................................................................................

3-3

Menus and LCD screens .................................................

3-4

Menus .......................................................................................................................

3-4

Program modes........................................................................................................

3-5

Version 1 probe tone frequencies ..........................................................................

3-5

Version 2 probe tone frequencies ..........................................................................

3-5

Version 1 LCD graphic traces .................................................................................

3-5

Version 2 LCD graphic traces .................................................................................

3-5

Probe lights ..............................................................................................................

3-6

LCD screen ...............................................................................................................

3-6

Erasing and clearing test data ................................................................................

3-7

Version 2 External reflex test stimuli .....................................................................

3-7

Paging test data .......................................................................................................

3-7

Version 2 cursor.......................................................................................................

3-8

Printing tests ............................................................................................................

3-8

Preparing an external printer ..................................................................................

3-8

Setting the printer parameters ..............................................................................

3-9

Left column printout data ....................................................................................

3-10

Color or black and white ....................................................................................

3-10

Changing Instrument Versions .......................................

3-11

Changing from a Version 2 to a Version 1 ...........................................................

3-11

Switching to V1 temporarily................................................................................

3-12

Switching back to V2 ..........................................................................................

3-12

Switching to V1 permanently ..............................................................................

3-12

Changing from a Version 1 to a Version 2 ...........................................................

3-13

Obtaining a License Code ..................................................................................

3-14

Replacing the V1 Probe with a V2 Probe ...........................................................

3-15

Switching to Version 2 software .........................................................................

3-16

Version 1 test procedures ..............................................

3-17

Tymp diagnostic.....................................................................................................

3-17

Manual Tymp ..........................................................................................................

3-17

Tymp screening .....................................................................................................

3-18

Reflex threshold .....................................................................................................

3-18

Automatic Auto Zero ...........................................................................................

3-18

Mark Threshold ..................................................................................................

3-19

Reflex Threshold Seeking ..................................................................................

3-19

Reflex decay ...........................................................................................................

3-20

Eustachian tube function ......................................................................................

3-20

Pressure Swallow Test (intact TM) .....................................................................

3-20

GSI TympStar Version 1 and Version 2 Service Manual

Contents - 3

Table of Contents

 

Perforated Ear Test (Perforated TM) ..................................................................

3-20

Auto sequence testing ..........................................................................................

3-21

Programming auto sequence tests ......................................................................

3-21

Version 2 test procedures ..............................................

3-22

Tymp diagnostic.....................................................................................................

3-22

Manual tymp ...........................................................................................................

3-23

Tymp screening .....................................................................................................

3-23

Reflex threshold .....................................................................................................

3-24

Automatic auto zero ...........................................................................................

3-25

Mark Threshold ..................................................................................................

3-25

Reflex Threshold Seeking ..................................................................................

3-25

Reflex decay ...........................................................................................................

3-26

Acoustic reflex latency test (ARLT) ......................................................................

3-26

Acoustic reflex sensitization (A.R. SENSI) ...........................................................

3-27

Eustachian tube function ......................................................................................

3-28

Pressure Swallow Test (intact TM) .....................................................................

3-28

Perforated Ear Test (Perforated TM) ..................................................................

3-28

Multiple frequency tympanometry (MULTIPLE Hz) .............................................

3-29

Auto sequence testing ..........................................................................................

3-30

Programming auto sequence tests ......................................................................

3-31

Calibration ....................................

4-1

Introduction ..............................................................................................................

4-1

When to calibrate the TympStar .............................................................................

4-2

Calibration requirements .........................................................................................

4-2

Complete calibration sequence ............................................................................

4-2

Routine calibration sequence ...............................................................................

4-3

Preparing for calibration ...................................................

4-4

Tools and equipment required ................................................................................

4-4

Cleaning the probe and Contra phone ...................................................................

4-4

Probe....................................................................................................................

4-4

Contra phone........................................................................................................

4-5

Cal/Normal switch ............................................................

4-6

Cal Option DIP switch ......................................................

4-6

Switch 1: Factory use only ...................................................................................

4-7

Switch 2: GSI/custom RTL transducer calibration..............................................

4-7

Switch 3: Unused ...................................................................................................

4-7

Switch 4: Unused ...................................................................................................

4-7

Switch 5: Unused ...................................................................................................

4-7

Switch 6: Diagnostic mode ...................................................................................

4-8

Contents - 4

Grason-Stadler

Table of Contents

 

Hardware Diagnostics .............................................................................................

4-8

DAC LEVELS .......................................................................................................

4-9

IPSI SOURCE.....................................................................................................

4-11

IPSI ON/OFF ......................................................................................................

4-11

CONTRA SOURCE ............................................................................................

4-11

CONTRA ON/OFF.............................................................................................

4-12

MUX INPUTS .....................................................................................................

4-12

PROBE/FILER ....................................................................................................

4-13

ROUTING ...........................................................................................................

4-14

PROBE ON/OFF ................................................................................................

4-15

PORTS DIAG. ..........................................................................................................

4-15

RS-232 INT. ON/OFF .........................................................................................

4-15

RS-232 INT. ON/OFF .........................................................................................

4-16

PARALLEL ON/OFF ...........................................................................................

4-16

MISC. DIAG .............................................................................................................

4-17

CALENDAR CLOCK ...........................................................................................

4-18

DISPLAY & LEDS ...............................................................................................

4-20

KEYS ..................................................................................................................

4-21

DIP SWITCHES ..................................................................................................

4-22

EEPROM ............................................................................................................

4-22

SOFTWARE TIMER ...........................................................................................

4-23

WATCHDOG TIMER ..........................................................................................

4-24

ERROR LOG ...........................................................................................................

4-25

Switch 7: Self-Cal..................................................................................................

4-26

Switch 8: Load default calibration data...............................................................

4-26

Probe serial number.......................................................

4-26

Resolving problems .......................................................

4-27

Calibration procedures...................................................

4-28

Hardkeys ............................................................................................................

4-28

Softkeys .............................................................................................................

4-29

Printing calibration sheets ..................................................................................

4-30

Adjusting Cal HL and Target SPL levels.............................................................

4-31

Custom transducers ..............................................................................................

4-32

Transducerconnections ........................................................................................

4-32

Calibration requirements .......................................................................................

4-33

Complete calibration sequence ..........................................................................

4-33

Routine calibration sequence .............................................................................

4-33

TympStar Version 1 Calibration......................................

4-33

Version 1 Calibration Procedures...................................

4-34

Self-Cal ...................................................................................................................

4-34

Loading default data ..............................................................................................

4-35

Contra, Ipsi and Probe tone calibration ...............................................................

4-36

Contra SPL Cal ..................................................................................................

4-36

GSI TympStar Version 1 and Version 2 Service Manual

Contents - 5

Table of Contents

 

Ipsi SPL Cal .......................................................................................................

4-37

Probe Tone SPL Cal...............................................................................................

4-38

Y Cal ........................................................................................................................

4-39

Altitude Cal .........................................................................................................

4-39

Pressure Cal ...........................................................................................................

4-41

Set ambient ........................................................................................................

4-42

Set -600/400 ............................................................................................................

4-44

Leak rate ............................................................................................................

4-45

Verify Cal ................................................................................................................

4-47

Diagnostic...............................................................................................................

4-49

Returning to the Normal Test Mode .....................................................................

4-50

TympStar Version 2 Calibration .....................................

4-51

Calibration requirements ......................................................................................

4-51

Complete calibration sequence ..........................................................................

4-51

Routine calibration sequence.............................................................................

4-51

Version 2 Calibration Procedures ..................................

4-52

Self-Cal ...................................................................................................................

4-52

Loading default data...........................................................................................

4-53

Contra, Ipsi and Probe tone calibration ...............................................................

4-54

Contra and Ipsi Cal ............................................................................................

4-54

External Input Calibration ...................................................................................

4-55

Click Calibration .................................................................................................

4-55

Contra SPL Cal .......................................................................................................

4-56

Ipsi Channel .......................................................................................................

4-56

Contra Channel ..................................................................................................

4-57

Ipsi SPL Cal ............................................................................................................

4-59

Ipsi Channel .......................................................................................................

4-59

Contra Channel ..................................................................................................

4-60

Probe Tone SPL Cal...............................................................................................

4-62

Y/B/G Cal ................................................................................................................

4-64

Altitude Cal .........................................................................................................

4-64

Pressure Cal and diagnostics ...............................................................................

4-66

Returning to Normal Test Mode ...........................................................................

4-66

Disassembly .................................

5-1

Introduction ..............................................................................................................

5-1

Disassembly Procedure ...................................................

5-3

Tools Required .........................................................................................................

5-3

Opening the cover ...................................................................................................

5-3

Removing the analog board ...................................................................................

5-4

Removing the Pump ................................................................................................

5-6

Contents - 6

Grason-Stadler

Table of Contents

 

Removing the power supply...................................................................................

5-8

Removing the power module .................................................................................

5-9

Fuse holder ..........................................................................................................

5-9

Removing the LCD contrast control ....................................................................

5-10

Removing the printer board ..................................................................................

5-11

Removing the printer .............................................................................................

5-12

Removing the PC104 Board ..................................................................................

5-15

Removing the digital board ...................................................................................

5-17

Removing the LCD or Softkeypad cables ............................................................

5-20

Removing the LCD .................................................................................................

5-25

Removing the LCD front panel label (softkey panel) ...........................................

5-27

Removing the instrument front panel label..........................................................

5-29

Removing panel keypads.......................................................................................

5-29

System Level Parts ......................

6-1

General .....................................................................................................................

6-1

Assembly drawings ..................................................................................................

6-1

Case/chassis ............................................................................................................

6-2

Overall assembly .....................................................................................................

6-4

LCD assembly ..........................................................................................................

6-5

Top case assembly ..................................................................................................

6-6

Bottom case assembly ............................................................................................

6-7

Instrument assembly ...............................................................................................

6-8

Labels .......................................................................................................................

6-9

Printer Assembly ....................................................................................................

6-11

Hardware description ...................

7-1

General .....................................................................................................................

7-1

System boot sequence ....................................................

7-1

Pre-CP Control .........................................................................................................

7-1

Main() ........................................................................................................................

7-1

Set_op_mode() ........................................................................................................

7-3

Tymp_sk() .................................................................................................................

7-4

Interconnection diagram ..................................................

7-5

Block diagram description of assemblies .............................................................

7-6

LCD assembly .....................................................................................................

7-6

Printer...................................................................................................................

7-6

Probe ...................................................................................................................

7-6

GSI TympStar Version 1 and Version 2 Service Manual

Contents - 7

Table of Contents

 

Pump ...................................................................................................................

7-6

Digital board .........................................................................................................

7-7

PC104 board ........................................................................................................

7-7

Analog board........................................................................................................

7-7

Power supply board ..............................................................................................

7-8

Printer board ........................................................................................................

7-8

System assembly diagram ..............................................

7-9

Troubleshooting ...........................

8-1

System power supply measurements ..............................

8-1

Power Supply (J2) ....................................................................................................

8-1

Power Supply (set +5VDC) ......................................................................................

8-2

Analog Board (J7) ....................................................................................................

8-2

Analog Board (J6) ....................................................................................................

8-2

Analog Board (J10) ..................................................................................................

8-3

Digital Board (J28) ...................................................................................................

8-3

Digital Board (J34) ...................................................................................................

8-3

Printer Board (Full View) .........................................................................................

8-4

Printer Board (J6) ....................................................................................................

8-4

Printer Board (J4) ....................................................................................................

8-4

Printer Board (J8) ....................................................................................................

8-5

Pressure Potentiometer (Digital Board) .................................................................

8-5

Error Codes .....................................................................

8-6

CP Error codes ........................................................................................................

8-6

SP Error codes .......................................................................................................

8-16

Error Messages..............................................................

8-19

LCD problem symptoms and probable causes ..............

8-22

Probe problem symptoms and probable causes ............

8-22

Pump problem symptoms and probable causes ............

8-23

Printer problem symptoms and probable causes ...........

8-23

Hardware Diagnostic mode............................................

8-24

Functional description ...........................................................................................

8-24

Pressure A/D MUX .................................................................................................

8-24

Mic. MUX.................................................................................................................

8-25

Probe tone and filter mode ...................................................................................

8-25

DAC levels ..............................................................................................................

8-25

Routing ...................................................................................................................

8-25

IPSI/CONTRA and OSC l/OSC 2 ............................................................................

8-26

Contents - 8

Grason-Stadler

Introduction

1

General

The GSI TympStar Version 1and Version 2 Middle-Ear Analyzers are techni-

 

cally advanced, computer-based admittance instruments designed to be used

 

in clinical or research settings. The TympStar builds on the sophistication,

 

functionality and flexibility of the GSI 33, offering unparalleled testing capa-

 

bilities. It contains total capabilities for complete, manual or automatic diag-

 

nostic testing for analysis of middle ear function.

 

Operators have a choice of using GSI

 

preprogrammed test parameters, or programming

 

their own test criteria. A large liquid crystal

 

display (LCD) clearly displays test param-

 

eter choices and the possible alterna-

 

tives. Admittance and pressure

 

indications are shown on the

 

LCD along with a

 

continuous digital

 

readout.

Test sta-

 

tus and

invalid

 

choices are also shown

 

on the LCD.

Test results are displayed in real-time. The user can view the results as they are being measured and then has the choice of printing the display or retesting the patient. The high-speed printer generates reports in concise graphical formats that are easy to read.

This manual addresses the service requirements of the Version 1 and the Version 2 instruments, and calls attention to the differences when necessary. Please refer to the appropriate Reference Instruction Manual for more detailed information regarding instrument installation and operation.

GSI TympStar Version 1 and Version 2 Service Manual

1 - 1

 

 

 

 

Chapter 1

Version 1

Admittance (Y) may be measured with a probe tone frequency of 226 Hz. The

 

extensive battery of test mode choices include:

 

• Diagnostic Tympanometry

 

• Acoustic Reflex Threshold and Decay Measurements

 

• Eustachian-Tube Function Testing (Both intact and perforated eardrums)

 

• Screening Tympanometry/Reflex (Automatic Only)

 

The tympanometric measurement results are automatically

 

scaled and presented in equivalent ml of compliance at “Y”,

 

226 Hz. Sensitivity scales for the display of reflex mea-

 

surement results can be selected manually. A cur-

 

sor is available in all test modes for calling out

 

numeric positions on the X and Y

 

axes.

Version 1 equipment

TympStar Version 1 options that can be

connections and

connected to the rear panel include RS232

options

serial communication, a keyboard for entering patient information and a VGA

 

monitor for displaying test results. Other options offered for the TympStar

 

Version 1 for managing and archiving data, include:

 

• Internal memory for storing up to 26 test results

 

• Data export to an external PC via RS232 serial interface

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Not used in TympStar

Version 1

1 - 2

Grason-Stadler

 

 

 

 

Introduction

Version 2

Admittance (Y), and its components Susceptance (B) and Conductance (G), may

 

be measured with probe tone frequencies of 226, 678, and 1000 Hz. The extensive

 

battery of test mode choices include:

 

• Diagnostic Tympanometry

 

• Acoustic Reflex Threshold and Decay Measurements

 

• Eustachian-Tube Function Testing (Both intact and perforated eardrums)

 

• Screening Tympanometry/Reflex (Automatic Only)

 

• Acoustic Reflex Latency Testing

 

• Acoustic Reflex Sensitization

 

• Multiple Frequency Tympanometry (250 Hz to 2000 Hz)

 

The tympanometric measurement results are automatically scaled and presented

 

in equivalent ml of compliance at “Y”, 226 Hz. All “B” and “G” measure-

 

ments and measurements performed at probe tone frequencies of 678 Hz and

 

1000 Hz are expressed in mmhos. Sensitivity scales for the display of reflex

 

measurement results can be selected manually. Reflex test stimuli can be in-

 

put from an external source and presented via external control. A cursor is

 

available in all test modes for calling out numeric positions on the X and Y

 

axes.

Version 2 equipment

TympStar options that can be connected to the rear panel include an external

connections and

stimulus source, an external Present control, RS232 serial communication, a

options

keyboard for entering patient information and a VGA monitor for displaying

 

test results. Other options offered for the TympStar for managing and archiving

 

data, include:

 

• Internal memory for storing up to 26 test results

 

• Data export to an external PC via RS232 serial interface

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Used only in TympStar

Version 2

GSI TympStar Version 1 and Version 2 Service Manual

1 - 3

 

Chapter 1

The probe

The innovative lightweight probe is designed for patient comfort, ease-of-seal, and

 

accurate test results. A wide variety of both standard and special sized eartips are

 

supplied with the GSI TympStar to hermetically seal the ear canal. In addition, a set

 

of screening eartips is provided for screening tymp and reflex tests.

 

The operator has a choice of three mountings to support the probe box; the

 

standard lightweight shoulder mounting, standard clothes clip, or an optional

 

operator wrist attachment. The probe box has 2 LED’s to indicate test status.

 

Within the probe box there are two small loudspeakers, a microphone and a

 

pressure transducer. One loudspeaker delivers the probe tone to the ear canal,

 

while the microphone monitors the intensity of the probe tone within the ear canal.

 

The second loudspeaker delivers the ipsilateral (ipsi) stimuli to the ear canal.

 

The contralateral (contra) insert phone contains its own loudspeaker. The

 

pressure within the ear canal can be varied within the range of +400 daPa

 

to -600 daPa. At no time is it possible to exceed specified maximum

 

limits. Pressure can be varied automatically or manually and from nega-

 

tive to positive or from positive to negative values. Pressure within

 

the ear canal is monitored continuously in order to maintain pressure

 

accuracy throughout each test sequence.

1 - 4

Grason-Stadler

 

Introduction

 

 

Instrument controls

A combination of hardkeys and softkeys are used to select the test modes and

 

parameters and to conduct tests.

 

 

Hardkeys and softkeys

Hardkeys are located on the front panel and the sides of the LCD panel and provide

 

fixed functions that do not change. Softkeys are located directly under the LCD and

 

change to support the requirements of a test session.

 

 

 

LCD panel

 

 

 

Softkey

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hardkeys

 

 

 

 

 

 

Front panel

 

 

 

 

 

 

 

 

 

 

 

Pressure control

Rotary pressure

A rotary pressure control is also provided to change or fine-tune pressure within the

control

ear canal.

 

 

Test modes and menu

Selecting a test mode by pressing a hardkey causes the required test screen to be

navigation

displayed on the LCD with the appropriate menu of test parameters shown across

 

the bottom. The softkeys are then used in conjunction with a few hardkeys to

 

navigate through the menus and set parameter values for the selected tests. For

 

example, pressing the TYMP hardkey causes the Tymp Diagnostic screen to be

Tymp hardkey

displayed.

 

 

Tymp Diagnostic screen

Tymp parameter menu

GSI TympStar Version 1 and Version 2 Service Manual

1 - 5

First level

Second level

First level

Second level

Chapter 1

Pressing the softkeys displayed across the bottom of the LCD allows the user to navigate through the Tymp Diagnostic parameter menus diagrammed below. These menus are from the Version 1, however, the process is the same in both versions. GSI default softkey selections are circled on menu diagrams.

The first level of parameter menu selections includes AUTO SEQUENCE, P-RANGE, START, GRADIENT, EAR and MORE.

AUTO

P-RANGE

START

 

GRADIENT

EAR

MORE

SEQUENCE

daPa

daPa

 

 

 

 

 

 

NORMAL WIDE -600 -400

-200

+200

+400

MORE TYMP WIDTH

RATIO OFF

RIGHT LEFT

 

 

 

 

 

 

daPa

ml

 

 

 

-500

-300

0

+300

MORE

 

 

 

 

 

 

 

 

P-RATE

BASELINE

MORE

 

 

 

 

 

daPa/s

 

 

 

 

 

 

 

12.5 50

200 600/200

ON OFF

 

Default selection

A second level of menus can be displayed by pressing the MORE softkey and includes P-RATE, BASELINE and MORE.

The MORE softkey is used to toggle between the top and lower levels of menus while the test screen portion above the softkeys remains unchanged.

1 - 6

Grason-Stadler

Introduction

Pressing a parameter menu softkey causes a sub-menu of parameter settings to be displayed. Often submenus will also contain MORE softkey selections that provide access to additional setting alternatives.

Sub-menu of

START

 

 

daPa

 

 

START daPa

 

 

 

 

-600 -400

-200

+200

+400

MORE

-500

-300

0

+300

MORE

Sub-menu of

START daPa

Changing parameter

Settings can be changed for a selected parameter by pressing the desired softkey as

settings

shown in this example of changing the Probe Hz from 226 to 1000.

 

Making the new selection returns the display to the previous menu level with the new

 

setting shown above the selected parameter.

 

If no change is desired, the display can be returned to the previous level by

 

pressing the RETURN hardkey.

 

In the manner described above, menus can be navigated and settings can be

 

changed for any of the test modes.

Menu diagrams

Menu structure diagrams like the diagrams shown on these pages will be used

 

throughout the remainder of this manual as a convenience to the user.

GSI default param- GSI default parameters are circled on eter settings menu structure diagrams shown throughout the remainder of this

manual.

START daPa

-600 -400 -200 +200 +400 MORE

GSI default value

-500 -300 0 +300 MORE

GSI TympStar Version 1 and Version 2 Service Manual

1 - 7

Chapter 1

1 - 8

Grason-Stadler

Specifications 2

Introduction

Detailed specifications are provided in this chapter for the TympStar Version 1

 

and TympStar Version 2 instruments. The specifications for each instrument

 

can also be found in its corresponding Reference Instruction Manual.

Version 1 Specifications

Standards

The GSI TympStar Version 1 meets or exceeds the following standards and

 

specifications for aural acoustic admittance instruments:

 

IEC 1027 1991-03

 

ANSI S3.39-1987

 

ANSI S3.6-1996

 

ANSI S3.7-1995

 

IEC 645-1 1992

 

IEC 126-1973 (also BS 6111-1981)

 

BS ISO 389-2 1994

 

Y2K Compliant

 

UL 2601-1 Part 1: General Requirements for Safety

 

CSA C22.2 No. 601.1-M90 (Canada)

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

Mr. Leo Hoogendoorn Nicolet Biomedical GMBH Saalackerstrasse 8

63801 Kleinostheim, Germany Tel: 011-49-6027-46980

Fax: 011-49-6027-469815

EN60601-1:1990 Safety Requirements for Medical Electrical Equipment

EN60601-1-2 Medical Electrical Equipment Emissions and Immunity

Requirements

This equipment has been tested for radio frequency emissions and has been verified to meet Radiated and Conducted Emissions per EN 55011-1998, Group 1, Class A and per CISPR, Class A.

GSI TympStar Version 1 and Version 2 Service Manual

2 - 1

 

 

 

Chapter 2

 

Sensitivity ranges

The following admittance measurements give maximum range at 226 Hz, Y

 

in ml.

 

 

 

 

 

Table 1: Tymp Mode

 

 

 

 

 

 

Frequency

 

Digital Read-Out

Graphical

 

 

 

Including Cursor

Display

 

 

 

 

 

 

226 Hz

 

-7.0 to +7.0

-1.0 to +7.0

 

 

 

 

 

 

Accuracy at 226Hz:

0.1 ml or 5%, whichever is greater.

 

 

 

 

Table 2: Reflex Mode

 

 

 

 

 

 

 

Frequency

 

Digital Read-Out

 

Graphical

 

 

 

Including Cursor

 

Display

 

 

 

 

 

 

 

226 Hz

 

-7.0 to +7.0

 

-0.16 to +0.80

 

 

 

 

 

 

+0.16 to -0.80

 

 

 

 

 

Accuracy: 226 Hz is 0.02 ml or 5%,whichever is greater.

Probe signal

Sinusoidal signal with the following characteristics:

 

Frequency:

 

226 Hz

 

 

Frequency accuracy:

 

±1%

 

 

 

Harmonic distortion:

<2%

 

 

 

(Measured in an HA-1 2cc coupler)

 

 

Signal level:

 

85 dB SPL

 

 

(In Real Ear and in Normal Test Mode)

 

 

NOTE

 

 

 

 

 

The probe tone level is set to be nominally 70 dB HL.

 

Signal level accuracy:

±1.5 dB SPL

 

2 - 2

Grason-Stadler

 

 

Specifications

Pneumatic System

Pressure Maximum Limits: -800 daPa to +600 daPa

 

Programmed Pressure Ranges:

 

Normal:

+ 200 to - 400 daPa

 

Wide:

 

+ 400 to - 600 daPa

 

Pressure Accuracy:

±10% or ±10 daPa, Whichever is greater in cavities

 

 

 

from 0.5 cc to 5.0 cc.

 

Pressure Sweep Rate:

12.5 daPa/sec

 

 

 

50 daPa/sec

 

 

 

600/200 daPa/sec

 

Manual Sweep Rate Limit: 600 daPa/sec

 

Sweep Rate Accuracy:

±10%

 

Pressure System Leak Rate: < 1. 0 daPa/sec

 

(Measured at -600 and +400 daPa, while pressure servo is disabled.)

Acoustic Reflex

Pure Tone Stimulus

 

Activating (Stimulus)

Frequencies for Contra phone and for Ipsi phone with time multiplexed

Signal

stimulus. See Table 3.

 

 

FrequencyAccuracy: ±1%

 

 

Total Harmonic Distortion (Acoustically): <2%

 

(Measured 5 dB HL below guaranteed maximum HL)

 

Noise Stimulus

 

 

 

The uniformity of the spectrum level of acoustic pressure for the noise signal over 20

 

averages measured acoustically within their respective band limits will be:

 

±10 dB for insert or probe type earphones

 

±5 dB for supra-aural type earphones

 

Noise Band Widths:

 

 

Low Band: 125 -1600 Hz

 

High Band: 1600 - 4000 Hz

 

Broad Band: 125 - 4000 Hz (Relative to level at 1 kHz)

 

Band-edges accurate to within ±15%

 

Roll off rate:

>12 dB/Octave

Stimulus Level Control

Tone Stimulus: The transfer of reference equivalent threshold values are based on the article; “Reference Threshold Levels For The ER-3A Insert Phone”, by Laura Ann Wilber, Barbara A. Krueger and Mead C. Killion, J. Acoustic Soc. Am. Suppl. 1, Vol. 81 Spring 1987. GSI determined the transfer data from an IEC 711 coupler to an ANSI HA-1 coupler. Using this data, the reference threshold values were determined for both the Ipsi and Contra insert earphones for calibration in an ANSI HA-1 2cc coupler.

Noise Stimulus: The transfer of reference threshold values was done by GSI using the “Threshold Determination Method”. The transfer data from an IEC 711 to an ANSI HA- 1 coupler was determined by GSI.

GSI TympStar Version 1 and Version 2 Service Manual

2 - 3

Chapter 2

Intensity levels are reduced as a function of volume at a rate of 1 dB SPL for each .1 ml. Intensity reduction begins at 1.2 ml.

Table 3: Upper limit of HL range in Reflex Threshold Mode

110 105

Lower limit of HL range for all stimulus signals (35 dB HL).

Hearing Level Increment:

5.0 dB

Hearing Level Increment Accuracy:

±0.5 dB

Hearing Level Control Linearity:

±1.0 dB

2 - 4

Grason-Stadler

 

Specifications

 

Stimulus

Signal ON/OFF Ratio:

>70 dB

Presentation Control

OFF mode signal level:

<20 dB SPL

 

Signal To Noise Ratio:

>70 dBA

 

Measured with disabled probe signal and “A” weighting for noise

 

measurement.

 

 

Residual noise:

<25 dBA SPL

 

(Stimulus Present switch in OFF position)

 

Unwanted Acoustic Probe Signals:

<60 dBA

Measured while pump is operating and probe tone is disabled. Measure it with “A” weighted filter in “SLOW” Time mode. The noise in normal operating mode will not effect the immittance measurement accuracy.

Signal separation between Ipsi and Contra channels; all frequencies: >70 dB

 

(Measured at the probes with the “ON” channel set to 90 dB)

 

Leaked signal: <20 dB SPL

 

The radiated acoustic noise from the instrument (with reflex stim off) when

 

measured at 1 meter from the instrument, shall be: <50 dBA

 

(“A” weighting and “SLOW” averaging)

Temporal Specifica-

Steady State Stimulus

tions of Stimulus

Initial Delay (elapsed time from present bar activation to 10% stimulus

Presentation

amplitude): < 100 msec

 

Terminal Delay (elapsed time from present bar deactivation to 90% stimulus

 

amplitude): <100 msec

 

Rise time: 7.5 ± 2.5 msec

 

Fall time: 7.5 ± 2.5 msec

 

Multiplexed Stimulus (Used in Reflex Threshold test mode)

Period data for frequencies: 250 and 500 Hz:

Period

124

msec

Stimulus on time

44

msec

Stimulus off time

62

msec

Rise and fall time

18

msec

Period data for all other frequencies:

Period

115 msec

Stimulus on time

44

msec

Stimulus off time

53

msec

Rise and fall time

18

msec

Temporal Spec. Accuracy:

±10% or 5 msec, whichever is greater

GSI TympStar Version 1 and Version 2 Service Manual

2 - 5

 

Chapter 2

 

Environmental

The GSI TympStar Version 1 meets ANSI S3.6-1996 Standards for temperature

 

and humidity specifications, and it meets the UL 2601-1, CSA 22.2 and IEC60601-

 

1 standards for safety.

 

 

Temperature:

 

 

Storage: -40 degrees C to +75 degrees C

 

 

Operating: +15 degrees C to +35 degrees C

 

Humidity: 90% at 35 degrees C (non-condensing)

Warm-UpTime

At room temperature; +15°C to +35°C:

10 Minutes

 

At room temperature; below +15°C:

1 Hour

2 - 6

Grason-Stadler

 

Specifications

 

Calibration Stability

All GSITympStar Version 1 specifications are met over the range of specified power

 

line, temperature and humidity variations.

 

 

Power Line:

 

 

 

Voltage Variation:

±10%

 

 

Frequency Variation:

± 5%

 

 

Power line short term variation which affects the performance of the instru-

 

ment will turn off all probe and stimulus signals.

 

Power Rating:

120

Watts maximum

 

Line Voltage Range:

100

VAC to 240 VAC

 

Power Line Frequency Range: 50 - 60 Hz

 

Temperature Operating Range: +15°C to +35°C

 

Relative Humidity Operating Limit: 90%

 

Guaranteed Operating Elevation: 6000 Ft. (1800m)

Connectors

STIMULUS: External Stimulus Input

 

 

(Phone Jack) Peak Voltage: 3 VAC

 

 

Input Impedance: 15,000 Ohms

 

PRESENT: External Present Control Input that turns the stimulus signal ON and OFF (Phone Jack).

Voltage Range: STIM OFF: +5.0 VDC STIM ON: 0.0 v

Input Impedance: 11,000 Ohms

Contra PHONE: Output Voltage: 7 VAC Output Impedance: 2.5 Ohms

Standard 9-pin RS232C serial port for interfacing with outside computer.

RXD

CTS

TXD

RTS

Standard VGAport for external monitor.

GSI TympStar Version 1 and Version 2 Service Manual

2 - 7

GSI TympStar User manual Versions 1

Chapter 2

Standard PS-2 keyboard port for external Keyboard.

Standard parallel printer port for external printer.

Electrical

The following apply to the TympStar system:

 

1)

Class 1 Medical Equipment

 

2)

Type B Medical Equipment

 

3)

IPXO ingress of water (ordinary equipment)

 

4)

Equipment not suitable for use in the presence of flammable anesthetic

 

 

mixture with air or with oxygen or nitrous oxide.

 

5)

Mode of operation - continuous

Input Voltage:

100 – 240 VAC

Input Frequency:

50 – 60 Hz

Input Current:

3.2 A maximum

Power Consumption:

120W maximum

2 - 8

Grason-Stadler

 

Specifications

 

SuppliedAccessories

Contra insert phone

GSI Part # 8000-0078

 

Calibration cavity (V1)

GSI Part # 2000-1036

 

Probe cleaning kit (2 boxes)

GSI Part # 2000-9610

 

Eartips:

 

 

1 pkg. 8 standard sizes, 4 ea. (Color coded)

GSI Part # 1700-9660

 

1 pkg. 6 special sizes, 2 ea.

GSI Part # 1700-9670

 

1 pkg. 6 screening sizes, 2 ea.

GSI Part # 1700-9622

 

Reference Instruction Manual

GSI Part # 2000-0100

 

Quick User Guide

GSI Part # 2000-0108

 

Printer paper (2 rolls) for orders including printer GSI Part # 1700-9619

 

Spare set of probe tubing

GSI Part # 2000-9617

 

Probe mount - shoulder

GSI Part # 1700-9646

 

Probe mount - wrist

GSI Part # 1700-9642

 

Probe mount - clothes

GSI Part # 1700-9608

 

Printer paper, adhesive-backed

 

 

for orders including a printer

GSI Part # 1770-9643

 

GSI TympStar dustcover

GSI Part # 1700-9618

 

Power cord with hospital-grade plug

GSI Part # 4204-0251

 

 

(USA)

 

Power cord part # varies depending on location

Mechanical

DIMENSIONS AND WEIGHT

 

 

W x D x H: 20.38 inches x 15 inches x 12.6 inches (LCD raised)

 

52cm x 38cm x 32cm

 

 

Height with LCD lowered - 6 inches (15cm)

 

 

Weight: 16.58 pounds, 7.53 kg

 

 

Shipping weight: 29.50 pounds, 13.38 kg

 

Materials of manufacture

Calibration requirements

Top Case, LCD Housing

 

Front & Rear & Hinges:

Lexan 500 w/10% Glass & 2% BlowingAgent,

 

UL 94V0 Rated

LCD Lense:

GE HP40S -OR- Duralan II

Switches:

Shincor Shin-Etsu/Novacor KE-951 U

Labels:

Lexan & Polycarbonate

Softkey Panel:

Mylar

Probe Cord:

Polyvinyl Chloride (PVC)

Probe Top & Bottom Housings:

Cycolac KJW, UL 94V0 Rated

Probe Tip:

Polypropolene

Eartips:

Kraton 3226

Tubing:

Vinyl and Polyurethane

GSI recommends quarterly calibration checks for the GSI TympStar along with annual certification. ASHArequires quarterly electro-acoustic calibration checks and annual electro-acoustic calibration. It is good practice to perform daily biologic checks. See Chapter 4: Calibration for complete calibration instructions.

GSI TympStar Version 1 and Version 2 Service Manual

2 - 9

Chapter 2

Version 2 Specifications

Standards

The GSI TympStar Version 2 meets or exceeds the following standards and speci-

 

fications for aural acoustic admittance instruments:

 

IEC 1027 1991-03

 

ANSI S3.39-1987

 

ANSI S3.6-1996

 

ANSI S3.7-1995

 

IEC 645-1 1992

 

IEC 126-1973 (also BS 6111-1981)

 

BS ISO 389-2- 1994

 

Y2K Compliant

 

UL 2601-1 Part 1: General Requirements for Safety

 

CSA C22.2 No. 601.1-M90 (Canada)

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

Mr. Leo Hoogendoorn Nicolet Biomedical GMBH Saalackerstrasse 8

63801 Kleinostheim, Germany Tel: 011-49-6027-46980

Fax: 011-49-6027-469815

EN60601-1:1990 Safety Requirements for Medical Electrical Equipment

EN60601-1-2 Medical Electrical Equipment Emissions and Immunity

Requirements

This equipment has been tested for radio frequency emissions and has been verified to meet Radiated and Conducted Emissions per EN 55011-1998, Group 1, Class A and per CISPR, Class A.

2 - 10

Grason-Stadler

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