Welch Allyn TM286 User Manual
Welch Allyn TM286
Ref. ANSI S3.6 / ISO 389
dB HL
Hz
M+
+10dB
R
L
AUDAUD
FM
TYMP
226 Hz
1 kHz
TYMP
REFLEX
IPSI
CONTRA
PROG
500 Hz
1000 Hz
2000 Hz
4000 Hz
1.5cm3 R
ECU
cm3
daPa
GR
-400
0 +200 daPa
M-
M--
Auto Tymp
Directions for use
Part Number 28603 Rev D
ii Welch Allyn TM286 Auto Tymp
©2011 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of
the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use,
reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn. Welch
Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure
to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual.
Welch Allyn is a registered trademark of Welch Allyn.
Software in this product is Copyright 2010 Welch Allyn or its vendors. All rights are reserved. The software is protected by United
States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled
to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is
embedded. The software may not be copied, decompiled, reverse-engineered, disassembled, or otherwise reduced to
human-perceivable form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the software
remain with Welch Allyn or its vendors.
For information about any Welch Allyn product, call Welch Allyn Technical Support:
Tel.: 1-800-535-6663 (In U.S.A. only)
Tel.:1-800-561-8797 (in Canada only)
REF 28603 (Printed, English only)
28603 Rev D, 2011-01
Compliance
The CE0344 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason-Stadler is an ISO 13485-certifed
corporation.
Manufactured for Welch Allyn by
Grason-Stadler
7625 Golden Triangle Drive
Suite F
Eden Prairie, MN 55344
www.grason-stadler.com
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153-0220 USA
www.welchallyn.com
Directions for use iii
1 - Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Unpacking and inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Supplied Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Recycling / disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Safety Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Tympanometry and Gradient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2 - Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Printer and Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Rear Panel Labels and Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Bottom Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3 - Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
226 Hz Probe Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Front Panel Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4 - Program Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Program Mode Menu Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Program Menu Page 1 Option Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Program Menu Page 2 Option Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
5 - Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
PreTest Tymp checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
6 - Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Ear Canal Volume - Tympanometry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Compliance Peak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Pressure Peak. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Gradient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Acoustic reflex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Audiometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Sample Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
7 - Computer Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
8 - Standards, Specifications, and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . 61
Standards and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Tympanometry modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Pneumatic System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Acoustic Reflex Stimuli. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Probe LED Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Audiometry mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
iv Welch Allyn TM286 Auto Tymp
Intensity Levels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Tone Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Environmental. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Mechanical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Head set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
1
Note
1
Introduction
The TM286 Auto Tymp (hereafter referred to as 'instrument' in this guide unless
otherwise noted for clarity) is a versatile combination instrument that provides testing
capability for tympanometry alone, tympanometry combined with screening acoustic
reflex measurements, and screening audiometry.
An optional soft-sided carrying case is available for portability. Also, a patient handswitch,
patch cords, and earphone sound enclosures may be purchased as optional accessories.
Unpacking and inspection
Examine the outside of the shipping container for any signs of damage. Notify the carrier
immediately if any damage is noted.
Carefully remove the TM286 Auto Tymp 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
a Welch Allyn representative.
If the instrument must be returned, repack it carefully (in the original TM286 Auto Tymp
container if possible) and return it prepaid to Welch Allyn for necessary adjustments.
Keep the original packing material and shipping container so the instrument can
be well packaged if it needs to be returned to the local service center for repair or
calibration.
Supplied Accessories
Check that all accessories itemized in Supplied Accessories below are received in good
condition. If any accessories are missing, contact Welch Allyn immediately. See
“Accessories” on page 66 and the listings below for the catalog numbers of accessories
and also for a listing of optional accessories.
Welch Allyn Part Number Welch Allyn Description
26100 TM Eartips (6 sizes, 2 each)
26241 TM Test Cavity
28203 DD45 Audiometry Headset External
28206 Threshold Audiometry Card
28600 TM286 Probe Assembly
28601 TM286 Power Brick (113-405800)
2 Introduction Welch Allyn TM286 Auto Tymp
28602 TM286 Cord, Power, Hosp Grade
28603 TM286 Directions for Use Manual (printed, English only)
28604 TM286 Quick Reference Guide
28605 TM286 Directions for Use Manual (printed, French only)
28607 TM Wall Chart for Tymp tracings
52600* Thermal Paper 4" wide (3 rolls shipped with system)
* Note: To reorder paper, use the 52600 part number.
Optional Accessories
26240 TM Dust Cover
05260-U TM Carrying Case
23221 Audiometry Single Patch Cord, 2-Conductor
23220 Audiometry Patient Response Switch
23222 Audiometry AudioCups
WARNING To ensure patient safety and optimal product performance, use only
Welch Allyn recommended accessories and supplies.
WARNING The use of parts or materials that are not recognized to be used with
the device can degrade minimum safety.
Recycling / disposal
Caution Many local laws and regulations require special procedures to recycle
or dispose of electric equipment-related waste including 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.
Safety Summary
Before using the TM286 Auto Tymp, familiarize yourself with the sections of this
directions for use that pertain to your use of the TM286 Auto Tymp.
• Failure to understand and observe any warning statement in this manual could lead to
patient injury, illness, or death.
• Failure to understand and observe any caution statement in this manual could lead to
damage to the device or other property, or loss of patient data.
WARNING Warnings indicate conditions or practices that could lead to illness,
injury, or death.
Caution Cautions indicate conditions or practices that could damage the
equipment or other property.
Directions for Use Introduction 3
Note
Notes help you identify areas of possible confusion and avoid potential problems
during system operation
Safety Notes
WARNING The TM286 is designed to be used with a hospital grade outlet.
Injury to personnel or damage to equipment can result when a three-prong to
two-prong adapter to is connected between the TM286 power plug and an AC
outlet or extension cord.
Additionally, the TM286 is equipped with a specific power transformer, (113405800, reorder number 28601), which should not be interchanged with any other
transformer or supply.
WARNING The TM286 is a specifically calibrated device and the periodic service
and adjustments, which the instrument may require, should be done only by an
authorized Welch Allyn service technician.
WARNING The TM286 Auto Tymp 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 are required. For patient and operator safety,
the TM286 must be used with properly grounded plug and receptacles at all
times. The TM286 is equipped with a specific power transformer (113-405800,
reorder number 28601), which should not be interchanged with any other
transformer or supply.
WARNING Any program aimed at obtaining reliable records of hearing
thresholds should be staffed and supervised by appropriately-trained individuals.
WARNING This symbol indicates the location of a service adjustment part
and is intended for service personnel only. The TM286 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 service technician.
WARNING Please read the entire manual prior to using the TM286 to become
familiar with the test functions and proper accessory connections.
WARNING 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. Everyone 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 a local Welch Allyn representative.
Caution The TM286 is designed to comply with the EMC requirements
according to IEC 60601 1-2.
Caution Radio transmitting equipment, cellular phones, etc. should not be used
in the close proximity of the device since this could influence the performance of
the device.
Caution Particular caution must be considered during use of strong emission
sources such as high frequency surgical equipment and similar devices. If in
doubt, contact a qualified technician or a local Welch Allyn representative.
4 Introduction Welch Allyn TM286 Auto Tymp
Note
Latex is not used any where in the manufacturing process.
The base material for the earphone cushions is made from natural and synthetic rubber.
The material used to manufacture Welch Allyn's eartips is Krayton Thermoplastic Rubber.
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 Welch Allyn.
WARNING 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 Welch Allyn certified service
technician.
Warranty
WARNING 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.
WARNING Have a service technician periodically perform electrical safety
checks on the unit in order to show continued compliance to IEC and UL 60601-1.
We, Welch Allyn, 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 product service facility.
Changes in the product not approved in writing by Welch Allyn shall void this
warranty. Welch Allyn 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.
Tympanometry and Gradient
Tympanometry provides an objective means for determining the amount of mobility
present within the eardrum and the ossicular chain. It is, however, important to keep in
mind the fact that the amount of mobility present within the ossicular chain may be
camouflaged by a scarred or thickened eardrum.
Directions for Use Introduction 5
Note
Acoustic energy, commonly referred to as the probe tone (226 Hz) is introduced into a
hermetically sealed ear canal by means of a loudspeaker located within the probe. The
intensity of this tone is monitored via a microphone, also located within the probe box.
Measurements are taken at fixed time intervals.
As pressure within the ear canal is varied, the eardrum is subjected to varying degrees of
stress which alters the mobility of the eardrum. Maximum mobility will occur when the
pressure on both sides of the eardrum are equal. Changes in mobility of the eardrum tend
to produce changes in the probe tone level within the ear canal. Probe tone intensity
changes indicate the amount of sound energy entering the middle ear.
Compliance is calculated based on these measurements. Since the sound pressure level
of the probe tone within the ear canal varies as a function of mobility, it is possible to
record these changes in mobility as a function of pressure. While the recording is
visualized in the horizontal direction (X-axis) as a function of differential pressure across
the eardrum, the tracing also moves in the vertical direction (Y-axis) as a function of
mobility or admittance of the middle ear system. A graphic presentation of this
information is known as a tympanogram.
The point of the tympanogram which represents the point of maximum compliance is the
compliance peak of the tympanogram. The air pressure (pressure at the peak) where this
compliance peak occurs approximates the pressure within the middle-ear system, since
maximum mobility is only possible when there is little or no pressure difference between
the ear canal and the middle-ear space. Compliance using a 226 Hz probe tone is
measured with respect to the ability of an equivalent volume of air to conduct sound and
the scientific quantity used is cm
3
.
Gradient
1.02 mmH2O = 1.0 daPa
The presence of a pathological condition which interferes with the mobility of the
tympanic membrane, the ossicular chain, or the air pressure within the middle-ear space
can be detected during tympanometry.
• If the air pressure within the middle-ear space becomes negative due to a blocked
eustachian tube, tympanometry measures this negative pressure and its effect on
middle-ear compliance.
• If fluid builds up within the middle-ear space, this fluid will restrict the ability of the
ossicular chain to conduct sound to the cochlea. If small air pockets exist within the
fluid, the tympanogram will indicate the negative pressure where the restricted
mobility occurs. With a totally fluid-filled middle-ear space, no mobility will be
measured during tympanometry at any pressure value.
• In the case of a “glue-ear”, the ossicular chain is restricted in mobility. This
tympanogram would depict a flat line with no identifiable pressure peak.
Gradient (width) measurements are used to describe the shape of a tympanogram near
the peak. Often, the presence or absence of fluid in the middle ear is not clearly indicated
by otoscopy and tympanometry alone. This evaluation is especially difficult when the peak
pressure is within the normal range.
The presence of fluid within the middle-ear space alters the shape of a tympanogram (i.e.,
makes the tympanogram wider near its peak). A larger-than-normal gradient can indicate
the presence of fluid in the middle ear when other parameters are within normal limits. In
this way, the gradient acts as an adjunct to the tympanogram and ear canal volume
6 Introduction Welch Allyn TM286 Auto Tymp
measurements by helping to differentiate between tympanograms with similar peak
values.
The instrument uses tympanometric width to determine the gradient by measuring the
pressure interval at one-half of the tympanogram peak height. Differing tympanogram
peak widths can point to different middle-ear conditions, even when peak height and
pressure are within normal range. For example, middle-ear effusion caused by secretory
otitis media many result in an increased tympanogram width and, therefore, an increased
gradient value. This would occur because the ossicular chain cannot react to the change in
pressure introduced during the tympanogram in the same way that it would if the middle
ear were properly aerated. The continued presence of effusion, leading eventually to a
completely fluid filled middle-ear cavity, will reduce the magnitude of the tympanogram to
the point where no change in compliance is detectable across the pressure range. Under
this condition, no gradient measurement is possible.
On the TM286, gradient measures are calculated for the 226 Hz probe tone conditions.
Screening acoustic reflex
An acoustic reflex occurs when a very loud sound (stimulus) is presented to the auditory
pathway. During acoustic reflex testing, the stimulus is presented to the ear canal through
a probe (ipsilateral). This stimulus then travels through the middle ear to the cochlea. From
the cochlea, frequency and intensity information is transmitted via the 8th nerve to the
brain stem where a determination is made as to whether or not the intensity of the
stimulus is high enough to elicit a reflex response. If it is, a bilateral response occurs (i.e.,
the right and left 7th nerves innervate their respective middle-ear muscles (stapedial
muscles) causing them to contract). As these muscles contract, they stiffen their
respective ossicular chains. This stiffening of the ossicular chain reduces the compliance
of each middle-ear system.
When the stimulus is presented to the same ear as the measurement, the test is referred
to as an ipsilateral (same side) acoustic reflex test.
During ipsilateral acoustic reflex testing, both the stimulus and the probe tone are
presented via the hand-held probe. In both cases, the measurement is made from the ear
where the probe is positioned. For 226 Hz probe tone reflex measurements, the air
pressure within the ear canal where the probe is positioned is set to the pressure value
measured at the point of maximum compliance for that ear during tympanometry with an
offset of -20 daPa (or +20 daPa for a positive pressure peak).
Acoustic reflex measurements are useful to determine the integrity of the neuronal
pathway involving the 8th nerve, brainstem, and the 7th nerve. Since the acoustic reflex
test is performed at high intensity levels and since it involves a measurement of middleear mobility, acoustic reflex testing is not a test of hearing.
The acoustic reflex also serves as a good validation of tympanometric results since an
acoustic reflex cannot be measured in the absence of a compliance peak. In other words,
if the tympanometric results indicate no mobility over the pressure range available, no
reflex will be observed. If the test results indicate a reflex response in the absence of a
compliance peak, one has cause to question the validity of the tympanometric test
results. This indicates that the tympanogram should be repeated.
Clinical middle-ear instruments allow the measurement of the acoustic reflex threshold
since they provide the ability to manually change the intensity of the stimulus to a level
where a reflex response is just barely detectable for each patient tested. However, this
screening instrument automatically presents the stimulus in a very definite stimulus
intensity sequence. This preset intensity sequence may start at a level above an
Directions for Use Introduction 7
individual's acoustic reflex threshold level. Also, since the instrument uses a hand-held
probe and noise from hand motion can be detected by the instruments circuitry, the
magnitude of a detectable response must be somewhat higher than the criterion
generally used during clinical acoustic reflex threshold testing to avoid artifact caused by
hand motion. The acoustic reflex measurements made with this instrument are referred
to as screening acoustic reflex testing. The purpose of these screening reflex tests is to
determine whether a reflex is detectable rather than to determine the lowest intensity at
which the reflex occurs (i.e., threshold testing).
Screening audiometry
While tympanometry and acoustic reflex measurements check the integrity of the middleear system, audiometry provides a means for checking the integrity of the entire auditory
pathway. Screening audiometry provides a method to determine an individual's ability to
hear a test signal at a particular intensity level or at the lowest possible intensity level
without the use of masking.
During screening audiometry, the test signal is generally presented through an earphone
to the ear. Different screening test protocols define the frequencies and intensity
sequence to be used to obtain a response. Audiometric testing requires a behavioral
response from the individual being tested. This consists of having the individual raise a
finger/hand or press a handswitch (optional) whenever the test signal is heard. The finger/
hand is lowered or the handswitch is released when the test signal is no longer audible.
The individual being tested must be able to understand a set of simple instructions and
have the ability to provide some physical sign when the test signal is heard.
The TM286 allows for both manual and automated audiometry. For further details on
automated audiometry, see “Automatic Hearing Level” on page 29 of this guide.
8 Introduction Welch Allyn TM286 Auto Tymp
Glossary of terms
Acoustic Reflex Reflexive contraction of the stapedius muscle in response to
loud sound.
Automated
Audiometry (Auto
HL)
Compliance Peak The point of maximum mobility in a tympanogram, which
Ear Canal Volume Volume measured between the tip of the probe and the
Ipsilateral Acoustic
Reflex
Normal Box Range of pressure peak and compliance peak values associated
Pressure Peak Pressure value where maximum mobility occurs in a
Probe Tone The pure tone that is held at a constant intensity level in the ear
Screening
Audiometry
Automated measurement of hearing that allows the listener to
control the intensity with a hand switch.
indicates the degree of mobility within the middle-ear system.
tympanic membrane at the starting pressure for a tympanogram
using a 226 Hz probe tone.
The acoustic reflex elicited when the stimulus is presented to
the same ear where the response is measured.
with normal middle-ear function. (-150 daPa to +100 daPa, 0.2
3
cm
to 1.4 cm3 per ASHA, 32, Supl. 2, 1990, 17-24) - only
available on 226 Hz probe tone testing.
tympanogram. This pressure value approximates the pressure
within the middle-ear space.
canal - assists in the measurement of middle ear function.
Rapid assessment of the ability of individuals to hear acoustic
signals across a frequency range at a fixed criterion intensity
level; designed to identify those who require additional
audiometric procedures.
Ty m p a n o g r a m Graph of the middle ear immittance as a function of the amount
of air pressure delivered to the ear canal.
Tympanometry Procedure used in the assessment of middle ear function in
which the immittance of the tympanic membrane and middle
ear is measured as air pressure delivered to the ear canal is
varied.
9
LCD
Printer
Paper cover
Probe holder
Probe cable connector
Probe
2
Installation
Printer and Display
Figure 1. TM286 major component identifications
Figure 2. Probe
10 Installation Welch Allyn TM286 Auto Tymp
R1 R2 R4 R3 R5 R6 R7
R8
R9
Rear Panel Labels and Connectors
Figure 3. Rear panel labels and connectors
R1 Symbol denotes a Type B
R2 Symbol denotes Attention, consult accompanying documents
R3 Connector for handswitch (Optional)
R4 Connector for contralateral insert phone (Not Available)
R5 Connectors for right and left earphone
R6 Power Input Jack for external power supply
R7 Power Switch with ON/OFF indicators
R8 USB port for connecting to an external printer
R9 USB port for connecting to a computer
WARNING Accessory equipment connected to the analog and digital interfaces
must be certified to the respective IEC standards (IEC 950 for data processing or
IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply
with the system standard IEC 60601-1-1. Everyone who connects additional
equipment to the signal input or signal output part configures a medical system,
and is, therefore, responsible that the system complies with the requirements of
the system standard IEC 60601-1-1. If in doubt, consult Welch Allyn at Tel.: 1-800535-6663 (In U.S.A. only) or Tel.:1-800-561-8797 (in Canada only).
Directions for Use Installation 11
Prop feet
CE Label and
serial number
Bumper Feet
Bottom Panel
Figure 4. Bottom panel
Symbols on the TM286 Auto Tymp
Symbol Description
Attention, consult accompanying documents.
Date of manufacture
CE Marked in accordance with the European Council Directive 93/42/EEC concerning
medical devices
Special Recycling Required. Do not dispose in landfill.
Type B equipment
Symbol for “CATALOG NUMBER”
Stand-by
Right Ear
Left Ear
12 Installation Welch Allyn TM286 Auto Tymp
Symbol Description
Patient Response Button
AC Power
Printer Connector
USB Type Connectors
Computer Connector
Initial set-up
Place the instrument on a stable counter or table where it will be used. The location
should be near a properly grounded wall outlet. Carefully attach purchased accessories to
their appropriately labeled connector on the rear panel of the instrument (see “Rear panel
labels and connectors” on page 10).
Locate the power switch on the rear panel of the instrument and move the switch to the
On position. When power is turned on, the light on the LCD will be illuminated and the
orange light on the probe will be lit. The display on the LCD will display a scroll bar across
the top to indicate the system is initializing.
The system will power up to the factory default test mode (to set user-defined power up
setting, see “Program Mode” on page 33) and the probe green lamp will begin to blink
indicating that the instrument is ready to begin the testing. If both the green and yellow
lamps are illuminated at the same time following power on, the probe is occluded or the
tympanogram software did not initialize properly. Simply move the power switch to the off
position, inspect the probe tip for any signs of an occlusion, and reposition the power
switch to On. If both green and yellow lamps are still illuminated and the probe is not
occluded, contact a local service representative or the Welch Allyn service department for
repair. In the mean time, it is still possible to use the Audiometry mode (if purchased).
Allow the instrument to warm-up for about 10 minutes before conducting a test. This
allows the electronic circuits to stabilize prior to use. If the storage temperature is lower
than the room temperature, allow additional time for the instrument to reach room
temperature.
Caution Use only the provided power supply. The TM286 Auto Tymp provided
power supply should only be connected to a power source meeting the following
range: 90-246VAC, 47-63Hz. In North America, the power source should be a
maximum of 120VAC.
Loading the paper
Remove the printer cover by placing fingers along the back edge of the printer and pulling
upward on the cover. Cut the printer paper so that the leading edge of paper is straight
across. Place the roll of paper inside the paper well so that the paper will unroll from the
lower surface. See the paper loading label located on the side of the paper well.
Directions for Use Installation 13
Paper Well
Paper Slot
Figure 5. Paper loading
Position the leading edge of the paper roll into the paper slot. Press the paper advance
button until a section of paper is long enough to pass through the printer cover.
Paper storage
The instrument is supplied with a thermal printer. This type of printer requires a heatsensitive paper to create an image. For maximum paper life, any spare rolls of paper
should be stored as follows:
a. Store in the dark (i.e., in a drawer or cabinet)
b. Do not store above 77° F (25° C)
c. Store at less than 65% relative humidity
The above recommendations are for the maximum paper life (greater than five years).
Storing thermal paper at high temperatures or high humidity levels will shorten the total
paper life. The paper will show some darkening if stored for 24 hours at 113° F (45° C) and
a relative humidity of greater than 90%. Avoid leaving paper in a hot car or other hot area
overnight. Always avoid storing unused paper or printed tests in a lighted area.
14 Installation Welch Allyn TM286 Auto Tymp
15
3
Operation
226 Hz Probe Indicators
Figure 6. Probe indicators
P1 - Yellow: The probe is occluded. Remove the probe and inspect for cause of occlusion.
P2 - Green lamp: Blinking - The instrument is ready to begin a Tymp. Steady green - Test successfully
started and in progress.
P3 - Orange: A pressure leak has been detected.
When doing a 226 Hz probe tone test, use the White Flat tips, 26100. The 226 Hz probe
tone test auto-starts the pressure sequence and placing the probe in the ear canal when
the pressurization begins can result in unwanted deflections in the tympanogram. The
White Flat ear tips allow the user to place the probe and hold the Probe Tip at the
entrance to the patient's ear canal while the tympanogram and reflex testing are
performed.
WARNING A Welch Allyn provided Probe Tip must be used. Using the probe
without the Probe Tip could result in injury to the subject.
16 Operation Welch Allyn TM286 Auto Tymp
F8
F13
F21
F14 F15 F18 F16 F19
F29
F30
F31
F1 F2 F3 F9 F5F4F10 F12F11F6
F28
F22
F20
F17
F32
F7
F23
F24 F25
F26
F27
M -
M - -
Front Panel Controls and Indicators
Figure 7. Front panel
Legend / Label Button Description
F1 / Print Screen
F2 / Print All Memory
F3 / Paper Advance
F4 / PAGE
F5 / M -
F6 / M - -
F7 / Data Transfer
Used to print the currently displayed page of memory or active test
screen.
Used to print all pages of data from memory.
Causes paper to feed through printer; may be used to load paper or to
provide space between printouts.
Enters Page Mode: Pressing F13 and F14 scrolls through the test results
stored in memory.
Erases currently displayed page of data from memory.
Erases all pages of data from memory.
Transfers test results to an attached computer.
Directions for Use Operation 17
M +
+10dB
AUD
FM
R
L
Legend / Label Button Description
F8 / M+
Save button; during Audiometry mode, saves threshold information per
frequency on the display; during Program mode, selects highlighted
option.
F9 / +10 dB
F10 / Aud(iometry)
F11 / Headphone
F12 / Insert
F13 and F14 / Decrease
and Increase Frequency Selecting advances the presentation tone to the next lower
F15 / Steady
F16 / Pulsed
Used to temporarily extend the intensity range by 10 dB; a large + sign
appears on the display indicating that the extended range has been
selected.
Selects Audiometry mode. When in Audiometry, this button starts the
Auto HL when held for 3 seconds.
Selects the calibration file for external headset transducers. When the
button is pressed, the display will flash. Press the button again to
engage the external headset transducer. The symbol is shown on the
right side of the display when selected.
Selects internal earphone calibration file for transducers. When the
button is pressed, the display will flash. Press the button
again to engage the internal earphone transducers. The symbol
is shown on the right side of the display when selected.
frequency; selecting advances the presentation tone to the next
higher frequency.
Used during Audiometry mode to select a continuous test tone when
Present Bar is depressed; the steady symbol appears on the display.
Used during Audiometry mode to select a pulsed tone when the Present
Bar is depressed; the pulsed symbol appears on the display.
F17 / FM
F18 / R
F19 / L
F20 / Attenuator Knob
(dB HL) Used to increase or decrease the intensity of the test tone presented in
F21 / Present Bar In Audiometry mode, used to present test signal to appropriate
F22 / TYMP
Used during Audiometry mode to select a frequency modulated test tone
when the Present Bar is depressed; the letters FM appears on the
display when selected.
Used to indicate the right ear is the test ear; so data stored in memory
and/or printed is properly identified. An R will appear on the LCD.
Used to indicate the left ear is the test ear; so data stored in memory
and/or printed is properly identified. An L will appear on the LCD.
Audiometry mode; counterclockwise rotation decreases the rotation;
clockwise rotation increases the intensity.
earphone; release to turn test tone off.
Selects Tympanometry only mode.
18 Operation Welch Allyn TM286 Auto Tymp
Legend / Label Button Description
F23 / Tymp Reflex
F24 / 226Hz Selects 226 Hz for Probe Tone Frequency.
F25 / 1KHz Not available with the 226 Hz Probe Tone.
F26 / IPSILATERAL Selects an ipsilateral reflex test.
F27 /CONTRALATERAL Not available with the 226 Hz Probe Tone.
F28 / Prog(ram) Selects Program mode screen which lists settings available for reflex
F29 / 500 Selects 500 Hz as a stimulus during reflex testing.
F30 / 1000 Selects 1000 Hz as a stimulus during reflex testing.
F31 / 2000 Selects 2000 Hz as a stimulus during reflex testing.
F32 / 4000 Selects 4000 Hz as a stimulus during reflex testing.
Selects Tympanometry and Reflex mode.
presentation format, printout header format, audiogram vs. tabular
format, display normal box, and identify frequency range for Audiometry
mode.
The figures 226 Hz Tympanometry screen, 226 Hz Tympanometry/Reflex screen, and
Audiometry screen show the individual display format for each test mode.
Figure 8. 226 Hz Tympanometry screen
A ASHA Box
B Scale of Tympanogram Compliance
C Te s t E a r
D Ear Canal Volume
E Peak Amplitude
F Pressure at peak
G Gradient/Tympanogram width
H Pressure sweep scale in daPa
Loading...