LORECa Hearing Instrument PKA 84 User manual

PKA 84
PEDIATRIC AUDIOMETER
User Manual
OCTOBER 5, 2016

Table of Contents .......................................................................................................................................1
Introduction.................................................................................................................................................2
Intended Use ................................................................................................................................................2
Precautions...................................................................................................................................................3
Basic Functions..........................................................................................................................................5
Description of Control Panel.........................................................................................................................5
Description of Stimuli Panel .........................................................................................................................6
Auditory Behaviour ...................................................................................................................................7
Auditory Behaviour -Test Overview..............................................................................................................7
Description of Various Tests .......................................................................................................................8
Auditory Behaviour Index for Infants ..........................................................................................................10
Reflex Audiometry by Neonates.................................................................................................................11
Maturation of Auditory Response...............................................................................................................12
Technical Specifications..........................................................................................................................14
Unpacking / Inspection ............................................................................................................................17
Contents of Shipment.................................................................................................................................16
Reporting Imperfections .............................................................................................................................18
Trouble Shooting......................................................................................................................................19
Appendix: General Maintenance Procedures........................................................................................20
Recommended Literature .......................................................................................................................21
Return Report............................................................................................................................................22
PKA Operation Manual Page 1
Table of Contents

The PKA handheld pediatricscreening audiometer is designedto be a device
for screening for hearing loss primarily amongst children. Output and
specificity of this type of device are based on the test characteristics defined
by the user, and may vary depending on environmental and operating
conditions. The screening for hearing loss using this kind of audiometer
depends on the interaction with the patient. However, for children not
responding well, various test possibilities allow the tester of having at least
some evaluative result. Thus, a “normal hearing” result should not allow for
ignoring other contra indications in this case. A full audiologic evaluation
should be administered if concerns about hearing sensitivity persist.
PKA Operation Manual Page 2
Introduction
Intended Use
Introduction

Notice - Be sure to use only stimulation intensities, which will be acceptable
for the patient.
Notice - The transducers (headphones, bone conductor, etc.) supplied with
the instrument are calibrated to this instrument - exchange of transducers
require a recalibration.
Notice - It is recommended that parts which are in direct contact with the
patient (e.g. earphone cushions) are subjected to standard disinfecting
procedure between patients. This includes physically cleaning and use of a
recognized disinfectant. Individual manufacturer's instruction should be
followed for use of this disinfecting agent to provide an appropriated level of
cleanliness.
Notice - Always remove the batteries when the instrument is left unused for
more than a month.
Notice - Although the instrument fulfils the relevant EMC requirements
precautions should be taken to avoid unnecessary exposure to
electromagnetic fields, e.g. from mobile phones etc. If the device is used
adjacent to other equipment it must be observed that no mutual disturbance
appears.
PKA Operation Manual Page 3
Precaution

Notice - Within the European Union it is illegal to dispose electric and
electronic waste as unsorted municipal waste. Electric and electronic waste
may contain hazardous substances and therefore has to be collected
separately. Such products will be marked with the crossed-out wheeled bin
shown below. The cooperation of the user is important in order to ensure a
high level of reuse and recycling of electric and electronic waste. Failing to
recycle such waste products in an appropriate way may endanger the
environment and consequently the health of human beings. Disposal of
batteries must be made according to national regulations.
PKA Operation Manual Page 4

Selected intensity LCD
Selected frequency LCD
LEDs which present feeding of STD device and the selected
stimulus Tone, NBN or WN.
Touch buttons to increase and decrease the stimuli
frequency 0.5, 1, 2, 3, 4 KHz
Touch buttons to increase and decrease the stimuli intensity,
between 20 to 80 db for stimuli Tone in steps of 10 db and 20
to 70 dB for noise stimuli, with distances on the device.
(50 cm or 16 cm).
Incentive touch button, to switch on the three red and blue
LEDs which are arranged around speaker in order to
condition the orientation reflex.
Touch button to present stimuli
Touch button to select stimuli: Tone, NB or WN
Push button to switch on PKA
ON” button should be pushed for a moment.
PKA will be switched off after 60 seconds of not using the
stimuli button.
PKA Operation Manual Page 5
Description of Control Panel
Basic Functions
LORECa

The loudspeaker is under the white grid.
The grid is positioned in a distance of 50cm from the ear.
3 LEDs arranged in a triangle for conditioning of the
orientation reflex in a ring.
Connector for single headphone TDH39S (optional)
When the headphone is connected to PKA, correct
calibration for Pure Tone Audiometry with TDH 39S will
automatically be applied.
The connector is a 3.5 mm stereo jack.
Connection of devices’ feeding (power) jack
In models with battery performance is the connection place
of special charger.
PKA Operation Manual Page 6
Description of Stimuli Panel

PKA Operation Manual Page 7
Waking
up
Respiration.
Aud
APR
COR
VRA
Recommended age
group (month)
0 - 3
0 - 4
0 - 12
4 - 15
6 - 30
Preferred
Frequency:
500 Hz
×
×
1000 Hz
×
×
2000 Hz
×
×
×
×
3000 Hz
×
×
×
×
×
4000 Hz
×
×
×
×
×
Tone Duration
(Sec)
1.5-2
1-2
0.5-1
0.5-1
0.5-1
Time between
Stimulation (sec)
30
20
10-20
10-20
10
MRL1 (sound
cabin) (dBHL)
40-80
40-80
40-80
30-60
20-40
Distance to test
ear (cm)
10-50
10-50
10-50
50-100
50-100
Condition of
child:
- sleeping
×
×
- half asleep
×
×
×
- awake
×
×
×
- playing
(x)
(x)
- playing alert
×
×
Recom . no. of
PKAs for the test:
1
1
1
2
2
Auditory Behaviour -Test Overview
Auditory Behavior

As found by Professor Sanford E. Gerber complex signals like White Noise
(WN) assure better responsiveness on neonates and up to the age of
approximately seven months than e.g. pure tones and Narrow Band Noise.
Therefore PKA has the possibility of stimulating with WN.
The APR Test:
The Auropalpebral Reflex is a startle reflex of the eyelid elicited by relatively
strong sounds, approximately 80 - 100 dB SPL (PKA is calibrated in dB HL).
The test can be performed on neonates from the day of birth and it is not
based on co-operation with the newborn child. Other responses than the
APR can be arousal from sleep,crying or diminished activity.
The COR Test:
The Paediatric Audiometer PKA can perform Conditioned Orientation
Audiometry based on a technique described by Suzuki and Ogiba (1961).
The phenomenon called “Orientation Reflex” is not a learned response, but
a natural reflex movement elicited by sound or visual stimulation.
If the visual stimulation elicits a reflex which is conditioned by a tone, the
child will look towards the visual stimulation, e.g. flashing light, as soon as
the tone is heard. If the conditioning is effective the child will look in the
direction of thesound source even before thevisual stimulation is presented.
The COR method requires cooperation from the child.
PKA Operation Manual Page 8
Description of Various Tests

The VRA Test:
The Paediatric Audiometer PKA can perform the Visual Reinforcement
Audiometry (Liden and Kankunen, 1969), which is an extension and
modification of COR, where the co-operation with the child is less important.
Liden and Kankunen accept notonly the sound localisationorientation reflex,
but also four other reactions: reflex reactions (body and face), search
reactions, orientation reactions and spontaneous reactions.
PKA Operation Manual Page 9

Age
Reaction on
noisemaker(approx.dB SPL)
Reaction
on warbledpure tones(dB HL)
Reaction
on Speech(dB HL)
Expected
Response
0–6 weeks
50-70 dB
78 dB(±6)
40-60 dB
Eye-widening,
eye-blink,
stirring
or arousal fromsleep, startle.
6-16 weeks
50-60 dB
70 dB(±10)
40dB (±2)
Eye-widening,
eye-shift, eyeblink, quieting:beginningrudimentaryhead turn by
four
month.
4-7 months
40-50 dB
51 dB(±9)
21dB (±8)
Head turn on
lateral plane
towards sound:listening
attitude.
7-9 months
30-40 dB
45 dB(±15)
15dB (±7)
Direct
localisation ofsounds to side,indirectly belowear level.
9-13 months
25-30 dB
38 dB(±8)
8dB (±7)
Direct
localisation ofsounds to side,directly belowear level
indirectly aboveear level
13-16 months
25-30 dB
32 dB(±10)
5dB (±5)
Direct
localisation ofsounds.
16-21 months
25 dB
25 dB(±10)
5dB (±1)
Same.
21-24 months
25 dB
25 dB(±10)
5dB (±1)
Same.
PKA Operation Manual Page 10
Auditory Behaviour Index for Infants

The reflex pattern elicited by sound can be divided into the following types of
reflexes (Relke and Frey 1966). The sound intensity is 75 –90dB.
Breathing Reflex
The breathing rhythm is changing when the sound is heard and should
stabilise after 5-10 seconds.
Auropalpebral Reflex (APR)
The open eyelids will be closed fast and clear.
Moving Reflex
The neonatal child will move heavily after a quiet period.
Crying Reflex (Scream)
The face of the child will indicate discomfort and shortly after
followed by weeping or a scream.
Astonishment Reflex
Crying and bodymovements stop momentarily as if the child is asking: “What
is going on”?
Waking up Reflex
The breathing rate is accelerating; the child starts moving, wakes up and
opens the eyes.
PKA Operation Manual Page 11
Reflex Audiometry by Neonates

Newborn to 2 months of age
Arousal from sleep. MRL2 in
quiet surroundings 50-70 dB.
MRL in noisy surroundings: 90
2 Minimum response level, dB HL. The MRL levels are recorded in sound cabins. In noisy surroundings the levels will
have to be correspondingly higher
.
Operation Manual Page 12
months of age4-3
Rudimentary head turn,
horizontally.
MRL: 50-60 dB
4-7 months of age
Sound localisation to the side
only, not above or below eye
level.
MRL: 40-50 dB
7-9 months of age
Sound localisation to the side
Indirect below. (Not above).
MRL: 30-40 dB.
Maturation of Auditory Response

Operation Manual Page13
9-13 months of
Sound localisation to the side
and direct below.
MRL: 25-35 dB.
13-16 months of age
Sound localisation to the side,
below and indirect above.
MRL: 25-35 dB.
16-21 months of age
Direct sound localisation to
the side, below, indirect
above.
MRL: 25-35 dB.
21-24 months of age
Locates directly sound at any
angle.
MRL: 25-30 dB.

Standards:
Audiometer: EN 60645-1, Type 5
Sound Pressure Level of the loudspeaker: ISO 389-7
Sound Pressure Level of the headphone: ISO 389-1
EMC: EN 60601-1-2
Frequencies:
500, 1000, 2000, 3000, 4000 Hz.
Stimuli:
Warble Tone, NB, and WN.
Intensities:
Distance 50 cm: 30 –80 dB HL in 10 dB steps for Warble Tone and WN.
20 –70 dB for NB
Distance 16 cm Increases the indicated intensity by 10 dB.
Warble Frequency:
5 Hz, ± 5%.
PKA Operation Manual Page 14
Technical Specifications

Stimulation using TDH39S:
Pure Tone: 500, 1000, 2000, 3000 and 4000 Hz.
Intensities of 30 –80 dB (independent calibration applied when TDH39S is
connected).
Sound Source:
Built-in loudspeaker or audiometric headphone TDH39S (independent
calibration registers).
Light Stimulation:
3 LED’s arranged in a triangle, flash speed 5 Hz (5 pulses per sec).
Tone and Light Stimulation:
Silent presentation switch.
Dimensions:
L x W x H: 22 x 6. 7 x 7.5 cm
Warm-up time:
The PKA is ready for instant use and does not require any warm-up time.
PKA Operation Manual Page 15

Environmental conditions:
The specification for the instrument is valid if the instrument is operated
within the following environmental limits:
Temperature: 15°C to 35 °C.
Humidity: 30 %RH to 90 %RH
Transportation and storage of the instrument should be within the following
environmental conditions:
Temperature: Transportation: -20° to 50°
Storage: 0° to 50°
Humidity: 10%RH to 95% RH
Non-condensing. Keep dry.
PKA Operation Manual Page 16

Check box and contents for damage:
When the instrument has been received, please check the shipping box for
rough handling and damage. If the box is damaged, it should be kept, until
the contents of the shipment have been checked mechanically and
electrically. If the instrument is faulty, please contact the nearest service
office. Keep the shipping material for the carrier’s inspection and
insurance claim.
Keep carton for future shipment:
The PKA comes in its own shipping carton, which is specially designed for
the PKA. Please keep this carton. It will be needed if the instrument has to
be returned for service. If service is required, please contact your nearest
sales and service office.
Delivered items with PKA:
PKA delivered as standard contains the following:
- PKA Pediatric Free Field Audiometer
- Special adaptor and connection cable 220V
- Calibration Certificate
- Multilingual Instruction for Use
PKA Operation Manual Page 17
Contents of Shipment
Unpacking / Inspection

Check numbers on PKA and Manual:
The identification label on the rear plate holds the serial number. This should
be checked with the manual number, and written down for later service
claims.
Report immediately any faults:
The cabinet and the accessories should be checked visually for scratches
and missing parts. Any missing part or malfunction should be reported
immediately to thesupplier of the instrument together with the invoice, serial
number and a detailed report of the problem. In the back of this manual you
will find a "Return Report", where you can describe the problem.
Please use "Return Report":
Please realise that if the service engineer does not know what problem to
look for he may not find it, so using the Return Record will be of great help
to us and is your best guarantee that the correction of the problem will be to
your satisfaction
PKA Operation Manual Page 18
Reporting Imperfections