Siemens HearCheck Screener User manual

HearCheck Screener
User Guide
Manufactured by Sivantos GmbH under Trademark License of Siemens AG.

Introduction
This booklet is a guide to the use and maintenance of
the HearCheck Screener, a hearing screening device.
You can now screen quickly and easily, determining
whether further assessment is indicated (e.g. by a local
hearing care professional).
Symbols:
Be especially aware of information marked with the
warning symbol WARNING!
WARNING points out a situation that could
lead to serious injuries.
Advice and tips on how to handle your
device better.
Instruction. Indicates that something has to
be done.
This symbol is placed on the bag containing
the ear cups and it indicates that the ear
cups should not be re-used.
This symbol is placed inside the ear cover
and indicates that the instructions for use
are containing important information for the
safe use of the device.
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t
Contents 2
Your HearCheck Screener 4
Important hints 6
Insert the batteries 8
Preparation before use 8
How to use 9
Reading the results 11
Maintenance 12
Applicable standards 13
Environmental conditions for use 13
Technical Data 14
Guidance and Manufacturers Declaration 15
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3Your HearCheck Screener
Contraindication:
The device shall not be used with children or babies and
with persons not able to respond properly.
Intended use:
The device is a screening test device intended to be
used with adult persons only and either operated by the
person under test or by a third person applying test tones
of particular frequency and level to the person under
test.
The device is intended to be used as a handheld device
only. Therefore all parts of the device are intended to be
touched by the operator or the person under test with
the hand. The opening of the Ear Cover is intended to be
applied to the area of the ear of the person under test
only when covered with an Ear Cup. Each Ear Cup is only
intended for single use with one patient.
No specific knowledge beyond the instructions given in
this user manual is required for the safe operation of the
device.
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Light indicators
Start button
Battery compartment
Ear cover
Label
Ear cup
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Included in delivery:
- HearCheck Screener
- Replacement ear cups (25 pcs.)
- User Manual
- 2x AAA batteries
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Please read the following information carefully before
using the device.
WARNING
No modification of this equipment is allowed.
WARNING
Do not use noisy equipment (e.g. like radio
wave transmitting devices or cellular phones) in
the vicinity of the HearCheck Screener to avoid
malfunction.
The device should not be used adjacent or stacked
with other equipment.
WARNING
To avoid improper function of the device use only
accessories specified by the manufacturer.
WARNING
Replace ear cup cover for each patient. Do not
reuse covers.
4Important hints
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Make sure the battery door is closed before using the
device.
This device is not an audiometer and should not be
used for the purpose of hearing disability diagnosis.
For reliable results you are advised to use the device
in environments where background noise does not
exceed 50 dB (A).
For battery replacement, please use only Alcaline Type
AAA batteries or NiMH or NiCd rechargeable batteries,
type AAA. Do not connect directly to any other power
source.
Remove the batteries if equipment is unlikely to be
used for some time.
Do not throw used batteries into household waste.
Use locally provided battery recycling systems for
environmentally correct disposal.
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6Preparation before use
Please insert a new ear cup into the ear cover of the
device before use. Use a new cup for each patient (or
each ear if there is any sign of infection).
Used ear cups can be disposed of in normal waste.
Replacement ear cups are available from the customer
service. Part number 101 74 191
Insert the batteries
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+
-+
-
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STEP 1. Gently place the cup of the
device over the ear. It's important
that the edges of the cup are in
contact with the patient's head.
Move any hair out of the way,
remove glasses, earrings and
hair bands or anything that may
prevent achieving adequate
contact around the ear.
STEP 2. Press the start button
once to initiate the functional test
sequence. If it is working correctly,
you will see all 3 lights flash in
sequence 3 times. This indicates
that the device is ready to use.
The test sequence will begin
in 3 seconds with three signals
at 1000 Hz. (55dBHL, 35dBHL,
20dBHL).
A light will appear when a tone
is being played: first left, then
middle, then right. The subject
should indicate when a tone is
heard to the tester by a suitable
method such as raising a finger.
How to use 7
9

6. How to use
STEP 3. Count and record the number of times indicated for
the first sequence.
STEP 4. The start button must be pushed within 20 seconds
of the end of the first sequence (after the third light has
appeared) to start the second sequence.
STEP 5. You will see all 3 lights flash in sequence 3x3 times.
The test sequence will begin in 3 seconds with three
signals at 3000 Hz. (75dBHL, 55dBHL, 35dBHL).
STEP 6. Count and record the number of times the
subject has indicated that a tone was heard.
STEP 7. Repeat steps 2 through 6 on the other ear.
Button should be pressed within 20 seconds after
the first test or the screener will turn off.
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Reading the results
Please note: these are screening results and should not
be used as audiometric assessment.
The lower the score, the more likely the patient
will benefit from a hearing aid. Please see below an
example of how the results should be recorded.
Score the right ear in exactly the same way.
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The device requires very little maintenance except
for daily wiping with a clean, dry or damp cloth.
Use water or lukewarm, diluted solution of water
and household detergent to wet the cloth. Do not
use alcohol or other solvents, and never immerse
the HearCheck Screener in water.
The device has been factory calibrated and should
be returned for recalibration three years after the
manufacturing date labelled inside the ear cover
or three years after first use, whatever is more
appropriate.
If you need to return the device, please contact the
customer service.
To determine proper functionality and adequate
calibration, an operator with normal hearing (or a
person who can hear all 6 signals) should perform a
hearing test on their own at least once a day or
before the device is used for another person
(as appropriate).
9Maintenance
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Applicable standards
EN 980:
Symbols for use in the labelling of medical device
EN 60601-1:
Medical electrical equipment - Part 1: General
requirements for safety
EN 60601-1-2:
Medical electrical equipment - Part 1: General
requirements for safety. Collateral standard.
Electromagnetic compatibility
Operation
Temperature range +10°C to +40°C
Relative humidity 30% to 75%, non condensing
Air pressure 70 kPa to 106kPa
During transportation
Temperature range -20°C to +60°C
Relative humidity 10% to 90%, non condensing
Air pressure 70 kPa to 106kPa
Environmental conditions for use 11
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General Classifications
Medical devices class: 2 a
Protection class: II
Applied parts: Type BF
IP protection class
according to IEC 60529: IPX0
AP or APG classification: Not applicable
Operating mode: Continuous operation
Power: Internally powered equipment
Sterilisation / disinfection: See manual chapter 9
Accuracy of measurement: 3 dB
Test frequencies: 1000 Hz, 3000 Hz
Tolerance of frequencies: +/- 5%
Total Harmonic Distortion
(THD): < 10%
Test levels: 20, 35, 55, 75 dBHL
Power save function: Automatic power off after 20sec.
Battery Size: AAA (1,5 V)
Number of batteries: 2
Battery Lifetime: 1000 measurements
Technical Data
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Guidance and Manufacturers Declaration
The device complies to EN 60601-1-2 and requires
special precautions regarding Electromagnetic
Compatibility (EMC). It must be installed and put into
service according to EMC information provided in this
document. Please take into account, that portable and
mobile RF communications equipment can affect
medical electrical equipment.
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Guidance and manufacturer's declaration -
electromagnetic emissions
The HearCheck Screener is intended for use in the electromagnetic environment
specified below. The customer or the user of the HearCheck Screener should
assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The HearCheck Screener uses RF energy
only for its internal function. Therefore,
its RF emissions are very low and are not
likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
The HearCheck Screener is suitable for use
in all establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Not applicable
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
Not applicable
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Guidance and manufacturer's declaration -
electromagnetic immunity
The HearCheck Screener is intended for use in the electromagnetic environment
specified below. The customer or the user of the HearCheck Screener should
assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV
contact
± 8 kV air
± 6 kV
contact
± 8 kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for
power supply
lines
± 1 kV for
input/output
lines
Not
applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV
differential
mode
± 2 kV
common
mode
Not
applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
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Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic
environment - guidance
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
< 5 %
U T
(> 95 % dip in U T)
for 0.5 cycle
40 %
U T
(60 % dip in U T)
for 5 cycles
70 %
U T
(30 % dip in U T)
for 25 cycles
< 5 %
U T
(> 95 % dip in U T)
for 5 sec.
Not
applicable
Mains power quality should be
that of a typical commercial
or hospital environment. If
the user of the HearCheck
Screener requires continued
operation during power
mains interruptions, it is
recommended that the
HearCheck Screener is
powered from an
uninterruptible power supply
or a battery.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note:
U T ist the a.c. mains voltage prior to application of the test level.
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Guidance and manufacturer's declaration -
electromagnetic immunity
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic
environment - guidance
Portable and mobile RF communications Equipment should be used no closer to
any part of the HearCheck Screener, including cables, than the recommended
separation distance calculated fom the equation applicable to the frequency of
the transmitter.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Not
applicable
3 V/m
Recommended separation
distance
Not applicable
d = 1.2 √ P
80 MHz to 800 MHz
d = 2.3 √ P
800 MHz to 2.5 GHz
Where
P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and
d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic
site survey, ashould be less than the compliance level in each frequency range b.
Interference may occur in the vicinity of equipment
marked with the following symbol:
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Note 1:
Note 2:
At 80MHz and 800MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.
a
b
Field strengths from fixed transmitters, such as base stations for
radio (mobile/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured
field strength in the location in which the HearCheck Screener is
used exceeds the applicable RF compliance level above, the
HearCheck Screener should be observed to verify normal
operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the
HearCheck Screener.
Over the frequency range 150 kHz to 80 MHz, field strengths
should be less than 3V/m.
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