Welch Allyn AM 232 Operating Instructions Manual

Tipo
Operating Instructions Manual
1
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AM 232
TM
Manual Audiometer
Operating Instruction Manual
Part Number 1717-0101 - Rev. 05
2
12-16-08
CE Mark per Medical Device Directive (93/42/EEC)
Electromagnetic compatibility (EMC)
3
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Table of contents
Electromagnetic compatibility (EMC) 2
Table of contents 3
Service and repair 5
Recalibration 5
Warranty 5
Rechargeable battery warranty 5
Safety notes 6
Specifications 7
Standards 7
Chapter 1
Introduction 9
Unpacking and inspection 10
Accessories supplied 10
Connectors, Controls, Indicators 11
Front panel controls and indicators (see Figure 1) 11
Rear panel connectors and indicators (see Figure 2) 12
Installation 14
Pretest procedure 15
Pretest noise recovery period 15
Elimination of ambient noise 16
Permissible noise levels 16
Disposal of non-contaminated electrical and electronic equipment
directive 2002-96-EC-WEEE 17
Chapter 2
Battery Option 19
NiCad BATTERY OPERATION 20
Recharging NiCad batteries 21
Replacing NiCad batteries 22
Alkaline battery installation/operation 23
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Chapter 3
Operation 25
Preliminary check 26
Instructing the subject 27
Placing the earphones 27
Response handswitch 27
Audiogram form 28
Routine calibration check 29
Routine test administration 30
HL control (F3) 30
Range Extension pushbutton (F2) 30
Tone Type Selector (F9) 30
Typical testing session 31
Pretest Review 31
Familiarization 31
Determining the threshold (Pure Tone) 32
Testing procedure 32
Chapter 4
Routine Maintenance 33
Calibration 34
Earphone cords 34
Hum and random noise 35
Distortion and frequency shift 35
Special messages 35
CAL 35
Exx 36
Bibliography 37
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Service and repair
Technical Service Department Technical Service Department
Welch Allyn, Inc. Welch Allyn Canada Limited
4341 State Street Road 160 Matheson Boulevard, East
Skaneateles Falls, NY 13153-0220 Mississauga, Ontario, Canada L4Z 1V4
Tel.: 1-800-535-663 (in U.S.A. only) Tel.: 1-800-561-8797 (in Canada only)
Recalibration
Welch Allyn recommends that the AM 232 Manual Audiometer be recalibrated
annually. Arrangements may be made by returning the instrument registration card or
by contacting Welch Allyn’s Technical Service Department (as listed above). A
moderate fee is charged for recalibration.
Warranty
Note: Return of the instrument registration card is required for proof of purchase
and warranty validation.
Welch Allyn, Inc. warrants the AM 232 Manual Audiometer 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 a variance from
the manufacturer’s specifications during the warranty period, Welch Allyn will repair,
replace or recalibrate the instrument or component(s) at no cost to the purchaser.
This warranty only applies to instruments purchased new from Welch Allyn or its
authorized distributors or representatives. The purchaser must return the instrument
directly to Welch Allyn or an authorized 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 Welch Allyn or a Welch Allyn authorized representative.
No other express or implied warranty is given.
Rechargeable battery warranty
Welch Allyn nickel-cadmium batteries are guaranteed by Welch Allyn for two years
from date of manufacture (when used in Welch Allyn instruments only). Defective
batteries will be replaced on a pro rata basis should failure occur prior to expiration
data on battery.
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Safety notes
WARNING
!
The AM 232 Manual Audiometer is designed to be used
with a hospital grade outlet. Injury to personnel or damage to equipment
can result when a three-prong or two-prong adapter is connected be-
tween the AM 232 Manual Audiometer power plug and an AC outlet or
extension cord. Additionally, the AM 232 Manual Audiometer is equipped
with a specific power transformer which should not be interchanged with
any other transformer or supply.
This symbol indicates the location of a service adjustment part and
is intended for service personnel only. The AM 232 Manual Audiometer is
a specifically calibrated audiometer and the periodic service and adjust-
ments for the instrument that may be required should be done only by an
authorized Welch Allyn service technician.
CAUTION
!
The AM 232 Manual Audiometer is designed to comply
with the EMC requirements according to IEC 60601-1-2.
Radio transmitting equipment, cellular phones, etc. shall not be used in
the close proximity of the device since this could influence the perfor-
mance of the device. Particular precaution must be considered during
use of strong emission sources such as High Frequency surgical equip-
ment and similar device so that e.g., the HF-cables are not routed on or
near the device. If in doubt, contact a qualified technician or your local
representative. Refer to the Electromagnetic Compatibility (EMC) Guide
on CD 482-638702.
7
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Specifications
Standards
The AM 232 Manual Audiometer meets ANSI S3.6 and IEC 645 Type 4 Audiometer
Standards.
UL 60601-1 Medical Electrical Equipment Requirements for Safety
IEC/EN 60601-1 General Requirements
CSA C22.2 No.601-1-M90
Protective Classification
This system is intended for continuous operation and has a protective classification
of Class II, Type B.
Class II Type B
equipment symbols
Degree of protection against harmful ingress of water: Ordinary (no protection)
Frequency Range
Discrete Frequencies: 125, 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, 8000 Hz
Accuracy: ±3%
Total Harmonic Distortion: <2%
Intensity
Ranges: 125 Hz: -10 to 50 dB HL
500 to 6000 Hz: -10 to 90 dB HL
250 and 8000 Hz: -10 to 70 dB HL (Increments of 5 dB steps)
Note: A “+10” dB switch extends maximum at all frequencies by 10 dB.
Accuracy: 125 to 4000 Hz: ±3 dB
6000 to 8000 Hz: ±5 dB
Signal to Noise Ratio: >70 dB
Tone Type
Rise/Fall Time: 20-50 msec
Continuous: Steady when present bar depressed
Pulsed: 2.5 pulse/sec
FM: 5 Hz, ±5%
Head set
Telephones TDH39 Earphones with MX41AR Cushions (60 ohm impedance).
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Power
Line Voltage: 100-240 V (±10%) Note: Desktop power supply
Range: 50-60 Hz (± 5%)
Consumption: 9 Watts
Battery
Types: Rechargeable (NiCad) or Non-Rechargeable (Alkaline)
Range: 7.0 V - 9.0 V
Capacity: NiCad - 22 hours continuous operations
Alkaline - 45 hours continuous operations
Environmental
Temperature:
Operating: 60° F to 105° F (15° C to 40° C)
Powerline Storage: -40° F to 140 ° F (-40° C to 60° C)
Battery Storage: -40° F to 105° F (-40° C to 40° C)
Humidity: 5% to 90%
Warm-up Time: 10 minutes for instruments stored at room temperature
Mechanical
Dimensions: 13.25" W x 14" D x 3.75" H
(33.66 cm x 35.56 cm x 9.53 cm)
Weight 5.6 lb (2.53 kg) net
8 lb (3.64 kg) shipping
10 lb (4.55 kg) shipping with battery included
Supplied Accessories Catalog Numbers
Test headset (TDH39) 23223
Audiogram Forms (1 pad of 50) 52300
Instruction Manual 232001
AC Power Module 8000-0246
Optional Accessories
Response Handswitch 23220
Patch Cord, 2 Conductor 23221
Audiocups 23222
Replacement NiCad Battery Only 72320
Battery Pack Assembly 72329
Battery Pack includes Welch Allyn supplied NiCad battery. May also be used
with six (6), Size C, Alkaline batteries (not included) Replacement NiCad
Catalog Listings
AM 232 Manual Audiometer, AC Power (USA) 23200
AM 232 Manual Audiometer, AC Power and Battery (USA) 23210
AM 232 Manual Audiometer , AC Power (Export) 23205
AM 232 Manual Audiometer, AC Power and Battery (Export) 23215
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Chapter 1
Introduction
The AM 232 Manual Audiometer is a single-channel, pure tone, air conduction,
portable instrument designed to provide basic audiometric screening capability for
physicians’ offices, schools and industry. The lightweight design allows easy
transport to a variety of testing locations, and the built-in storage cavity and case
provide enough room to contain all instrument accessories. The clearly labeled front
panel controls and full frequency range make accurate, reliable testing a simple matter
for any user.
The AM 232 Manual Audiometer is a precisely designed and calibrated instrument.
With proper care it will deliver accurate sound-pressure levels to subject ears for your
hearing screening program.
Note: The AM 232 Manual Audiometer should be recalibrated yearly (or sooner if a
problem develops). See Chapter 4.
10
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Unpacking and inspection
Although your AM 232 Manual Audiometer was carefully tested, inspected and
packed for shipping, it is good practice after receiving the instrument to immediately
examine the exterior of the container for any signs of damage. Notify your carrier if
any damage is noted.
Carefully remove your AM 232 Manual Audiometer from its shipping container. If
the instrument appears to have suffered mechanical damage, notify the carrier
immediately so that a proper claim can be made. Be certain to save all packing
materials so that the claim adjuster can inspect it as well. As soon as the carrier has
completed the inspection, notify your Welch Allyn representative.
If the instrument must be returned to the factory, repack it carefully (in the original
container if possible) and return it prepaid to the factory for necessary adjustments.
Check that all accessories itemized in Accessories supplied below are received in
good condition. If any accessories are missing, contact Welch Allyn immediately.
See the Specifications section for the catalog numbers of accessories and also for a
listing of optional accessories.
Accessories supplied
Test Headset Assembly (TDH39)
Audiogram Pad (1 pad of 50)
Battery Pack Assembly (used with #23210 and #23215 models only)
AC power cord
11
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Connectors, Controls, Indicators
Figure 1: Front panel.
Front panel controls and indicators (see Figure 1)
F1 - Power switch and indicator for ON and OFF .
F2 - Range extension pushbutton allows you to increase the stimulus intensity 10 dB
above the standard maximum HL at any frequency. When in use, a “+” appears
on the LCD.
F3 - HL control for setting stimulus intensity level. Level is indicated on LCD.
F4 - Present bar for stimulus presentation.
F5 - Stimulus being presented via an earphone. Presentation indicated by illuminated
green LED.
F6 - Subject response indicator shows you when the test subject has pressed the
handswitch button by an illuminated green LED (with optional handswitch only).
F7 - Control for setting stimulus frequency. Frequency is indicated in the window
adjacent to the control.
F8 - Routing switch for stimulus presentation to the earphone. Left or right indicated
by illustration of subject.
F9 - Switch for setting the stimulus tone type.
FM = warble tone
__ = steady tone
- - - = pulsed tone
F10 - Low battery indicator to alert you of a limited operating time. Recharge or
replace batteries (dependent on whether NiCad or Alkaline batteries are used).
12
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Rear panel connectors and indicators (see Figure 2)
Figure 2: Rear panel.
R1 - Power input jack (5-pin DIN Connector) with front panel illustration showing its
location and a rear panel label giving the input power specifications.
R2 -
!
Attention, consult accompanying document for instructions or warnings
pertaining to these parts.
R3 - Earphone output jacks (standard phone jacks). Front panel illustration shows
left and right phone.
R4 - Response handswitch input jack (standard phone jack) with front panel illustra-
tion showing location.
R5 - Entry by qualified service personnel only.
Note: The above symbol is located inside the storage compartment. It denotes a
Type B, Class II product per IEC 878 as referenced in IEC 60601-1.
13
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Note: There is a symbol on the bottom panel (marked B1 in Figure 3) that indicates
entry by qualified service personnel only.
Figure 3 : Bottom panel.
14
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Installation
1. Plug the power cord into the appropriate jack (R1) on the back panel of the
instrument.
2. Plug the other end into a line power (mains) outlet.
3. Plug the earphones into the earphone jacks (R3) on the rear panel. Note the
symbol along the top of the front panel, which indicates which is right (RED) and
which is left (BLUE).
4. Turn the power switch to ON.
Note: For battery operation, please refer to Chapter 2.
15
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Pretest procedure
Note: The AM 232 is a versatile audiometer designed for use in doctor offices,
schools, industrial settings, the military, etc. The generic term “subject” used in this
manual is used to identify the person whose hearing is being evaluated.
Any program aimed at obtaining reliable records of hearing thresholds should be
staffed and supervised by appropriately-trained individuals. Training courses
leading to certification are available for audiometric technicians in most urban areas.
Two prerequisites are of particular importance to the procurement of reliable audio-
grams:
Prior to testing, allow adequate time for the subject to recover from the effects of
a previous exposure to high-level sound.
Tests should be performed in a quiet area.
Pretest noise recovery period
Exposure to high levels of sound (unmuffled lawn mowers, power tools, loud music,
gunfire, etc.) tends to create a temporary threshold shift (TTS), which diminishes with
time after exposure. Any subject tested soon after such exposure may manifest a
hearing loss that does not reflect the subject’s normal hearing threshold. It is,
therefore, important that the testing procedure prescribe some time interval - usually
at least 16 hours - between the last exposure to high-level sound and the administra-
tion of any hearing test.
16
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Elimination of ambient noise
Excessive noise in the test environment such as that produced by conversation,
typewriters, or other machines also reduces test validity because it tends to mask the
test signals particularly at the lower frequencies where earphone cushions provide
less effective attenuation. An acoustically tested room may be required if ambient
noise at the subject’s ears reaches objectionable levels - i.e., sufficient to cause
apparent hearing loss at the low frequencies. Also, Audiocups are available from
Welch Allyn as an optional accessory. If the test subject is in the same room as the
audiometer, it is recommended that the subject be seated about 1 meter (-3 ft) away
from the instrument.
Maximum permissible test environment sound-pressure levels are specified by
American National Standard Criteria for Permissible Background Noise during
Audiometric Testing, S3.1-1977 (revised). Table 2 shows the maximum background
levels that can be present inside the room while a valid hearing test is being con-
ducted. For more comprehensive information about hearing testing and hearing
conservation, refer to the Bibliography.
Permissible noise levels
Test Tone Frequency (Hz) 125 250 500 750 1000 1500 2000 3000 4000 6000 8000
Test Room
* 34.0 22.5 19.5 21.5 26.5 26.5 28.0 33.5 34.5 38.0 43.5
Test Room
** 29.0 17.5 14.5 16.5 21.5 21.5 23.0 28.5 29.5 33.0 38.5
*Ears covered maximum permissible octave band levels.
**Ears covered maximum permissible one-third octave band levels.
17
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English Do not dispose of this product as unsorted municipal waste. Prepare this product for reuse or separate collection as
specified by Directive 2002/96/EC of the European Parliament and the Council of the European Union on Waste
Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply.
For more specific disposal information, see www.welchallyn.com/weee, or contact Welch Allyn Customer Service at
+44 207 365 6780.
ý
esky Tento výrobek nelikvidujte s net
Ĝ
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ným domovním odpadem. P
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separovaného odpadu podle sm
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rnice Evropského parlamentu a Rady Evropské unie
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íslo 2002/96/EC o likvidaci
elektronických a elektrických za
Ĝ
ízení (Waste Electronic and Electrical Equipment, WEEE). Pokud je výrobek
kontaminován, tato sm
Č
rnice pro n
Č
j neplatí.
Podrobn
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jší sm
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rnice o likvidaci najdete na adrese www.welchallyn.com/weee nebo zavolejte odd
Č
lení služeb
zákazník
Ĥ
spole
þ
nosti Welch Allyn na
þ
ísle +353 46 9067790.
Dansk Produktet må ikke bortskaffes som usorteret husholdningsaffald. Produktet skal forberedes til genbrug eller særskilt
indsamling som angivet i Europa-Parlamentets og Rådets Direktiv 2002/96/EF om affald af elektrisk og elektronisk
udstyr (WEEE). Hvis produktet er kontamineret, gælder Direktivet ikke.
Yderligere oplysninger om bortskaffelse fås på www.welchallyn.com/weee eller ved at kontakte Welch Allyn
Kundeservice på +353 46 9067790
Deutsch Dieses Produkt darf nicht mit unsortiertem Hausmüll entsorgt werden. Bereiten Sie dieses Produkt zur
Wiederverwertung oder zur getrennten Sammlung entsprechend der Richtlinie 2002/96/EG des Europäischen
Parlaments und des Rats der Europäischen Union über Elektro- und Elektronik-Altgeräte (WEEE-Richtlinie) vor. Diese
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Detailliertere Informationen zur Entsorgung finden Sie unter www.welchallyn.com/weee bzw. erhalten Sie beim
Kundendienst von Welch Allyn unter der Telefonnummer +49 7477 92710
Español No deseche este producto como residuos municipales sin clasificar. Prepare este producto para su reutilización o
recogida selectiva como se especifica en la Directiva 2002/96/CE del Parlamento Europeo y el Consejo sobre
residuos de aparatos eléctricos y electrónicos (RAEE). Si este producto está contaminado, no se aplica esta directiva.
Para obtener información más específica sobre los desechos, consulte www.welchallyn.com/weee o póngase en
contacto con el servicio de atención al cliente de Welch Allyn llamando al +34 91 7499357.
Eesti keeles Ärge vabanege antud tootest kui sorteerimata olmejäätmest. Valmistage toode ette korduvkasutamiseks või
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Täpsemat teavet jäätmekõrvaldamise kohta saab www.welchallyn.com/weee või võtke ühendust Welch
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+44 207 365 6780.
Français Ne mettez pas au rebus ce produit avec les ordures ménagères non triées. Préparez-le en vue d'un recyclage ou d'une
collecte séparée, comme stipulé par la Directive 2002/96/EC du Parlement européen et du Conseil de l'Union
européenne sur les déchets d'équipements électroniques et électriques (WEEE). Cette directive ne s'applique pas si le
produit est contaminé.
Pour des informations plus spécifiques sur la mise au rebus, visitez le site www.welchallyn.com/weee, ou contactez le
service clientèle Welch Allyn au +33 1 55695849.
Disposal of non-contaminated electrical and
electronic equipment directive 2002-96-EC-WEEE
18
12-16-08
Italiano Non smaltire questo prodotto con i normali rifiuti. Approntare il prodotto per il riutilizzo oppure smaltirlo in modo
differenziato, in base a quanto stabilito dalla Direttiva 2002/96/EC del Parlamento Europeo e del Consiglio dell'Unione
Europea in materia di smaltimento delle apparecchiature elettriche ed elettroniche (WEEE). Se il prodotto è
contaminato, tale direttiva non viene applicata.
Per ulteriori informazioni sui metodi di smaltimento, visitare il sito Web all'indirizzo www.welchallyn.com/weee oppure
contattare l'assistenza clienti Welch Allyn al numero +39 02 69682425.
Lietuvi
ǐ
k. Neišmeskite šio gaminio kartu su ner
nj
šiuotomis miesto atliekomis. Paruoškite š
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pakartotinam naudojimui ar
surinkimui atskirai, kaip nurodyta Europos Parlamento ir Tarybos direktyvoje 2002/96/EB d
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Nor
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s informacijos, žr. www.welchallyn.com/weee, arba susisiekite su Welch Allyn
Klient
ǐ
aptarnavimo skyriuje +353 46 9067790.
Magyar Ne dobja ki a terméket a települési vegyes hulladékgy
Ħ
jt
Ę
be. A terméket az újrafelhasználási vagy egyéb, speciálisan
ilyen célokra kijelölt gy
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jt
Ę
helyen kell leadni, az Európai Parlament és a Tanács elektromos és elektronikai
berendezésekb
Ę
l származó hulladékról (WEEE) szóló, 2002/96/EK számú irányelvének megfelel
Ę
en. Ha a termék
befert
Ę
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Ę
dött, az említett irányelv rendelkezései nem vonatkoznak a kidobására.
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Nederlands Dit product mag niet worden weggegooid bij niet-gesorteerd huishoudelijk afval. Het product moet worden
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en de Raad van de Europese Unie inzake de verwerking van elektrisch en elektronisch afval (WEEE - Waste
Electronic and Electrical Equipment). Deze richtlijn is niet van toepassing indien het product is verontreinigd.
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produktet er forurenset, gjelder ikke dette direktivet.
Se www.welchallyn.com/weee eller kontakt Welch Allyn kundeservice på +44 207 365 6780 for nærmere opplysninger
om avfallshåndtering.
Polski Nie nale
Ī
y wyrzuca
ü
tego produktu razem z nieposortowanymi odpadami komunalnymi. Nale
Ī
y przygotowa
ü
go do
ponownego wykorzystania lub rozdzieli
ü
jego elementy, zgodnie z Dyrektyw
ą
nr 2002/96/WE Parlamentu
Europejskiego i Rady w sprawie zu
Ī
ytego sprz
Ċ
tu elektrycznego i elektronicznego (WEEE, Waste Electronic and
Electrical Equipment). Ta dyrektywa nie ma zastosowania, je
Ğ
li produkt jest ska
Ī
ony.
Szczegółowe informacje na temat usuwania mo
Ī
na znale
Ĩü
na stronie www.welchallyn.com/weee lub uzyska
ü
w
biurze obsługi klienta firmy Welch Allyn pod numerem +353 46 9067790
Português Não elimine este produto como lixo urbano indiferenciado. Prepare este produto para reutilização ou recolha
diferenciada em conformidade com a Directiva 2002/96/EC do Parlamento Europeu e do Conselho da União Europeia
sobre Reciclagem de Resíduos Eléctricos e Electrónicos (WEEE). Se este produto estiver contaminado, esta directiva
não será aplicável.
Para obter informações mais específicas sobre a eliminação de resíduos, consulte www.welchallyn.com/weee ou
contacte Welch Allyn Customer Service no número +353 46 9067790
Suomi Älä hävitä tätä tuotetta lajittelemattoman yhdyskuntajätteen mukana. Tuote on kierrätettävä tai vietävä erilliseen
keräyspisteeseen Euroopan parlamentin ja neuvoston antaman sähkö- ja elektroniikkalaiteromua koskevan direktiivin
2002/96/EY mukaisesti. Jos tuote on saastunut, direktiivi ei koske sitä.
Lisätietoja tuotteiden hävittämisestä saa käymällä osoitteessa www.welchallyn.com/weee tai ottamalla yhteyttä Welch
Allynin asiakaspalveluun, puh. +44 207 365 6780.
Svenska Kassera inte denna produkt som osorterat kommunalt avfall. Förbered denna produkt för återanvändning eller särskild
insamling enligt Europaparlamentets och rådets direktiv 2002/96/EG om avfall som utgörs av eller innehåller elektriska
eller elektroniska produkter (WEEE). Om denna produkt är kontaminerad gäller inte detta direktiv.
Gå in på www.welchallyn.com/weee eller kontakta kundtjänsten hos Welch Allyn på +46 42330220 för mer information
om kassering.
19
12-16-08
Chapter 2
Battery Option
This chapter describes the battery option of the AM 232 Manual Audiometer. It
pertains only to those customers who purchased Models #23210 or #23215 with the
battery pack installed or to those who later purchased the #72329 Battery Pack
Assembly. In both cases, a rechargeable NiCad battery is included.
20
12-16-08
NiCad BATTERY OPERATION
The AM 232 Manual Audiometer battery option is supplied with an installed,
rechargeable NiCad battery pack. It requires about 18 hours to charge fully, which will
provide about 22 hours of continuous operation. The green LED on the pack itself
illuminates when charging is in progress. The words LO BAT illuminates on the front
panel LCD when the battery charge is getting low, alerting you to recharge the
batteries. When LO BAT appears, the instrument will operate (continuously) for
about two more hours before it shuts down completely.
Note: In no instance will loss of battery power affect the instrument calibration.
To save battery life, the AM 232 Manual Audiometer has a special “Sleep Mode” in
which the instrument will shut down after 5 minutes of no operation. You will know
the instrument is “asleep” because the LCD will show three dash lines (- - -). To
“wake up” the instrument, press the Present bar. There is no danger of presenting a
loud tone to the test subject when the instrument “wakes up” because no tone is
presented until the Audiometer is awake. In addition, the instrument automatically
resets its output to 0 dB HL.
If the AM 232 Manual Audiometer is operated until the battery charge has dropped
below an acceptable voltage level, the instrument will cease to function. The display
will be blank except for the LO BAT indication, and the controls will cease to
function. To restore operation, the batteries must be recharged for some period of
time, up to 18 hours (full charge), or line power (mains) may be used. If the Audiom-
eter is operated off of line power (mains) with the rechargeable batteries in place,
some battery charging will occur.
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Welch Allyn AM 232 Operating Instructions Manual

Tipo
Operating Instructions Manual

in altre lingue