User Manual
16 Pages
Preview
Page 1
User manual Version 1.00
Oscilla
®
SM920-P Screening Audiometer with built-in Printer
Firmware versions 1.06, 1.07, 2.00, 2.01
Manufactured by: Inmedico A/S, 8520 Lystrup – Denmark Tel: +45 8674 2622 / Fax: +45 8674 2616 Mail: [email protected] / Web: www.inmedico.com
-0543
User manual Oscilla® SM920-P
Table of contents 1
GENERAL DESCRIPTION... 3
2
DESCRIPTION OF FRONT PANEL ... 4
3
DESCRIPTION OF BACK PANEL... 5 3.1
4
HOOK-UP... 5
OPERATION... 6 4.1 TONE ATTENUATOR... 6 4.2 TONE ... 6 4.3 AIR... 6 4.4 PULSE... 6 4.5 WARBLE... 6 4.6 FREQUENCY ... 7 4.7 MODE ... 7 4.8 ERASE AN AUDIOGRAM ... 8 4.9 AUDIOMETER IDENTIFIKATION ... 8 4.10 PRINT ... 9
5
TECHNICAL SPECIFICATIONS ... 10
6
PLEASE REMARK ... 12 6.1 6.2 6.3 6.4 6.5 6.6 6.7
7
SAFETY PRECAUTION ... 12 PACKING GUIDANCE ... 12 CALIBRATION ... 12 CLEANING / DISINFECTION ... 12 PRODUCT WARRANTY... 12 PRODUCT LIFE ... 12 SYMBOLS ... 13
EMC... 14
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User manual Oscilla® SM920-P
1 General description OSCILLA® SM 920-P is a manual screening audiometer, featuring pulse tone as well as serial port. The device is controlled by an advanced microprocessor, which makes it very quick and accurate to operate. The device is equipped with a serial port so it is possible to transfer a measurement to a computer. This can done using the AudioConsole software, developed by Inmedico. Finally the SM920-P also features a built-in printer to print measurement without being connected to a computer.
Function This device supports pure-tone and can perform screening hearing tests in order to determine the hearing ability of a person. Intended application The intended application of the device is to be used within a screening environment operated by trained health personal or likewise. Classification Type 4 - Screening Audiometer For additional information refer to the technical specifications on page 10.
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User manual Oscilla® SM920-P
2 Description of front panel
1
2
3 4 5 6
7
8
9
10
11
1 ISO hearing level - The actual sound pressure in dB 2 Frequency - The actual frequency in Hz 3 Mode - Select between Data off, Data on, Data Auto and Automatic test 4 Clear - Erase audiogram 5 Transmit - Transmits data to pc 6 Print - Prints the measurement via the built-in printer 7 Tone attenuator - Push the DOWN/UP to change attenuator 8 Tone - Sends tone to the patient 9 AIR - Determines whether the tone is going to the right or left ear 10 Pulse - Starts a pulsing tone with a modulation frequency of 2.5 Hz 11 Frequency - Pushing one of the buttons changes the frequency to the next fixed value
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User manual Oscilla® SM920-P
3 Description of back panel 3.1
Hook-up
Earphones and patient answer button is mounted with jacks, which fit into the connectors on the back of the device. Also, connection for net-adapter is placed here. After having connected the above mentioned accessories and connected the adapter to a mains outlet, turn on the device by means of the ON/OFF button. Frequency will be set on 1000 Hz and attenuator display on 20 dB. If data transmission is enabled, the attenuator will show the last used sound level for 1000 Hz.
1
2
3
4
5
6
1 Right - Right earphone 2 Left - Left earphone 3 Response - Patient answer button 4 Serial - Connection for PC 5 On/off - Power on/off 6 Power - Power connector
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User manual Oscilla® SM920-P
4 Operation 4.1 Tone attenuator By applying light pressure to the DOWN/UP buttons the attenuator steps up or down in 5 dB
The actual sound pressure can be read in the display
Holding down one of the buttons, the sound pressure is increased or decreased until the button is released. Increments: in the range from -10 dB to 110 dB (refer to max. intensities under Technical Specifications).
4.2 Tone With the interrupter button TONE a tone is delivered to the patient.
4.3 AIR The output button determines whether the tone is going to the right or left ear.
The tone lamp will be on as long as the tone is present.
When the L (left) lamp is on, the tone is sent to the left ear.
Oppositely, the tone is sent to the right ear, when the R (right) light is on.
For each touch of the AIR key, ears are changed.
4.4 Pulse By pushing the PULSE button a pulsing tone with a modulation frequency of 2.5 Hz is emitted.
4.5 Warble This adds a frequency modulation to the tone at a modulation frequency of 5 Hz.
One more push turns off this modulation.
One more push turns off this modulation.
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User manual Oscilla® SM920-P
4.6 Frequency Pushing one of the buttons changes the frequency to the next fixed value.
The actual frequency can be read in the display
Holding one of the buttons down the frequencies is repeatingly changed to lower (DOWN) or higher (UP) values until the key is released.
4.7 MODE The MODE button chooses how data are transferred to a PC, and also selects automatic hearing test.
There are 4 possible states: DATA OFF:
Memory and data transfer option are disabled, data will NOT be transferred to PC. In this state the built-in printer cannot be used and data cannot be transferred to a computer.
DATA ON:
Memory is enabled. The audiometer will remember and recall the sound pressure levels for all frequencies. By pressing the TRANSMIT button data will be transferred when you decide. By pressing PRINT the measurement will be printed using the built-in printer.
DATA AUTO: Works like DATA ON, but the measurement will be transferred automatically when the sound pressure changes for a frequency. AUTO TEST: Autotest is enabled. When the TONE button is pressed, the automatic screening test starts. The automatic test is a 20dB randomized screening test. It starts at 1000Hz right ear, then 1000Hz left ear. After this, it selects the remaining frequencies and which ear to test, in a random order. It also varies the pauses between tone presentations and the lengths of the tones, randomly. This makes it impossible for the patient to guess the next tone presentation. When the patient responds to a tone, the next frequency is selected. If there is no response, the sound level is increased by 5 dB, until there is response, or the maximum level is reached. If the patient responds to 20dB at all frequencies, the screening test can be considered passed and AUTO END is displayed together with a beep sound. If some of the frequencies are not responded to at 20dB, the test flashes “AUTO ERR” in the display when it ends. The TONE button should be pressed to acknowledge that the message has been seen, and then the frequencies can be stepped through to see which frequencies was not responded to. The auto test can be interrupted by pressing the TONE button at any time.
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User manual Oscilla® SM920-P 4.8
Erase an audiogram
The CLEAR button erases the stored audiogram
The button must be held down for one second to erase the audiogram. This is to prevent unwanted erasure. The audiometer shows CLR in the display while the button is held down, and after one second DONE – This indicates that the audiogram has been erased.
4.9
Audiometer identifikation
When the audiometer is powered on, it will transmit an identification packet to a computer (if such one is connected). This is necessary in order for the device to work with Inmedicos software AudioConsole. If used with other software programs it is possible that this identification packet may cause problems. If this is indeed the case the identification can be disabled in the following manner: Disabling identification: Hold down the button FREQUENCY DOWN and turn on the device. The display will output ID OFF. Enabling identification: Hold down the button FREQUENCY UP and turn on the device. The display will output ID ON. The last state of identification (enable/disable) will be remembered until changed.
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User manual Oscilla® SM920-P 4.10 Print The PRINT button prints the stored audiogram using the built-in printer. Please note that it is not possible to print if MODE is set to DATA OFF. The printer in the audiometer is a thermo printer. It prints on heat-sensitive paper and does not require ink or toner. The only requirement is the paper which must be 56.5 – 58.5 mm wide and roll-height not more than 30 mm. The heat-sensitive side should turn outward. It is possible to print the audiogram in vertical and horizontal orientation. To change the orientation setting, turn on the device while holding the PRINT button until the display show either PRINT HORI or PRINT VERT. The picture below illustrates an example of both orientations:
Horizontal
Vertical
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User manual Oscilla® SM920-P
5 Technical specifications Standards compliance:
Audiometer TDH-39 sound pressure: Safety: Electromagnetic compliance: Medical Instrument Directive: (CE Mark)
Classification:
EN 60645-1, EN 60601-1, EN 60601-1-1, EN 60601-1-2 EN ISO 389-1 EN 60601-1:1990 + A1:1993 + A2: 1995 + A13:1996 EN 60601-1-2:2001 + EMC Directive 89/336/EEC MDD 93/43/EEC
Group 1, class B EN 60601-1-2:2002 Type of protection against electric shock:
Class I equipment
Degree of protection against electric shock:
Type B applied part
Degree of protection against liquid penetration: Degree of safety of application in the presence of flammable anaesthetics: Mode of operation:
IPO, ordinary equipment N/A Continuous operation
Medical CE- mark:
Inmedico A/S is approved for medical CE marking, by DGM. Identification number 0543
Transducers:
TDH-39 air
Power Supply:
12-18 volt AC or DC, 15 watt max.
Adaptor:
Primary: Secondary:
230 VAC, 50/60 Hz 18 VAC, 20 VA, ± 10 %
Environmental Conditions for Operation Ambient Temperature: +15 to +35 degree Celsius. Relative Humidity: 30 % to 90 % Surrounding pressure: 80 kPa to 120 kPa
Environmental Conditions for Storage Ambient Temperature: -10 to +50 degree Celsius Relative Humidity: 95% or less (non-condensing) Surroundings pressure: 50 kPa to 120 kPa Physical Attributes Dimensions: Weight: Casing material:
295 (W) x 180 (D) x 55 (H) mm (front : 25 mm) ~ 0,9 kg including accessories Aluminium
Calibration:
Data is saved in eeprom memory, EN 60604-1
Warm-up time:
< 3 seconds.
Included parts:
1 audiometer, 1 set of Peltor noise reducing headphones mounted with telephones, 1 response button, 1 mains adapter, 1 user manual and calibration certificate. Page 10 of 16
User manual Oscilla® SM920-P Accessories:
carrying bag, serial cable, AudioConsole software
Measurement specifications Measurement Method
Manual and automatic threshold test with storage of data.
Measurement Range Maximum Intensities:
Measurement Accuracy Tolerance frequency: In/output impedance: Distortion speaker: Single signal channel: Air conductor:
Frequency
Air
125 Hz 250 Hz 500 Hz 750 Hz 1000 Hz 1500 Hz 2000 Hz 3000 Hz 4000 Hz 6000 Hz 8000 Hz
70 dB 90 dB 110 dB 110 dB 110 dB 110 dB 110 dB 110 dB 110 dB 100 dB 90 dB
± 1 %. Left / Right channel < 1 ohm, Patient response ~ 10 K ohm TDH-39: < 1 %, 4. and higher harmonic + sub harmonic < 0,3 %.
± 4 dB (125 Hz – 4 kHz) ± 5 dB (6 kHz – 8 kHz)
Noise reduction Peltor H7A (Optime II): http://www.peltor.se Frequency 125 250 500 1000
2000
4000
8000
Mean att.
14.5
20.3
32.6
39.1
35.1
34.7
39.8
Stand. dev.
1.8
2.6
2.4
2.5
2.3
2.7
2.5
APV-value
12.7
17.7
30.2
36.6
32.8
32.0
37.3
H
M
L
SNR
34 DB
28 DB
20 DB
31 DB
SNR (Single Number Rating or simplified Noise Level Reduction) indicates the attenuation level in dB in an average industrial noise environment. (H), (M) and (L) values in dB indicate the attenuation in high frequency (H), medium frequency (M) and in low frequency (L) noise.
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User manual Oscilla® SM920-P
6 Please remark 6.1 Safety precaution Medical electrical equipment need special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents. Portable and mobile RF communications equipment can affect medical electrical equipment. The audiometer should be placed in such a way that the patient can not see or hear when it is operated. If a sound booth is not used, place the audiometer at least 1 meter from the patient. Operate the interrupter buttons with a light soft touch to prevent the patient from hearing any sounds from the buttons. Interruptions of the mains adapter must be carried out on the outlet. If the audiometer / personal computer are exposed to a powerful static discharge, this can cause interruption of the signal without interruption of the device. Should this rare state occur? Turn the audiometer off and then on. Under normal conditions the device should function again. Neither the patient nor user will be exposed to any danger; likewise the calibrations settings or other functions would be affected. If a failure should occur, meaning the device is missing a function or has a fault, please contact the seller of the device or the manufacture. Repair of the device must be accomplished by Inmedico A/S or special trained persons with a given permission to repair the product. PC, printers or other equipment there are used together with the audiometer, must meet the specified demands there are given in standard EN60601-1 § 14.1a Always use accessories, such as, attachments or spare parts, provided for exclusive use of this instrument. Using other than them may cause the instrument to fail or fulfill its function completely.
6.2 Packing guidance By shipment, the device must be wrapped into bubble plastic and put into an ordinary export case. None of the audiometer parts must be able to touch the sides in the box. The audiometer withstand ordinary air freight and similar.
6.3 Calibration It’s recommended to get the device Calibrated every 2nd year, by qualified personal.
6.4 Cleaning / disinfection Audiometer parts that are in contact with the patient include patient response and headset. Both can be cleaned with a cloth wrung in lukewarm water and a little soap. Disconnect both parts from the audiometer before cleaning and make sure they are dry before connecting them again.
6.5 Product Warranty 2 years – device only
6.6 Product Life 20 years - estimated
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User manual Oscilla® SM920-P 6.7
Symbols
12-18V AC (alternating current) or DC (direct current)
Caution
Type B, EN60601-1
Information about elimination of this product (Applicable in the European Union and other European countries with separate collection systems) On the end of the life, the present product mustn’t be eliminated as urban refusal, but it must be eliminated in a separated collection. If the product is eliminated in unsuitable way, it is possible that some parts of the product (for example some accumulators) could be negative for the environment and for the human health. The symbol on the side (barred dustbin on wheel) denotes that the products mustn’t throw into urban refuses container but it must be eliminated with separate collection. In case of abusive elimination of this product, could be foreseen sanctions.
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User manual Oscilla® SM920-P
7 EMC Guidance and manufacture´s declaration – electromagnetic emission The SM920-P is intended for use in the electromagnetic environment specified below. The customer or the user of the SM910 should assure that it is used in such an environment.
Emissions test
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic emissions
Complies
IEC 61000-3-2 fluctuations/flicker emissions
Complies
Electromagnetic environment - guidance The SM920-P 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.
The SM920-P 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.
IEC 61000-3-3
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User manual Oscilla® SM920-P
Guidance and manufacture´s declaration – electromagnetic immunity The SM920-P is intended for use in the electromagnetic environment specified below. The customer or the user of the SM910 should assure that it is used in such an environment.
Immunity test
Compliance level
Electromagnetic environment – guidance
± 6 kV contact
± 6 kV contact
± 8 kV air
± 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
± 2 kV for power supply lines
± 2 kV for power supply lines
IEC 61000-4-5
± 1 kV for input/output lines
± 1 kV for input/output lines
Surge
± 1 kV differential mode
± 1 kV differential mode
IEC 61000-4-5
± 2 kV common mode
± 2 kV common mode
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines
<5 % UT (>95 % dip in UT) for 0,5 cycle
<5 % UT (>95 % dip in UT) for 0,5 cycle
Mains power quality should be that of a typical commercial or hospital environment.
40 % UT (60 % dip in UT) for 5 cycle
40 % UT (60 % dip in UT) for 5 cycle
70 % UT (30 % dip in UT) for 25 cycle
70 % UT (30 % dip in UT) for 25 cycle
If the user of the SM910 requires continued operation during power mains interruptions, it is recommended that the SM910 be powered from an uninterruptible power supply or a battery.
<5 % UT (>95 % dip in UT) for 5 sec
<5 % UT (>95 % dip in UT) for 5 sec
3 A/m
3 A/m
Electrostatic discharge (ESD)
IEC 60601 Test level
IEC61000-4-2
IEC 61000-4-11
Power frequency (50/60 Hz) magnetic field
Mains power quality should be that of a typical commercial or hospital environment.
Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment.
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
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User manual Oscilla® SM920-P
Guidance and manufacture´s declaration – electromagnetic immunity The SM920-P is intended for use in the electromagnetic environment specified below. The customer or the user of the SM910 should assure that it is used in such an environment.
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 SM920-P, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance
d = 1,17 P Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2,5 GHz
3 Vrms
d = 1,17 P 80 MHz to 800 MHz 3 V/m
d = 2,33 P 800 MHz to 2,5 MHz 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, a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol:
3
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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