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SM010-3 Siemens SD 270 Operating & Service Manual Page 43

Appendix 4 - Use with Non-medical Electrical Equipment

Any person who connects external equipment to signal input, signal output
or other connectors has created a medical electrical system and is
therefore responsible for the system complying with the requirements of
clause 16 of IEC 60601-1:2005

(General requirements for basic safety

and essential performance).

If connections are made to standard equipment such as printers and
computers, special precautions must be taken in order to maintain medical
safety. The following notes are provided for guidance in making such
connections to ensure that the general requirements of clause 16 of IEC
60601-1:2005 are met.

The following signal inputs and outputs on the SD 270 audiometer are
electrically isolated to the requirements of IEC 60601-1 in order to reduce
any potential hazard associated with the use of mains-powered equipment
connected to these inputs and outputs:

Socket
Label

Socket Type

Typical
Connection

DATA

6 pin mini DIN

Printer

LINE IN

3.5mm jack

CD/Tape Player

LINE OUT

3.5mm jack

Amplifier

USB

USB Connector Computer

External equipment intended for connection to signal input, signal output
or other connectors, shall comply with the relevant IEC or international
standards (e.g. IEC 60950, CISPR 22 & CISPR 24 for IT equipment, and
the IEC 60601 series for medical electrical equipment).

Equipment not complying with IEC 60601 shall be kept outside the patient
environment, as defined in IEC 60601-1 (at least 1.5m from the patient).

The operator must not touch the connected equipment and the patient at
the same time as this would result in an unacceptable hazard.

Please refer to Diagrams 1 to 5 below for typical configurations of
connected peripheral equipment.

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Содержание SD 270

Страница 1: ...Siemens SD 270 Diagnostic Audiometer Service Manual Applies from serial number 7000 onwards ...

Страница 2: ...Page 2 D00073611 Siemens SD 270 Service Manual Contents ...

Страница 3: ...tch 10 3 5 Audiometer display 10 3 6 Audiometer controls 11 3 7 Threshold Retention Function 15 3 8 Uncomfortable Loudness Levels 15 3 9 Saving audiograms in internal memory 16 3 10 Loading audiograms from internal memory 16 3 11 Printing audiograms 16 3 12 Data transfer to a NOAH database 16 4 Sequence of Operation and Suggested Test Procedure 17 4 1 Pre test 17 4 2 Test 17 4 3 Post test 18 5 Spe...

Страница 4: ... 26 Appendix 2 Free Field Calibration Procedure 31 Appendix 3 EMC Guidance Manufacturer s Declaration 37 Appendix 4 Use with Non medical Electrical Equipment 43 Appendix 5 Calibration of the Instrument 49 Appendix 6 Replacement of Headset Lead 52 Appendix 7 Enabling Different Earphone Types 55 Appendix 8 Technical Support Contacts 58 ...

Страница 5: ...l audiometry tests 1 2 Unpacking Open the shipping carton and carefully remove all the equipment Check against the delivery note that all the accessories ordered have been included with your audiometer If anything is missing please contact Siemens Customer Support see Appendix 8 If you have purchased from a distributor you should contact them directly Please retain the shipping carton and packing ...

Страница 6: ...ransducers supplied with the audiometer are specifically calibrated with it if these transducers are changed calibration will be required Do not immerse the unit in any fluids See Section 8 for the proper cleaning procedure for the instrument and its accessories and the function of single use parts Do not use the instrument in an oxygen rich environment or in the presence of a flammable anaestheti...

Страница 7: ...ent is required please contact your Siemens distributor All other connections must be made before connecting the output lead from the adapter into the POWER input socket on the back of the audiometer Switch on the mains supply the indicator on the adapter and the POWER indicator on the audiometer will both illuminate green showing that the instrument is ready for use The output from mains adapter ...

Страница 8: ...nnect the accessories supplied with the instrument or supplied by Siemens or a Siemens distributor These parts have been tested for use with the Siemens SD 270 Diagnostic Audiometer for compliance with the standards IEC 60601 1 and IEC 60601 1 2 The use of accessories other than those specified may compromise compliance with these standards For other sockets refer to Appendix 4 2 5 Data transfer t...

Страница 9: ...ctrical equipment to medical electrical equipment The Siemens SD 270 has audio line in out connections for CD or tape player input e g for recorded speech testing and amplifier output Important Note Line out connections are switched on only when FREEFIELD is selected The following connections apply to both LINE IN and LINE OUT Main Body Segment Mid segment End segment Ground Right Channel Left Cha...

Страница 10: ...el switch off press the key under NO or QUIT 3 3 Operating Language To select the operating language for the audiometer English or German continue to hold the key when switching on An additional display will allow the selection of English Softkey 1 or Deutsch Softkey 3 3 4 Testing the patient response switch Press the patient response switch and the light labeled RESPONSE to the left of the displa...

Страница 11: ... press LOAD key to retrieve test results Contrast Adjust using the UP and DOWN keys Bone masking Selects the headset or the optional masking earpiece as the means of masking select Insert or Phones key Select phones This option is only available if a secondary headphone is enabled use Softkeys 1 or 2 to select the required headphone type FF equiv speech This option is only available if either DD45...

Страница 12: ...n WARBLE Selects a frequency modulated tone as the test signal the indicator above the key illuminates green SPEECH Selects speech mode the indicator above the key illuminates green refer to Appendix 1 for details note that initially only Softkeys 1 3 have a function MASK Switches on masking at 30dBHL narrow band for pure tones or speech weighted masking the indicators above the key and to the rig...

Страница 13: ...nates green when active The MASK control adjusts masking independently AIR Outputs the signal to the earphones the indicator above the key illuminates green BONE Outputs the signal to the bone vibrator the indicator above the key illuminates green FREEFIELD Routes signals to LINE output socket the indicator above the key illuminates green Hz Press the key to lower the frequency and the key to incr...

Страница 14: ... Menu Option Description STENG Stenger Routes tone or speech to both earphones simultaneously Use the SIGNAL rotary control to adjust the Left channel level and the MASK rotary control to adjust the right Refer to Appendix 1 for details of the Stenger test in speech mode ABLB Alternate Binaural Loudness Balance Routes tone to each earphone alternately Use the SIGNAL rotary control to adjust the Le...

Страница 15: ...a NOAH database on a computer To review the retained thresholds select the frequency using Hz frequency keys The stored value for the left ear designated L and the stored value for the right ear designated R are shown on the lower line of the display SIGNAL FREQUENCY MASKING 10dBHL 4kHz OFF 20L 10R THL This display shows thresholds at 4kHz Thresholds Left ear 20dBHL Right ear 10dBHL To clear the T...

Страница 16: ...ct the required audiogram 1 12 using the UP key then press the LOAD key Press the QUIT key once confirmation that the thresholds have been retrieved appears on screen 3 11 Printing audiograms Connect the audiometer to the printer with supplied printer cable refer to Section 2 5 of this operating manual for printer set up Insert the 6 pin mini DIN into the DATA socket on the back of the audiometer ...

Страница 17: ... the signal level in 10dB steps until they no longer respond then increase the signal level in 5dB steps until the patient responds 9 If the patient fails to hear the first tone increase the signal level in 5dB steps until they do respond and then continue with step 10 10 Repeat the test by reducing the signal level in 10dB steps until the patient no longer responds then increase the signal level ...

Страница 18: ... Air 125 8KHz Bone 250Hz 8KHz Frequency accuracy 1 Distortion 2 Output level range AC 10dBHL to 120dBHL maximum Output level range BC 10dBHL to 70dBHL maximum Output level range FF Up to 90dB Insert masking output 90dBHL max 250 4KHz Output level accuracy Within 3dB Output level step size 2 5 or 5dB Output transducer AC DD45 earphones supplied E 5A insert earphones option Output transducer BC B 71...

Страница 19: ...deep x 100mm high Weight 1 6kg Safety IEC 60601 1 plus UL CSA EN deviations EMC IEC 60601 1 2 CE mark To the EU Medical Device Directive 5 4 Equipment classification Type of protection against electric shock Powered via SELV ClassII mains adapter Degree of protection against electric shock Type B applied part Degree of protection against ingress of water Not protected Mode of operation Continuous ...

Страница 20: ...nt auxiliary current The applied parts are the left right earphones bone vibrator insert masker patient response switch and the associated cables Definition The output from the Mains AC adaptor is Direct Current Definition Class II equipment equipment in which protection against electric shock does not rely on BASIC INSULATION only but in which additional safety precautions such as DOUBLE INSULATI...

Страница 21: ...ing of 70dBHL with level meter at 0dB Masking Sounds Masking sounds available Narrow bands at test frequencies and Speech weighted noise NB noise bandwidth Meets IEC 60645 1 Speech noise bandwidth Meets IEC 60645 2 Insert Masking Earpiece Calibration method With 2cc coupler compliant with IEC 126 Transducers Types and reference levels DD45 ISO 389 1 Table 2 E 5A ISO 389 2 Table 1 B 71 ISO 389 3 Ta...

Страница 22: ...n required Refer to ISO 8253 1 for additional guidance 8 2 Transducer maintenance Before use check the transducer cables and connectors for signs of wear and or damage If you find any please replace the item immediately by contacting Siemens or your Siemens distributor requesting the relevant part number see Section 12 Handle the audiometric headset bone vibrator headset and other accessories with...

Страница 23: ...this will pose the risk of ear to ear or patient to patient cross infection Further guidance is provided below Ensure that the black tubing protruding the foam eartip is not applied to the patient this must be attached to the sound tube of the insert transducer Roll the foam eartip into the smallest possible diameter Insert the eartip into the ear canal of the patient Hold the eartip until it has ...

Страница 24: ...e repair There are no user serviceable parts within it When packing the instrument for shipping please use the original shipping carton and packing materials Please also ensure that the headset leads are not wrapped around the headband of the headset 11 Guarantee All Siemens instruments are guaranteed against faulty materials and manufacture The instrument will be repaired free of charge for a per...

Страница 25: ... Important Note see 2 3 106 00 112 Patient response switch 105 98 698 Audiogram cards pack of 50 104 26 135 Siemens SD 270 operating manual 106 00 113 Microphone and monitor headset 106 00 114 Insert masker 100 55 806 Insert earphones 106 00 115 6 pin printer cable for audiometer to printer 105 98 699 Siemens link driver disk NOAH incl USB cable 106 00 116 Printer Able AP1300 106 00 117 Thermal Pr...

Страница 26: ...masking insert outputs and ensures that the correct calibrated output levels are achieved Free field equivalent output is available from the headphones in Speech mode see Section 3 6 of this operating manual Operator Monitoring Where an acoustic booth room is used a patient microphone is connected to the MIC2 input while the operator headset earpiece is connected to the MONITOR output The operator...

Страница 27: ...ternal microphone is selected c The microphone is initially routed to the left earphone To select the right earphone press RIGHT d The input signal is adjusted in 1dB steps by use of the MASK rotary control e Input signal adjustment should be made to adjust for the operator s voice to peak at the 0dB point on the LEVEL dB bar graph the earphone output will then be 89dBSPL for a SIGNAL setting of 7...

Страница 28: ...put signal is adjusted in 1dB steps by use of the MASK rotary control e Play the 1kHz calibration tone on the recorded material and adjust the input signal such that the LEVEL dB bar graph reads 0dB the headphone output measured in an IEC 318 ear simulator will now be 89dBSPL for a setting of 70 dBHL g The output level is controlled in 5dB steps by the SIGNAL control 3 2 Procedure As described in ...

Страница 29: ...r to the LINE OUT jack socket refer to Section 2 7 of this operating manual b Connect a microphone to the MIC1 input on the audiometer c Press SPEECH FREEFIELD and use Softkey 1 to ensure that MIC is displayed in capitals indicating that the external microphone is selected d The external microphone is now routed to the external amplifier and speaker use LEFT and RIGHT to select the required amplif...

Страница 30: ... b Select internal masking source using Softkey 4 the INT option is displayed in capitals wideband noise is routed to the competing LINE OUT channel c The level of competing noise is adjusted in 5db steps using the MASK rotary control 7 2 Procedure As described in 3 2 but adjusting the competing noise level as required 8 Free Field Recorded Speech Audiometry with Competing Noise Recorded 8 1 Set U...

Страница 31: ...on Once calibrated items should not be moved removed or added to the room without re calibration 2 External Amplifier and Loudspeaker The following external equipment is specified for use of the Siemens SD 270 audiometer in free field modes of operation Amplifier Interacoustics AP70 Loudspeaker Interacoustics ALS7 3 Calibration Overview The following calibration should be performed before any free...

Страница 32: ...t in two stages 1 the speech channel which contains two elements an optional equalisation phase a level setting phase 2 the competing noise channel which may be omitted if competing noise is not required 4 1 Calibrating the Speech Channel 4 1 1 Equalisation Optional To perform equalisation connect an external speech source to the audiometer e g CD or tape player From the default switch on conditio...

Страница 33: ...ternal amplifier or graphic equalizer controls if used for equalisation If more than one set of test recordings is to be used then the following procedure can be used to allow for minor differences in calibration levels Set up as above for the most commonly used test recording Measure the actual listening point level for when playing the calibration tone of each alternative set of test recordings ...

Страница 34: ...0 8000 dB SPL 92 81 74 72 72 70 5 68 5 64 63 5 72 5 81 5 If a calibration of the speech channel has already been carried out Adjust the calibration level for the 1kHz Left channel using the SIGNAL control to reach the SPL level specified above as measured by the SLM If a calibration of the speech channel is not required The output of the external amplifier should be set in order to achieve the lev...

Страница 35: ... not the following is a possible solution Set all of the frequencies for which calibration can be achieved For frequencies where this is not possible adjust each to be a multiple of 5dBs from the required level Produce a correction table for each frequency for which calibration could not be achieved to be applied to the output level of the audiometer while conducting a test to relate the instrumen...

Страница 36: ...istent levels Connect a microphone to the MIC1 input on the audiometer Press SPEECH and use Softkey 1 to ensure that MIC is displayed in capitals indicating that the external microphone is selected The input signal is adjusted in 1dB steps with the MASK rotary control Input signal adjustment should be made to adjust for the operator s voice to peak at the 0dB point on the LEVEL dB bar graph If rec...

Страница 37: ... Electromagnetic environment guidance RF emissions CISPR 11 Group 1 SD 270 Audiometer uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause interference in nearby electronic equipment RF emissions CISPR 11 Class A The SD 270 Audiometer is suitable for use in all establishments other than domestic and those directly connected to the public...

Страница 38: ...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 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typ...

Страница 39: ...les 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the SD 270 Audiometer requires continued operation during power mains interruptions it is recommended that the SD 270 Audiometer be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 610...

Страница 40: ... RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150kHz to 80MHz 3 V m 80MHz to 2 5GHz 3 Vrms 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the SD 270 Audiometer including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P 80MHz ...

Страница 41: ...d people a Field strengths from fixed transmitters such as base stations for radio cellular 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...

Страница 42: ...um output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equa...

Страница 43: ...e electrically isolated to the requirements of IEC 60601 1 in order to reduce any potential hazard associated with the use of mains powered equipment connected to these inputs and outputs Socket Label Socket Type Typical Connection DATA 6 pin mini DIN Printer LINE IN 3 5mm jack CD Tape Player LINE OUT 3 5mm jack Amplifier USB USB Connector Computer External equipment intended for connection to sig...

Страница 44: ...Page 44 D00073611 Siemens SD 270 Service Manual Diagram 1 SD 270 used with the medically approved mains adapter Mains Outlet Medical Mains Adapter SD 270 Audiometer ...

Страница 45: ...70 Operating Service Manual Page 45 Diagram 2 SD 270 used with the medically approved mains adapter and printer Mains Outlet Medical Mains Adapter SD 270 Audiometer Mains Outlet Printer Printer via DATA socket Power Supply ...

Страница 46: ...D00073611 Siemens SD 270 Service Manual Diagram 3 SD 270 used with the medically approved mains adapter and PC Mains Outlet Medical Mains Adapter SD 270 Audiometer Mains Outlet PC Power Supply PC via USB socket ...

Страница 47: ... 270 Operating Service Manual Page 47 Diagram 4 SD 270 used with the medically approved mains adapter and CD Tape player Mains Outlet Medical Mains Adapter SD 270 Audiometer Mains Outlet CD Tape Player via Line In Socket ...

Страница 48: ...611 Siemens SD 270 Service Manual Diagram 5 SD 270 used with the medically approved mains adapter and external amplifier Mains Outlet Medical Mains Adapter SD 270 Audiometer Mains Outlet Amplifier via Line Out Socket ...

Страница 49: ...then display Enter Password Enter the 4 digit calibration code using the four Softkeys located just below the screen Press each key until the required digit of the code is displayed on the screen When the correct code is shown press the ON key to confirm If the correct code has been entered the unit will then be in calibration mode signified by Cal being displayed on the screen If a secondary head...

Страница 50: ...se in the opposite ear to the one selected change the calibration level by using the MASK control This should be done for both Left and Right earphones Note that the SIGNAL control will continue to adjust the speech calibration Pressing the BONE key will enable calibration of the bone vibrator Change the calibration level by using the SIGNAL control There are 10 different frequencies to calibrate ...

Страница 51: ...functions are required Refer to Appendix 7 if it is required to enable a secondary headphone 4 Output Levels in Calibration The levels output when in calibration mode are given below for reference Air Conduction Bone Conduction Masking Insert Frequency Puretone NB Noise Speech WB Noise Puretone NB Noise 125 50 30 250 70 50 30 70 500 70 70 40 70 750 70 70 40 70 1000 70 70 40 70 1500 70 70 40 70 200...

Страница 52: ...ch ear It is essential that earphones are used only with the audiometer and channel ear for which they are calibrated 1 Preparation If necessary extend the headphones such that the individual earphones are accessible as shown below 2 Procedure 1 Work with the left blue earphone first and complete the replacement of the blue headphone lead before working with the right red earphone 2 Carefully remo...

Страница 53: ... left blue lead plug in the earphone see below 7 Remove the blue 2 pin plug from the earphone and withdraw it through the aperture in the housing 8 Feed the left blue plug from the new headphone lead through the aperture in the housing fit it into the earphone and tighten both lead retaining screws finger tight 9 While supporting the earphone feed the left blue lead and plug back through the apert...

Страница 54: ...ed the earphone should be held securely in place between the ear cushion and the plastic housing of the headset 13 Repeat steps 2 to 12 for the right red channel 14 Connect the headset to the audiometer and test for sound output at a safe listening level 15 The headset is now ready for use Note for the correct stock number for the headset lead please refer to Section 12 of this manual ...

Страница 55: ...ly calibrated and verified before use 1 Primary Earphone Type The primary earphone type may be set to one of Interacoustics DD45 Telephonics TDH 49 Telephonics TDH 39 Eartone 5A E 5A Note that the audiometer does not store calibration data for all of the above earphone types These are simply labels to aid the operator in identification of the primary earphone type in use THEREFORE IF AN ALTERNATIV...

Страница 56: ...ated at the same time it is recommended that the calibration date is not changed but left as the date of the original calibration This will keep the calibration of the alternative primary headphone in step with the remainder of the transducers On completion the calibration process should be verified The table in Appendix 5 Section 4 may be used for this purpose and if necessary the entire calibrat...

Страница 57: ...enabled and the option for the operator to select a secondary earphone will be disabled Before calibrating the secondary headphone ensure the correct earphone type is displayed at the right of the lower line If necessary use the PHONES key to switch between the primary and secondary earphone types and then calibrate as described in Appendix 5 Section 2 To retain existing calibration values for oth...

Страница 58: ...com sg hearing UK Ireland Technical Support Siemens Hearing Instruments Ltd Phone 01293 423671 E mail servicedesk shi uk siemens com Internet www siemens co uk hearing Japan Siemens Hearing Instruments KK Phone 81 800 222 4133 Internet http hearing siemens com jp Siemens International Sales Albania Armenia Austria Azerbaijan Belarus Bosnia Herzegnowina Bulgaria Croatia Cyprus Czech Republic Estoni...

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