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Technical Data

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Service Handbook

Safety Standards

6.3

6.3 Safety Standards

Safety standard

IEC/EN 60601-1
IEC/EN 60601-2-25

EMC

IEC/EN 60601-1-2

Protection class

I according to IEC/EN 60601-1 (with internal power supply)

Conformity/Classification

CE/IIa according Directive 93/42/EEC

Protection

This device is not designed for outdoor use (IP 20)

Содержание AT-101

Страница 1: ...A 0 ervi e andboo3 Art no 7 5400 Rev a 400 A 0 7 annel E G Devi e ...

Страница 2: ...ation The SCHILLER sales and service centre network is world wide For the address of your local distributor contact your nearest SCHILLER subsidiary In case of dif ficulty a complete list of all distributors and subsidiaries is provided on our internet site http www schiller ch Sales information can also be obtained from sales schiller ch Article no 2 540037 Rev a Issue date 08 09 04 ...

Страница 3: ... 2 1 5 Back Panel 10 2 2 Keypad 11 2 3 LCD Screen 13 3 Operation 14 3 1 Start up and Initial Preparation 14 3 1 1 Connecting AT 101 14 3 1 2 Battery Operation 15 3 1 3 Switching ON and OFF 15 3 1 4 Isolating the Mains Supply 15 3 1 5 Potential Equalisation 15 3 1 6 LCD contrast adjustment 15 3 2 Entering the SETUP Menu 16 3 2 1 Navigating in the Setup Screens 16 3 3 ECG Settings 17 3 3 1 Automatic...

Страница 4: ... 37 5 2 12 ECG lead and patient cable test 38 5 2 13 External printer test 41 5 2 14 Communication RS 232 Test 41 5 3 Safety Tests 42 5 3 1 Maximum values safety test 42 5 4 Maintenance interval for the battery 43 5 4 1 Charging the battery 43 5 4 2 Testing battery 43 5 4 3 Replacing battery 44 5 4 4 Battery disposal 44 5 5 Changing the fuse and mains voltage 45 5 6 Cleaning 46 5 6 1 Cleaning the ...

Страница 5: ...Page 3 A 0 Service Handbook Art no 2 540037 Rev a 7 1 2 AT 101 pictures 55 7 2 Electrical drawing 57 7 2 1 Power supply 57 7 2 2 Component layout 58 8 Appendix 59 8 1 Checklist 59 9 Index 63 ...

Страница 6: ...Page 4 Art no 2 540037 Rev a ...

Страница 7: ...e used for the recording analysis and evaluation of ECG Recordings Recordings made with the AT 101 can be used as a diagnostic aid for heart function and heart conditions The AT 101 is de signed for indoor use and can be used for all patients of both sexes all races and all ages Only operate the device in accordance with the specified technical data Do not use or repair this unit in areas where th...

Страница 8: ...suspected of being damaged Damaged cable connections and connectors must be replaced immediately The electrical safety devices such as fuses must not be altered Ruptured fuses must only be replaced with the same type and rating as the orig inal Use only accessories and other parts recommended or supplied by SCHILLER AG Use of other than recommended or supplied parts may result in injury inac curat...

Страница 9: ... situation which could lead to heavy bodily injury or to death For a possibly dangerous situation which could lead to personal injury This symbol is also used to indicate possible damage to property For general safety notes as listed in this chapter Used for electrical dangers warnings and other notes in regarding operation with elec tricity Note For possibly dangerous situations which could lead ...

Страница 10: ...turer can only be held responsible for the safety reliability and perform ance of the apparatus if assembly operations extensions readjustments modifications or repairs are car ried out by persons authorized by him and the SCHILLER AT 101 and approved attached equipment is used in accordance with the manufacturers instructions Potential equalization CF symbol This unit is classified safe for inter...

Страница 11: ...anual printout of the re cording 2 1 2 Optional Features External printers ECG Interpretation Memory for up to 40 recordings Thrombolysis 2 1 3 Initiating Functions or Tasks Most functions and tasks are initiated by the 5 softkeys 1 situated immediately below the LCD The function of the softkeys varies according to the screen displayed and is displayed on the LCD immediately above the key itself D...

Страница 12: ...PT connector for the connection of an external printer 3 RS 232 for connection of a modem or a PC for export of stored recordings 4 Mains connector with fuse above 5 Potential equalisation stud All externally connected hardware must be approved by SCHILLER Connection of any hardware not approved by SCHILLER is at the ownerks risk The unit guar antee may also be invalid See also safety note paragra...

Страница 13: ...on 1 Softkeys the function of these keys changes depending on the screen dis played The function of these keys is shown on the screen above the keys If nothing is written above a softkey it has no function for the current screen 2 Auto Mode recording in Auto mode 1 Press the SHIFT followed by the START key 2 for auto mode 2 3 STOP printout ...

Страница 14: ...s a 1mV reference marker on the screen and printout Re centres the trace 9 Toggles the QRS beeper ON OFF 10 Myogram filter ON OFF The cutoff frequency can be user defined in kSetupk 11 Delete last typed character 12 Patient data key Press this key to enter a new patient or modify the data for the current one 13 ON OFF Key 14 Mains Indicator lit when mains connected 16 Shift key to select capital l...

Страница 15: ...isition only 4 Current Heart Rate averaged over 4 beats and refreshed every 2 seconds The HR is also given on a manual printout Note that with an auto mode printout the HR is averaged over the full 10 seconds of the recording 5 Electrode connections when an electrode indication flashes an audible alarm is also given it indicates that the electrode resistance is too high The elec trode s must be re...

Страница 16: ... Voltage setting 2 115 or 230 V Refer to chapter 5 5 for the mains voltage 2 Connect the power cable at the rear of the unit The mains indicator lamp 6 is always lit when the unit is connected to the mains supply If the unit is switched on the relevant symbol is displayed on the LCD 7 Leave the AT 101 connected to the mains for 7 hours to fully charge the battery 3 Connect the potential equalisati...

Страница 17: ...wer a battery symbol 1 is displayed When working from battery power the unit is automatically switched off after 5 min utes 30 seconds if battery capacity is limited if no key is pressed for Battery recharging refer to chapter 5 4 The unit can remain connected to the mains supply without damage to either the battery or the unit The AT 101 is switched ON and OFF with the ON OFF key 1 HR 78 min Filt...

Страница 18: ...N and the softkey SETUP Note The Setup text above the key appears first if the FN key is pressed MENU ECG REST SETUP MEMORY SETUP 1 Select desired parameters with the Softkeys UP DOWN 1 2 Changes setting with the softkey SELECT 2 and UP DOWN 1 3 Confirm the setting with the softkey SELECT 2 4 Go to the next screen with the softkey NEXT 3 NEXT SELECT EXIT 2 1 3 1 1 Select desired parameters with th...

Страница 19: ...he UP DOWN softkeys 2 to highlight the various options Use the NEXT softkey to go to the next menus Automatic Format 1 and 2 internal Automatic Format 1 and 2 external Filter Interpretation Lead General In units where the interpretation option is not installed interpretation statements can not be displayed AUTOMATIC FORMAT 1 ECG Printout short at 25 mm S Averages Cycles 2x6 50bmm s 2 Rythm Rhythm ...

Страница 20: ...intout of the ECG given at the end of an auto mode recording the recording can be stored in the memory and printed at a later time if re quired 4x3 25 mm s Leads are printed in a 4 x 3 format at 25mm s 4x3 50 mm s Leads are printed in a 4 x 3 format at 50mm s 2x6 50 mm s 1 Rhythm Leads are averaged over the entire 10 second recording and printed in 2 groups of 6 at 50mm s with the one rhythm lead ...

Страница 21: ... Rhythm Leads are averaged over the entire 10 second recording and printed in 4 groups of 3 leads at 25mm s with the two selected rhythm leads at the bottom of the page at 25mm s 4x3 50mm s 2 Rhythm Leads are averaged over the entire 10 second recording and printed in 4 groups of 3 at 50mm s with the two selected rhythm leads at the bot tom of the page at 25mm s 2x6 50mm s 2 Rhythm Leads are avera...

Страница 22: ...red ECG either with or without passing the myogram filter Filter ON is indicated on the LCD Myogram filter On at power up Off at power up Filter status selectio at power up Mains filter Off 50 Hz 60 Hz The mains filter is an adaptive digital interference filter designed to sup press an interference without attenuating or distorting the ECG Set the mains filter in accordance with the frequency of y...

Страница 23: ...ing Parameter Options Description Sensitivity High or low Selecting sensitivity Age Assumed to be 30 yrs 30 yrs Greater than 30 years or 30 years and under Note The kPatient age assumed to be k setting is only applicable when patient data has not been entered When a patientks date of birth has been entered this setting is ignored Abnormal ECG Print Not Print Normalk kAbnormalk is printed or not pr...

Страница 24: ...e leads can also be printed when displayed only in manual mode The lead groups are changed both on the screen and on the manual printout with the lead next previous keys On Off Lead group 5 II avF III Lead group 6 V2 V4 V5 aLeft Posterior V4 V9 On Off Lead group 5 V4 V5 V6 Lead group 6 V7 V8 V9 aRight Precordials V5r On Off Lead group 5 V1 V2 V3 Lead group 6 V3r V4r V5r aRight Precordials V6r On O...

Страница 25: ...MENU 2 Press the function key FN and the softkey SETUP Note The Setup text above the key appears first if the FN key is pressed 3 Press the softkey SYSTEM SETTINGS 4 Press the softkey UNIT MENU ECG REST SETUP MEMORY SETUP ECG SETTINGS SYSTEM SETINGS MENU TEST AND INFO EXIT COMM UNIT Use the SELECT softkey 1 to select the different settings Use the UP DOWN softkeys 2 to highlight the various option...

Страница 26: ...uage Deutsch English Default Francais Svensk American Italiano Espanol Portuges Dutch Several languages are already programmed into the unit Select the lan guage for the screen display and for the printout The language will also set the units used by the system The difference between American and English is as follows American Standard English measurements in inches measurements in centimetres tem...

Страница 27: ...ine Modem line computer connected directly to the RS 232 interface modem for transmission over the phone network Phone No T 0417608787 P 0417608787 Enter the telephone number preceded by kTkor kPk tone or pulse A comma k k gives a one second pause in dialling this may be necessary for example if an outside line is required Modem Init ATB0L1V0Q0E0S0 0 Enter the modem initialisation codes Full detai...

Страница 28: ...r the telephone network proceed as follows 1 Set Communication mode to MODEM see page 25 2 Enter Phone number and modem initialisation codes see page 25 3 Connect the modem cable assembly supplied with modem between the RS 232 connector on the AT 101 and the modem 4 Ensure that the SEMA communication program SEMACOMM is active on the remote computer see SEMA handbook 5 Press the TRANSMIT softkey T...

Страница 29: ...reen A code of the options installed is given after the software version These are as fol lows Basic configuration M Measurement C Measurement and Interpretation Optional configuration m Memory t Thrombolysis TEST AND INFO EXIT COMM UNIT PRINT SETUP EXIT COMM TEST BASE INIT SOFTWARE AT 101 V1 0 Ctm RI5 73 070 1234567 26 09 2003 Copyright 2002 03 SCHILLER AG Switzerland ...

Страница 30: ...ntout of signals Sequential or Simultaneous Auto Centering Enabled or Suppressed Lead Group Rhythm V9 V4r V6r DAJ ON or OFF for each lead group Filter Baseline Filter 0 05 0 15 or 0 30 Hz Mains Filter 50 60 Hz or OFF Myogram Filter 25 or 35 Hz ON or OFF SSB Filter Smoothing Filter Enabled or Suppressed SSF Filter Baseline Stabiliser Enabled or Suppressed Interpretation Sensitivity Low or high sens...

Страница 31: ...le When software is selected two option are given for update Software new software and upgrade Software activating options See details in the following procedures Requirement to run Install exe file Win NT4 Win 98 Win 2000 Win XP Connect the AT 101 to the mains Do not power off during update RS 232 cable Download software Install AT101xxx exe PRINT SETUP EXIT COMM TEST BASE INIT SOFTWARE 1 Start t...

Страница 32: ...are dialogue box Make sure the device is powered by mains 1 Switch on the device 2 Select menu SETUP SYSTEM SETTINGS TEST AND INFO 3 Press button Program Update EXIT UPGRADE UPDATE 5 The bargraph shows the progress of the download After downloading the device will restart automatically 6 Check the Software version in the menu TEST and INFO CANCEL AT 101 1 01 ...

Страница 33: ... and INFO screen SETUP SYSTEM SETTINGS TEST AND INFO 2 Select SOFTWARE 3 Select UPGRADE 4 Enter the upgrade code 6 digits When the correct code is entered acceptance of the code is indicated by a series of beeps The option can be used immediately The number of unsuccessful trials will be displayed on the right side of the code box 1 More than 10 attempts to enter the incorrect code blocks the unit...

Страница 34: ...2 ECG 25mm s Long ooo ECG 25mm s long ooo external Rhythm Leads V1 Rhythm Leads V1 II MECG none Measurements Suppressed Marks Enabled Interpretation Enabled Filter Baseline 0 05Hz Baseline 0 05Hz Mains Filter 50Hz 60Hz Mains Filter 50Hz 60H Myogram off at power up Myogram off at power up Myogram 35Hz OFF Myogram 35Hz OFF SBS OFF SBS OFF SSF OFF SSF OFF Interpretation Settings Sensitivity low Age 3...

Страница 35: ...ry 6 months Keyboard test LED test Visual inspection of the unit and cables User Every 12 months Every servicing of the six month interval Functional tests according to the Service Handbook Electrical safety tests according to IEC 60601 1 Clause 18 and 19 By SCHILLER AG author ised technician Every 24 months Every servicing of the 6 and 12 months interval Every measuring test and calibrations acco...

Страница 36: ...l Check following items Voltage selector is set correctly Fuses according table see page 45 Safety labels are on the device and are readable Mechanical condition of the device allows a further safe operation cracks in the shell mains cable etc there is no soiling which could hamper the safety of the device Opening of the Device Whenever a device is opened for repairs or calibration a functional an...

Страница 37: ...keyboard as follows With C device go to the menu Edit Interpretation and test all keys In all other devices the test is carried out in the menu Patient Data 5 2 6 LCD Screen test 1 Connect the power cable at the rear of the unit The mains indicator lamp 6 is always lit when the unit is connected to the mains supply 2 Switch the unit on The relevant symbol is displayed on the LCD 7 3 Disconnect the...

Страница 38: ...th If individual points are missing the problem is usually with the thermal print head If the print quality is inadequate control the electrical mechanical setting of the print head according to the comparison in this handbook Fig 5 1 Printer quality test 1 Connect the simulator to the ECG device using the patient cable and select a HR of 60 min No arrhythmias 2 Check that the HR shows exactly 60 ...

Страница 39: ...n impulses should be lined up vertically and exactly below one an other The maximum deviation may not be more than 0 5 square If the values are outside this tolerance the mechanical adjustment of the print head has to be corrected Fig 5 3 Printer adjustment test 1 Start the manual printout with 25 mm s and 20 mm mV 2 Press the 1 mV key 3 Check the amplitude height of the calibration impulse accord...

Страница 40: ...tmias 5 Check following all leads stops blinking Uel for all leads is 15 15 mV Udif 3985 4015 mV TPH 18 30 C 6 Press RETURN TEST 7 Press key 8 Check amplitude and polarity according following printouts Fig 5 5 ECG amplifier ECG AMPLIFIER U el mV Uref 2002 R 517 Uref 2000 L 518 Udif 4001 C1 520 Uoff 166 C2 516 Calib 1000 C3 521 C5 515 C6 517 TPH TEMP 23 C Eprom 623 ECG AMPLIFIER U el mV Uref 2002 R...

Страница 41: ...ce 5 A 0 Service Handbook Functional test 5 2 Art no 2 540037 Rev a ECG leads printout This printout can be used on a transparency foil to compare your printout Be sure that no Zoom is used for a print on a transparency foil ...

Страница 42: ...5 Care Maintenance 5 2 Functional test A 0 Page 40 Art no 2 540037 Rev a ...

Страница 43: ...s test uses a special test plug DB9 Pin 2 and 3 bridged to check transmission line and connector to ensure that the AT 101 transmission circuits are functioning 1 Connect RS 232 loop test connector at the RS 232 port 2 Select MENU SETUP SYSTEM SETTINGS TEST AND INFO COMM TES UART TEST 3 Type R and T receive and transmit The screen shows hex characters when the serial port is ok ECG AMPLIFIER U el ...

Страница 44: ...inted by the tester Always include one copy of the results with the repair report The original remains with the device and is given to the customer for his files 5 3 1 Maximum values safety test Ground Resistance 0 2 Voltage Type BF Type CF normal condition first error normal condition first error Earth current general mA 0 5 1 0 0 5 0 5 Shell current mA 0 1 0 5 0 1 0 5 Patient current mA 0 1 0 5 ...

Страница 45: ...G TEST AND INFO and enter following code 032 A full test print out will be executed The device must run 4 hours when the battery was fully charged Important The battery is maintenance free during its normal life The battery should remain charged during storage If the storage period exceeds three months recharge the battery Philips screwdriver 1 Important A totally discharged battery requires appro...

Страница 46: ... back housing 3 Remove the cover 4 Take the battery 1 out and remove the cable 5 Insert a new battery and connect the cable Check the polarity 6 Charge the battery see section 4 1 1 Fig 5 7 Battery replacement Danger of explosion Battery may not be burned or disposed of domestic refuse Danger of acid burns Do not open the battery The battery is to be disposed of in municipally approved areas or se...

Страница 47: ...220 240 VAC 2 250 V 200 mA T slow blow 100 115 VAC 2 115 V 315 mA T slow blow Changing the fuse 1 Disconnect the device from the mains and remove the mains plug See paragraph 3 1 4 2 Loosen the fuse inset using a screwdriver and remove it 3 Replace existing fuses with the same type See table above 4 Re insert the fuse inset Changing the mains voltage 1 Disconnect the device from the mains and remo...

Страница 48: ...d be done with gas only and not with steam To disinfect wipe the cable with hospital standard disinfectant 5 6 3 Cleaning the Thermal Print Head If the printer is used a lot a residue of ink from the grid on the paper can build up on the print head This can cause the print quality to deteriorate We recommend there fore that every month the print head is cleaned with alcohol as follows Extend the p...

Страница 49: ...t handling to normal paper as it can react with chemicals and to heat However when the following points are remembered the paper will give reliable results The following points apply to both storage and when archiving the results 1 Before use keep the paper in its original cardboard cover Do not remove the cardboard cover until the paper is to be used 2 Store in a cool dark and dry area 3 Do not s...

Страница 50: ...nter 1 Disconnecting device from the mains 2 Loosen the 6 Phillips screw from the back housing 3 Remove the cover 4 Open the Printer and remove the paper 5 Loosen the four Phillips screws 1 6 Loosen the screw for the ground cable 7 Unplug Printer cable 3 and 4 8 Replace printer 1 2 3 4 ...

Страница 51: ...ure mains filter is correct for mains supply If the trace is still knoisyk Call your local SCHILLER rep resentative No printout obtained after an auto mode recording No paper Wrong settings Ensure that paper is loaded Check Settings ensure that at least one item is selected for print after an auto ECG is recorded If the printer still doesnkt work Call your local SCHILLER representative Printout fa...

Страница 52: ... A full list of all SCHILLER representatives can be found on the SCHILLER website www schiller ch In case of difficulty contact our head office Our staff will be pleased to help process your order or to provide any details for all SCHILLER products Always use SCHILLER replacement parts and disposables or products ap proved by SCHILLER Failure to do so may endanger life and invalidate the guarantee...

Страница 53: ...perating conditions 4 years 90 approx 7 hours 100 approx 15 hours Line frequency filter Distortion free suppression of superimposed 50 or 60 Hz sinusoidal interferences by means of adaptive digital filtering Printer Frequency range Chart paper High resolution thermal head printer 8 dots mm amplitude axis 40 dots mm time axis 25 mm s 0 05 150 Hz IEC AHA Thermo reactive Z folded 72 mm wide Interface...

Страница 54: ...mm automatic base line adjustment Automatic lead programs 3 12 channel presentations of 12 simultaneously recorded standard leads Nu merous print out formats can be selected Data record With optional interpretation C program Patient data name age height weight BP user ID Listing of all ECG recording conditions date time filter ECG measurements results intervals amplitudes electrical axes average c...

Страница 55: ... 6 3 Safety Standards Safety standard IEC EN 60601 1 IEC EN 60601 2 25 EMC IEC EN 60601 1 2 Protection class I according to IEC EN 60601 1 with internal power supply Conformity Classification CE IIa according Directive 93 42 EEC Protection This device is not designed for outdoor use IP 20 ...

Страница 56: ...s 7 1 Drawings Printer A 0 Page 54 Art no 2 540037 Rev a 7 Drawing and spare parts 7 1 Drawings Printer Fig 7 1 Drawing printer 7 1 1 Flap and Drive roll Fig 7 2 Drawing flap and drive roll 3x SK M3x6 Thermal printer 3 920907 ...

Страница 57: ...Page 55 Drawing and spare parts 7 A 0 Service Handbook Drawings Printer 7 1 Art no 2 540037 Rev a 7 1 2 AT 101 pictures Fig 7 3 AT 101 open top view ...

Страница 58: ...7 Drawing and spare parts 7 1 Drawings Printer A 0 Page 56 Art no 2 540037 Rev a Fig 7 4 Detail cabling ...

Страница 59: ...ng 7 2 Art no 2 540037 Rev a 7 2 Electrical drawing The electrical drawing are confidental Therefore just the most important drawing or parts of drawing are printed here 7 2 1 Power supply TP151 Batt 4 8 V if mains connected and Device switch on U10 9 6 U5 5V TP174 13 6 V ...

Страница 60: ...7 Drawing and spare parts 7 2 Electrical drawing A 0 Page 58 Art no 2 540037 Rev a 7 2 2 Component layout SI 1 R485 R465 R470 ...

Страница 61: ...able see page 45 3 Safety labels are on the device and are readable 4 Mechanical condition of the device allows a further safe operation cracks in the shell mains cable etc 5 there is no soiling which could hamper the safety of the device 5 2 3 Mains indicator LED test page 35 1 The mains indicator lamp 6 is always lit when the unit is connected to the mains supply 2 The relevant symbol is display...

Страница 62: ...If the values are outside this tolerance the mechanical adjustment of the print head has to be corrected 5 2 11 ECG amplifier page 37 1 Check the amplitude height of the calibration impulse according to the pa per grid It should be 20 mm 0 5 square 5 2 12 ECG lead and patient cable test page 38 1 all leads 1 are blinking 2 Uel for all leads is 350 to 550 mV 3 all leads stops blinking 4 Uel for all...

Страница 63: ...Page 61 Appendix 8 A 0 Service Handbook Checklist 8 1 Art no 2 540037 Rev a Other remarks ...

Страница 64: ...8 Appendix 8 1 Checklist A 0 Page 62 Art no 2 540037 Rev a ...

Страница 65: ...n 18 19 21 K Keypad 11 L Languag 24 LCD Screen 13 Lead Sequence 22 Leads 22 Left Posterior V4 V9 22 Line Transmission 26 M M Memory 27 Mains filter 20 Maintenance interval for the battery 43 Markings 18 19 Measurement 18 19 Mode 25 Modem Init 25 Modem Transmission 26 Myogram filter 20 N Navigation with Keypad buttons 16 Navigation with Softkeys 16 P Paper Mode 24 Phone No 25 Potential Equalisation...

Страница 66: ...9 Index A 0 Page 64 Art no 2 540037 Rev a ...

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