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ES601

Plus

OPERATING MANUAL

EQUIPMNT:

If set to "ON", leakage tests are performed with the power switch of
the DUT in the "ON" position only. If set to "ON/OFF", leakage
tests are performed with the DUT power switch "ON", and then the
entire leakage test sequence is repeated after the DUT power switch is
set to "OFF".

"DUT OFF" leakage tests are a mandatory requirement of IEC60601
and AAMI-ES1 standards. These standards recognize some types of
equipment do not disconnect from the AC supply when switched
"OFF", but simply enter a standby state in which, for example, an
internal battery is charged. When operating in this state, DUT leakage
may potentially be greater than leakage observed with DUT switched
"ON".

According to IEC60601 and AAMI-ES1, "DUT OFF" is a
supplementary test condition which is required for equipment that
does not fully disconnect from the AC supply when the power switch
is set to "OFF".

POLARITY:

If set to "NORMAL", tests are performed with the AC supply at
normal polarity only. If set to "NORM/REV", tests are performed
with the AC supply in normal and reversed polarities. "NORM/REV"
is the typical setting and is the test requirement specified by all safety
standards.

LINE 2:

If set to "NORMAL", tests are performed with Line 2 (neutral) of the
AC supply in normal condition only. If set to "NORM/OPEN", tests
are performed with Line 2 in normal and single-fault conditions
("open"). "NORM/OPEN" is the typical setting and is the test
requirement specified by most safety standards.

GROUND:

If set to "NORMAL", tests are performed with ground (protective
earth) of the AC supply in normal condition only. If set to
"NORM/OPEN", tests are performed with ground in normal and
single-fault conditions ("open"). "NORM/OPEN" is the typical setting
and is the test requirement specified by most safety standards.

Manual Testing/Chapter 5

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Summary of Contents for ES601 Plus

Page 1: ...Operating Manual ES601Plus Inte rnatio nal Auto m ate d Ele c tric al Safe ty Analyze r ...

Page 2: ......

Page 3: ...mated Electrical Safety Analyzer Operating Manual 2015 Datrend Systems Inc Unit 130 4020 Viking Way Richmond BC CANADA V6V 2L4 Tel 800 667 6557 North America Only or 604 291 7747 Fax 604 294 2355 e mail customerservice datrend com ...

Page 4: ......

Page 5: ...alized products products labelled with a distinct serial number and accessories are eligible for partial refund and or credit Non serialized parts and accessory items cables carrying cases auxiliary modules etc are not eligible for return or refund In order to receive a partial refund credit the product must not have been damaged and must be returned complete meaning all manuals cables accessories...

Page 6: ...trument Improper power supply such as low voltage incorrect voltage defective wiring or inadequate fuses Accident alteration abuse or misuse of the instrument Fire water damage theft war riot hostility acts of God such as hurricanes floods etc Only serialized products those items bearing a distinct serial number tag and their accessory items are covered under this warranty PHYSICAL DAMAGE CAUSED B...

Page 7: ... serial number for your instrument as well as a valid reason for breaking the Quality Seal You should break this seal only after you have received factory authorization Do not break the Quality Seal before you have contacted us Following these steps will help ensure that you will retain the original warranty on your instrument without interruption WARNING Unauthorized user modifications or applica...

Page 8: ...Page iv ...

Page 9: ...acle 2 Kelvin Cable 2 AUX1 Terminal MAP 3 AUX2 Terminal 3 To DUT Case Terminal 3 Applied Parts Terminals 3 1 5 ECG Simulator 3 Performance Waveforms 3 Arrhythmia Waveforms 4 Defibrillator AED Test Waveforms 4 Output Amplitude 4 Accuracy 4 1 6 User Interface 4 Display 4 Keypad 4 Audio Indicator 4 1 7 Non Volatile Memory 5 Memory Type 5 Data Capacity 5 1 8 Printer Port Data Output 5 Hardware Interfa...

Page 10: ...Current 11 2 1 5 Leakage Current 11 2 1 6 Touch Current 12 2 1 7 Earth Leakage Current 12 2 1 8 Patient Leakage Current 13 2 1 9 Patient Auxiliary Leakage Current 15 2 1 10 Alternative and Direct Methods of Leakage Current Measurement 15 2 1 11 Battery Power Protocols 16 2 1 12 Safety AutoSequences 17 2 2 Characteristics of ES601Plus 18 2 2 1 Test Receptacle Configuration 18 2 2 2 Standard Accesso...

Page 11: ...Viewing a Record 85 5 14 2 Report Output 90 5 14 3 Using HyperTerminal to Capture Test Results 92 5 15 ECG Simulator 94 5 16 Technician Timer 97 6 AUTOMATED TESTING 99 6 1 Automated Testing with ES601Plus 99 6 1 1 Safety AutoSequences 99 6 1 2 ECG AutoSequences 104 6 1 3 Other AutoSequences 106 6 1 4 Test Procedures 114 6 2 Automated Testing Principles 116 6 2 1 ES601Plus Instructions 116 6 2 2 Ge...

Page 12: ...nce Title 146 8 5 2 Choosing the Standard 146 8 5 3 Limits All Standards 147 8 5 4 Equipment Class 147 8 5 5 Line Voltage 147 8 5 6 Insulation Resistance 147 8 5 7 Load Current 148 8 5 8 Protective Earth 148 8 5 9 Leakage Current IEC60601 and AAMI ES1 148 8 5 10 Leakage Current VDE0751 and IEC62353 148 8 5 11 Leakage Current Battery powered devices 148 8 5 12 Leakage Current IEC61010 149 8 5 13 De...

Page 13: ... 160 8 7 5 Printing Test Reports 161 8 7 6 Saving Test Reports 161 8 8 AutoSequence Editor 162 8 8 1 Editing an Inspection or User Tester Sequence 162 8 8 2 Editing an AutoSequence 163 8 8 3 Editing an Instruction 164 Selecting the Op Code 165 Selecting the Category 165 Entering the Command Prompt 166 8 8 4 Creating a New Instruction 166 8 8 5 Filtering the Instructions 167 8 8 6 Deleting an Instr...

Page 14: ...ted PM procedure Test Procedure for that device Flash Memory Non volatile memory used for storing Test Records and other configuration related data such as user settings AutoSequences Test Procedures and Equipment Records The contents of the flash memory are retained when the power to ES601Plus is switched off GND or Ground The line conductor connected to a place that is maintained at Ground or Ea...

Page 15: ...e AAMI Association for Advancement of Medical Instrumentation IEC International Electrotechnical Commission VDE Verband der Elektrotechnik Elektronik und Informationstechnik Test Procedure A type of AutoSequence that can be linked to the control number of a device through an Equipment Record Test Record Safety ECG and other test result data which have been saved to the non volatile flash memory as...

Page 16: ...ector will be ON APPLIED PARTS Hazardous Voltage 264 VAC or 500 VDC max This warning appears on the Applied Parts label on the front of ES601Plus During testing of the isolation of the DUT Applied Parts with respect to either ground or to the power input leads a voltage of either 110 of the AC line voltage or 500 VDC may be present on the Applied Parts CAT I connectors This voltage may reach a max...

Page 17: ...he load current for the Device Under Test D U T should not exceed 11A These limits are set by the Electrical Code in most jurisdictions in an attempt to avoid unexpected circuit overloads and subsequent circuit failure If the D U T load is expected to approach the maximum value on a routine basis it is recommended that a circuit with only a single receptacle be provided for use with ES601Plus WARN...

Page 18: ...al safetytest on the D U T ES601Plus mayapply high voltages up to 264 VAC or 500 VDC to the D U T While these voltages are current limited they do represent a shock hazard to the operator if precautions are not followed Consult the instructions in this manual regarding Mains on Applied Part leakage current tests and Insulation Resistance tests for further information Definitions Page xiv ...

Page 19: ...ES601Plus OPERATING MANUAL Definitions Page xv ...

Page 20: ...01 for battery powered medical device AAMI BAT AAMI ES1 for battery powered medical device VDE BAT VDE 0751 for battery powered medical device IEC353 BAT IEC62353 for battery powered medical device 1 2 Automated Testing By Safety AutoSequence By ECG AutoSequence By General Inspection By Tester AutoSequence By Test Procedure By Device ID Control Number Search 1 3 Manual Mode Safety Tests Line Volta...

Page 21: ... 1996 VDE 0751 IEC62353 IEC61010 Range 0 to 14000 uA RMS 0 to 25000 uA DC Method True RMS reading Accuracy DC 25Hz 200kHz 1 of reading 2LSD 200kHz 1MHz 4 of reading 3LSD Mains on Applied Parts voltage is 110 of AC supply for IEC60601 tests or 100 of AC supply for other safety standards 1 4 Electrical Safety Measurement Terminals Test Receptacle CAT II Max Voltage 132 VAC North America 264 VAC Euro...

Page 22: ... Max Voltage 264 VAC MAP Test 500 VDC Insulation Test Max Current 14mA AC 264 VAC 50mA DC 500 VDC Connect measurement terminals ONLY as instructed in this manual see Chapter 4 Connecting to ES601 1 5 ECG Simulator Performance Waveforms DC Pulse 4 seconds Square Wave 2 Hz Triangle Wave 2 Hz Havertriangle Pulse 10 25 40 100 and 200 msec 60 BPM Sine Wave 0 5 10 20 40 50 60 70 and 100 Hz Normal Sinus ...

Page 23: ... Asystole Supraventricular Tachycardia SVT Polymorphic VTach 140 BPM PVT140 Monomorphic VTach 160 BPM PVT160 Ventricular Fibrillation VFIB Missed beat 80 120 BPM Output Amplitude Selectable 1mV 2mV or 0 5 mV on Lead ll Accuracy Rate 0 2 Amplitude 2 1 6 User Interface Display Graphic LCD 4 53 x 3 40 11 5 cm x 86 cm Monochrome backlit 320 x 240 pixel graphics 53 character x 30 lines text Keypad Touc...

Page 24: ...ections 12 Pulse Oximeter Tester AutoSequences 12 IV Pump Tester AutoSequences 24 Defibrillator Tester AutoSequences 60 AutoSequences for user defined Testers AutoSequences Inspections and PM test procedures are user programmable via the ES601pc software package included on CDROM 1 8 Printer Port Data Output Hardware Interface DB25F Centronix standard 1 9 RS 232 Port Data Output Hardware Interface...

Page 25: ... 2 0 compliant Data Transfer Rate 1 Mbit sec 1 11 Ethernet Data Transfer Capture Hardware Interface RJ 45 Protocol TCP IP Data Transfer Rate 10baseT 10 Mbits sec maximum 1 12 Keyboard and Barcode Scanner Ports RS 232 barcode scanner PS 2 keyboard or PS 2 barcode scanner Specifications Chapter 1 Page 6 ...

Page 26: ... Fuses 1A 250V AGC Transient overvoltages typically present on the mains supply are expected to be impulse withstand overvoltage category II of IEC 60364 4 443 1 14 Environment for Use 15 to 40 EC 10 to 90 RH Altitude 2000m max Indoor use only Pollution Degree 2 1 15 Dimensions 9 23 cm W x 9 23 cm D x 10 25 cm H 1 16 Weight 12 lbs 5 4 kg Standard 17 lbs 7 7 kg with PETM option 1 17 Standard Access...

Page 27: ...stomer Service for complete details Refer to Chapter 9 for contact information 1 21 Compliance With Standards ES601Plus has been certified to meet the following safety standards CAN CSA C22 2 No 61010 1 2 Edition Safety Requirements for Electrical Equipment for nd Measurement Control and Laboratory Use Part 1 General Requirements UL Std No 61010 1 2 Edition Safety Requirements for Electrical Equip...

Page 28: ...ontrol number or run independently In addition to the industry standard input output connections RS 232 and Centronix ES601Plus has added both USB and Ethernet connectivity for ease of control and rapid data transfer to both stand alone and networked PC systems ES601Plus also provides connections for RS 232 barcode scanners and PS 2 keyboards or PS 2 barcode scanners ES601Plus is a truly INTERNATI...

Page 29: ... between the applied parts and the line cord ground pin and measures the resistance 2 1 2 Protective Earth In this test ES601Plus will source one amp of DC current through the dead short circuit that should exist from the ground pin on the line cord of the DUT to any exposed metal part on the DUT s enclosure In practice the connection from the ground pin to the enclosure of the DUT has a non zero ...

Page 30: ...d PE and L2 and PE 2 1 4 Load Current To perform this measurement ES601Plus connects an internal ammeter to the DUT and measures the current it draws from the AC line when the DUT is powered up and running 2 1 5 Leakage Current Different safety standards require different types of leakage measurements to be performed ES601Plus focuses on medical device testing and implements the four general types...

Page 31: ...limit specified in the safety standard When measuring the touch current ES601Plus can be configured to record AC and DC values for these test conditions Normal Polarity Normal Condition Single Fault Condition Line 2 Open Single Fault Condition Earth Open NP NC NP SF L2O NP SF EO Reverse Polarity Normal Condition Single Fault Condition Line 2 Open Single Fault Condition Earth Open RP NC RP SF L2O R...

Page 32: ... patient leakage must be measured is highly dependent on the specified group Type If the safety standard is IEC60601 and an applied part group is designated Type CF then the leakage current produced by each patient connection within that group is measured individually in turn For an applied part group which is Type B or Type BF all patient leads of the group are connected together and then the col...

Page 33: ...akage setup according to the characteristics of the DUT Optional STC include performing tests with the DUT power switch in the ON position and also in the OFF position ON OFF test conditions applying mains supply voltage to isolated signal inputs outputs on the DUT or connecting such 1 isolated signals to protective earth MIO IOE test conditions and connecting floating ungrounded metal parts on th...

Page 34: ...ondition Single Fault Condition Line 2 Open Single Fault Condition Earth Open RP NC RP SF L2O RP SF EO In addition to these six test conditions IEC60601 and AAMI ES1 standards require a supplementary test condition STC where the power switch on the DUT can be set to either ON or OFF If this STC is enabled ES601Plus measures auxiliary leakage for each normal NC or single fault SF condition in combi...

Page 35: ...d IEC62353 standards ES601Plus records all results from all leakage measurements enabled by the user in the test setup For the direct method of measurement ES601Plus will record AC and DC values for these test conditions Device Leakage Normal Polarity Single Fault Condition Earth Open NP SF EO Reverse Polarity Single Fault Condition Earth Open RP SF EO Patient Leakage record for each Group defined...

Page 36: ...afety AutoSequence can include measurements of line voltage load current leakage enclosure or device earth patient auxiliary protective earth and insulation resistance For devices having patient applied parts each Safety Autosequence can be set up to organize the parts into Functional Groups of defined Protection Class with names assignable to each Group as well as to each Part within each Group U...

Page 37: ...ftware Operator s Manual Installed Software Modules Safety Limits Editor Safety AutoSequence Editor ECG AutoSequence Editor Test Report Generator Autosequence Test Procedure Editor Equipment Record Plug in CMMS Data Converters Oxitest Autosequences Infutest Autosequences Phase 3 Autosequences 2 2 3 Optional Accessories Barcode Scanner P N 7600 051 or 7600 052 PC Interface Cable DB9F DB9M P N 3140 ...

Page 38: ...NTERFACE for PS 2 Keyboard or PS 2 Barcode Scanner 9 CONTRAST ADJUSTMENT POTENTIOMETER embedded 10 RS 232 BARCODE SCANNER INTERFACE 11 FIRMWARE UPLOAD SWITCH toggles between normal and update mode embedded FRONT PANEL 12 ECG APPLIED PARTS Universal ECG jacks for connecting applied parts and ECG leads 13 Graphic LCD 53 character x 30 lines backlit touch screen TOP PANEL 14 Three safety style banana...

Page 39: ...ES601Plus OPERATING MANUAL Overview Chapter 2 Page 20 ...

Page 40: ...y or may be automatically replaced by either the MANUAL MODE menu or the AUTO MODE menu after a few seconds Optionally the STARTUP MODE can be set to enable a test of the AC supply voltage at five seconds after power on If the AC supply test at startup has been enabled ES601Plus will produce an alarm if a reversed supply condition is detected Note that a reversed AC supply may affect test results ...

Page 41: ...ts and other types of automated tests Refer to chapter 6 SYSTEM SETTINGS Enters a menu for programming system settings such as time and date user preferences and automated safety test setups Refer to the following Section 3 2 REVIEW TESTS Selects a Test Record previously stored in memory for viewing as a Report on the LCD printing to an attached printer or downloading via RS232 to a PC Refer to Se...

Page 42: ...ttings Menu 1 are STARTUP MODE Determines how ES601Plus performs after power is switched on The options available are Select Auto or Manual Mode from Start up screen default Wait 5 seconds then display Auto Mode Menu Wait 5 seconds then display Manual Mode Menu Wait 5 seconds Test Line Volts then display Auto Mode Menu Wait 5 seconds Test Line Volts then display Manual Mode Menu EDIT SAFETY Enters...

Page 43: ...its communication from the PC running ES601pc ETHERNET PORT Opens the connection via the ETHERNET Port and awaits communication from the PC running ES601pc ESCAPE Exit Computer Interface mode to the System Settings menu CAL TOUCHSCN Enters a utility for calibrating the ES601Plus analog touch screen Note If the user chooses to perform the calibration procedure the calibration must be completed as d...

Page 44: ...equence Controls from System Settings Menu 2 are recalled and are shown on the display Before proceeding with the test the user may modify the default Sequence Controls to suit the specific needs of the equipment being tested After the manual test is completed the Sequence Controls revert to the default settings shown on System Settings Menu 2 System Settings Menu 2 should therefore be configured ...

Page 45: ...ng described above and will cause a manual leakage test to fully sto p immediately after the AC supply is connected to the DUT by ES601Plus ES601Plus will then prompt the user to activate the DUT and will not proceed until the user acknowledges by pressing the CONTINUE button This feature accommodates equipment with a momentary ON OFF power switch which cannot be switched ON until a full AC supply...

Page 46: ... of attachment of the Kelvin Cable of ES601Plus and the other being the point of attachment of a test lead which connects to the TO DUT CASE jack of ES601Plus If set to NO factory default point to point resistance testing is disabled in manual mode This control works with the MULTIPLE PE TEST control and TEST LINE CORD control above to provide various protocols for protective earth testing as desc...

Page 47: ...ular EXIT Exits to the previous menu AUTO or MANUAL or to AUTO MODE if the Systems Settings menu was entered from the startup screen On exit changes made to the Sequence Controls are saved in the non volatile memory of ES601Plus MORE SETTINGS Displays System Settings Menu 3 If a password has been enabled via SYSTEM SETTINGS Menu 3 the user will be prompted to enter the password when MORE SETTINGS ...

Page 48: ... D is set at time of manufacture to MY ES601 and can be edited using this utility which allows the user to input a unique I D to identify ES601Plus within the user s equipment management system This I D is meant to be a control number or similar reference and should not be confused with the unit serial number Pressing this button will activate the QWERTY touch keypad of ES601Plus allowing the user...

Page 49: ...ion 3 5 for more information on operation and features of the QWERTY keypad NETWORK SETUP Allows the user to input Ethernet settings IP address netmask and gateway for ES601Plus see Fig ure 5 Addresses are entered with decimal delimiters A touch keypad that provides for numerical input only is displayed in response to pressing any of the CHANGE keys Pressing EXIT saves changes made and restores th...

Page 50: ... time the QWERTY keypad is displayed ES601Plus reacts differently to data arriving via the Barcode Reader Port compared to data from a PS 2 keyboard For data received via the Barcode Port ES601Plus will wait until a complete string of characters terminated by carriage return is received After sensing a carriage return ES601Plus removes the QWERTY keypad from the LCD display and shows the Barcode d...

Page 51: ...equences These sequences can be programmed by means of the Safety AutoSequence module of the ES601pc software package included with ES601Plus see Chapter 8 Alternatively the sequences can be programmed using the operator interface of ES601Plus as described in this section Note that figures appearing in this section illustrate example settings only the specific appearance of menus on your ES601Plus...

Page 52: ...he other buttons on the editor SAFETY LIMITS Press to choose between PER STANDARD and USER DEFINED User defined safety limits allow you to set alternative protective earth and leakage current limits to suit older equipment manufacturer specifications or other special test requirements One user defined table of limits is provided for each of the safety standards and these special tables are program...

Page 53: ...buttons enable or disable testing of applied parts and enable or disable supplementary test conditions such as mains on isolated data I O and testing of ungrounded metal parts Refer to Section 5 10 for further details on the leakage test conditions configured by the buttons on this menu Specific buttons provided by the leakage current menu have a common function regardless of the safety standard T...

Page 54: ...rring back to the main menu of the AutoSequence editor Fig ure 8 this button enters a submenu for enabling or disabling tests of line voltage load current insulation resistance of line input to ground LINE GND insulation resistance of applied parts to ground AP GND and protective earth resistance Tests provided by this submenu will depend on the safety standard For example if the safety standard p...

Page 55: ...uttons on the right of the Sequence Control menu affect operation of the protective earth test as described in Sections 3 3 and 5 9 Note that Safety AutoSequences do not include an offset calibration for point to point resistance measurement there is only one OFFSET calibration for ES601Plus and this is input by means of System Settings Menu 2 according to Section 3 3 When a Safety AutoSequence is...

Page 56: ...Responding YES to the displayed prompt will store the AutoSequence settings to the memory location indicated and will return ES601Plus to System Settings Menu 1 Pressing NO will return ES601Plus to Systems Settings Menu 1 without storing the AutoSequence ESCAPE Referring back to the main menu of the editor pressing this button causes ES601Plus to return to System Settings Menu 1 Any changes which ...

Page 57: ...ES601Plus OPERATING MANUAL Setup Chapter 3 Page 38 ...

Page 58: ...Plus Test Socket Connect the Kelvin Cable to a grounded terminal on the enclosure of the DUT AUX1 connects to electrically isolated input output signals Typically this connection would be for testing a transformer isolated data communications interface on the DUT such as an Ethernet Port Review DUT documentation or check with the DUT manufacturer before making this connection or performing tests o...

Page 59: ...ES601Plus OPERATING MANUAL Fig ure 13 Connecting to a line powered DUT Connecting To ES601 Chapter 4 Page 40 ...

Page 60: ...UT CASE jack of ES601Plus connects to the enclosure of the DUT or alternatively to aluminum foil which is wrapped over the DUT if the enclosure is made of plastic As required AUX1 may connect to electrically isolated input output signals Most typically this connection would be for testing a transformer isolated data communications interface on the DUT such as an Ethernet Port Note the Test Socket ...

Page 61: ...g ure 15 Connecting Peripheral Devices 4 3 Connecting Peripheral Devices Input connections for data entry during tests are optional Data can always be entered via the on screen QWERTY keyboard Connecting To ES601 Chapter 4 Page 42 ...

Page 62: ...ests are performed with ES601Plus the individual test results are collected in a temporary area of memory which is designated the Clip Record When testing is complete and results are saved the contents of the Clip Record are copied to a Test Record which resides in non volatile or flash memory When a Test Record is recalled from flash memory the Record data is placed in the Clip Record The Clip Re...

Page 63: ... test Pressing the STANDARD button or AUTO MODE button on the MANUAL MODE menu will c le ar the Clip Re c o rd Clip Record data which has not been saved as a Test Record will be e rase d 5 3 Safety Standards NOTE The safety standard should not be changed during a manual test Pressing this button during a manual test will erase all measurement data in the Clip Record Select the standard first then ...

Page 64: ...nu by pressing the EXIT button on the SYSTEM SETTINGS menu The above procedure will program the default setting of the safety standard for the MANUAL MODE into the non volatile flash memory of ES601Plus This default may be changed at any time by repeating the above procedure 5 4 Safety Limits User defined Safety Limits are an accessory option for ES601Plus This accessory feature allows the user to...

Page 65: ...tiple devices of the same make model location and facility can be tested without having to re enter any additional information The device information fields are printed in the heading of the Test Report generated by ES601Plus This information helps identify the equipment beyond the I D or control number This is helpful for those facilities that do not use a Computerized Maintenance Management Syst...

Page 66: ... the DEVICE INFO menu will be automatically displayed by ES601Plus if the ID Number field is blank and SAVE TEST on the MANUAL MODE menu is pressed A Test Record m ust have an ID Number to be SAVED In addition to the field edit buttons other buttons on the menu provide these functions ESCAPE Returns the display to the MANUAL MODE menu CLEAR ALL Clears all information fields shown on menu CLEAR I D...

Page 67: ...dition is detected V V ES601Plus will produce an alarm Safety tests should not be performed if the AC supply is reversed as this may affect leakage results In the event of a reversed supply alarm connect to a different wall outlet or investigate the wiring of the wall outlet in use before proceeding with further tests After all three voltages have been displayed the following options become availa...

Page 68: ...ystem Settings after which ES601Plus will measure the current If STOP AFTER of the System Settings is set to YES ES601Plus will activate the test socket and then wait until you press the CONTINUE button The measurement is performed after you press CONTINUE Alternatively you may press ESCAPE to abort the measurement and return to the MANUAL MODE menu Note the purpose of the STOP AFTER break is to a...

Page 69: ...d current result to be moved to the Clip Record where other safety test measurements are collected If there is a previous load current measurement in the Clip Record it is overwritten After pressing either REPEAT or CONTINUE and if STOP BEFORE of the System Settings is NO see Section 3 3 ES601Plus will switch OFF the test socket and return to the MANUAL MODE menu If STOP BEFORE is YES ES601Plus wi...

Page 70: ...YES Note the purpose of the STOP BEFORE break is to allow you to accommodate power sensitive equipment such as a personal computer or equivalent DUT which cannot be arbitrarily disconnected from the AC supply without potentially damaging the DUT Manual Testing Chapter 5 Page 51 ...

Page 71: ...before selecting this test from the menu AC Power is removed from the test receptacle for the duration of this test Options available on the insulation test selection menu are TEST Toggles the test between measuring insulation resistance BETWEEN GROUND AND L1 L2 SHORTED TOGETHER and BETWEEN GROUND AND ALL APPLIED PARTS ESCAPE Returns the display to the MANUAL MODE menu No insulation test result is...

Page 72: ...m Unterminated leads attached to the AP jacks therefore present a minor non lethal shock hazard to the careless user Always take care to make proper electrical connections to the DUT before starting an insulation resistance test Disconnect all unused leads or cables from the AP jacks on ES601Plus After approximately two seconds the measurement result in megohms is displayed On the insulation test ...

Page 73: ...d to the Clip Record REPEAT Causes the measurement to be repeated CONTINUE Moves the measurement data and Pass Fail limit if shown to the Clip Record If there is a previous result from this test in the Clip Record it is overwritten The user interface returns to the MANUAL MODE menu Manual Testing Chapter 5 Page 54 ...

Page 74: ...rotective earth PE test and will then display these on the LCD You may change these settings to suit the upcoming test After the test is completed the Sequence Controls will revert to their System Setting defaults The buttons provided on the Sequence Control menu are MULTIPLE PE TEST If set to YES this control will enable multiple protective earth and or general resistance measurements within the ...

Page 75: ...S NO Measure resistance once between Kelvin Cable and test socket of ES601Plus Conventional PE test of equipment which connects to the AC supply by means of a line cord NO NO YES Measure resistance once between Kelvin Cable and DUT CASE lead The OFFSET calibration is subtracted from the measurement to obtain the final result The Kelvin Cable is connected to a PE equipotential stud located near the...

Page 76: ...lvin Cable and the test socket of ES601Plus one time After this measurement the user disconnects the DUT line cord from ES601Plus and connects the DUT CASE lead to the DUT For measurement 2 3 4 the resistance between the Kelvin Cable and DUT CASE lead is then measured with the OFFSET calibration being subtracted to obtain the results The Kelvin Cable and test lead may be moved to arbitrary points ...

Page 77: ...h will be used for point to point measurement to the TO DUT CASE jack of ES601Plus 3 Connect the free ends of the Kelvin Cable and the test lead together Verify a solid mechanical contact exists between the two cables at the far end 4 Press the CALIBRATE OFFSET button The resistance will be measured and displayed within one second 5 The result should be 0 05 ohms or lower for a typical test lead o...

Page 78: ...enu are CURRENT Selects either 1 amp DC bipolar or 25 amp AC RMS test current ESCAPE Aborts the test and returns to MANUAL MODE menu No results are saved to the Clip Record RUN TEST Initiates the test protocol represented by the Sequence Control settings displayed on the test current menu If the 1 Amp test is selected the resistance measurement will be performed using a regulated calibrated test c...

Page 79: ...easurement according to the figure above The three buttons will provide these functions ESCAPE Returns the display to the MANUAL MODE menu The result is discarded and not saved to the Clip Record REPEAT Causes the measurement to be repeated CONTINUE Moves the resistance measurement and Pass Fail limit to the Clip Record If there is a previous result from this test in the Clip Record it is overwrit...

Page 80: ...sistance The MEASUREMENT counter is incremented by one Up to ten resistance values can be recorded by means of this button If the button is pressed more than ten times the additional measurements overwrite the tenth resistance recorded Normally the user will change the connection of the Kelvin Cable and or DUT CASE lead immediately before pressing this button This will depend on test requirements ...

Page 81: ...he reduced measurement interval minimizes the risk of overheating the connections and changing the resistance of the test cables which could potentially invalidate the measurement results WARNING You must be careful to ensure you are using a Protective Earth PE connection during the 25 amp test A true PE connection is designed to conduct in excess of 25 amps However exposed metal parts or terminal...

Page 82: ...to allow the sequence to be paused and individual measurements in the sequence to be repeated if desired Test conditions provided by the leakage setup menu will depend on the safety standard which has been selected on the MANUAL MODE menu For the IEC60601 menu shown above the test conditions are CLASS Selects Class I default or Class II Class I equipment has a 3 wire AC supply connection incorpora...

Page 83: ...t that does not fully disconnect from the AC supply when the power switch is set to OFF POLARITY If set to NORMAL tests are performed with the AC supply at normal polarity only If set to NORM REV tests are performed with the AC supply in normal and reversed polarities NORM REV is the typical setting and is the test requirement specified by all safety standards LINE 2 If set to NORMAL tests are per...

Page 84: ... will depend on the number of leads that must be tested ISOLATED SIGNAL I O Options are DO NOT TEST default or TEST This parameter determines whether an isolated voltage equal to 110 of the AC supply will be output from the AUX1 jack of ES601Plus The AUX1 output is current limited to a few milliamperes AUX1 is intended to connect to isolated input or output signals provided by the DUT An example o...

Page 85: ...nce Datrend Systems Inc will not be responsible for damage resulting from incorrect application of this test UNGROUNDED METAL Options are DO NOT TEST default or TEST This parameter determines whether the AUX2 output of ES601Plus will be connected to protective earth of the AC supply AUX2 is intended to connect to flo ating e xpo se d metal on the DUT This test is required under the IEC60601 standa...

Page 86: ...e copied to the Clip Record NEXT Advances ES601Plus to the next step of the leakage test If APPLIED PARTS is set to DO NOT TEST Sequence Controls for manual leakage testing will be displayed when the NEXT button is pressed If APPLIED PARTS is set to TEST a setup menu for APPLIED PARTS is displayed when NEXT is pressed Manual Testing Chapter 5 Page 67 ...

Page 87: ... standards require applied parts or patient leads to be tested in related Gro ups For IEC and VDE safety standards Groups are organized by m e dic al func tio n ECG defib paddles blood pressure transducer etc ES601Plus provides connections for up to ten applied parts via the AP jacks located on the front panel where the AP jacks can be organized in up to five functional Groups For the AAMI standar...

Page 88: ... measurements Group 1 cannot be disabled GROUP TYPE Selects the type of group B NON ISOLATED BF ISOLATED default or CF ISOLATED Refer to Chapter 2 to review the meaning of Type B Type BF and Type CF protection classes of the safety standard The setting of GROUP TYPE affects the limits applied in patient leakage tests NAME OF GROUP Pressing this button causes the QWERTY touch keypad to be displayed...

Page 89: ...For testing a defibrillator per IEC60601 2 4 Assign ECG leads to one group and set the GROUP TYPE to CF ISOLATED Assign the defibrillator paddles to a second group and set NUMBER OF LEADS equal to two Set the GROUP TYPE to BF ISOLATED or CF ISOLATED according to manufacturer specifications Finally enter PADDLES PIASTRE or PALETTE for the NAME of the group The above special settings will enable ES6...

Page 90: ...s the user to more easily interrupt a sequence in progress so a particular leakage measurement of interest can be repeated as desired This control can be set to NO to disable the pause POWER UP DELAY During the test ES601Plus will wait for the indicated time when the AC supply is applied to the DUT before proceeding with the sequence This delay allows the DUT to start up and stabilize before subse...

Page 91: ...e the test to fully sto p immediately before a step which disconnects the AC supply from the DUT ES601Plus will prompt the user to shut down the DUT and will not proceed until the user acknowledges by pressing the CONTINUE button After CONTINUE is pressed ES601Plus will then disconnect the AC supply from the DUT This feature accommodates equipment having special shutdown requirements such as diagn...

Page 92: ...d parts between AUX1 of ES601Plus and DUT signal I O and between AUX2 and exposed ungrounded metal on the DUT WARNING If testing of Type BF or Type CF applied parts has been enabled HIGH VOLTAGE MAP voltage will be periodically output from the AP jacks during the test The MAP voltage is isolated from the AC mains and is internally current limited to 8 milliamperes maximum at 264 VAC output Untermi...

Page 93: ...equence Control is not set to NO ES601Plus will delay an additional 1 to 5 seconds between consecutive leakage measurements The type of measurement being performed and the AC supply conditions are shown on the display above the leakage readings RMS and DC limits corresponding to the test conditions are also shown on the right above the readings Each RMS and DC value is respectively compared to its...

Page 94: ...completely disabled allowing you to trade off operation of the PAUSE button against total execution time of the leakage test If the leakage test is paused the keypad buttons will be changed to ESCAPE Aborts the sequence in progress and return to the MANUAL MODE menu No new leakage test data is saved to the Clip Record REPEAT Repeats the measurement for the test conditions listed at the top of the ...

Page 95: ...dition NP SF EO At each configuration 1 4 of the AC supply measurements of enclosure and earth leakage are performed Following these measurements patient and auxiliary lead to lead leakage will be measured if those tests were enabled by the user on the setup menu When ES601Plus changes the AC supply from SF L2O to NC and if STOP AFTER of the Sequence Controls is NO Fig ure 31 ES601Plus will pause ...

Page 96: ...us changes the AC supply from NC to SF L2O ES601Plus will not stop if STOP BEFORE of the Sequence Controls is NO Fig ure 31 If STOP BEFORE is YES ES601Plus will stop and prompt you to shut down the equipment before supply Line 2 is disconnected After CONTINUE is pressed ES601Plus will disconnect Line 2 from the DUT and will then prompt you to reset the DUT power switch to ON This is necessary to s...

Page 97: ... Many types of medical equipment do not fully disconnect from the AC supply when the power switch is set to OFF Even when OFF this type of equipment remains effectively connected to the AC supply and continues to operate in a standby state for example by charging an internal battery For this type of equipment DUT OFF leakage tests are required under IEC60601 and AAMI ES1 standards DUT OFF leakage ...

Page 98: ...sequence occur until the end of the test Once the leakage measurement sequence has stepped through all specified test conditions ES601Plus will stop and display the last measurement taken during the leakage test Pressing the CONTINUE button on the display saves the leakage measurement data in the Clip Record along with the limits corresponding to each measurement Refer to Chapter 2 for a discussio...

Page 99: ... to the Re vie w ing Te sts section later in this chapter for more details on Record viewing features 5 12 Saving a Test Press the SAVE TEST button on the MANUAL MODE menu to save safety test data and device information in the Clip Record to a Test Record Usually this is the final step of a manually conducted safety test The SAVE TEST RECORD menu shows selected fields of the device information the...

Page 100: ...information and data in the Clip Record are erased SAVE TEST AND ADD MODULE Saves the test data according to the description above for SAVE TEST RECORD and creates a link to the next record to be saved through the Parent ID field of the Test Record A practical application of this feature is to link results for a modular patient monitor under the control number of the monitor s mainframe but where ...

Page 101: ...he LCD as described in the following section of this chapter If a previously stored Test Record is recalled from the flash memory in this manner any safety test data or device information that may exist in the Clip Record will be overwritten with the data of the recalled Record Any manual test data that may have been collected in the Clip Record will therefore be lo st unless it is first saved via...

Page 102: ...on the Data Flash memory ES601Plus monitors flash memory erase stress and to prevent loss of retained data will prevent you from erasing individual records one at a time once a maximum stress level has been reached Once maximum erase stress is reached you will then only be able to erase all records currently stored in the memory When all records are erased the flash memory will then be reset refre...

Page 103: ...TER INTERFACE Opens the COMPUTER INTERFACE menu to allow for communication with the ES601pc software See Chapter 8 SELECT RECORD Displays the contents of the highlighted Test Record Within the Record viewing menu the various pages comprising a multi page test result report can be seen on the LCD The report can be printed via ES601 Printer Port or RS 232 Port Manual Testing Chapter 5 Page 84 ...

Page 104: ...has been obtained when VIEW RECORD is pressed or if the Clip Record has been erased by changing the safety standard or saving a Test Record ES601Plus will display THERE IS NO MEASUREMENT DATA TO VIEW and will automatically return to the MANUAL MODE menu If a safety test was performed page 1 of the Test Record will include results for line voltage load current and insulation resistance Page 2 of th...

Page 105: ...ts in the Record where the latter 15 pages will list values recorded for patient and auxiliary leakage tests This represents are large volume of data however such recording and reporting of results is a mandatory requirement of the IEC60601 standard Other standards such as IEC62353 do not require as many safety measurements and therefore produce far shorter reports than tests performed according t...

Page 106: ...ement are reported in parentheses Depending on the safety standard the type of leakage measurement and the supplementary conditions enabled by the user for the test mnemonics appearing in brackets may be as follows No supplementary condition condition not applicable to test or condition not enabled by user ON DUT power switch in ON position OFF DUT power switch in OFF position APO All applied part...

Page 107: ... may prompt the user to repeat the test with the correct conditions For all safety standards except IEC61010 patient leakage results will follow enclosure leakage results if the user has enabled testing of applied parts One page is provided for each functional group of applied parts as configured by the user in the test setup see example below For the IEC60601 safety standard the patient leads of ...

Page 108: ...sults with one page being provided for each individual patient lead or applied part Additional pages may follow the safety test data if results were obtained from automated ECG and or procedural tests Examples of such data are provided in the two figures which follow Automated testing is discussed in Chapter 6 of this manual Manual Testing Chapter 5 Page 89 ...

Page 109: ...results Fig ure 47 Select Printer Port 5 14 2 Report Output A hardcopy of the results shown on the LCD may be output to either the Printer Port or the RS 232 Port of ES601Plus by pressing the OUTPUT REPORT button on the Test Record screen Manual Testing Chapter 5 Page 90 ...

Page 110: ...Send To destination for the generated Test Report as either Centronix Printer Port or RS 232 Port OUTPUT REPORT Send the report to the selected Port Once a print job has been started by pressing OUTPUT REPORT the status of the print job is shown on the LCD If ES601Plus determines the receiving device is off line an alarm message is displayed The ABORT button can be pressed to abort the print job a...

Page 111: ... desktop click Start point to All Programs point to Accessories point to Communications and click on HyperTerminal You will be prompted to enter a name for the HyperTerminal connection and select an icon associated with this new connection Enter a suitable name select the desired icon and click on OK Subsequently click on this icon from Explorer or the Start menu to avoid having to set up a new co...

Page 112: ...click Start HyperTerminal is now ready to receive data sent from ES601Plus to the PC Connect the RS 232 Port of ES601Plus to the PC COM Port selected in HyperTerminal and use the REPORT OUTPUT menu to send the test results via the RS 232 Port Once all Test Records have been transferred stop capturing text In the Transfer menu of HyperTerminal point to Capture Text and click on Stop Manual Testing ...

Page 113: ...onvert the AP jacks to ECG snap connections if required P N 7500 425 The ECG MENU button on the MANUAL MODE menu accesses the submenu for manual operation of the ECG simulator There are five main ECG simulator category selections in the manual operating mode The five submenus below the main menu provide eight waveforms within each category as listed below PERFORMANCE WAVE DC Pulse 4 seconds a Squa...

Page 114: ...THMIA Second Degree A V Block blk II g Premature Atrial Contraction PAC g Right Bundle Branch Block RBBB g Premature Ventricular Contraction PVC g R on T PVC RonT g Multifocal PVC mfPVC g Run of 5 PVC Run5 g Bigeminy BGEM g DEFIB PACER Atrial Fibrillation AFIB h I Asystole ASYS h j Supraventricular Tachycardia SVT h Polymorphic VTach 140BPM PVT140 h Monomorphic VTach 160BPM MVT160 h Ventricular Fi...

Page 115: ...itor BPM accuracy and R wave recognition g Tests arrhythmia detection algorithms h Tests AED shock no shock or defibrillator shock advisory report i Coarse waveform j Random low frequency baseline fluctuation k Tests pacemaker in demand mode When a waveform is selected its title is highlighted on the LCD and the simulator begins to output the corresponding signal immediately The RELATIVE SCALE but...

Page 116: ...n types of work This requirement is satisfied in ES601Plus by an elapsed time counter which is started and stopped in response to activity of the analyzer When ES601Plus is powered up the tech time counter is initially reset and then stopped When any measurement task is selected the timer is started if it is not currently running The timer counts upward in elapsed seconds and has sufficient range ...

Page 117: ...ES601Plus OPERATING MANUAL Manual Testing Chapter 5 Page 98 ...

Page 118: ...ect various automated tests as well as administrative functions System Settings Review Tests etc as previously described in Chapter 5 6 1 1 Safety AutoSequences Safety AutoSequences of ES601Plus correspond to lists of sequential voltage current and resistance measurements made on the DUT Twenty four default Safety AutoSequences allow ES601Plus to be immediately usable upon delivery Descriptions of...

Page 119: ... sequence s title ESCAPE returns to the AUTO MODE main menu Upon selecting the desired test you will be presented with various menus that will allow you to modify the settings of the AutoSequence before the test is started These displays will be similar to menus described in detail in Sections 3 3 and 5 10 of this manual Any changes made to AutoSequence settings will remain in effect for the durat...

Page 120: ...up the next menu displayed will show the applied part configuration Applied part names may be modified by means of the menu Applied part assignment to functional groups and protection class B BF CF can be modified after pressing the EDIT button If the AutoSequence setup does not specify applied parts this menu is bypassed Automated Testing Chapter 6 Page 101 ...

Page 121: ...the test sequence progresses the display of ES601Plus provides user prompts and instructions as necessary and reflects real time information about the tests performed This includes the type of test currently being executed within the sequence line voltage protective earth leakage current etc the safety standard used AC supply status the measured value s the pass fail limits and the pass fail asses...

Page 122: ... 3 Line voltage OFF 4 Leakage RP SF L2O OFF 5 Leakage RP NC ON 6 Leakage NP SF L2O OFF 7 Leakage NP NC ON 8 Load current ON 9 Test completion OFF Throughout the test sequence PAUSE ESCAPE REPEAT and CONTINUE buttons are available as applicable to the test being performed The functions of these keys are described in Chapter 5 Automated Testing Chapter 6 Page 103 ...

Page 123: ...601Plus by means of the ECG AutoSequence plug in of the ES601pc software package Editing the default ECG AutoSequences is described in Chapter 8 Descriptions of the default ECG AutoSequences are provided in Appendix A Selecting ECG AUTOSEQUENCE from the AUTOSEQUENCE MODE menu opens the ECG AutoSequence menu This menu lists six ECG AutoSequences Press the appropriate button to invoke the desired EC...

Page 124: ...ound and Corrected indicates the problem causing what would normally be a failure was resolved such as a bad lead that was replaced during the test After stepping through the waveform sequence the QWERTY keypad is displayed to allow comments to be added to the test such as Lead 2 RL bad Replaced The comments field allows for 40 ASCII characters Entry of the comment is optional When the ENTER key o...

Page 125: ...has the required accessory options installed in it the AutoSequence Editor of ES601pc will allow the user to program AutoSequences for the five User Defined Testers of ES601Plus as well as the General Inspections In addition Datrend product specific AutoSequence selections are available for devices such as pulse oximeter testers Oxitest Plus7 infusion pump testers Infutest 2000 and defibrillator t...

Page 126: ... pressed This menu provides access to eighteen General Inspections listed across three menu screens Scroll through these screens using the PREVIOUS or NEXT buttons to locate the desired Inspection Select the Inspection by pressing the button to the left of the Inspection s title ESCAPE returns to the AUTO MODE main menu When a General Inspection is run the user may be presented with OK PASS FAIL a...

Page 127: ...L Records a FAIL in the Clip Record for the current step and advances the test to the next step FAULT FOUND AND CORRECTED Records SERVICED in the Clip Record for the current step and advances the test to the next step This button records repairs in process where a minor failing item can be corrected without interrupting the procedure ENTER TEST DATA Displays the QWERTY touch keypad allowing the us...

Page 128: ...he optional accessory feature for General Inspections has been installed in ES601Plus then User Defined Tester AutoSequences will also be provided via the OTHER SEQUENCES menu discussed earlier AutoSequences for User Defined Testers are accessed by pressing the USER DEFINED TESTER button on the OTHER SEQUENCES menu From the five banks of User Tester AutoSequences provided on the menu in Fig ure 64...

Page 129: ...enus specifically designed for Datrend test products such as Oxitest 7 Infutest 2000 and Phase3 Oxitest AutoSequences allow ES601 to configure the simulator via RS232 remote control then permit the user to pass or fail the oximeter response and optionally enter test data by means of the QWERTY keypad or PS 2 keyboard Automated oximeter alarm tests are also provided by Oxitest AutoSequences With In...

Page 130: ... parameters which have been programmed by the user as part of the AutoSequence setup Fig ure s 66 70 show how the test process works for the case of Infutest 2000 analyzing the flow rate performance of a 2 channel infusion device 4 channel pumps can also be tested this way using Infutest 2000 with RSM Display screens are similar in principle for the case of Phase3 testing a defibrillator or pacer ...

Page 131: ...1Plus OPERATING MANUAL Fig ure 68 ES601 monitors Infutest status while Infutest tests the IV pump Fig ure 69 After Infutest is finished ES601 downloads measurement data Automated Testing Chapter 6 Page 112 ...

Page 132: ...ester options are installed the ES601pc software package will provide an easy to use interface for creating test sequences to meet virtually any need For instructions on programming Oxitest Infutest or Phase3 AutoSequences refer to the Help menus included with the corresponding plug in module of ES601pc Automated Testing Chapter 6 Page 113 ...

Page 133: ...Provided ES601Plus has the Test Procedure accessory option installed the Test Procedure Editor of ES601pc will allow the user to program ES601Plus with Test Procedures The Test Procedure Editor of ES601pc is described in Chapter 8 ES601Plus menus associated with selecting and running Test Procedures created by the Test Procedure Editor are discussed below If the optional accessory feature associat...

Page 134: ...rocedure is executed ESCAPE BACK and SKIP buttons are also available and will function as described earlier in this chapter At particular steps in the Test Procedure remote control commands may be transmitted from ES601Plus to an attached Analyzer or Tester via one of the RS232 Tester Ports on ES601Plus The behaviour of ES601Plus at each step in the Test Procedure will depend on the Instruc tio n ...

Page 135: ...of the AutoSequence Editor of the ES601pc software A General Inspection can comprise from 1 to 24 steps where each step corresponds to an ES601Plus Instruction In principle General Inspections are intended for work tasks in which the user will be visually inspecting the equipment under test and will be recording simple pass or fail results for each item inspected General Inspections are intended t...

Page 136: ...and the baud rate to be used for RS232 serial communications with your analyzer These selections are made with the AutoSequence Editor of ES601pc A Tester AutoSequence cannot include an ES601Plus Safety AutoSequence or ECG AutoSequence to include a safety and or ECG test within the scope of another automated test requires you to set up a full Test Procedure 6 2 4 Test Procedures Test Procedures ar...

Page 137: ... the P Instruction is shown in Fig ure 72 The c o m m and of the P Instruction is displayed on the LCD as the TASK and may be up to 41 characters in length Buttons provided on the LCD allow the user to save a test result for the displayed TASK as pass fail corrected or skip i e not tested or not applicable When any of the test result buttons PASS FAIL CORRECTED etc is pressed ES601Plus sequencer a...

Page 138: ...r displaying comments prompts or setup instructions is shown in Fig ure 73 The buttons provided for the K Instruction are ESCAPE and BACK plus an OK button Pressing OK causes an OK to be saved as the test result for that step recording the fact the user took the indicated action The Procedure is then incremented to the next step Automated Testing Chapter 6 Page 119 ...

Page 139: ... The requested information can be entered by means of the QWERTY touch keypad displayed on the LCD or by means of an external PS 2 keyboard connected to ES601Plus Up to 41 characters can be entered which are saved as the test data for that step The command of the I Instruction is displayed on the top line of the LCD providing a prompt to the user Automated Testing Chapter 6 Page 120 ...

Page 140: ... the E Instruction up to 41 characters can be entered via the QWERTY touch keypad or PS 2 keyboard after the ENTER TEST DATA button is pressed PASS FAIL and CORRECTED buttons save the user s assessment with test data that may have been entered and advances ES601Plus sequencer forward one step SKIP BACK and ESCAPE buttons provide the functions described for the P Instruction Note that the E Instruc...

Page 141: ...tion Editor of the AutoSequence or Test Procedure plug in to help you remember what the command does when you are creating Tester AutoSequences and Procedures When ES601Plus executes a C Instruction it will transmit the command via the Tester Port specified in the AutoSequence and will wait for a response from the Tester If a response is received ES601Plus will record OK as the test result for tha...

Page 142: ...pO2 or NIBP which do not by themselves generate measurement data When ES601Plus executes the R Instruction it will transmit the command portion of the Instruction via the Tester Port specified in the AutoSequence The prompt portion of the Instruction will be displayed on the LCD as the TASK The ENTER TEST DATA button on the LCD allows the user to record measurement data or observations via the QWE...

Page 143: ...he AutoSequence The prompt portion of the Instruction will then be displayed on the LCD as the TASK However if the first character of the Instruction command is a whitespace or a TAB character ES601Plus does not transmit anything and will immediately display the user interface of Fig ure 77 In the event that data is not immediately received from the tester a count up timer is displayed on the TEST...

Page 144: ...32000 seconds The instruction also provides a prompt which is displayed on the LCD as the TASK while the timer counts down ES601Plus will automatically advance to the next step of the sequence when the timer reaches zero count In this case an OK is saved as the test result for the delay step Alternatively the user may press SKIP to bypass any remaining delay The BACK button decrements ES601Plus se...

Page 145: ... Instructions that invoke General Inspections and or Tester AutoSequences The total number of procedural steps generated by including such General Inspections and or Tester AutoSequences in a Test Procedure via corresponding A Instructions cannot exceed a maximum of 96 ste ps Practically speaking since General Inspections and other types of automated tests may have up to 24 steps each a Test Proce...

Page 146: ...these will require an optional accessory feature to be installed in ES601Plus to operate correctly If when running a Test Procedure ES601Plus encounters an A Instruction for which the respective accessory option has not been installed for example the option for ESU Analyzer AutoSequences ES601Plus will skip over that A Instruction to the next step of the Test Procedure Command prefix Type of AutoS...

Page 147: ...ce is displayed on the LCD as the TASK the title and number of the AutoSeqeuence are also shown A SKIP button allows the AutoSequence to be bypassed Pressing the CONTINUE button runs the displayed AutoSequence BACK and ESCAPE keys assume the same functions described previously for other Instructions Automated Testing Chapter 6 Page 128 ...

Page 148: ... in seconds ESCAPE BACK SKIP E Data Entry with Pass Fail ESCAPE PASS FAIL FAULT CORRECTED BACK SKIP ENTER TEST DATA I Input Requested QWERTY touch keypad K OK Prompt ESCAPE BACK OK M Tester Measurement ESCAPE PASS FAIL BACK SKIP P Pass Fail ESCAPE PASS FAIL BACK SKIP FAULT CORRECTED R Tester Remote Control with User Data Entry ESCAPE PASS FAIL FAULT CORRECTED BACK SKIP ENTER TEST DATA Automated Te...

Page 149: ...ories require the Equipment Record and Test Procedure options to be installed in ES601Plus 6 3 1 Device ID Search The optional Equipment Record accessory for ES601Plus provides for easy test initiation by entering the equipment control number using the DEVICE ID SEARCH button on the AUTOSEQUENCE MODE menu If Equipment Records have been installed in ES601Plus pressing the DEVICE ID SEARCH button di...

Page 150: ...en the test is completed the SAVE TEST RECORD menu will be displayed If after opening the DEVICE INFO menu the Device ID Control Number is changed the indicated Test Procedure will still run and when saved will display the edited Device ID Control Number This will not however update the corresponding Equipment Record in the memory of ES601Plus Automated Testing Chapter 6 Page 131 ...

Page 151: ...ES601Plus OPERATING MANUAL Automated Testing Chapter 6 Page 132 ...

Page 152: ... every measurement performed whether the test condition is normal single fault or supplementary For computer control ES601Plus is connected to a serial COM Port on the PC For PC s without a COM Port any third party USB to RS232 converter cable can be used which will allow the user s software to communicate with ES601Plus via a Virtual COM Port a Virtual COM Port or VCP is driver software which is ...

Page 153: ...e 19200 baud No parity 8 data bits 1 stop bit 19200 N 8 1 Note that for computer control the baud rate 19200 is not the same as that used for printing Test Record reports via the ES601Plus serial port No handshaking is required and should be disabled in the PC COM setup 7 4 Protocol 7 4 1 General Format of Data Commands and data are conveyed as strings of ASCII text The carriage return character r...

Page 154: ... seconds of the r response from ES601Plus otherwise ES601Plus will time out and abort the protocol If ES601Plus receives a character other than a to x ES601Plus returns r to the PC and aborts the protocol As an alternative to sending a lower case letter PC software can alternatively send an upper case letter A 0x41 specifies AutoSequence 1 B 0x42 specifies AutoSequence 2 and so on up to X 0x58 whi...

Page 155: ...two lines of CSV text each line being terminated by carriage return r Refer to Section 7 4 4 following for description of the measurement data format f Upon conclusion of the sequence ES601Plus sends END r f to the PC PC software may detect this message or simply the form feed f to identify end of protocol g Optionally the user may choose to abort the sequence in progress by pressing the ESCAPE ke...

Page 156: ...ts ES601Plus sends one line of data Each line of data is terminated with a carriage return r 0x0D Measurement data is separated into fields by the comma character 0x2C This type of format is referred to as comma separated variables CSV and files containing such data are directly compatible with Microsoft Excel The first field of the CSV data is a 3 character mnemonic which specifies the type of me...

Page 157: ... value limit uArms uAdc P F r Leakage Patient VDE IEC62353 direct method LPA ON P L2N EN AP GPx APyy value limit uArms uAdc P F r Leakage Patient VDE IEC62353 alternate method LPA ALTERNATE METHOD GPx APyy value limit uArms uAdc P F r Leakage Encl IEC61010 LEN ON P L2 E value limit uArms uAdc P F r Leakage pt to pt IEC61010 LPP ON P L2 E value limit uArms uAdc P F r Test completed END r f Test abo...

Page 158: ...O DUT power switch ON or OFF P Supply polarity NP normal or RP reversed L2 Supply line 2 L2N normal or L2O single fault condition E Protective earth EN normal or EO single fault condition AP Applied part s AP disconnected APE to earth normal condition or APM to mains single fault condition X1 Mains on isolated data I O mains not connected to isolated I O or X1M mains on I O single fault condition ...

Page 159: ...ES601Plus OPERATING MANUAL Computer Control Chapter 7 Page 140 ...

Page 160: ...mbdrive into your computer s USB port Select the ES601 product and install the ES601pc software In the event the installation program does not start automatically use the file explorer utility on your computer to locate the USB drive Browse this drive to locate the file called ES601pc version_no _Setup exe where version_no is the 4 digit version number of the software Double click or otherwise exe...

Page 161: ...Plus to your PC using the USB cable provided When ES601Plus is connected to the PC for the first time Windows should detect the connection and automatically launch the New Hardware Wizard which will prompt you for the USB driver Fig ure 82 Fig ure 83 New Hardware ES601pc Software Chapter 8 Page 142 ...

Page 162: ...it does select Continue Anyway and the USB driver will be installed Fig ure 85 Fig ure 84 Driver Fig ure 85 Driver Installation NOTE During installation of the USB drivers Windows XP users may receive a warning message that the driver has not been Logo Tested Please ignore this warning and clear the message by clicking the Continue Anyway button 8 3 Running ES601pc When ES601pc is executed you wil...

Page 163: ...e box that allows you to select the image bmp format you wish to use as the background image for ES601pc Clear the Background Image this will clear the background image completely leaving a blue screen as the background Help From this drop down you can select the following utilities Help a comprehensive help utility for ES601pc About ES601pc displays current software version and contact informatio...

Page 164: ... through the Backup and Restore feature is identified by date and time in a listing making it easy to select a particular configuration for restoration After a Restore operation AutoSequences and other configuration data can be uploaded into the memory of ES601Plus Making changes to any AutoSequence before a Backup is created will make the original AutoSequence unavailable requiring the user to ma...

Page 165: ...y will change depending on the options available in the safety standard The standards that may be selected are IEC60601 Standard AAMI ES1 Standard VDE0751 Standard IEC62353 Standard IEC601 Battery Standard AAMI Battery Standard VDE Battery Standard IEC353 Battery Standard IEC61010 Standard Note Limits used are those specified in IEC60601 3 Edition For equipment that must be tested rd according to ...

Page 166: ...asure or disabled by selecting Skip 8 5 6 Insulation Resistance IEC60601 AAMI ES1 VDE0751 IEC62353 and IEC61010 Insulation Resistance is a test of the breakdown strength of insulating materials between electrical conductors that should be electrically isolated from the ground connection at the AC receptacle Two tests can be enabled Line 1 2 to Ground and Applied Parts to Ground ES601Plus can perfo...

Page 167: ...default to a 1 amp test current or the 1 amp test current can be selected via the radio button The Skip option will skip the protective earth test entirely 8 5 9 Leakage Current IEC60601 and AAMI ES1 If the Leakage Current checkbox is checked ES601Plus will perform Enclosure and Earth Leakage Current tests Patient and Auxiliary Leakage Current tests may be optionally enabled Conditions of the AC p...

Page 168: ...ce power ON or test with the device power ON then repeat with device power OFF 8 5 14 Polarity IEC60601 AAMI ES1 VDE0751 and IEC62353 Perform the leakage current test with AC Line polarity Normal or test with polarity Normal then repeat with Line polarity Reversed 8 5 15 Line 2 IEC60601 AAMI ES1 and IEC61010 Perform the leakage current test with AC Line 2 Normal connected or test with Line 2 Norma...

Page 169: ...lways enabled and has at least 1 applied part The Applied Part editor is accessed by clicking on the Applied Parts tab The Applied Parts tab will be accessible only if Leakage Current is enabled and one of Patient Applied Parts or Auxilliary Interlead Leakages is selected After clicking the Applied Parts tab an Applied Part Group can be enabled by either checking the Group checkbox or by entering ...

Page 170: ...through the human body load and into all the other applied parts shorted together The test will be repeated for each applied part This test is pertinent to IEC60601 and AAMI standards only 8 5 20 Isolated Signals Inputs Outputs IEC60601 AAMI ES1 IEC60601 Battery and AAMI Battery If Isolated Signals Inputs Outputs is enabled the effect on patient leakage by connecting isolated input output signals ...

Page 171: ...ions are made via jacks AP1 and AP2 on ES601Plus This test is pertinent to the IEC61010 standard only 8 5 24 Uploading AutoSequences To upload Safety AutoSequences to ES601Plus press the Upload To ES601 button Choose either uploading via USB Ethernet or Serial Port and then press Connect If the connection is via ethernet enter the IP address assigned to ES601Plus the IP address of ES601Plus is dis...

Page 172: ...iogram ECG simulator The ECG Simulator of ES601Plus generates 40 different test signals the user can activate manually using a menu system In addition to the waveform the amplitude of the output signal can be set to one of three values 1 mV standard 2 mV or 0 5 mV in Lead II As an alternative to manually operating the simulator the user can run an ECG AutoSequence in which ES601Plus can be stepped...

Page 173: ... ure 90 The two lines can hold up to 18 characters each 8 6 2 Adding a Waveform To add a step to a sequence select a waveform from the Simulator Waveforms pane on left side of the screen Select the desired relative scale by clicking on the Relative Scale radio buttons The options are x1 x2 or x0 5 scale corresponding to 1 mV 2 mV or 0 5 mV QRS amplitude on ECG Lead II Press the Add button The wave...

Page 174: ... move the waveform to the last step of the sequence 8 6 5 Deleting a Sequence An entire sequence can be deleted by pressing the Delete Sequence button A message box will appear prompting you to be sure you want to delete the sequence Press Yes if you are sure and all the waveforms in the sequence will be removed as well as the sequence title 8 6 6 Uploading AutoSequences To upload ECG AutoSequence...

Page 175: ...f the ES601pc application by pressing this button Remember at this point all changes that have been made have already been saved If the configuration that existed when entering the Editor may be required at a later time be sure to Backup the configuration before making any edits 8 7 Test Report Generator standard accessory This utility is used to download test report data from ES601Plus and view p...

Page 176: ...message box with a transfer progress bar will appear see Fig ure 92 After the transfer is complete each test report will appear as a row denoted by the test number parent I D device I D date device description make and model see Fig ure 93 ES601pc Software Chapter 8 Page 157 ...

Page 177: ...he Device Info for this test record has been modified by the test technician This can be an indication the device tested is new the control number was not in the Equipment Record system of ES601Plus or it may mean additional data was entered on the Device Info screen during a test Tech Code Facility Location etc This provides an indication to the user the Device Information should be reviewed Some...

Page 178: ...pend on the number of records and the filtered result may be slightly delayed An alternate to the search filter is ordering the fields alphanumerically Pressing on a field name eg Model will sort the field appropriately 8 7 3 Opening Existing Test Reports To open a previously saved test report for viewing press Open Existing and a standard Windows Openfile dialogue box will be presented Browse for...

Page 179: ...s simply click the checkbox of the desired test report and press View Checked The checked test reports will appear in the Test Report Viewer Double clicking anywhere along the row will also select a test report To select all the test reports for viewing click the Check All checkbox Unchecking the Check All checkbox will deselect all test reports To select a range of test reports simply highlight a...

Page 180: ...pear Select the directory where the test reports should be saved A report for each individual test will now be saved in its own file with the following filename format DeviceID yyyy_mm_dd hh_mm_ss txt Where DeviceID is the device ID equipment control number or other ID yyyy is the year mm is the month dd is the day hh is the hour mm is the minute and ss is the second in which the Test Report was c...

Page 181: ...ve file dialog will appear Select the desired directory and specify a name for the CSV file The CSV file and all corresponding test reports will be saved in the chosen directory 8 8 AutoSequence Editor Upon selecting AUTOSEQUENCE EDITOR you are taken to the Inspection Procedures screen see Fig ure 95 8 8 1 Editing an Inspection or User Tester Sequence From the Inspection Procedures tab edit an Ins...

Page 182: ...t the User Tester Sequence and press Edit Sequence or double click on the sequence The AutoSequence Editor will appear see Fig ure 96 and Fig ure 97 8 8 2 Editing an AutoSequence From the Autosequence Editor screen the name Title1 and Title2 the Tester Port and Baud Rate can be edited Available Instructions can be added to and removed from the Autosequence by using the appropriate buttons in the c...

Page 183: ...vidual Instructions can be edited by selecting Edit Instruction Table large button on the right margin of the Inspection Procedure or User Tester Sequence screens or below the Available Instruction list on the AutoSequence Editor screen In the Instruction Table select an instruction then press Edit Instruction The instruction properties in the lower panel must be enabled for editing Double clickin...

Page 184: ... op code M See Auto m ate d Te sting Princ iple s in Chapter 6 for a more complete discussion of the Op Codes and their functionality Under the Op Code dropdown menu select the desired op code Depending on the op code the command will show a different number of text boxes which accept different kinds of data 8 8 3 2 Selecting the Category Category is used by ES601pc to select and sort Instructions...

Page 185: ...uire the user to enter OK PASS comments such as PADDLES CHECKED AND OK or any other information to be saved as a comment in the Test Record The Prompt can be up to 40 characters and must be in capital letters Capital letters are the default when using ES601pc s Instruction Table editor Op Codes C M D and R will in addition to the Prompt allow editing or entering a Command The Command is used to se...

Page 186: ... window Check the categories or op codes of the instructions that should appear see Fig ure 102 Press Select All Categories or Select All Op Codes to select all the checkboxes Press OK to filter the Instruction Table 8 8 6 Deleting an Instruction Select an instruction from the Instruction Table Press Delete Instruction A warning message will appear which will list the sequences which currently use...

Page 187: ...created Op Code is a single capital letter denoting the op code If the op code does not exist the new instruction will default to the C op code Command is a string of up to 40 characters If the op code calls for more than one value separate the values with a tab character After selecting the desired CSV file and pressing Open the instruction will be added to the bottom of the master instruction li...

Page 188: ...ion is via serial port choose the COM port to which ES601Plus is connected After pressing Connect a message box with a transfer progress bar will appear After the transfer is completed a Transfer Complete message will appear and the message box will disappear 8 8 10 Downloading AutoSequences Sometimes it is desirable to download sequences stored in ES601Plus You can do this by pressing the Downloa...

Page 189: ...u of ES601pc will display the Test Procedures screen which lists all available Test Procedures To edit an existing Test Procedure highlight it and press the Edit Procedure button Similar to editing General Inspections and Tester Autosequences as described in the immediately preceding section of this chapter Instructions can be added to and removed from the Test Procedure by using the appropriate b...

Page 190: ...eate the Instruction command UT105 To help in creating AutoSequence Instructions for use in Test Procedures it is assumed the user of the ES601pc program will have a list of Safety ECG or User Tester AutoSequence titles printed out and available for reference Such printouts can be made from the Editors used to make those types of sequences Alternatively the user can run a second instance of ES601p...

Page 191: ...entially available selections however some of these will require an optional accessory feature to be installed in ES601Plus to operate correctly If when running a Test Procedure ES601Plus encounters an A Instruction for which the accessory option has not been installed ES601Plus will skip over the Instruction to the next step of the Test Procedure A Test Procedure may have one Safety Autosequence ...

Page 192: ...s in the Test Procedure Contents see Fig ure 108 The Title Tester Port and Baud Rate can be changed in this screen and Instructions can be added to the list on the right to create a custom Test Procedure Pressing OK saves the new Test Procedure and it will be included in the next upload to ES601Plus ES601pc Software Chapter 8 Page 173 ...

Page 193: ...ES601Plus OPERATING MANUAL ES601pc Software Chapter 8 Page 174 ...

Page 194: ...ill require return of ES601Plus to an authorized service facility for repair Ope ning the c ase o f ES601Plus fo r any re aso n w ill vo id the w arranty and m ay c o m pro m ise use r safe ty For calibration or service assistance contact Datrend for a Return Materials Authorization RMA number and the location of the nearest Service Facility Datrend Systems Inc 5355 Parkwood Place Richmond BC CANA...

Page 195: ...ES601Plus OPERATING MANUAL ES601pc Software Chapter 8 Page 176 ...

Page 196: ...utoSequence to allow the AutoSequence to be invoked from a Test Procedure see Auto m ate d Te sting Princ iple s Chapter 6 and Te st Pro c e dure Edito r Chapter 8 SAFETY AUTOSEQUENCE 1 SAF01 IEC601 SAFETY TEST CHASSIS LKG GND Standard IEC60601 Limits Used IEC60601 Limits Equipment Class Class I Line Voltage Measure Load Current Skip Insulation Resistance Line 1 and 2 to Ground Skip Insulation Res...

Page 197: ...t Enclosure and Earth Plus Applied Part Groups None SAFETY AUTOSEQUENCE 3 SAF03 IEC601 SAFETY TEST 3 LEADS ECG Standard IEC60601 Limits Used IEC60601 Limits Equipment Class Class I Line Voltage Measure Load Current Measure Insulation Resistance Line 1 and 2 to Ground Measure Insulation Resistance Applied Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Powe...

Page 198: ...nce Line 1 and 2 to Ground Measure Insulation Resistance Applied Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Auxiliary Interlead Leakages Applied Part Groups Group 1 Name ECG Type BF Parts 5 AP 1 RA AP 2 RL AP 3 LA AP 4 LL AP 5 V A...

Page 199: ...round Measure Insulation Resistance Applied Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Auxiliary Interlead Leakages Applied Part Groups Group 1 Name ECG Type BF Parts 10 AP 1 RA AP 2 RL AP 3 LA AP 4 LL AP 5 V1 AP 6 V2 AP 7 V3 AP 8...

Page 200: ...Measure Insulation Resistance Applied Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Auxiliary Interlead Leakages Applied Part Groups Group 1 Name ECG Type BF Parts 5 AP 1 RA AP 2 RL AP 3 LA AP 4 LL AP 5 V Group 2 Name PADDLES Type CF...

Page 201: ...istance Applied Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Auxiliary Interlead Leakages Applied Part Groups Group 1 Name ECG Type BF Parts 5 AP 1 RA AP 2 RL AP 3 LA AP 4 LL AP 5 V Group 2 Name PADDLES Type CF Parts 2 AP 6 APEX AP ...

Page 202: ... Resistance Line 1 and 2 to Ground Measure Insulation Resistance Applied Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Applied Part Groups Group 1 Name TEMP Type BF Parts 1 AP 1 TEMP Group 2 Name SPO2 Type BF Parts 1 AP 2 SPO2 Append...

Page 203: ... Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Auxiliary Interlead Leakages Applied Part Groups Group 1 Name ECG Type BF Parts 5 AP 1 RA AP 2 RL AP 3 LA AP 4 LL AP 5 V Group 2 Name IBP Type CF Parts 1 AP 6 BP XDCR Group 3 Name TEMP T...

Page 204: ...d Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Auxiliary Interlead Leakages Isolated Signal Inputs Outputs Applied Part Groups Group 1 Name ECG Type BF Parts 5 AP 1 RA AP 2 RL AP 3 LA AP 4 LL AP 5 V Group 2 Name IBP Type CF Parts 1 AP 6 BP XDCR Gro...

Page 205: ...ts Outputs Skipped Applied Part Groups Group 1 Name ECG Type BF Parts 3 AP 1 RA AP 2 RL LL AP 3 LA SAFETY AUTOSEQUENCE 12 SAF12 IEC601 BAT POWERED ECG TELEMETRY 5 LD Standard IEC601 Battery Limits Used IEC 60601 Limits Device Power On Auxiliary Interlead Leakages Measured Isolated Signal Inputs Outputs Skipped Applied Part Groups Group 1 Name ECG Type BF Parts 5 AP 1 RA AP 2 RL AP 3 LA AP 4 LL AP ...

Page 206: ...al Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Applied Part Groups None SAFETY AUTOSEQUENCE 14 SAF14 AAMI CHASSIS LKG INSULATION GND Standard AAMI ES1 Limits Used AAMI ES1 Limits Equipment Class Class I Line Voltage Measure Load Current Measure Insulation Resistance Line 1 and 2 to Ground Measure Insulation Resistance Applied Parts to Ground Skip Protective Earth Me...

Page 207: ...tance Line 1 and 2 to Ground Measure Insulation Resistance Applied Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Auxiliary Interlead Leakages Applied Part Groups Group 1 Name ECG Type Isolated Parts 3 AP 1 RA AP 2 RL LL AP 3 LA Appen...

Page 208: ...Line 1 and 2 to Ground Measure Insulation Resistance Applied Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Auxiliary Interlead Leakages Applied Part Groups Group 1 Name ECG Type Isolated Parts 5 AP 1 RA AP 2 RL AP 3 LA AP 4 LL AP 5 V...

Page 209: ...d Measure Insulation Resistance Applied Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Auxiliary Interlead Leakages Applied Part Groups Group 1 Name ECG Type Isolated Parts 10 AP 1 RA AP 2 RL AP 3 LA AP 4 LL AP 5 V1 AP 6 V2 AP 7 V3 AP...

Page 210: ... 2 to Ground Measure Insulation Resistance Applied Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Auxiliary Interlead Leakages Applied Part Groups Group 1 Name ECG PAD Type Isolated Parts 7 AP 1 RA AP 2 RL AP 3 LA AP 4 LL AP 5 V AP 6 ...

Page 211: ...Resistance Line 1 and 2 to Ground Measure Insulation Resistance Applied Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Auxiliary Interlead Leakages Applied Part Groups Group 1 Name LEADS Type Isolated Parts 2 AP 1 TEMP AP 2 SPO2 Appen...

Page 212: ... to Ground Measure Insulation Resistance Applied Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Auxiliary Interlead Leakages Applied Part Groups Group 1 Name LEADS Type Isolated Parts 8 AP 1 RA AP 2 RL AP 3 LA AP 4 LL AP 5 V AP 6 IBP ...

Page 213: ...re Insulation Resistance Applied Parts to Ground Measure Protective Earth Measured At 1 Amp Leakage Current Measure Device Power On Polarity Normal Reverse Line 2 Normal Open Ground Normal Open Test Enclosure and Earth Plus Patient Applied Parts Auxiliary Interlead Leakages Isolated Signal Inputs Outputs Applied Part Groups Group 1 Name LEADS Type Isolated Parts 8 AP 1 RA AP 2 RL AP 3 LA AP 4 LL A...

Page 214: ... 4 LL AP 5 V SAFETY AUTOSEQUENCE 23 SAF23 IEC62353 SAFETY TEST 5 LEADS ECG Standard IEC62353 Limits Used IEC62353 Limits Equipment Class Class I Line Voltage Measure Load Current Measure Insulation Resistance Line 1 and 2 to Ground Measure Insulation Resistance Applied Parts to Ground Measure Protective Earth Measure Leakage Current Measure Protocol Alternate Method Polarity Normal Test Applied Pa...

Page 215: ...toSequences may be modified using the ES601pc software supplied on CDROM with ES601Plus AutoSequences in the following list are identified as ECG AUTOSEQUENCE NN ECGNN ECGNN refers to the command assigned by Datrend to the AutoSequence to allow the AutoSequence to be invoked from a Test Procedure see Auto m ate d Te sting Princ iple s Chapter 6 and Te st Pro c e dure Edito r Chapter 8 ECG AUTOSEQU...

Page 216: ...5 DC Pulse 4 seconds x 2 0 06 DC Pulse 4 seconds x 0 5 07 Triangle Wave 2Hz x 1 0 08 Triangle Wave 2Hz x 2 0 09 Triangle Wave 2Hz x 0 5 10 Sine Wave 10 Hz x 1 0 11 Sine Wave 40 Hz x 1 0 12 Sine Wave 60 Hz x 1 0 13 Sine Wave 70 Hz x 1 0 14 Sine Wave 100 Hz x 1 0 15 ECG 60 BPM x 1 0 16 ECG 30 BPM x 1 0 17 ECG 120 BPM x 1 0 18 ECG 180 BPM x 1 0 19 ECG 240 BPM x 1 0 20 Havertriangle Pulse 10 msec 60BP...

Page 217: ...traction PVC x 1 0 16 Multifocal PVC mfPVC x 1 0 ECG AUTOSEQUENCE 5 ECG05 ARRHYTHMIA WAVE TEST SEQUENCE 01 Square Wave 2Hz x 1 0 02 DC Pulse 4 seconds x 1 0 03 Triangle Wave 2Hz x 1 0 04 ECG 60 BPM x 1 0 05 ECG 30 BPM x 1 0 06 ECG 120 BPM x 1 0 07 ECG 240 BPM x 1 0 08 Second Degree A V Block blk II x 1 0 09 Premature Atrial Contraction PAC x 1 0 10 Right Bundle Branch Block RBBB x 1 0 11 Premature...

Page 218: ...ipped with the following accessory options General Inspections and User Tester AutoSequences Test Procedures TEST RECORD No 22 Test Report ES601 ES071200050 Ver 3 00 I D MY ES601 Device ID CN0472 Parent ID Date Time 18 FEB 2009 12 14 02 Descrip DEFIB W PCR SPO2 Make HEWLETT PACKARD Serial No A14 567100E Model CODEMASTER XL Facility ST JOSEPH S HOSP Loc EMERG Tech Code MEM Tech Time 00 14 40 SAFETY...

Page 219: ...N 148 0 10000 PASS TOUCH CURRENT TEST CONDITION uArms uAdc LIMIT NP NC ON 2 0 100 PASS NP SF L2O ON 6 1 500 PASS NP SF EO ON 21 1 500 PASS RP NC ON 1 0 100 PASS RP SF L2O ON 4 0 500 PASS RP SF EO ON 19 1 500 PASS ECG TEST ECG AUTOSEQ 5 STEP WAVEFORM SCALE RESULT 1 Square Wave 2 Hz 1mV PASS 2 DC Pulse 4 seconds 1mV PASS 3 Triangle Wave 2 Hz 1mV PASS 4 Sine Wave 10 Hz 1mV PASS 5 Sine Wave 40 Hz 1mV ...

Page 220: ...ECK PATIENT CABLE LEADS FOR DAMAGE PASS 12 CHECK CONTROLS AND SWITCHES PASS 13 CHECK CAUTION OPERATION LABELLING PASS 14 CHECK PADDLES FOR SIGNS OF DAMAGE PITTING PASS 15 CHECK BATTERY AND REPLACE IF NECESSARY SERVICED 16 CHECK POWER ON SEQUENCE PASS 17 CHECK FOR UNUSUAL NOISE OR VIBRATION PASS 18 CHECK DISPLAY FOCUS INTENSITY ALIGNMENT PASS 19 CHECK RECORDER OPERATION PASS 20 CLEAN INTERIOR EXTER...

Page 221: ...100 OK 41 END OF SEQUENCE OK 42 MEASURE RECORD DEFIB OUTPUT AT 50 J 49 8 JOULES PASS 43 MEASURE RECORD DEFIB OUTPUT AT 100 J 98 4 JOULES PASS 44 MEASURE RECORD DEFIB OUTPUT AT 200 J 198 1 JOULES PASS 45 MEASURE RECORD DEFIB OUTPUT AT 300 J 297 3 JOULES PASS 46 MEASURE RECORD DEFIB OUTPUT AT 360 J 352 8 JOULES PASS 47 TEST MAX ENERGY WITH DEFIB ON BAT POWER 350 2 JOULES OK PASS 48 TEST CHARGE TIME ...

Page 222: ...ans of the Test Procedure Editor of the ES601pc software package According to the above report Procedure 89 includes measurement of enclosure and earth leakage current testing of protective earth resistance visual inspection of the defibrillator chassis paddles ECG leads battery and chart recorder performance tests of the ECG monitor tests of the defibrillator output energy tests of the transcutan...

Page 223: ...ES601Plus OPERATING MANUAL Appendix B Page 204 ...

Page 224: ... DEVICE INSPECTION Tester Port None Baud Rate N A Step Category Op Code Command 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Battery Battery End P Pass Fail P Pass Fail P Pass Fail P Pass Fail P Pass Fail P Pass Fail P Pass Fail P Pass Fail P Pass Fail P Pass Fail P Pass Fail P Pass Fail P Pass Fail P Pass Fail K OK Prompt CHECK FOR SIGNS OF PHYSICAL DAMAGE ABUSE CHECK FOR SECURE MOUNTING CHECK AC LINE COR...

Page 225: ...try R Rem Ctrl Entry R Rem Ctrl Entry R Rem Ctrl Entry C Tester Ctrl R Rem Ctrl Entry R Rem Ctrl Entry C Tester Ctrl R Rem Ctrl Entry R Rem Ctrl Entry C Tester Ctrl K OK Prompt SELECT PULSE OXIMETER ON OXITEST HR60 SET HEART RATE 60BPM PA100 SET PULSE AMPL 100 AF0SET ARTIFACT OFF SO1 CHECK SPO2 96 98 RATE 59 61 SO3 CHECK SPO2 88 92 RATE 59 61 SO4 CHECK SPO2 78 82 RATE 59 61 SO5 CHECK SPO2 68 72 RA...

Page 226: ...TESTER TEST EQUIPMENT STOP WATCH CHECK FOR SIGNS OF PHYSICAL DAMAGE ABUSE CHECK FOR EVIDENCE OF FLUID SPILLS CHECK AC LINE CORD AND PLUG RECEPTACLE CHECK STRAIN RELIEF BOTH ENDS OF CORD CHECK PATIENT CABLE LEADS FOR DAMAGE CHECK CONTROLS AND SWITCHES CHECK CAUTION OPERATION LABELLING CHECK PADDLES FOR SIGNS OF DAMAGE PITTING CHECK BATTERY AND REPLACE IF NECESSARY CHECK POWER ON SEQUENCE CHECK FOR ...

Page 227: ...ES601Plus OPERATING MANUAL Appendix C Page 208 ...

Page 228: ...ES601Plus OPERATING MANUAL APPENDIX D Importing Equipment Records Appendix D Page 209 ...

Page 229: ...ES601Plus OPERATING MANUAL Appendix D Page 210 ...

Page 230: ...ES601Plus OPERATING MANUAL Although columns may be matched later in the process the equipment records to be imported should be in the following format Appendix D Page 211 ...

Page 231: ... is an example of a short equipment list There can be more fields but this will demonstrate the function In this case Column E is the test procedure number This can be added or changed later Be sure to save the file as CSV Appendix D Page 212 ...

Page 232: ...ES601Plus OPERATING MANUAL If not already assigned test procedures can be assigned now and custom fields can be added or edited Appendix D Page 213 ...

Page 233: ...nd the unit connected to the PC as per section 8 2 then upload the data to the ES601Plus and the equipment records and associated test procedures will be ready Refer to manual MN 049 6100 428 on the ES601 product CD for more details on the Equipment Record Editor Appendix D Page 214 ...

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