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ES601-US OPERATING MANUAL

Specifications/Chapter 1

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Specifications

Equipment Performance Specifications

1.1 Electrical Safety Testing Standards

- ANSI/AAMI-ES1:1996
- IEC60601-1:2005, Third Edition
- IEC60601-2-4:2002, Second Edition
- DIN VDE 0751-1:2001
- IEC62353:2007, FDIS Edition 1
- IEC61010-1:2001, Second Edition
- AAMI-BAT (AAMI-ES1 for battery-powered medical device)
- IEC601-BAT (IEC60601 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 Control Number Search
- By PM Checklist
- By Safety AutoSequence
- By ECG AutoSequence
- By Physical Inspection
- By Tester AutoSequence

1.3 Manual Mode Safety Tests

- Line Voltage
- Load Current
- Insulation Resistance
- Ground Resistance
- Leakage Current

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Summary of Contents for ES601-US

Page 1: ...Operating Manual ES601 US Automated Electrical Safety Analyzer ...

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Page 3: ...ated Electrical Safety Analyzer Operating Manual 2012 2014 Datrend Systems Inc Unit 130 4020 Viking Way Richmond BC CANADA V6V 2L4 Tel 604 291 7747 or 800 667 6557 Fax 604 294 2355 e mail customerservice datrend com ...

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Page 5: ...d 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 etc within 90 days of original ...

Page 6: ...ikes Damage in transit or when moving the instrument 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...

Page 7: ...ur 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 application beyond the publi...

Page 8: ...Page iv ...

Page 9: ...ls 2 Test Receptacle 2 Kelvin Cable 2 AUX1 Terminal 3 AUX2 Terminal 3 To DUT Case Terminal 3 Applied Part patient lead 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 O...

Page 10: ...e Voltage 10 2 1 4 Load Current 10 2 1 5 Leakage Current 11 2 1 6 External Case Leakage Current 11 2 1 7 Internal Case Leakage Current 12 2 1 8 Lead Leakage Current 12 2 1 9 Lead to Lead Leakage Current 14 2 1 10 Alternative and Direct Methods of Leakage Current Measurement 15 2 1 11 Battery Power Protocols 16 2 1 12 Safety AutoSequences 16 2 2 Characteristics of ES601 US 18 2 2 1 Test Receptacle ...

Page 11: ... 12 Saving a Test 76 5 13 Reviewing Tests 78 5 14 Viewing Test Data and Report Output 81 5 14 1 Viewing a Record 81 5 14 2 Report Output 86 5 14 3 Using HyperTerminal to Capture Test Results 88 5 15 ECG Simulator 90 5 16 Capturing Test Time 93 6 AUTOMATED TESTING 95 6 1 AutoSequence Overview 95 6 1 1 Safety AutoSequences 99 6 1 2 ECG AutoSequences 104 6 1 3 Tester AutoSequences 106 6 1 4 Checklist...

Page 12: ...r 146 8 5 1 Downloading Test Reports 146 8 5 2 Pass Indication 147 8 5 3 New Indication 147 8 5 4 Searching For Test Reports 147 8 5 5 Opening Existing Test Reports 147 8 5 6 Viewing Test Reports 148 8 5 7 Printing Test Reports 149 8 5 8 Saving Test Reports 149 8 5 8 1 Saving as TXT 149 8 5 8 2 Saving as CSV 149 8 6 Safety AutoSequence Editor 150 8 6 1 Editing the AutoSequence Title 150 8 6 2 Choo...

Page 13: ...ting the AutoSequence Title 162 8 8 2 Adding a Waveform 162 8 8 3 Removing a Waveform 162 8 8 4 Modifying the Order of Waveforms in a Sequence 162 8 8 5 Deleting a Sequence 163 8 8 6 Uploading AutoSequences 163 8 8 7 Downloading AutoSequences 163 8 8 8 Printing AutoSequences 163 8 8 9 Return to Main Window 163 8 9 Checklist Module 164 8 9 1 Uploading Checklists 165 8 9 2 Downloading Checklists 165...

Page 14: ...uipment Records 183 8 11 7 Uploading Equipment Records 184 8 11 8 Printing Equipment Records 185 8 11 9 Record Viewing Options 185 8 12 CMMS Interface Module 187 8 12 1 Exporting CMMS Data to ES601 US 187 8 12 2 Importing a MUP File from ES601 US 190 8 12 3 Modifying Options 191 8 12 3 1 Download Checkitems Option 191 8 12 3 2 medTester to ES601 Translation Table 192 9 CALIBRATION AND MAINTENANCE ...

Page 15: ... an associated maintenance procedure Checklist for that device Flash Memory Non volatile memory used for storing Test Records and other configuration related data such as user settings AutoSequences Checklists and Equipment Records The contents of the flash memory are retained when the power to ES601 US is switched off GND or Ground The line conductor connected to a place that is maintained at Gro...

Page 16: ...rganizations include AAMI Association for Advancement of Medical Instrumentation IEC International Electrotechnical Commission VDE Verband der Elektrotechnik Elektronik und Informationstechnik Test Record Safety ECG and other test result data which have been saved to the non volatile flash memory as a record of all tests performed on a particular device as identified by the equipment control numbe...

Page 17: ...jacent to the AUX1 connector will be ON APPLIED PARTS Hazardous Voltage 264 VAC or 500 VDC max This warning appears on the Applied Parts patient leads label on the front of ES601 US During testing of the isolation of the DUT patient leads 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 part CAT I conn...

Page 18: ...ions 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 ES601 US WARNING OPENING THE ES601 MAY COMPROMISE USER SAFETY REFER SERVICING TO DATREND AUTHORIZED AGENT ES601 US is a complex instrument which ...

Page 19: ...y apply 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 patient lead leakage current tests and Insulation Resistance tests for further information ...

Page 20: ...ES601 US OPERATING MANUAL Definitions Page xvi ...

Page 21: ...001 Second Edition AAMI BAT AAMI ES1 for battery powered medical device IEC601 BAT IEC60601 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 Control Number Search By PM Checklist By Safety AutoSequence By ECG AutoSequence By Physical Inspection By Tester AutoSequence 1 3 Manual Mod...

Page 22: ...01 1 AAMI ES1 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 Lead isolation test 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 26...

Page 23: ...ed Part patient lead Terminals CAT I Max Voltage 264 VAC Isolation 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 ...

Page 24: ...veforms Atrial Fibrillation AFIB 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 chara...

Page 25: ...uences 18 Physical Inspections 12 AutoSequences for Oxitest 7 Pulse Oximeter Tester 12 AutoSequences for Infutest 2000 IV Pump Tester 24 AutoSequences for Phase 3 Defibrillator Pacemaker Tester 60 AutoSequences for user defined Testers AutoSequences Inspections and PM Checklists are user programmable via the ES601pc US software package included on CDROM 1 8 Printer Port Data Output Hardware Interf...

Page 26: ...terface USB Device Protocol USB 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 ...

Page 27: ... circuit Externally Accessible 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 C 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 PET...

Page 28: ...t Generator 1 20 Compliance With Standards ES601 US has been certified to meet the following safety standards CAN CSA C22 2 No 61010 1 2nd Edition Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 1 General Requirements UL Std No 61010 1 2nd Edition Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 1 General Requ...

Page 29: ...US has added both USB and Ethernet connectivity for ease of control and rapid data transfer to both stand alone and networked PC systems ES601 US also provides connections for RS 232 barcode scanners and PS 2 keyboards or PS 2 barcode scanners ES601 US is a fully AUTOMATED Electrical Safety Analyzer designed to verify the electrical safety of medical devices and provides the most complete implemen...

Page 30: ...nd pin and measures the resistance 2 1 2 Ground Resistance In this test ES601 US 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 resistance in the range of 0 02 to 0 2 ohms and t...

Page 31: ...losure risk current or enclosure leakage In this test ES601 US measures the current that flows from a metal part on the DUT enclosure that should be grounded to the actual ground from the AC electrical supply The current is obtained by measuring the voltage developed across a resistor capacitor network simulating the AC impedance of the human body as defined by the safety standard ES601 US measure...

Page 32: ...uch as AAMI ES1 the isolated voltage is equal to the AC line voltage For the IEC60601 standard the isolated voltage equals 110 of the AC line voltage supplying the DUT As with all leakage tests lead leakage current is measured in microamps while simulating various conditions at the DUT In addition to specifying the individual test cases the lead leakage measurement for some safety standards requir...

Page 33: ... of the group Type The complicated details of testing patient lead leakage are managed automatically by ES601 US simply by making a choice of safety standard and selecting an appropriate Type for each different group of patient connections provided by the DUT ECG invasive blood pressure temperature SpO2 and so on Setting up ES601 US to perform patient leakage measurements is relatively simple and ...

Page 34: ... such setups as automated test sequences which are further described in Section 2 1 12 2 1 9 Lead to Lead Leakage Current In this test sometimes called an auxiliary leakage test ES601 US measures the current that flows out of one patient lead through the human body load and into all the other patient leads shorted together As with all leakage tests lead to lead leakage is measured in microamps whi...

Page 35: ...o IEC60601 but are tailored to suit the simplified nature of the test protocols The advantage of the Alternative Method or Direct Method of leakage testing under VDE 0751 is either method requires far fewer leakage measurements than either the IEC60601 standard or AAMI ES1 standard VDE 0751 allows safety tests to be completed much more rapidly particularly when executed by ES601 US Another electri...

Page 36: ...rd for self powered device 2 1 12 Safety AutoSequences ES601 US can be programmed to automatically conduct the safety measurements described above Automated safety measurements are always performed by ES601 US in a predefined order The settings of an ES601 US Safety AutoSequence determine which measurements within the sequence are enabled but do not affect the order in which the measurements are c...

Page 37: ...l settings enable specific features within the ground resistance test such as multiple resistance measurements or point to point testing ES601 US is shipped from the Datrend factory with 24 default Safety AutoSequences programmed into its memory These default sequences are useful for testing many typical devices such as patient monitors defibrillators electrosurgical units infusion pumps and other...

Page 38: ...hecklists Equipment Records CMMS Interface Module Test Report Generator 2 2 3 Optional Accessories Barcode Scanner P N 7600 051 or 7600 052 Dymo LabelWriter Printer Cable P N 7200 099 PC Interface Cable DB9F DB9M P N 3140 010 AMPS1 to ES601 Adaptor Cable P N 3140 429 Phase3 Solo to ES601 Adapter Cable P N 7500 435 Oxitest to ES601Adapter Cable P N 3140 060 Infutest 2000 to ES601Adapter Cable P N 7...

Page 39: ...software 8 PS 2 INTERFACE for connection of PS 2 Keyboard or PS 2 Barcode Scanner 9 CONTRAST ADJUSTMENT POTENTIOMETER embedded 10 RS 232 BARCODE INTERFACE for connection of RS 232 Barcode Scanner 11 FIRMWARE UPLOAD SWITCH embedded toggles between normal and firmware update mode FRONT PANEL 12 ECG PATIENT LEADS ten safety style banana jacks for connecting ECG and other patient leads 13 Graphic LCD ...

Page 40: ...ES601 US OPERATING MANUAL Overview Chapter 2 Page 20 ...

Page 41: ...N MENU of ES601 US Figure 3 Startup Menu Figure 4 Main Menu Optionally the STARTUP MODE of ES601 US can be set to enable a test of the AC supply voltage at power on If the AC supply test at startup has been enabled ES601 US will produce an alarm if a reversed supply condition is detected Note that a reversed AC supply may affect test results particularly the leakage measurements In the event of a ...

Page 42: ...ply voltage at power on The default is do not test EDIT SAFETY Enters a menu for editing the settings of Safety AutoSequences Refer to Section 3 6 following COMPUTER INTERFACE Enters a menu for uploading instrument configuration data AutoSequences Checklists equipment control number lists into ES601 US as transmitted by a personal computer PC running the ES601pc US software program This menu is al...

Page 43: ...EST INSPECTION Determines whether or not a physical inspection of the equipment is requested at the start of an automated test autosequence or checklist If enabled the user will be asked to enter up to two lines of comments to describe the inspection that was performed and the results POST TEST COMMENT Determines whether or not the user will be prompted to enter comments at the end of an automated...

Page 44: ...ODE menu the applicable Sequence 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...

Page 45: ...STOP AFTER SUPPLY ON If set to YES this control will override the power up delay setting described above and will cause a manual leakage test to fully stop immediately after the AC supply is connected to the DUT by ES601 US ES601 US 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...

Page 46: ...eing the point of attachment of the Kelvin Cable of ES601 US and the other being the point of attachment of a test lead which connects to the TO DUT CASE jack of ES601 US If set to NO factory default point to point resistance testing is disabled in manual mode This control works with the TEST MULTIPLE RESISTANCES control and the TEST GROUND WIRE control above thereby providing a variety of protoco...

Page 47: ...nce test and for point to point test instructions in particular MAIN MENU Returns the display to the MAIN MENU On exit changes made to the Sequence Controls are saved in the non volatile memory of ES601 US 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 on Menu 2 is pressed Th...

Page 48: ...MM DD EDIT ID ES601 US I 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 ES601 US 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 ES60...

Page 49: ...ord is shown as it is typed for verification Refer to Section 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 ES601 US see Figure 6 Addresses are entered with decimal delimiters A touch keypad that provides for numerical input only is displayed in response to pressing any of the CHAN...

Page 50: ...ce or checklist after the Test Record has been saved to the memory of ES601 US EDIT TITLE Displays the QWERTY keypad allowing the user to enter the title which appears at the top of the printed label Typically this would be the name of the institution which owns the equipment NEXT TEST IN These increment decrement buttons allow adjustment of the PM interval for the equipment tested The PM DUE date...

Page 51: ...disabled until the next time the QWERTY keypad is displayed ES601 US 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 ES601 US will wait until a complete string of characters terminated by carriage return is received After sensing a carriage return ES601 US removes the QWERTY keypad from the LCD display and...

Page 52: ...ammable Safety AutoSequences These sequences can be programmed by means of the Safety AutoSequence module of the ES601pc US software package included with ES601 US see Chapter 8 Alternatively the sequences can be programmed using the operator interface of ES601 US as described in this section Note that figures appearing in this section illustrate example settings only the specific appearance of me...

Page 53: ...353 IEC61010 VDE 0751 and their variants for battery powered devices This setting will affect which tests are provided by the 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 ground and leakage current limits to suit older equipment manufacturer specifications or other special test requirements O...

Page 54: ...utoSequence Additional buttons enable or disable testing of patient leads 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 o...

Page 55: ...ence editor OTHER TESTS Referring back to the main menu of the AutoSequence editor Figure 10 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 patient leads to ground AP GND and ground resistance Tests provided by this submenu will depend on the safety standard For example if the...

Page 56: ... in the test sequence Buttons on the right of the Sequence Control menu affect operation of the ground resistance 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 ES601 US and this is input by means of System Settings Menu 2 according to Section 3 3 When a...

Page 57: ...in non volatile memory Responding YES to the displayed prompt will store the AutoSequence settings to the memory location indicated and will return ES601 US to System Settings Menu 1 Pressing NO will return ES601 US to Systems Settings Menu 1 without storing the AutoSequence ESCAPE Referring back to the main menu of the editor pressing this button causes ES601 US to return to System Settings Menu ...

Page 58: ...ES601 US OPERATING MANUAL Setup Chapter 3 Page 38 ...

Page 59: ...al Safety s ECG Simulator and Test Device Autosequences but if you wish to have power applied during other types of Autosequences or Checklists power must be applied or removed through the use of the TRPN or GTOL commands see 6 1 5 7 The M Checkitem Connect the Kelvin Cable to a grounded terminal on the enclosure of the DUT AUX1 connects to electrically isolated input output signals Typically this...

Page 60: ...ES601 US OPERATING MANUAL Connecting To ES601 Chapter 4 Page 40 Figure 17 Connecting to a line powered DUT ...

Page 61: ...l equipment should be OFF The TO DUT CASE jack of ES601 US 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 Et...

Page 62: ...nnecting To ES601 Chapter 4 Page 42 Figure 19 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 ...

Page 63: ...anual safety tests 5 2 Data Buffer As safety measurements are performed in MANUAL MODE each measurement result may be copied to a temporary data buffer Current contents of the buffer may be viewed from the MANUAL MODE menu via the VIEW DATA button When manual testing is complete a non volatile Record of the results stored in the data buffer may then be created by pressing the SAVE RECORD button Re...

Page 64: ...red equipment AAMI BAT AAMI standard for battery powered equipment VDE BAT VDE0751 standard for battery powered equipment IEC353 BAT IEC62353 standard for battery powered equipment IEC61010 When one of the BAT safety standards is selected on the MANUAL MODE menu buttons for LINE VOLTAGE LOAD CURRENT and GROUND RESISTANCE are removed from the menu leaving just the LEAKAGE CURRENT and INSULATION RES...

Page 65: ...751 IEC62353 and IEC61010 is allocated one user programmable table of limit values The five user tables are maintained in the non volatile flash memory of ES601 US Leakage and other limit values in these tables may be edited using the Electrical Safety Limits module of the ES601pc US software package provided with the analyzer 5 5 Equipment Information Menu Press the EQUIP INFO button to enter inf...

Page 66: ...enu pressing the button located to the left of each data field activates the QWERTY touch keypad with an appropriate prompt displayed on the top line of the display Using an external PS 2 keyboard to enter device information is also possible and may prove to be more efficient Refer to Chapter 3 for further details on operation and features of the QWERTY touch keypad Device information fields accep...

Page 67: ... reversed supply condition is detected VNEUT GND VHOT GND ES601 US 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 t...

Page 68: ...power up delay specified in the System Settings after which ES601 US will measure the current If STOP AFTER of the System Settings is set to YES ES601 US 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 ...

Page 69: ... overwritten Returns to the MANUAL MODE menu REPEAT Repeats the Load Current measurement ESCAPE Returns to the MANUAL MODE menu The result is discarded and is not copied to the data buffer After pressing either REPEAT or CONTINUE and if STOP BEFORE of the System Settings is NO see Section 3 3 ES601 US will switch OFF the test socket and return to the MANUAL MODE menu If STOP BEFORE is YES ES601 US...

Page 70: ...f STOP BEFORE system setting is 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 ...

Page 71: ...itch of the DUT should be set to ON 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 HOT NEUTRAL SHORTED and BETWEEN GROUND AND ALL PATIENT LEADS ESCAPE Returns the display to the MANUAL MODE ...

Page 72: ...limited to 2 milliamperes maximum 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 ES601 US After approximately two seconds the measurement result in megohms is di...

Page 73: ...shown to the temporary data buffer 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 REPEAT Repeats the insulation resistance measurement ESCAPE Returns to the MANUAL MODE menu The result is discarded and is not copied to the data buffer ...

Page 74: ...esistance 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 TEST MULTIPLE RESISTANCES If set to YES this control will enable multiple ground and or point to point resistance measurements within the sco...

Page 75: ...ES NO Measure resistance once between Kelvin Cable and test receptacle of ES601 US Conventional ground resistance test of equipment which connects to the AC supply by means of a power 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 an equipotential gro...

Page 76: ...ES YES Measure resistance between Kelvin Cable and the test receptacle of ES601 US one time After this measurement the user disconnects the DUT line cord from ES601 US 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 ...

Page 77: ...be used for point to point measurement to the TO DUT CASE jack of ES601 US 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 of 2 mete...

Page 78: ... high resistance condition is detected the display will show X XXX instead of a resistance value As resistance is continuously measured during the test while viewing the display above you may move the connection of the Kelvin Cable to various points on the equipment enclosure to locate a point which produces the worst case highest resistance When ready press the ACCEPT button to capture the resist...

Page 79: ...ed upon completion of one measurement according to the figure above The three buttons will provide these functions CONTINUE Moves the resistance measurement and Pass Fail limit to the temporary data buffer If there is a previous result from this test in the buffer it is overwritten The user interface returns to the MANUAL MODE menu REPEAT Causes the measurement to be repeated ESCAPE Returns the di...

Page 80: ...his button This will depend on test requirements and the selected protocol CONTINUE Moves the acquired resistance values and the Pass Fail limit to the data buffer If there are previous results from this test in the data buffer they are overwritten The user interface returns to the MANUAL MODE menu Continuous measurement and display of resistance is performed for AAMI ES1 and IEC60601 safety stand...

Page 81: ... provided on the LCD to allow the sequence to be paused at any given step With the test sequence paused the selected leakage measurement can then 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 AAMI ES1 menu shown above the test conditions are CLASS Selects Class I default or Class ...

Page 82: ...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 NEUTRAL If set to NORMAL tests are performed with Neutral of the AC supply in normal condition only If set to NORM OPEN tests are performed w...

Page 83: ...ent limited to a few milliamperes AUX1 is intended to connect to isolated input or output signals provided by the DUT An example of an isolated signal input output would be a Ethernet data connection which achieves isolation by means of a signal transformer internal to the DUT This test is mandatory under AAMI ES1 and IEC60601 standards when the DUT has an isolated data connection such as an Ether...

Page 84: ...ition is a requirement for testing per IEC60601 Options are DO NOT TEST default or TEST This parameter determines whether the AUX2 output of ES601 US will be connected to ground of the AC supply AUX2 is intended to connect to floating exposed metal on the DUT Therefore this button enables a supplementary test condition for patient leakage tests per IEC60601 The expected result is the patient leaka...

Page 85: ...rs and or digits as a name for the ECG lead or other patient connection that will be connected to jack AP1 of ES601 US Only the name can be entered via this menu and only if the corresponding GROUP is ENABLED If the part is DISABLED a name entered by the QWERTY keypad will be rejected AP2 10 As above for button AP1 EDIT Enter the GROUPS editor menu described following BACK Returns to the menu for ...

Page 86: ...ads which are not isolated from ground Type B For IEC and VDE safety standards Groups are organized by medical function ECG defib paddles blood pressure transducer etc ES601 US provides connections for up to ten patient leads via the AP jacks located on the front panel where the AP jacks can be organized in up to five functional Groups The assignment of patient leads to Groups is indicated on the ...

Page 87: ...patient lead AP1 If the DUT is a defibrillator and has been specified by the manufacturer as meeting the requirements of the IEC60601 2 4 standard Particular requirements for the safety of cardiac defibrillators group settings can be programmed via the GROUPS editor menu to enable special leakage tests which are required by that standard For testing a defibrillator per IEC60601 2 4 Assign ECG lead...

Page 88: ... applied to the DUT before proceeding with the sequence This delay allows the DUT to start up and stabilize before subsequent leakage measurements are taken The available options are 2 to 9 seconds in one second steps Equipment requiring more than 9 seconds to start up are better accommodated through the STOP AFTER control described following STOP AFTER SUPPLY ON If set to YES this control will ov...

Page 89: ...ing a PC BACK Returns to the previous menu leakage test conditions or patient lead setup as appropriate NEXT Displays instructions for connecting the DUT to ES601 US The instructions displayed will depend on the safety standard The example menu shown following is for the AAMI ES1 standard According to the CONNECTIONS menu at minimum a AAMI safety test will require the user to connect the DUT to th...

Page 90: ...hal shock hazard to the careless user Always take care to make proper electrical connections to the DUT before starting a leakage test Disconnect all unused leads or cables from the AP jacks on ES601 US Once the leakage test has been set up and the connections are made the test is started by pressing the CONTINUE button on the CONNECTIONS menu The required measurements are performed automatically ...

Page 91: ...y time to pause the sequence and freeze the most recent measurement on the display see Figure 37 Individual leakage readings are rapidly made by ES601 US each reading usually requiring less than one second If it is expected you may want to pause individual values during a test in order review them you should set the PAUSE AFTER setting on the Sequence Control menu Figure 34 to at least 2 seconds s...

Page 92: ...gle fault condition RP OPEN N 2 Reverse polarity supply in normal condition RP NORM or with Ground in single fault condition RP OPEN G 3 Normal polarity Neutral in single fault condition NP OPEN N 4 Normal polarity supply in normal condition NP NORM or with Ground in single fault condition NP OPEN G At each configuration 1 4 of the AC supply measurements of external and internal case leakage are p...

Page 93: ...t and return to the MANUAL MODE menu Note the purpose of the STOP AFTER break is to allow you activate a DUT which cannot be switched ON until a full AC supply is provided to the DUT When ES601 US changes the AC supply from normal condition to neutral open ES601 US will not stop if STOP BEFORE of the Sequence Controls is NO Figure 34 If STOP BEFORE is YES ES601 US will stop and prompt you to shut ...

Page 94: ...n than equipment that can be switched OFF at any time The more typical setting of STOP BEFORE is therefore NO in which case the BREAK menus of Figure 39 and Figure 40 will not be displayed 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...

Page 95: ...no further breaks in the sequence occur until the end of the test Once the leakage measurement sequence has stepped through all specified test conditions ES601 US will stop and display the last measurement taken during the leakage test Pressing the CONTINUE button on the display copies the leakage measurement results to the temporary data buffer along with the limits corresponding to each measurem...

Page 96: ...play as would result from recalling a Test Record from flash memory for viewing or printing Refer to the Reviewing Tests section later in this chapter for more details on Record viewing and printing features 5 12 Saving a Test Press the SAVE RECORD button on the MANUAL MODE menu to save safety test data and equipment information in the data buffer to a Test Record Usually this is the final step of...

Page 97: ...and measurement data for the test in progress and returns to the MANUAL MODE menu The data buffer is erased by pressing this button VIEW TEST DATA View measurement data currently stored in the data buffer SAVE TEST DATA Saves the equipment information and measurement results to a Test Record in flash memory and returns the display to the MANUAL MODE menu Manufacturer model location facility and Te...

Page 98: ...i page report which is explained 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 equipment information that may exist in the data buffer will be overwritten with the data of the recalled Record Any manual test data that may have been collected in the buffer will therefore be lost unless it is first...

Page 99: ... records places some stress on the internal flash device ES601 US 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 ...

Page 100: ... the MAIN MENU of ES601 US COMPUTER INTERFACE Opens the COMPUTER INTERFACE menu to allow for communication with the ES601pc US 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 the PRINTER PORT or the RS 232 PORT ...

Page 101: ...20 lines or less If no data has been obtained when VIEW DATA is pressed or if the buffer has been erased by changing the safety standard or saving a Test Record ES601 US will display THERE IS NO MEASUREMENT DATA TO VIEW and will automatically return to the MANUAL MODE menu If a safety test has been performed page 1 of the Test Record will include results for line voltage load current and insulatio...

Page 102: ...volume of data however such recording and reporting of results is a mandatory requirement of the AAMI and IEC60601 standards Other standards such as IEC62353 do not require as many safety measurements and therefore produce far shorter reports than tests performed according to AAMI or IEC60601 Leakage results follow the page of ground resistance results For AAMI ES1 standard the first page of leaka...

Page 103: ...ementary or optional test conditions for leakage measurement 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 OF...

Page 104: ...onditions pertaining to the AC supply OPEN N OPEN G results indicate the user may have inadvertently forgotten to enable the test This 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 patient leads One page is provided for each functional group...

Page 105: ...iliary leakage tests If this test was enabled by the user patient leakage results will be followed by the lead to lead leakage results with one page being provided for each individual patient lead Additional pages may follow the safety test data if results were obtained from automated tests for example an ECG AutoSequence or a Checklist Examples of such data are provided in the two figures which f...

Page 106: ...51 Example of results from a Checklist Figure 52 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 ES601 US by pressing the OUTPUT REPORT button on the Test Record screen ...

Page 107: ...w screen SELECT PORT Select the 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 ES601 US determines the receiving device is off line an alarm message is displayed The ABORT button can be p...

Page 108: ... with ES601 US From the Windows 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 ...

Page 109: ...escriptive name for the file and click Start HyperTerminal is now ready to receive data sent from ES601 US to the PC Connect the RS 232 Port of ES601 US 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 an...

Page 110: ... adapter plug is available to convert 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...

Page 111: ...CG 240 BPM f ECG 300 BPM f ARRHYTHMIA 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 VTac...

Page 112: ...r frequency response f Tests monitor 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 im...

Page 113: ...is initially reset to zero and is inhibited from counting When any measurement is selected from the menu the timer is started if it is not currently running The timer counts upward in elapsed seconds and has sufficient range to clock up to 18 hours The timer continues to run until a Test Record is saved The Test Time is then saved in the Test Record along with the measurement data The actual time ...

Page 114: ...ES601 US OPERATING MANUAL Manual Testing Chapter 5 Page 94 ...

Page 115: ...s pulse oximeters infusion pumps defibrillators pacemakers electrosurgical units NIBP monitors and other medical devices Figure 58 Main Menu of ES601 US Figure 59 Automated tests menu All automated tests provided by ES601 US follow the same general pattern at test startup and conclusion according to configuration settings which can be made via the System Settings menu Refer to Section 3 2 for more...

Page 116: ...tion menu shown below According to System Settings as the next step the user may be prompted to perform a physical inspection of the equipment and enter details of the inspection Up to two lines of 40 characters each may be entered to describe the inspection Inspection prompts can be skipped if desired by pressing a SKIP button which is at lower left on the screen As with all QWERTY touchscreen di...

Page 117: ...be applied or removed through the use of the TRPN or GTOL commands see 6 1 5 7 The M Checkitem After all test measurements have been completed according to System Settings the user may be optionally prompted to input concluding comments about the test performed As with the prompt for physical inspection this data entry can be skipped by pressing the SKIP button Entry of test comments may be option...

Page 118: ...of the test performed If an equipment Control Number has not been entered by this stage in the test sequence the user will be requested to enter it in order to create a Test Record Upon saving the Test Record to the flash memory according to System Settings the user may be prompted to print a PM tag or label Such printing is accomplished with an accessory adhesive label printer Dymo SE300 which ca...

Page 119: ...f sequential voltage current and resistance measurements made on the DUT Twenty four default Safety AutoSequences allow ES601 US to be immediately usable upon delivery Descriptions of the default Safety AutoSequences are provided in Appendix A Safety AutoSequences can be programmed as desired by means of the System Settings Menu see Section 3 6 Alternatively Safety AutoSequences can be edited and ...

Page 120: ...ng the RUN TEST button However to save a Record of the test it will be necessary to enter at least a Control Number which can be done after the safety test is complete Per Section 6 1 if pre test inspection has been enabled in the System Settings you will be prompted to inspect the equipment and enter comments Following the inspection prompts you are presented with various menus that will allow yo...

Page 121: ... pressed to advance the sequence to the next setup menu If patient leads have been specified in the AutoSequence setup the next menu displayed will show the patient lead configuration Names of the patient leads may be modified by means of the menu Assignment of patient leads to functional groups and protection class B BF CF can be modified after pressing the EDIT button If the AutoSequence setup d...

Page 122: ...tail in Sections 3 3 5 9 and 5 10 of this manual Any changes made to these settings are retained for the duration of the test and revert to the values stored in memory upon test completion This includes the OFFSET calibration shown on this display which pertains to point to point measurement in the ground resistance test Note also for an AutoSequence the PAUSE AFTER control will introduce a delay ...

Page 123: ...s and the pass fail assessment of the measurement result 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 Depending on STOP AFTER and STOP BEFORE settings of the Sequence Control setup ES601 US may stop at selected steps in the test sequence and prompt you to operate ...

Page 124: ...losed neutral ON 8 Load current ON 9 Test completion OFF Upon completion of the safety test sequence operation of ES601 US will depending on settings configured via the SYSTEM SETTINGS menu After a test sequence has ended the user may be optionally prompted to input concluding comments about the safety test as well as a labor time user time After saving the Test Record the user may be prompted to ...

Page 125: ...n be edited and uploaded to ES601 US by means of the ECG AutoSequence module of the ES601pc US software package Editing of ECG AutoSequences is described in Chapter 8 Selecting ECG SIMULATOR AUTOSEQUENCE from the AUTOMATED TESTS menu opens the ECG AutoSequence menu Press the appropriate button to invoke the desired ECG AutoSequence or press BACK to return to the AUTOMATED TESTS menu As with all au...

Page 126: ...to the waveform output by the ECG simulator FAIL indicates the waveform is not correctly displayed on the DUT Pressing the FAULT FOUND AND CORRECTED button means that a problem seen with the DUT was resolved by the user for example a bad lead may have been replaced Upon completion of the ECG AutoSequence operation of ES601 US will depending on settings configured via the SYSTEM SETTINGS menu After...

Page 127: ...edge of the remote command language of the Tester and an understanding of ES601 US Checkitems and Checklists which are explained later in this chapter As illustrative examples ES601 US is provided with default example AutoSequences installed for Fluke Biomedical Impulse 4000 defibrillator pacemaker tester as well as for Pronk SimCube NIBP monitor tester Accessory cables are available for connectin...

Page 128: ...nd Oxitest Infutest and Phase 3 instruments respectively with submenus of corresponding AutoSequences being provided on the right of the AUTOMATED TESTS menu Performance tests for ESU NIBP and others are accessed from the USER DEFINED TESTER menu shown below This menu also provides access to alternative AutoSequence tests for defibrillator and pacemaker which may be executed with the Impulse 4000 ...

Page 129: ... may be optionally entered at this point Press the RUN TEST button to start the test Power will be applied to the Test Receptacle at this point Prompts for equipment physical inspection may be displayed according to System Settings Refer to Section 6 1 AutoSequence Overview for further details Tester AutoSequences differ from other automated tests of ES601 US in that a specific test instrument is ...

Page 130: ...lled and the test parameters which have been programmed by the user as part of the AutoSequence setup Figures 76 80 show how the test process works for the case of Datrend 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 Although specific details will differ display screens are similar in princ...

Page 131: ...ES601 US OPERATING MANUAL Automated Testing Chapter 6 Page 111 Figure 79 ES601 prompts user to start the IV pump Figure 80 ES601 monitors Infutest status while Infutest tests the IV pump ...

Page 132: ...ES601 US OPERATING MANUAL Automated Testing Chapter 6 Page 112 Figure 81 After Infutest is finished ES601 downloads measurement data Figure 82 ES601 automatically passes or fails the final test results ...

Page 133: ...pter 8 Checklists are accessed by pressing the CHECKLISTS button on the MAIN MENU of ES601 US Increment decrement buttons on the CHECKLISTS menu allow a Checklist title to be highlighted in the list The Checklist is then initiated by pressing the SELECT button Figure 83 Main Menu of ES601 US Figure 84 Checklist menu ES601 US is supplied with three factory default Checklists installed in memory The...

Page 134: ...cumstances Note that the power is not automatically applied to the Test Receptacle when a Checklist is run This is to allow for tasks to be performed which should not be done with the power applied Iif you wish to have power applied during Checklists power must be applied or removed through the use of the TRPN or GTOL commands see 6 1 5 7 The M Checkitem Some entries in a Checklist such as Electri...

Page 135: ...ES601 US OPERATING MANUAL Automated Testing Chapter 6 Page 115 ...

Page 136: ...mance test ES601pc US software can also be used to create Checkitems for visual inspection and then use these Checkitems to create a detailed Physical Inspection procedure that suits a particular device With ES601pc US software the user can compose Checklists which consist of Checkitems alone AutoSequences alone Physical Inspections alone or any combination of AutoSequences Physical Inspections an...

Page 137: ...ed on the LCD allow the user to save a test result for the displayed TASK as pass fail not applicable or skip i e item was not inspected or tested When any of the test result buttons PASS FAIL NOT APPLICABLE is pressed ES601 US records the button pressed as the inspection result and automatically advances to the next step of the Checklist A BACK button on the LCD allows the user to move back to th...

Page 138: ...Checkitem which is intended for displaying comments prompts or setup instructions is shown in Figure 85 The buttons provided for the K Checkitem 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 Checklist is then incremented to the next Checkitem ...

Page 139: ...formation or comments Figure 86 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 ES601 US Up to 41 characters can be entered which are saved as the test data for that step The command of the I Checkitem is displayed on the top line of the LCD providing a prompt to the user ...

Page 140: ...alternatively enter more explicit data rather than simple a pass or fail result If entering data via QWERTY touchscreen or external keyboard barcode scanner ES601 US will interpret a in the data entry as a FAIL mark SKIP BACK and ESCAPE buttons provide the functions described for the P Checkitem Note that the E Checkitem does not force the user to enter any test data if no data is entered the test...

Page 141: ...h may be entered via the Checkitem Editor of the AutoSequence or Checklist plug in to help you remember what the command does when you are creating Tester AutoSequences and Checklists When ES601 US executes a C Checkitem it will transmit the command via the Tester Port specified in the AutoSequence or Checklist and will wait for a response from the Tester If a response is received ES601 US will re...

Page 142: ... with patient simulators e g ECG SpO2 or NIBP which do not by themselves generate measurement data When ES601 US executes the R Checkitem it will transmit the command portion of the Checkitem via the Tester Port specified in the AutoSequence The prompt portion of the Checkitem will be displayed on the LCD as the TASK The ENTER TEST DATA button on the LCD allows the user to record measurement data ...

Page 143: ...outputting a waveform shut down the ECG simulator W001 Enable output of ECG performance wave 2 HZ SQR W002 Enable output of ECG performance wave 4 SEC PUL W003 Enable output of ECG performance wave 10 HZ SINE W004 Enable output of ECG performance wave 40 HZ SINE W005 Enable output of ECG performance wave 60 HZ SINE W006 Enable output of ECG performance wave 100 HZ SINE W007 Enable output of ECG ar...

Page 144: ...rhythmia R on T PVC W024 Enable output of ECG arrhythmia Bigeminy W025 Enable output of ECG arrhythmia Run 5 PVC W026 Enable output of ECG arrhythmia polymorphic VTACH 140BPM W027 Enable output of ECG arrhythmia RBBB W028 Enable output of ECG arrhythmia monomorph VTACH 160BPM W029 Enable output of ECG arrhythmia VFIB W030 Enable output of ECG arrhythmia Asystole Optionally a predefined M command m...

Page 145: ... TASK However if the first character of the Checkitem command is a whitespace or a TAB character ES601 US does not transmit anything and will immediately display the user interface of Figure 90 In the event that data is not immediately received from the tester in response to the command a count up timer is displayed on the TEST DATA line as shown above Once test data is received the timer is remov...

Page 146: ... from 1 to 32000 seconds The Checkitem also provides a prompt which is displayed on the LCD as the TASK while the timer counts down ES601 US will automatically advance to the next step of the Checklist when the timer reaches zero count In this case an OK is saved as the test result for the delay Checkitem Alternatively the user may press SKIP to bypass any remaining delay The BACK button also canc...

Page 147: ...an optionally have one or more A Checkitems that invoke Tester AutoSequences and or Physical Inspections The total number of Checkitems resulting from the inclusion of such Physical Inspections and or Tester AutoSequences in a Checklist via corresponding A Checkitems cannot exceed a maximum of 96 steps Practically speaking since Physical Inspections and other Tester AutoSequences may have up to 24...

Page 148: ...rom the USER TESTER AUTOS menu When an A Checkitem is executed the type of AutoSequence 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 provide the same functions described previously for other Checkitems Command prefix ...

Page 149: ...ES601 US OPERATING MANUAL Automated Testing Chapter 6 Page 129 Figure 95 Checklist in progress A Checkitem ...

Page 150: ...E BACK NEXT D Timed Delay in seconds ESCAPE BACK SKIP E Data Entry with Pass Fail ESCAPE PASS FAIL NOT APPLICABLE BACK SKIP ENTER TEST DATA I Input Requested QWERTY touch keypad K OK Prompt ESCAPE BACK OK M Multi function If tester control command 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 NOT APPL...

Page 151: ... which may appear at the start of any automated test and which can be globally enabled or disabled under the System Settings as explained in Section 3 2 Like Checklists Physical Inspections are comprised of Checkitems Physical Inspections differ from Checklists in that Inspections are shorter providing a maximum of 24 Checkitems per Inspection Unlike a Checklist a Physical Inspection cannot invoke...

Page 152: ...ELLING 5 General P Pass Fail CHECK CABLES AND STRAIN RELIEFS 6 Receptacle M Multi Func TRPN TEST RECEPTACLE ON 7 General P Pass Fail POWER UP AND CHECK POWER ON SEQUENCE 8 General P Pass Fail RUN SELF TEST IF EQUIPPED 9 General P Pass Fail CHECK CONTROLS AND SWITCHES 10 General P Pass Fail CHECK INDICATORS AND DISPLAYS 11 General P Pass Fail CHECK AUDIO ALARMS AND SIGNALS 12 General P Pass Fail CH...

Page 153: ...rom the equipment management system 6 2 1 Control Number Search The Equipment Record capability of ES601 US provides for easy test initiation by entering the equipment control number using the CONTROL No SEARCH button on the MAIN MENU Figure 97 Main Menu of ES601 US Pressing the CONTROL No SEARCH button displays the QWERTY keypad through which a control number belonging to an Equipment Record can ...

Page 154: ...layed 6 2 3 Equipment Records by Checklist Device information on the EQUIPMENT INFO menu can be modified at Checklist startup or immediately before a Record of a test is saved This capability suggests an alternative or additional application of the Equipment Record feature the control number field of the Equipment Record can alternatively be set to the title of a Checklist using the Equipment Reco...

Page 155: ...rol allows user supplied software to acquire leakage data from every measurement performed whether the test condition is normal single fault or supplementary For computer control ES601 US 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 ES601 US via a Virtual COM...

Page 156: ... RS232 MODE At the PC the required COM Port or VCP settings are 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 ES601 US 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 conv...

Page 157: ...ill time out and abort the protocol If ES601 US receives a character other than a to x ES601 US 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 which specifies AutoSequence 24 The difference is that sending lower...

Page 158: ... pressing the ESCAPE key which appears on the ES601 US touch screen In this event the protocol is terminated and ES601 US sends ESC r f to the PC 7 4 3 Test Report Download Upon conclusion of the test protocol described in the preceding section user software may optionally send a report download command SREP r In response to this command ES601 US will internally generate and then transmit a comple...

Page 159: ...g on the type of measurement the acceptance limit specified in the standard may be included in the data and if so the last field before the terminating carriage return r will be either a P pass or F fail character as appropriate For each measurement performed by ES601 US the format of the return data is listed in the following table Safety standard STD standard r Line voltages ACV VL1 L2 VL1 GND V...

Page 160: ...dc 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 aborted ESC r f In the table above numeric data fields are identified by angled brackets Text fields are indicated by square...

Page 161: ...rtinent Test Condition Possible options 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 Ground EN normal or EO single fault condition AP patient lead 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 ...

Page 162: ...ES601 US OPERATING MANUAL Computer Control Chapter 7 Page 142 ...

Page 163: ...r computer s CDROM drive and close the drive The CD menu application will begin automatically unless your computer is set to ignore autorun applications In the event the CD menu does not start automatically use the file explorer utility on your computer to locate the CDROM drive Browse this drive to locate the file called autorun exe Double click or otherwise execute this file to open the CD menu ...

Page 164: ...ing USB Drivers When installation is complete connect ES601 US to your PC using the USB cable provided When ES601 US 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 Figure 102 New Hardware ...

Page 165: ...r all other systems Direct the Wizard to the appropriate folder for your Windows system and the driver files should then be installed During installation the dialog box shown in Figure 101 may appear If it does select Continue Anyway and the USB driver will be installed Figure 102 Figure 103 Driver Figure 104 Driver Installation NOTE During installation of the USB drivers Windows XP users may rece...

Page 166: ...S application the following options are available Tools From this drop down you can select the following utilities Set the Background Image this opens a dialogue box that allows you to select the image bmp format you wish to use as the background image for ES601pc US Clear the Background Image this will clear the background image completely leaving a blue screen as the background Help From this dr...

Page 167: ...erous AutoSequences the Backup And Restore function allows the user to save the configuration as it exists on entry to the ES601pc US program Each Backup created 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 in...

Page 168: ...nnect If the connection is via ethernet enter the IP address assigned to ES601 US note this IP address is displayed on the LCD of ES601 US when the Safety Analyzer is operating in Ethernet Mode If the connection is via serial port choose the COM port to which the Safety Analyzer is connected see Figure 108 under Safety AutoSequences After pressing Connect a message box with a transfer progress bar...

Page 169: ...d should be reviewed Some equipment information will appear on the screen directly if data is available Description Make or Model 8 5 4 Searching For Test Reports In the main window there is a search text box in the upper right hand corner Use this to filter the Test Record results by control number type make and model The search is real time so results will display as the characters are typed int...

Page 170: ...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 number o...

Page 171: ... and CSV Comma Separated Values formats To save test reports in text format press Save To Text in the Test Report Viewer A directory browser will appear 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 equipment control number or o...

Page 172: ...y AutoSequences loaded into the Editor are those last edited with this utility or those which have been Restored from a Backup before entering the Editor 8 6 1 Editing the AutoSequence Title The sequence title can be modified by first selecting the sequence in the Safety Autosequence dropdown menu Press the Edit Autosequence Title button and a window will appear prompting you to enter a new autose...

Page 173: ...user defined limits may be selected using the Safety Limits Editor see Section 8 7 8 6 4 Equipment Class AAMI ES1 IEC60601 VDE0751 and IEC62353 A Class I device has a ground conductor AC supply has 3 wires A Class II device does not have a ground conductor AC supply has 2 wires The equipment class may be selected by radio buttons 8 6 5 Line Voltage AAMI ES1 IEC60601 VDE0751 IEC62353 and IEC61010 L...

Page 174: ...powered and running This test can be enabled under the Load Current radio group by selecting Measure or disabled by selecting Skip 8 6 8 Ground Resistance AAMI ES1 IEC60601 VDE0751 IEC62353 and IEC61010 Ground resistance is a test where ES601 US tries to source current into 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...

Page 175: ...rding to the requirements of IEC61010 Supply Conditions 8 6 13 Equipment Power AAMI ES1 IEC60601 AAMI Battery and IEC60601 Battery Test with equipment power ON only or test with the equipment power ON then repeat with equipment power OFF 8 6 14 Polarity AAMI ES1 IEC60601 VDE0751 and IEC62353 Perform the leakage current test with AC Line polarity Normal or test with polarity Normal then repeat with...

Page 176: ...ab will be accessible only if Leakage Current is enabled and one of Patient Leads or Lead to Lead Leakages is selected After clicking the Patient Leads tab a Group of leads can be enabled by either checking the Group checkbox or by entering a non zero number of patient leads for that Group The patient lead Names and Status panel will display the patient leads that have been enabled A name can be g...

Page 177: ...s Inputs Outputs is enabled the effect on patient lead leakage by connecting isolated input output signals of the DUT to ground or to mains will be observed An example of an isolated input output would be an ethernet connection or similar transformer isolated data interface on a medical device for example a multi parameter patient monitor This test is pertinent to AAMI and IEC60601 standards only ...

Page 178: ...olated Leads 8 6 23 Test Point to Point IEC61010 Clicking this check box enables measurement of Enclosure Leakage Current from one arbitrary point on the DUT enclosure to a second arbitrary point The point to point enclosure connections are made via jacks AP1 and AP2 on ES601 US This test is pertinent to the IEC61010 standard only 8 6 24 Uploading AutoSequences To upload Safety AutoSequences to ES...

Page 179: ...c US with the sequences from the ES601 US These sequences can then be uploaded to a different ES601 US or they can be optionally modified and uploaded to the same ES601 US unit or additional ES601 US units 8 6 26 Printing AutoSequences Press the Print button to show the print dialogue Select the current sequence radio button and press OK to print out the current AutoSequence Select the All Sequenc...

Page 180: ...ropriate and could produce invalid failing results To allow testing of equipment that predates a given regulatory standard ES601 US provides one alternate or user defined limit table for each of the standards With the Safety Limits Editor you can tailor the pass fail limits of a user defined table to suit the device being tested Prior to starting a safety test you can choose to apply limits accord...

Page 181: ...01pc US after uploading the data to ES601 US The safety limit data are also saved after downloading limits from ES601 US into the editor or exiting the editor to the main menu of ES601pc US An individual limit can be reverted to its most recently saved value by right clicking on its textbox and choosing Revert in the popup menu which will appear Figure 111 Clicking the Revert All button at the bot...

Page 182: ...After pressing Connect a message box with a transfer progress bar will appear Figure 109 under Safety AutoSequences After the transfer is completed a Transfer Complete message will appear and the message box will disappear 8 7 3 Downloading Safety Limits Sometimes it is desirable to bring data stored in the ES601 US back into your PC This way you can transfer setups from one ES601 US analyzer to a...

Page 183: ...ually operating the simulator the user can run an ECG AutoSequence in which ES601 US can be stepped through a predetermined list of up to 24 selected waveforms of given amplitudes At each step of the ECG AutoSequence the user can enter either a PASS or FAIL At the end of the ECG AutoSequence the user can optionally enter a comment of up to 40 characters e g LEAD III NOT WORKING ES601 US provides 6...

Page 184: ...ill appear in the Waveform Sequence pane on the right side of the screen Optionally you can select a waveform from the Simulator Waveforms pane and drag and drop the waveform to the Waveform Sequence pane The waveform will appear in the Waveform Sequence window at the end of the sequence 8 8 3 Removing a Waveform Select a waveform in the Waveform Sequence pane on the right side of the screen and p...

Page 185: ...essage will appear and the message box will disappear 8 8 7 Downloading AutoSequences Sometimes it is desirable to bring data stored in the ES601 US back into your PC This way you can transfer AutoSequence setups from one ES601 US analyzer to another You can retrieve AutoSequence setups from a ES601 US by pressing the Download From ES601 button Choose to download via USB Ethernet or Serial Port Do...

Page 186: ...ter 6 of this manual The Checklist module of ES601pc US allows the user to create up to 500 Checklists which can be uploaded and then run on the ES601 US analyzer Pressing Checklists on the main window of ES601pc US will display the Checklist Library window which lists all available Checklists Three example or starter Checklists are included with ES601pc US and following installation of the softwa...

Page 187: ...ransfer progress bar will appear After the transfer is completed a Transfer Complete message will appear and the message box will disappear 8 9 2 Downloading Checklists Sometimes it is desirable to bring data stored in the ES601 US back into your PC This way you can transfer Checklists from one ES601 US analyzer to another You can retrieve Checklists from a ES601 US by pressing the Download From E...

Page 188: ...control commands to externally connected test instruments then the Tester Port can be set to unused and the Baud Rate left blank Items from the Checkitem Database listed in the table on the left can be added to and removed from the Checklist on the right by using the appropriate buttons in the center margin of the screen All Checkitems can be removed from the Checklist by pressing the Clear button...

Page 189: ...ighlight a Checkitem and then click Edit Checkitem This will enable editing of the Checkitem via the properties panel at the bottom of the window The Checkitem properties panel includes an op code dropdown category dropdown and a number of command textboxes according to the Checkitem s op code 8 9 4 1 Selecting the Op Code The Op Code defines what the Checkitem does and which buttons are presented...

Page 190: ...Category Category is used by ES601pc US to select and sort Checkitems based on description or intended application Categories are user defined and associate the category name with an upper case ASCII letter For example the user can create a Defib Category and assign to this the letter D In the Checkitem Database Checkitems can thereby be created or modified under the Defib category In the Checkite...

Page 191: ...in Chapter 6 In principle the Prompt is intended to ask the technician to enter OK PASS FAIL comments or results such as RF LEAKAGE IS 248 UA and so on which will then be saved in the Test Record Op Codes C M D and R will in addition to the Prompt allow editing or entering a Command The Command is used to transmit a message via a TESTER PORT to an external testing device for example a patient simu...

Page 192: ...m command UT105 To help in creating AutoSequence Checkitems for use in Checklists it is assumed the user of the ES601pc US 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 ES601pc US and use the Safety...

Page 193: ...ll appear at the end of the Checkitem Table The Checkitem Properties panel will also be enabled To edit the new Checkitem follow the same procedure as in Editing an Checkitem The Checkitem may be saved after all information is added or edited by pressing the OK button or quit without saving by pressing the QUIT button Command prefix Type of AutoSequence NN SAF Safety AutoSequence 01 to 24 ECG ECG ...

Page 194: ... Checkitem Filter window Check the categories or op codes of the Checkitems that should appear Press Select All Categories or Select All Op Codes to select all the checkboxes Press OK to filter the Checkitem Table 8 9 7 Deleting a Checkitem While viewing the Checkitem Editor select a Checkitem from the Checkitem Table Press Delete Checkitem A warning message will appear which will list the sequenc...

Page 195: ...he op code If the op code is not recognized the new Checkitem 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 Checkitems in the file will be added at the end of the database 8 9 9 Printing Checkitems The Checkitem Database can be ...

Page 196: ...ta from a specific test instrument which connects to the ES601 US analyzer via a TESTER PORT Inspections and Tester AutoSequences are limited in length to 24 steps and either or both can be called from a Checklist by means of the A Checkitem More information can be found in the Automated Testing Principles section of Chapter 6 Pressing Inspections and User Tester on the main window of ES601pc US w...

Page 197: ...o the User Tester name Example Tester AutoSequences for a number of popular test instruments and patient simulators are included with ES601pc US and following installation of the software these examples will be evident on the User Testers tab as shown below The name assigned to a User Tester can be modified Double click on a User Tester in the list above and a dialog will appear allowing you the e...

Page 198: ...fter the transfer is completed a Transfer Complete message will appear and the message box will disappear 8 10 2 Downloading AutoSequences Sometimes it is desirable to bring data stored in the ES601 US back into your PC This way you can transfer Inspections and AutoSequences from one ES601 US analyzer to another You can retrieve data from a ES601 US by pressing the Download From ES601 button Choos...

Page 199: ... are provided for modifying Title 1 Title 2 Tester Port Number 1 to 6 and Tester Port Baud Rate 2400 to 19200 baud If the Inspection AutoSequence does not issue remote control commands to externally connected test instruments then the Tester Port can be set to unused and the Baud Rate left blank Normally this is the case for Physical Inspections Items from the Checkitem Database listed in the tabl...

Page 200: ...alog allowing the test sequence on the right to be sent to a printer Available Checkitems listed on the left of the window can be created or modified by clicking the Edit Checkitem Database button This button appears on the main Inspections Autosequences window and on the Inspection User Tester Editor screen Figure 129 Refer to Section 8 9 4 for more information on the Checkitem Database Editor ...

Page 201: ...ord Editor In conjunction with the Checklist Editor and Test Report Generator of ES601pc US the Equipment Record Editor provides you with a simple computer based system for equipment tracking and maintenance including means for creating and monitoring an equipment inventory retaining and reviewing the service history of equipment in your inventory and creating PM inspection procedures for specific...

Page 202: ...will then appear allowing you to enter specific information about the device such as its control number make model and so on 8 11 2 Copying Equipment Records To copy one or more pre existing Equipment Records click on a specific Record in the Table or click and drag the mouse over a group of consecutive Records and then click Copy At the end of the Table new Records will be created having the same...

Page 203: ... the Enter key on the keyboard The Equipment Record Editor will appear Text boxes are provided allowing you to input an Equipment Control Number Manufacturer Model and Description The Editor also provides three user defined Custom Fields into which you can enter any desired information The Checklist to be associated with the Control Number is selected by clicking on a Checklist in the list at the ...

Page 204: ...pment Records to determine how Checklists were assigned to Control Numbers in your system or when creating new Equipment Records for devices added to your system in the future 8 11 5 Searching Equipment Records To search Equipment Records enter search terms in one or more of the Search boxes located above the Equipment Record Table see Figure 130 After entering one or more Search terms you may the...

Page 205: ...ile to delimit the columns The delimiter character can be specified through the Delimiter dropdown list of the Import Records dialog To specify a delimiter other than those appearing in the list select Other and then enter a single character into the Delimiter textbox which appears If one or more lines at the beginning of the CSV file do not contain equipment information use the spinner buttons to...

Page 206: ...contain arbitrary data are also provided Refer to Appendix D for an illustrative example of importing Equipment Records into ES601pc US from a CSV export file produced by a CMMS 8 11 7 Uploading Equipment Records To upload to ES601 US press the Upload To ES601 button Choose uploading via USB Ethernet or Serial Port and then press Connect If the connection is via ethernet enter in the IP address as...

Page 207: ...m the printout by unchecking the box corresponding to the undesired information By default all fields of the Equipment Record are included in the printout 8 11 9 Record Viewing Options To modify the viewing options of the Equipment Record Table click the Options button below the Table see Figure 130 The Options dialog will then appear Figure 135 Columns can be unchecked and excluded from view in t...

Page 208: ...ES601 US OPERATING MANUAL ES601pc US Software Chapter 8 Page 188 Figure 137 Record viewing options ...

Page 209: ...MA 8 12 1 Exporting CMMS Data to ES601 US To load CMMS data into the ES601 US analyzer you must first create export files for a medTester from within the CMMS The export files required are designated MTEXPORT ITM MTEXPORT LST and MTEXPORT IDN by the CMMS If the CMMS is Sentinel32 generate these files by selecting medTester Serial Interface from the main menu of the Sentinel32 program Click the Med...

Page 210: ... files by browsing your local drives try using Windows Search to find them When you click Export CMMS Data the plugin will warn you that ES601pc US Checklists Equipment Records and all Checkitems of category type Z will be overwritten with data from the CMMS Checkitems from the CMMS will be assigned to the Z Instruction category which will be given the category name CMMS Before starting the import...

Page 211: ...erface will then start the conversion and transmission of CMMS data to the ES601 US analyzer The process involves converting the imported data into ES601 compatible format backing up the existing data of ES601pc US saving the newly converted CMMS data to disk and then uploading the information into the non volatile memory of the safety analyzer ...

Page 212: ...r s naming convention of month day hour and minutes each specified as 2 digit numbers followed by a MUP file extension e g 02171432 MUP corresponding to Feb 17 14 32 After selecting the default or entering an alternative name for the exported file the plugin will then begin to download Test Report data from the ES601 US The test results will then be converted into medTester MUP format and will be ...

Page 213: ... download the Checkitem Database currently stored in the memory of the ES601 US immediately before it opens the MTEXPORT data from the CMMS The purpose of this option is to make sure that certain AutoSequence data stored in the safety analyzer is correctly preserved before the export process modifies the Checkitem Database in the analyzer As such data preservation is essential to successful conver...

Page 214: ...signated by commands listed at extreme right in the table such as SAF or UT On installation of ES601pc US default AutoSequence files for the ES601 US analyzer are installed and the Translation Table of the CMMS Interface is initialized to suit these default AutoSequences as shown in Figure 140 If you modify a ES601 US AutoSequence in ES601pc US it may then be necessary to choose a different AutoSe...

Page 215: ...internal voltmeter Failure of these functions will require return of ES601 US to an authorized service facility for repair Opening the case of ES601 US for any reason will void the warranty and may compromise user safety 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 Unit 130...

Page 216: ...ES601 US OPERATING MANUAL Maintenance Chapter 9 Page 196 ...

Page 217: ...oSequence to be invoked from a Checklist see Automated Testing Principles Chapter 6 and Checklist Editor Chapter 8 SAFETY AUTOSEQUENCE 1 SAF01 A1 A6 10LD X I 10 LEAD ECG TEST Standard AAMI ES1 Limits Used AAMI ES1 Limits Equipment Class Class I Line Voltage Measure Load Current Measure Insulation Resistance Hot Neutral to Ground Skip Insulation Resistance Patient Leads to Ground Skip Ground Resist...

Page 218: ...Insulation Resistance Patient Leads to Ground Skip Ground Resistance Measured At 1 Amp Leakage Current Measure Equipment Power On Off Polarity Normal Reverse Neutral Normal Open Ground Normal Open Test External and Internal Case Leakages plus Patient Leads Lead to Lead Leakages Patient Lead Groups Group 1 Name ECG Type Isolated Leads 3 LD 1 RA LD 2 RL LD 3 LA SAFETY AUTOSEQUENCE 3 SAF03 A3 A8 4LD ...

Page 219: ...Patient Lead Groups Group 1 Name ECG Type Isolated Leads 4 LD 1 RA LD 2 RL LD 3 LA LD 4 LL SAFETY AUTOSEQUENCE 4 SAF04 A4 A9 CASE X I CASE LKG CRITICAL Standard AAMI ES1 Limits Used AAMI ES1 Limits Equipment Class Class I Line Voltage Measure Load Current Measure Insulation Resistance Hot Neutral to Ground Skip Insulation Resistance Patient Leads to Ground Skip Ground Resistance Measured At 1 Amp ...

Page 220: ...p Leakage Current Measure Equipment Power On Off Polarity Normal Reverse Neutral Normal Open Ground Normal Open Test External and Internal Case Leakages Patient Lead Groups None SAFETY AUTOSEQUENCE 6 SAF06 A11 BLANK Standard AAMI ES1 Limits Used AAMI ES1 Limits Equipment Class Class I Line Voltage Measure Load Current Skip Insulation Resistance Hot Neutral to Ground Skip Insulation Resistance Pati...

Page 221: ...pment Class Class I Line Voltage Measure Load Current Skip Insulation Resistance Hot Neutral to Ground Skip Insulation Resistance Patient Leads to Ground Skip Ground Resistance Skip Leakage Current Skip Patient Lead Groups None SAFETY AUTOSEQUENCE 12 SAF12 A17 ENVMON GROUNDING TEST Standard AAMI ES1 Limits Used AAMI ES1 Limits Equipment Class Class I Line Voltage Skip Load Current Skip Insulation ...

Page 222: ...Reverse Neutral Normal Open Ground Normal Open Test External and Internal Case Leakages Patient Lead Groups None SAFETY AUTOSEQUENCE 14 SAF14 IEC60601 TEST DEFIBRILLATOR Standard IEC60601 Limits Used IEC60601 Limits Equipment Class Class I Line Voltage Measure Load Current Measure Insulation Resistance Hot Neutral to Ground Skip Insulation Resistance Patient Leads to Ground Skip Ground Resistance ...

Page 223: ...oltage Measure Load Current Measure Insulation Resistance Hot Neutral to Ground Skip Insulation Resistance Patient Leads to Ground Skip Ground Resistance Measured At 1 Amp Leakage Current Measure Equipment Power On Polarity Normal Reverse Neutral Normal Open Ground Normal Open Test Touch Current and Earth Leakage plus Patient Leads Lead to Lead Leakages Patient Lead Groups Group 1 Name ECG Type CF...

Page 224: ...d Skip Insulation Resistance Patient Leads to Ground Skip Ground Resistance Measured At 1 Amp Leakage Current Measure Equipment Power On Polarity Normal Reverse Neutral Normal Open Ground Normal Open Test Touch Current and Earth Leakage plus Patient Leads Lead to Lead Leakages Patient Lead Groups Group 1 Name ECG Type CF Leads 5 LD 1 RA LD 2 RL LD 3 LA LD 4 LL LD 5 V Group 2 Name IBP Type CF Leads...

Page 225: ... Skip Leakage Current Skip Patient Lead Groups None SAFETY AUTOSEQUENCE 18 SAF18 IEC60601 TEST BLANK See SAFETY AUTOSEQUENCE 17 SAFETY AUTOSEQUENCE 19 SAF19 IEC62353 TEST GENERAL DEVICE Standard IEC62353 Limits Used IEC62353 Limits Equipment Class Class I Line Voltage Measure Load Current Measure Insulation Resistance Hot Neutral to Ground Measure Insulation Resistance Patient Leads to Ground Skip...

Page 226: ... Method Polarity Normal Reverse Test Patient Leads Patient Lead Groups Group 1 Name ECG Type CF Leads 4 LD 1 RA LD 2 RL LD 3 LA LD 4 LL Group 2 Name PADDLES Type CF Leads 2 LD 5 APEX LD 6 STERNUM SAFETY AUTOSEQUENCE 21 SAF21 IEC62353 TEST DIAGNOSTIC ECG Standard IEC62353 Limits Used IEC62353 Limits Equipment Class Class I Line Voltage Measure Load Current Measure Insulation Resistance Hot Neutral ...

Page 227: ...53 Limits Used IEC62353 Limits Equipment Class Class I Line Voltage Measure Load Current Measure Insulation Resistance Hot Neutral to Ground Measure Insulation Resistance Patient Leads to Ground Measure Ground Resistance Measure Leakage Current Measure Protocol Direct Method Polarity Normal Reverse Test Patient Leads Patient Lead Groups Group 1 Name ECG Type CF Leads 5 LD 1 RA LD 2 RL LD 3 LA LD 4...

Page 228: ...t Neutral to Ground Measure Insulation Resistance Patient Leads to Ground Skip Ground Resistance Measure Leakage Current Measure Protocol Direct Method Polarity Normal Patient Lead Groups None SAFETY AUTOSEQUENCE 24 SAF24 IEC61010 LABORATORY DEVICE Standard IEC61010 Limits Used IEC61010 Limits Line Voltage Measure Load Current Measure Insulation Resistance Skip Ground Resistance Measured At 1 Amp ...

Page 229: ...472 Date Time 18 DEC 2011 12 14 02 Type DEFIB W PCR SPO2 Make HEWLETT PACKARD Serial No A14 567100E Model CODEMASTER XL Facility ST JOSEPH S HOSP Loc EMERG Tech Code MEM Test Time 00 14 40 SAFETY TEST STANDARD IEC60601 LIMITS PER STANDARD AUTOSEQ 15 CLASS I GROUND FAULT NONE LINE VOLTAGE HOT NEUT HOT GND NEUT GND 120 0 V 120 0 V 2 3 V LOAD CURRENT 0 43 AMPS INSULATION RESISTANCE LIMIT UNITS HOT NE...

Page 230: ...50 PASS 01 RP NORM ON 0 10 PASS 01 RP ISO TST ON 0 50 PASS 02 RP OPEN N ON 1 50 PASS 01 RP OPEN G ON 0 50 PASS LEAD LEAKAGE uAdc LD TEST CONDITION VALUE LIMIT 02 NP NORM ON 1 10 PASS 01 NP ISO TST ON 1 50 PASS 03 NP OPEN N ON 1 50 PASS 01 NP OPEN G ON 0 50 PASS 03 RP NORM ON 1 10 PASS 02 RP ISO TST ON 1 50 PASS 02 RP OPEN N ON 1 50 PASS 01 RP OPEN G ON 1 50 PASS CONTROL No CN0432 GROUP 2 PADDLES L...

Page 231: ...mV PASS COMMENT INTERMITTENT LL LEAD REPLACED PROCEDURE TEST TYPE Checklist TEST No 089 STEP TASK RESULT 1 PHYSICAL INSPECTION 1 CASE PADDLES IN GOOD CONDITION OK 2 PHYSICAL INSPECTION 2 SKIP 3 CAUTION HIGH VOLTAGE OK 4 REVIEW MANUFACTURER LITERATURE AS NEEDED OK 5 TEST EQUIPMENT DEFIBRILLATOR TESTER OK 6 TEST EQUIPMENT PACEMAKER ANALYSER OK 7 TEST EQUIPMENT PULSE OXIMETRY TESTER OK 8 TEST EQUIPME...

Page 232: ...UT101 OXITEST 7 DEMO AUTOSEQUENCE OK 28 SELECT PULSE OXIMETER ON OXITEST 7 OK 29 SET HEART RATE 60BPM OK 30 SET PULSE AMPL 100 OK 31 SET ARTIFACT OFF OK 32 CHECK SPO2 96 98 RATE 59 61BPM SPO2 96 RATE 60BPM OK PASS 33 CHECK SPO2 88 92 RATE 59 61BPM SPO2 89 RATE 60BPM OK PASS 34 CHECK SPO2 78 82 RATE 59 61BPM SPO2 79 RATE 60BPM OK PASS 35 CHECK SPO2 68 72 RATE 59 61BPM SPO2 68 RATE 60BPM OK PASS 36 ...

Page 233: ...ME hours 1 2 OK CONTROL No CN0472 THIS EQUIPMENT HAS PASSED Technician ____________________________ Date ________________ The Test Report prior reflects a full PM inspection of a defibrillator and provides a good example of the potential capabilities of ES601 US The prior results were obtained by executing Checklist 89 which was created and loaded into ES601 US memory by means of the Checklist Edi...

Page 234: ...ES601 US OPERATING MANUAL Appendix B Page 214 ...

Page 235: ...DAMAGE ABUSE 2 General P Pass Fail CHECK FOR SECURE MOUNTING 3 General P Pass Fail CHECK AC LINE CORD AND PLUG 4 General P Pass Fail CHECK FUSES MATCH LABELLING 5 General P Pass Fail CHECK CABLES AND STRAIN RELIEFS 6 Receptacle M Multi Func TRPN TEST RECEPTACLE ON 7 General P Pass Fail POWER UP AND CHECK POWER ON SEQUENCE 8 General P Pass Fail RUN SELF TEST IF EQUIPPED 9 General P Pass Fail CHECK ...

Page 236: ... M Multi Func CHKENERGY VERIFY ENERGY 43 TO 58 JOULES 11 Impulse K OK Prompt SET DEFIB TO 100J DISCHARGE INTO IMPULSE 12 Impulse M Multi Func CHKENERGY VERIFY ENERGY 85 TO 115 JOULES 13 Impulse K OK Prompt SET DEFIB TO 200J DISCHARGE INTO IMPULSE 14 Impulse M Multi Func CHKENERGY VERIFY ENERGY 170 TO 230 JOULES 15 Impulse K OK Prompt SET DEFIB TO 300J DISCHARGE INTO IMPULSE 16 Impulse M Multi Func...

Page 237: ...MENT DEFIBRILLATOR 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 TRPN TEST RECEP...

Page 238: ...ES601 US OPERATING MANUAL Appendix C Page 218 ...

Page 239: ...ES601 US OPERATING MANUAL Appendix D Page 219 APPENDIX D Importing Equipment Records ...

Page 240: ...ES601 US OPERATING MANUAL Appendix D Page 220 ...

Page 241: ...ES601 US OPERATING MANUAL Appendix D Page 221 Although columns may be matched later in the process the equipment records to be imported should be in the following format ...

Page 242: ...Page 222 The preceding 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 Checklist number This can be added or changed later Be sure to save the file as CSV ...

Page 243: ...ES601 US OPERATING MANUAL Appendix D Page 223 If not already assigned Checklists can be assigned now and custom fields can be added or edited ...

Page 244: ...Appendix D Page 224 Ensure that the USB Driver for ES601 US is installed and the unit connected to the PC as per section 8 2 then upload the data to the ES601 US and the equipment records and associated Checklists will be ready ...

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