TEST PASSED. Date: 07/03/2016 Ansur Version Record:

Transcription

1 ElecoTek INC 1640 W. Hubbard Street Unit B Chicago IL Test Record TEST PASSED Test Performed Ansur Components Used Date: 07/03/2016 Ansur Version Record: Zoll E.#AB07B mtr Plug-In: AVPI Version Plug-In: ESA620 Version Template: Zoll E.mtt Plug-In: Impulse7000 Version Template Version: Plug-In: Index2 Version Plug-In: BPPump2 Version Test Setup Selections Service Events Performed Device under test MTI Data s Performed User defined Serial Number AB07B Model Defibrillator Manufacturer Zoll Location ElecoTek Type E series Test Instrument Serial Number Firmware Version IMPULSE 7000DP Index 2XL FE BPPump S Page 1 of 53

2 Signatures ElecoTek INC 9552E790-B72A-A34C-B59C-3A5270EB5FC7 Test Result Restore Defaults Restore all default settings press soft key buttons 1 and 5 simultaneously and turn DUT on. Recorded All defaults restored Setting Time and Date Setting Time and Date Check the time and date on the recorder annotation. If it is not correct, reset the time and date (from System Utilities mode) manually, by dial-up to a National Institute for Science and Technology (NIST) site, or using the GPS synchronization feature. After implementing time reset using any of the methods described below, verify that the time and date are set correctly by pressing the RECORDER button to generate a stripchart recording. Check that the stripchart is correctly annotated with the current time and date, selected ECG size, source and heart rate. Verify that the real-time clock is operating correctly by waiting for several minutes then running the stripchart recorder again. Set the time on the unit at least once every 2 weeks to prevent significant discrepancies between the unit's time and standard Greenwich Mean Time (GMT). Turn the selector switch to OFF. The device must remain off for at least 10 seconds before entering System Utilities mode. Note: Time and date may require resetting if the device's internal battery is depleted or the time zone has changed. Note: For both automated dial-up and GPS synchronization methods, the correct time zone and DST option must be set in System Configuration mode for the updated date and time to be correct. Manual Method 1. Press and hold the left-most softkey on the unit while turning the selector switch to MONITOR (ON for AED units). When the "System Utilities" screen appears on the monitor, release the softkey. 2. Press the MORE softkey and then the Clock Sync softkey to display the set time option menu. 3. Press the Manual Time Set softkey to display the Set Time screen. The month field will be highlighted. 4. Press the Inc or Dec softkeys to select the appropriate month. 5. Press the Next Field softkey to set the selected month and move the highlight to the next field (day). 6. Repeat steps 4 and 5 to set the correct day, year, hours and minutes field. Note: The last field does not automatically scroll (wrap) to the beginning. You must press the Prev Field Page 2 of 53

3 softkey to enter the values for the last field. If you need to make corrections, press the Prev Field softkey to move the highlight to the field previously entered. 7. Press the Enter and Return softkey to set all values and return to normal monitoring mode. Note: Repeated display of the "SET CLOCK" or "CLOCK FAULT" message may indicate that the internal battery powering the unit's Real Time Clock is depleted. See the Troubleshooting Guidelines in Section 13 of this manual for more information. Recorded Setting Time and Date Check the time and date on the recorder annotation. If it is not correct, reset the time and date (from System Utilities mode) manually, by dial-up to a National Institute for Science and Technology (NIST) site, or using the GPS synchronization feature. After implementing time reset using any of the methods described below, verify that the time and date are set correctly by pressing the RECORDER button to generate a stripchart recording. Check that the stripchart is correctly annotated with the current time and date, selected ECG size, source and heart rate. Verify that the real-time clock is operating correctly by waiting for several minutes then running the stripchart recorder again. Set the time on the unit at least once every 2 weeks to prevent significant discrepancies between the unit s time and standard Greenwich Mean Time (GMT). Turn the selector switch to OFF. The device must remain off for at least 10 seconds before entering System Utilities mode. Note: Time and date may require resetting if the device s internal battery is depleted or the time zone has changed. Note: For both automated dial-up and GPS synchronization methods, the correct time zone and DST option must be set in System Configuration mode for the updated date and time to be correct. Manual Method 1. Press and hold the leftmost softkey on the unit while Page 3 of 53

4 Recorded turning the selector switch to MONITOR (ON for AED units). When the System Utilities screen appears on the monitor, release the softkey. 2. Press the MORE softkey and then the Clock Sync softkey to display the set time option menu. 3. Press the Manual Time Set softkey to display the Set Time screen. The month field will be highlighted. 4. Press the Inc or Dec softkeys to select the appropriate month. 5. Press the Next Field softkey to set the selected month and move the highlight to the next field (day). 6. Repeat steps 4 and 5 to set the correct day, year, hours and minutes field. Note: The last field does not automatically scroll (wrap) to the beginning. You must press the Prev Field softkey to enter the values for the last field. If you need to make corrections, press the Prev Field softkey to move the highlight to the field previously entered. 7. Press the Enter and Return softkey to set all values and return to normal monitoring mode. Note: Repeated display of the SET CLOCK or CLOCK FAULT message may indicate that the internal battery powering the unit s Real Time Clock is depleted. See the Troubleshooting Guidelines in Section 13 of this manual for more information. Housing Visual inspection Is the unit clean and undamaged? Does the unit show signs of excessive wear? Does the handle work properly? Does the recorder door open and close properly? Are input connectors clean and undamaged? Are there any cracks in the housing? Recorded Page 4 of 53

5 Recorded Do the front panel or selector swirches have any damage or cracks? Are there any loose housing parts? Cables Visual Inspection Are the cables free of cracks, cuts, exposed or broken wires? Are all bend/strain reliefs undamaged and free of excessive cable wear? Recorded Battery visual Inspection Is the Zoll battery fully charged? is the battery seated in the battery well correctly? Recorded Front Panel Button Test 1. Install strip chart paper into recorder tray. 2. Install the battery in the unit or connect the A/C power cord to the unit and then plug the cord into an electrical outlet. 3. Connect the universal cable and ECG cable (3 lead, 5 lead, or 12 lead) to the Fluke Biomedical Impulse 7000DP. Recorded Turn the selector switch to MONITOR. (For AED units, turn the selector switch to ON and select Manual mode.) Listen for 4 beep tones. PADS and MONITOR display on the monitor. NOTE: Pads is a factory default setting. Press the LEAD button, three times for the 3 lead cable and seven times for the 5 lead cable. Each time you press the LEAD button, a different lead number appears under the LEAD heading on the display. Not Applicable PADS, I, II, III will display a 3 lead ECG cable if connected or no ECG cable is connected. PADS, I, II, III, AVR, AVL, AVF, V1 will display a 5 lead ECG cable. Connect the 12 lead cable to unit and simulator. Press the LEAD button and select the lead for each of the 12 lead settings. A 12 Lead cable will display PADS I, II, III, AVR, AVL, AVF, VI, V2, V3, V4, V5, V6 Page 5 of 53

6 Recorded Set the simulator to NSR of 120 BPM. To Check the size of the ECG waveform, press the SIZE button. As you press the size button five times (0.5, 1.0, 1.5, 2.0, 3.0), note that the size of the ECG waveform appropriatley changes on the display. Press the ALARM SUSPEND button. Alarm symbol changes from disabled to enabled. If the alarm sounds, press the ALARM SUSPEND button to turn it off. The alarm will only be suspended for 90 seconds at this point. Press and hold the ALARM SUSPEND button for 3 seconds to disable alarms. Press the RECORDER button. The strip chart paper moves out of the unit from the paper tray. Check that the correct time, date, ECG lead annotation and waveform are recorded on the paper. (Ser Time and Date, if necessary.) Open the paper compartment door. Press the RECORDER button. CHECK RECORDER message appears on the monitor. Close the paper compartment door. Press RECORDER button. Strip chart paper flows out of paper tray. verify that the CHECK RECORDER message no longer displays. Press RECORDER button. Strip chart paper stops flowing out of paper tray. Press the VOLUME softkey. To increase the volume of the beep, press the Inc. softkey. The volume bar graph displays. Audible beep when the QRS wave displays. The bar graph increases on the display indicating an increase in volume. This action does not increase the volume which is normal. Note: The QRS tone is on or off. There is no gradual change in volume. This action does not increase the vloume. If equipped, voice prompts are gradual. Note: The voice volume has 5 settings. Setting 3 is in the mid-range. Page 6 of 53

7 Recorded To decrease the volume of the beep, press the Dec. Softkey. The bar graph decreases on the display indicating a decrease in volume. The volume shuts off at the last bar, otherwise, the volume is the same as originally set. Press the CONTRAST button. Contrast menu displays. Press the CONTRAST button. To increase the contrast of the display, press the Inc. softkey. Background light and characters display. The bar graph increases on the display indicating an increase in contrast. To decrease the contrast of the display, press the Dec. softkey. The bar graph decreases on the display indicating a decrease in contrast. The display contrast changes. Press the SUMMARY button. Summary menu displays on the monitor showing the summary report options. Press the CODEMARKER button. Code marker menu displays. Connect a/c current and install the battery. Turn the unit off. the CHARGER ON indicator lights. The amber green lights illuminate. Note: If both lights flash ON/OFF, the unit is defective or no battery is installed. Remove the battery. Note that both charge lights (green and amber) flash alternately. Replace the battery and turn the unit on. Note that the yellow charge light illuminates. Connect Fluke Impulse 7000 and Press the ANALYZE button. The SLECT DEFIB MODE message appears on the monitor. (For manual devices.) Move the selector switch to DEFIB. Select 2J. Press the CHARGE button. the display shows that the unit is charging. The SHOCK button lights. Press and hold the ENERGY SLECT down arrow. Unit discharges internally and selected energy decrements to 1J. Page 7 of 53

8 Recorded Press and release the ENERGY SELECT up arrow 19 times. 1-10, 15, 20, 30, 50, 70, 85, 100, 150, 200J. Press the CHARGE button. Note the display shows the unit charged up to 200J and the SHOCK button lights. Press the SHOCK button. The unit discharges and the SHOCK button is no longer lit. A 15 second strip chart automatically prints, displaying the number of joules delivered (if equipped with recorder and configured to print event.) 12 Leads Test Test each cable seperately. 1. The E series unit must be configured to display ECG LEAD OFF message. 2. Connect the lead wires appropiate to each test to the Fluke Biomedical Impulse 7000DP. Recorded Turn the selector switch to MONITOR. For AED units, turn the selector switch to ON and select Manual mode.) Select leads. NO ECG LEADS OFF message displayed. Disconnect one lead from the simulator. The ECG LEAD OFF message displays within 3 seconds (if configured). Reconnect the lead. Repeat step 3.2 with the remaining leads. Wait for ECG LEAD OFF message to clear from the display (if configured). Repeat 3.2 and 3.3 for 12 lead cables. Note: If heart rate alarm sounds, press and hold the ALARM SUSPEND button for 4 seconds to disable the alarms. Note: When testing the 12 lead cable, the ECG LEAD OFF message displays when you pull off a limb lead. When you pull off a V lead, the ECG VX LEAD OFF message displays where "X" is the number between 1 and 6. Power Supply Test Tools Needed: 2 red miniature alligator leads. 1 black miniature alligator test lead. DC power supply (15 Amp minimum) 0.1 OHM 1% resistor (1/4 or greater) OHM 1% 1/4W resistor. Fluke 75 multimeter or equivalent. Set to DC. Page 8 of 53

9 Test Setup: 1. make sure the unit and power supply are turned off. Unplugged. 2. Connect one end of the black lead to the "-" terminal in the battery well. 3. Connect the other end of the black lead to the "-" terminal of the power supply. 4. Connect the red lead to "+" terminal socket of the battery well. Use the middle pin with the plastic gaurd around it. Connect the other end of the red lead to the "+" terminal of the power supply. 5. Set the power supply voltage to 7V. Caution: Be sure to connect the power supply properly to the E series battery well terminals or damage to the unit may result. Do NOT raise the power supply voltage above 12V. Turn the selector switch to MONITOR. (For AED units, turn the selector switch to ON and select Manual mode.) The unit should not turn on. Turn the unit off. Adjust the power supply voltage to 10.3V and turn the selector switch to MONITOR (for AED units, turn the selector switch to ON). The unit should turn on. Battery Test. Set voltage to 9.9V. No LOW BATTERY message displays. Set voltage to 9.4V. LOW BATTERY message displays within 30 seconds. Shut Down Test. Set voltage to 8.5V. Unit should shut off within 30 seconds. Recorded Test Setup for Test Test Setup for Test: 1. Remove 0.1O resistor and replace with 1KO. 2. Connect DMM across resistor. 3. Set voltage scale to DCV. 4. Measure voltage across resistor Recorded Test Measure across resistor with unit turned off. should be less than 450 mv (<450 µa of current) Earth Leakage Earth Leakage Tools Needed: See the manufacturer's instructions or supplied specifications for the leakage tester you use. Test Setup: See the manufacturer's instructions or supplied specifications for the leakage tester you use. Repeat leakage test with accessories: MFC, external paddles, and anterior/posterior paddles. Maximum Leakage Acceptance Limits Normal Condition Single Fault Condition* ECG 10µA 50µA MFC 100µA 100µA Earth 500µA 1000µA *Single fault considered AC mains on applied part Unused Applied Parts: Floating Page 9 of 53

10 Earth Leakage Normal Condition Normal Condition Unit Limit Limit Normal Condition 0.8 uaac+dc Earth Leakage Open Neutral Open Neutral Unit Limit Limit Open Neutral 1 uaac+dc Earth Leakage Normal Condition, Reversed mains Normal Condition, Reversed mains Unit Limit Limit Normal Condition, Reversed mains 0.7 uaac+dc Earth Leakage Open Neutral, Reversed Mains Open Neutral, Reversed Mains Unit Limit Limit Open Neutral, Reversed Mains 0.8 uaac+dc (Manufacturer) Auto Sequence (1) Connect the DUT to the ESA620 as indicated in the operators manual. (2) Ensure that DUT power is off. (3) Click module setup and specify the patient leads that are to be tested. (4) Connect patient leads as indicated. (5) Press Start Test to perform the AAMI safety test.. Applied Part setup # Applied Part info Class Leads 1 A.P. Code RA I 1 Serial No. Type 2 A.P. Code LL I 1 Serial No. Type 3 A.P. Code LA I 1 Serial No. Type 4 A.P. Code RL I 1 Serial No. Type 5 A.P. Code V1 I 1 Serial No. Type 6 A.P. Code V2 I 1 Serial No. Type 7 A.P. Code V3 I 1 Serial No. Type 8 A.P. Code V4 I 1 Serial No. Type 9 A.P. Code V5 I 1 Serial No. Type 10 A.P. Code V6 I 1 Serial No. Type Page 10 of 53

11 (Manufacturer) - Power Auto Sequence Line Mains Test checks 120V. The voltage of a power transmission circuit or distribution circuit up to the point of transformation or utilization. Mains Live to Neutral Live to Neutral Unit Limit Limit Live to Neutral V Mains Neutral to Ground Neutral to Earth Unit Limit Limit Neutral to Ground 0.2 V Mains Live to Ground Live to Earth Unit Limit Limit Live to Ground V Ground Wire Resistance Earth Resistance Test : Unit Limit Limit PE Resistance Ohm 0.3 User defined Protective Earth Resistance Protective Earth Resistance Test : Unit Limit Limit PE Resistance Ohm 0.3 User defined Chassis Leakage Unused Applied Parts: Floating Enclosure Leakage Normal Condition Enclosure Leakage Normal Condition Unit Limit Limit Normal Condition 1 uaac+dc 300 Open Neutral Enclosure Leakage Open Neutral Unit Limit Limit Open Neutral 0.9 uaac+dc 500 Open Ground Enclosure Leakage Open Earth Unit Limit Limit Open Ground 0.3 uaac+dc 300 Normal Condition, Reversed mains Enclosure Leakage Normal Condition, Reversed mains Unit Limit Limit Normal Condition, Reversed mains 0.9 uaac+dc 300 Page 11 of 53

12 Enclosure Leakage Open Neutral, Reversed Mains Open Neutral, Reversed Mains Unit Limit Limit Open Neutral, Reversed Mains 0.9 uaac+dc 500 Enclosure Leakage Open Ground, Reversed Mains Open Earth, Reversed Mains Unit Limit Limit Open Ground, Reversed Mains uaac+dc 300 Leads Isolation Total Leakage: No Unused Applied Parts: Floating Mains on Applied Parts Mains on Applied Parts Single Fault Condition Single Fault Condition Unit Limit Limit RA 12.8 ua 50 LL 12.9 ua 50 LA 12.3 ua 50 RL 12.9 ua 50 V ua 50 V ua 50 V ua 50 V ua 50 V ua 50 V ua 50 Single Fault Condition, Reversed Mains Mains on Applied Parts Single Fault Condition, Reversed Mains Unit Limit Limit RA 12.8 ua 50 LL 12.9 ua 50 LA 12.4 ua 50 RL 12.1 ua 50 V ua 50 V ua 50 V ua 50 V ua 50 V ua 50 V ua 50 Lead to Ground Leakage Total Leakage: No Unused Applied Parts: Floating Patient Leakage Normal Condition Patient Leakage Normal Condition Unit Limit Limit RA 0.3 uaac+dc 10 LL 0.3 uaac+dc 10 LA 0.3 uaac+dc 10 RL 0.3 uaac+dc 10 V1 0.3 uaac+dc 10 V2 0.3 uaac+dc 10 V3 0.3 uaac+dc 10 V4 0.3 uaac+dc 10 V5 0.3 uaac+dc 10 V6 0.3 uaac+dc 10 Open Ground Patient Leakage Open Earth Unit Limit Limit RA 4.3 uaac+dc 50 Page 12 of 53

13 Unit Limit Limit LL 4.4 uaac+dc 50 LA 3.9 uaac+dc 50 RL 5.7 uaac+dc 50 V1 3.9 uaac+dc 50 V2 3.9 uaac+dc 50 V3 3.9 uaac+dc 50 V4 3.9 uaac+dc 50 V5 3.9 uaac+dc 50 V6 3.9 uaac+dc 50 Patient Leakage Normal Condition, Reversed mains Normal Condition, Reversed mains Unit Limit Limit RA 0.3 uaac+dc 10 LL 0.3 uaac+dc 10 LA 0.3 uaac+dc 10 RL 0.3 uaac+dc 10 V1 0.3 uaac+dc 10 V2 0.3 uaac+dc 10 V3 0.3 uaac+dc 10 V4 0.3 uaac+dc 10 V5 0.3 uaac+dc 10 V6 0.3 uaac+dc 10 Patient Leakage Open Ground, Reversed Mains Open Earth, Reversed Mains Unit Limit Limit RA 4.1 uaac+dc 50 LL 4.3 uaac+dc 50 LA 3.8 uaac+dc 50 RL 5.5 uaac+dc 50 V1 3.8 uaac+dc 50 V2 3.8 uaac+dc 50 V3 3.7 uaac+dc 50 V4 3.8 uaac+dc 50 V5 3.7 uaac+dc 50 V6 3.8 uaac+dc 50 (Manufacturer) - Power On Auto Sequence Enclosure Leakage Unused Applied Parts: Floating Enclosure Leakage Open Neutral Enclosure Leakage Open Neutral Unit Limit Limit Open Neutral 0.9 uaac+dc 500 Open Ground Enclosure Leakage Open Earth Unit Limit Limit Open Ground uaac+dc 300 Normal Condition, Reversed mains Enclosure Leakage Normal Condition, Reversed mains Unit Limit Limit Normal Condition, Reversed mains 1 uaac+dc 300 Open Neutral, Reversed Mains Enclosure Leakage Open Neutral, Reversed Mains Unit Limit Limit Open Neutral, Reversed Mains 1 uaac+dc 500 Page 13 of 53

14 Enclosure Leakage Open Ground, Reversed Mains Open Earth, Reversed Mains Unit Limit Limit Open Ground, Reversed Mains uaac+dc 300 Lead to Ground Leakage Total Leakage: No Unused Applied Parts: Floating Patient Leakage Patient Leakage Normal Condition Normal Condition Unit Limit Limit RA 0.3 uaac+dc 10 LL 0.3 uaac+dc 10 LA 0.3 uaac+dc 10 RL 0.4 uaac+dc 10 V1 0.3 uaac+dc 10 V2 0.3 uaac+dc 10 V3 0.3 uaac+dc 10 V4 0.3 uaac+dc 10 V5 0.3 uaac+dc 10 V6 0.3 uaac+dc 10 Patient Leakage Open Ground Open Earth Unit Limit Limit RA 4.3 uaac+dc 50 LL 4.4 uaac+dc 50 LA 3.9 uaac+dc 50 RL 5.7 uaac+dc 50 V1 3.9 uaac+dc 50 V2 3.9 uaac+dc 50 V3 3.9 uaac+dc 50 V4 3.9 uaac+dc 50 V5 3.9 uaac+dc 50 V6 3.9 uaac+dc 50 Normal Condition, Reversed mains Patient Leakage Normal Condition, Reversed mains Unit Limit Limit RA 0.3 uaac+dc 10 LL 0.3 uaac+dc 10 LA 0.3 uaac+dc 10 RL 0.4 uaac+dc 10 V1 0.4 uaac+dc 10 V2 0.3 uaac+dc 10 V3 0.3 uaac+dc 10 V4 0.4 uaac+dc 10 V5 0.3 uaac+dc 10 V6 0.4 uaac+dc 10 Open Ground, Reversed Mains Patient Leakage Open Earth, Reversed Mains Unit Limit Limit RA 4.2 uaac+dc 50 LL 4.3 uaac+dc 50 LA 3.8 uaac+dc 50 RL 5.6 uaac+dc 50 V1 3.8 uaac+dc 50 V2 3.8 uaac+dc 50 V3 3.8 uaac+dc 50 V4 3.8 uaac+dc 50 V5 3.8 uaac+dc 50 V6 3.8 uaac+dc 50 Leads Isolation Mains on Applied Parts Page 14 of 53

15 Total Leakage: No Unused Applied Parts: Floating Mains on Applied Parts Single Fault Condition Single Fault Condition Unit Limit Limit RA 12.8 ua 50 LL 12.9 ua 50 LA 12.4 ua 50 RL 12.9 ua 50 V ua 50 V ua 50 V ua 50 V ua 50 V ua 50 V ua 50 Mains on Applied Parts Single Fault Condition, Reversed Mains Single Fault Condition, Reversed Mains Unit Limit Limit RA 12.8 ua 50 LL 13 ua 50 LA 12.4 ua 50 RL 12.8 ua 50 V ua 50 V ua 50 V ua 50 V ua 50 V ua 50 V ua 50 Mains Mains Checks voltage at 120V. The voltage of a power transmission circuit or distribution circuit up to the point of transformation or utilization. Live to Neutral Mains Live to Neutral Unit Limit Limit Live to Neutral V Neutral to Earth Mains Neutral to Earth Unit Limit Limit Neutral to Earth 0.2 V Live to Earth Mains Live to Earth Unit Limit Limit Live to Earth V Insulation Resistance Insulation Resistance The measured resistance is intended to indicate the condition of the insulation or dieletric between two conductive parts, where the higher the resistance, the better the condition of the insulation. Ideally, the insulation resistance would be infinite "XX." Test : 500V Applied Part setup # Applied Part info Class Leads 1 A.P. Code RA I 1 Serial No. Type 2 A.P. Code LL I 1 Page 15 of 53

16 Serial No. Type 3 A.P. Code LA I 1 Serial No. Type 4 A.P. Code RL I 1 Serial No. Type 5 A.P. Code V1 I 1 Serial No. Type 6 A.P. Code V2 I 1 Serial No. Type 7 A.P. Code V3 I 1 Serial No. Type 8 A.P. Code V4 I 1 Serial No. Type 9 A.P. Code V5 I 1 Serial No. Type 12 A.P. Code V6 I 1 Serial No. Type Insulation Resistance Mains to Protective Earth Mains to Protective Earth Unit Limit Limit Mains to Protective Earth MOhm Applied Parts to Protective Earth Insulation Resistance Applied Parts to Protective Earth Unit Limit Limit Applied Parts to Protective Earth MOhm Mains to Applied Parts Insulation Resistance Mains to Applied Parts Unit Limit Limit Mains to Applied Parts MOhm Mains to Non-Earth Accessible Conductive Part Insulation Resistance Mains to Non-Earth Accessible Conductive Part Unit Limit Limit Mains to Non-Earth Accessible Conductive Part MOhm Applied Parts to Non-Earth Accessible Conductive Part Insulation Resistance Applied Parts to Non-Earth Accessible Conductive Part Unit Limit Limit Applied Parts to Non- Earth Accessible Conductive Part MOhm Impulse 6000D/7000DP Normal Sinus Wave Test Normal Sinus Wave Test Simulates a normal sinus waveform on the defibrillator monitor. Tools Needed: Calibrated ECG simulator with 60Hz sine wave output capability. Mini-phone plug for measuring output signal from 1 Volt ECG OUT jack (optional). Page 16 of 53

17 ECG Cable (3 or 5 leads). Test Setup: 1. Turn the selector switch to MONITOR. Press LEAD button until "I" displays. 2. Connect the ECG leads to the Fluke Biomedical Impulse 4000 or equivalent. 3. Connect the ECG cable to the unit. Duration 60 s Rate 120 BPM ECG Amplitude ECG Monitor 1.00 mv Unit 80 BPM Calibrating Pulses on Strip Chart Test Recorded Press the RECORDER button Press and hold SIZE button to activate the calibration signal. The strip chart displays a signal of 300 ppm with an amplitude of 10 mm +/- 1 mm. The signal also appears on the video display. Notch Filter Test Tools Needed: Fluke Biomedical Impulse Test Setup: 1. Connect the ECG cable to the Fluke Biomedical Impulse 4000 or equivalent. 2. Connect the ECG cable to the unit Recorded Turn the selector switch to MONITOR mode. (For AED units, turn the selector switch to ON and select Manual mode.) Select lead I, size 3x. Select 60Hz (or 50 Hz for a 50Hz unit) on the Fluke Biomedical Impulse Press RECORDER button. Verify that the waveform amplitude on the strip chart is less than 1.5 mm. Turn the ECG simulator off. Heart Rate Alarm Test Tools Needed: Fluke Biomedical Impulse Recorded Turn the selector switch to MONITOR mode. (For AED units, turn the selector switch to ON and select Manual mode.) Connect the ECG leads to the Fluke Biomedical Impulse Set the simulator to 120 BPM and the defibrillator to lead II. Lead II message displays. NSR ECG at 120 BPM +/- 2 displayed. Press ALARMS. The alarm menu displays. Page 17 of 53

18 Recorded Press SELECT PARAM softkey until ECG HR displays. Cursor scrolls through parameters. Press INC> for state. Cursor scrolls through ENABLE, AUTO and DISABLE. Press DEC>for state. Cursor scrolls through ENABLE, DISABLE, AND AUTO. Press INC> until ENABLE displays. ENABLE displays. Set LOW to 30, HIGH to 150 then, press the RETURN softkey. MONITOR displays. Press ALARM SUSPEND button. No alarm sounds. Remove a lead wire from the Fluke Biomedical Impulse The alarm symbol flashes and the heart symbol stops flashing. The ECG LEAD OFF alarm tone sounds. Recorder prints a stripchart showing a low heart rate, if enabled. Reattach ECG Lead wire to Fluke Biomedical Impulse 7000 and hold the ALARM SUSPEND button on unit for 4 seconds. The alarm symbol has an "X" through it. The heart symbol flashes with each QRS wave. Press the ALARM SUSPEND button. Alarm is enabled. Alarm symbol (without "X") displays Set simulator to 160 BPM or higher. Heart Rate is highlighted, alarm tone sounds, the alarm and the heart symbol both flash. Press the ALARM SUSPEND button in the unit. Alarm is suspended for 90 seconds. The alarm symbol has an "X" through it. The heart symbol flashes with each QRS wave. Press and hold ALARM SUSPEND for 4 seconds to disable alarms. Defibrillator Self Test SHOCK HAZARD! TAKE THE NECESSARY PRECAUTIONS TO GUARD AGAINST SHOCK OR INJURY BEFORE YOU START CONDUCTING THE DEFIBRILLATOR TESTS. Keep hands and all other objects clear of the multi-function cable connections and defibrillator analyzer when discharging the defibrillator. Before you discharge the defibrillator, warn everyone near the equipment to STAND CLEAR. Caution Do NOT internally discharge the unit more than 3 times in 1 minute. Note that multiple rapidly repeating internal discharges at more than 30 Joules may damage the unit. Tools Needed: Page 18 of 53

19 MFC Test Port Connector with universal cable. MFC Test Adaptor Connector (Fluke Biomedical Part Number or equivalent). Fluke Biomedical Impulse 7000 or equivalent defibrillator analyzer. ECG Cable. Stop watch. Test Setup: 1. Ensure the unit is turned off 2. Ensure the ECG cable is connected to the unit and analyzer. Note: The universal cable should not be connected to any equipment at the beginning of this test. Recorded Turn the selector switch to DEFIB mode. (For AED units, turn the selector switch to ON and select Manual mode.) Set leads to PADS. CHECK PADS/POOR PAD CONTACT message displays. Connect the universal cable to the MFC test port. DEFIB PAD SHORT message displays. Select energy level of 100J and press the CHARGE button. The charge time is >2 second and <10 seconds and SELECT 30J FOR TEST is displayed. Press the SHOCK button. Unit does not discharge. DEFIB PAD SHORT message displays. Set energy level to 30J. Unit internally discharges. Press the CHARGE button. Unit charges to 30J and displays DEFIB 30J READY. The charge ready tone sounds. Press and hold SHOCK button. Unit discharges. TEST OK message and number of joules delivered message displays. For example, using the message at the top of the printed strip chart would read as follows: 30 JOULES TEST OK. TEST_CUR=10-14A DEFIB_IMPED=0. The impedance value may range from 0 to 5O. Impulse 6000D/7000DP Charge Time Test Charge Time Test Measures the time it takes to charge to a given energy and then discharge the defibrillator. Normal Sinus ECG Amplitude 1.00 mv Post Shock Waveform No Convert Rate 90 BPM 50 Ohms Unit Charge Time 3.4 s J Page 19 of 53

20 Unit Phase 1 Peak 437 V 407 V Phase 1 Peak 8.7 A 8.1 A 6.3 ms Phase 2 Peak 428 V 327 V Phase 2 Peak 8.6 A 6.5 A Synchronized Cardioversion Test Tools Needed: Fluke 7000DP Defibrillator Analyzer. Test Setup: 1.Connect the universal cable via the adapter (D.N.I # ) to the defibrillator analyzer. 2.Set ECG on analyzer to BPM. Recorded Press LEAD button to select PADS and Size x1 Press the SYNC softkey on the defibrillator. Enter synchronized cardioversion timing test mode on the defibrillator analyzer. Sync markers appear on display. Note:Sync markers display on the monitor. The sync marker appears as a down arrow over the ECG R- wave peaks on strip chart and display. Impulse 6000D/7000DP Sync Time Test Sync Time Test Measures defibrillator energy, peak voltage, peak current and cardio delay time. Tools Needed: Fluke Biomedical Impulse 7000 defibrillator analyzer. Test Setup: 1. Connect the universal cable via the adapter (D.N.I # ) to the defibrillator analyzer. Normal Sinus ECG Amplitude 1.00 mv Post Shock Waveform No Convert Rate 90 BPM 50 Ohms Unit Type = Monophasic Sync Time Peak Peak Pulse Width 50% NO SYNC J 6047 V A 8.7 ms ms 60 Page 20 of 53

21 Unit Pulse Width 10% 8.7 ms Impulse 6000D/7000DP Measurement Test Measurement Test Connect Fluke Impulse Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 101 V 4.6 A 4.0 A 6.3 ms 110 V 72 V 4.4 A 2.8 A Impulse 6000D/7000DP Measurement Test Measurement Test 50 Ohms Unit Phase 1 Peak Phase 1 Peak J V 161 V 3.5 A Page 21 of 53

22 Unit 3.2 A 6.3 ms Phase 2 Peak 168 V 129 V Phase 2 Peak 3.4 A 2.6 A Impulse 6000D/7000DP Measurement Test Measurement Test 75 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 231 V 3.3 A 3.1 A 6.3 ms 210 V 170 V 2.8 A 2.3 A Page 22 of 53

23 Impulse 6000D/7000DP Measurement Test Measurement Test 100 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 264 V 2.9 A 2.6 A 6.2 ms 238 V 202 V 2.4 A 2.0 A Impulse 6000D/7000DP Measurement Test Measurement Test Page 23 of 53

24 125 Ohms Unit J Phase 1 Peak 305 V 283 V Phase 1 Peak 2.4 A 2.3 A 6.2 ms Phase 2 Peak 258 V 225 V Phase 2 Peak 2.1 A 1.8 A Impulse 6000D/7000DP Measurement Test Measurement Test 150 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak J V 294 V 2.1 A 2.0 A 6.2 ms 273 V 243 V Page 24 of 53

25 Unit Phase 2 Peak 1.8 A 1.6 A Impulse 6000D/7000DP Measurement Test Measurement Test 175 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 305 V 1.8 A 1.7 A 6.2 ms 284 V 259 V 1.6 A 1.5 A Page 25 of 53

26 Impulse 6000D/7000DP Measurement Test Measurement Test 25 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 330 V 14.6 A 13.2 A 6.3 ms 361 V 233 V 14.4 A 9.4 A Impulse 6000D/7000DP Measurement Test Measurement Test Page 26 of 53

27 50 Ohms Unit J Phase 1 Peak 564 V 525 V Phase 1 Peak 11.3 A 10.5 A 6.3 ms Phase 2 Peak 554 V 423 V Phase 2 Peak 11.1 A 8.5 A Impulse 6000D/7000DP Measurement Test Measurement Test 75 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak J V 747 V 10.8 A 10.0 A 6.3 ms 686 V 549 V Page 27 of 53

28 Unit Phase 2 Peak 9.1 A 7.3 A Impulse 6000D/7000DP Measurement Test Measurement Test 100 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 856 V 9.4 A 8.6 A 6.2 ms 770 V 650 V 7.7 A 6.5 A Page 28 of 53

29 Impulse 6000D/7000DP Measurement Test Measurement Test 125 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 910 V 7.8 A 7.3 A 6.2 ms 838 V 730 V 6.7 A 5.8 A Impulse 6000D/7000DP Measurement Test Measurement Test Page 29 of 53

30 150 Ohms Unit J Phase 1 Peak 1017 V 954 V Phase 1 Peak 6.8 A 6.4 A 6.2 ms Phase 2 Peak 888 V 792 V Phase 2 Peak 5.9 A 5.3 A Impulse 6000D/7000DP Measurement Test Measurement Test 175 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak J V 987 V 6.0 A 5.6 A 6.2 ms 931 V 840 V Page 30 of 53

31 Unit Phase 2 Peak 5.3 A 4.8 A Impulse 6000D/7000DP Measurement Test Measurement Test 25 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 462 V 20.4 A 18.4 A 6.3 ms 507 V 327 V 20.2 A 13.0 A Page 31 of 53

32 Impulse 6000D/7000DP Measurement Test Measurement Test 50 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 733 V 15.7 A 14.7 A 6.3 ms 773 V 590 V 15.5 A 11.8 A Impulse 6000D/7000DP Measurement Test Measurement Test Page 32 of 53

33 75 Ohms Unit J Phase 1 Peak 1143 V 1058 V Phase 1 Peak 15.2 A 14.1 A 6.3 ms Phase 2 Peak 972 V 780 V Phase 2 Peak 13.0 A 10.4 A Impulse 6000D/7000DP Measurement Test Measurement Test 100 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak J V 1206 V 13.2 A 12.1 A 6.2 ms 1088 V 918 V Page 33 of 53

34 Unit Phase 2 Peak 10.9 A 9.2 A Impulse 6000D/7000DP Measurement Test Measurement Test 125 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 1278 V 11.0 A 10.2 A 6.2 ms 1175 V 1025 V 9.4 A 8.2 A Page 34 of 53

35 Impulse 6000D/7000DP Measurement Test Measurement Test 150 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 1339 V 9.5 A 8.9 A 6.2 ms 1245 V 1110 V 8.3 A 7.4 A Impulse 6000D/7000DP Measurement Test Measurement Test Page 35 of 53

36 175 Ohms Unit J Phase 1 Peak 1467 V 1383 V Phase 1 Peak 8.4 A 7.9 A 6.2 ms Phase 2 Peak 1303 V 1180 V Phase 2 Peak 7.4 A 6.7 A Impulse 6000D/7000DP Measurement Test Measurement Test 25 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak J V 652 V 29.6 A 26.0 A 6.3 ms 745 V 415 V Page 36 of 53

37 Unit Phase 2 Peak 29.8 A 16.6 A Impulse 6000D/7000DP Measurement Test Measurement Test 50 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 1159 V 26.8 A 23.2 A 6.2 ms 943 V 685 V 18.9 A 13.7 A Page 37 of 53

38 Impulse 6000D/7000DP Measurement Test Measurement Test 75 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 1481 V 25.2 A 19.8 A 6.1 ms 1131 V 909 V 15.1 A 12.1 A Impulse 6000D/7000DP Measurement Test Measurement Test Page 38 of 53

39 100 Ohms Unit J Phase 1 Peak 2169 V 1683 V Phase 1 Peak 21.7 A 16.8 A 6.2 ms Phase 2 Peak 1304 V 1102 V Phase 2 Peak 13.0 A 11.0 A Impulse 6000D/7000DP Measurement Test Measurement Test 125 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak J V 1758 V 17.3 A 14.1 A 6.2 ms 1436 V 1250 V Page 39 of 53

40 Unit Phase 2 Peak 11.5 A 10.0 A Impulse 6000D/7000DP Measurement Test Measurement Test 150 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 1831 V 14.5 A 12.2 A 6.2 ms 1549 V 1381 V 10.3 A 9.2 A Page 40 of 53

41 Impulse 6000D/7000DP Measurement Test Measurement Test 175 Ohms Unit Phase 1 Peak Phase 1 Peak Phase 2 Peak Phase 2 Peak J V 1870 V 12.4 A 10.7 A 6.2 ms 1621 V 1467 V 9.3 A 8.4 A Shock Test Page 41 of 53

42 200J and 50 Ohm Recorded Press the CHARGE button and start timing with a stopwatch. Stop timing when the SHOCK button lights. The charge time is between 3-6 seconds. Press the SHOCK button. On the strip chart, the Patient is between Amps, and the Defib Impedance is between Ohms Turn unit to Defib (for AED units, turn to on and select Manual Mode Set energy level to 200 Joules. Press CHARGE. When the SHOCK button lights, press the SELECT DOWN ARROW. The unit does not display any fault messages, and the Fluke Impluse 7000 Defibrillator Analyzer shows that no discharges have been delivered Set energy level to 200 Joules. Have the stop watch ready. Press CHARGE. When the SHOCK button lights, start the stop watch. The unit holds the energy for 60 seconds (15 seconds for AED units), then the unit discharges internally. The unit does not display fault messages. AED units only.) Disconnect the cable from the analyzer. The unit issues the CHECK PADS audio prompt. Summary Report Test Test Setup: 1. Connect the universal cable to the defibrillator analyzer. 2. If you are using paddles, place the paddles on the analyzer's discharge plates. Recorded Press and hold the SUMMARY softkey for 4 to 8 seconds to erase any previously stored data. ERASING REPORT displays. Set selector switch to DEFIB. Select 200J using the ENERGY SELECT button, and press the CHARGE button. When charged, press the SHOCK button to discharge into the defibrillator analyzer. The unit successfully discharges and prints a strip chart. Page 42 of 53

43 Recorded Wait 18 seconds, then press the Code Marker softkey. Press the CPR softkey. The Code Markers display. Turn the unit off. Wait 10 seconds and then turn the unit on. Press the SUMMARY softkey, then press the PRINT CHART softkey. Summary report prints. The report displays the correct date, time, the shock delivered and Code Marker event. Advisory Message Test Test Setup: 1. Connect the universal cable via the adapter (D.N.I # ). 2. Attach the E Series to the defibrillator analyzer Recorded Turn the selector switch to DEFIB mode. (For AED units, turn the selector switch to ON.) Select VF (ventricular fibrillation) on the simulator, then press the ANALYZE button. ANALYZING ECG message displays. STAND CLEAR message displays.* SHOCK ADVISED message displays.* PRESS SHOCK message displays*+ *AED s audio prompts are standard. Advisory audio prompts are user configurable. +If configured for auto charge. Press the SHOCK button. Unit discharges. Select the NSR (normal sinus rhythm) on the simulator, then press the ANALYZE button. ANALYZING ECG message. STAND CLEAR message.* NO SHOCK ADVISED message.* *AED s audio prompts are standard. Pacer Test (1) Tools Needed: Fluke Biomedical Impulse 7000 Analyzer (software 1.06 or higher) with optional external plug in pacing module (TQA-17) or equivalent. Note: The following tests are to be performed only on E Series units equipped with the optional pacing function. The pacer output can be measured using an oscilloscope set to DC coupling connected across a load resistor. (See diagram in column for universal cable connector polarity.) The load resistor is a 100 ohm, 5 watt or greater. The pacer output is a positive going pulse, 40 +/- 2 ms duration with an amplitude of 0.1 volt per milliamp of selected output (e.g., 40 milliamps of selected output has an amplitude of 4 +/- 0.5 volts the specified tolerance displayed on the oscilloscope). If an external non-invasive pacer analyzer is being used, then follow the manufacturer's guidelines for measuring the frequency (ppm), output (ma) and the pulse width measured in milliseconds. Note that the analyzer pace load resistor must be less than 250 ohms. Test Setup: 1. Connect the universal cable from the E Series to the External Pacer Load (TQA-17) of the Impulse Page 43 of 53

44 Recorded Turn the Main Selector knob of the unit to Pacer Mode.Set the PACER OUTPUT to 14 ma and disconnect MFC connector from the Fluke Impulse 7000 analyzer. The unit displays the CHECK PADS and POOR PAD CONTACT messages displays, and the pace alarm is active. Reconnect the universal cable to the Fluke Biomedical Impulse Press Clear Pace Alarm softkey. CHECK PADS and POOR PAD CONTACT message disappears. The pace alarm is cleared. Set rate to 180 ppm, output to 0mA. No output appears on the Impulse 7000DP. Impulse 7000DP Pacer Parameter Test Pacer Parameter Test Collects measurements from pacer signals. Input Jacks Pacer Load 100 Ohms Brand Zoll Unit Pacer Rate PPM Pacer Amplitude Pulse Width Pacer ma ms 59.2 mj Impulse 7000DP Pacer Parameter Test Pacer Parameter Test Collects measurements from pacer signals. Input Jacks Pacer Load 100 Ohms Brand Zoll Unit Pacer Rate PPM Pacer Amplitude Pulse Width Pacer ma ms 80.1 mj Impulse 7000DP Pacer Parameter Test Pacer Parameter Test Collects measurements from pacer signals. Input Jacks Pacer Load 100 Ohms Brand Zoll Page 44 of 53

45 Unit Pacer Rate PPM Pacer Amplitude ma Pulse Width 39.7 ms Pacer 5.74 mj Impulse 7000DP Pacer Parameter Test Pacer Parameter Test Collects measurements from pacer signals. Input Jacks Pacer Load 100 Ohms Brand Zoll Unit Pacer Rate Pacer Amplitude Pulse Width Pacer PPM ma 39.7 ms 14.3 mj Impulse 7000DP Pacer Parameter Test Pacer Parameter Test Collects measurements from pacer signals. Input Jacks Pacer Load 100 Ohms Brand Zoll Unit Pacer Rate Pacer Amplitude Pulse Width Pacer PPM ma 39.7 ms 14.3 mj Pacer Test (2) Connect the ECG cable to the E Series and 7000DP. Select the ECG at 60 BPM on the 7000DP. Decrease the pacer rate on the unit to 58ppm. The unit displays ECG at 60 BPM with no stimulus markers. Press the Async Pace softkey. The unit displays ECG at 60 BPM with stimulus markers, and displays the Async pace message. Turn off the analyzer. Set Pacer Rate to 100ppm. Press the RECORDER ON button. The unit displays pace stimulus markers every 15mm +/-1mm. Recorded Page 45 of 53

46 Recorded Press and hold 4:1 button. The unit displays pace stimulus markers every 60 mm+/- 1.5 mm. SpO2 Monitor Test (1) Tools Needed: Masimo Reusable Sensor. Masimo Patient Cable. Fluke Biomedical Index 2PFE SpO2 Simulator (or equivalent). Test Setup: 1. Connect the universal cable to the MFC test plug. 2. DO NOT connect the ECG cable to the simulator. 3. Install the Masimo Patient Cable and attach the Masimo sensor to the patient cable. 4. Connect the Masimo sensor to the finger simulation post. 5. Place a fully charged battery into the battery well or connect to ac power (dc power, if equipped). 6. Ensure that the SpO2 Simulator is off Recorded Turn the selector switch to MONITOR. (For AED units, turn the selector switch to ON and select Manual mode.) The SpO2 saturation percentage appears as a dashed line on the monitor Wait ten seconds. Turn on the SpO2 simulator. Press the SIM softkey on the Index SpO2 Simulator. Press the MAN softkey. The unit displays the SpO2 PULSE SEARCH message. SpO2 Simulation Test SpO2 Simulation Test Depending on the vintage of oximeter being tested, the detection-time, and settling-time before the actual simulated values are displayed on the oximeter may be long. Wait for the simulation values to be displayed. Unit Simulation Type Optical Oximeter make name Masimo TLC 4000 SpO2 level 98 % Beats per minute 80 BPM Pulse amplitude 5 % Unit Limits: SpO2 level Beats per minute % BPM AAMI/NFPA- 99 AAMI/NFPA- 99 SpO2 Simulation Test SpO2 Simulation Test Depending on the vintage of oximeter being tested, the detection-time, and settling-time before the actual simulated values are displayed on the oximeter may be long. Wait for the simulation values to be displayed. Unit Simulation Type Optical Oximeter make name Masimo TLC 4000 SpO2 level 98 % Beats per minute 230 BPM Pulse amplitude 5 % Unit Limits: SpO2 level Beats per minute % BPM AAMI/NFPA- 99 AAMI/NFPA- 99 Page 46 of 53

47 SpO2 Simulation Test SpO2 Simulation Test Depending on the vintage of oximeter being tested, the detection-time, and settling-time before the actual simulated values are displayed on the oximeter may be long. Wait for the simulation values to be displayed. Unit Simulation Type Optical Oximeter make name Masimo TLC 4000 SpO2 level 98 % Beats per minute 50 BPM Pulse amplitude 5 % Unit Limits: SpO2 level Beats per minute % BPM AAMI/NFPA- 99 AAMI/NFPA- 99 SpO2 Simulation Test SpO2 Simulation Test Depending on the vintage of oximeter being tested, the detection-time, and settling-time before the actual simulated values are displayed on the oximeter may be long. Wait for the simulation values to be displayed. Unit Simulation Type Optical Oximeter make name Masimo TLC 4000 SpO2 level 72 % Beats per minute 50 BPM Pulse amplitude 5 % Unit Limits: SpO2 level Beats per minute % BPM AAMI/NFPA- 99 AAMI/NFPA- 99 SpO2 Monitor Test (2) Press Wave 2 softkey. Select the SpO2 waveform. For CCT units: Press the Traces softkey, and then select SET TRACE 2, and press Enter. Select SPO2, press Enter. Plethysmographic waveform appears on the ZOLL display Press RECORDER. The plethysmographic waveform prints on the strip chart paper Recorded SpO2 Simulation Test SpO2 Simulation Test Depending on the vintage of oximeter being tested, the detection-time, and settling-time before the actual simulated values are displayed on the oximeter may be long. Wait for the simulation values to be displayed. Unit Simulation Type Optical Oximeter make name Masimo TLC 4000 SpO2 level 72 % Beats per minute 230 BPM Pulse amplitude 5 % Unit Limits: SpO2 level Beats per minute % BPM AAMI/NFPA- 99 AAMI/NFPA- 99 Page 47 of 53

48 EtCO2 Monitor Test (for EtCO2 Option) Tools Needed: CAPNOSTAT 5 Mainstream cable with airway adapter, or CAPNOSTAT 5 Sidestream cable with cannula. Test Setup: 1. Install the battery. Connect the CAPNOSTAT 5 CO2 Mainstream cable with airway adapter attached, or the CAPNOSTAT 5 Sidestream cable with the cannula attached, to the yellow connector at the back of the E Series. NOTE: Make sure the airway adapter (for Mainstream), or the cannula (for Sidestream) is installed in the CO2 cable. Set the front panel switch to MONITOR or ON. For AED units, enter Manual Mode. WARM UP message appears on the display. NOTE: Warming up may take about 1 minute When the WARM UP message disappears, press the Param softkey, then select EtCO2 and press Enter. Press the ZERO softkey, then wait for the ZERO DONE message. The ZERO DONE message appears. Press the Return softkey. Press the Wave 2 softkey until the CO2 waveform appears. A flat baseline CO2 waveform appears. Breath normally into the airway adapter. A capnogram waveform appears. Recorded Barometric Pressure Calibration Check *The barometric pressure can be obtained from a calibrated barometer, or from the National Weather Service at (enter your local zip code to get the local barometric pressure). Note that the barometric pressure is in inches of mercury, multiply it by 25.4 to convert to mmhg. Recorded Connect the CAPNOSTAT 5 CO2 Sensor to the yellow connector at the back of the E Series unit, and connect an airway adapter to the sensor. While pressing and holding the second softkey from the left, turn the selector switch to Monitor (ON for AED units). The unit displays EtCO2 Calibration screen. Page 48 of 53

49 Recorded Wait for the sensor to warm up. The message WARM UP is displayed for approximately one minute. Obtain the local barometric pressure in mmhg.* Press the Baro Pr. softkey to enter the Barometric Pressure Calibration screen. Use the Inc> and Dec< softkeys to set the second value on the pressure display line equal to your local barometric pressure. Press the Return softkey to store the offset and return to the main EtCO2 Calibration screen. Accuracy Check (Optional test to check EtCO2 NA sensor) The calibration gas mixture and regulator are available from Respironics Novametrix. (Equivalent alternatives are available from other suppliers.) Gas Regulator: PN Calibration Gas (carton of 4 tanks): PN Recorded NA NA NA NA NA NA NA NA NA NA NA NA NIBP Volume Leak Test with Fluke Biomedical NIBP Analyzer (1) The volume leak test verifies the integrity of the pneumatic system on the NIBP module. This test is optional at 6 months, but should be performed annually or every 10,000 readings, whichever comes first. Tools Needed: Fluke NIBP simulator (the values and procedure that we provide are specific to the BP Pump 2). Test Setup: Connect the Analyzer s simulator hose to the NIBP connector on the E Series unit. Configure the NIBP Analyzer for the volume leak test. For example, on the Fluke Biomedical BP Pump: Press the Cuff softkey for volume cuff test. Verify the cuff is set to External Make sure the ECG cable is not connected to the E Series unit. If the SpO2 option is installed, make sure that the Masimo cable is NOT connected to the E Series unit. Recorded Turn the Selector Switch to OFF. After 10 seconds, press and hold the fourth softkey from the left and turn the Selector Switch to MONITOR. The M Series powers on in the NIBP Service Mode. Press the Leak Test softkey. The M Series displays the NIBP Leak Test Screen. Page 49 of 53