Stryker LIFEPAK 20 Inspection Procedure Download Page 8

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LIFEPAK

Performance Inspection Procedure (PIP)

3201896-000_B

--- CONTENTS ---

Page 8 of 61

Test Instructions

PIP - General Instruction



This section lists the general instructions for performing the Performance Inspection Procedure (PIP).



Perform the PIP in the order presented.



Use the

Performance Inspection Procedure Checklist

to record your results.

WARNING

POSSIBLE EQUIPMENT DAMAGE

Only use accessories approved by Physio-Control.

Summary of Contents for LIFEPAK 20

Page 1: ... Performance Inspection Procedure PIP 3201896 000_B 2019 Stryker CONTENTS Page 1 of 61 LIFEPAK 20 MONITOR DEFIBRILLATOR _______________________________________________________ Performance Inspection Procedure PIP ...

Page 2: ...orm the PIP after any repair replacement or calibration procedure The Performance Inspection Procedure Checklist is provided as a tool for the recording of PIP test results Contents PIP Scope and Applicability PIP Resource Requirements PIP Test Equipment PIP Test Equipment Verification PIP Workstation Power PIP Test Equipment Requirements PIP Test Instruction PIP General Instruction PIP Exterior P...

Page 3: ...Defibrillator ECG Characteristic Tests PIP QUIK COMBO Defibrillator ECG Gain Test PIP QUIK COMBO Defibrillator a Positive R wave Test PIP Quik Combo Sync Remote Test PIP Standard Paddles Users Test PIP Standard Paddles Defibrillator Sync Test at 2J PIP Standard Paddles Defibrillator Delivered Energy Tests at 2J and 70J PIP Standard Paddles Defibrillator Delivered Energy and Charge Time Tests at 36...

Page 4: ...Test Setup PIP Direct Equipment Leakage Test at Single Fault Condition SFC PIP Safety Analyzer Setup on Direct Applied Part Leakage Tests PIP Direct Applied Part Leakage Test ECG PIP Direct Applied Part Leakage Test Therapy PIP Direct Applied Part Leakage Test SPO2 PIP Safety Analyzer Setup on Earth Leakage Tests PIP Earth Leakage Test at Normal Condition NC PIP Earth Leakage Test at Single Fault ...

Page 5: ...IP Use the PIP Checklist to record your results Resource Requirements This section describes the requirements for PIP equipment PIP test equipment verification PIP workstation power Test Equipment To perform the PIP you must use the equipment listed in the PIP Test Equipment Requirements table Although the table lists specific test equipment by manufacturer test equipment with equivalent specifica...

Page 6: ...e equivalent Lead I 70 amplitude of Lead II Sine wave 10 Hz 1 mV 2 based on Lead II Fluke Biomedical Impulse 7000DP with QUIK COMBO adapter accessory 16 7 D P ADPT104 Safety Analyzer 90 V ac rms to 264 V ac rms mains voltage Current range 0 1999 A Current accuracy 5 of reading or 1 digit whichever is greater Fluke Biomedical ESA612 Decade resistance box 0 to 9 M resistance box Resolution 1 accurac...

Page 7: ...10 000030 Cable Assembly 5 Lead ECG 11110 000066 Cable Assembly Analog ECG Output 11110 000067 Cable QUIK COMBO to Snap Termination 3009139 Adapter Test Paddles Leakage LP12 LP20 3206631 Cable Test ECG snap to banana plug 3305684 QUIK COMBO Leakage Cable 3207066 1210 Adapter for ESA612 Fluke 1210 BJ2 ECG Input Jack Adapter 1 for ESA612 and 2 for 1210 Adapter Fluke BJ2 Banana plug cable connect bet...

Page 8: ...IP General Instruction This section lists the general instructions for performing the Performance Inspection Procedure PIP Perform the PIP in the order presented Use the Performance Inspection Procedure Checklist to record your results WARNING POSSIBLE EQUIPMENT DAMAGE Only use accessories approved by Physio Control ...

Page 9: ...e lower enclosure Reinstall or replace rubber feet as necessary 4 Inspect the Therapy ECG SpO2 if equipped DB 9 DB 15 AED door and IrDA connectors for damage and or cracks 5 Inspect the keypads and overlays for damage cracks and separations 6 Check all other accessory cables Paddles ECG SpO2 sensors and related items for expiration dates general condition and suitability for use 7 Inspect carrying...

Page 10: ... Unless properly used as described in these operating instructions this energy may cause serious injury or death Do not attempt to operate this device unless thoroughly familiar with these operating instructions and the function of all controls indicators connectors and accessories 1 Connect the AC Power cable into the device 2 Install a roll of printer paper into the printer Figure 1 1 Device Set...

Page 11: ...Manual mode Note Be sure to make note of the customer settings to restore the device to the user selected MANUAL ACCESS configuration at the completion of this PIP To perform the device for Manual mode access 1 Access the Setup mode as follows a Press and hold OPTIONS and EVENT and then turn the device ON b When the Setup mode passcode prompt appears enter 5433 2 Select MANUAL MODE in the Setup me...

Page 12: ...ingle tone from the speaker and then three distinct beeps from the sonalert AC loss alert 2 Verify that all lamps light momentarily except for the ON and AC mains indicators which remain on throughout self test Note The initial display indicates self test in progress as shown in Figure 1 3 3 Verify that the device completes the Power On sequence 4 Verify that AC Main indicator remains ON 5 Verify ...

Page 13: ...evice ON 3 Press OPTIONS to access the Options menu 4 Select USER TEST from the Option menu When asked to Start user test Select Yes and confirm using the Speed Dial 5 Confirm the printed results that the device passes the user test and that the correct date and time values are displayed on the printout as shown in Figure 1 4 Note If the date and time are incorrect reset using the Options Date Tim...

Page 14: ...the SpO2 finger probe Allow several seconds for the probe to find your pulse 5 Confirm the SpO2 reading is between 50 to 100 6 Remove finger from SpO2 finger probe Message should display on screen SpO2 Check Sensor with audible alarm 7 Unplug SpO2 finger probe from the device while on current patient record message should display SpO2 No Sensor Detected Note Alarms will clear when device is turned...

Page 15: ... any order 4 Verify with each button pressed that its associated text box is highlighted Note A failure is indicated by a text box that is not highlighted It is normal for the buttons with up down arrows to highlight only the arrows 5 Press the switch located between the OPTIONS and PAUSE buttons Note The switch is hidden in the elastomer keypad 6 Verify the TEST COMPLETE message appears on the bo...

Page 16: ... Test 1 Select TESTS in the Service menu 2 Select PIXELS in the Service Tests submenu The pixels test screen appears as shown in Figure 1 7 3 Carefully examine the screen for any anomalies Rotate SPEED DIAL to scroll through test screens 4 Press the SPEED DIAL to exit the test 5 Continue with the next test while still in Service mode Figure 1 7 Pixels Test ...

Page 17: ...vice Tests submenu as shown in Figure 1 8 2 Select START to produce voice prompts from the speaker 3 Confirm that the voice prompts are clearly audible and reproduced without distortion Note You can listen to a complete replay of all voice prompts and tones but it is not required for verification of this function 4 Continue with the next test while still in Service mode Figure 1 8 Audio Test ...

Page 18: ...l lines print one very close to the lower paper margin c The character set prints clearly without broken characters d Vertical lines spaced 25 mm 1mm approx 24 to 26 mm apart print correctly 4 Open the printer door and verify the CHECK PRINTER message appears at the bottom of the screen 5 Remove the printer paper and then close the printer door 6 Verify the CHECK PRINTER message appears at the bot...

Page 19: ...ENTS Page 19 of 61 PIP ECG Performance Testing ECG Performance Testing consist of PIP ECG Performance Testing PIP 3 Lead ECG Tests PIP 3 Lead ECG Leads Off Detection Test PIP 3 Lead ECG Gain Test PIP 5 Lead ECG Tests PIP 5 Lead ECG Leads Off Detection Test PIP 5 Lead ECG Gain Test ...

Page 20: ...evice LEAD selection to Lead II 4 Remove the LA lead from the Impulse 7000DP and verify the device displays the ECG LEADS OFF message and a repeating priority 3 tone shall sound when the Lead is removed Reconnect the LA lead 5 Remove the RA lead from the Impulse 7000DP and verify the device displays the RA LEADS OFF message and a repeating priority 3 tone shall sound when the Lead is removed Recon...

Page 21: ... ECG SIZE to 4 0 3 Set the device LEAD selection to LEAD I 4 Print five seconds of ECG Lead I and confirm the printed signal amplitude is 25 mm to 31 mm peak to peak as shown in Figure 1 11 5 Set the device LEAD selection to LEAD II 6 Print five seconds of ECG Lead II and confirm the printed signal amplitude is 36 mm to 44 mm peak to peak as shown in Figure 1 11 7 Turn the printer OFF Figure 1 11 ...

Page 22: ...he RA lead from the Impulse 7000DP and verify the device displays an RA LEADS OFF message and a repeating priority 3 tones shall sound when the Lead is removed Reconnect the RA lead 6 Remove the LL lead from the Impulse 7000DP and verify the device displays an LL LEADS OFF message and a repeating priority 3 tones shall sound when the Lead is removed Reconnect the LL lead 7 Set the device lead sele...

Page 23: ...3 Set the device LEAD selection to LEAD I 4 Print five seconds of ECG Lead I and confirm the printed signal amplitude is 25 mm to 31 mm peak to peak as shown in Figure 1 13 5 Set the device LEAD selection to LEAD II 6 Print five seconds of ECG Lead II and confirm the printed signal amplitude is 36 mm to 44 mm peak to peak as shown in Figure 1 13 7 Repeat steps 5 and 6 for C Lead 8 Turn the printer...

Page 24: ...s shown in Figure 1 14 2 Turn the device ON 3 Using the ECG cable supplied with the device input a 1 mV 10 Hz sine wave from the Impulse 7000DP 4 Set device LEAD selection to LEAD II Note The Analog ECG output is in real time at a nominal 1 V mV and is not affected by the device ECG SIZE setting 5 Verify the amplitude of the signal displayed on the oscilloscope is between 0 90Vp p and 1 10Vp p 6 D...

Page 25: ...ECG Gain Test PIP QUIK COMBO Defibrillator a Positive R wave Test PIP Quik Combo Sync Remote Test PIP Standard Paddles Users Test PIP Standard Paddles Defibrillator Sync Test at 2J PIP Standard Paddles Defibrillator Delivered Energy Tests at 2J and 70J PIP Standard Paddles Defibrillator Delivered Energy and Charge Time Tests at 360 J Battery Powered PIP Standard Paddles ECG Characteristic Tests PI...

Page 26: ...defibrillator pulses to the pacer inputs of the analyzer 2 Turn the device ON 3 Set the device Manual mode ECG Size to 1 0 LEAD selection to Lead II 4 Set the Defibrillator Analyzer to measure SYNC 5 Press the SYNC button ON and select LOCAL if Remote Sync is set to on 6 Verify the Sync LED turns on and R wave markers appear on the ECG waveform 7 Press the ENERGY SELECT button to select 2J 8 Press...

Page 27: ... on the device and select 2 J 3 Press the CHARGE button and wait for the device to reach full charge Then push the SHOCK button to discharge the device 4 Verify the defibrillator analyzer indicates the delivered energy is within 1 0 J to 3 0J 5 Repeat steps 2 and 3 for the energy level at 70J 6 Verify the defibrillator analyzer indicates the delivered energy is within 59 5 J to 80 5J Note Perform ...

Page 28: ...tablish the setup as shown in Figure 1 16 2 Disconnect the AC power cable from the device and turn the device ON by battery 3 Press ENERGY SELECT on the device and select 360 J 4 Start a Stop Watch then press the CHARGE button and wait for the device to reach full charge Stop a Stop Watch and then press the SHOCK button to discharge the device 5 Verify the defibrillator analyzer indicates the deli...

Page 29: ... a single procedure and step numbers are continuous from one step to the next PIP QUIK COMBO Defibrillator ECG Gain Test PIP QUIK COMBO Defibrillator a Positive R wave Test PIP Quik Combo Defibrillator ECG Gain Test To perform ECG Gain Test 1 Set the Impulse 7000DP output to ECG Performance 1 mv 10 Hz sine wave 2 Set the device ECG SIZE to 4 0 3 Set the LEAD selection to PADDLES 4 Print 10 seconds...

Page 30: ... To perform A positive R wave test 1 Set the Impulse 7000DP to a 1mV Normal Sinus 60 BPM 2 Set the device ECG SIZE to 1 0 3 Set the LEAD selection to PADDLES 4 Print 10 seconds of paddles ECG recorded on printer paper 5 Turn the printer OFF 6 Confirm the R Wave polarity on the paper matches image as shown in Figure 1 18 Figure 1 18 A Positive R Wave ...

Page 31: ... Test Pulse Generator 3 On the Manual Mode setup page set the device to Remote Sync ON 4 Turn the device OFF and then turn the device ON 5 Set the device Manual mode lead selection to PADDLES 6 Press the SYNC button on the device 7 On the Sync mode screen select REMOTE 8 Verify the SYNC LED is flashing 9 Charge the device to 200 J 10 Upon reaching full charge press the SHOCK button to discharge th...

Page 32: ...K HAZARD The conductive gel wet or dry on the paddle handles and in the paddle wells may allow the electrical energy to arc between paddles during discharge Thoroughly clean and dry the paddles and the paddle wells after use and before performing the Standard Paddles User Test 1 Connect the standard paddles to the device Place the paddles in the paddle wells as shown in Figure 1 20 2 Turn the devi...

Page 33: ... electrodes to contact any person or conductive surface except as described below Note Ensure that the Standard Paddles is connected between the device and the Impulse 7000 DP using the appropriate adapters Note Verify that the metal surface of the paddles are free of burn or arc marks and are free of pits scratches insulting films contaminants or raised nicks that can be felt with the finger tip ...

Page 34: ...YNC button ON and select LOCAL if Remote Sync is set to on 6 Verify the Sync LED turns on and R wave markers appear on the ECG waveform 7 Press the ENERGY SELECT button to select 2J 8 Press the CHARGE button on Standard Paddles and wait for the device to reach full charge Then push both SHOCK buttons on Standard Paddles to discharge the device 9 Verify the defibrillator analyzer measures a sync R ...

Page 35: ...and select 2 J 3 Press the CHARGE button on Standard Paddles and wait for the device to reach full charge Then push both SHOCK buttons on Standard Paddles to discharge the device 4 Verify the defibrillator analyzer indicates the delivered energy is within 1 0 J to 3 0J 5 Repeat steps 2 and 3 for the energy level at 70J 6 Verify the defibrillator analyzer indicates the delivered energy is within 59...

Page 36: ... AC power cable from the device and turn the device ON by battery 3 Press the ENERGY SELECT button to select 360 J 4 Start a Stop Watch then press the CHARGE button on Standard Paddles and wait for the device to reach full charge Stop a Stop Watch and then push both SHOCK buttons on Standard Paddles to discharge the device 5 Verify the defibrillator analyzer indicates the delivered energy is withi...

Page 37: ... single procedure and step numbers are continuous from one step to the next PIP Standard Paddles Defibrillator ECG Gain Test PIP Standard Paddles Defibrillator a Positive R wave Test PIP Standard Paddles Defibrillator ECG Gain Test To perform ECG Gain Test 1 Set the Impulse 7000DP output to ECG Performance 1 mv 10 Hz sine wave 2 Set the device ECG SIZE to 4 0 3 Set the LEAD selection to PADDLES 4 ...

Page 38: ...est To perform A positive R wave test 1 Set the Impulse 7000DP to a 1mV Normal Sinus 60 BPM 2 Set the device ECG SIZE to 1 0 3 Set the LEAD selection to PADDLES 4 Print 10 seconds of paddles ECG recorded on printer paper 5 Turn the printer OFF 6 Confirm the R Wave polarity on the paper matches image as shown in Figure 1 24 Figure 1 24 A Positive R Wave ...

Page 39: ...ync Test Pulse Generator 3 On the Manual Mode setup page set the device to Remote Sync ON 4 Turn the device OFF and then turn the device ON 5 Set the device Manual mode lead selection to PADDLES 6 Press the SYNC button on the device 7 On the Sync mode screen select REMOTE 8 Verify the SYNC LED is flashing 9 Charge the device to 200 J 10 Upon reaching full charge press the SHOCK button to discharge...

Page 40: ...ction Procedure PIP 3201896 000_B 2019 Stryker CONTENTS Page 40 of 61 PIP Pacer Characteristic Tests The pacer characteristics consist of PIP Pacer Leads Off Detection Test PIP Pacer Output Current Test PIP Pacer Pulse Width Test ...

Page 41: ...to measure Pacer 4 Press PACER button press F1 Brand to Physio Control press F2 Input to Defib and press F3 Load to 50 ohms 5 Press PACER on the device 6 Verify the PACER LED is on and the Pacer overlay appears 7 Disconnect one of the test post adapter snaps from the Impulse 7000DP 8 Verify the Pacing Connect Electrodes overlay appears accompanied by an audible alarm 9 Reconnect the test post adap...

Page 42: ... Set Pacer Rate at 60PPM 4 Press CURRENT on the device and select a pacer current 10 mA then 100 mA and then 200 mA 5 Verify the defibrillator analyzer indicates the pacer output current is within the acceptable output limits shown in Table below results may appear as negative numbers Note If the Impulse 7000DP does not detect a pacing output current reading then operate the Impulse 7000DP and dev...

Page 43: ...st To perform the pacer pulse width test 1 Set pacer rate on the device at 60 PPM 2 Press CURRENT on the device and select a pacer current of 200 mA 3 Verify the measured pacer pulse width is between 19 0 and 21 0 ms Note Perform TCP Pacer Self Calibration if the peak pacer current falls outside the acceptable output range ...

Page 44: ...s shown in Figure 1 27 2 Set the decade resistance box to 50 ohms 3 Turn the device ON and set the lead selection to PADDLES 4 Verify the PADDLES LEADS OFF message are not visible 5 Set the decade resistance box to 248 ohms 6 Verify the device displays the PADDLES LEADS OFF message 7 Set the decade resistance box to 182 ohms 8 Verify the PADDLES LEADS OFF message are not visible 9 Remove the decad...

Page 45: ... analyzer To perform the Direct Equipment Leakage Direct Applied Part Leakage and Protective Earth Resistance tests in accordance with IEC 62353 set up the Safety Analyzer as follows Press the SETUP button on the Safety Analyzer 1 Press the SETUP button on the Safety Analyzer 2 Press the F4 MORE button 3 Press the F2 INSTRUMENT button 4 Press the F1 STANDARD button 5 Press the UP DOWN arrows to se...

Page 46: ... operation to eliminate test lead resistance from your measurements 2 Set the Safety Analyzer controls to measure Ohms by selecting the Ohm button on the Safety Analyzer 3 Establish the setup as shown in Figure 1 30a Note Ensure all connectors and connection points are clean and are firmly attached If not you will see higher readings from the safety analyzer 4 Measure the resistance of AC power co...

Page 47: ...l see higher readings from the safety analyzer 6 Ensure the device is off 7 Measure the resistance of device with the AC power cord per figure 1 30b Record the resistance value on the PIP checklist 8 Calculate the resistance of device only by subtracting the value obtained in Step 4 from the value obtained in Step 7 The calculated value must be less than 0 2 ohms Record the calculated value on PIP...

Page 48: ...cedures Leakage Current flow induced by the application of high voltage to a material or object with high dielectric strength Normal Condition N C AC voltage is applied in either normal or reversed polarity that is measurements made with the POLARITY switch in both NORMAL NC and REVERSED RM positions The earth ground is intact during these measurements Single Fault Condition S F C AC voltage is ap...

Page 49: ...he Ground stud 2 Connect the customer ECG Lead cable Item 1 between the LIFEPAK 20 and the 1210 box Connect Item 5 between the 1210 box and the Safety Analyzer ESA612 at RA snap Note The customer ECG cable is 5 Wire or 3 Lead 3 Connect the Therapy cable Quik Combo Items 2 and 3 or Standard Paddles Item 8 between the LIFEPAK 20 and the Safety Analyzer ESA612 at LL and LA snaps 4 Connect the SPO2 ca...

Page 50: ...TENTS Page 50 of 61 1 LP20 DEVICE FACE LP20 DEVICE REAR LP20 LEAKAGE CURRENT TEST SETUP Std Paddles Connect Paddles To Device 8 6 7 5 4 1 2 LP20 DEVICE FACE LP20 DEVICE REAR LP20 LEAKAGE CURRENT TEST SETUP Quik Combo Cable 3 6 7 5 4 OR Figure 1 28 LP20 Leakage Current Test Setup ...

Page 51: ...cted to the safety analyzer 1 Turn the device ON 2 Press the A button on the Safety Analyzer 3 Press the F1 DIRECT EQUIPMENT button on the Safety Analyzer and set the Safety Analyzer controls as follows Note Pause briefly between switching polarity to prevent damage to the defibrillator 4 Verify the device AC Mains LED is ON 5 Verify the measured current is between 15 A and 270 A 120 VAC or betwee...

Page 52: ...Setup on Direct Applied Part Leakage Tests WARNING SHOCK HAZARD During Direct Applied Part Leakage tests high voltage is present on the Safety Analyzer electrode snaps Do not touch snaps or device connections during these tests WARNING POSSIBLE EQUIPMENT DAMAGE Do not defibrillate when connected to the safety analyzer ...

Page 53: ...t up the Safety Analyzer to measure Direct Applied Part Leakage 1 Press the A button on the Safety Analyzer 2 Press the F4 MORE button 3 Press the UP DOWN arrows to select the appropriate A P groups as shown in Figure 1 29 4 Press F1 SELECT then F1 Direct A P Figure 1 29 Direct Applied Part Leakage Setup ...

Page 54: ...AMAGE Do not defibrillate when connected to the safety analyzer 1 Turn the device ON 2 Press the LEFT RIGHT arrows to select the RA lead and set the Safety Analyzer controls as follows 3 Press the TEST button to measure the Direct Applied Part Leakage current 4 Verify the device AC Mains LED is ON 5 Verify the measured current is between 2 A and 45 A 120 and 240 VAC ...

Page 55: ...fety analyzer 1 Turn the device ON 2 Press the LEFT RIGHT arrows to select the LL and LA leads and set the Safety Analyzer controls as follows Note The A P group should be set up to measure the combined leakage of the LL and LA leads 3 Press the TEST button to measure the Direct Applied Part Leakage current 4 Verify the device AC Mains LED is ON 5 Verify the measured current is between 2 A and 262...

Page 56: ...pO2 WARNING POSSIBLE EQUIPMENT DAMAGE Do not defibrillate when connected to the safety analyzer 1 Turn the device ON 2 Press the LEFT RIGHT arrows to select the RL lead and set the Safety Analyzer controls as follows 3 Press the TEST button to measure the Direct Applied Part Leakage current 4 Verify the device AC Mains LED is ON 5 Verify the measured current is less than 2625 A 120 VAC and 240 VAC...

Page 57: ... Do not defibrillate when connected to the safety analyzer To perform the Earth Leakage test in accordance with IEC 60601 set up the Safety Analyzer as follows 1 Press the SETUP button on the Safety Analyzer 2 Press the F4 MORE button 3 Press the F2 INSTRUMENT button 4 Press the F1 STANDARD button 5 Press the UP DOWN arrows to select the 60601 Standard 6 Press the DONE button ...

Page 58: ...n connected to the safety analyzer 1 Turn the device ON 2 Press the A button on the Safety Analyzer 3 Press the F1 EARTH button on the Safety Analyzer and set the Safety Analyzer controls as follows Note Pause briefly between switching polarity to prevent damage to the defibrillator 4 Verify the device AC Mains LED is ON 5 Verify the measured current is between 15 A and 2250 A 120 VAC and 240 VAC ...

Page 59: ...the device ON 2 Press the A button on the Safety Analyzer 3 Press the F1 EARTH button on the Safety Analyzer and set the Safety Analyzer controls as follows Note Pause briefly between switching polarity to prevent damage to the defibrillator 4 Verify the device AC Mains LED is ON 5 Verify the measured current is between 15 A and 2625 A 120 VAC and 240 VAC ...

Page 60: ...spection Procedure PIP 3201896 000_B 2019 Stryker CONTENTS Page 60 of 61 PIP Restore Customer Settings Restore customer settings 1 Enter SETUP menu 2 Choose MANUAL MODE 3 Choose MANUAL ACCESS 4 Choose CUSTOMER S NORMAL SETTINGS ...

Page 61: ... Road NE Redmond WA 98073 9708 USA Tel 425 867 4000 Fax 425 458 1404 www strykeremergencycare com Stryker Australia Pty Ltd 8 Herbert Street St Leonards NSW 2065 Australia Physio Control Inc 11811 Willows Road NE Redmond WA 98052 USA Stryker European Operations B V Herikerbergweg 110 1101 CM Amsterdam The Netherlands _________________________________________________________________________________...

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