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Arrhythmia Detector Performance

ECG Analysis System - ECG Database Test

ECG

Rhythm

Class

Rhythms

Minimum test

sample size

Performance

goal

Test

sample

size

Shock

Decision

No Shock

Decision

Observed

Performance

90% One

Sided Lower

Confidence

Limit

Coarse
VF

200

>90%

sensitivity

219 213 6

97.26%

(213/219)

sensitivity

95%

KABL

Fast VT

>75%

sensitivity

137 111 26

81.02%

(111/137)

sensitivity

76%

Normal
Sinus
Rhythm

100

minimum

(arbitrary)

> 99%

specificity

100 0 100

100%

(100/100)

specificity

97%

AF,SB,S
VT, heart
block,
idioven-
tricular
PVC’s

(arbitrary)

> 95%

specificity

219 1 218

99.54%

(218/219)

specificity

98%

ON S

Asystole 100

> 95%

specificity

132 5 127

96.21%

(127/132)

specificity

93%

Содержание i-PAD NF1200

Страница 1: ...1 Service Manual CU Medical Systems Inc i PAD NF1200 ...

Страница 2: ...2 i PAD NF1200 Quick Reference Card Rescue Steps 1 Connect the defibrillator pads to the i PAD and then place on patient 2 Stand clear and press the SHOCK button if instructed 3 Administer CPR ...

Страница 3: ...vice specifications contained in this manual at any time without prior notice or obligation to customers Printed in the Republic of Korea Publication Date March 2007 Service Manual Part No 2007 CU Medical Systems Inc No part of this manual may be reproduced without the permission of CU Medical Systems Inc ...

Страница 4: ... 4 Batteries 16 3 Performance Verification 17 3 1 Self Tests 17 3 2 Automatic Self Tests 18 3 3 Battery Insertion Test 18 3 4 Self Test Results 18 3 4 1 Automatic Self Tests 18 3 4 2 Battery Insertion Test 18 3 5 Shock Waveform Verification Test 20 3 6 Data Transmission Test 22 3 7 Impedance Measurement Test 23 3 8 Voice and Text Prompt Testing 24 4 Troubleshooting 26 4 1 How to Use This Section 2...

Страница 5: ...or qualified service personnel who will repair and service the i PAD NF1200 1 3 Warnings Cautions and Notes WARNING used to denote conditions hazards or unsafe practices that can result in serious personal injury or death CAUTIONS used to denote conditions hazards or unsafe practices that can result in minor personal injury damage to the i PAD NF1200 or loss of data stored in it NOTES used to deno...

Страница 6: ...esistor Battery Pack High Voltage Power Supply Therapy Capacitor General Power Supply 12V Electrical energy High Voltage Electrical energy High Voltage Electrical energy 15V 5V 3 3V 3 3V 1 8V To various parts of the device Data Storage and Backup Subsystem To External Device High Voltage Subsystem Analog Front end Subsystem Main Digital Subsystem Power Supply Subsystem Data Storage and Backup Subs...

Страница 7: ...7 1 4 1 Operating Controls Indicators and Accessories 1 4 1 1 Device Parts Illustration Top View of the i PAD NF1200 with its cover closed ...

Страница 8: ...8 Perspective view of the i PAD NF1200 with its cover open ...

Страница 9: ...es last use information and it senses and waits for a possible data transfer to a personal computer Handle An easy grip carrying handle for increased portability of the i PAD Cover Covers the front panel of the i PAD and retains the defibrillator electrode pads package SHOCK button Press this button when the i PAD prompts you to Press the flashing orange button now Pressing this button delivers a ...

Страница 10: ...sable non rechargeable LiMnO2 battery pack Power source of the i PAD NF1200 This battery is inside the case of the device RETURN the i PAD NF1200 to an authorized service representative in case the battery pack needs to be replaced Optional Accessory Carrying Case Used to store the i PAD NF1200 and the accessories needed for a rescue operation Using accessories and cables other than the ones speci...

Страница 11: ...en delivered to the patient Begin CPR now Indicates the start of CPR You may touch the patient after this prompt is given Push the chest down fast two inches Indicates that you have to push the chest down for about two inches during CPR The chest has to be pushed down fast Give two breaths Breath breath Indicates that you have to give artificial breaths to the patient Time the breaths with the bre...

Страница 12: ...e Indicates the duration in minutes that the i PAD NF1200 was ON In this case the i PAD NF1200 was ON for 10 minutes during its previous usage Shock delivery is 4 times Given during administration mode Indicates the number of shocks that the i PAD NF1200 delivered In this case the i PAD NF1200 delivered four shocks during its previous usage ...

Страница 13: ...ed with any of the following solvents Soap and water 70 solution isopropyl alcohol Chlorine bleach and water mixture 30 ml bleach liter of water Ammonia based cleaners Hydrogen peroxide Do not immerse any part of the i PAD NF1200 in fluids Do not let any fluid enter the case of the device Do not spill liquids on the case of the device Do not use strong acetone based cleaners in cleaning the device...

Страница 14: ... Check supplies accessories and spare parts for damage and expiration If any supplies have expired replace them immediately Initiate complete self test by doing a Manual Self Test If the self test detects any problem see the chapter on Troubleshooting Check the case of the i PAD NF1200 and the accessories for any sign of apparent damage If there is any apparent damage to the case of the device con...

Страница 15: ...eduled Frequency i PAD NF1200 Clean no signs of damage free of excessive wear Supplies Available 2 sets of defibrillator electrode pads undamaged sealed within expiration date supplementary supplies razor scissors gloves gauze Remarks Problems Corrective Actions Inspected by Signature of operator doing the inspection ...

Страница 16: ...with a new one The sequence of indications from a to e above is also given when the low battery level is detected during battery insertion test Keep the battery pack out of children s reach If the battery pack leaks and the leaked liquid gets in the eyes wash them with clean water and consult a physician immediately Do not leave the battery pack in direct sunlight or in high temperature areas Do n...

Страница 17: ...he tests done during automatic self tests You have to insert a functioning battery pack to initiate a battery insertion test Daily self tests as the name indicates are conducted daily A test counter is incremented whenever an automatic self test is conducted Reckoning of self test timing starts whenever a battery pack is inserted For example if the battery pack is inserted at 11 am on January 1 th...

Страница 18: ...attery with a new one if the i PAD NF1200 detected a low battery level System failure Error code is 2 if the i PAD NF1200 detected a system failure The error code is a number from 2 to 128 v The i PAD NF1200 turns off automatically vi The State LED flashes in red every 5 seconds and the beeper emits three successive beeps every minute to signify the occurrence of an error 3 4 2 Battery Insertion T...

Страница 19: ...en if the cause of the error is a system error The error code is a number between 2 and 128 e The i PAD NF1200 turns OFF automatically f The State LED flashes in red every 5 seconds and the beeper emits three successive beeps every minute to signify the occurrence of an error The list of ERRORS and the corresponding meanings are given in the following table Table Self Test Error Codes Error Name E...

Страница 20: ...robes up to 2500 V capacity and current probe up to 100 A capacity X 25Ω 1 100W Wire Wound 50Ω 1 100W Wire Wound 100Ω 1 100W Wire Wound 125Ω 1 100W Wire Wound 150Ω 1 100W Wire Wound Various 100 Watt resistances Y 50Ω 1 100W Wire Wound Test Setup Defibrillator under test Defibrillator Analyzer X Y Oscilloscope Current probe resistance resistance ...

Страница 21: ...the impedance load adjustment network 5 Connect the high voltage probe to the connector as shown in the test setup above 6 Set the output of the i PAD NF1200 7 Set the defibrillator analyzer to output a shockable rhythm 8 Set the defibrillator analyzer to measure the energy of the DUT output 9 Set the oscilloscope for a single sequence operation and set the trigger level accordingly 10 Set the osc...

Страница 22: ...tup run for at least 1 minute 3 Turn the setup OFF 4 Disconnect the defibrillator analyzer from the i PAD NF1200 5 Connect the i PAD NF1200 to the personal computer through any desired COM Port using the IrDA Com Port Serial Adapter 6 Set the options of the CU Expert for a data reception in accordance with the instructions in its user s manual Do not begin data reception yet 7 Set the CU Expert to...

Страница 23: ...resistive impedance load to 10Ω 3 Turn the i PAD NF1200 ON 4 Verify that the i PAD NF1200 does not go beyond the prompt ATTACH PADS The i PAD NF1200 senses that the impedance is outside the acceptable limits and it interprets the situation as having the pads not attached to the patient 5 Turn the i PAD NF1200 OFF 6 Do steps 2 to 5 Vary the setting in step 2 from 10Ω to 200Ω 7 Verify that the i PAD...

Страница 24: ...nd the actions that the operator and bystanders must do during a rescue operation Test Procedure Equipment needed Defibrillating ECG Pads Assembly Defibrillator Analyzer 1 Set the defibrillator analyzer to output an 80 bpm 1 mV normal sinus rhythm ECG waveform Connect the i PAD NF1200 to the defibrillator analyzer 2 Verify that the i PAD NF1200 goes through the protocol shown in the figure in the ...

Страница 25: ...25 i PAD NF1200 Rescue Protocol ...

Страница 26: ...easy to replace items like fuses 4 4 Troubleshooting Guide Failure i PAD NF1200 does not turn ON Possible Causes Action s 1 Low Battery Charge This condition is detectable by the self tests Perform a battery insertion test using a new battery pack 2 Discontinuity between the battery pack and the power board Check the condition of the battery pack contact spring J8 on the power board If damaged rep...

Страница 27: ...lat cable connector between terminal J3 on the main PCB board and terminal J7 on the power board If there is a fault change the connector If the problem is not with the flat cable connector change the power board If the problem is not with the cable connector and the power board change the main PCB board SYSTEM ERROR 0032 Charging failure Replace the power board If the problem is not with the powe...

Страница 28: ...a Connect the i PAD NF1200 to an AED analyzer Set the analyzer to output a normal sinus rhythm any rate between 40 and 150 bpm Verify that the i PAD NF1200 goes past the ATTACH PADS prompt b Connect a 50Ω resistor across the ECG DEFIB port Verify that the i PAD NF1200 goes past the ATTACH PADS prompt If the problem persists after the replacement of the power board put the original power board back...

Страница 29: ... codec interface failure Change the main PCB Verify the solution by doing the verification step in possible cause no 1 If the problem is not solved contact the manufacturer Failure Beeper is not working Possible Causes Action 1 Beeper failure Replace the Beeper Verify that the problem is solved by running the i PAD NF1200 with a Ventricular Fibrillation input from a defibrillator analyzer Verify t...

Страница 30: ...e verification test in possible cause no 3 above 5 High voltage subsystem failure Replace the power board with a new one Verify the solution by running the verification in possible cause no 3 above If the problem persists put the original power board back 6 Defibrillating capacitor failure Replace the defibrillating capacitor with a new one Verify the solution by running the verification step in p...

Страница 31: ...d Verify the solution by making the i PAD NF1200 conduct automatic self tests If the problem persists put the original main board back and contact the manufacturer Failure The i PAD NF1200 keeps incorrect date and time Possible Causes Action 1 Real time clock chip battery failure Replace the dedicated real time clock battery cell Verify the solution by doing the following 1 Synchronize the i PAD N...

Страница 32: ...en the IrDA port and the IrDA COM Port Serial Adapter is blocked Verify that the pathway between the IrDA port of the i PAD NF1200 and the IrDA COM Port Serial Adapter is not blocked 5 IrDA COM Port Serial Adapter failure Replace the IrDA COM Port Serial Adapter 6 IrDA port controller failure Replace the main board PC side 8 Incorrect COM Port setting Verify that the COM Port set on the Options di...

Страница 33: ... if the SHOCK button is not pressed 15 seconds after a prompt to press the shock button is given It is also designed to dump the charge if it is turned OFF while the defibrillating capacitor contains a charge Thus under normal circumstances no charge will be stored in the defibrillating capacitor if it is turned OFF However in cases when the device malfunctions the internal dumping functionality o...

Страница 34: ...e battery pack from its receptacle 2 Remove the screws at the bottom of the chassis of the device These screws hold the top and bottom cases of the device together The locations of the screws are shown encircled in the figure below ...

Страница 35: ...ing Discharge the defibrillating capacitor Disconnect the defibrillating capacitor connector shown encircled above The ENERGY stored in the DEFIBRILLATING CAPACITOR is LETHAL To prevent any chance of unintentional SHOCK the DEFIBRILLATING CAPACITOR MUST BE DISCHARGED before handling ...

Страница 36: ...onnection between the power board and the main board Disconnect the connectors between the power board and the ECG Defib port and the ECG Hybrid circuit Remove the screws that hold down the power board These are encircled in the picture below ...

Страница 37: ...37 5 Lift the power board 6 Remove the insulator between the power board and the main PCB board by removing the screws encircled in the picture below ...

Страница 38: ...38 7 Remove the screw that holds the main PCB board to the i PAD NF1200 chassis This screw is shown encircle below Then lift the main PCB board off the chassis ...

Страница 39: ...39 8 You will see the top case after you lift up the main PCB board This is shown in the picture below ...

Страница 40: ...40 5 2 Reassembly 1 Reverse the disassembly process Place the boards and the screws and reconnect the connectors in reverse order of the disassembly process ...

Страница 41: ...41 6 Assembly Diagram ...

Страница 42: ...42 Assembly Diagram Larger version A3 size ...

Страница 43: ...non condensing Temperature 4 F to 140 F 20 C to 60 C Storage Conditions device only no AED pads Humidity 5 to 95 non condensing Altitude Operating 0 to 15 000 feet Storage 0 to 15 000 feet Shock Drop Abuse Tolerance Withstands 1 2 meter drop to any edge corner or surface MIL STD 810F Method 516 5 Procedure IV Vibration Meets MIL STD 810F Method 514 5 Road Transportation Air Transportation Road Ope...

Страница 44: ...ce Limit Coarse VF 200 90 sensitivity 219 213 6 97 26 213 219 sensitivity 95 SHOCKABLE Fast VT 50 75 sensitivity 137 111 26 81 02 111 137 sensitivity 76 Normal Sinus Rhythm 100 minimum arbitrary 99 specificity 100 0 100 100 100 100 specificity 97 AF SB S VT heart block idioven tricular PVC s 30 arbitrary 95 specificity 219 1 218 99 54 218 219 specificity 98 NON SHOCKABLE Asystole 100 95 specificit...

Страница 45: ... button beep from the beeper Disarm Once charged the i PAD disarms itself if Patient s heart rhythm changes to non shockable rhythm or The SHOCK button is not pressed within 15 seconds after the i PAD is armed or The ON OFF button is pressed to turn OFF the i PAD or The defibrillator pads are removed from the patient or the pads connector is disconnected from the i PAD The battery pack is removed ...

Страница 46: ...00 Joules Patient Impedance Ohms Phase A Duration milliseconds Phase B Duration milliseconds Energy Delivered Joules 25 1 9 1 9 200 50 3 8 3 8 200 75 5 7 5 7 200 100 7 3 7 3 199 125 9 2 9 2 199 150 11 0 11 0 200 175 12 8 12 8 200 ...

Страница 47: ...ts Category Nominal Specifications Controls Power On Off Button i Button Shock Button Indicators State LED Graphical Rescue Guide LED Audio Speaker Provides voice prompts Beeper Provides various audible indications Low Battery Detection Automatic during daily weekly and monthly testing Power ON and runtime testing Low Battery Indicator State LED and Voice Prompt Prompts Voice prompts guide the use...

Страница 48: ...lation pads for patients 8 years of age and older or 55 lbs 25 kg and over Surface Area Adult 110cm2 each Cable Length 1 5m Data Recording and Transmission Category Nominal Specifications Infrared Wireless transmission of event data to PC through IrDA port Data Stored First 40 minutes of ECG and the entire incident s events and analysis decisions ...

Страница 49: ...are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B Harmonic Emissions IEC 61000 3 2 Not Applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not Applicable The i PAD NF1200 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply netw...

Страница 50: ...pplicable Surge IEC 61000 4 5 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment 5 UT 95 dip in UT for 0 5 cycles Not Applicable 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles Mains power quality shoul...

Страница 51: ...range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency ...

Страница 52: ...12 m 23 m For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequen...

Страница 53: ...ggi 431 070 Republic of Korea Tel 82 31 478 5725 Fax 82 31 478 5729 Service Request and Technical Support Customer Service Team CU Medical Systems Inc Medical Instrument Industry Park 1720 26 Taejang dong Wonju si Kangwon do Korea Tel 82 33 747 7690 Fax 82 33 747 7659 Homepage www cu911 com Sales inquiries sales cu911 com Technical inquiries techinfo cu911 com Service service cu911 com ...

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