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Instruction Manual for the IPAD SP1

1. NO i button is v Voice Prompt Re analyzing I heart rhythm in 2 minutes YES Y Voice Prompt Place the heel of one hand on the center of the chest Voice Prompt Re analyzing between the nipples heart rhythm in 1 minute Y Y Voice Prompt Place the heel of your other hand on top of the first Voice Prompt Re analyzing heart rhythm in 40 seconds Y Y Adult Pediatric Voice Prompt Re analyzing dult or Pediatric heart rhythm in 20 seconds v Y v Voice Prompt Push the chest down Voice Prompt Push the chest down 2 A firmly 2 Inches in time with the beat Inches in time with the beat v Voice Prompt Beat Sound Pediatric Adult or Pediatric i Voice Prompt oo n Continue ji Voice Prompt Tilt head pinch nose Voice Prompt Pinch nose tilt head and i compressions and give breath give small breaths v Voice Prompt Breathe j P NO Number of Cycle gt 5 gt i YES o 47 B Parts and Accessories To order replacement parts and accessories cite the part and ordering numbers given in the following table B 1 Standard Accessories Name Part Number Ordering Number Adult Pads disposable CUA1007S SP OA03 Disposable Battery Pack CUSA1103BB SP OA02
2. V TI The pads are beyond their expiration date Replace the pads with a new one E gt e AA Press the pads firmly to the bare skin of the patient Voice Prompt No shock delivered Cause An error has occurred in the device The Pad Connector is disconnected The pad has been previously used The pad is not properly attached to the patient s The pad is not properly adhering to the patient s skin Resolution Immediately replace the defibrillator and perform CPR if appropriate Replace the battery with a new one Replace the pad with a new one Replace the battery with a new one Ensure the Pad Connector is properly connected Replace the pad with a new one Replace the pad with a new one E lt lt andl securely attached to the patient s skin P ETT patient s skin Shave chest hair or wipe off moisture if necessary 41 Voice Prompt Shock button was not pressed Although an electric shock is needed the Shock Button was not pressed within 15 seconds Deliver an electric shock by pressing the Shock Button with the next voice instruction e If the problem cannot be solved during an emergency you should follow the following steps Quickly replace the defibrillator if possible GH no replacement device is available check the patient s condition and perform CPR as necessary Contin
3. 90 One ECG Minimum Test Performan Shock No Shock Observed Sided Lower Rhythm Rhythms test sample sample ce goal Decision Decision Performance Confidence Class size size Limit 97 26 gt 90 Coarse VF 200 219 213 6 213 219 95 B sensitivity D sensitivity Y o Q 81 02 o gt 75 Fast VT 50 137 111 26 111 137 76 sensitivity sensitivity 100 100 Normal Sinus gt 99 minimum 100 0 100 100 100 97 Rhythm specificity arbitrary specificity uj AF SB SVT heart 99 54 S 30 gt 95 O block 219 1 218 218 219 98 T arbitrary specificity idioven specificity tricular PVC s 96 21 gt 95 Asystole 100 132 5 127 127 132 93 specificity specificity 62 Control Devices Indicators Voice Instructions Category Nominal Specifications Control Devices Power Button i Button Shock Button Adult Pediatric Selection Switch Status LCD Displays device status battery level and pad status Do Not Touch Patient Indicator Lights when the defibrillator is analyzing or delivering an electric shock Pad Patch Position Indicators Flashes when the defibrillator is turned on turns off when the pad is attached on the patient Pad Connector Status Indicator Flashes when the defibrillator is turned on and the pad connector is not connected lights when the pad connector is connected Indicator CPR Detection Indicator Lights if CPR is detected flashe
4. A2 2007 EMI Radiated Group 1 Class B Meets IEC 60601 1 2 limits method EN 61000 4 3 2006 A1 2008 Level 3 10V m 80MHz to 2500MHz EMI Immunity 58 Defibrillator Category Operating Mode Waveform Output Energy Charge Control Charging Time Time from initiation of rhythm analysis voice instruction DO NOT TOUCH PATIENT ANALYZING HEART RHYTHM to readiness for discharge voice instruction PRESS THE Nominal Specifications Semi automated e cube biphasic Truncated exponential type 150 Jat 50 Q load for adults 50 Jat 50 Q load for children Controlled by an automated patient analysis system Within 10 seconds from when the voice instruction An electric shock is needed is issued New battery pack 10 Seconds typical New battery pack 16 shock FLASHING ORANGE BUTTON NOW DELIVER SHOCK NOW discharge 11 Seconds typical Time from Power ON to readiness for discharge voice instruction PRESS THE FLASHING ORANGE New battery pack 16 shock discharge 25 Seconds typical BUTTON NOW DELIVER SHOCK NOW Charging Indicator Time from CPR to Shock Discharge Shock Delivery Shock Delivery Vector Patient Isolation e Voice Instruction Press the Flashing Orange Button Now Deliver Shock Now e Flashing Shock Button e Beeper At least 6 seconds from the completion of CPR to shock delivery The device performs a self discharge in the following events
5. CU Expert includes ECG review and printing functions Position the IrDA adapter to face the IrDA port on the device as shown in the figure below 2When the i Button is pressed for at least 1 second in standby mode the mode changes to administrator mode with a voice guide 29 3 The device gives the you a summary the total hours of the last device use and the number of defibrillation shocks delivered The voice guide gives the S W version of the device When instructed to transfer the treatment history press the i Button to transfer the data If there is treatment data in the device s internal memory The voice guide reports the total number of individual treatment data recorded in the device By default of a maximum of 5 individual treatment data the first on the list is the most recent Gin order to rearrange the order for copying to a PC press the Shock Button to change the order to most recent last and then press the i Button to transfer the selected data Run CU Expert on the PC Refer to the CU Expert manual for detailed information regarding how to receive data S The device will be connected with the CU Expert within a few seconds and data will be automatically transferred 6When copying is completed the mode changes to CPR guide setting mode Refer to Section 5 3 Device Setting for details regarding changing CPR guide setting If there is no treatment data in the device s internal memory The device m
6. e When the patient s ECG changes to a rhythm that does not require defibrillation e When the Shock Button is not pressed within 15 seconds from the completion of the charge e When the device is turned off by pressing the Power Button for at least second e When the pad is detached from the patient s body or the pad connector is detached from the device e When the impedance of the patient is out of the range of defibrillation 250 1750 Shock is delivered if the SHOCK button is pressed while the CU SP1 is armed e Adult pads in the anterior anterior position e Pediatric pads in the anterior posterior position Type BF defibrillation protected 59 current A time ms Biphasic Truncated Exponential Type The shock waveform profile is automatically compensated for the patient s transthoracic impedance A first phase duration B second phase duration0 C interphase duration D peak current Output Waveform for Adult 150 Joules Patient Impedance First Phase duration Second Phase duration Peak Current Energy Joules J Energy Accuracy Ohms Q 25 50 75 100 125 150 175 milliseconds ms 2 4 4 4 6 3 8 8 10 7 12 7 15 0 milliseconds ms 2 4 4 4 6 3 8 8 10 7 12 7 15 0 Output Waveform for Child 50 Joules Patient Impedance First Phase duration Second Phase duration A 64 5 32 7 22 5 15 9 13 0 11 0 9 5 Peak Current 147 8 149 7
7. Instructions for Use SP1 OPM E 01 S B 2 Optional Accessories Pediatric Pads disposable CUA1102S SP OA04 IrDA Adapter IR 220LPLUS SP OA05 SD Card HD1 CARD SD SP OA07 SD Card Reader HD1 CARD READER SP OA08 Carrying Case SP1 A BAG 3010 SP OA01 PC SW CU Expert ver 3 50 or higher SP OA06 48 C Description of Symbols C 1 i PAD CU SP1 Defibrillator Symbol Description Power ON OFF button fe A L i Button SHOCK button Adult Pediatric Selection Switch Do Not Touch Patient Indicator CPR Detection Indicator BF type defibrillation proof equipment A Attention Refer to accompanying documents ce CE Mark meets the requirements of the European Medical TuS Device Directive 93 42 EEC and its revisions SN Serial Number ow Date of manufacture 49 C 2 i PAD CU SP1 Packaging Stack up to 6 cartons high only Wa lt 3 E o This side up Keep dry Fragile breakable Use no hooks 9 is lle EN 3 8 5o I Storage Temperature limits 0 Cto 43 432 Fto 109 F CE Mark meets the requirements of the European Medical C 0470 Device Directive 93 42 EEC and its revisions SN Serial Number 50 C 3 Accessories C 3 1 Disposable Battery Pack CUSA1103BB Symbol Description Lithium Manganese Dioxide battery LOT Lot Number ed exp DATE Expiration date and Install by date Do not mu
8. LCD and the i Button will flash in red When the i Button is pressed as directed by the voice instructions the device will report the error and turn itself off Refer to Section 8 3 Troubleshooting for more information 38 Self Test Type Description Power ON Test The device performs a self diagnostic test when the Power Button is pressed Run time Test The device monitors itself in real time during its operation Periodic This device performs self diagnostic tests daily weekly and monthly The Self Diagnostic periodic self test checks important features of the device such as the Test battery status pad status and internal circuits If the device fails to perform any self test during use and is unable to defibrillate it will instruct the you to replace the device and start the voice instruction for CPR In order to check the error turn the device off by pressing the Power Button If you press and hold the i button the voice will direct the you to press the blinking red i Button You can verify the cause of the error via the voice instruction by pressing the i Button Refer to Section 8 3 Troubleshooting for more information CAN caution CAUTION It is recommended to run the battery insertion test only during the times enumerated in the table above The battery insertion test consumes battery power and will shorten battery life if done more frequently than necessary 39 8 2 Device Status T
9. cu911 com Branch Office of CU Medical Systems Inc in Germany Kuester Strasse 6 30519 Hannover Germany Tel 49 511 365 4353 Fax 49 511 848 6054 Service and Technical Support Customer Service Team CU Medical Systems Inc 5F Cheonggye Plaza 991 4 Cheonggye Uiwang Gyeonggi Republic of Korea Tel 82 31 421 9700 Fax 82 31 421 9911 E mail addresses service cu911 com IPA P INZALS Intelligent Public Access Defibrillator CU SP1 Operator s Manual Edition 1 CU Medical Systems Inc Table of contents INTRODUCTION nan nn a a ir 6 OVERVIEW anna Ban mama ia 7 Be INTRODUCTION ne iii in Pura aan nan 8 ial DEVICE DESCRIPTION dee SE vetro 8 1 2 INDICATED USE cn pito A A AAA NN en IN BnR 8 1 9 INTENDED USERS 42 2 tet di en dies 9 ER LOCAL ien tere 9 1 5 ADDITIONAL INFORMATION anakan 9 2 DEVICE FEAT URE S etienne tet aan aa Laga naa 10 3 PREPARATION FOR USE a An a Iit rere tre tnnt bian nn akan angan 13 3 1 STANDARD PACKAGE CONTENTS WWW WWW Wanna 13 3 2 SETTING UP THE I PAD GU S RTL ee ata samaan 14 4 HOW TO USE THE I PAD CU SPT oooooooooo om momo an na 16 zm e ensi 16 4 2 PREPARATION FOR DEFIBRILLATION nennen nennen nennt snnt nnns nnne nnns 17 4 3 DEFIBRILLATION IN ADULT Mon 21 Step 1 Place pads on the patient oo WoWoWoWo WWW WWW WWW 21 Step 2 Press the Shock Button if instructed oooooWooWo WoW
10. gt 8 PAD CU Medical Systems Inc cana CU SP1 Semi automatic External Defibrillator Instructions for Use ZEN PT E CU Medical Systems Inc Instructions Step 1 Tear open the packaging of the pads We the pads from the packaging to Remo gi Note The pads are attached to a single liner Step 3 1 Battery Pack Disposable Peel off the pads from the liner one by one s each pad is peeled off attach itto the patient as shown in step 4 4 1 8 D 3 1 Pack of Adult Pads Disposable Please contact the manufacturer for replacement supplies refer to Appendix B Parts and Accessories of these Instructions for Use Gi WARNING v Only parts and accessories recommended and approved by CU Medical Systems Inc must be used with the i PAD CU SP1 Using unapproved parts and accessories may compromise the safety and effectiveness of the i PAD CU SP1 v Extra battery packs and pads are recommended 3 2 Setting up the i PAD CU SP1 Do the following to set up the i PAD CU SP1 Open the package and verify that it contains all the items listed in the packing list 2 Familiarize yourself with the device features by referring to Chapter 2 Device Features of these Instructions for Use S Insert the battery pack into the battery compartment on the device as shown in the figure below As the
11. the heart causing ineffective circulation Ventricular fibrillation is accompanied with an acute cardiac arrest A status in which the indicator is flashing A button to check the most recent device usage to report error messages to transfer the ECG and event data and to change the CPR guide settings A communication port that sends and receives data between the device and computer Since this IrDA port utilizes light infrared care needs to be taken to reduce interference Refer to the CU Expert manual for more information A status in which the indicator is lit An O on the Status LCD while the device is on indicating that the device is properly operating The pad stated in these Instructions for Use refers to a pad disposable for defibrillation Refers to a pad that is placed under the right clavicle Please refer to the picture on the pad The position may be switched with pad 2 Refers to a pad that is placed on the ribs on the patient s lower left chest directly under the armpit Please refer to the picture on the pad the position may be switched with pad 1 55 Pad Connector PC S W CU Expert CU EX1 Pediatric Power Button Device Pad liner SD Card Self Test Internal discharge disarm The connector on the pad that is used to connect the pad with the i PAD CU SP1 PC software used to modify the settings of the i PAD CU SP1 and to manage treatment data Refer to the app
12. the pad Refer to the figure below for checking the expiration date EXP 2 MM YYYY 1234567890 wm HI E SE vas Do The expiration date is marked as The expiration date is marked to the left follows of the Multifunction Defibrillation MM YYYY ADULT PADS label on the pad YYYY Year package MM Month 2 Used or expired pads should be replaced Hold the top and bottom of the pad connector with your fingers pull it out and take the pads out from the Pad Storage Compartment as illustrated below 36 3 Insert the pad connector of the new pad into the Defibrillator Pads Connector and then put the pad package in the Pads Storage Compartment as illustrated below 6 2 3 Cleaning the i PAD CU SP1 Clean the device with a soft cloth The following detergents may be used to clean the exterior of the device Dilute soap and water Dilute chlorine bleach dilute 30 ml of chlorine bleach in one liter of water Dilute ammonia based cleaners Dilute hydrogen peroxide ED CAUTION Do not immerse the device or its accessories in liquids Be careful not to allow any liquids to get into the device If the device is immersed in liquids immediately contact the manufacturer or its authorized service center Giving excessive force or shock while cleaning the device may cause damage Do not use an acetone based strong detergent or abrasive when
13. when performing CPR 32 6 Maintenance 6 1 Device Storage Please refer to the precautions below when storing the Device in order to avoid device damage Do not operate or store the device in conditions that are beyond the following specified limits Storage Conditions The device is stored together with the defibrillator pads and the battery pack is inserted ready to be used in an emergency Temperature 0 C 43 C 32 F 109 F Humidity 5 95 non condensing Transport Environment device only no defibrillator pads and battery pack included Temperature 20 C gt 60 C 4 F gt 140 F Humidity 5 95 a location with no condensation Do not store the device in areas that are directly exposed to sunlight Do not store the device in areas with highly fluctuating temperatures Do not store the device near heating equipment Do not store the device in areas where there is high vibration in excess of Road Transportation and Helicopter Minimum Integrity of MIL STD 810G Method 514 5C Do not operate or store the device in environments with high concentration of flammable gas or anesthetics Do not operate or store the device in areas with high concentration of dust Only personnel authorized by the manufacturer may open the device for servicing There are no user serviceable components inside the device 33 6 2 Maintenance 6 2 1 Device Inspection The i PAD CU SP1 has self testing capabil
14. 151 5 148 1 149 148 2 148 8 Energy Joules J Joules J 150 15 150 15 150 15 150 15 150 15 150 15 150 15 we e Jeer A S Energy Accuracy Ohms Q 25 50 75 100 125 150 175 milliseconds ms 2 3 4 3 6 3 8 5 10 6 12 7 15 0 milliseconds ms 2 3 4 3 6 3 8 5 10 6 12 7 15 0 60 A 35 4 18 4 12 3 9 1 7 3 5 8 4 9 50 2 50 7 49 7 49 5 50 3 49 49 6 Joules J See 0 15 ECG Acquisition Category Acquired ECG Lead Frequency Response ECG Analysis System Category Function Impedance Range Shockable Rhythms Non Shockable Rhythms Analysis Protocol Sensitivity and Specificity Nominal Specifications Lead Il 1 Hz to 30 Hz Nominal Specifications Determines the impedance of the patient and evaluates the ECG of the patient to determine whether it is shockable or non shockable 250 to 1750 shock will not be delivered if the patient s impedance is beyond this range Ventricular Fibrillation or Fast Ventricular Tachycardia ECG rhythms excluding ventricular fibrillation and ventricular tachycardia When a rhythm that does not require defibrillation is detected the device directs you to perform CPR Prepare for shock delivery of pause for CPR depending on the results of analysis Meets ANSI AAMI DF80 guidelines 61 ECG Analysis System ECG Database Test
15. 4 If you have not been trained in CPR you should perform only chest compression or follow the instructions of the emergency medical services agent on the phone elf you are trained for CPR and able to perform artificial respiration perform the chest compression along with artificial respiration e The CPR guide can be set on an administrator s mode Refer to Section 5 3 Device Setting for more information SD CAUTION e While playing the CPR guide the device does not analyze the patient s ECG After the CPR guide the device automatically starts the reanalysis of the patient s ECG In order to turn the device off after use press the Power Button for at least 1 second 25 4 4 Defibrillation Procedures in Pediatric Mode When the patient is older than 1 year and younger than 8 years defibrillation can be done using the pediatric pads When the device is in pediatric mode pediatric pads are connected to the device or the Adult Pediatric Selection Switch is set to Pediatric it automatically sets the defibrillation energy to 50 J and provides pediatric CPR guide Place pads on the middle of the chest and back as illustrated above Pads are not specific to either chest or back If there are no pediatric pads for the pediatric patient use adult pads but set the Adult Pediatric Selection Switch to Pediatric Mode and then perform defibrillation according to the voice instructions Follow the instructions
16. ILLATOR oo Wen 49 2 PAD GU SP1 PACKAGING Senah daa minum mantau nina ana ikan 50 G 3 ACCESSORIES iii Me aa an nan 51 C 3 1 Disposable Battery Pack CUSA1103BB oo Wo WWW WWW 51 C 3 2 Pads CUA1007S CUATTIO2E oo WWW mann 52 D GLOSSARY an ena san enakan 53 E DEVICE SPECIFICATIONS in hn cz tac ocio an ma ama 58 F I PAD CU SP1 SHOCK WAVEFORM PLOTS oo m mann nan nan 66 G ELECTROMAGNETIC COMPATIBILITY oom Woman an nan nan 73 Introduction These Instructions for Use contain information necessary for the correct use of this device Please contact us regarding any questions or issues on the use of the device arising from information found in these Instructions for Use Chapter 9 Device Servicel The company or its authorized distributor is not responsible for any injury incurred by the user or patient due to any apparent negligence or improper use by the user Hereinafter device refers to CU SP1 We or Us refers to CU Medical Systems Inc Pad refers to defibrillation electrode pad Battery Pack refers to a disposable battery pack These Instructions for Use emphasizes the safety procedures and precautions for the device use by using the terms below Please acquaint yourself with the warnings cautions and references stated in these Instructions for Use in order to safely use the device AN WARNING WARNING Conditions hazards or unsafe practices that can result in serious personal
17. Instructions for Use i PAD CU SP1 The information in these Instructions for Use applies to the i PAD CU SP1 This information is subject to change Please contact CU Medical Systems Inc or its authorized representatives for information on revisions Revision History Edition 1 Publication Date July 2011 Document No SP1 OPM E 01 Published by CU Medical Systems Inc Printed in the Republic of Korea Copyright 2011 CU Medical Systems Inc No part of these Instructions for Use may be reproduced without the permission of CU Medical Systems Inc Medical Device Directive The i PAD CU SP1 complies with the requirements of the Medical Device Directive 93 42 EEC and its revisions CE 0470 Important Quick defibrillation is needed if sudden cardiac arrest occurs Since the chance of success is reduced by 7 to 10 for every minute that defibrillation is delayed defibrillation must be performed promptly The i PAD CU SP1 is manufactured by CU Medical Systems Inc Dongwha Medical Instrument Complex 1647 1 Dongwha ri Munmak eup Wonju si Gangwon do 220 801 Republic of Korea Authorized EU Representative Medical Device Safety Service Schiffgraben 41 30175 Hannover Germany Contact Us Product and Order Inquiries Overseas Sales Team CU Medical Systems Inc 5F Cheonggye Plaza 991 4 Cheonggye Uiwang Gyeonggi Republic of Korea Tel 82 31 421 9700 Fax 82 31 421 9911 E mail addresses sales
18. an environment 80 MHz to 2 5 GHz 75 Immunity IEC 60601 Test Complia Electromagnetic environment guidance Test level nce level Portable and mobile RF communications equipment should be used no closer to any part of the i PAD CU SP1 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted 3 Vrms 3 Vrms 3 5 RF IEC 150 kHz to 80 MHz d EUIS 61000 4 6 outside ISM bands 10 Vrms 10 Vrms 12 150 kHz to 80 MHz d vP V2 in ISM bands Radiated 10 V m 10 V m 12 RFIEC 80 MHz to 2 5 GHz d IVP 80 MHz 800 MHz 61000 4 3 20 V m 20 V m d CHNP 800 MHz 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in metres m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Cp NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and refection from structures objects and people The ISM industrial scientific and medical bands bet
19. battery pack is inserted the device starts a self test If the device status is norma O is shown on the Status LCD If x O or i is displayed on the Status LCD after the self test please refer to Chapter 8 Troubleshooting of these Instructions for Use Af you have a carrying case please safely store the Device in the carrying case If you want to purchase the carrying case please contact us by referring to Appendix A Accessories of these Instructions for Use Storage and maintenance considerations Refer to Section 6 1 Device Storage for proper device storage instructions When the device is in storage check the Status LCD periodically to ensure that the device is in good condition Store the CU SP1 in accordance with your local emergency first aid protocol Store the device in an easy to access location where its Status LCD can be checked periodically and its technical alarms can be easily heard e g alarm on low battery or other device problems t is also recommended to place an emergency use telephone near the device s storage area so that emergency medical services can be easily called during emergencies Store the accessories along with the device in the device s carrying case for easy and quick access eT WARNING Electromagnetic interference may affect the performance of the device While the device is in use it should be kept away from devices that cause electromagnetic interference Device
20. below when giving first aid during pediatric cardiac arrest When giving first aid during a pediatric cardiac arrest ask others to call the emergency medical center and to bring the i PAD CU SP1 while you are performing pediatric CPR When there is no one else around perform CPR for 1 to 2 minutes call emergency medical services and then get the i PAD CU SP1 If you witnessed the child s collapse call emergency medical services immediately and then get the i PAD CU SP1 26 5 After Using the i PAD CU SP1 5 1 Maintenance After Each Use Check if the device for signs of damage and contamination If there is dirt contamination see Section 6 2 3 on how to clean the device Run a battery insertion test Refer to Section 8 1 Self Diagnostic Test for the procedure If O is displayed on the Status LCD after running the test the device status is normal Dispose of the used pads properly Place a new pouch of defibrillator pads into the pads storage compartment See to it that the pads are not beyond their expiration date The i PAD CU SP1 uses disposable pads Do not reuse them Refer to Section 6 2 2 Replacing Supplies on how to replace the pads warning WARNING You should use only the defibrillator pads provided and recommended by the manufacturer Do not open the pad package until immediately before use Since the adhesive material on the pad starts to dry out as soon as the package is opened the pads may
21. cleaning the device In particular the filter on the IrDA port may be damaged Do not use a detergent containing abrasive ingredients Do not sterilize the i PAD CU SP1 7 Disposal Dispose of CU SP1 and its accessories in accordance with local regulations 37 8 Troubleshooting 8 1 Self Tests The following table lists the self tests done by the device Self Test Type Battery Insertion Test Description Runs when the battery pack is inserted into the device Perform this test Before the device is deployed After each use When replacing the battery When the device is suspected to be damaged CAUTION Do not run this test when you are about to use the device to treat a sudden cardiac arrest victim because this test takes time around 20 seconds If a new battery pack is inserted just before a treatment do the following to cancel this test Press the Power Button Wait for the device to turn OFF Press the Power Button again to turn the device ON Aside from testing its internal systems the device also tests the following during this self test Shock Button and i Button press the buttons one by one when instructed Defibrillator pads status the device tests the connection status whether connected or not and the expiration date of the defibrillator pads If no error is detected O will be displayed on the Status LCD If an error is detected X will be displayed on the Status
22. cription CU SP1 is an easy to use Semi Automated External Defibrillator AED that is small light and portable and uses a battery The AED automatically reads the patient s electrocardiogram ECG and determines if a cardiac arrest that requires defibrillation has occurred so that both medical professionals and the general public can easily operate it Cardiac arrest can occur anytime to anyone at any place and may threaten the patient s life if the appropriate CPR and or electric shock with a defibrillator are not applied within a few minutes The i PAD CU SP1 is a semi automated external defibrillator AED If connected to a patient the i PAD CU SP1 automatically acquires and analyzes the electrocardiogram ECG of the patient for the presence of Ventricular Fibrillation or Ventricular Tachycardia also known as shockable rhythms If a shockable rhythm is detected the device automatically charges itself Defibrillating shock is delivered when the you press the SHOCK button The i PAD CU SP1 is easy to use lt guides the you throughout a rescue operation using voice prompts and indicators LED and graphical indicators The i PAD CU SP1 is small light highly portable and battery powered It is highly suitable for use in public out of hospital settings 1 2 Indicated Use The i PAD CU SP1 is indicated for use on patients that are exhibiting the symptoms of sudden cardiac arrest SCA with all of the following signs a No mov
23. e i PAD CU SP1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the i PAD CU SP1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the i PAD CU SP1 as transmitters recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated 150 kHz to 80 MHz 150 kHz to 80 80 MHz to 800 MHz 800 MHz to 2 5 maximum outside ISM bands MHz in ISM bands GHz output 3 5 12 12 23 power d BKS d ale d Five d e transmitter W El E1 E1 Ela V1 3 Vrms V2 10 Vrms 10 V m 20 V m 10 V m 20 V m 0 01 0 06 0 12 0 12 0 06 0 23 0 16 0 1 0 11 0 38 0 38 0 19 0 73 0 36 1 0 35 1 20 1 20 0 60 2 3 0 1 15 10 1 11 3 79 3 79 1 90 7 27 3 64 100 3 50 12 00 12 00 6 00 23 00 11 50 applies watts W according to the transmitter manufacturer For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters 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 NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range NOTE 2 The ISM industrial scientific and medical band
24. e picture on each pad Y and stick to the bare skin of the patient Voice Prompt Peel off the pad labeled 1 cture exactly as shown in the pi Y Voice Prompt Peel off the pad labeled 2 and stick to the bare skin of the patient exactly as shown in the picture Y Voice Prompt Press the pads firmly to the bare skin of the patient 45 CA Ki T Voice Prompt Do not touch the patient Analyzing heart rhythm Y i PAD CU SP detect decide CG Shockable ES Voice Prompt Y Shock advised Stand clear Voice Prompt Charging now N Com Y Charging ra plete ES Y Voice Prompt Press the flashing orange button now Deliver shock now YES v ithin 15 seconds HOCK button is NO v v Voice Prompt No shock advised Voice Prompt Shock delivered Voice Prompt Shock button was not pressed v Voice Prompt Be sure Emergency Medical Services have been called v Voice Prompt You may touch the patient v Voice Prompt Begin CPR now 46 7 se Voice Prompt Press the flashing blue i button for CPR voice prompt ithin 20 seconds
25. ement and no response when shaken b No normal breathing Do not use the i PAD CU SP1 on patients who show either of the following signs a Movement or response when shaken b Presence of normal breathing 1 3 Intended Users The i PAD CU SP1 is intended for use in or out of the hospital by emergency care personnel or healthcare professionals or laypersons The manufacturer recommends that users train on the use of the device 1 4 Local Protocol Please contact your local health authority for information on the requirements of ownership and usage of defibrillators 1 5 Additional Information Please contact CU Medical Systems Inc or its local distributors for any additional information on the i PAD CU SP1 2 Device Features Adult Pediatric Selection Switch Status LCD Defibrillator Pads Connector oot Os gt 8 1 8 IPAD Pads Storage Compartment CU Medical Systems Inc ASD Card AIDA 2 i Button Ca i Do Not Touch Patient Indicator e i e CPR Detection Indicator Pad Connector Status Indicator Pad Position Indicators Power Button Shock Button Battery Pack SD Card Port Power Button i Button Status LCD Shock Button Adult Pediatric Selection Switch Adult Pediatric Selection Switch Cover Defibrillator Pads Connector Pad Connector Status Indicator Pad Position Ind
26. endix on accessories if you want to purchase this software The child in these Instructions for Use is defined as a person who is older than 1 year and younger than 8 years as well as lighter than 25 kg A green button on the front of the device The device turns on when the Power Button is pressed during Standby Mode and it turns off when the Power Button is pressed for one second while the device is on If the Power Button is pressed during the battery insertion test the battery insertion test is canceled The Device referred to in these Instructions for Use is the i PAD CU SP1 Semi Automated External Defibrillator AED The liner that protects the conductive gel of the pads during storage inside the pads pouch An external memory card that could be used to store treatment data ECG and event from the internal memory of the device Self diagnostic tests that verify the proper operation of the subsystems of the device The i PAD CU SP1 dumps the charge in its defibrillating capacitor into an internal load If you do not press the Shock Button or if the device determines that the patient does not need an electric shock due to the change in the patient s ECG 56 Semi Automated External Defibrillator AED Shock Button Standby Mode A device that delivers a defibrillating shock after analyzing and recognizing a shockable rhythm You must concur with the shock delivery by pressing the SHOCK button The bu
27. eous circulation 5 Integrated post cardiac arrest care Transfer the patient to a medical institution or a specialized facility f finding and or operating the defibrillator takes time monitor the patient s status until the defibrillator is available perform CPR if necessary 4 2 Preparation for Defibrillation Set the Adult Pediatric Selection Switch to match the victim Adult victim Open the switch cover GER PF ITAL CU Medical Systems Inc Set the switch to adult defibrillation mode as shown in the following picture I Oo A PEDA PF MAD CU Medical Systems Inc Child victim victim is under 25kb or 8 years old If the pediatric pads are attached the i PAD CU SP1 automatically adjusts its defibrillation energy output for pediatric defibrillation regardless of the position of the Adult Pediatric Selection Switch i e the output will be pediatric even if the selection switch is set to adult If there are no pediatric pads for the pediatric patient adult pads may be used Ensure that the Adult Pediatric Selection Switch is set to Pediatric Mode If the switch has not been set yet move it to Pediatric Mode as shown in the figures below Open the switch cover PEDA m MAU CU Medical Systems Inc Set the switch to pediatric defibrillation mode as shown in the following picture f a A 28 IDA PD ITAL CU Medical Sy
28. ethod A material used to sharpen and clean the surface of metal glass stone and wood which includes emery quartz powder and glass dust Do not use these abrasives to clean the device The adhesive material on the pad is very important for maintaining the optimum adhesion between the skin and pad Therefore never open the pad package when the pad is not needed and periodically check the expiration date of the pad The adult in these Instructions for Use is defined as a person who is older than 8 years or heavier than 25 kg The default settings of this device direct the you to perform CPR immediately after one electric shock in accordance with the 2010 CPR Guidelines Also the CPR guide is composed of 5 cycles with the chest compression to artificial respiration ratio of 30 2 if the device is set to a default setting of 5 cycles 30 2 If you are not trained in artificial respiration perform only the chest compression Refer to Section 5 3 Device Setting for the CPR setting Please contact the manufacturer for additional information 53 Arrhythmia Battery Pack Cardiac Arrest Patient Communication Port Condensation CPR Mode Defibrillation Defibrillator Pads Connector Disposable Battery Pack ECG An abnormal heart rhythm A disposable battery that supplies power to the i PAD CU SP1 A patient with cardiac arrest symptoms This device should be used for the patient with the fo
29. evice acquires and analyzes the patient s ECG immediately after being connected The device will instruct you not to touch the patient by flashing the Do Not Touch Patient Indicator and by issuing the voice prompt Do not touch the patient analyzing heart rhythm After analyzing the ECG the device will determine whether or not the patient needs defibrillation warning WARNING Do not move or touch the patient during ECG analysis If the patient needs defibrillation the device will do the following The device announces that a defibrillation shock is needed and instructs you to keep away from the patient AN CAUTION e While the device is charging after a shockable rhythm is detected the ECG of the patient is continuously acquired and analyzed The device disarms itself if the ECG rhythm changes to a non shockable rhythm before shock delivery When it is charged the device activates the following indicators in sequence continuous beep while the Shock Button flashes in orange the device instructs you to press the flashing orange Shock button a P Q you should press the Shock Button at this time ker SS ia When the Shock Button is pressed the device delivers a defibrillating shock to the patient If defibrillation is properly done the device reports that an electric shock has been delivered After shock delivery the device indicates that you may touch the patient and the CPR Mode Indicat
30. he SD card on the PC to FAT FAT16 format Open the SD Card Cover on the device and insert the SD card into the port 28 3When the i Button is pressed for more than 1 second in standby mode the mode changes into administrator mode with voice guide The device then gives you a summary the total hours of the last device use and the number of defibrillation shocks delivered GThe voice guide gives the S W version of the device 6 When instructed by the voice guide to transfer the treatment history press the i Button to copy the data onto the SD card If there is treatment data in the device s internal memory The device informs you that copying of the treatment data onto the SD card has started and starts to copy the data When copying is completed the device mode changes to CPR guide setting mode Refer to Section 5 3 Device Setting for details regarding CPR guide setting If there is no treatment data in the device s internal memory The device mode changes to CPR guide setting mode after informing you that no treatment data exists If the file has already been transferred the device will inform you that the same file exists in the PC Press the Shock Button to overwrite the existing file in the PC or press the i Button to cancel the copying of the file 2 Transferring Treatment Data via IrDA The data may be transferred to a PC using the data management software CU Expert Ver 3 50 or higher from the manufacturer
31. he status of the device is indicated by the following symbols Indicator Status LCD Device Operation O n a rr NO Y Device Operation x 2 san T_T Battery Level Indicator Status LCD Status LCD TT Battery Level Indicator P SF Battery Level Indicator d n x e E A Pad Status Y n ADT Pad Status A S rr TN Pad Status Do Not Touch Patient Indicator Off Do Not Touch Patient Indicator Light CPR Detection Indicator Flashing Shock Button Flashing in Orange Description The device is functioning normally Less than half battery power remains Less than a quarter battery power remains The expiration date of the pad is more than 3 months Indicates that CPR is not performed or not properly performed n S SC Press the i Button for more information E shock Press the Shock Button to deliver a shock Note 40 8 3 Troubleshooting The device informs you of its current status or of problems via status indicators beeps and or voice instruction Refer to the following for details 8 3 1 Troubleshooting While the Device is Operating Symptom Voice Instruction Status LCD Device Operation Status LCD Battery Level ro Indicator n TT Ya 7 Pad Status Q Voice Prompt Low battery Replace the battery with a new gt or OO Plug the pads connector into the device S o d gu e Used pads Replace the pads with a new one
32. icators Do Not Touch Patient Indicator Turns the device on or off When the device is on a green LED is lit Reports device usage the total hours of the last usage and number of shocks checks the S W version downloads events and ECG data via an IrDA and SD Card sets the CPR mode the number of compressions breaths and cycles compression rate per minute pausing time detailed guide on off and checks for errors Displays the current status of the device battery and pads Delivers defibrillating shock when pressed while flashing in orange Selects Adult Pediatric modes Covers the Adult Pediatric Selection Switch to prevent accidental switching Connects with the connectors of the pads Indicates the connection status of the defibrillator pads connector Indicates the pad position on the patient Warns when not to touch the patient CPR Detection Indicator Battery Pack IrDA Port SD Card External Memory Port Pad Storage Indicates performance of CPR on the patient The indicator is lit if CPR is performed and flashes if CPR is not performed The disposable power source of the device Transmits and receives treatment data between the device and a personal computer Port for copying device records to a SD card Stores pads 3 Preparation for Use 3 1 Standard Package Contents The following are the standard package contents of this device
33. ice The i PAD CU SP1 must be serviced only by authorized personnel e The i PAD CU SP1 will be serviced free of charge during the warranty period After the warranty period the cost of material and service shall be shouldered by the user When the i PAD CU SP1 is not operating properly immediately bring it for servicing to an authorized service center Please fill out the following table with the necessary information when requesting for service Device classification Semi Automated External Defibrillator Device Name i PAD Model Number CU SP1 Serial Number Date of Purchase Sales Representative User Information Contact no Brief description of the problem 44 Appendix A Rescue Protocol amp Power ON A i Voice Prompt Call Emergency Medical Services now M c Voice Prompt Plug the pads connector into the device lt Pads Connected EC d edi SC YES y Voice Prompt Adult mode or Pediatric mode Voice Prompt Follow the voice prompt calmly PADS ON SCH hing from chest and stomach v a xy Voice Prompt Remove all clot Rip clothing if necessary y s from the bottom of the device Voice Prompt Take out the pad Y Voice Prompt Tear open the pads packaging v Voice Prompt Look closely at th
34. injury or loss of life ED CAUTION Conditions hazards or unsafe practices that can result in minor or moderate personal injury damage to the device or loss of treatment data stored in the device particularly if precautionary steps are not taken Used to denote items that are important during installation operation or maintenance of the device Overview Thank you for purchasing the i PAD CU SP1 This device can be effectively and safely used for a long period if you familiarize yourself with the instructions warnings precautions and notices contained in these Instructions for Use prior to its use warning WARNING A defibrillator discharges electric shock with high voltage and current You must be well acquainted with the instructions warnings and precautions contained in these Instructions for Use You must follow the instructions warnings cautions and notices in these Instructions for Use when using this device e The manufacturer will not be responsible for any problems involving the device that are caused by the user s negligence This device shall be serviced only by the manufacturer or its authorized service centers If the Device is intended to be connected to equipment other than those stated in these Instructions for Use contact the manufacturer If this Device does not operate properly contact the manufacturer or its authorized service center 1 Introduction 1 1 Device Des
35. ity The device performs a self test as soon as the battery is inserted turns itself off when the test is done and periodically wakes up to perform the daily weekly and monthly self tests To initiate a battery insertion self test remove the battery pack and reinsert Refer to Section 8 1 Self Diagnostic Test for more information ED CAUTION e Inspect the i PAD CU SP1 daily to ensure that it is always ready for an emergency Check the current status of the device battery and pads as displayed on the Status LCD Refer to Section 8 2 Device Status for information regarding the Status LCD 6 2 2 Replacing Supplies When the device is in storage check the battery level indicator and the pad status on the Status LCD daily to ensure that the device is always ready for an emergency Replace the battery pack or the defibrillator pads when it is depleted or when they go beyond their expiration date respectively Disposable Battery Pack Replacement of the Disposable Battery Pack Replace the battery pack when it becomes depleted Refer to Chapter 8 Troubleshooting on how to check the battery status Dispose of depleted battery packs in accordance with local environmental regulations Use only the battery packs recommended and provided by the manufacturer The battery pack is disposable Do not recharge Replacing the Disposable Battery Pack 1 Remove the discharged battery pack by pulling it out while pressing the lock on the b
36. llowing symptoms No response no movement and no normal breathing A port that sends and receives data between the device and PC Moisture has an adverse effect on the device when condensation is formed on the device surface The device should be stored in a dry environment without excessive humidity The device provides guidance for CPR while pausing analysis of the patient s ECG such that you can easily perform CPR The CPR mode on this device complies with AHA s 2010 CPR Guidelines Refer to Section 4 3 Step 3 Perform CPR for more information Is a process in which an electronic device gives an electric shock to the heart This helps reestablish normal contraction rhythms in a heart having dangerous arrhythmia or in cardiac arrest A connector on the device that is used to connect the device with defibrillator pads A disposable battery pack that provides power to the device Never charge this battery pack An abbreviation for electrocardiogram A record of the heart s electrical rhythm as detected by the defibrillation pads 54 Electric Shock Error Fibrillation Flashing i Button IrDA Port Light Operation Mode Pad Pad 1 Pad 2 This device charges large energy in a short time and performs defibrillation via an electric shock A status in which the device does not properly operate Refer to Section 8 3 Troubleshooting for more information Refers to an irregularity of
37. msidi Impedance 50 Ohms Type Pediatric Energy 50J 67 Impedance 75 Ohms Type Adult Energy 151J Timebase 0 00 ms Of Impedance 75 Ohms Type Pediatric Energy 51J 68 Impedance 100 Ohms Type Adult Energy 150J Impedance 100 Ohms Type Pediatric Energy 50J mebase 0 00 ms 69 Impedance 125 Ohms Type Adult Energy 150J x 60 0 Jidiv 5 00 e 5 00 msidi 500 kS 0 Impedance 125 Ohms Type Pediatric Energy 50J 70 Impedance 150 Ohms Type Adult Energy 150J Impedance 150 Ohms Type Pediatric Energy 50J 71 Impedance 175 Ohms Type Adult Energy 150J 50 0 Jidiv e 5 00 msidi Impedance 175 Ohms Type Pediatric Energy 50J 72 G Electromagnetic Compatibility Guidance and manufacturer s declaration electromagnetic emissions The i PAD CU SP1 is intended for use in the electromagnetic environment specified below The customer or the user of the i PAD CU SP1 should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance The i PAD CU SP1 uses RF energy only for its RF Emissions E internal functi
38. n gt i Button gt Shock Button gt Shock Button a ies 50 dee The voice guide will give information regarding the current CPR guide setting Press the Shock Button to change the setting or press the i Button to proceed to the next step 31 8 Settings can then be changed in the following order Number of Chest Compressions Number of Artificial Respirations Chest Compression rate Pausing Time and Detailed Guide Selection Refer to Table 1 CPR Guide Setting Options below When the setting is completed the voice guide will give information regarding the set CPR guide which may be saved or canceled 0Press the i Button to save or the Shock Button to cancel according to voice instructions When the CPR guide setting is either saved or canceled the device automatically shuts down Table 1 CPR Guide Setting Options Setting 1 Number x Range Unit Default Description Option Number of Perform 30 compressions Chest 15 30 Compression Number of Give 2 breaths Artificial 0 to 2 Respiration Perform 5 cycles of chest Number of 2 to 10 compression and artificial Cycles Bet respiration Chest Compress the chest at a rate of 100 to Compression 5 100 100 compressions per minute 120 Rate CPR Pause 30 to Pause for 120 seconds 30 sec 120 sec time 180 sec 2 minutes Turns on detailed voice Detailed Guide On Off Selection instructions for the chest compression and artificial respiration
39. not be usable regardless of the expiration date 27 5 2 Saving and Transferring Treatment Data 5 2 1 Device Usage This device automatically saves the following treatment data ECG data Usage information The treatment data is automatically recorded in the internal memory This data is not erased even if the device is turned off The recorded treatment data may be transferred to a personal computer PC CAN CAUTION CAUTION This i PAD CU SP1 keeps the data of the 5 most recent treatment operations and can save up to 3 hours of ECG data for each rescue operation ECG data beyond 3 hours will not be recorded When the device is used more than 5 times it deletes the oldest treatment data to make room for data from a new treatment operation It is recommended to transfer treatment data to a PC after each use of the device e If the battery pack is removed while the device is operating treatment data cannot be properly recorded If you wish to remove the battery pack turn the power off by pressing the Power Button for at least 1 second before removing the battery pack 5 2 2 Transferring Treatment Data The treatment data may be transferred via a SD card or IrDA The entire treatment data of all patients that is recorded on the device is transferred using only the SD card method while the treatment data of one patient can be transferred using only the IrDA method 1 Copying Treatment Data by Using the SD Card Format t
40. oW Wo WWW rn on 22 Step 3 Perform CPR Dan denda ente get or n leet mara 24 4 4 DEFIBRILLATION PROCEDURES IN PEDIATRIC Mon 26 5 AFTER USING THE I PAD CU SPI1 om momo nan nan 27 5 1 MAINTENANCE AFTER EACH Uer 27 5 2 SAVING AND TRANSFERRING TREATMENT Data 28 5 2 1 Device USage EE 28 5 2 2 Transferring Treatment Data ann nad aih a AA el nennen nns 28 5 9 DEVICE SETTING ia EN NN NN i 31 5 3 1 dE EE 31 5 3 2 Setting the CPR Guide 31 6 MAINTENANCE coo aan ie 33 GEN Neger 33 6 2 MAINTENANCE EE 34 6 2 1 Device eet Lu E 34 6 2 2 Replacing SUPPIES AANS A Tan vere lin eh elle hited tae aan 34 Disposable Battery Pack carioca eee de naga 34 Replacing the Pads cde i bulan Hana 36 6 2 3 Cleaning the i PAD CU SP1 nnne nnn rnnt nnns 37 a DISPOSAL PES 37 8 TROUBLESHOOTING inre iii 38 Gilt SSEEE TESTS ne ne ata an na 38 8 2 DEVICE STATUS A MAA A SNN RN GE BNN AN 40 8 3 TROUBLESHOOTINGY a ti etus 41 8 3 1 Troubleshooting While the Device is Operating 41 8 3 2 Troubleshooting While the Device is not Operating aa 42 9 DEVICE SERVICE ia ana aa na ana aa 43 APPEND aa aa eu Mau Naa 45 A RESCUE PROTOCOL sis sic inti teritur port iaa 45 B PARTS AND ACCESSORIES sereni ieri ein 48 B 1 STANDARD ACCESSORIES ii 48 B 2 OPTIONAL AGCESSORIES i ioni EA Haa ee 48 C DESCRIPTION OF SYMBOLS inai an amen anakan 49 C 1 PAD CU SP1 DEFIBR
41. ode changes to CPR guide setting mode after informing you that no treatment data exists ED CAUTION e The distance between the IrDA port on the device and the IrDA adapter should be within 30 cm while their angle should be within 15 Also since external light source affects the IrDA try to use it in indoors and away from fluorescent and or incandescent lamps 30 5 3 Device Setting 5 3 1 CPR Guide Setting The default CPR setting on CU SP1 is 5 cycles with 30 chest compressions and 2 breaths in accordance with the American Heart Association AHA 2010 CPR Guidelines However you may customize these You can set the following Number of chest compressions Number of artificial respirations Number of cycles Number of chest compressions per minute Pausing time Detailed guide selection 5 3 2 Setting the CPR Guide DWhen the i Button is pressed for at least 1 second in standby mode the mode changes into administrator mode with a voice guide 2 The device gives you a summary the total hours of the last device use and the number of electric shocks SWhen instructed to transfer the treatment data do not press the i Button but instead wait for 5 seconds 4 When instructed to set the CPR guide press the i Button to enter the CPR guide setting mode SWhen instructed to enter a password enter the set password Password press the following buttons in sequence i Button gt i Button gt Shock Butto
42. on Therefore its emissions are very rou CISPR 11 i low and are not likely to cause any interference in nearby electronic equipment RF Emissions Class B CISPR11 The i PAD CU SPI is suitable for use in all Harmonic emissions establishments including domestic establishments Not applicable IEC 61000 3 2 and those directly connected to the public low voltage power supply network that supplies Voltage fluctuations mi buildings used for domestic purposes flicker emissions Not applicable IEC 61000 3 3 MINO WARNING e The i PAD CU SP1 should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the i PAD CU SP1 should be observed to verify normal operation in the configuration in which it will be used 73 Guidance and manufacturer s declaration electromagnetic immunity The i PAD CU SP1 is intended for use in the electromagnetic environment specified below The customer or the user of the i PAD CU SP1 should assure that it is used in such an environment Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 1 test Complianc Electromagnetic Immunity Test level e level environment guidance 6 kV Floors should be wood concrete or Electrostatic 6 kV Contact Contact ceramic tile If floors are covered discharge ESD with synthetic material the relative IEC 61000 4 2 8 kV air 8 kV air humidity sh
43. or is lit Then the voice instruction for CPR starts If the flashing Shock Button is not pressed within 15 seconds the device will cancel the shock delivery and disarm Then the device issues CPR instructions 22 If the patient does not need defibrillation the device will do the following in sequence the device announces that the patient does not need a defibrillating shock and that you may touch the patient the CPR Mode Indicator is lit voice instruction for CPR starts MIMO WARNING Do not touch you or anybody else the patient during shock delivery Before defibrillation make sure that there is no contact between 1 and 2 below which may provide unwanted pathways for the defibrillating current the patient s body such as exposed skin or head or limbs conductive fluids such as gel blood or saline metal objects such as bed frame or stretcher CED CAUTION While analyzing ECG keep the patient still and minimize movements around the patient Do not touch the patient and pads while the Do Not Touch Patient Indicator is on Electrical noise interference may delay the ECG analysis As a safety measure the device will not deliver a shock until the flashing orange SHOCK button is pressed If the SHOCK button is not pressed within 15 seconds of the voice instruction to press the SHOCK button the device will disarm itself dumps the shock energy in its internal load and will instruct you to make s
44. ottom of the device Refer to the figure below 34 2 Insert a new battery pack in the direction of the arrow with the label facing upward as shown in the figure below ior SS exp DATE LiMnO 5 DON Gu CE om Intelligent Public Access Defibrillator CA CAUTION CAUTION Battery Pack Precautions Do not subject the battery pack to serious physical impact Do not attempt to open or break apart the battery pack Do not let the battery pack come into contact with open flames or hot objects Do not short circuit the terminals of the battery pack Keep out of the reach of children If any leakage gets in the eye immediately clean the eye with water and consult with a doctor Do not store the battery pack under direct sunlight Do not store the battery pack in a wet or very humid place Comply with local regulations when disposing of the battery pack Do not destroy or incinerate the battery pack Never attempt to recharge the disposable battery pack 35 Replacing the Pads Check the pad status on the Status LCD daily Do not use pads that are beyond the expiration date Check the pad package for damage Check the cable outside the packaging pouch for possible defecis Only pads provided by the manufacturer should be used with the i PAD CU SP1 Replacing Pads 1 Check the expiration date of
45. ould be at least 30 2 kV for power Electrical fast Mains power quality should be that supply lines Not transient burst of a typical commercial or hospital 1 kV for input output Applicable IEC 61000 4 4 environment lines 1 kV differential Mains power quality should be that Surge Not mode of a typical commercial or hospital IEC 61000 4 5 Applicable 2 kV common mode environment lt 5 Ur gt 95 dip in Mains power quality should be that Ur for 0 5 cycles of a typical commercial or hospital Voltage dips short environment If the user of the i interruptions and 40 78 9 OUR IDI PAD CU SP1 image intensifier voltage variations Ur f r 5 cyeles Not requires continued operation during on power supply 70 Ur 30 dip in Applicable power mains interruptions it is input lines Ur for 25 cycles recommended that the i PAD CU IEC 61000 4 11 SP1 image intensifier be powered lt 5 Ur gt 95 dip in from an uninterruptible power Ur for 5 s supply 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level 74 Guidance and manufacturer s declaration electromagnetic immunity The i PAD CU SP1 is intended for use in the electromagnetic environment specified below The customer or the user of the i PAD CU SP1 should assure that it is used in such
46. s 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 NOTE 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and refection from structures objects and people TT
47. s if CPR is not detected Shock Button Flashes orange when the defibrillator is charged and ready to deliver a shock Blue i Button Flashes when guiding CPR transferring the treatment history and setting the CPR mode Red i Button Flashes when an error occurs Speaker Voice instruction output the volume varies depending on the ambient noise Beeper Various beeping output Battery Level The battery level is automatically performed during periodic self tests power ON self test and run time self test Low Battery Indicator Shown on the Status LCD announced via voice instruction and indicated via the flashing red i Button Voice Instruction Guides the user via voice instructions 63 Self Diagnostic Test e Power On Self Test Run time Self Test Auto e Daily Weekly and Monthly Self Test Battery Pack Insertion Test done when the user inserts the battery pack into Manual the battery pack compartment of the device Disposable Battery Pack CUSA1103BB Category Nominal Specifications 12V DC 2 8Ah Li MnO Disposable Standard Battery Type 12V DC 4 2Ah Li MnO Disposable Long life Standard At least 50 shocks for a new battery or 4 hours of operating time at room temperature Capacity Long life At least 200 shocks for a new battery or 8 hours of operating time at room temperature Standard At least 3 years from the date of manufacture if stored and Standby Life After main
48. s that may cause such interference include motors X ray equipment radio transmitters and cell phones Refer to Appendix E Electromagnetic Compatibility of these Instructions for Use for more information The use of accessories or cables other than those referred to in these Instructions for Use may increase electromagnetic radiation from the device or reduce the device s electromagnetic immunity Only accessories and cables that are authorized by the manufacturer should be used with the i PAD CU SP1 4 How to Use the i PAD CU SP1 4 1 Chain of Survival If you think that you are witnessing someone go down in sudden cardiac arrest perform the chain of actions recommended by the American Heart Association AHA in its Chain of Survival emergency response to sudden cardiac arrest 1 Immediate recognition and activation of the emergency response system Check for a response by tapping the victim on the shoulder and shouting at the victim Activate the community emergency response system e g call 911 or the equivalent service in your locality Early CPR N Perform CPR 3 Early defibrillation Use this device i PAD CU SP1 Using this device can be summarized in 3 steps After pressing the Power Button Step 1 Place pads on the patient Step 2 Press the Shock Button if instructed by the device Step 3 Perform CPR 4 Effective advanced life support Perform advanced care in order to restore spontan
49. s warranty does not apply if the device has been damaged by accident or misuse or as the result of service or modification by entities other than CU Medical Systems Inc or its authorized representatives INNO EVENT SHALL CU MEDICAL SYSTEMS BE LIABLE FOR CONSEQUENTIAL DAMAGES Only devices with serial numbers and their accessories are covered under this warranty PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER THE WARRANTY Items such as cables and modules without serial numbers are not covered under this warranty Warranty Disclaimer The following renders this warranty null and void Servicing by unauthorized personnel If the factory seal is broken without proper authorization from CU Medical Systems Inc Failure or damage caused by a fall or external shock after purchase Damage by natural disasters such as fire earthquake flood and or lightning Failure or damage by environmental pollution or abnormal voltage Damage caused by storage in conditions beyond the specified limits Failure due to depletion of consumables Failure caused by sand and or soil getting inside the device The purchase date customer name distributor name batch number and other listed information being arbitrarily changed No proof of purchase provided along with the device warranty Usage of accessories and parts not recommended by the manufacturer Other failure or damage caused by inappropriate operation 43 Serv
50. stems Inc If a young victim is over 25kg or 8 years old or if you are not sure of the exact weight or age DO NOT DELAY TREATMENT Set the Adult Pediatric Selection Switch to Adult mode Use the adult pads ZN WARNING WARNING Never perform defibrillation in pediatric mode to a patient who is either heavier than 25 kg or older than 8 years old Ensure the slide key for Adult Pediatric Mode is as shown on the You can switch the adult pediatric selection switch before or after turning on the i PAD CU SP1 However the defibrillation mode should be changed before placing the pads on the patient Once the pads are in place you cannot change the defibrillation mode anymore When the mode is correctly selected the defibrillation energy is set to an adult value 150 J or pediatric value 50 J Turn the device on by pressing the Power Button When the power turns ON the following occurs in sequence the beeper will beep for 1 seconds S Voice instruction Call emergency Medical services now Remove clothes from patient s chest CA CAUTION CAUTION e Time is essential for the cardiac arrest patient Tear or cut clothes if removing them will take time Dry the patient s skin such that pads can adhere well on the chest Shave hair on the chest if necessary Remove the pads package from the Pad Storage Compartment at the bottom of the device Take pads o
51. tained in accordance with the instructions in this document Inserting the Battery Long life At least 5 years from the date of manufacture if stored and maintained in accordance with the instructions in this document e Operating Temperature 0 C 43 C 82 F gt 109 F Temperature Ranges e Storage Temperature 20 C 60 C 4 F 140 F Adult Defibrillation Pad CUA1007S Category Nominal Specifications Type Adult Electrode Area 120 cm Cable Length Total 120 cm Inside the pouch 95 cm Outside the pouch 25 cm Shelf life At least 36 months from the date of manufacture 64 Pediatric Defibrillation Pad CUA1102S Category Nominal Specifications Type Pediatric Electrode Area 46 43 cm Cable Length Total 120 cm Inside the pouch 80 cm Outside the pouch 40 cm Shelf life At least 30 months from the date of manufacture Data Storage and Transfer Category Nominal Specifications IrDA For PC communications Internal Memory Data 5 individual treatments up to 3 hours per treatment Capacity External memory Data may be copied from the internal memory to the SD Card SD Card 65 F i PAD CU SP1 Shock Waveform Plots Impedance 25 Ohms Type Adult Energy 149J imebase 0 00ms Impedance 25 Ohms Type Pediatric Energy 50J 1 64 Negative 66 Impedance 50 Ohms Type Adult Energy 150J 50 0 Jidiv 2 00
52. tilate the battery or open the battery case Do not expose the battery to high heat or open flames Do not incinerate the battery amp Do not crush the battery Do not dispose of the battery in municipal waste Follow local regulations on battery disposal Attention Refer to accompanying documents CE 0470 CE Mark 51 C 3 2 Pads CUA1007S CUA1102S Symbol Description Temperature limits 0 Cto 43 C 32 F to 109 F e a So Sg 3 8 T O Lot number Expiration date Order reference number Single use only do not reuse DE Do not fold or bend x Contains no latex Contains no Latex NC MM YYYY T OOO Expiration Date and Lot number sticker LOT 1234567890 Attention Refer to accompanying documents CE Mark meets the requirements of the applicable European directive m gt 52 D Glossary 1 CPR 1 Cycle Abrasive Adhesive on the Pad Gel Material Adult American Heart Association AHA 2010 CPR Guidelines 1 CPR consists of 5 cycles When the device is set to 5 cycles as default Refers to 30 chest compressions followed by 2 breaths during CPR When the device is set to the default setting 30 2 If you specify the number of compression and number of breath the cycle is performed in accordance with the specified protocol Refer to Section 5 3 Device Setting for detailed setting m
53. tton that you must press to deliver an electric shock to a cardiac arrest patient The mode of the i PAD CU SP1 when the Power Button is OFF but the battery pack is inserted If O is shown on the Status LCD while the device is in standby mode the device is ready to be used as needed in an emergency Refers to CU Medical Systems Inc 57 E Device Specifications Model Name CU SP1 Physical Category Nominal Specifications Dimensions 260mm x 256mm x 69 5mm Width x Length x Height Weight 2 4kg Including the battery pack and pads Environmental Category Nominal Specifications Operational Status The device is in emergency use Temperature 0 C 43 C 82 F gt 109 F Humidity 5 95 non condensing Storage Status The device is stored together with the defibrillator pads and the battery pack is inserted ready to be used in an emergency Temperature 0 C 43 C 82 F gt 109 F Humidity 5 95 non condensing Transport Status device only no defibrillator pads and battery pack included Temperature 20 C 60 C 4 F 140 F Humidity 5 95 non condensing Altitude 0 to 15 000 feet operational and storage Drop Withstands 1 2 meter drop to any edge corner or surface Vibration Operating Meets MIL STD 810G Fig 514 5C 17 random Standby Meets MIL STD 810G Fig 514 5C 18 swept sine helicopter Sealing IEC 60529 IP55 ESD Meets IEC 61000 4 2 2001 Meets IEC 60601 1 2 limits method EN 55011 2007
54. uously check the patients condition and perform CPR until the emergency medical services arrives 8 3 2 Troubleshooting While the Device is not Operating Symptom Status LCD Device Operation A Status LCD Battery Level Indicator Status LCD Pad Status Cause System error The pad has been used Press the i Button and hold for at least 1 second The device then goes into Administration Mode After going into Administration Mode the device will issue the voice instruction Press the flashing red i Button Press the flashing red i Button and the device will then announce system error and the associated error code Contact us by referring to Chapter 9 Device Servicel Replace the pad with a new one Resolution elf the problem is not resolved or if no replacement battery is available contact the manufacturer refer to Chapter 9 Device Service 42 9 Device Service Device Warranty Device Name Model Name Serial No Purchase Name Distributor Person in Charge e This device is warranted by CU Medical Systems Inc against defects in materials and workmanship for five full years from the date of original purchase During the warranty period we will repair or at our option replace at no charge a device that proves to be defective provided you return the device shipping prepaid to us or to our authorized representative e Thi
55. ure that emergency medical services have been called The device will then instruct you to begin CPR During defibrillation disconnect other medical electrical equipment which has no defibrillation proof applied parts from the patient e If the device malfunctions during a rescue operation it will instruct you to get a replacement defibrillator and will start the voice instruction for CPR Have CPR performed until the replacement defibrillator is ready to use 23 Step 3 Perform CPR Perform CPR when the i PAD CU SP1 instructs you to do so By default the CU SP1 gives voice instruction for CPR during pause for CPR after a shock delivery When voice instruction for CPR is needed outside of the default setting press the flashing blue i Button for at least 20 seconds CPR Method 1 Compression Point Place the heel of your hand in the middle of the patient s chest between nipples which is the lower half of the sternum and put the heel of your other hand on top of the first so that your hands are overlapped and parallel 2 Compression Speed and Depth Compress the chest at least 5 cm deep and at a rate of at least 100 compressions per minute 3 Opening the Airway While lifting the patient s chin up tilt the head backward to open the airway 4 Artificial Respiration Method Pinch the patient s nose as shown in the figure below and give the patient enough breath to make the chest rise significantly 2
56. ut of the pad package Refer to the pictures on both pads Adult Pads AN CAUTION e The adhesive material on the pads starts to dry out as soon as the package is opened Use immediately after opening Refer to Section 6 2 Maintenance of these Instructions for Use for procedures on how to check the expiration date of the pads and pads maintenance 20 4 3 Defibrillation in Adult Mode Step 1 Place pads on the patient Remove pad 1 from the single liner and stick the pad to the patient s upper chest as shown below 2 Remove pad 2 from the single liner and stick the pad to the patient s side torso as shown below If the device detects the connection with the patient after placing the pads follow the voice instruction of the device Defibrillation can be done even if the pads are reversed If the locations of pads are switched follow the next voice instruction without changing the directions of pads It is more important to begin defibrillation as soon as possible n the event the pad is not adhering well check if the adhesive side of the pad is dry Each pad has an adhesive gel If the gel does not adhere well replace it with a new pad MIMO WARNING Ensure the patient is not on a wet surface when performing defibrillation If the patient s skin is wet dry the skin first prior to using the device 21 Step 2 Press the Shock Button if instructed The d
57. ween 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 The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the i PAD CU SP1 is used exceeds the applicable RF compliance level above the CU SP1 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the i PAD CU SP1 Qa Over the frequency range 150 kHz to 80 MHz field strengths should be less than V1 V m 76 Recommended separation distances between portable and mobile RF communications equipment and the CU SP1 Th

Instruction Manual for the IPAD SP1

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