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CU-SP2_Manual_Eng_Ver0.90_Rev.A

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1. The i PAD CU SP2 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 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 The mode in which the device monitors the patient or executes CPR defibrillation when turned on The pads stated in these Instructions for Use refers to a pads 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 82 Pad 2 Pads Connector Pairing PC S W CU Expert CU EX1 Pediatric Power Button Pads liner Rechargeable Battery Pack SD Card Self Test 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 pads the position may be switched with pad 1 The connector on the pads that is used to connect the pads with the i PAD CU SP2 The process of connecting the Device with an external Bluetooth device for communication PC software used to modify the settings of the i PAD CU SP2 an
2. When giving first aid during a pediatric cardiac arrest ask others to call the emergency medical center and to bring an i PAD CU SP2 while you are performing pediatric CPR Since most pediatric cardiac arrests are caused by suffocation rather than heart failure when there is no one else around perform CPR for 1 to 2 minutes call the emergency medical services and then get an i PAD CU SP2 e The Adult Pediatric Mode can be changed under Menu Mode For further details please refer to Section 5 4 Device Setup in these Instructions for Use 30 4 7 Printer The i PAD CU SP2 supports connection to an external Bluetooth printer Please familiarize yourself with the User s Manual for the printer prior to use To use the printer you must first pair the CU SP2 and the printer in Menu Mode For further details on pairing the printer please refer to Section 5 4 Device Setup A printer needs to be paired only once and will be automatically connected in the future However you will need do pairing again for a different printer If the printer is in use you can check the printer icon on top of the LCD Screen while the device is Operating 00 00 38 EH f 30 2 Press the flashing blue i button for CPR voice prompt When a paired printer is turned on while administering defibrillation on the patient ECG and event analysis from the point of the ECG analysis to the defibrillation will be printed e Printers not designated
3. Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 1 test Complianc level e level 6 kV 6 kV Contact Contact 8 kV air 8 kV air 2 kV for power supply lines Not 1 kV for input output Applicable lines 1 kV differential Not mode Applicable 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycles 40 Ur 60 dip in Ur for 5 cycles Not 70 Ur 30 dip in PPlicable Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 s Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the i PAD CU SP2 image intensifier requires continued operation during power mains interruptions it is recommended that the i PAD CU SP2 image intensifier be powered from an uninterruptible power supply 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 96 Guidance and manufacturer s declaration
4. When pressed the device will attempt to connect with the CU EM1 00 00 43 30 2 Message Connecting 32 After connecting to the CU EM1 the device will shift into Monitor Mode receive ECG data from the CU EM1 and display the data on the LCD Screen 00 03 49 MN 30 2 a Monitor Mode Battery Status of E EM1 Battery Screen configuration for Monitor Mode ECG Displays the ECG data received from the CU EM1 via Bluetooth Battery Status of the Displays the battery status of the connected CU EM1 from 0 to CU EM1 100 in 10 units To turn off Monitor Mode press Soft Key 1 which reads SEMI AUTO When pressed the device will shift into defibrillation mode 00 03 49 MM 30 2 Monitor Mode EN Battery E IE e ECG transmission devices not designated by the manufacturer are not compatible with the PAD CU SP2 e Turn on the CU EM1 prior to use e The CU EM1 can be connected and used with up to 10m of open space between the CU EM1 and the i PAD CU SP2 e The CU EM1 is not a part of the standard package contents If you want to purchase the CU EM1 please contact us by referring to Appendix A Parts and Accessories of these Instructions for Use 33 4 9 CU EM1 ECG Transmission Device 4 9 1 Device Features E d4 Belt Clip Battery Cover 34 Gr CU Medical Systems Inc a 3 Lead ECG Measurement Cabl
5. 3 Preparation for Use 3 1 Standard Package Contents The following are the standard package contents of this device CU SP2 Semi automated External Defibrillator Instructions for Use ces PA DS alge CU Medical Systems Inc Instructions CUA1997S Step 1 Step 2 Ez LOT CUA1203RB sal Monuactrued by hesttwall medica fy MES Manz ctr Made in Korea EN 2 Tear open the packaging of the pads ove the pads fro ckaging Li lon Q X Note The pads are attac single liner DC 11 1V D Step 3 Step 4 ESN mir a IrAv cama A KG Use only CU Medical Systems Inc batteries ana chargers BOSA N T Intelligent Public Access Defibrillator cig at eee D Please refer to fore using battery CE Rechargeable Battery amp CU Medical Systems Inc K 2 4 O Q CN FAX Ss S4 Peel off the pads from the liner one by one Altach the pads to the patien As each pad is peeled off See the illustration at the back of attach it to the patient as shown in step 4 each pad for proper placement 1 Battery Pack 1 hel O YE ES A E Comas no Latex Ses separate user nstuctons E Rechargeable 1 Pack of Adult Pads Disposable E e wa Battery Charge Dock Battery Charger 12 3 2 Key Accessories low PEDIATRIC PADS poa CU Medical Systems Inc Pp Ht seme Gr Fc nr a RO Cupra qero e pe These pods must NOT be used for
6. If stored and managed in accordance with instructions in the document At least 5 years from the date of manufacture e Operating Environment Temperature 0 C 43 C 32 F 109 F e Storage Environment Temperature 20 C 60 C 4 F 140 F 93 Adult Defibrillation Pads Category Type Pad Size Cable Length Pad Storage Life Pediatric Defibrillation Pads Category Type Pad Size Cable Length Pad Storage Life General Specifications Adult 120 cm dTotal 120cm Inside 95cm Outside 25cm At most 36 months from the date of manufacture General Specifications Pediatric 46 43 cm Total 120cm Inside 80cm Outside 40cm At most 30 months from the date of manufacture Data Storage and Transmission Category Infrared Data Association Data Storage SD Card Bluetooth General Specifications Able to communicate with a PC via IrDA Saves 3 events on the internal memory up to 17 hours per event Copies the ECG and event data from the device s internal memory through the PC software CU Expert in order to check the ECG and event data Uses Bluetooth to communicate with the Printer or the CU EM1 ECG transmission device 94 E Electromagnetic Compatibility Guidance and manufacturer s declaration electromagnetic emissions The i PAD CU SP2 is intended for use in the electromagnetic environment specified below The customer or the user of the PAD CU SP2 should assu
7. Low battery Replace the battery with a new one Voice Prompt Plug the pads connector into the device Voice Prompt Used pads Replace the pads with a new one Voice Prompt The pads are beyond their expiration date Replace the pads with a new one Voice Prompt Press the pads firmly to the bare skin of the patient Voice Prompt No shock delivered Voice Prompt Shock button was not pressed The battery is low The Pads Connector is disconnected The pads has been previously used The pads has expired The pads is not properly attached to the patient s skin The pads is not properly adhering to the patient s skin Although an electric shock is needed the Shock Button was not pressed within 15 seconds Resolution Replace the battery with a new one Ensure the Pads Connector is properly connected Replace the pads with a new one Replace the pads with a new one Check if the pads is securely attached to the patient s skin Press the pads firmly to the patient s skin Shave chest hair or wipe off moisture if necessary before attaching the pads Deliver an electric shock by pressing the Shock Button with the next voice instruction e f the problem cannot be solved during an emergency you should follow the following steps 1 Quickly replace the defibrillator if possible 2 If no rep
8. electromagnetic immunity The i PAD CU SP2 is intended for use in the electromagnetic environment specified below The customer or the user of the PAD CU SP2 should assure that it is used in such an environment Immunity IEC 60601 Test Complia Test level nce level Conducted 3 Vrms RF IEC 150 kHz to 80 MHz 61000 4 6 outside ISM bands 10 Vrms 150 kHz to 80 MHz in ISM bands Radiated 10 V m RF IEC 80 MHz to 2 5 GHz 61000 4 3 20 V m 80 MHz to 2 5 GHz 97 Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the i PAD CU SP2 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 5 d l VP 80 MHz 800 MHz 23 E1 d JVP 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 d is 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 a NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations E
9. 13 12 20 2012 04 12 11 44 02 2012 04 12 11 39 29 EXIT The third tab is for exiting Menu Mode e If pads are attached to the patient while the device is in Menu Mode the device will automatically switch from Menu Mode into Operation Mode to enable defibrillation 5 4 2 Setting the Operation of the Device The user can set the options below under the DEVICE SETUP tab of Menu Mode DEVICE SETUP DATA REVIEW EXIT AED Mode Manual Override OFF Adult Pediatric Mode ADULT Shock Energy Fixed 200J ECG Gain 10 mmim Device Volume 1 Graphic Indication ON e Device Mode You must enter the password to change the Device Mode The default password of the device is Soft Key 13131731 Soft Keys are labeled 1 3 from left to right AED Mode The device manually or automatically executes ECG analysis and defibrillation Manual Override The user can manually set the device s shock energy and administer defibrillation based on user judgment 51 e The Device Mode setup is an additional option This function will not be installed by default if Manual Override has not been optionally added upon purchasing the CU SP2 If you want to purchase the Device Mode option please contact us by referring to Appendix A 3 Service Center of these Instructions for Use e Manual Override You must enter the password to change the Manual Override The default password of the device is Soft Key 13131 1 Soft Ke
10. Manual Override Only medical professionals may use this mode e AED Mode ANALYZE Only licensed emergency medical technicians or medical professionals may use this mode CHARGE Only medical professionals may use this mode OFF Licensed emergency medical technicians medical professionals and the general public may use this mode QUID CAUTION e When administering R Sync energy the patient may be administered with defibrillation energy recognized as R waves if there is interference resulting from external contact or if the patient is moved while the pads are attached Avoid moving or touching the patient while administering R Sync energy e Manual Override is an additional option If you want to add the manual override option please contact us after referring to Section A 3 Service Center in these Instructions for Use 40 5 After Using the i PAD CU SP2 5 1 Maintenance After Each Use Check the device for signs of damage and contamination If there is any damage or contamination please refer to Section 6 2 3 Cleaning the i PAD CU SP2 in these Instructions for Use Conduct a self test on the battery by referring to Section 7 1 Self Tests in these Instructions for Use If the device shuts down normally after running a self test on the battery the device status is normal The i PAD CU SP2 uses disposable pads Dispose of the used pads and replace them with new pads after checking their expiration date For further
11. device will operate in Pediatric Mode When set to Pediatric Mode the device will maintain the mode even if it is connected to the adult pads connector e Shock Energy Fixed 1504 The patient will be delivered 150J of shock energy Fixed 200J The patient will be delivered 200J of shock energy Escalating 150J 200J The patient will be delivered 150J of shock energy for the first time and then 200J of shock energy in subsequent shocks Escalating 150J 150J 200J The patient will be delivered 150J of shock energy for the first and second time and then 200J of shock energy in subsequent shocks e ECG Gain 5mm mV The ECG graph will be indicated as 5mm mV on the Graphic LCD Screen 10mm mV The ECG graph will be indicated as 10mm mV on the Graphic LCD Screen 20mm mV The ECG graph will be indicated as 20mm mV on the Graphic LCD Screen AUTO The device will automatically set the ECG gain and the ECG graph will be indicated as 10mm mV on the Graphic LCD Screen e Device Volume 1 10 Sets the volume of the device between 1 10 in units of 1 AUTO The default volume is set to 7 and automatically changes depending on the level of surrounding noise e Graphic Indication ON Includes an image guide when the device is operated OFF Does not include an image guide when the device is operated e Voice Instruction Detail Gives detailed guidance on how to operate the device Short Gives simple guidance on ho
12. step the device will give voice instructions for the pause period When voice instruction for CPR is needed press the flashing blue i Button within 15 seconds For further details on CPR please refer to the CPR Method below CPR Method 1 Compression Point Place the heel of your hand in the middle of the patient s chest between the 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 overlapping and parallel Then spread or lock your fingers without touching the chest Keep your elbows straight and your arms vertical to the ground and use your weight to start the compression 2 Compression Speed and Depth Compress the chest at least 5cm up to 6cm deep and at a rate of at least 100 compressions per minute up to 120 times 3 Opening the Airway While lifting the patient s chin up tilt the head backward to open the airway 28 4 Artificial Respiration Method Pinch the patient s nose as shown in the figure below place your mouth over the patient s mouth and blow in sufficient air to make the chest rise significantly f ZN CAUTION J CAUTION e After the CPR guidance the device automatically starts reanalysis of the patient s ECG according to the device settings or the user can press ANALYZE button to start the reanalysis Do not touch the patient once the device starts to reanalyze the patient s ECG e If you have not
13. the Shock Button is pressed e The pads Lead II are placed anterior anterior for the adult 86 Administering Shock The pads are placed anterior posterior for the child Patient Insulation BF Type defibrillation protected 87 Dl gt C current A time ms Biphasic Truncated Exponential Type The shape of the waveform is automatically adjusted according to the patient s defibrillation impedance In the graph A is the duration of the first phase of the waveform B is the duration of the second phase C is the delay between phases 500us and D is the peak current Output Waveform for Adults 200 Joules Patient ALE ks ACHAT Peak Discharging Energy Interval Interval Impedance pe Current Energy Accuracy A Joules J Joules J milliseconds milliseconds Ohms Q ms ms 88 Output Waveform for Adults 150 Joules First Phase Second Phase Patient Interval Interval Impedance milliseconds milliseconds SAL Energy Accuracy De aed ms ms A Joules J Joules J 25 50 5 150 175 Peak Discharging Energy First Phase Second Phase Peak KAUN Interval Interval Current pe sora milliseconds milliseconds ms ms Discharging Energy A Energy Accuracy Joules J Joules J 25 50 5 100 125 150 175 89 ECG Accuracy Category ECG Acquisition Route Response Frequency ECG Analysis System Category Function Measured Impedance Range
14. used when loading previous ECG CO Pauses ECG used when loading previous ECG Button 3 MC Moves right down on the menu For further details on the Menu Mode and the use of Soft Keys in Menu Mode please refer to Section 5 4 Device Setup of these Instructions for Use Soft Keys are labeled 1 3 from left to right Soft Key Functions in Operation Mode Before attaching pads on the patient Button Indication Function When pressed the i PAD CU SP2 will attempt to establish Bluetooth connection to the CU EM1 ECG 0 transmission device lf successful the device will MONITOR MODE operate in Monitor Mode In Monitor Mode ECG analysis and shock treatment Button 1 i will not be available The Defibrillation Mode will operate under Monitor Mode When pressed the i PAD CU SP2 will sever its SEMI AUTO connection to the CU EM1 and transition into the Operation Mode which will enable defibrillation This function is activated when the No of Chest Compressions under the CPR setting of the device is set to 15 times When pressed the setting will Button 2 change to 30 times The x refers to the No of Artificial Respirations under the CPR setting 19 This function is activated when the No of Chest Compressions under the CPR setting of the device is set to 30 times When pressed the setting will change to 15 times Th
15. you change the password on a regular basis to prevent password exposure The password is changed in the following 3 steps Input Password DEVICE SETUP DATA REVIEW EXIT Voice Indication Detail Extemal Device Input Password CPR Guidance New Password DEVICE SETUP DATA REVIEW EXIT Voice Indication Detail Extemal Device New Password CPR Guidance 56 Confirm Password DEVICE SETUP DATA REVIEW EXIT Voice Indication Detail External Device Confirm Password CPR Guidance Setup Option Set Value Default Device Mode eee AED Mode Manual Override ANALYZE Manual Override CHARGE OFF Adult Pediatric Adult Mode Mode Pediatric Mode Fixed 1503 Fixed 2003 Adult Mode Shock Energy 1 1 Fixed 150J 3 Escalating 150J 200J Escalating 150J 150J 200J 5mm mV 10mm mV ECG Gain 2 10mm mV 20mm mV AUTO Device Volume Graphic Indication External Device Refer to Table 2 of Section CPR Guidance 5 4 3 Setting the CPR Guidance Change Soft Key 1 1 1 1 Password 97 5 4 3 Setting the CPR Guidance The CU SP2 complies with the 2011 Korea Guidelines for CPR recommended by the Korean Association of Cardiopulmonary Resuscitation KACPR and the 2010 Guidelines for CPR recommended by the American Heart Association AHA The default CPR is set to 5 cycles of 30 chest compressions followed by 2 artificial respirations Also the C
16. ADULT patients A terrano carretas a gt A ARA 1 Pack of Pediatric Pads IrDA Adapter SD Card 2GB 1 Battery Pack Disposable SD Card Printer CU EM1 ECG Transmission Device The accessories above are not included in the standard package contents Please contact us after referring to Appendix A Parts and Accessories for additional supplies e Please keep spare pads and battery packs handy to quickly respond to emergency situations 13 3 3 Preparation for Use Do the following to set up the i PAD CU SP2 4 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 3 Insert the battery pack into the battery compartment on the device as shown in the figures below As the battery pack is inserted the device starts a self test and displays the following on the Monitor LCD SYSTEM TEST After the self test is complete the device will automatically shut down If the self test fails please refer to Chapter 7 Troubleshooting of these Instructions for Use 4 If 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 Parts and Accessories of these Instructions for Use 6 Store the device r
17. Category Operation Type Output Type Output Energy Charge Control Charge Time Arming Indicator Time from End of CPR to Administering Shock Disarm Electric Shock Vector for General Specifications Semi automated External Defibrillator e cube biphasic Truncated exponential type AED Mode 1504 200J at 500 load for adults 50J at 500 load for children Manual Override Not Option 2J 3J 5J 7J 10J 20J 30J 50J 70J 1004 1504 200J Controlled by an automated patient analysis system For the first defibrillation of a new battery capable of administering shock within 9 seconds of the given voice instruction Need electric shock e Voice instruction Press the flashing orange button e Flashing Shock Button e Beeper At least 6 seconds from the completion of CPR to the shock delivery The device disarms the electric load under the following situations When the patient s ECG is changed into a status that does not require defibrillation When the Shock Button is not pressed within 15 seconds from the completion of the charge When the equipment is turned off by pressing the Power Button for over 1 second When the pad is detached from the patient s body or the pads connector is detached from the device When the impedance of the patient is out of the range of defibrillation 250 1750 After charging is completed the device delivers a defibrillating shock to the patient when
18. EXIT SPP R200 CU EM1 CUEM1 45f7d6 EXIT EXIT Connecting If connection fails during the test the CU SP2 will display the following message for 3 seconds and return to the previous page DEVICE SETUP DATA REVIEW EXIT CU EM1 Message DEVICE SETUP DATA REVIEW EXIT SPP R200 CU EM1 CUEM1 45f7d6 EXIT EXIT e The CU SP2 can only communicate with the devices designated by the manufacturer e Before pairing the CU SP2 with an external device Printer CU EM1 turn on the power of the device to be connected e When the CU SP2 is paired with an external device the external device will operate as follows Printer Displays the message You can use this printer CU EM1 3 long beeps 55 e The Printer and CU EM1 are not part of the standard package contents If you want to purchase them please contact us by referring to Appendix A Parts and Accessories of these Instructions for Use e CPR Guidance Refer to Section 5 4 3 Setting the CPR Guidance in these Instructions for Use e Change Password The default password of the device is Soft Key 1 gt 31 gt 3 1 gt 3 1 Soft Keys are labeled 1 3 from left to right and the password is a combination of the three Soft Keys Settings that demand the password under Device Setup have varying authorities depending on the setting We recommend to change the password after receiving the CU SP2 in order to prevent access by unauthorized users Also we recommend that
19. Instructions for Use i PAD CU SP2 The information in these Instructions for Use applies to the i PAD CU SP2 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 2012 Document No SP2 OPM E 01 Published by CU Medical Systems Inc Printed in the Republic of Korea Copyright 2012 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 SP2 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 SCA occurs Since the chance of success is reduced by 7 to 10 for every minute that defibrillation is delayed defibrillation must be performed promptly However defibrillation may not work on some patients even when administered promptly due to the fundamental causes of SCA The i PAD CU SP2 is manufactured by CU Medical Systems Inc Dongwha Medical Instrument Complex 130 1 Dongwhagongdan ro 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 Ch
20. Rhythm Requiring Defibrillation Rhythm Not Requiring Defibrillation Analysis Protocol Algorithm sensitivity and specifications that require defibrillation General Specifications Lead Il 1 Hz 30 Hz General Specifications Analyzes whether the rhythms of the patient s impedance and ECG require a defibrillation 250 1750 Ventricular fibrillation and several ventricular tachycardia including ventricular flutter The CU SP2 uses multiple variables to determine the shockability of the heartbeat Some extremely low amplitudes or low frequency heartbeats are not interpreted as shockable VF beats Also some VT beats are not interpreted as rhythms requiring defibrillation ECG rhythms excluding those requiring a defibrillation When a rhythm that does not require a defibrillation is detected the device informs the user by voice to perform CPR Prepares to administer shock or give voice instructions on CPR according to the analysis result Satisfies AAMI DF80 90 ECG Analysis System ECG Database Test 90 One Minimum Performa Shock No Shock Observed Sided Lower Rhythms test sample nce goal Decision Decision Performance Confidence size Limit 97 26 gt 90 Coarse VF 213 219 sensitivity sensitivity 81 02 50 100 SHOCKABLE gt 75 Fast VT 111 137 sensitivity sensitivity 100 Normal Sinus gt 99 minimum 100 100 Rhythm specificity arbitrary specif
21. U SP2 provides the user with a function enabling CPR guidance The user can set the following items at CPR Guidance under Device Setup in Menu Mode Compressions Breath Cycle Compression Speed Pause Time Detail Guidance DEVICE SETUP DATA REVIEW EXIT 30 Times Breath 2 Cycle 5 Compression Speed Pause Time Detail Guidance EXIT p_a Setting the CPR Guidance No Setup Option Range Unit Default Default Description i mE Executes 30 chest compressions Compressions 15 30 times 1 i 1 30 times In Adult Mode the number of chest 7 times l l 2 _ compressions is fixed to 30 times Breath 0 2 times Executes 2 artificial respirations 0 Executes 5 cycles of chest 2 10 times e compression and artificial respiration Compression 100 Executes chest compression at a Speed 120 times 1 speed of 100 times per minute Pause Time 30 180 sec 120 sec Pauses CPR for 120 sec 2 min Does not provide detailed voice Detail _ guidance on chest compression and Guidance e artificial respiration during CPR 58 e The CU SP2 does not provide Detail Guidance on chest compression and artificial respiration during CPR by default To receive Detail Guidance change the Detail Guidance setting to ON Once Detail Guidance is set to ON the device will provide detailed voice instructions on CPR e The CU SP2 will give voice instructions on applying chest compress
22. been trained in CPR or are unconfident at administering artificial respiration you should perform only chest compression or follow the instructions of the emergency medical services agent on the phone e If you are trained for CPR and capable of performing artificial respiration perform chest compression along with artificial respiration e The CPR guidance can be set under Menu Mode For further details please refer to Section 5 4 Device Setup on these Instructions for Use e In order to safely turn the device off after use press the Power Button for at least 1 second 29 4 6 Defibrillation in Pediatric Mode When the patient is between 1 year old and 8 years old defibrillation can be done using the pediatric pads When the device is connected through pediatric pads it automatically sets the defibrillation energy to 50J and provides pediatric CPR guidance Turn on the device and remove clothes as directed by the voice instructions to expose the patient s chest and back Place pads on the middle of the chest and back as illustrated below Pads are not specific to either chest or back You may attach them regardless of direction If there are no pediatric pads for the pediatric patient use adult pads but set the Adult Pediatric Mode to Pediatric Mode under Menu Mode and then perform defibrillation according to the voice instructions e Follow the instructions below when giving first aid during a pediatric cardiac arrest
23. by the manufacturer are not compatible with the PAD CU SP2 e Turn on the printer prior to use e The printer can be connected and used with up to 10m of open space between the printer and the i PAD CU SP2 e The printer is not a part of the standard package contents If you want to purchase the printer please contact us by referring to Appendix A Parts and Accessories of these Instructions for Use 31 4 8 Monitor Mode Monitor Mode is used in connection with the CU EM1 ECG transmission device In Monitor Mode the i PAD CU SP2 uses Bluetooth to receive ECG data from the CU EM1 and displays it on the LCD Screen When using Monitor Mode the pads cannot be used and defibrillation cannot be performed If you think that defibrillation is necessary while using Monitor Mode on the patient immediately turn Monitor Mode off and administer defibrillation To use the CU EM1 you must first pair the CU SP2 and the CU EM1 in Menu Mode For further details on pairing the CU EM1 please refer to Section 5 4 Device Setup in these Instructions for Use The CU EM1 needs to be paired only once and will be automatically connected in the future However you will need to do pairing again for a different CU EM1 To use Monitor Mode press Soft Key 1 which reads Monitor Mode without attaching the pads on the patient 00 00 40 Peel off the pad labeled 1 and stick to the bare skin of the patient exactly as shown in the picture
24. d to manage treatment data Refer to the appendix 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 liner that protects the conductive gel of the pads during storage inside the pads pouch A rechargeable battery pack that supplies power to the device which can be reused after recharging Recharge and reuse low batteries 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 83 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 button that you must press to deliver an electric shock to a cardiac arrest patient The standby mode where the device executes periodic self tests for use under emergency situati
25. d ON the following occurs in sequence f e Beeper The beeper will beep for 0 5 seconds e Connection Indicator The blue indicator will light 2 Attach the 3 Lead ECG Measurement Cable to the patient Attach the 3 lead disposable ECG pads Turn on the Monitor Mode in the CU SP2 For further details on using the Monitor Mode please refer to Section 4 8 Monitor Mode in these Instructions for Use 4 9 5 Where to Attach ECG Pads RA R Below the right collarbone LA L Below the left collarbone LL F Left side torso QUID CAUTION e Using expired disposable ECG pads or disposable ECG electrodes with damaged packaging will not guarantee accurate measurement of ECG e The disposable ECG pads must be firmly adhered to the patient s skin Keep the attachment areas dry e For further details on charging the battery of the CU EM1 please refer to Section 6 2 Maintenance of these Instructions for Use e In order to turn the CU EM1 off after use press the Power Button for at least 1 second 36 4 10 Manual Override Not Option This function will be installed by default if manual override has been optionally added upon purchasing the CU SP2 To use the manual override you must set the device mode to Manual Override For further details on setting the manual override please refer to Section 5 4 Device Setup in these Instructions for Use When the device mode has been changed to manual override Manual wil
26. details on replacing the pads please refer to Section 6 2 2 Replacing the Pads in these Instructions for Use C N WARNING WARNING e You should use only the defibrillator pads provided by the manufacturer e Do not open the pad packaging until immediately before use Since the adhesive material on the disposable pads starts to dry out as soon as the package is opened the pads will become unusable after a certain amount of time has elapsed regardless of the expiration date 41 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 saved on the internal memory This data can be transferred to a personal computer PC and is not erased even if the device is turned off QUITO CAUTION e The i PAD CU SP2 saves the 3 most recent treatments and is able to save up to 17 hours for each event lf more than 17 hours of ECG data are recorded for one event any ECG data over 17 hours will not be recorded e When the device is used more than 3 times it overwrites the oldest treatment data with the newest data Therefore we recommend you to save the recorded treatment data by transferring it to a PC after using the device e f the battery pack is removed while the device is operating the treatment data will not be properly recorded If you wish to remove the battery pack turn the power off by pressing th
27. device and accessories with a soft cloth The following detergents may be used to clean the exterior surface of the device Light soapy water Light chlorine bleach dilute 30ml of chlorine bleach per 1 liter of water Light ammonia compound Light hydrogen peroxide AN CAUTION e Do not immerse the device or accessories in liquid or detergent e Be careful not to allow any liquids to get into the device e f the device is immersed immediately contact the manufacturer or a service center certified by the manufacturer e Applying excessive force or shock while cleaning the device may result in malfunction e Do not use an acetone based strong detergent or abrasive to clean the device e Do not use a detergent containing abrasive ingredients e Do not sterilize this device 6 2 5 Disposal Appropriately dispose of the CU SP2 and accessories in accordance with local regulations 68 7 Troubleshooting 7 1 Self Tests There are several types of self test Each self test examines different contents Refer to the table below for details Self Test o T Description ype Perform the battery self test of inserting the battery pack in the following events When initially purchasing the device When inspecting the equipment after use When replacing the battery pack When the device is damaged The device checks the Shock Button i Button and Soft Keys during the self test During the battery self test the u
28. do the following e The device announces that a defibrillation shock is needed and instructs you to keep away from the patient ee e When armed the device will continuously beep while the Shock Q 7 Button flashes in orange lle e The device instructs you to press the flashing orange Shock Button You should press the Shock Button at this time 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 issues voice instructions on CPR 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 26 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 Then the voice instruction for CPR starts ZN WARNING WARNING e When administering defibrillation do not position the patient on conductive fluids If the patient s skin is wet remove the moisture prior to using the device e When administering defibrillation remove all other medical equipment on the patient that is unprotected from the defibrillating shock e The user and everyone near the patient must avoid making the fo
29. e LOW Battery Indicator Power and Connection Indicator Lead Fault Indicator Power Button 4 9 2 Button and Indicators Power Button This button turns the CU EM1 on and off LOW Battery Indicator The red indicator will light when the remaining battery of the CU EM1 falls below 10 You need to recharge the battery when the LOW Battery Indicator is on Power and Connection Indicator The blue indicator will light when the CU EM1 is turned on When the CU SP2 is switched to Monitor Mode and transmitting via Bluetooth the blue indicator will blink in 1 second intervals Lead Fault Indicator The green indicator on Lead Fault will light if the ECG Measurement Cable is not properly connected to the patient the cable is faulty or the ECG pads are faulty 4 9 3 Beeper 1 long beep Beeps when the CU EM1 is turned on 2 long beeps Beeps when the CU EM1 is turned off 3 long beeps Beeps when the CU EM1 is paired with the CU SP2 Beeps in 10 second intervals when in standby for connecting to the CU SP2 1 short beep in Monitor Mode 2 short beeps Beeps when connecting to the CU SP2 in Monitor Mode Beeps when disconnecting Monitor Mode or the Bluetooth connection 3 short beeps including unstable Bluetooth connections or communication problems 35 4 9 4 How to Use the CU EM1 Turn the device on by pressing the Power Button When the power of the CU EM1 is turne
30. e Power Button for more than 1 second and then remove the battery pack 5 2 2 Transferring Treatment Data The treatment data may be transferred via an SD card or IrDA The treatment data of all patients recorded on the device is transferred using the SD card method whereas the treatment data of one patient is selectively transferred with the IrDA method 1 Copying Treatment Data by Using an SD Card 4 Format the SD card on the PC to the FAT FAT16 format 2 Open the SD card cover on the device and insert an SD card into the port 42 8 When pressing the i Button for more than 1 second in standby mode the device will switch to Administration Mode and give instructions by voice and LCD Screen 4 The device displays the summary the total hours of the last device usage and the number of defibrillation shocks delivered of the device usage on the LCD Screen Displays the S W version of the device on the LCD Screen Serial Number ABCDE123456 Model CU SP2 Useage Time 3 Minute s Shock Delivery 1 Time s Software Version 1 00 7 1 00 1 00 When the voice guide instructs to transfer the treatment data 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 starts to copy the data after informing the user by voice that the treatment data is being copied onto the SD card When copying is completed the device informs you by voic
31. e x refers to the No of Artificial Respirations under the CPR setting When pressed the device will enter the Menu Mode For further details on the Menu Mode please refer to Button 3 Section 5 4 Device Setup in these Instructions for Use Soft Keys are labeled 1 3 from left to right Soft Key Functions in Operation Mode After attaching pads on the patient Button Indication Function ANALYZE When pressed the device will start analyzing the patient s ECG STOP This function is activated while the device is analyzing the patient s ANALYZE ECG When pressed the device will stop analyzing the patient s ECG Saar Bhar When pressed the device will start charging energy for administering a shock This function is activated while the device is charging energy When DISARM pressed the device will stop charging and internally discharge the energy stored within the device This function is activated when the No of Chest Compressions under the CPR setting of the device is set to 15 times When pressed the setting will change to 30 times The x refers to the No of Artificial Respirations under the CPR setting Button 2 This function is activated when the No of Chest Compressions under the CPR setting of the device is set to 30 times When pressed the setting will change to 15 times The x refers to the No of Artificial Respirations under the CPR sett
32. e and automatically shuts down Transmit The Recue Data 2012 01 04 01 27 59 2011 12 20 05 02 40 2011 11 10 09 07 11 If there is no treatment data in the device s internal memory The device informs you by voice that no treatment data exists and automatically shuts down e If the SD card already has the same treatment data file the device informs the user that the same file already exists upon copying the treatment data onto the SD card Press the Shock Button to overwrite the existing file or press the i Button to cancel copying the file 43 2 Transferring Data via IrDA The data may be transferred to the PC by using the PC software CU Expert Ver 3 70 or higher which is provided by the manufacturer CU Expert is PC software that includes ECG review and printing functions Position the IrDA adapter to face the IrDA port on the device as shown in the figure below 2 When pressing the i Button for more than 1 second in standby mode the device will switch to Administration Mode and give instructions by voice and LCD Screen 34 The device displays the summary the total hours of the last device usage and the number of defibrillation shocks delivered of the device usage on the LCD Screen 4 Displays the S W version of the device on the LCD Screen Serial Number ABCDE123456 Model CU SP2 Useage Time 3 Minute s shock Delivery 1 Time s Software Version 1 00 7 1 00 1 00 6 When t
33. e held liable in such cases 61 6 2 Maintenance 6 2 1 Device Inspection This device provides a self test The device performs a self test as soon as the battery is inserted automatically turns off after the test is completed and regularly turns on to perform the self test If the user wants to initiate the self test remove the battery and then reinsert For further details on self tests please refer to Section 7 1 Self Tests in these Instructions for Use f N CAUTION J CAUTION e We recommend to regularly inspect this device to prepare for emergencies There are two supplies that must always be inspected upon storing the device Since the device cannot be used in an emergency if the battery level is low you must regularly check the self test results Since the appropriate amount of energy cannot be delivered to the patient in an emergency if the pads are in poor condition you must regularly check the expiration date on the pads 6 2 2 Recharging and Replacing the Battery Battery Pack Rechargeable Replacing the battery pack The battery pack should be exchanged with a fresh one and recharged if it is low For further details on checking the battery status please refer to Chapter 7 Troubleshooting in these Instructions for Use You must use only a battery pack provided by the manufacturer 62 How to replace the battery pack 1 Remove the spent battery pack by pulling it out while pressing the locki
34. echargeable batteries that are low can be reused after recharging You can recharge the battery by using the Battery Charger and Battery Charge Dock provided by the manufacturer The red LED lights up on the Battery Charger when charging and the green LED lights up when charging is complete Refer to the figure below for charging the Battery Pack Rechargeable Battery Dock gt YW SN ES r a t __ CU EM1 Battery gq Battery Charger 65 f N CAUTION J CAUTION e Precautions for using the battery pack Do not subject to impact disassemble or damage the device Do not place the device near hot objects such as heating appliances Do not keep the battery pack near metal objects This may cause a short circuit Keep out of the reach of children Do not use a battery pack that is externally damaged e g leakage replace it with a new one If the leakage gets into the eye immediately wash with water and consult with a physician Do not store the device under direct sunlight Do not store the device in a wet or highly humid place Comply with local regulations when disposing of the device Do not burn or make a hole in the device Do not insert the disposable battery pack into the Battery Charge Dock to recharge e Rechargeable batteries may induce hazards including inflammation fire and explosion Please comply with the following Batteries whose casing is vi
35. eferring to the following considerations You must store the defibrillator according to the storage policy Please refer to Section 6 1 Device Storage for proper device storage instructions Store the defibrillator in an easy to access location where its technical alarms can be easily heard e g alarm on low battery or other device problems Store the accessories along with the device in the device s carrying case for easy and quick access 14 ZN WARNING WARNING e 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 Devices that may cause such interference include motors X ray equipment radio transmitters and cell phones Please refer to Appendix D Electromagnetic Compatibility of these Instructions for Use for more information e 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 SP2 15 4 How to Use the PAD CU SP2 4 1 LCD Screen The configuration of the Graphic LCD Screen is as shown below The screen configuration can be changed according to the Graphic Indication For detailed instructions on setting the Graphic Indication please refer
36. ent you can press Soft Key 3 on the device to enter Menu Mode 00 00 40 4 Button Description du Leftiup E Right Down Peel off the pad labeled 1 BE Select Exit Back and stick to the bare skin of the patient exactly as shown in the picture MONITOR MODE Once you enter Menu Mode the Button Description page is displayed Press any of the 3 Soft Keys to close the page In Menu Mode you can set the operation of the device and the CPR guidance or check the saved treatment data using the three buttons The basic functions of the Soft Keys are as shown below Soft Key 1 Left Up Soft Key 2 Select Confirm Soft Key 3 Right Down i Button Exit Back 5 4 1 Configuring the Menu Mode Menu Mode is comprised of three tabs The first tab is comprised of two pages You can set the operation of the device add external devices set the CPR guidance and change the password DEVICE SETUP DATA REVIEW EXIT DEVICE SETUP DATA REVIEW EXIT AED Mode Voice Indication Detail Manual Override OFF Extemal Device Adult Pediatric Mode ADULT CPR Guidance Shock Energy Fixed 200J Change Password ECG Gain 10 mmimV Device Volume 1 Graphic Indication ON 50 The second tab displays the treatment data saved on the device For further details on DATA REVIEW on the second tab please refer to Section 5 3 Data Review in these Instructions for Use DEVICE SETUP DATA REVIEW EXIT 2012 04 12
37. eonggye Plaza 991 4 Cheonggye Uiwang Gyeonggi Republic of Korea Tel 82 31 421 9700 Fax 82 31 421 9911 E mail addresses sales cu911 com Branch Office of CU Medical Systems Inc in Germany Kuester Strasse 6 30519 Hannover Germany Tel 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 FAM FM IF TAL Intelligent Public Access Defibrillator NEEB Edition1 CU Medical Systems Inc Table of Contents roduc UO Necesito broca a alcobas 7 OV OT VIG W minn a A eosccd 8 1 Product Information ira 9 ti Device DeESCIDUO trata e E ec aldoiessreiaaolnicaaide 9 A pe cre USTs NE AAA nn mt ee oe Re 9 1 3 Intended Use e o e e Salt 9 14 AgdaitionalntormalON ainda e a 9 Zu Device Features ratas 10 Oe Preparation for USE anta 12 3 1 Standard Package Contents ali A 12 SZ KEV ACCOSSONG Sereni E e ed e bd ro 13 Jo Pleparaton Or US ida 14 4 How to Use the i PAD CU SP 2 oooocconcccncocococccoccocaconononnconccnncnnnnnnnonnronnnnancnnrrnnrnnnrnnnenanenanos 16 4 ECD A A A gn O E 16 A LAA E aes eae ee ee eee 19 4 3 Procedure for Using the Device coocccconccocccocncconccocnconncconocnnnnnnnnnnnnnnnnnnnnnnannnnnnnnaninaninns 21 4 4 Preparation for Defibrillation occooccoccconcconcconconnco
38. f 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 SP2 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 This device is a semi automated external defibrillator that can be administered on sudden cardiac arrest SCA patients MENTA WARNING e 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 Users of this device must follow these instructions e You must follow the instructions warnings cautions and notices in these Instructions for Use when using this device e The manufacturer or its authorized distributor will not be responsible for any problems involving the device that are caused by the user s negligence e This device shall be serviced only by the manufacturer or its authorized service centers The manufacturer or its authorized service centers will not be liable for devices serviced at the user s own discretion e f the device is intended to be connected to equipment other than that stated in these Instructions for Use contact the man
39. following table A 1 Standard Accessories Name Part Number Ordering Number Adult Pads disposable CUA1007S Rechargeable Battery Pack CUA1203RB Instructions for Use SP2 OPM E 01 Battery Adapter K 820 Kkamnyng Battery Charge Dock CUA1207CH A 2 Optional Accessories Carrying Case SP2 A BAG 3010 Disposable Battery Pack Long life CUSA1103BB Pediatric Pads disposable CUA1102S IrDA Adapter IR 220LPLUS PC S W CU Expert ver 3 70 or higher SD Card HD1 CARD SD SD Card Reader HD1 CARD READER Printer SPP R200 ECG Transmission Device CU EM1 15 B Description of Symbols B 1 CU SP2 Defibrillator Symbol Description Power Button ON OFF CN x Shock Button D BF Type defibrillation proof equipment C 0470 Europe CE Certification Serial Number Manufactured Date Caution Refer to related documents 76 B 2 CU SP2 Packaging Symbol Description Stacking No Up to 6 tt W fe No Hooking Europe CE Certification Id B 3 Accessories B 3 1 Rechargeable Battery Pack Description Lithium lon Battery LOT Number KC Safety Certification Manufactured Date Do Not Dissemble Do not cut the battery or open the battery case Avoid Fire Do not burn the battery or expose it to high heat or flame Do not break or apply pressure on the battery Do not discard the battery indiscriminately Discard in accordance with local regulations Caution Refer to related documents Euro
40. formation 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 The Device referred to in these Instructions for Use is a Semi Automated External Defibrillator AED for which the model name is CU SP2 a product from the i PAD product family of the manufacturer A disposable battery pack that supplies power to the device and cannot be recharged Replace expired or spent batteries with a new battery pack An abbreviation for electrocardiogram A record of the heart s electrical rhythm as detected by the defibrillation pads 81 Electric Shock Error Fibrillation Flashing i Button Internal discharge disarm IrDA Port Light Operation Mode Pads Pad 1 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 7 3 Troubleshooting for more information Refers to an irregularity of the heart causing ineffective circulation Ventricular fibrillation is accompanied with an acute cardiac arrest A status in which the indicator is flashing The button for checking the most recent device usage displaying error messages transferring ECG and event data etc
41. ge 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 73 Service e The i PAD CU SP2 must be serviced only by authorized personnel e The i PAD CU SP2 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 e When the i PAD CU SP2 is not operating properly immediately bring it for servicing to an authorized service center e Please fill out the following table with the necessary information when requesting for service Semi Automated External Defibrillator Date orPurese h Name Address User Information Contact no Brief description of the problem 14 Appendix A Parts and Accessories To order replacement parts and accessories cite the part and ordering numbers given in the
42. he 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 2003 or pediatric value 50 J e For further details on setting the menu please refer to Section 5 4 Device Setup of these Instructions for Use 22 2 Remove clothes from patient s chest QUID CAUTION e Time is essential for the cardiac arrest patient Thus time should not be wasted in completely removing their clothes Tear or cut clothes to attach the pads as soon as possible if removing them will take too much time e Dry the patient s skin such that the pads can adhere well on the chest Shave chest hair if necessary e Avoid laying the patient on conductive locations such as metal an electric pad and water Remove the pads package from the Pads Storage Compartment at the bottom of the device 23 Refer to the pictures on both pads and accurately identify the locations where the pads will be attached 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 e For procedures on checking the expiration date of the pads and maintaining them please refer to Section 6 2 Maintenance of these Instructions for Use 24 4 5 Defibrillation in Adult Mode Step 1 Place pads on the patient 4 Remove pad 1 fr
43. he patient Displays the status of the battery in 4 steps Step 1 The battery is full Step 2 E Less than half of the battery is remaining Step 3 LE Less than of the battery is remaining Step 4 __ The battery is almost depleted Displays the heart rate of the patient after the pads are attached Displays the ECG of the patient after the pads are attached Uses the text to guide the user in operating the device Describes the functions of the three Soft Keys 17 e The Graphic LCD Screen illustrated in these Instructions for Use may not match the actual screen during operation depending on the device settings e The Printer and CU EM1 are not a part of the standard package contents If you want to purchase them please contact us by referring to Appendix A Parts and Accessories of these Instructions for Use 18 4 2 Soft Keys There are three Soft Keys in the center of the PAD CU SP2 which operate the device and the menu mode The Soft Keys operate in two modes Operation Mode and Menu Mode When in Operation Mode the functions of the Soft Keys are changed according to the Manual Override For further details on Manual Override please refer to Section 5 4 Device Setup of these Instructions for Use Soft Keys are labeled 1 3 from left to right Soft Key Functions in Menu Mode Button 1 Moves left up on the menu WC Selects or sets the current item Button 2 A Plays ECG
44. he voice guide instructs to transfer the treatment data press the i Button to transfer the data If there is treatment data in the device s internal memory 4 The device informs the total number of treatments and information saved on the device by voice and LCD Screen 44 Transmit The Recue Data 2012 01 04 01 27 59 2011 12 20 05 02 40 2011 11 10 09 07 11 2 There are at most 3 treatment data The first treatment data is the most recent 8 Press the Shock Button to change the transfer order of the treatment data as follows 1st treatment data gt 2nd treatment data gt 3rd treatment data gt 1st treatment data gt Transmit The Recue Data 2011 12 20 05 02 40 2011 11 10 09 07 11 4 If you wish to transfer the selected treatment data press the i Button 6 Run CU Expert on the PC Please refer to the CU Expert manual for further details The device is connected to CU Expert within a few seconds and treatment data is automatically transferred 7 When the transfer is completed the device automatically shuts down If there is no treatment data in the device s internal memory The device informs you by voice that no treatment data exists and automatically shuts down QUAD CAUTION e Maintain a distance of 30cm and an angle of 15 between the IrDA port on the device and the IrDA adapter Also since external light sources affect the IrDA try to use it indoors and away from f
45. ical 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 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 99
46. icity AF SB SVT heart 99 54 30 gt 95 block 218 219 arbitrary specificity idioventricular specificity PVC s 96 21 NON SHOCKABLE gt 95 Asystole 100 127 132 specificity specificity a A Statement for Health Professionals from the AHA American Heart Association Task Force on AED Subcommittee on AED Safety and Efficacy Automatic External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety Published 1997 95 1677 1682 b According to AHA Recommendations a and AAMI based DF80 SVT is clearly included in the non shockable rhythm grade 91 Control Devices Indicators Voice Instructions Category Control Devices Graphic LCD Indicators Speakers Beeper Low Battery Check Low Battery Indicator Voice Instruction Self Tests Auto General Specifications Power Button i Button Shock Button 3 Soft Keys Displays the operating status of the device and instructions e Shock Button Flashes in orange when the defibrillator is charged and ready to deliver a shock e Blue i Button Flashes when guiding CPR transferring treatment data or setting the CPR mode e Red Button Flashes when an error occurs Outputs voice instructions e f the device determines based on its settings that the surrounding environment is noisy and it cannot give accurate v
47. ier 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 ventilation ratio of 30 2 if the device is set to a default setting of 5 cycles 30 2 If you are not trained in ventilation perform only the chest compression Refer to Section 5 4 Device Setup for the CPR setting Please contact the manufacturer for additional information An abnormal heart rhythm A disposable or rechargeable battery pack that supplies power to the device 80 Cardiac Arrest Patient Communication Port Condensation CPR Mode Defibrillation Defibrillator Pads Connector Device Disposable Battery Pack ECG A patient with cardiac arrest symptoms This device should be used for the patient with the following 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 in
48. ing CPR START When pressed the device will guide you through CPR Button 3 This function is activated while the device is guiding you through CPR STOP CPR 3 When pressed the device will stop the CPR guidance 20 For further details on the functions of the Soft Keys please refer to Section 4 5 Defibrillation in Adult Mode and Section 4 6 Defibrillation in Pediatric Mode in these Instructions for Use e Button 2 is activated only when the device is set to Pediatric Mode e When Manual Override is set to OFF Soft Keys 1 and 3 will be deactivated after attaching the pads on the patient 4 3 Procedure for Using the Device If you think that you are witnessing someone suffering sudden cardiac arrest perform the chain of actions recommended by the Korean Association of Cardiopulmonary Resuscitation KACPR and the American Heart Association AHA in their Chain of Survival emergency response to sudden cardiac arrest 1 Immediate recognition and activation of the emergency response system Activate the community emergency response system e g call 911 or the equivalent service in your locality 2 Early CPR Perform CPR 3 Early defibrillation Use this device i PAD CU SP2 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 when instructed by the device Step 3 Perform CPR 4 Effective adva
49. ing according to the set energy level along with a charging sound The charged energy amount can be checked on the LCD Screen 00 00 58 Manual 38 If you want to stop charging press the DISARM button using Soft Key 3 When pressed the device will cease charging and dump the shock energy internally 00 00 58 When armed the Shock Button will flash in orange to signal readiness for defibrillation At this time you can administer defibrillation by pressing the Shock Button If the flashing Shock Button is not pressed within 15 seconds the device will automatically cancel the shock delivery and disarm 4 10 3 Using R Sync When the device is switched to manual override Soft Key 2 will be activated as SYNC ON Pressing Soft Key 2 will display the SYNC symbol in the upper center of the LCD Screen and enable administration of R Sync energy Using R Sync will detect the R wave of the patient s ECG and display the R Sync mark on the LCD Screen with a short beep 00 00 36 t Manual Y Dade snoor At this time you may charge shock energy by pressing Charge using Soft Key 3 if you think that defibrillation is necessary Press the Shock Button to administer defibrillation The device will automatically administer defibrillation if R wave is detected To stop using R Sync press SYNC OFF using Soft Key 2 39 f N CAUTION J CAUTION e The usage authority differs for each device mode e
50. ion for 2 minutes when setting Detail Guidance to OFF and Breath to 0 regardless of other CPR settings It will then automatically reanalyze the patient s ECG Once the device starts to reanalyze the patient s ECG immediately stop applying chest compressions and do not touch the patient 59 6 Maintenance 6 1 Device Storage Please refer to the precautions below when storing the device Do not store in an environment with large fluctuations in temperature Storage Environment The device is connected to the pads and battery pack and is ready for immediate use in case of an emergency Temperature 0C 43 32 F 109 Humidity 5 95 a location with no condensation Transportation Environment The device is not connected to the pads and battery pack and is separately stored for a long period of time or while being transported Temperature 20 C 60 C 4 F 140 F Humidity 5 95 a location with no condensation Do not store the device under direct sunlight Do not store the device in a moist environment 60 Do not store the device near electric heating appliances Do not store the device where it is susceptible to excessive shock or vibration Do not store the device where it is exposed to chemicals or explosive gas Take care not to allow dust particularly metallic particles into the device Do not dismantle or disassemble the device The manufacturer will not b
51. l be displayed on the upper left corner of the LCD Screen Also the Soft Keys will be activated as follows Soft Key 1 ENERGY Soft Key 2 SYNC ON Soft Key 3 MENU CHARGE 00 00 28 Manual Attach pads 4 10 1 Changing the Energy Value When in manual override the user can set the energy value for defibrillation The range of the output energy will change depending on Adult Pediatric Mode For further details on changing the Adult Pediatric Mode please refer to Section 5 4 Device Setup in these Instructions for Use Press Soft Key 1 which reads ENERGY to change the energy setting 00 00 28 Manual Attach pads a smcon me 37 When pressing Soft Key 1 the output energy value displayed on the upper right corner of the LCD Screen will be highlighted in white Also the Soft Keys will be activated as follows Soft Key 1 A INCREASE ENERGY Soft Key 2 Y DECREASE ENERGY Soft Key 3 CONFIRM At this time use Soft Keys 1 and 2 to change the energy value and press Soft Key 3 to confirm 00 01 59 Manual Attach pads 4 10 2 Charging the Device and Administering Electric Shock Treatment In manual override the user may use their own discretion to charge the energy and administer defibrillation After attaching the pads on the patient press Charge using Soft Key 3 if you believe that the patient requires defibrillation based on the ECG value When pressing Soft Key 3 the device will start charg
52. lacement device is available check the patient s condition and perform CPR as necessary Continuously check the patient s condition and perform CPR until the emergency medical services arrives 72 8 Device Service Device Warranty Device name E Purchase Name Pp Serial No Distributor pe 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 This 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 IN NO EVENT SHALL CU MEDICAL SYSTEMS BE LIABLE FOR CONSEQUENTIAL DAMAGES e 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 dama
53. lectromagnetic propagation is affected by absorption and refection from structures objects and people 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 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 SP2 is used exceeds the applicable RF compliance level above the CU SP2 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 SP2 Over the frequency range 150 kHz to 80 MHz field strengths should be le
54. llowing contacts Do not touch any body parts of the patient such as the body head arms and legs Do not touch any conductive fluids such as gel blood and saline Do not touch any conductive metal objects such as a stretcher or wheelchair Making such contacts may provide unwanted pathways for the defibrillating current e The user must not touch the patient when pressing the Shock Button The defibrillating shock may harm the user or bystanders e After starting the ECG analysis the device will continue the analysis up to the point of pressing the Shock Button When the patient s ECG returns to a state that does not require defibrillation the device will disarm itself It will then reanalyze the patient s ECG e 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 and instruct you to make sure that emergency medical services have been called The device will then instruct you to begin CPR e f the device malfunctions during a rescue operation it will instruct you to get a replacement defibrillator and will start the voice instruction for CPR Perform CPR until the replacement equipment is ready to use 27 Step 3 Perform CPR The user must immediately perform CPR while temporarily suspending emergency treatment on the patient During this
55. luorescent and or incandescent lamps e The PC software CU Expert Ver 3 70 or higher and the IrDA adapter are not a part of the standard package contents If you want to purchase them please contact us by referring to Appendix A Parts and Accessories of these Instructions for Use 45 5 3 Data Review If the Defibrillator Pads Connector has not been inserted or the pads have not yet been attached to the patient you can press Soft Key 3 on the device to enter Menu Mode In Menu Mode you can easily check the device setup and the treatment data saved on the device Press the Menu button to enter Menu Mode 00 00 40 Peel off the pad labeled 1 and stick to the bare skin of the patient exactly as shown in the picture MONITOR MODE After entering Menu Mode press the right arrow button to move to the second tab DATA REVIEW DEVICE SETUP DATA REVIEW 2012 04 12 13 12 20 2012 04 12 11 44 02 2012 04 12 11 39 29 EXIT A O ee The saved treatment data is displayed on the left side of the screen Press the confirm button in the center to select the treatment data to review DEVICE SETUP DATA REVIEW 2012 04 12 11 44 02 2012 04 12 11 39 29 EXIT 46 Select the review method The options are Event List ECG Segment Print and Print All DEVICE SETUP DATA REVIEW EXIT ECG Segment Print Print All EXIT Event List Displays the list of events saved on the de
56. nced life support Perform advanced care in order to restore spontaneous circulation 5 Integrated post cardiac arrest care Transfer the patient to a medical institution or a specialized facility 21 e When you witness someone suffering sudden cardiac arrest you must perform the chain of actions recommended by the Korean Association of Cardiopulmonary Resuscitation KACPR and the American Heart Association AHA in their Chain of Survival emergency response to sudden cardiac arrest If finding and or operating the defibrillator takes time monitor the patient s status and activate the emergency response system until the defibrillator is available and perform CPR if necessary 4 4 Preparation for Defibrillation Turn the device on by pressing the Power Button When the power turns ON the following occurs in sequence e Beeper The beeper will beep for 1 second e A self test will be initiated e The device will give voice instructions to call emergency medical S services and on the Adult Pediatric Mode e The guide on how to use the device will be given through the LCD Screen and by voice ZN WARNING e Never perform defibrillation in pediatric mode to a patient who is either heavier than 25 kg or older than 8 years old e You can change the adult pediatric mode under Menu Mode after turning on the i PAD CU SP2 However the defibrillation mode should be changed before placing the pads on the patient Once t
57. ng mechanism on the bottom of the device Refer to the figure below 2 Insert a new battery pack in the direction of the arrow with the label facing upward as shown in the figure below 3 Push the battery pack in until you hear a click 63 How to recharge the battery pack Rechargeable batteries that are low can be reused after recharging You can recharge the battery by using the Battery Charger and Battery Charge Dock provided by the manufacturer Familiarize yourself with the Battery Charger manual before use The red LED lights up on the Battery Charger when charging and the green LED lights up when charging is complete Refer to the figure below for charging the Battery Pack Rechargeable lt q Battery Pack Rechargeable Battery Dock _ Battery Charger Y Battery Pack Disposable Replacing the battery pack The battery pack should be replaced if the battery is low For further details on checking the battery status please refer to Chapter 7 Troubleshooting in these Instructions for Use You must use only a battery pack provided by the manufacturer The disposable battery pack used in this device is not rechargeable Do not insert the disposable battery pack into the Battery Charge Dock The Battery Pack Disposable can be replaced in the same manner as the Battery Pack Rechargeable 64 Charging the CU EM1 Battery R
58. noconionnnonocanocanonnnnonocanonnnnnnonanes 22 4 5 Defibrillation in Adult Mode oocccoccoccconcconcccnconiconnonnnocnnononononcnnononanonnnnnnnononanoncnnnnnnnnos 25 Step 1 Place pads on the patient ooccconcccncocncococonccnncnnnnonccononcnnnnnnnnnnanonnnnnnonaninnnnoninanos 25 Step 2 Press the Shock Button when instructed ooccocccoccconcccncocncocnconcconcnnnconnnanoncnnonnnonos 26 Sepo REMNOM GER 28 4 6 Defibrillation in Pediatric Mode ocooccconccnncccncociconiconconnnonocononcnnonnconocanonnnnononanoncnnnnnnanos 30 A E A E PORO PO E O A O Ne 31 AO MONITOR Mode id 32 4 9 CU EM1 ECG Transmission Device coocccocccconccccncnocnccnnconcnononononononnnnnnonanonnnonaninaninos 34 4 9 1 Device Fear S sta nada 34 4 9 2 B tom and IMdICalOrS seerne iaa 35 4 9 3 01 AAA A e 35 4 9 4 POW 10 Use he CUEM i aa inieey wonda one done seemed mamnaduuenss 36 4 9 5 Where to Attach ECG PAIS a 36 4 10 Manual Override Not Option usuesociasnta iia 37 4 10 1 Changing the Energy Value occococococccocncconoconnnocnonanonanonnnnonanonannnnnnonanenaninnnns 37 4 10 2 Charging the Device and Administering Electric Shock Treatment 38 AOS USING IR SY NG aiian E 39 5 After Using the PAD CU SP 2 aaa Aa 41 5 1 Maintenance After Bach USC cidcid studs Ran Gear diny sanatsiwnapdenietiaks 41 5 2 Saving and Transferring Treatment Data oocccocncoccccccncocncnooncnncncncnonnn
59. oice instructions it will automatically increase the volume for the user Outputs various beeps The check is automatically performed through periodical self tests as well as in real time when the equipment is in use or the power is turned on The Graphic LCD on the device indicates low battery along with voice instructions and a flashing red i Button Guides the user via voice instructions e Power Self Test Real time Self Test e Daily Weekly Monthly Self Test Manual Battery Pack Self Test performed when the user inserts the battery pack 92 Battery Pack Rechargeable Category Battery Type Capacity Standby Life After Inserting the Battery Temperature Ranges for Storage and Use Battery Pack Disposable Category Battery Type Capacity Standby Life After Inserting the Battery Temperature Ranges for Storage and Use General Specifications 12V DC 1 9Ah Li ion rechargeable For fully charged new batteries at least 70 possible shocks or 3 hours of operation at 25 C 77 F If stored and managed in accordance with instructions in the document At least 2 years from the date of manufacture e Operating Environment Temperature 0 C 43 C 32 F 109 F e Storage Environment Temperature 20 C 60 C 4 F 140 F General Specifications 12V DC 4 2Ah LiMnO disposable For fully charged new batteries at least 150 possible shocks or 5 hours of operation at 25 C 77 F
60. om the single liner and stick the pad to the patient s upper right chest below the collarbone as shown below 2 Remove pad 2 from the single liner and stick the pad to the patient s left side torso in line with the armpit as shown below 3 If the device detects the connection to the patient after placing the pads follow the voice instructions of the device e Defibrillation can be done even if the pads are reversed If the locations of the 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 e In the event the pads are not adhering well check if the adhesive side of the pads is dry Each pad has an adhesive gel If the gel does not adhere well replace it with a new pad 25 Step 2 Press the Shock Button when instructed The device acquires and analyzes the patient s ECG immediately after being connected According to the device settings automatic analysis will become available along with ANALYZE and CHARGE If the device is set to automatic analysis the device will automatically start analyzing the ECG as soon as the pads are attached to the patient N WARNING e Do not touch the patient when the device instructs you not to touch the patient The ECG analysis may become inaccurate if you touch the patient during the analysis If the patient needs defibrillation after the ECG analysis the device will
61. onnnncnnnnnanonaninonoss 42 5 2 1 na E E 42 5 2 2 Transferring Treatment Data oooccconncocnoconccocncocnocononnnnnnnnncanocnnnnnnnncnnonnnnonaninannnns 42 99 Data REVIEW ia A SAS a A 46 5 3 1 EVENGI endotelio N 47 A c E PORC a E ee oe eee 48 5 3 3 Segment PA ie ee 48 SSA PINAN on a e eteree 49 OA DEVICE SEUD aae A ta 50 5 4 1 Configuring the Menu Mode oocccnoccccccocccncccnonononocncncnnnonononnnnnnnnnnnnnnnnnnnnnnnonaninanonos 50 5 4 2 Setting the Operation of the Device coocccocccocccnccncocncoonononncocononcnonnnoncnnnnnnaninnnonos 51 5 4 3 setting ihe CPR Guidance ui 58 65 Manten Cera 60 Bil Device tradi nds laa cod arden ed ered ed eed sla dp ees 60 02 WMOANMEN ANCE cuidara 62 6 2 1 Device INS DS GUO MN e ies sate ees a a be abate anche ced cece Bi Sati oy tore 62 6 2 2 Recharging and Replacing the Battery ocococccocccocccoconcncononncononcnnncnconnnonancnnnonos 62 6 2 3 Replacing ING Pads nue ase ee ee ee ee 67 6 2 4 Cleaning Ne EPADCU SP2 metil os 68 6 2 5 PB A A a A ee 68 Ts TEOUDICSNOOUNG sisiicccesicacereccieieeventent van E aE E 69 TM E 69 eae DECE SAUE er eee O O A 71 7 3 TFOUBDIGSHOOUNG is 72 ds Device DOI 73 A B C D E A 1 Standard Parts and Accessories sisi ACCES SOMOS EN EE A A A NEE NE E A A AA AZ Optional ACCES SONES ed Descripti ON OTS VIMO Sua B GUESP2 DCIS FINAL ON a A BZ CUSSEZ PACKAGING eae ccceiet achec cette ne cb ele le
62. ons Refers to CU Medical Systems Inc 84 D Device Specifications Model Name CU SP2 Product Exterior Category General Specifications Dimensions 260mm x 256mm x 69 5mm Width x Length x Height Weight 2 4kg Including the battery pack and pads Environmental Conditions Category General Specifications Operating Environment The device can be used immediately in case of an emergency Temperature 0 C 43 C 32 F 109 F Humidity 5 95 a location with no condensation Storage Environment The device has pads and a battery and is ready to be used for an emergency Temperature 0 C 43 C 32 F 109 F Humidity 5 95 a location with no condensation Transportation Environment The device does not have pads and a battery and is separately stored or transported over a long period of time Temperature 20 C 60 C 4 F 140 F Humidity 5 95 a location with no condensation 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 6E 1 random Standby Meets MIL STD 810G Fig 514 6E 2 swept sine helicopter Sealing IEC 60529 IP55 ESD Meets IEC 61000 4 2 2001 EMI Radiated Meets IEC 60601 1 2 limits method EN 55011 2007 A2 2007 Group 1 Class B EMI Immunity Meets IEC 60601 1 2 limits method EN 61000 4 3 2006 A1 2008 Level 3 10V m 80MHz to 2500MHz 85 Defibrillator
63. pe CE Certification 78 B 3 2 Pads Description Temperature Limit Store at a temperature between OTC 43 LOT Number Expiration Date Reference Order Number Disposable Do Not Reuse Do not fold or crush this product Contains no Latex Expiration Date Caution Refer to related documents Europe CE Certification 79 C Glossary 1 CPR 1 Cycle Abrasive Adhesive Material on the Pads Gel Adult American Heart Association AHA 2010 CPR Guidelines Arrhythmia Battery Pack 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 4 Device Setup for detailed setting method 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 pads is very important for maintaining the optimum adhesion between the skin and pads Therefore never open the pads package when the pads is not needed and periodically check the expiration date of the pads The adult in these Instructions for Use is defined as a person who is older than 8 years or heav
64. re that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance The i PAD CU SP2 uses RF energy only for its RF Emissions internal function Therefore its emissions are very CISPR 11 low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B The i PAD CU SP2 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 buildings used for domestic purposes flicker emissions Not applicable IEC 61000 3 3 N WARNING e The i PAD CU SP2 should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the i PAD CU SP2 should be observed to verify normal operation in the configuration in which it will be used 95 Guidance and manufacturer s declaration electromagnetic immunity The i PAD CU SP2 is intended for use in the electromagnetic environment specified below The customer or the user of the i PAD CU SP2 should assure that it is used in such an environment Immunity Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11
65. s complete training in CPR or the use of the defibrillator for quick and systematic emergency treatment 1 4 Additional Information Please contact CU Medical Systems Inc or its local distributors for any additional information on the i PAD CU SP2 We will help to answer all of your questions 2 Device Features Graphic LCD Defibrillator Pads Connector i Button Power Button IrDA Port Battery Pack SD Card Port Shock Button Power Button i Button Graphic LCD Shock Button Defibrillator Pads Connector Battery Pack IrDA Port SD Card External Memory Port Soft Keys Pads Storage Compartment Turns the device on or off When the device is on a green LED is lit Provides the following information by voice and LCD screen Reports device usage the total hours of the last usage and number of shocks Checks the S W version Checks for errors Transmits event and ECG data through IrDA and SD Card Displays the current status of the device user s guide ECG heart rate etc Delivers defibrillating shock when pressed Connects with the connectors of the pads The rechargeable disposable is optional power source of the device Transmits and receives treatment data between the device and a personal computer Port for copying device records to an SD card Three buttons that control device settings and movements Stores pads 11
66. ser should perform the device check by pressing buttons according to the voice or screen instructions Also check the connection status of the pad connector as well as the pad status during the self test If the self test is successful the device will Battery Pack automatically shut down Self Test If the self test is not successful the i Button flashes in red When pressing the i Button according to the voice instruction the device will automatically shut down after reporting the error by voice and LCD Screen For further details please refer to Section 7 3 Troubleshooting in these Instructions for Use The battery self test performs a very detailed inspection which takes about 20 seconds If an emergency occurs during the battery self test turn the device off by pressing the Power Button Then turn it back on by pressing the Power Button and quickly respond to the emergency by following the voice instructions Power The device performs a power self test when turning on the device by Self Test pressing the Power Button Real time l i The device checks itself in real time during operation Self Test S This device periodically performs a self test once every day week and Periodic month The periodic self test checks important features of the device such Self Test as the battery status pad status and internal circuits 69 If the self test fails during operation and defibrillation cannot be administered
67. sibly swollen may be hazardous Immediately contact the manufacturer or distributor Use only a genuine Battery Charger designated by the manufacturer Do not leave the battery inside a vehicle during summer Use a lithium secondary battery guaranteed by the manufacturer Do not expose the battery to high heat above 60 e The battery s performance may temporarily drop in low temperatures We recommend not to store or use the battery in a low temperature environment 66 6 2 3 Replacing the Pads You cannot use expired pads Check if the pads package is damaged You should use only the pads provided by the manufacturer How to replace pads 1 Check the expiration date of the pad Refer to the figure below for checking the expiration date EXP MM YYYY DATE 1234567890 The expiration date is marked to the left The expiration date is indicated as of the Multifunction Defibrillation follows ADULT PADS label on the pads MM YYYY package MM Month YYYY Year 2 Used or expired pads should be replaced Pull out the top and bottom of the pads connector with your fingers and take the pads out from the Pads Storage Compartment Refer to the figure below 67 3 Insert the pads connector of the new pads into the Pads Connector Insert and then put the Pads Package in the Pads Storage Compartment Refer to the figure below 6 2 4 Cleaning the i PAD CU SP2 Always clean the
68. ss than V1 V m 98 Recommended separation distances between portable and mobile RF communications equipment and the CU SP2 The i PAD CU SP2 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 SP2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the i PAD CU SP2 as 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 3 5 12 12 23 V1 3 V output ower of n pees AvP aa WP d JWP E1 E1 E1 E1 rms V2 10Vrms 10 V m 20 V m 10 V m 20 V m IC oe ore on ozs one ree ee ee ee Too so eo eo om 00 nso For transmitters rated at a maximum output power not listed above the recommended transmitter W T 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 watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and med
69. t to the printer after you have selected the second event DEVICE SETUP DATA REVIEW EXIT Power On 00 00 00 P Message 16 P 0 Connecting 1 1 00 00 55 Pause For CPR 00 00 58 48 Once connected the printer will print the ECG and event list of the selected segment Press the i Button to stop printing DEVICE SETUP DATA REVIEW EXIT Power On 00 00 00 P Message 16 Printing 00 00 55 Pause For CPR 00 00 58 q 5 3 4 Print All Select Print All to directly connect to the printer When connected the device will print all saved events and ECGs Press the i Button to stop printing DEVICE SETUP DATA REVIEW EXIT Event List DEVICE SETUP DATA REVIEW EXIT Event List ECG Message ECG Message Segment Print Segment Print Connecting e f the device is not paired with a printer you cannot access Segment Print or Print All e For further details on using the printer please refer to the printer s manual and Section 4 7 Printer in these Instructions for Use e The printer is not a part of the standard package contents If you want to purchase a printer please contact us by referring to Appendix A Parts and Accessories of these Instructions for Use 49 5 4 Device Setup In PAD CU SP2 you can set the operation of the device and the CPR guidance under Menu Mode If the Defibrillator Pads Connector has not been inserted or the pads have not yet been attached to the pati
70. the device will instruct you to get a replacement defibrillator and will guide CPR by voice To learn more about the error first press the Power Button to turn off the device Press and hold down the i Button and the device will notify the error by voice and LCD Screen and then automatically shut down For further details please refer to Section 7 3 Troubleshooting of these Instructions for Use QUID CAUTION e Since the CU SP2 performs a self test on a daily basis you do not need to frequently perform a self test for the battery pack Frequently self testing the battery pack consumes battery power and shortens the battery life e Periodically check if the i Button flashes in red in order to prepare for emergencies If the i Button flashes in red please refer to Section 7 3 Troubleshooting in these Instructions for Use 70 7 2 Device Status The device notifies the user of its status in the following ways Indicator Description Remarks The device detected an error e g low i Button Flashing in red battery Press the i Button to identify the error The device is ready to deliver an electric Shock Button Flashing in shock Press the Shock Button to deliver orange an electric shock 71 7 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 Symptom Voice Instruction Voice Prompt
71. to Section 5 4 Device Setup of these Instructions for Use Compression Breath Ratio Adult Printer CU EM1 pediatric Mode No of Shocks Connection Status Operation Time Shock Energy Battery Status 00 00 40 lt q Heart Rate Image Guide EG Peel off the pad labeled 1 y Se E RE EUR EUA Text Guide gt 4 exactly as shown in the picture MONITORMODE fT mew 4 Soft Key Screen configuration for setting the graphic indication SUMON DESENPLON 00 00 18 E 30 2 ECG Remove all clothing from chest and stomach Text Guide Rip clothing if necessary Screen configuration for unsetting the graphic indication 16 Image Guide Operation Time Printer CU EM1 Connection Status Adult Pediatric Mode Compression Breath Ratio No of Shocks Shock Energy Battery Status Heart Rate ECG Text Guide Button Description Uses the image to guide the user in operating the device Displays the actual operation time of the device Displayed when using the Printer CU EM1 e Printer E e CU EM1 Changes based on the Adult Pediatric Mode of the device e Adult e Pediatric ES Displays the CPR setting of the device Can be changed by pressing the Soft Keys during operation when in Pediatric Mode The chest compression number is fixed to 30 when in Adult Mode Displays the number of administered shocks Displays the amount of shock energy administered to t
72. ts dd eS AC COS SOMOS icici cece eres ecu dee ee tect ade etd care EEE dave a aman eee tena B 3 1 Rechargeable Battery Packs ene ee ete tc B 3 2 Pads Glossary Electrom Device SPECI CAUOINS ina aghetic COMM ATOMIC esis on at ii 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 8 Device Service 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 SP2 We or Us refers to CU Medical Systems Inc Pads refers to disposable defibrillation electrode pads for adult or pediatric modes and Battery Pack refers to the rechargeable or disposable battery pack These Instructions for Use emphasize 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 MENTA WARNING Conditions hazards or unsafe practices that can result in serious personal injury or loss of life CAN CAUTION CAUTION Conditions hazards or unsafe practices that can result in minor or moderate personal injury damage to the device or loss o
73. ufacturer e f this device does not operate properly contact the manufacturer or its authorized service center 1 Product Information 1 1 Device Description CU SP2 is an easy to use Semi Automated External Defibrillator AED that is small light and portable and uses a battery The AED automatically or manually reads the sudden cardiac arrest SCA patient s electrocardiogram ECG and determines if a cardiac arrest that requires defibrillation has occurred so that licensed emergency medical technicians medical professionals and the general public can easily operate it SCA 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 1 2 Indicated Use The i PAD CU SP2 is indicated for use on patients that are exhibiting the symptoms of sudden cardiac arrest SCA with all of the following signs e No movement and no response when shaken e No normal breathing If the patient is suspected of displaying the symptoms above attach the pads and use the defibrillator according to each step of the voice instructions 1 3 Intended Users The i PAD CU SP2 is intended for use by licensed emergency medical technicians or medical professionals Also the general public untrained in CPR or the use of the defibrillator may use this device according to its settings However the manufacturer recommends that inexperienced user
74. vice ECG Displays the ECG data saved on the device Segment Print The user selects and prints the segment to review Print All Prints all usage data 5 3 1 Event List Select Event List to check the list of events saved on the device You can move to the next or previous page by using the Left Right arrow buttons Event List displays the history of events on the left and the time elapsed since the last usage of the device on the right Press the Exit button in the center to exit Event List DEVICE SETUP DATA REVIEW EXIT Power On 00 00 00 Pads On 00 00 06 Pads Off 00 00 10 Pads On 00 00 51 Analyzing 00 00 51 No Shock Advised 00 00 55 Pause For CPR 00 00 58 47 5 3 2 ECG You can check the ECG saved on the device Select ECG to play the saved ECG You can press the pause button in the center to stop playing After stopping you can move to the next or previous page by using the Left Right arrow buttons Press the i Button to exit ECG DEVICE SETUP DATA REVIEW EXIT 5 3 3 Segment Print Select Segment Print to choose and print a segment on the Event List DEVICE SETUP DATA REVIEW EXIT Power On 00 00 00 Pads On 00 00 06 Pads Off 00 00 10 00 00 51 Analyzing 00 00 51 00 00 55 Pause For CPR 00 00 58 q You can only select two events in order to identify the start and end of the segment Once the first event is selected the device will automatically attempt to connec
75. w to operate the device This option is not recommended to the general public who are not licensed in rescue procedures 93 e External Device Pairs the CU SP2 with the printer and CU EM1 ECG transmission device Selecting External Device displays Printer and CU EM1 on the left side of the screen The model number of devices currently connected to the CU SP2 are displayed on the right If no device is paired the right spaces will be left blank DEVICE SETUP DATA REVIEW EXIT SPP R200 CU EM1 CUEM1 45f7d6 EXIT First select the device to pair from the options on the left After selecting the CU SP2 will search for nearby devices Searches up to 5 devices DEVICE SETUP DATA REVIEW EXIT SPP R200 CU EM1 Message 45F7d6 EXIT Searching After searching the CU SP2 displays the list of searched devices on the right side of the screen DEVICE SETUP DATA REVIEW EXIT CU EM1 EXIT If no device is found the CU SP2 will display the following message for 3 seconds and return to the previous page 54 DEVICE SETUP DATA REVIEW EXIT SPP R200 CU EM1 Message 45t7d6 EXIT No Device Check and select a device from the list to pair with the CU SP2 After selecting the CU SP2 will test connection with the selected device After testing the CU SP2 will save the connection information and return to the previous page DEVICE SETUP DATA REVIEW EXIT CU EM1 Message DEVICE SETUP DATA REVIEW
76. ys are labeled 1 3 from left to right ANALYZE The user can choose to monitor the patient s ECG through the pads start analyzing the patient s ECG and start end the CPR guidance CHARGE The user can monitor and analyze the patient s ECG through the pads to determine whether to start charging the device s energy for defibrillation Also the user can choose to start end the CPR guidance OFF The device automatically analyzes the patient s ECG when the pads are attached If defibrillation is necessary the device will automatically charge the energy necessary for defibrillation and direct the user to administer defibrillation CTD WARNING e The usage authority differs for Device Mode and Manual Override setup and requires a password The default password is vulnerable to exposure We recommend that you change the password on a regular basis e Manual Override Only medical professionals may use this mode e AED Mode ANALYZE Only licensed emergency medical technicians or medical professionals may use this mode CHARGE Only medical professionals may use this mode OFF Licensed emergency medical technicians medical professionals and the general public may use this mode 52 e Adult Pediatric Mode Adult Mode The device will operate in Adult Mode In the case of a pediatric patient connecting the device with the pediatric pads connector will automatically switch the device to Pediatric Mode Pediatric Mode The

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