AED Trainer NF1200-T. Operator s Manual

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AED Trainer i-pad NF1200-T Operator s Manual

NF1200-T Table of Contents Table of Contents 2 1. Introduction 3 Product Description 3 Intended Use 3 2. Device Orientation 4 3. Setting up the i-pad 8 Package Contents 8 Infrared Remote Controller (Remocon) 9 Rescue Scenarios 11 Setting up the i-pad NF1200-T 14 4. Using the i-pad NF1200-T 15 Simulated Rescue Preparation 15 Simulated Main Rescue Sequence 18 5. Servicing the i-pad NF1200-T 23 Warranty 23 Warranty Disclaimer 23 Service 24 How to Contact Us 25 2 CU Medical Systems, Inc.

Operator s Manual Ver 1.30 1. Introduction Product Description The i-pad NF1200-T is a defibrillator simulator designed to mimic the operations of the i-pad NF1200. It can simulate functions of the i-pad NF1200 such as charging and shock delivery. NOTICE The charging and shock delivery operations of the i-pad NF1200-T are simulated only. The device does not contain any defibrillating capacitor and thus it can not deliver a real defibrillating shock. It has preprogrammed rescue scenarios that are in accordance with the recommended rescue protocol of international rescue policy making bodies such as the American Heart Association, the European Resuscitation Council, and the American Red Cross. It is to be used in conjunction with the resuscitation mannequin from CU Medical Systems, Inc. It has a standard infrared remote control accessory which renders it operable by an instructor from a distance. Intended Use The i-pad NF1200-T is intended for use during Advanced Cardiac Life Support training, Basic Life Support training, or any other physician approved trainings that deal with the operation of an automated external defibrillator. The i-pad NF1200-T is not intended for use during actual rescue operations as it can not deliver a defibrillating shock. 3

NF1200-T 2. Device Orientation Handle i-button Remote control sensor State LED Power ON/OFF button ON/OFF Cover 1 Turn ON First 1 Turn ON Then Open 2 Top View of the i-pad NF1200-T with its cover closed 4 CU Medical Systems, Inc.

Operator s Manual Ver 1.30 Graphical Rescue Guide Cover AED Electrode Pads Connector Port Quick Reference Guide Shock Button Battery Pack IrDA (Communication) Port Perspective view of the i-pad NF1200-T with its cover open Power ON/OFF Button Press this button to turn the i-pad NF1200-T ON or OFF. i-button This button may be used to change the compression-ventilation ratio. When no pads are attached, entering administration mode by pressing this button is disabled in this version of the i-pad NF1200-T. State LED Indicates the status of the i-pad NF1200-T blinking green: the i-pad NF1200-T is in standby mode and ready for a rescue operation solid green: the i-pad NF1200-T is in rescue mode. blinking red: the i-pad NF1200-T detected a system error or low battery level during a self-test. solid blue: the i-pad NF1200-T is conducting a self-test. 5

NF1200-T Handle An easy-grip carrying handle for increased portability of the i-pad NF1200-T. Cover Covers the front panel of the i-pad NF1200-T and retains the defibrillator electrode pads package. SHOCK button Press this button when the i-pad NF1200-T prompts you to Press the flashing orange button now. Pressing this button delivers a simulated defibrillation shock to the manikin. AED electrode pads connector port Plug the connector of the AED electrode pads into this port Graphical Rescue Guide Guides you by indicating the current step in the simulated rescue process. Quick Reference Guide A printed card that summarizes the steps of a simulated rescue process using the i-pad NF1200-T. Battery Pack Provides power to the i-pad NF1200-T. IrDA Communication Port This port is disabled in this version of the i-pad NF1200-T. Remote Control Sensor Senses the infrared control signal from the remote controller. Point the remote controller at this sensor when you want to control the i-pad NF1200-T. 6 CU Medical Systems, Inc.

Operator s Manual Ver 1.30 For product installation and storage, be sure to refer to the following instructions and avoid damage to the product. Do not store the device in areas with highly fluctuating temperatures. Do not store the device in areas that are directly exposed to sunlight. Do not operate or store the device in conditions that are beyond the following specified limits. Standby conditions Temperature: 0 C to 43 C (32 F to 109 F) Humidity: 5 % to 95 % (non - condensing) Operating Conditions Temperature: 0 C to 40 C (32 F to 104 F) Humidity: 5 % to 95 % (non - condensing) Storage Conditions Temperature: -20 C to 60 C (-4 F to 140 F) Humidity: 5 % to 95 % (non - condensing) Do not store the device near heating equipment. Do not install or store in environments where humidity tends to rapidly increase or there is a ventilation problem. Do not store the device in areas where there is high vibration (in excess of Category 10 of MIL-STD-810E). Do not operate or store the device in environments with high concentration of flammable gas or anesthetics. Do not operate or store the device in areas with high concentration of dust. Only personnel authorized by the manufacturer may open the device for servicing. There are no user serviceable components inside the device. 7

Then Open 2 NF1200-T 3. Setting up the i-pad NF1200-T Package Contents The i-pad packaging box contains the following items. i-pad NF1200-T Operator s Manual ON/OFF 1 Turn ON First 1 Turn ON Disposable, non-rechargeable battery pack Trainer Pads Rechargeable battery pack (option) Battery Charger (option) Infrared Remote Controller 8 CU Medical Systems, Inc.

Operator s Manual Ver 1.30 Infrared Remote Controller (Remocon) This enables an instructor to control the i-pad NF1200-T from a maximum distance of 3 meters. The Remote Controller should be pointed at the remote controller sensor of the i-pad NF1200-T when controlling its operation. The instructor should control the i-pad NF1200-T using this Remote Controller only. Any changes in simulated ECG and training scenario should be done using this Remote Controller. Infrared Remote Controller 9

NF1200-T Infrared Remote Controller Functions Key Function POWER OFF Turns the power of the i-pad NF1200-T OFF when pressed while the i-pad NF1200-T is ON. PAD ON/OFF Simulates pads ON and pads OFF conditions. Toggles between the said two conditions when pressed (i.e. if the pads are ON, turns OFF the pads when pressed; if the pads are OFF, turns ON the pads when pressed). After the trainee attaches the pads to the manikin, pressing this button simulates the attachment of the pads and starts rescue scenario 1. LOW BAT Simulates a low battery condition when pressed. UP Increases the level of audio volume when pressed. DOWN Decreases the level of audio volume when pressed. S1 to S8 Rescue scenarios 1 to 8. The rescue scenarios simulate rescue conditions in the field. The trainee may react to the scenarios by doing the appropriate actions. Only scenarios 1 to 8 are implemented on this version of the i-pad NF1200-T 10 CU Medical Systems, Inc.

Operator s Manual Ver 1.30 Rescue Scenarios Scenario Number Scenario S1 a. Shockable rhythm b. Shock delivery c. CPR administration (30 chest compressions, 2 artificial breaths) d. Normal Sinus Rhythm e. CPR administration (30 chest compressions, 2 artificial breaths) S2 a. Normal Sinus Rhythm b. CPR administration (30 chest compressions, 2 artificial breaths) c. steps a and b looped continuously S3 a. Shockable rhythm b. First Shock delivery c. CPR administration (30 chest compressions, 2 artificial breaths) d. Shockable rhythm e. Second Shock delivery f. Normal Sinus Rhythm g. CPR administration (30 chest compressions, 2 artificial breaths) S4 a. Shockable rhythm b. First shock delivery c. CPR administration (30 chest compressions, 2 artificial breaths) d. Normal Sinus Rhythm e. CPR administration (30 chest compressions, 2 artificial breaths) f. Rhythm changes to shockable rhythm. g. Second shock delivery h. CPR administration (30 chest compressions, 2 artificial breaths) i. Normal Sinus Rhythm j. CPR administration (30 chest compressions, 2 artificial breaths) 11

NF1200-T Rescue Scenarios, continued Scenario Number Scenario S5 a. Shockable rhythm b. Shock delivery c. CPR administration (30 chest compressions, 2 artificial breaths) d. Steps a to c looped continuously S6 a. Shockable rhythm b. First Shock delivery c. CPR administration (30 chest compressions, 2 artificial breaths) d. Shockable rhythm e. Second shock delivery f. CPR administration (30 chest compressions, 2 artificial breaths) g. Normal Sinus Rhythm h. CPR administration (30 chest compressions, 2 artificial breaths) i. Rhythm changes to shockable rhythm j. Third shock delivery k. CPR administration (30 chest compressions, 2 artificial breaths) l. Normal Sinus Rhythm m. CPR administration (30 chest compressions, 2 artificial breaths) 12 CU Medical Systems, Inc.

Operator s Manual Ver 1.30 Rescue Scenarios, continued Scenario Number Scenario S7 a. Shockable rhythm b. First Shock delivery c. CPR administration (30 chest compressions, 2 artificial breaths) d. Shockable rhythm e. Second shock delivery f. CPR administration (30 chest compressions, 2 artificial breaths) g. Shockable rhythm h. Third shock delivery i. CPR administration (30 chest compressions, 2 artificial breaths) j. Normal Sinus Rhythm k. CPR administration (30 chest compressions, 2 artificial breaths) S8 a. Normal Sinus Rhythm b. CPR administration (30 chest compressions, 2 artificial breaths) c. Shockable Rhythm d. Shock delivery e. CPR administration (30 chest compressions, 2 artificial breaths) f. Normal Sinus Rhythm g. CPR administration (30 chest compressions, 2 artificial breaths) 13

2 Then Open 2 First Turn ON/OFF NF1200-T Setting up the i-pad NF1200-T 1 Upon opening the packaging box, verify that it contains all the items listed in the packing list. 2 Familiarize yourself with the controls and features of the i-pad NF1200-T. Study the functions of the buttons, switches, indicators, and connection ports. 3 Place the trainer defibrillator pads package as shown in the following figures. 1 Turn ON 4 Install the battery pack. 1 ON 1 Turn ON Then Open 5 Place the i-pad NF1200-T inside the carrying case if you have purchased this optional accessory. 14 CU Medical Systems, Inc.

Then Open 2 Operator s Manual Ver 1.30 4. Using the i-pad NF1200-T Simulated Rescue Preparation 1. Open the cover of the i-pad NF1200-T 1 Turn ON 2. Press the ON/OFF button to turn the i-pad NF1200-T ON The i-pad NF1200-T activates the following Indicators and Voice Prompt, in sequence: State LED: turns solid blue Beeper: emits a short continuous beep State LED: turns solid green Voice prompt: Attach pads The voice prompt is played until the training instructor presses the PAD ON/OFF or any scenario key (S1 to S8) button to simulate a rescue scenario. The training instructor must press the PAD ON/OFF button only after the pads are attached to the manikin by the trainee. 15

NF1200-T 3. Remove the clothing of the patient simulator (manikin) CAUTION To the training instructor: Emphasize the following caution to the trainee. Do not waste time in removing the patient simulator s clothing. If necessary, rip off or cut off the patient simulator s clothing. 4. Tear open the packaging of the pads 5. Take the pads out of its packaging 16 CU Medical Systems, Inc.

Operator s Manual Ver 1.30 6. Plug the connector of the pads into the AED electrode pads connector port of the i-pad NF1200-T 7. Look at the graphics on the back of the pads. The graphics indicate the positions of the pads on the patient s body. Adult Pediatric 8. Peel off the protective sheets of the pads. 17

NF1200-T Simulated Main Rescue Sequence STEP 1: Attach the pads To the training instructor: As soon as the pads are attached, press the PAD ON/OFF button or run the desired scenario by pressing the appropriate scenario key on the remote controller. Pressing the PAD ON/OFF button runs scenario 1 by default. STEP 2: Press the SHOCK button if instructed The i-pad NF1200-T begins rhythm analysis simulation as soon as the training instructor presses the PAD ON/OFF button or any scenario button from S1 to S8. The i-pad NF1200-T activates the following Indicator and Voice prompt during simulated rhythm analysis: Voice prompt: Analyzing heart rhythm Graphical Rescue Guide: lights up the second step of the rescue operation. After simulated rhythm analysis, the i-pad NF1200-T proceeds according to the rhythm predetermined by the chosen rescue scenario. 18 CU Medical Systems, Inc.

Operator s Manual Ver 1.30 If a shock is needed: Indicators and Voice prompts: Beeper: 1 second continuous beep Voice prompt: Shock advised Beeper: beeps continuously until the SHOCK button is pressed or until the i-pad NF1200-T disarms itself if the SHOCK button is not pressed within 15 seconds. Voice prompt: Press the flashing orange button, now. Deliver shock, now SHOCK button backlight: flashing orange. You must press the SHOCK button to deliver the simulated shock. If you press the SHOCK button, the i-pad NF1200-T delivers a simulated defibrillating shock. It informs you of the shock delivery with the voice prompt: Shock delivered If you do not press the SHOCK button within 15 seconds, the i-pad NF1200-T disarms itself and proceeds to CPR Guidance. If a shock is not needed: Indicator: Voice prompt: No shock advised WARNING To the training instructor: Emphasize the following warning to the trainee. Do not let anybody touch the patient when you press the SHOCK button. Defibrillation shock can cause operator or bystander injury. 19

NF1200-T STEP 3: Perform CPR The i-pad NF1200-T directs you to do CPR after delivering one shock or if the ECG rhythm is not shockable, after rhythm analysis. Indicators and Voice Prompts Graphical Rescue Guide: lights up the third step of the rescue operation. For other indicators and voice prompts, see CPR Protocol In the real i-pad NF1200 device, the CPR protocol depends on the following settings: 1. Rescue Provider Lay Rescuer Healthcare Provider 2. Compression-Ventilation Ratio 30:2 (30 compressions, 2 breaths) 15:2 (15 compressions, 2 breaths) In the i-pad NF1200-T, the rescue provider setting may not be changed. The rescue provider is set to Healthcare Provider setting period. The compression-ventilation ratio setting may be changed by pressing the i-button during CPR administration. 20 CU Medical Systems, Inc.

Operator s Manual Ver 1.30 CPR Protocol Scenario 1: The ECG rhythm of the patient is shockable and a shock has been delivered. Voice Prompt: Begin CPR, now Beeper: 1 second continuous beep CPR Guidance: played on the speaker, see following pages for complete description Healthcare Provider Mode Scenario 2: The ECG rhythm of the patient is nonshockable and no shock has been delivered. Voice Prompt: Check pulse Beeper: 1 second continuous beep i-pad NF1200-T pauses for 10 seconds to allow the trainee to check the pulse of the simulated patient. Voice Prompt: Begin CPR, now (ECG Rhythm is Asystole) If no pulse, begin CPR (ECG Rhythm is other than Asystole) CPR Guidance: played back on the speaker, see following pages for complete description Compression-Ventilation Ratio Setting 30:2 Thirty chest compressions for every 2 breaths delivered to the patient. 15:2 Fifteen chest compressions for every 2 breaths delivered to the patient. 21

NF1200-T CPR Guidance The i-pad NF1200-T gives guidance in the form of prompts and beat rhythm during CPR. Following is the description of the guidance sequence. Step Description Your Action(s) 1 Voice Prompt: Push the chest down fast two inches Place your hands, one on top of another on the area between the nipples of the patient Push the chest down 2 inches 2 Beat sound: Rhythm beat sound played at 100 beats per minute. The number of beats depends on the Compression - Ventilation ratio setting 30:2 setting: 30 beats 15:2 setting: 15 beats Push the chest of the patient hard and fast in time with the beat provided by the i-pad NF1200-T. 3 Voice Prompt: Give two breaths Immediately open the airway using a head tiltchin lift maneuver. 4 Voice Prompt: Breathe, breathe Give two breaths Each breath must last for 1 second. Each breath must have enough volume to produce visible chest rise Give the two breaths within 5 seconds 5 Cycles: Steps 1 to 4 are repeated for 5 cycles Do 5 cycles of CPR. 22 CU Medical Systems, Inc.

Operator s Manual Ver 1.30 5. Servicing the i-pad NF1200-T Warranty This device is warranted by CU Medical Systems, Inc. against defects in materials and workmanship for two full years from the date of original purchase. During the warranty period, we will repair or, at our option, replace at no charge a product that proves to be defective, provided you return the product, shipping prepaid, to CU Medical Systems, Inc. or its authorized representative. This warranty does not apply if the product has been damaged by accident or misuse or as the result of service or modification by an entity other than CU Medical Systems, Inc. or its authorized representatives. IN NO EVENT SHALL CU MEDICAL SYSTEMS BE LIABLE FOR CONSEQUENTIAL DAMAGES. Only products with serial numbers and their accessories are covered under this warranty. PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER THIS WARRANTY. Items such as cables and modules without serial numbers are not covered under this warranty. Warranty Disclaimer Servicing by unauthorized personnel renders this warranty null and void. If the factory seal is broken without proper authorization from CU Medical Systems, Inc., this warranty becomes null and void. 23

NF1200-T Service The i-pad NF1200-T must be serviced only by authorized personnel. Unauthorized servicing during the warranty period renders the warranty null and void. The i-pad NF1200-T will be serviced free of charge during the warranty period. After the warranty period, the cost of material and service shall be shouldered by the user. When the i-pad NF1200-T is not operating properly, immediately bring it for servicing to an authorized service center. Please fill up the following table with the necessary information when requesting for service. Product classification Semi-Automated External Defibrillator Trainer Product Name i-pad Trainer Model Name i-pad NF1200-T Serial Number Date of Purchase Sales Representative Name User Information Address C o n t a c t no. Brief description of the problem 24 CU Medical Systems, Inc.

Operator s Manual Ver 1.30 How to Contact Us CU Medical Systems, Inc. Product and Order Inquiries: Overseas Sales Department 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 Service Request and Technical Support Customer Service Team CU Medical Systems, Inc. Dongwha Medical Instrument Complex 1647-1 Dongwha, Munmak, Wonju, Gangwon, Republic of Korea Tel: +82 33 747 7657 Fax: +82 33 747 7659 Homepage : Sales inquiries : Technical inquiries : Service : www.cu911.com sales@cu911.com techinfo@cu911.com service@cu911.com EU Authorized Respresentative of CU Medical Systems, Inc. Medical Device Safety Service Schiffgraben 41, 30175 Hannover, Germany TEL : +49 511 6262 8630 FAX : +49 511 6262 8633 Branch Office of CU Medical Systems, Inc. in Germany Kuester Strasse 6, 30519 Hannover, Germany TEL:+49 511 365 4353 FAX:+49 511 848 6054 25

AED Trainer i-pad NF1200-T Dongwha Medical Instrument Complex 1647-1 Dongwha, Munmak, Wonju, Gangwon, Republic of Korea Tel : +82-33-747-7657 Fax : +82-33-747-7659 Homepage : www.cu911.com