NFK200 Instructions for Use Edition 2

Contact Us CU Medical Systems, Inc. KR-MF-000018333 130-1, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Republic of Korea 26365 Tel: +82 33 747 7657 / Fax: +82 33 747 7659 http://www.cu911.com Product and Order Inquiries Overseas Sales Team 130-1, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Republic of Korea 26365 Tel : +82 31 421 9700/Fax: +82 31 421 9911 E-mail: [email protected] Service and Technical Support Customer Service Team 130-1, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Republic of Korea 26365 Tel : +82 31 421 9700/Fax: +82 31 421 9911 E-mail: [email protected]

CU Medical Germany GmbH DE-IM-000005078 Berliner Str. 44, 10713 Berlin, Germany Tel: +49 30 6781 7804 / Fax: +49 30 6782 0901 E-mail: [email protected]

Medical Device Safety Service DE-AR-000005430 Schiffgraben 41, 30175 Hannover, Germany E-mail: [email protected]

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Table of contents INTRODUCTION ... 6 OVERVIEW ... 7 1.

INTRODUCTION ... 8

1.1

DEVICE DESCRIPTION... 8

1.2

INDICATED USE ... 8

1.3

INTENDED USERS ... 9

1.4

LOCAL PROTOCOL ... 9

1.5

ADDITIONAL INFORMATION... 9

2.

DEVICE FEATURES ... 10

3.

PREPARATION FOR USE ... 12

3.1

STANDARD PACKAGE CONTENTS ... 12

3.2

SETTING UP THE NFK200 ... 13

4.

HOW TO USE THE NFK200 ... 15

4.1

CHAIN OF SURVIVAL ... 15

4.2

PREPARATION FOR DEFIBRILLATION ... 16

4.3

DEFIBRILLATION PROCEDURES FOR ADULT VICTIM... 19

4.4

DEFIBRILLATION PROCEDURES FOR PEDIATRIC VICTIM ... 24

5.

AFTER USING THE NFK200 ... 26

5.1

M AINTENANCE AFTER EACH USE ... 26

5.2

SAVING AND TRANSFERRING TREATMENT DATA... 26

5.2.1

Device Usage ... 26

5.2.2

Transferring Treatment Data ... 27

5.3

DEVICE SETTING ... 28

5.3.1

CPR Guide Setting ... 28

5.3.2

Setting the CPR Guide ... 28

6.

MAINTENANCE ... 31

6.1

DEVICE STORAGE ... 31

6.2

M AINTENANCE ... 32

6.2.1

Device Inspection ... 32

6.2.2

Replacing Supplies ... 32

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6.2.3

Cleaning the NFK200 ... 35

7.

DISPOSAL ... 37

8.

TROUBLESHOOTING ... 38

8.1

SELF-TESTS ... 38

8.2

DEVICE STATUS ... 39

8.3

TROUBLESHOOTING ... 40

9.

8.3.1

Troubleshooting While the Device is Operating ... 40

8.3.2

Troubleshooting While the Device is not Operating(Standby Mode) ... 41

DEVICE SERVICE ... 42

APPENDIX ... 45

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Introduction These Instructions for Use contain information necessary for the correct use of this device. Please contact us regarding any questions or issues on the use of the device arising from information found in these Instructions for Use [Chapter 9: Device 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. Here in after, "Device" refers to [NFK200] "We" or “Us" refers to CU Medical Systems, Inc. "Pads" refers to defibrillation electrode pads, "Battery Pack" refers to a 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.

 Conditions, hazards, or unsafe practices that can result in serious personal injury or loss of life.

 Conditions, hazards, or unsafe practices that can result in minor or moderate personal injury, damage to the device, or loss of treatment data stored in the device, particularly if precautionary steps are not taken.

 Used to denote items that are important during installation, operation, or maintenance of the device.

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Overview Thank you for purchasing the NFK200. 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.

 You must follow the instructions, warnings, cautions, and notices in these Instructions for Use when using this device.  The manufacturer will not be responsible for any problems involving the device that are caused by the user's negligence.  This device shall be serviced only by the manufacturer or its authorized service centers.  If the Device is intended to be connected to equipment other than those stated in these Instructions for Use, contact the manufacturer.  If this Device does not operate properly, contact the manufacturer or its authorized service center.

 A defibrillator discharges electric shock with high voltage and current. You must be wellacquainted with the instructions, warnings, and precautions contained in these Instructions for Use.

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1. Introduction 1.1 Device Description NFK200 is an easy-to-use Semi-Automated External Defibrillator (AED) that is small, light, and portable, and uses a battery. The AED automatically reads the patient's electrocardiogram (ECG) and determines if a cardiac arrest that requires defibrillation has occurred, so that both medical professionals and the general public can easily operate it. Cardiac arrest can occur anytime to anyone at any place and may threaten the patient's life if the appropriate CPR and/or electric shock with a defibrillator are not applied within a few minutes.

The NFK200 is a semi-automated external defibrillator (AED). If connected to a patient, the NFK200 automatically acquires and analyzes the electrocardiogram (ECG) of the patient for the presence of Ventricular Fibrillation or Ventricular Tachycardia (also known as shockable rhythms). If a shockable rhythm is detected, the device automatically charges itself. Defibrillating shock is delivered when you press the SHOCK button.

The NFK200 is easy to use. It guides you throughout a rescue operation using voice prompts and indicators (LED and graphical indicators).

The NFK200 is small, light, highly portable, and battery powered. It is highly suitable for use in public, out-of-hospital settings.

1.2 Indicated Use The NFK200 is indicated for use on patients that are exhibiting the symptoms of sudden cardiac arrest (SCA) with all of the following signs:

a) No movement and no response when shaken b) No normal breathing

Do not use the NFK200 on patients who show either of the following signs:

a) Movement or response when shaken b) Presence of normal breathing

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1.3 Intended Users The NFK200 is intended for use in or out of the hospital by emergency care personnel or healthcare professionals or laypersons. The manufacturer recommends that users train on the use of the device.

1.4 Local Protocol Please contact your local health authority for information on the requirements of ownership and usage of defibrillators.

1.5 Additional Information Please contact CU Medical Systems, Inc. or its local distributors for any additional information on the NFK200.

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2. Device Features

Power Button

Turns the device on or off (When the device is on, a green LED is lit)

Status LED

Displays the current status of the device.

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Shock Button

Delivers defibrillating shock when pressed while flashing in orange.

pediatric mode

Adult and pediatric mode selection, which change with toggle

selection button

operation.

i-Button

Get information regarding the device's last usage (usage time and number of shocks delivered). Get information regarding errors that were detected during self-tests.

Defibrillator Pads

Connects with the connectors of the pads.

Connector

Pads Position

Indicates the pads position on the patient.

Indicators

Do-Not-Touch-Patient

Warns when not to touch the patient.

Indicator

CPR Step Indicator

Indicates step of CPR cycle.

Battery Pack

The disposable power source of the device.

USB Port

Port for copying device records to a USB.

Pads Storage

Stores pads with removable magnetic attached cover.

Compartment

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3. Preparation for Use 3.1 Standard Package Contents The following are the standard package contents of this device

NFK200 Semi-automated External

Instructions for Use

Defibrillator

1 Pack of Adult/Pediatric Pads

1 Battery Pack (Disposable)

(Disposable)

※ Pictures shown on this document may be different from the actual device and accessories.

Please contact the manufacturer for replacement supplies (refer to [Appendix B: Parts and Accessories] of these Instructions for Use).

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 Only parts and accessories recommended and approved by CU Medical Systems, Inc. must be used with the NFK200.  Using parts or accessories manufactured by a third party may compromise device safety and performance.  Any damage, loss, or incident resulting from the use of parts or accessories that were supplied by unauthorized distributors will not be covered by CU Medical Systems, Inc.

 Extra battery packs and pads are recommended.

3.2 Setting up the NFK200 Do the following to set up the NFK200 ① 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 figure below.

As the battery pack is inserted, a beep sounds for 1 second and the power button flashes in green, the device starts a self-test according to following process.

• Battery Level Check • Pads Connector Connection Check • Status of Pads Check • Button Check To check the result of the self-test, please refer to [Chapter 8: Troubleshooting] of these Instructions for Use.

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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: Accessories] of these Instructions for Use. ⑤ Storage and maintenance considerations:

• Refer to [Section 6.1: Device Storage] for proper device storage instructions. • When the device is in storage, check the Status LED periodically to ensure that the device is in normal condition.

• Store the NFK200 in accordance with your local emergency first aid protocol. • Store the device in an easy-to-access location where its status LED can be checked periodically and its technical alarms can be easily heard (e.g. alarm on low battery or other device problems).

• It is also recommended to place an emergency use telephone near the device’s storage area so that emergency medical services can be easily called during emergencies.

• Store the accessories along with the device in the device’s carrying case for easy and quick access.

 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. Refer to [Appendix F: Electromagnetic Compatibility] of these Instructions for Use for more information.  The use of accessories or cables other than those referred to in these Instructions for Use may increase electromagnetic radiation from the device or reduce the device’s electromagnetic immunity. Only accessories and cables that are authorized by the manufacturer should be used with the NFK200.

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4. How to Use the NFK200 4.1 Chain of Survival If you think that you are witnessing someone go down in sudden cardiac arrest, perform the chain of actions recommended by the American Heart Association (AHA) and the European Resuscitation Council (ERC) in its Chain of Survival emergency response to sudden cardiac arrest.

1

2

3

4

5

6

1. Activation of Emergency Response

• Check for a response by tapping the victim on the shoulder and shouting at the victim. • Activate the community emergency response system (e.g. call 911 or the equivalent service in your locality) 2. High-Quality CPR

• Perform CPR. 3. Defibrillation.

• Use this device (NFK200). Using this device can be summarized in 3 steps: After pressing the Power Button, Step 1: Place pads on the patient. Step 2: Press the Shock Button if instructed by the device. Step 3: Perform CPR. 4. Advanced Resuscitation. 5. Post-Cardiac Arrest Care. 6. Recovery.

 If finding and/or operating the defibrillator takes time, monitor the patient's status until the defibrillator is available, perform CPR if necessary.

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4.2 Preparation for Defibrillation ①Turn the device on by pressing the Power Button.

When the power turns ON, the following occurs in sequence:  The beeper will beep for 1seconds.  The power button has a green light.  Self-tests are performed.  Voice instruction: “Call emergency Medical services, now” As the power is on, self-tests following status of device are performed.

• Pads Connector Connection Check • Check whether to use the pads • Expiration date of pads Check

To check the result of self-tests, please refer to the [chapter 8: Troubleshooting].

 When the device is turned on, if the LED lights red and the device notice device error with voice message, get a replacement defibrillator immediately.  If there is no replacement device, do not delay the time to care the patient and perform CPR as soon as possible.

② Select patient mode: Adult/Pediatric Mode When the pads is connected to the device, the following occurs:  Voice instruction: “Adult Mode.”

If it is need to use the device with the pediatric mode, please press the pediatric mode selection button to change the patient mode.

 If the Pediatric Mode Selection Button is changed during the operation of the device, the defibrillation time may be delayed because the ECG analysis starts again. Therefore, it is necessary to carefully select the Pediatric Mode Selection Button before using the device.

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 When compatible pediatric pads is connected to the device, pediatric mode selection button will not be working.

③ Remove clothes from patient's chest.

 Time is essential for the cardiac arrest patient. Tear or cut clothes if removing them will take time.  Dry the patient's skin such that pads can adhere well on the chest. Shave hair on the chest if necessary.

④ Take out the pads package from the Pads Storage Compartment at the top of the device. Transparent top cover can be removed easily and attach to the device.

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⑤ Open the pads package.

⑥ Take pads out of the pads package.

⑦ Refer to the pictures on both pads. Adult/Pediatric Pads

 The adhesive material on the pads starts to dry out as soon as the package is opened. Use immediately after opening. Refer to [Section 6.2: Maintenance] of these Instructions for Use for procedures on how to check the expiration date of the pads and pads maintenance.

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4.3 Defibrillation Procedures for Adult victim Step 1: Place pads on the patient. ① Peel pad 1 off the liner, and stick the pad to the patient’s upper chest as shown below.

② Peel pad 2 off the liner, and stick the pad to the patient’s side torso as shown below.

③If the device detects the connection with the patient after placing the pads, the Do-Not-TouchPatient Indicator lights. Please follow the voice instruction of the device.

If the device does not detect the patient, the device repeats the voice instructions for attaching the pads to the patient until the device detects the connection with the patient after placing the pads.

 In emergency of pediatric patient (1 to 8 years old, 10kg to 25kg), follow the Defibrillation Procedures for pediatric patients in this Instructions for Use.  Defibrillation can be done even if the pads are reversed. If the locations of pads are switched, follow the next voice instruction without changing the directions of pads. It is more important

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to begin defibrillation as soon as possible.  In the event the pad is 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 pads.

 Ensure the patient is not on a wet surface when performing defibrillation. If the patient's skin is wet, dry the skin prior to using the device.  Do not place pads directly on an implanted pacemaker or cardioverter-defibrillator. Place pads away from implanted devices.  Disconnect from the patient any medical electrical equipment which has no defibrillationproof applied parts when using the NFK200

Step 2: Press the Shock Button if instructed. The device acquires and analyzes the patient's ECG immediately after being connected. The device will instruct you not to touch the patient by flashing the Do-Not-Touch-Patient Indicator and by issuing the voice prompt: “Do not touch the patient, analyzing heart rhythm”. After analyzing the ECG, the device will determine whether or not the patient needs defibrillation.

 Do not move or touch the patient during ECG analysis. Contact with the patient while analyzing the patient’s ECG may result in errors in the ECG analysis.

If the patient needs defibrillation, the device will do the following: The device announces that a defibrillation shock is needed, and instructs you to keep away from the patient.

 While the device is charging after a shockable rhythm is detected, the ECG of the patient is continuously acquired and analyzed. The device disarms itself if the ECG rhythm changes to a non-shockable rhythm before shock delivery.

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When it is charged, the device activates the following indicators in sequence: The device informs you that an electric shock is needed and instructs you to stay away from the patient.  Continuously beep while the Shock Button flashes in orange.  The device instructs you to press the flashing orange Shock button. You should press the Shock Button within 15 seconds.

When the Shock Button is pressed, the device delivers a defibrillating shock to the patient. If defibrillation is properly done, the device reports that an electric shock has been delivered. After shock delivery, the device indicates that you may touch the patient, and the CPR Mode Indicator is lit. Then, the voice instruction for CPR starts.

If the flashing Shock Button is not pressed within 15 seconds, the device operates following: • Voice instructions: “Shock button is not pressed.” • The light of shock button off • Internal discharge

Then, the device instructs performing CPR.

 Do not touch (you or anybody else) the patient during shock delivery.  Before defibrillation, make sure that there is no contact between 1 and 2 below which may provide unwanted pathways for the defibrillating current. • the patient’s body (such as exposed skin or head or limbs), conductive fluids (such as gel), blood, or saline • metal objects (such as bed frame or stretcher)

 While analyzing ECG, keep the patient still and minimize movements around the patient. Do not touch the patient and pads while the Do-Not-Touch-Patient Indicator is on. Electrical noise (interference) may delay the ECG analysis.  As a safety measure, the device will not deliver a shock until the flashing orange SHOCK button is pressed. If the SHOCK button is not pressed within 15 seconds of the voice instruction to press the SHOCK button, the device will disarm itself (dumps the shock energy in its internal

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