i-PAD SP1 Instructions for Use Edition 5

The i-PAD CU-SP1 is manufactured by: CU Medical Systems, Inc. 130-1 Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Republic of Korea

Authorized EU Representative Medical Device Safety Service Schiffgraben 41, 30175 Hannover, Germany

Contact Us Product and Order Inquiries Overseas Sales Team CU Medical Systems, Inc. 5F, Cheonggye Plaza, 221, Anyangpangyo-ro, Uiwang-si, Gyeonggi-do, Republic of Korea Tel : +82 31 421 9700 / Fax: +82 31 421 9911 E-mail addresses : [email protected]

German Branch Office CU Medical Germany GmbH, Cicero Str.26, 10709 Berlin, Germany Tel: +49 30 6781 7804 Fax: +49 30 6782 0901

Service and Technical Support Customer Service Team CU Medical Systems, Inc. 5F, Cheonggye Plaza, 221, Anyangpangyo-ro, Uiwang-si, Gyeonggi-do, Republic of Korea Tel : +82 31 421 9700 / Fax: +82 31 421 9911 E-mail addresses : [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 ... 13

3.1

Standard Package Contents ... 13

3.2

Setting up the i-PAD CU-SP1 ... 14

4.

How to Use the i-PAD CU-SP1 ... 16

4.1

Chain of Survival ... 16

4.2

Preparation for Defibrillation ... 17

4.3

Defibrillation in Adult Mode ... 21

Step 1: Place pads on the patient... 21 Step 2: Press the Shock Button if instructed. ... 22 Step 3: Perform CPR. ... 24 4.4

Defibrillation Procedures in Pediatric Mode ... 26 After Using the i-PAD CU-SP1 ... 27

5. 5.1

Maintenance After Each Use ... 27

5.2

Saving and Transferring Treatment Data ... 28

5.2.1

Device Usage ... 28

5.2.2

Transferring Treatment Data ... 28

5.3

Device Setting ... 31

5.3.1

CPR Guide Setting ... 31

5.3.2

Setting the CPR Guide ... 31

6. 6.1

Maintenance ... 34 Device Storage ... 34

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6.2

Maintenance ... 35

6.2.1

Device Inspection ... 35

6.2.2

Replacing Supplies ... 35

Disposable Battery Pack... 35 Replacing the Pads ... 37 6.2.3

Cleaning the i-PAD CU-SP1... 38

7.

Disposal ... 38

8.

Troubleshooting ... 39

8.1

Self-Tests ... 39

8.2

Device Status ... 41

8.3

Troubleshooting ... 42

9.

8.3.1

Troubleshooting While the Device is Operating ... 42

8.3.2

Troubleshooting While the Device is not Operating ... 43

Device Service ... 44

Appendix ... 46 A . Rescue Protocol ... 46 B . Parts and Accessories ... 49 B.1 Standard Accessories ... 49 B.2 Optional Accessories... 49 C . Description of Symbols... 50 C.1 i-PAD CU-SP1 Defibrillator ... 50 C.2 i-PAD CU-SP1 Packaging ... 51 C.3 Accessories ... 52 C.3.1 Disposable Battery Pack (CUSA1103BB, CUSA1103BS) ... 52 C.3.2 Pads (CUA1007S, CUA1102S)... 53 D . Glossary... 54 E . Device Specifications ... 59 F . Electromagnetic Compatibility ... 67

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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. Hereinafter, "device" refers to [CU-SP1] "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 emphasizes the safety procedures and precautions for the device use by using the terms below. Please acquaint yourself with the warnings, cautions and references stated in these Instructions for Use in order to safely use the device.

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 i-PAD CU-SP1. This device can be effectively and safely used for a long period if you familiarize yourself with the instructions, warnings, precautions, and notices contained in these Instructions for Use prior to its use.

 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.

 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.

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1. Introduction 1.1 Device Description CU-SP1 is an easy-to-use Semi-Automated External Defibrillator (AED) that is small, light, and portable, and uses a battery. The AED automatically reads the patient's electrocardiogram (ECG) and determines if a cardiac arrest that requires defibrillation has occurred, so that both medical professionals and the general public can easily operate it. Cardiac arrest can occur anytime to anyone at any place and may threaten the patient's life if the appropriate CPR and/or electric shock with a defibrillator are not applied within a few minutes.

The i-PAD CU-SP1 is a semi-automated external defibrillator (AED). If connected to a patient, the i-PAD CU-SP1 automatically acquires and analyzes the electrocardiogram (ECG) of the patient for the presence of Ventricular Fibrillation or Ventricular Tachycardia (also known as shockable rhythms). If a shockable rhythm is detected, the device automatically charges itself. Defibrillating shock is delivered when the you press the SHOCK button.

The i-PAD CU-SP1 is easy to use. It guides the you throughout a rescue operation using voice prompts and indicators (LED and graphical indicators).

The i-PAD CU-SP1 is small, light, highly portable, and battery powered. It is highly suitable for use in public, out-of-hospital settings.

1.2 Indicated Use The i-PAD CU-SP1 is indicated for use on patients that are exhibiting the symptoms of sudden cardiac arrest (SCA) with all of the following signs:

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

Do not use the i-PAD CU-SP1 on patients who show either of the following signs:

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

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1.3 Intended Users The i-PAD CU-SP1 is intended for use in or out of the hospital by emergency care personnel or healthcare professionals or laypersons. The manufacturer recommends that users train on the use of the device.

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

1.5 Additional Information Please contact CU Medical Systems, Inc. or its local distributors for any additional information on the i-PAD CU-SP1.

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2. Device Features Adult/Pediatric Selection Switch

Status LCD Defibrillator Pads Connector

Pads Storage Compartment

i-Button Do-Not-Touch-Patient Indicator CPR Detection Indicator Pad Connector Status Indicator Pad Position Indicators Power Button Adult/Pediatric Selection

Shock Button

Switch Cover

IrDA Port Battery Pack

SD Card Port

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Power Button

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

i-Button

 Reports device usage (the total hours of the last usage and number of shocks)  checks the S/W version  downloads events and ECG data via an IrDA and SD Card  sets the CPR mode (the number of compressions, breaths and cycles; compression rate per minute; pausing time; detailed guide on/off)  and checks for errors

Status LCD

Displays the current status of the device, battery and pads.

Shock Button

Delivers defibrillating shock when pressed while flashing in orange.

Adult/Pediatric

Selects Adult/Pediatric modes.

Selection Switch

Adult/Pediatric

Covers the Adult/Pediatric Selection Switch to prevent

Selection Switch

accidental switching.

Cover

Defibrillator Pads

Connects with the connectors of the pads.

Connector

Pads Connector

Indicates the connection status of the defibrillator pads

Status Indicator

connector.

Pads Position

Indicates the pads position on the patient.

Indicators

Do-Not-Touch-Patient

Warns when not to touch the patient.

Indicator

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CPR Detection

Indicates performance of CPR on the patient.

Indicator

(The indicator is lit if CPR is performed, and flashes if CPR is not performed)

Battery Pack

The disposable power source of the device.

IrDA Port

Transmits and receives treatment data between the device and a personal computer.

SD Card (External

Port for copying device records to a SD card.

Memory) Port

Pads Storage

Stores pads.

Compartment

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

CU-SP1 Semi-automated External Defibrillator

Instructions for Use

1 Battery Pack (Disposable)

1 Pack of Adult Pads (Disposable)

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

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 Only parts and accessories recommended and approved by CU Medical Systems, Inc. must be used with the i-PAD CU-SP1. Using unapproved parts and accessories may compromise the safety and effectiveness of the i-PAD CU-SP1.

 Extra battery packs and pads are recommended.

3.2 Setting up the i-PAD CU-SP1 Do the following to set up the i-PAD CU-SP1 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, the device starts a self-test. If the device status is normal, is shown on the Status LCD. If

,

or

is displayed on the Status LCD after the self-

test, please refer to [Chapter 8: 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: Accessories] of these Instructions for Use.

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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 LCD periodically to ensure that the device is in good condition.

• Store the CU-SP1 in accordance with your local emergency first aid protocol. • Store the device in an easy-to-access location where its Status LCD can be checked periodically and its technical alarms can be easily heard (e.g. alarm on low battery or other device problems).

• 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 E: Electromagnetic Compatibility] of these Instructions for Use for more information.

 The use of accessories or cables other than those referred to in these Instructions for Use may increase electromagnetic radiation from the device or reduce the device’s electromagnetic immunity. Only accessories and cables that are authorized by the manufacturer should be used with the i-PAD CU-SP1.

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4. How to Use the i-PAD CU-SP1 4.1 Chain of Survival If you think that you are witnessing someone go down in sudden cardiac arrest, perform the chain of actions recommended by the American Heart Association (AHA) in its Chain of Survival emergency response to sudden cardiac arrest.

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2

3

4

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1. Immediate recognition and activation of the emergency response system.

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

• Perform CPR. 3. Early defibrillation

• Use this device (i-PAD CU-SP1). Using this device can be summarized in 3 steps: After pressing the Power Button, Step 1: Place pads on the patient. Step 2: Press the Shock Button if instructed by the device. Step 3: Perform CPR. 4. Effective advanced life support – Perform advanced care in order to restore spontaneous circulation. 5. Integrated post-cardiac arrest care – Transfer the patient to a medical institution or a specialized facility

 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 ① Set the Adult/Pediatric Selection Switch to match the victim. Adult victim • Open the switch cover

• Set the switch to adult defibrillation mode as shown in the following picture

Child victim (victim is under 25kg or 8 years old) If the pediatric pads are attached, the i-PAD CU-SP1 automatically adjusts its defibrillation energy output for pediatric defibrillation regardless of the position of the Adult/Pediatric Selection Switch (i.e. the output will be pediatric even if the selection switch is set to adult)

If there are no pediatric pads for the pediatric patient, adult pads may be used. Ensure that the Adult/Pediatric Selection Switch is set to Pediatric Mode. If the switch has not been set yet, move it to Pediatric Mode as shown in the figures below • Open the switch cover

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• Set the switch to pediatric defibrillation mode as shown in the following picture

If a young victim is over 25kg or 8 years old, or if you are not sure of the exact weight or age: • DO NOT DELAY TREATMENT • Set the Adult/Pediatric Selection Switch to Adult mode. • Use the adult pads.

 Never perform defibrillation in pediatric mode to a patient who is either heavier than 25 kg or older than 8 years old. Ensure the slide key for Adult/Pediatric Mode is as shown on the bottom.

 You can switch the adult/pediatric selection switch before or after turning on the i-PAD CUSP1. However, the defibrillation mode should be changed before placing the pads on the patient. Once the pads are in place, you cannot change the defibrillation mode anymore. When the mode is correctly selected, the defibrillation energy is set to an adult value (150 J) or pediatric value (50 J).

② Turn the device on by pressing the Power Button.

When the power turns ON the following occurs in sequence:

 the beeper will beep for 1 seconds  Voice instruction: “Call emergency Medical services, now”

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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 Remove the pads package from the Pads Storage Compartment at the bottom of the device.

⑤ Open the pads package.

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⑥ Take pads out of the pads package.

⑦ Refer to the pictures on both pads.

Adult Pads

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 in Adult Mode Step 1: Place pads on the patient. ① Rem ove pad 1 from the single liner and stick the pad to the patient’s upper chest as shown below.

② Remove pad 2 from the single liner, and stick the pad to the patient’s side torso as shown below.

③ If the device detects the connection with the patient after placing the pads, follow the voice instruction of the device.

 Defibrillation can be done even if the pads are reversed. If the locations of pads are switched, follow the next voice instruction without changing the directions of pads. It is more important to begin defibrillation as soon as possible.  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 first prior to using the device.

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