iPAD SP1 Instructions for Use Edition 2 Nov 2011

The i-PAD CU-SP1 is manufactured by: CU Medical Systems, Inc. Dongwha Medical Instrument Complex 1647-1 Dongwha-ri, Munmak-eup, Wonju-si, Gangwon-do, 220-801 Republic of Korea

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

Contact Us Product and Order Inquiries Overseas Sales Team CU Medical Systems, Inc. 5F, Cheonggye Plaza, 991-4, Cheonggye, Uiwang, Gyeonggi, Republic of Korea Tel : +82 31 421 9700 / Fax: +82 31 421 9911 E-mail addresses : [email protected]

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 : [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 5.

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

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.

1

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 Remove pad 1 from the single liner and stick the pad to the patient’s upper chest as shown below.

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

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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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.

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.

When it is charged, the device activates the following indicators in sequence:

continuous beep while the Shock Button flashes in orange.
the device instructs you to press the flashing orange Shock button; 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 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 will cancel the shock delivery and disarm. Then, the device issues CPR instructions.

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If the patient does not need defibrillation, the device will do the following in sequence: • the device announces that the patient does not need a defibrillating shock and that you may touch the patient. • the CPR Mode Indicator is lit. • voice instruction for CPR starts.

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 load) and will instruct you to make sure that emergency medical services have been called. The device will then instruct you to begin CPR.
During defibrillation, disconnect other medical electrical equipment which has no defibrillationproof applied parts from the patient.
If the device malfunctions during a rescue operation, it will instruct you to get a replacement defibrillator and will start the voice instruction for CPR. Have CPR performed until the replacement defibrillator is ready to use.

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Step 3: Perform CPR. Perform CPR when the i-PAD CU-SP1 instructs you to do so. By default, the CU-SP1 gives voice instruction for CPR during pause for CPR after a shock delivery. When voice instruction for CPR is needed outside of the default setting, press the flashing blue i-Button for at least 15 seconds.

[CPR Method] 1. Compression Point Place the heel of your hand in the middle of the patient's chest between nipples (which is the lower half of the sternum), and put the heel of your other hand on top of the first so that your hands are overlapped and parallel.

2. Compression Speed and Depth Compress the chest at least 5 cm deep, and at a rate of at least 100 compressions per minute.

3. Opening the Airway While lifting the patient's chin up, tilt the head backward to open the airway.

4. Ventilation Method Pinch the patient's nose as shown in the figure below, and give the patient enough breath to make the chest rise significantly.

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If you have not been trained in CPR, you should perform only chest compression or follow the instructions of the emergency medical services’ agent on the phone.
If you are trained for CPR and able to perform ventilation, perform the chest compression along with ventilation.
The CPR guide can be set on an administrator's mode. Refer to [Section 5.3: Device Setting] for more information.

While playing the CPR guide, the device does not analyze the patient's ECG. After the CPR guide, the device automatically starts the reanalysis of the patient's ECG.

In order to turn the device off after use, press the Power Button for at least 1 second.

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4.4 Defibrillation Procedures in Pediatric Mode

When the patient is older than 1 year and younger than 8 years, defibrillation can be done using the pediatric pads. When the device is in pediatric mode (pediatric pads are connected to the device or the Adult/Pediatric Selection Switch is set to Pediatric), it automatically sets the defibrillation energy to 50 J and provides pediatric CPR guide.

Place pads on the middle of the chest and back as illustrated above. Pads are not specific to either chest or back.

If there are no pediatric pads for the pediatric patient, use adult pads but set the Adult/Pediatric Selection Switch to Pediatric Mode, and then perform defibrillation according to the voice instructions.

Follow the instructions below when giving first aid during pediatric cardiac arrest. • When giving first aid during a pediatric cardiac arrest, ask others to call the emergency medical center and to bring the i-PAD CU-SP1 while you are performing pediatric CPR. • When there is no one else around, perform CPR for 1 to 2 minutes, call emergency medical services, and then get the i-PAD CU-SP1. • If you witnessed the child’s collapse, call emergency medical services immediately, and then get the i-PAD CU-SP1.

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5. After Using the i-PAD CU-SP1 5.1 Maintenance After Each Use • Check if the device for signs of damage and contamination. • If there is dirt contamination, see Section 6.2.3 on how to clean the device. • Run a battery insertion test. Refer to Section [8.1: Self-Tests] for the procedure. If

is displayed on the Status LCD after running the test, the device status is normal.

• Dispose of the used pads properly. Place a new pouch of defibrillator pads into the pads storage compartment. See to it that the pads are not beyond their expiration date. The i-PAD CU-SP1 uses disposable pads. Do not reuse them. Refer to Section [6.2.2: Replacing Supplies] on how to replace the pads.

You should use only the defibrillator pads provided and recommended by the manufacturer.
Do not open the pads package until immediately before use. Since the adhesive material on the pads starts to dry out as soon as the package is opened, the pads may not be usable regardless of the expiration date.

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5.2 Saving and Transferring Treatment Data 5.2.1 Device Usage This device automatically saves the following treatment data: • ECG data • Usage information The treatment data is automatically recorded in the internal memory. This data is not erased even if the device is turned off. The recorded treatment data may be transferred to a personal computer (PC).

This i-PAD CU-SP1 keeps the data of the 5 most recent treatment operations and can save up to 3 hours of ECG data for each rescue operation. ECG data beyond 3 hours will not be recorded.
When the device is used more than 5 times, it deletes the oldest treatment data to make room for data from a new treatment operation. It is recommended to transfer treatment data to a PC after each use of the device.
If the battery pack is removed while the device is operating, treatment data cannot be properly recorded. If you wish to remove the battery pack, turn the power off by pressing the Power Button for at least 1 second before removing the battery pack.

5.2.2 Transferring Treatment Data The treatment data may be transferred via a SD card or IrDA. The entire treatment data of all patients that is recorded on the device is transferred using only the SD card method, while the treatment data of one patient can be transferred using only the IrDA method.

1. Copying Treatment Data by Using the SD Card ① Format the SD card on the PC to FAT (FAT16) format. ② Open the SD Card Cover on the device and insert the SD card into the port.

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③ When the i-Button is pressed for more than 1 second in standby mode, the mode changes into administrator mode with voice guide. ④ The device then gives you a summary (the total hours of the last device use and the number of defibrillation shocks delivered). ⑤ The voice guide gives the S/W version of the device. ⑥ When instructed by the voice guide to transfer the treatment history, press the i-Button to copy the data onto the SD card. If there is treatment data in the device’s internal memory: • The device informs you that copying of the treatment data onto the SD card has started, and starts to copy the data. • When copying is completed, the device mode changes to CPR guide setting mode. Refer to [Section 5.3: Device Setting] for details regarding CPR guide setting. If there is no treatment data in the device’s internal memory: • The device mode changes to CPR guide setting mode after informing you that no treatment data exists.

If the file has already been transferred, the device will inform you that the same file exists in the PC. Press the Shock Button to overwrite the existing file in the PC or press the i-Button to cancel the copying of the file.

2. Transferring Treatment Data via IrDA The data may be transferred to a PC using the data management software (CU Expert Ver.3.50 or higher) from the manufacturer. CU Expert includes ECG review and printing functions. ① Position the IrDA adapter to face the IrDA port on the device as shown in the figure below. ② When the i-Button is pressed for at least 1 second in standby mode, the mode changes to administrator mode with a voice guide.

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③ The device gives the you a summary (the total hours of the last device use and the number of defibrillation shocks delivered). ④ The voice guide gives the S/W version of the device. ⑤ When instructed to transfer the treatment history, press the i-Button to transfer the data.

If there is treatment data in the device’s internal memory: ① The voice guide reports the total number of individual treatment data recorded in the device. ② By default, of a maximum of 5 individual treatment data, the first on the list is the most recent. ③ In order to rearrange the order for copying to a PC, press the Shock Button to change the order to most recent last, and then press the i-Button to transfer the selected data. ④ Run CU Expert on the PC. Refer to the CU Expert manual for detailed information regarding how to receive data. ⑤ The device will be connected with the CU Expert within a few seconds, and data will be automatically transferred. ⑥ When copying is completed, the mode changes to CPR guide setting mode. Refer to [Section 5.3: Device Setting] for details regarding changing CPR guide setting.

If there is no treatment data in the device’s internal memory: The device mode changes to CPR guide setting mode after informing you that no treatment data exists.

The distance between the IrDA port on the device and the IrDA adapter should be within 30 cm, while their angle should be within ±15°. Also, since external light source affects the IrDA, try to use it in indoors and away from fluorescent and/or incandescent lamps.

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5.3 Device Setting 5.3.1 CPR Guide Setting The default CPR setting on CU-SP1 is 5 cycles with 30 chest compressions and 2 breaths in accordance with the American Heart Association (AHA) 2010 CPR Guidelines. However, you may customize these. You can set the following: • Number of chest compressions • Number of ventilation • Number of cycles • Number of chest compressions per minute • Pausing time • Detailed guide selection

5.3.2 Setting the CPR Guide ① When the i-Button is pressed for at least 1 second in standby mode, the mode changes into administrator mode with a voice guide. ② The device gives you a summary (the total hours of the last device use and the number of electric shocks). ③ When instructed to transfer the treatment data, do not press the i-Button, but instead wait for 5 seconds. ④ When instructed to set the CPR guide, press the i-Button to enter the CPR guide setting mode. ⑤ When instructed to enter a password, enter the set password.

Password: press the following buttons in sequence: i-Button
i-Button
Shock Button
i-Button
Shock Button
Shock Button

⑥ The voice guide will give information regarding the current CPR guide setting. ⑦ Press the Shock Button to change the setting, or press the i-Button to proceed to the next step.

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⑧ Settings can then be changed in the following order: Number of Chest Compressions, Number of Ventilation, Chest Compression rate, Pausing Time, and Detailed Guide Selection. Refer to [Table 1] CPR Guide Setting Options below. ⑨ When the setting is completed, the voice guide will give information regarding the set CPR guide, which may be saved or canceled. ⑩ Press the i-Button to save or the Shock-Button to cancel according to voice instructions. ⑪ When the CPR guide setting is either saved or canceled, the device automatically shuts down.

[Table 1] CPR Guide Setting Options Number

Setting Option

Range

Unit

Default

Number of 1

Chest

Description Perform 30 compressions.

15, 30

15

30

0 to 2

1

2

2 to 10

1

5

Compression 2

3

Number of Ventilation Number of Cycles Chest

4

Compression Rate

5

100 to 120

CPR Pause

30 to

time

180 sec.

Guide

Perform 5 cycles of chest compression and ventilation. Compress the chest at a rate of

5

100

30 sec.

120 sec.

100 compressions per minute.

Pause for 120 seconds (2 minutes). Turns ON or OFF detailed voice

Detailed 6

Give 2 breaths.

On/Off

Off

Selection

instructions for the chest compression and ventilation when performing CPR.

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By default, Detailed Guide Selection is OFF during CPR so that you can concentrate on the compression rate and ventilation guidance. If you want the Detailed Guide Selection to be ON during CPR, set it ON as outlined in the previous pages.
If the Detailed Guide Selection is OFF and the Number of ventilation is set to 0, the CU-SP1 provides only chest compression guidance for 2 minutes. After 2 minutes, the CU-SP1 automatically reanalyzes the patient’s ECG.

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6. Maintenance 6.1 Device Storage Please refer to the precautions below when storing the Device in order to avoid device damage.

Do not operate or store the device in conditions that are beyond the following. specified limits. • Storage Conditions The device is stored together with the defibrillator pads and the battery pack is inserted - ready to be used in an emergency Temperature: 0℃ ~ 43℃ (32℉ ~ 109℉) Humidity: 5% ~ 95% (non condensing) • Transport Environment device only, no defibrillator pads and battery pack included Temperature: -20℃ ~ 60℃ (-4℉ ~ 140℉) Humidity: 5% ~ 95% (a location with no condensation)

Do not store the device in areas that are directly exposed to sunlight

Do not store the device in areas with highly fluctuating temperatures

Do not store the device near heating equipment

Do not

store

the device

in

areas where

there

is high

vibration

(in

excess of

Road Transportation and Helicopter Minimum Integrity of MIL-STD-810G Method 514.5C)

Do not operate or store the device in environments with high concentration of flammable gas or anesthetics.

Do not operate or store the device in areas with high concentration of dust

Only personnel authorized by the manufacturer may open the device for servicing. There are no user serviceable components inside the device.

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6.2 Maintenance 6.2.1 Device Inspection The i-PAD CU-SP1 has self-testing capability. The device performs a self-test as soon as the battery is inserted, turns itself off when the test is done, and periodically wakes up to perform the daily, weekly, and monthly self-tests. To initiate a battery insertion self test, remove the battery pack and reinsert. Refer to [Section 8.1: Self-Tests] for more information.

Inspect the i-PAD CU-SP1 daily to ensure that it is always ready for an emergency. Check the current status of the device, battery, and pads as displayed on the Status LCD.
Refer to [Section 8.2: Device Status] for information regarding the Status LCD.

6.2.2 Replacing Supplies When the device is in storage, check the battery level indicator and the pads status on the Status LCD daily to ensure that the device is always ready for an emergency. Replace the battery pack or the defibrillator pads when it is depleted or when they go beyond their expiration date, respectively.

Disposable Battery Pack Replacement of the Disposable Battery Pack • Replace the battery pack when it becomes depleted. Refer to [Chapter 8: Troubleshooting] on how to check the battery status. • Dispose of depleted battery packs in accordance with local environmental regulations. • Use only the battery packs recommended and provided by the manufacturer. • The battery pack is disposable. Do not recharge. Replacing the Disposable Battery Pack 1. Remove the discharged battery pack by pulling it out while pressing the lock on the bottom of the device. Refer to the figure below.

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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 until you hear it click into place.

Battery Pack Precautions • Do not subject the battery pack to serious physical impact. • Do not attempt to open or break apart the battery pack • Do not let the battery pack come into contact with open flames or hot objects. • Do not short-circuit the terminals of the battery pack. • Keep out of the reach of children. • If any leakage gets in the eye, immediately clean the eye with water and consult with a doctor. • Do not store the battery pack under direct sunlight. • Do not store the battery pack in a wet or very humid place. • Comply with local regulations when disposing of the battery pack. • Do not destroy or incinerate the battery pack. • Never attempt to recharge the disposable battery pack.

36

Replacing the Pads • Check the pads status on the Status LCD daily. Do not use pads that are beyond the expiration date. • Check the pads package for damage. • Check the cable outside the packaging pouch for possible defects. • Only pads provided by the manufacturer should be used with the i-PAD CU-SP1.

Replacing Pads 1. Check the expiration date of the pads. Refer to the figure below for checking the expiration date.

The expiration date is marked as The expiration date is marked to the left

follows:

of the “Multifunction Defibrillation

MM / YYYY

ADULT PADS” label on the pads

YYYY – Year

package.

MM – Month

2. Used or expired pads should be replaced. Hold the top and bottom of the pads connector with your fingers, pull it out, and take the pads out from the Pads Storage Compartment as illustrated below.

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3. Insert the pads connector of the new pads into the Defibrillator Pads Connector , and then put the pads package in the Pads Storage Compartment as illustrated below.

6.2.3 Cleaning the i-PAD CU-SP1 Clean the device with a soft cloth. The following detergents may be used to clean the exterior of the device: • Dilute soap and water • Dilute chlorine bleach (dilute 30 ml of chlorine bleach in one liter of water) • Dilute ammonia-based cleaners • Dilute hydrogen peroxide

Do not immerse the device or its accessories in liquids.
Be careful not to allow any liquids to get into the device.
If the device is immersed in liquids, immediately contact the manufacturer or its authorized service center.
Giving excessive force or shock while cleaning the device may cause damage.
Do not use an acetone-based strong detergent or abrasive when cleaning the device. In particular, the filter on the IrDA port may be damaged.
Do not use a detergent containing abrasive ingredients.
Do not sterilize the i-PAD CU-SP1.

7. Disposal Dispose of CU-SP1 and its accessories in accordance with local regulations.

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8. Troubleshooting 8.1 Self-Tests The following table lists the self-tests done by the device. Self-Test Type Battery Insertion Test

Description Runs when the battery pack is inserted into the device. Perform this test: • Before the device is deployed • After each use • When replacing the battery • When the device is suspected to be damaged

CAUTION Do not run this test when you are about to use the device to treat a sudden cardiac arrest victim because this test takes time (around 20 seconds).

If a new battery pack is inserted just before a treatment, do the following to cancel this test: • Press the Power Button • Wait for the device to turn OFF. • Press the Power Button again to turn the device ON.

Aside from testing its internal systems, the device also tests the following during this self-test: • Shock Button and i-Button – press the buttons one by one when instructed • Defibrillator pads status – the device tests the connection status (whether connected or not) and the expiration date of the defibrillator pads.

If no error is detected,

will be displayed on the Status LCD.

If an error is detected,

will be displayed on the Status LCD and the i-

Button will flash in red. When the i-Button is pressed as directed by the voice instructions, the device will report the error and turn itself off. Refer to [Section 8.3: Troubleshooting] for more information.

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Self-Test Type

Description

Power ON Test

The device performs a self-diagnostic test when the Power Button is pressed

Run-time Test

The device monitors itself in real-time during its operation.

Periodic

This device performs self-diagnostic tests daily, weekly and monthly. The

Self-Diagnostic

periodic self-test checks important features of the device such as the

Test

battery status, pads status and internal circuits.

If the device fails to perform any self-test during use and is unable to defibrillate, it will instruct the you to replace the device and start the voice instruction for CPR. In order to check the error, turn the device off by pressing the Power Button. If you press and hold the i-button, the voice will direct the you to press the blinking red i-Button. You can verify the cause of the error via the voice instruction by pressing the i-Button. Refer to [Section 8.3: Troubleshooting] for more information.

It is recommended to run the battery insertion test only during the times enumerated in the table above. The battery insertion test consumes battery power and will shorten battery life if done more frequently than necessary.

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8.2 Device Status The status of the device is indicated by the following symbols:

Indicator Status LCD Device Operation Status LCD Device Operation Status LCD Battery Level Indicator Status LCD Battery Level Indicator Status LCD Battery Level Indicator Status LCD Battery Level Indicator

Description The device is functioning normally.

The device has an error.

The battery is fully charged.

Less than half battery power remains.

Less than a quarter battery power remains.

Battery is low.

Status LCD

The expiration date of the pads is more than

Pads Status

3 months.

Status LCD Pads Status Status LCD Pads Status Do-Not-Touch-Patient Indicator: Off Do-Not-Touch-Patient Indicator: Light

The pads will expire within 3 months.

The pads is used or expired.

You may touch the patient.

You may not touch the patient.

CPR Detection Indicator: Light

Indicates that CPR is being performed.

CPR Detection Indicator:

Indicates that CPR is not performed or not

Flashing

properly performed.

i-Button: Flashing in Red

Shock Button: Flashing in Orange

The device detected an error. Press the i-Button for more information. The device is ready to deliver a defibrillating shock. Press the Shock Button to deliver a shock.

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Note

8.3 Troubleshooting The device informs you of its current status or of problems via status indicators, beeps, and/or voice instruction. Refer to the following for details:

8.3.1 Troubleshooting While the Device is Operating Symptom/Voice Instruction

Cause

Status LCD

An error has occurred in

Device Operation

the device.

Status LCD Battery Level

The battery is low.

Indicator

Resolution Immediately replace the defibrillator and perform CPR if appropriate. Replace the battery with a new one.

Status LCD

The pads is expired.

Replace the pads with a

Pads Status

The pads has been used.

new one.

Voice Prompt : “Low battery”, “Replace the battery with a new

The battery is low.

Replace the battery with a new one.

one.” Voice Prompt : “Plug the pads connector into the device.” Voice Prompt : ” Used pads”, “Replace the pads with a new one”

The Pads Connector is disconnected

Ensure the Pads Connector is properly connected.

The pads has been

Replace the pads with a

previously used.

new one.

Voice Prompt : ” The pads are beyond their expiration date”,

The pads has expired.

Replace the pads with a new one.

“Replace the pads with a new one” Voice Prompt :

The pads is not properly

Check if the pads is

” Press the pads firmly to the bare

attached to the patient's

securely attached to the

skin of the patient”

skin.

patient's skin. Press the pads firmly to the

Voice Prompt : ” No shock delivered”

The pads is not properly

patient's skin.

adhering to the patient's

Shave chest hair or wipe

skin.

off moisture if necessary before attaching the pads.

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Although an electric shock

Deliver an electric shock by

Voice Prompt :

is needed, the Shock

pressing the Shock Button

” Shock button was not pressed”

Button was not pressed

with the next voice

within 15 seconds.

instruction.

If the problem cannot be solved during an emergency, you should follow the following steps: ① Quickly replace the defibrillator if possible. ② If no replacement 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.

8.3.2 Troubleshooting While the Device is not Operating Symptom

Cause

Resolution Press the i-Button and hold for at least 1 second. The device then goes into Administration Mode.

After going into Administration Mode, the device will issue the voice Status LCD Device Operation

instruction “Press the flashing red iSystem error

Button”

Press the flashing red i-Button and the device will then announce system error and the associated error code. Contact us by referring to [Chapter 9: Device Service]. Status LCD Battery Level Indicator Status LCD Pads Status

The battery is low.

Replace the battery with a new one.

The pads is expired. The pads has been

Replace the pads with a new one.

used.

If the problem is not resolved or if no replacement battery is available, contact the manufacturer (refer to [Chapter 9: Device Service])

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9. Device Service Device Warranty Device Name

Model Name

Purchase Name

Serial No.

Distributor

Person in Charge

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.
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.
Only devices with serial numbers and their accessories are covered under this warranty. PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER THE WARRANTY. Items such as cables and modules without serial numbers are not covered under this warranty.

Warranty Disclaimer The following renders this warranty null and void: • Servicing by unauthorized personnel. • If the factory seal is broken without proper authorization from CU Medical Systems, Inc. • Failure or damage caused by a fall or external shock after purchase • Damage by natural disasters such as fire, earthquake, flood and/or lightning • Failure or damage by environmental pollution or abnormal voltage • Damage caused by storage in conditions beyond the specified limits. • Failure due to depletion of consumables • Failure caused by sand and/or soil getting inside the device • The purchase date, customer name, distributor name, batch number and other listed information being arbitrarily changed • No proof of purchase provided along with the device warranty • Usage of accessories and parts not recommended by the manufacturer. • Other failure or damage caused by inappropriate operation.

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Service
The i-PAD CU-SP1 must be serviced only by authorized personnel.
The i-PAD CU-SP1 will be serviced free of charge during the warranty period. After the warranty period, the cost of material and service shall be shouldered by the user.
When the i-PAD CU-SP1 is not operating properly, immediately bring it for servicing to an authorized service center.
Please fill out the following table with the necessary information when requesting for service.

Device classification Device Name

Semi-Automated External Defibrillator i-PAD

Model Number

Serial Number

Date of Purchase

Sales Representative Name User Information

Address Contact no.

Brief description of the problem

45

CU-SP1

Appendix A . Rescue Protocol Power ON

Voice Prompt: “Call Emergency Medical Services, now.”

Pads Connected?

NO

Voice Prompt: “Plug the pads connector into the device.”

YES Voice Prompt: “Adult mode” or “Pediatric mode”

Voice Prompt: “Follow the voice prompt calmly.”

Voice Prompt: “Remove all clothing from chest and stomach. Rip clothing if necessary.”

Voice Prompt: “Take out the pads from the bottom of the device.”

Voice Prompt: “Tear open the pads packaging.”

Voice Prompt: “Look closely at the picture on each pad.”

Voice Prompt: ”Peel off the pad labeled ‘1’ and stick to the bare skin of the patient, exactly as shown in the picture.”

Voice Prompt: “Peel off the pad labeled ‘2’ and stick to the bare skin of the patient, exactly as shown in the picture.”

Voice Prompt: “Press the pads firmly to the bare skin of the patient.”

46

PADS ON

A

47

B’

Voice Prompt: “Press the flashing blue i-button for CPR voice prompt.”

Within 15 seconds, i-button is:?

NO Voice Prompt: Re-analyzing heart rhythm in 2 minutes.” Voice Prompt: “Re-analyzing heart rhythm in 1 minute.” Voice Prompt: “Re-analyzing heart rhythm in 40 seconds.”

YES Voice Prompt: “Place the heel of one hand on the center of the chest, between the nipples.”

Voice Prompt: “Place the heel of your other hand on top of the first.”

Adult

Pediatric Adult or Pediatric?

Voice Prompt: “Re-analyzing heart rhythm in 20 seconds.”

Voice Prompt: “Push the chest down firmly 2 Inches, in time with the beat.”

A

Voice Prompt: “Push the chest down 2 Inches, in time with the beat.”

Voice Prompt: “Beat Sound”

Adult

Pediatric Adult or Pediatric?

Voice Prompt: “Do CPR, now.”

Voice Prompt: “Continue chest compressions.”

Voice Prompt: “Tilt head, pinch nose and give breath.”

Voice Prompt: “Pinch nose, Tilt head and give small breaths.”

YES NO

Voice Prompt: “Breathe”

CPR is being Performed? NO

Number of Cycle > 5 YES A

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B . Parts and Accessories To order replacement parts and accessories, cite the part and ordering numbers given in the following table.

B.1 Standard Accessories Name

Part Number

Ordering Number

Adult Pads (disposable)

CUA1007S

SP1-OA04

Disposable Battery Pack(Long-life)

CUSA1103BB

SP1-OA03

Instructions for Use

SP1-OPM-E-02

-

Carrying Case

SP1-A-BAG-3010

SP1-OA01

Disposable Battery Pack(Standard)

CUSA1103BS

SP1-OA02

Pediatric Pads (disposable)

CUA1102S

SP1-OA05

IrDA Adapter

IR-220LPLUS

SP1-OA06

PC S/W

CU Expert ver. 3.50 or higher

SP1-OA07

SD Card

HD1-CARD-SD

SP1-OA10

SD Card Reader

HD1-CARD-READER

-

B.2 Optional Accessories

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C . Description of Symbols C.1 i-PAD CU-SP1 Defibrillator Symbol

Description Power ON/OFF button

i-Button

SHOCK button

Adult / Pediatric Selection Switch

Do-Not-Touch-Patient Indicator

CPR Detection Indicator

BF type, defibrillation-proof equipment

Attention: Refer to accompanying documents. CE Mark; meets the requirements of the European Medical Device Directive 93/42/EEC and its revisions. Serial Number

Date of manufacture

50