NF1200-T2 User Manual Ver 1.00E

NF1200-T2

Contents Contents •••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••2 1. Overview••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• 3 1 . 1 O v e r v i e w • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •3

2. General Information •••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• 4 2.1 Product Overview •••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••4 2.2 Features ••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••4 2.3 Exterior and Interior•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••5

3 . P r e p a r a t i o n •••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••7 3.1 Basic Components••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••7 3.2 Preparation••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••8 3.2 Product Storage••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••8

4. How to Use•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••10 4.1 Function Switch•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• 10 4.1.1 How to Use Function Switch••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••1 0 4.1.1 Scenario ••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••12 4.2 How to Use Product •••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• 13 4.2.1 How to Use Product ••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••13 4.2.2 Cardiopulmonary Resuscitation (CPR) •••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••18

5. Safety Precautions •••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• 19 6. Product Service ••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••20

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CU Medical Systems, Inc.

User Manual Ver. 1.00E

1. Overview 1.1 Overview Thank you for purchasing i-PAD NF1200-T2. i-PAD NF1200-T2 is a training product designed to provide training on a semi-automated external defibrillator.

※ The Product is intended to provide education and training on the defibrillator and must not be used for emergency measures in case of emergency.

This user manual describes how to use and manage NF1200-T2 and its features in detail. Hereinafter the Product and the Company refer to NF1200-T2 and CU Medical Systems, Inc., respectively. Please read this user manual carefully before use to ensure safe operation without problems and familiarize yourself with operations and safety precautions. ■

Make sure to follow all the instructions described in the manual.

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Keep the manual in a safe place after reading and available for next use.

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Always keep the manual close to you and refer to it whenever you encounter problems.

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The Company will not be held liable for problems resulting from negligent operation or management by users.

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Contact only an authorized distributor for product repairs and services.

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For safety and reliability, be sure to use parts and accessories provided by the Company.

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Please contact the Company before connecting the Product with any other products not described in the manual.

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If the Product does not work properly, contact the service center for immediate service.

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NF1200-T2

2. General Information 2.1 Product Overview NF1200-T2 is training equipment designed to provide training on the use of a semi-automated external defibrillator and help users respond to emergencies more swiftly.

2.2 Features ■■

The Product provides eight scenarios for more swift response to emergency situations.

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The Product is equipped with the electrocardiogram rhythm, making a defibrillator simulator unnecessary for training.

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The Product is powered by six disposable (rechargeable) AA batteries, and is lightweight and easy to carry.

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Users can control all the functions of the Product with the Function switch and i-button, making it possible to provide training easily anywhere, anytime.

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User Manual Ver. 1.00E

2.3 Exterior and Interior

••Exterior of NF1200-T2

••Interior of NF1200-T2 5

NF1200-T2

① Power ON/OFF Button

Switch the Product on and off.

Lights up or flickers in various colors to inform users of the current status of the Product.

② State LED

• Green Flickering: Standby mode. • Green On: Normal operation. • Red Flickering: Battery shortage or equipment error. • Blue On: Self-test in progress. • White On: Administrator mode. Communicates data from last equipment use • with the computer.

③ i-Button

Used to select scenario mode (sequential progress). Information mode: Total usage time, error message and battery shortage

④ Handle

A handle used to carry the Product.

⑤ Cover

Used to protect the inside of the Product and store the pads.

⑥ Graphical Rescue guide

Indicates the current stage when using the Product.

⑦ Training Pads Connector Port

A port to connect the training pads connector.

⑧ Quick Reference Guide

Illustrations summarizing how to use the Product for emergencies.

⑨ Shock Button

A button used to apply the use of electric shock. Flickers orange when electric shock is needed. The Product does not supply electric shock.

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⑩ Battery Pack

Supplies power to the Product.

⑪ Function Switch

Used to select scenario mode, information mode, administrator mode and volume function. For more information, refer to page 10.

CU Medical Systems, Inc.

User Manual Ver. 1.00E

3. Preparation 3.1 Basic Components i-PAD NF1200-T2 The Product is intended for providing education and training on defibrillator and must not be used for emergency measures in case of emergency.

Training pad for i-PAD NF1200 Do not use the pads for i-PAD NF1200, an actual defibrillator. The pads cannot apply electric shock. • Training Pads

NF1200-T2 user manual

• User Manual

Function switch instruction label attached This component is a model and does not supply power. • Battery Model

Power supply (for six disposable AA batteries or rechargeable AA batteries) • Battery Pack

Used with the battery pack • AA Batteries

The disposable batteries last up to 8 hours for continuous use. If the i-button turns red, this indicates battery shortage. In this case, the batteries must be replaced with new ones.

For product carrying and storage • Bag (optional)

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NF1200-T2

3.2 Preparation You can prepare the Product for use very easily. Following the instructions below.

① Open the package box and check all the components.

② Refer to 2.3 Exterior and Interior in the user manual and familiarize yourself with each feature.

③ Insert the pads bag as shown in Figure [1] and close the cover.

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Figure [1]

Figure [2]

④ Put AA batteries into the battery pack on the back of the Product as shown in Figure [3].

Figure [3] ⑤ If you have a carrying bag, keep the Product in it safely.

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CU Medical Systems, Inc.

Figure [4]

User Manual Ver. 1.00E

3.2 Product Storage Read the following precautions carefully before storing the Product to prevent any possible damage.

Avoid moisture exposure.

Avoid direct sunlight.

Avoid large temperature fluctuation. · Preliminary Environment Temperature Range: 0 ºC~43 ºC (32 ºF~109 ºF) Humidity Range: 5%~95% (non-condensing) · Operation Environment Temperature Range: 0 ºC~40 ºC (32 ºF~104 ºF) Humidity Range: 5%~95% (non-condensing)

Avoid heating devices.

· Storage Environment Temperature Range: -20 ºC~60 ºC (-4 ºF~ 140 ºF) Humidity Range: 5%~95% (non-condensing)

Avoid high humidity and poor ventilation.

Avoid excessive shock or vibration.

Avoid chemicals or explosive gas.

Avoid dust and metallic substances.

Do not disassemble the Product. The Company will not be liable for any damage resulting from it.

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NF1200-T2

4. How to Use 4.1 Function Switch 4.1.1 How to Use Function Switch You can use the function switch to select administrator mode, scenario mode, error message and volume function.

Function Switch Button

Description Selects the volume control function (default value: OFF)

1, 2 Volume Control

1 OFF, 2 OFF: Minimum

->

1 OFF, 2 ON: Middle

->

1 ON, 2 ON: Maximum

3 CPR Selection

ON 1 2 3 4 5 6

ON 1 2 3 4 5 6

ON

->

1 2 3 4 5 6

Selects CPR (default value: OFF) OFF: (30:2) ON: (15:2)

ON

->

1 2 3 4 5 6

ON

->

1 2 3 4 5 6

Reproduces emergency scenario 1-8 provided by the Product (default value: OFF)

5, 6 Scenario Selection

5, 6 Error Message

ON

5 OFF, 6 OFF: Scenario 1, 2, 3 reproduction

->

5 ON, 6 OFF: Scenario 4, 5, 6 reproduction

->

5 OFF, 6 ON: Scenario 7, 8 reproduction

->

1 2 3 4 5 6

ON

Reproduces error message. 5 ON, 6 ON: Error message reproduction

1 2 3 4 5 6

ON

1 2 3 4 5 6

ON

->

1 2 3 4 5 6

Make sure to switch the Product off and remove the battery model from the body before using the function switch (If the function switch does not work properly, contact the Company). Do not expose the battery model to moisture after removing it from the body. The function switch instruction label is attached to the battery model.

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User Manual Ver. 1.00E

Scenario Selection Function Switch

ON 1 2 3 4 5 6

ON 1 2 3 4 5 6

i-button

Scenario

Default value

Reproduce scenario 1

Press once

Reproduce scenario 2

Press twice

Reproduce scenario 3

Default value

Reproduce scenario 4

Press once

Reproduce scenario 5

Press twice

Reproduce scenario 6

Default value

Reproduce scenario 7

Press once

Reproduce scenario 8

ON 1 2 3 4 5 6

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NF1200-T2

Scenario 1 (S1)

① Apply first shock, CPR (30:2, 15:2) ② Reproduce normal electrocardiogram, CPR (30:2, 15:2)

Scenario 2 (S2)

① Apply first shock, CPR (30:2, 15:2) ② Apply second shock, CPR (30:2, 15:2) ③ Reproduce normal electrocardiogram, CPR (30:2, 15:2)

Scenario 3 (S3)

① Reproduce normal electrocardiogram, CPR (30:2, 15:2) ② Apply first shock, CPR (30:2, 15:2) ③ Reproduce normal electrocardiogram, CPR (30:2, 15:2)

Scenario 4 (S4)

① Reproduce normal electrocardiogram continuously, CPR (30:2, 15:2)

Scenario 5 (S5)

① Apply first shock, CPR (30:2, 15:2) ② Reproduce normal electrocardiogram, CPR (30:2, 15:2) ③ Apply second shock, CPR (30:2, 15:2) ④ Reproduce normal electrocardiogram, CPR (30:2, 15:2)

Scenario 6 (S6) ① Reproduce ventricular fibrillation continuously, CPR (30:2, 15:2)

Scenario 7 (S7)

① Apply first shock, CPR (30:2, 15:2) ② Apply second shock, CPR (30:2, 15:2) ③ Reproduce normal electrocardiogram, CPR (30:2, 15:2) ④ Apply third shock, CPR (30:2, 15:2) ⑤ Reproduce normal electrocardiogram, CPR (30:2, 15:2)

Scenario 8 (S8)

① Apply first shock, CPR (30:2, 15:2) ② Apply second shock, CPR (30:2, 15:2) ③ Apply third shock, CPR (30:2, 15:2) ④ Reproduce normal electrocardiogram, CPR (30:2, 15:2)

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User Manual Ver. 1.00E

4.2 How to Use Product 4.2.1 How to Use Product 1) Open the cover.

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2) Press the power button to switch the Product on.

If the Product is turned on, you will see the following operations. - Status LED: Turns green indicating normal operation. - Voice Instruction: "Attach pads."

This voice instruction is repeated until the pads connector is connected.

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NF1200-T2

3) Remove the upper garment from the patient (mannequin).

Timing is extremely important when dealing with a patient with an acute heart attack. Therefore, you must not waste time in removing the patient's upper garment entirely. You must be trained to remove the upper garment from the patient (mannequin) as quickly as possible before attaching the pads.

4) Open the pads bag and take out the training pads.

5) Identify where to attach the pads as described in the illustrations on the pads.

RA

LL Adults

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Children

User Manual Ver. 1.00E

6) Remove the protective film from the pads.

7) Attach the pads. Attach one pad (RA) right below the clavicle on the right side of the patient (mannequin)'s chest and the other pad (LL) on the ribs below the left side of the chest in line with the armpit. Refer to the illustrations below for the locations of the pads.

LL

RA

8) Insert the pads connector into the connector port.

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NF1200-T2

9) If you select a scenario by setting the function switch, the Product will function as follows. - Voice Instruction: “Do not touch the patient.” “Analyzing heart rhythim.” - Stage Indicator Lamp: The second stage indicator lamp, which indicates electrocardiogram analysis, flickers. After electrocardiogram analysis, the Product determines whether defibrillation is necessary.

A. If defibrillation is needed, the Product will function as follows. - Beeper: Beeps one second. - Voice Instruction: “Shock advised.” “Stand clear” - Beeper: Beeps continuously. - Shock Button Flickering: If the Product is recharged completely, the shock button starts to flicker. - Voice Instruction: “Press the flashing orange button, now." “Deliver shock, now"

* Then, you must press the shock button.

* If the shock button is pressed, the Product applies electric shock to the patient (mannequin). - Voice Instruction: “Shock delivered.”

(This Product does not apply electric shock.) B. If defibrillation is not needed, the Product will function as follows. - Voice Instruction: “No shock advised."

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User Manual Ver. 1.00E

10) Perform CPR. A. CPR will be carried out in two different ways. The first is the voice instructions provided when electric shock is applied. - Voice Instruction: "Shock delivered." "Begin CPR, now."

The second is the voice instructions provided when electric treatment is not needed. - Voice Instruction: "No shock advised." "Begin CPR, now."

B. The third stage indicator lamp, which indicates CPR mode, flickers. C. The CPR protocol functions differently depending on the settings below. Chest Compression / Artificial Respiration - 30 : 2 (30 chest compressions, 2 artificial respirations) - 15 : 2 (15 chest compressions, 2 artificial respirations)

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NF1200-T2

4.2.2 Cardiopulmonary Resuscitation (CPR) i-PAD NF1200-T2 provides voice instructions and beeps for CPR. Stage 1

Voice Instruction and Beep Voice Instruction: Perform chest compression.

Beeper:

•• Place both hands between the nipples. •• Press the chest down to 4-5 cm. •• Perform chest compression following beeps from i-PAD NF1200-T2.

100 beeps per minute are triggered. The number of beeps triggered is different depending on settings. 30:2 setting: 30 beeps 15:2 setting: 15 beeps

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How to Perform CPR

Voice Instruction: Perform artificial respiration.

•• Lean the head back to open the airway.

•• Perform two artificial respirations •• Perform each artificial respiration for at least one second. •• Blow in enough air until the chest swells for each artificial respiration. •• Perform two artificial respirations within ten seconds.

Voice Instruction: 4

5

Puff~, Puff~

Stages 1~4 are repeated five times.

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•• Perform CPR five times.

User Manual Ver. 1.00E

5. Safety Precautions The following safety levels are used in this user manual to highlight safety precautions that users must abide by. Make sure to read the warning, caution and note messages carefully throughout the manual for safe operation. The Company and its authorized distributors will not be liable for any personal injuries resulting from negligent or incorrect operation by users.

Safety Level

Possible Risks or Risk Factors Indicates a possible risk that may cause serious injury or death when instructions are not followed.

Indicates the policies of the Company directly or indirectly to protect human life or physical properties.

Indicates term explanation or additional information.

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NF1200-T2

6. Product Service ■Warranty Product Name Purchase Date

Model Name .

.

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Serial No. Person in Charge

Purchase Place

■About Services CU Medical Systems, Inc. designs and manufactures all the products based on international standards (NS-EN ISO9001 : 2000/ISO13485 : 2003-MDD 93/42/EEC) In addition, the Product and its functions went through strict tests and verifications across all manufacturing processes. In the case that any problem occurs, CU Medical Systems, Inc. provides the warranty as described below, based on the consumer dispute resolution standard (announced by the Fair Trade Commission). ※ Services are provided free of charge if a problem occurs within the warranty period (two years). (If you use the Product for sales purpose, the warranty period is shortened in half.)

Damage Type

Compensation Criteria

When a repair is requested because of malfunction that occurred during normal operation within one month after purchase

Product replacement or free repair

Any malfunction that occurred during normal operation within the warranty period

When a fault occurs

Free repair

When repair is impossible

Product replacement or refund

When product replacement is impossible

Refund

Remarks

Refund after fixed amount deduction

Product replacement Any damage caused because service centers do not retain spare parts within the part retention period

When the Product is lost by the Company or its distributors after consumer requested repair

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Within the warranty period

Product replacement after charging the amount corresponding to charged repair

After the warranty period

Refund by adding 10% to the price deducted by fixed amount

Within the warranty period

Product replacement or refund

After the warranty period

Refund by adding 10% to the price deducted by fixed amount

Refund after fixed amount deduction