CU-ERT Operators Manual Ver 1.10

CU-ERT Operator’s Manual_ver 1.10

Operator’s Manual Semi-automated External Defibrillator Trainer CU-ERT ver 1.10

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CU-ERT Operator’s Manual_ver 1.10

Specifications and information contained in this Operator’s Manual are subject to change without prior notice.

The operation protocol of the Semi-automated External Defibrillator Trainer CU-ERT has been upgraded to comply with the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC). 2005 CPR Guidelines are applied to the ERT after software version 1.10

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CU-ERT Operator’s Manual_ver 1.10

TABLE OF CONTENTS

Table Of Contents ... 4 General ... 6 Warranty ... 7 Service... 8 Contact Us ... 9 1 How to Use This Manual ...10 1.1 Contents of This Manual ...10 1.2 Safety Messages ...10 2 Device Operation Guidelines ...11 2.1 General Guidelines ...11 2.2 Storage and Operating Environment Guidelines ...12 2.4 Cleaning and Maintenance ...13 3 Introduction ...14 3.1 Product Description ...14 3.2 Intended Use ...14 4 Basic Orientation ...15 4.1 Controls, Indicators, and Ports ...15 4.2 Operating Controls ...16 4.3 Indicator Lamps ...16 4.4 Parts and Accessories ...17 4.5 Input / Output Ports ...17 4.6 Voice and Text Prompts...18 4.7 User Interface ...19 4.7.1 LCD Display ...19 4.7.2 Power Switch and SHOCK Button ...22 4.7.3 Menu Buttons ...22 4.7.4 Infrared Remote Controller...23 4.7.5 Light indicators...25 4.7.6 Speaker and beeper ...25 4.8 Menu Operation...26 5 Device Preparation/Set Up ...36 5.1 Unpacking ...36 5.2 Power Connection...36 5.3 Rescue Setup...36 6. Operation...36 6.1 Operation Scenario Groups ...36 6.2 Paramedic CU-ERT Operation ...36 6.3 Scenarios ...37 6.3.1 PAD ON/OFF...37 6.3.2 LOW BAT ...37 6.3.3 NSR ...37 6.3.4 VF...37 6.3.5 VT...37 6.3.6 Asystole ...37 6.3.7 S1, Training Scenario 1...38 6.3.8 S2, Training Scenario 2...38 6.3.9 S3, Training Scenario 3...38 6.3.10 S4, Training Scenario 4 ...38 6.3.11 S5, Training Scenario 5 ...39 6.3.12 S6, Training Scenario 6 ...39 6.3.13 S7, Training Scenario 7 ...39 6.3.14 S8, Training Scenario 8 ...39 6.3.15 S9, Training Scenario 9 ...40 6.3.16 S10, Training Scenario 10 ...40

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CU-ERT Operator’s Manual_ver 1.10

7. Power Supply...41 7.1 External Disposable Battery Pack...41 7.2 AC/DC Adapter...42 8. Data Management ...43 8.1 Overview...43 8.2 Data Review ...44 8.2.1 Internal Flash Memory...44 8.2.2 SmartMedia Card ...44 8.2.2.1 Installation of a SmartMedia Card ...44 8.2.2.2 Removal of a SmartMedia Card ...44 8.2.2.3 Reviewing Data Using A SmartMedia Card ...45 8.3 Data Transfer To Personal Computer...46 8.3.1 IrDA...46 8.3.2 UART Port ...48 8.4 Printing Using a Stand-alone Serial Printer...50 9. Maintenance ...56 9.1 Cleaning the Paramedic CU-ERT ...58 9.2 Troubleshooting Guide ...59 9.3 Safety Considerations ...59 APPENDIX A...60

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CU-ERT Operator’s Manual_ver 1.10

◐ General Thank you for acquiring the Paramedic CU-ERT. Please read this Operator’s Manual carefully and thoroughly before using it. This Manual contains instructions on how to operate and maintain the Paramedic CU-ERT. CU Medical Systems, Inc. designs and manufactures all of its products in accordance with international standards (NS-EN ISO9001:2000/ ISO13485:1996-MDD 93/42/EEC). This ensures that CU Medical Systems, Inc. provides products of high quality and reliability. In this regard: z

Only persons authorized by CU Medical Systems, Inc. should do all servicing of the

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You should ensure that all power sources are properly installed or connected before using

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You should operate this device in accordance with the instructions specified in this

device. There are no user serviceable parts in this device. this device. manual. This device is intended for use during trainings such as CPR training, Basic Cardiac Life Support (BCLS) training, or Advanced Cardiac Life Support training. This device is not intended for use during sudden cardiac arrest resuscitation operations as it can not deliver a defibrillating shock. To ensure safety and reliability, use only parts and accessories recommended by CU Medical Systems, Inc. If you intend to use this device in conjunction with other devices not specified in this manual, please notify the manufacturer.

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CU-ERT Operator’s Manual_ver 1.10

◐ WARRANTY z

The products of CU Medical Systems, Inc. are designed and manufactured according to international standards (NS-EN ISO9001:2000/ ISO13485:1996-MDD 93/42/EEC). Every device that goes out of the assembly line passes through a battery of reliability tests. In case of problems, our maintenance and exchange policies are in accordance with the relevant consumer protection laws and regulations in the particular country where the device is sold.

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The warranty period of this device is within two years after the date of purchase.

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When the device malfunctions during the warranty period, it will be repaired free of charge at our service centers.

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When you submit the device for maintenance, please specify the details as listed below : The name of model, product serial number, date of purchase, name of sales representative, information of customer and a brief description of the problems.

Name of Product

Name of Model

AED (semi Automated External Defibrillator) Trainer

CU-ERT

Date of Purchase

Serial No.

Sales Representative

Address

Customer Information

Name

Contact No.

Brief Description of Problems

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CU-ERT Operator’s Manual_ver 1.10

◐ Service Only CU Medical Systems, Inc. or its authorized representatives should service the device. If unauthorized personnel service the device during the warranty period, the warranty will become null and void. CU Medical Systems, Inc. or its authorized representatives are obliged to service the device free of charge during the warranty period. When the device is not functioning properly, it has to be submitted for maintenance immediately. When any abnormalities are found in the device or when a danger to bodily harm exists, the device has to be repaired fast and adequately by authorized personnel. When the need for maintenance arises: z

Please contact CU Medical Systems, Inc. or its authorized representatives immediately. Prepare a summary of the problems. Also include the name of model, product serial number, date of purchase, name of sales representative, information of customer.

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There are no user-serviceable parts in the Paramedic CU-ERT. The user should not attempt any repair beyond what we recommend in the maintenance section of this manual.

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CU-ERT Operator’s Manual_ver 1.10

◐ CONTACT US You can contact us at the following address and telephone number for services and supplies. Product and Order Inquiries: International Marketing Team CU Medical Systems, Inc. #534, Dusan VentureDigm,,126-1 Pyeongchon, dongan, Anyang-si, Gyeonggi-do, Republic of Korea Tel: +82 31 478 5725 Fax: +82 33 478 5729 email address: [email protected] Service Request and Technical Support Customer Service Team CU Medical Systems, Inc. Dongwha Medical Instrument Complex 1647-1 DongHwa-Ri, Munmak-Eup, Wonju-si, Gangwon-do, Republic of Korea Tel: +82 33 747 7657 Fax: +82 33 747 7659 email address: [email protected] Our website http://www.cu911.com

EU Authorized Respresentative of CU Medical System ,Inc. Branch Office of CU Medical System,Inc. in Germany Kuester Strasse 6, 30519 Hannover, Germany TEL:+49 511 365 4353 FAX:+49 511 848 6054

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CU-ERT Operator’s Manual_ver 1.10

1. How to Use This Manual 1.1 Contents of This Manual z

This Operator’s Manual contains all the information a user needs to operate the Paramedic CUERT properly.

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In case you have any problems regarding the operation of the device, please don’t hesitate to contact us.

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This Operator’s Manual contains information on a device that is subject to upgrades to incorporate additional features. Specifications and information herein are subject to change without prior notice.

1.2 Safety Messages The following safety messages are used to emphasize the safety practices that must be observed and followed during the operation of the Paramedic CU-ERT. The operator must follow the instructions in all the Warnings, Cautions, and Notices found throughout this Operator’s Manual In the event that the product is damaged due to misuse or negligence by a user, the manufacturer or the authorized representatives shall not be responsible for the damage or loss to the product.

Conditions, hazards, or unsafe practices that can result in serious personal injury or death.

Conditions, hazards, or unsafe practices that can result in minor personal injury, damage to the Paramedic CU-ERT, or loss of data stored in the device.

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

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CU-ERT Operator’s Manual_ver 1.10

2. Device Operation Guidelines 2.1 General Guidelines Do not operate or store the device in conditions that are beyond the following specified limits. Operating Conditions Temperature 0 °C to 50 °C Humidity 5 % to 95 % (non-condensing) Storage Conditions Temperature -20 °C to 70 °C Humidity 5 % to 95 % (non-condensing)

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 Category 10 of MIL-STD-810E)

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

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

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

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CU-ERT Operator’s Manual_ver 1.10

2.2 Storage and Operating Environment Guidelines z

Avoid damp locations. Do not operate and store the device beyond the specified limits. Do not operate the device with wet hands. Do not conduct rescue operations with patients on wet surfaces.

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Do not expose the device to direct sunlight during storage.

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Do not store the device in areas with highly fluctuating temperatures.

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Do not store the device close to heating equipment and appliances.

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Do not store the device near sources of vibration.

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Do not store and operate the device in locations that are exposed to chemicals, explosive gas and solvents.

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Keep the device away from dusty environments.

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There are no user serviceable parts inside the Paramedic CU-ERT. Only authorized service personnel should open the device for repairs.

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During recharging, when the device is connected and disconnected from the mains power connector, hold the plug and not the electrical cord.

Operating environmental condition limits: z

Temperature: 0 °C to 50 °C

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Relative Humidity: 5 % to 95 % (non-condensing)

Storage environmental condition limits: z

Temperature: -20 °C

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Relative Humidity:

to 70 °C

5 % to 95 % (non-condensing)

Do not use the Paramedic CU-ERT if it has been submerged in water. Call immediately for service assistance.

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CU-ERT Operator’s Manual_ver 1.10

2.3 Cleaning and Maintenance After each use, clean the Paramedic CU-ERT using a soft, damp cloth moistened with any of the following solvents: Soap and water 70% solution isopropyl alcohol Chlorine bleach and water mixture (30 ml bleach/liter of water) Ammonia-based cleaners Hydrogen peroxide

Do not immerse any part of the Paramedic CU-ERT in fluids. Do not let any fluid enter the case of the device. Do not spill liquids on the case of the device. Do not use strong, acetone-based cleaners in cleaning the device. Do not use abrasive materials in cleaning the unit, especially on the LCD display and the infrared filter on the IrDA port. Do not sterilize the Paramedic CU-ERT.

Although there are no user serviceable parts inside the Paramedic CU-ERT, the operator can do maintenance checks that will help ensure that the device stays in mint condition. z

Check the case of the device for any apparent damage.

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Check the ports (defibrillator lead port, UART port, adapter power port) to see that they are tightly in place.

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Check the accessories, especially the defibrillation pads, to see that they are in good condition and that they have not yet reached their expiration dates.

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CU-ERT Operator’s Manual_ver 1.10

3 Introduction 3.1 Product Description The Paramedic CU-ERT is a defibrillator simulator designed to mimic the operations of the Paramedic CU-ERT. It can simulate all the functions of the Paramedic CU-ERT including charging and shock delivery.

The charging and shock delivery operations of the Paramedic CU-ERT are simulated only. The device does not contain any defibrillating capacitor and thus can not charge itself.

It has preprogrammed rescue scenarios that were generated in accordance with the recommended rescue protocol of international rescue policy making bodies such as the American Heart Association, the European Resuscitation Council, and the American Red Cross. It is to be used in conjunction with the resuscitation mannequin from CU Medical Systems, Inc. It has a standard infrared remote control accessory which renders it operable by an instructor from a distance.

3.2 Intended Use The Paramedic CU-ERT is intended for use during Advanced Cardiac Life Support training, Basic Life Support training, or any other physician approved trainings that deal with the operation of an automated external defibrillator. The Paramedic CU-ERT is not intended for use during actual rescue operations as it can not deliver a defibrillating shock.

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CU-ERT Operator’s Manual_ver 1.10

4 Basic Orientation 4.1 Controls, Indicators, and Ports

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CU-ERT Operator’s Manual_ver 1.10

4.2 Operating Controls

Turns the power of the Paramedic CU-ERT ON or OFF. ON/OFF button

Flashes its red backlight when the Paramedic CU-ERT is ready to deliver a simulated shock. Delivers the simulated shock when pressed (while the backlight is flashing).

SHOCK button

Control special functions such as device setup and data management and review.

MENU keys

4.3 Indicator Lamps

POWER

Indicates that the source of power is the AC adapter.

BATTERY

This indicator is not used (no function) in the Paramedic CU-ERT

ERROR

Indicates that a system error occurred. If error lamp is on, contact the service representatives.

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CU-ERT Operator’s Manual_ver 1.10

4.4 Parts and Accessories Infrared remote controller

Used to control the training functions of the Paramedic CU-ERT Used to connect the Paramedic CU-ERT to the resuscitation

AED Pads

mannequin. For simulation only. No signal acquisition and shock deliveries are involved.

Quick Reference Card

Quick reference for the steps involved in a rescue operation

AC/DC Adapter

Used to provide power to the trainer using power from the mains

Power Cord

Used to connect the AC/DC Adapter to the power mains

SmartMedia Card

Used to store resuscitation data.

Thermal Printer

Used to print data

UART Cable

Used to connect the trainer to a personal computer for data transmission

Car Cigar Lighter Jack

Used to connect the trainer to a car cigar lighter jack for power

Power Cord

supply

Carrying Case

Used to contain the trainer and all its accessories

External Disposable Battery

Used to power the trainer

Pack Resuscitation Mannequin

Used to simulate connection with a patient

IrDA COM Port Serial

Used to transmit data to a personal computer

Adapter

4.5 Input / Output Ports

ECG-DEFIB port

Used to connect the defibrillator pad assembly to the device. Also used to connect the custom made ECG MONITORING CABLE AND CONNECTOR ASSEMBLY to the Paramedic CU-ERT.

SmartMedia Card port

Receptacle for the SmartMedia card, which is used for storage of incident information. (ECG waveform, voice record, and rescue events)

IrDA port

Used for transfer of data between the Paramedic CU-ERT and other devices. (personal computer or thermal printer)

UART port

Used to transfer data between the Paramedic CU-ERT and a personal computer (PC). Also used to download data for printing to the thermal printer. Use only the UART cable that is supplied by the manufacturer. Using others may cause damage to the device.

AC/DC Adapter port

Receptacle for the 12V DC power supply from an AC adapter unit or a car cigar lighter jack.

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CU-ERT Operator’s Manual_ver 1.10

4.6 Voice and Text Prompts

ATTACH PADS

Indicates that the operator has to attach the defibrillation pads to the bare chest wall of the patient. In the trainer, the instructor operator should press the PAD ON/OFF button on the infrared remote controller.

CHECK PADS

Indicates that the operator has to check the attachment of the pads to the bare chest wall of the patient. In the trainer, the instructor operator should press the PAD ON/OFF button on the infrared remote controller.

ANALYZING ECG

Indicates that the Paramedic CU-ERT is doing an analysis of the patient’s ECG signal.

SHOCK ADVISED

Indicates that the patient has a shockable ECG rhythm such as VF or VT with rates greater than 150 bpm.

DO NOT TOUCH THE PATIENT

Indicates that the Paramedic CU-ERT is analyzing the ECG signal acquired from the patient. The operator should not touch the patient to minimize artifacts. Motion during ECG acquisition will introduce artifacts.

STAND CLEAR

Indicates that everybody in the vicinity of the patient should stand clear and not touch the patient.

NO SHOCK ADVISED

Indicates that the patient has a non-shockable ECG rhythm.

CHARGING

Indicates that the Paramedic CU-ERT is charging its capacitor for a subsequent shock delivery.

CHARGING COMPLETE

Indicates that the Paramedic CU-ERT has finished charging its capacitor for a subsequent shock delivery.

PRESS THE SHOCK BUTTON

Indicates that the user has to press the SHOCK button for the delivery of a defibrillation shock. At this time, SHOCK button is flashing and the beeper is beeping.

SHOCK BUTTON NOT PRESSED

Indicates that a shockable rhythm has been detected and a prompt to press the SHOCK button has been given but the SHOCK button is not pressed within 15 seconds. The device will discharge through its internal discharge circuit. The device will then re-analyze the ECG of the patient.

SHOCK DELIVERED

Indicates that a defibrillation shock has been delivered.

CHECK PATIENT, IF NO PULSE, DO CPR

Tells the operator to check the patient and do cardiopulmonary resuscitation (CPR) if the patient has no pulse.

PAUSED FOR CPR

Indicates that the analysis of the patient’s ECG signal has been stopped so that a CPR could be done on the patient for one minute. Do a CPR to the patient.

STOP CPR

This tells the operator to stop administering CPR.

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CU-ERT Operator’s Manual_ver 1.10

4.7 User Interface The Paramedic CU-ERT has exactly the same user interface as the Paramedic CU-ERT except for the infrared remote controller that is not available on the Paramedic CU-ERT. 4.7.1 LCD Display Splash Screen When the power is turned ON, the following splash screen is displayed on the LCD of the Paramedic CU-ERT.

Splash Screen

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CU-ERT Operator’s Manual_ver 1.10

Initial Screen After a second or two, the Splash Screen is replaced by the Initial Screen shown in the following figure.

Current Date

Prompt

Flashing arrows

Elapsed Time

Battery Status Icon

SmartMedia Card Indicator

CPR Ratio

Flashing Arrows

Point to the location where the pads should be placed

Battery Status Icon

Shows the power level of the external battery pack of the Paramedic CU-

When the External

ERT. It also indicates when the Paramedic CU-ERT is powered by an AC

Battery Pack

adapter or a Car cigar lighter jack.

(LiMnO2) is on Use

Battery level > 90% of full level. 90% > Battery level > 40% of full level. 40% > Battery level > 10% of full level. Battery level < 10% of full level. At this level, the device can still deliver ten 150J shocks. When this is displayed, the battery pack should be replaced. Do not wait for the battery pack to be drained below the level where the Paramedic CUERT could not operate anymore.

Battery Status Icon When the AC/DC Adapter is on Use

the device is powered by an AC adapter or a Car cigar lighter jack

Prompt

Displays the action that needs to be done by the operator

Elapsed Time

The time that elapsed since the Paramedic CU-ER2 was turned ON

SmartMedia Card

This icon is displayed when the SmartMedia Card is inserted in its port

Indicator

before the Paramedic CU-ERT is turned ON

Current Date

Displays the present date.

CPR Ratio

Displays the status of setting for CPR Ratio (30:2, 15:2)

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