CU Medical Systems Paramedic Series Operator's Manual
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CU Medical Systems Paramedic Series Operator's Manual

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Emergency Responder 1
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CU – ER1
Operator's Manual
CU Medical Systems, Inc.
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Centro médico de reabilitação
March 12, 2025

Há baterias à venda para substituição

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1 comments:
Mr. Anderson
March 12, 2025

Yes, the Paramedic CU-ER1 can be powered using an external, disposable LiMnO battery pack available from CU Medical Systems, Inc. Additionally, the internal rechargeable battery pack should be replaced by the manufacturer or authorized representatives when it reaches the end of its lifecycle.

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Summary of Contents for CU Medical Systems Paramedic Series

  • Page 1 Emergency Responder 1 CU – ER1 Operator’s Manual CU Medical Systems, Inc.
  • Page 2 CU-ER1 Operator’s Manual _ver 3.00 Paramedic CU-ER1 Quick Reference Card...
  • Page 3 CU-ER1 Operator’s Manual _ver 3.00 Notice Paramedic CU-ER1 Operator’s Manual CU Medical Systems, Inc. reserves the right to make changes on the device specifications contained in this manual at any time without prior notice or obligation to customers. Printed in the Republic of Korea Publication Date: April 2006 Operator’s Manual Part No.: CU-ER1 version 3.00...

  • Page 4: Table Of Contents

    CU-ER1 Operator’s Manual _ver 3.00 TABLE OF CONTENTS Table Of Contents ................. 4 General ..................7 Warranty ..................8 Warranty Disclaimer .............. 8 Service..................9 Contact Us ................. 10 1 How to Use This Manual ............11 1.1 Contents of This Manual ..........11 1.2 Manual Conventions ............
  • Page 5 CU-ER1 Operator’s Manual _ver 3.00 5 Device Setup and Storage............51 5.1 Unpacking ..............51 5.2 Setup................51 5.2.1 Manual Self-Test..........51 5.2.2 Battery Charge Check .......... 52 5.2.3 Battery Charging..........52 5.2.4 Configuration Settings.......... 52 5.3 Storage ................ 53 6.
  • Page 6 CU-ER1 Operator’s Manual _ver 3.00 11.3.2 UART Port............84 11.4 Printing Using a Stand-alone Serial Printer....... 85 APPENDIX A ................91 e~cube Biphasic Technology ..........91 APPENDIX B ................98 Rescue Protocol ..............98 APPENDIX C ................99 Parts and Accessories Number ..........99 APPENDIX D................100 Technical Specifications............100 Electromagnetic Compatibility ..........108...

  • Page 7: General

    Please read this Operator’s Manual carefully and thoroughly before using the Paramedic CU-ER1 to be fully acquainted with its operating and maintenance instructions. CU Medical Systems, Inc. designs and manufactures all of its products in accordance with international standards (NS-EN ISO9001:2000/ ISO13485:2003-MDD 93/42/EEC). This ensures that CU Medical Systems, Inc.

  • Page 8: Warranty

    This warranty does not apply if the product has been damaged by accident or misuse or as the result of service or modification by an entity other than CU Medical Systems, Inc. or its authorized representatives. IN NO EVENT SHALL CU MEDICAL SYSTEMS, INC.

  • Page 9: Service

    CU-ER1 Operator’s Manual _ver 3.00 ◐ Service The Paramedic CU-ER1 must be serviced only by authorized personnel. Unauthorized servicing during the warranty period renders the warranty null and void. The Paramedic CU-ER1 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.

  • Page 10: Contact Us

    You may contact us at the following address and telephone number for services and supplies. Product and Order Inquiries: International Marketing Team CU Medical Systems, Inc. Room No. 534, DooSan Venture Digm, 126-1, Pyeongchon-dong, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea...

  • Page 11: How To Use This Manual

    CU-ER1 Operator’s Manual _ver 3.00 1 How to Use This Manual 1.1 Contents of This Manual This Operator’s Manual contains all the information a user needs to operate the Paramedic CU-ER1 properly. In case you have any problems regarding the operation of the device, please don’t hesitate to contact the manufacturer.

  • Page 12: Device Operation Guidelines

    CU-ER1 Operator’s Manual _ver 3.00 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 32 °F to 104 °F (0 °C to 40 °C) Humidity 5 % to 95 % (non-condensing) Standby conditions (Stored with defibrillator electrode pads, ready...

  • Page 13: Electrical Safety Guidelines

    Do not use the Paramedic CU-ER1 if it has been submerged in water. Call immediately for service assistance. To ensure safety and reliability, use only parts and accessories approved by CU Medical Systems, Inc. 2.2 Electrical Safety Guidelines Use the correct power supply during recharging. See the Chapter on Power Supply for more details.

  • Page 14: Introduction

    (150J into 50Ω). The Paramedic CU-ER1 may also be powered using the external, disposable LiMnO battery pack available from CU Medical Systems, Inc. The battery pack has a capacity of 200 shocks (150J into 50Ω) when used at an ambient temperature of...

  • Page 15: Indicated Use

    CU-ER1 Operator’s Manual _ver 3.00 3.2 Indicated Use The Paramedic CU-ER1 is indicated for use on patients that are exhibiting the symptoms of sudden cardiac arrest (SCA). The Paramedic CU-ER1 is to be used on patients that are suspected of suffering from sudden cardiac arrest with all of the following signs: a) Unresponsiveness b) Absence of normal breathing...

  • Page 16: Device Orientation

    CU-ER1 Operator’s Manual _ver 3.00 4. Device Orientation 4.1 Device Parts Illustration Figure 4-1. The Paramedic CU-ER1 Figure 4-2. Side view of the Paramedic CU-ER1...
  • Page 17 CU-ER1 Operator’s Manual _ver 3.00 Device Parts Explanation Displays the ECG of the patient and the various LCD Screen prompts and indicators. Microphone Captures audio signals during a rescue operation. Plays voice prompts during rescue operation and Speaker recorded audio signal during recording playback. Outlines the steps to be taken during a rescue Quick Reference Guide operation...
  • Page 18 CU-ER1 Operator’s Manual _ver 3.00 Device Parts Explanation, continued Input/Output Ports Used to connect the Defibrillator Electrode Pads assembly to the Paramedic CU-ER1. ECG-DEFIB port Also used to connect the custom made ECG MONITORING CABLE AND CONNECTOR ASSEMBLY to the Paramedic CU-ER1. SmartMedia Receptacle for the SmartMedia card.

  • Page 19: Accessories

    CU-ER1 Operator’s Manual _ver 3.00 4.2 Accessories Only parts and accessories approved by CU Medical Systems, Inc. must be used with the Paramedic CU-ER1. Using parts and accessories that are not approved by CU Medical Systems, Inc. may degrade performance.
  • Page 20 CU-ER1 Operator’s Manual _ver 3.00 Standard Accessories Self adhesive, pre-gelled defibrillator electrode pads used to acquire the ECG signal from the patient and to deliver the defibrillation shock to the patient. Defibrillator Electrode Pads and Connector Assembly A reference card that enumerates the steps to be done during a rescue operation.
  • Page 21 Electrode Pads Connector Adapter Used for storage of rescue data (ECG, Rescue Event Highlights, and Voice). Only SMCs supplied by CU Medical Systems, Inc. are compatible with the Paramedic CU- ER1. Do not use any other kind of flash memory SmartMedia Card card.
  • Page 22 CU-ER1 Operator’s Manual _ver 3.00 Optional Accessories, continued A stand-alone thermal printer that enables you to print the ECG and rescue data stored in the internal and removable flash memories of the Paramedic CU-ER1 Thermal Printer Used to connect the device to a car cigar lighter jack for recharging the batteries.
  • Page 23 CU-ER1 Operator’s Manual _ver 3.00 Optional Accessories, continued Used to store the Paramedic CU-ER1 and the accessories needed for a rescue operation. Carrying Case...

  • Page 24: Screen Display Views

    CU-ER1 Operator’s Manual _ver 3.00 4.3 Screen Display Views 4.3.1 Initial Screen Display Turn on the Paramedic CU-ER1 and observe the initial screen display shown on Figure 4- 3. This screen is shown right after the Paramedic CU-ER1 is done with its Power-On Self- Test (Power-On Self-Test is indicated by a text prompt “STARTING UP”).
  • Page 25 CU-ER1 Operator’s Manual _ver 3.00 Initial Screen Display Legend Flashing pads Indicate the location where the defibrillator electrode pads must be icon placed Battery Level Indicator: Power provided by the internal battery pack Shows the charge status of the battery pack of the Paramedic CU-ER1 The battery is fully charged Battery level is 80% of full charge Battery level is 65% of full charge...

  • Page 26: Screen Display; Rescue Operation Ongoing

    CU-ER1 Operator’s Manual _ver 3.00 4.3.2 Screen Display; Rescue Operation Ongoing Heart Rate Energy Shock Count Waveform Text Prompt Elapsed Time SmartMedia Card Recording Indicator Battery Chest Compression: Breath Status Icon Ratio Indicator Figure 4-4. Screen Display During Rescue Operation Energy Indicates the amount of energy to be delivered to the patient...
  • Page 27 CU-ER1 Operator’s Manual _ver 3.00 SmartMedia Card Recording Indicator Indicates that the SmartMedia card is in its port and recording of ECG waveform, voice, and event data is being done. When is displayed, the voice recording option is ON and audio signals in the vicinity of the rescue operation are being recorded.

  • Page 28: Voice And Text Prompts

    CU-ER1 Operator’s Manual _ver 3.00 4.4 Voice and Text Prompts Prompt Type/Meaning Voice and Text ATTACH PADS Indicates that you have to attach the defibrillator electrode pads to the bare chest wall of the patient. Voice and Text Indicates that the Paramedic CU-ER1 is analyzing the ECG DO NOT TOUCH THE signal acquired from the patient.
  • Page 29 CU-ER1 Operator’s Manual _ver 3.00 Voice and Text Prompts, continued Prompt Indication Voice and Text BEGIN CPR, NOW You must administer cardiopulmonary resuscitation (CPR) Voice and Text PUSH THE CHEST DOWN Do compression by pushing the chest down fast two FAST TWO INCHES inches.

  • Page 30: Menu Operation

    CU-ER1 Operator’s Manual _ver 3.00 4.5 Menu Operation Enter Menu Operation by pressing the MENU key button after turning the device ON without connecting any connector into the ECG-DEFIB port. Upon entering Menu Operation, the Paramedic CU-ER1 displays the following screen: DEVICE INFORMATION DEVICE HISTORY BATTERY HISTORY...

  • Page 31: Device History

    CU-ER1 Operator’s Manual _ver 3.00 4.5.1 Device History Device History contains the history of the device during its lifetime. The following data are displayed on the LCD: number and total elapsed time of device usage number of shocks delivered number and total elapsed time of trainings conducted using the device number and total elapsed time of the different tests (daily, weekly, monthly, and manual tests) To access Device History turn ON the device and press the sequence of keypad buttons...
  • Page 32 CU-ER1 Operator’s Manual _ver 3.00 In this example the Device History indicates the following: Uses Middle Number of times the Paramedic CU-ER1 was used in RESCUE column operations. In this example, the Paramedic CU-ER1 was used 15 times in rescue operations. A rescue operation is counted when the following conditions occur: The Paramedic CU-ER1 is turned ON.

  • Page 33: Battery History

    CU-ER1 Operator’s Manual _ver 3.00 4.5.2 Battery History The battery history indicates the number of minutes that the battery has been in use and the current state of the battery (GOOD or LOW). To access Battery History turn ON the device and press the sequence of keypad buttons shown in the following table.
  • Page 34 CU-ER1 Operator’s Manual _ver 3.00 Battery History, continued Press the following button(s) The Paramedic CU-ER1 displays the following in sequence: screen(s) in sequence: BATTERY HISTORY 43500 USAGE TIME Menu Button GOOD STATUS PRESS THE MENU KEY TO RETURN Battery History indicates the following: USAGE TIME Total time that the internal battery pack is used as the power supply of the Paramedic CU-ER1.

  • Page 35: Usage Review

    CU-ER1 Operator’s Manual _ver 3.00 4.5.3 USAGE REVIEW USAGE REVIEW displays the list of Rescue Events recorded together with their time stamp. The list of Rescue Events is given in the following table. Name of Event Event Power ON Indicates the time when the Paramedic CU-ER1 is turned ON. Power OFF Indicates the time when the Paramedic CU-ER1 is turned OFF Indicates the time when the Paramedic CU-ER1 senses a...
  • Page 36 CU-ER1 Operator’s Manual _ver 3.00 To access Usage Review turn ON the device and press the sequence of keypad buttons shown in the following table. Press the following button(s) The Paramedic CU-ER1 displays the following in sequence: screen(s) in sequence: DEVICE INFORMATION DEVICE HISTORY Menu Button...
  • Page 37 CU-ER1 Operator’s Manual _ver 3.00 Usage Review, continued Press the following button(s) The Paramedic CU-ER1 displays the following in sequence: screen(s) in sequence: USAGE REVIEW 7 Sep 2003 22:00 ELAPSED TIME 00:03:22 Menu Button TOTAL SHOCKS DETAILED REVIEW RETURN USAGE REVIEW POWER ON 00:00:00 PADS ON...

  • Page 38: Ecg Review

    CU-ER1 Operator’s Manual _ver 3.00 4.5.4 ECG REVIEW ECG REVIEW • Displays the ECG record stored in the internal memory or the SmartMedia Card memory. • ECG data from the latest rescue operation can be scrolled to the right or to the left (earlier or later part of the recording, respectively).
  • Page 39 CU-ER1 Operator’s Manual _ver 3.00 ECG Review, continued Press the following button(s) The Paramedic CU-ER1 displays the following in sequence: screen(s) in sequence: REVIEW INCIDENT USAGE REVIEW ECG REVIEW Down Button VOICE REVIEW RETURN ECG REVIEW Menu Button 1 / 13 PRESS THE MENU KEY TO RETURN...

  • Page 40: Voice Review

    CU-ER1 Operator’s Manual _ver 3.00 4.5.5 VOICE REVIEW VOICE REVIEW • Plays back the voice recorded during a rescue operation. • Works only if the SmartMedia Card is inserted (Voice record can be stored only in the SmartMedia Card). To access Voice Review, turn ON the device and press the sequence of keypad buttons shown in the following table.
  • Page 41 CU-ER1 Operator’s Manual _ver 3.00 Voice Review, continued Press the following button(s) The Paramedic CU-ER1 displays the following in sequence: screen(s) in sequence: REVIEW INCIDENT USAGE REVIEW ECG REVIEW Down Button VOICE REVIEW RETURN REVIEW INCIDENT USAGE REVIEW ECG REVIEW Down Button VOICE REVIEW RETURN...

  • Page 42: General Device Setup

    CU-ER1 Operator’s Manual _ver 3.00 4.5.6 GENERAL DEVICE SETUP GENERAL DEVICE SETUP • enables you to change or adjust operating parameters such as date, time, and voice recording. To access General Device Setup, turn ON the device and press the sequence of keypad buttons shown in the following table.
  • Page 43 CU-ER1 Operator’s Manual _ver 3.00 General Device Setup, continued Press the following button(s) The Paramedic CU-ER1 displays the following in sequence: screen(s) in sequence: DEVICE SETUP GENERAL Menu Button ADMINISTRATION RETURN GENERAL DATE 03 / 09 / 09 TIME 00:15 Menu Button VOICE REC.
  • Page 44 CU-ER1 Operator’s Manual _ver 3.00 General Device Setup, continued The parameter variables are highlighted one by one by pressing the MENU button while the parameter is highlighted. For example, when DATE is highlighted, the day, month, or year can be highlighted by pressing the MENU button repeatedly until the desired variable is reached.

  • Page 45: Administration Device Setup

    CU-ER1 Operator’s Manual _ver 3.00 4.5.7 ADMINISTRATION DEVICE SETUP In the DEVICE SETUP, ADMINISTRATION, you may set or adjust operating parameters such as Compression:Breath Ratio and ECG Gain. To access Device Setup, Administration, turn ON the device without connecting any connector into the ECG-DEFIB port and press the sequence of keypad buttons shown in the following table.
  • Page 46 CU-ER1 Operator’s Manual _ver 3.00 Device Setup, Administration, continued Press the following button(s) The Paramedic CU-ER1 displays the following in sequence: screen(s) in sequence: DEVICE SETUP GENERAL Menu Button ADMINISTRATION RETURN DEVICE SETUP GENERAL DOWN Button ADMINISTRATION RETURN ADMINISTRATION Compression - Breath Ratio 30 : 2 ECG GAIN 10 mm/mV...
  • Page 47 CU-ER1 Operator’s Manual _ver 3.00 You may scroll the highlighter between Compression-Breath ratio and ECG GAIN by pressing the UP or DOWN key button. You may change the Compression-Breath ratio or ECG GAIN setting by pressing the Menu button while Compression-Breath ratio or ECG GAIN is highlighted, respectively. When the parameter variable is highlighted, change its value by pressing the UP or DOWN button.

  • Page 48: Printing And Transferring Data

    CU-ER1 Operator’s Manual _ver 3.00 4.5.8 Printing and Transferring Data The ECG and rescue data stored in the internal flash memory or the SmartMedia Card may be printed through the optional stand-alone thermal printer or transferred to a personal computer. If the SmartMedia Card is not inserted, the data stored in the internal flash memory is printed.
  • Page 49 CU-ER1 Operator’s Manual _ver 3.00 Communication-Print, continued Press the following button(s) The Paramedic CU-ER1 displays the following in sequence: screen(s) in sequence: DEVICE SETUP GENERAL ADMINISTRATION DOWN Button MONITOR RETURN COMMUNICATION DATA TRANSMISSION DATA RECEPTION DOWN Button PRINT RETURN COMMUNICATION DATA TRANSMISSION DATA RECEPTION MENU Button...

  • Page 50: Return

    CU-ER1 Operator’s Manual _ver 3.00 Press the following button(s) The Paramedic CU-ER1 displays the following in sequence: screen(s) in sequence: COMMUNICATION DATA TRANSMISSION DATA RECEPTION DOWN Button PRINT RETURN The data transmission and printing processes are discussed thoroughly in Chapter 11 – Data Management and Review.

  • Page 51: Device Setup And Storage

    CU-ER1 Operator’s Manual _ver 3.00 5 Device Setup and Storage 5.1 Unpacking • Carefully inspect the packing container and the device for any damage that might have been sustained during shipping. • Check the shipping list to ensure that the unit comes with the complete accessories. It is important to have all the necessary accessories all the time.

  • Page 52: Battery Charge Check

    CU-ER1 Operator’s Manual _ver 3.00 5.2.2 Battery Charge Check The internal battery pack of the Paramedic CU-ER1 is fully charged before leaving the factory. In the course of storage in the distribution system, the battery pack may be depleted when the Paramedic CU-ER1 reaches you. The Manual Self-Test in the previous section can detect a drained battery pack condition.

  • Page 53: Storage

    CU-ER1 Operator’s Manual _ver 3.00 5.3 Storage Place the Paramedic CU-ER1 in an accessible place so that it can be used readily during emergencies. Do not open the Battery Compartment Cover. Do not disconnect the internal battery pack during storage. The internal battery pack must be connected all the time so that: •...

  • Page 54: Using The Paramedic Cu-Er1 In Emergencies

    CU-ER1 Operator’s Manual _ver 3.00 6. Using the Paramedic CU-ER1 in Emergencies Overview This chapter discusses the steps during a rescue operation. Read Appendix B to familiarize yourself with all the possible prompts and other indicators that the Paramedic CU-ER1 gives during a rescue operation. The complete step by step rescue protocol of the Paramedic CU-ER1 is shown in this Appendix.

  • Page 55: Step 1: Preparation

    CU-ER1 Operator’s Manual _ver 3.00 6.1 Step 1: Preparation Insert the SmartMedia Card, if desired. TURN ON the Paramedic CU-ER1 by pressing the ON/OFF button. Assess the condition of the patient. Make sure that the patient is in a state indicated for defibrillation (see Section 3.2).
  • Page 56 CU-ER1 Operator’s Manual _ver 3.00 CHILD DEFIBRILLATION Remove clothing from the patient’s upper body. Wipe moisture off the skin of the patient on the area where the defibrillator pads are to be attached. Reduced-energy Pediatric Defibrillator Pads as shown in the figure at the right.

  • Page 57: Step 2: Ecg Acquisition And Analysis

    CU-ER1 Operator’s Manual _ver 3.00 6.2 Step 2: ECG Acquisition and Analysis Follow the instructions provided by the voice and text prompts of the Paramedic CU-ER1 • The Paramedic CU-ER1 automatically acquires and analyzes the ECG of the patient when: The pads are correctly attached to the patient And the plug of the pads connector is connected to the ECG-DEFIB port of the Paramedic CU-ER1.

  • Page 58: Step 3 Shock Delivery

    CU-ER1 Operator’s Manual _ver 3.00 NO SHOCK ADVISED: If the decision is 1. The Paramedic CU-ER1 gives the prompts “CHECK PULSE” and “IF NO PULSE, BEGIN CPR”. 2. Check the patient and do CPR if the patient has no pulse. Attend to the patient according to CPR guidelines on AED Treatment.
  • Page 59 CU-ER1 Operator’s Manual _ver 3.00 The patient should be kept motionless during signal acquisition and analysis. If the patient is being transported in an emergency vehicle, the vehicle should be stopped during ECG signal acquisition and analysis. Attach the defibrillator electrode pads as described on their reverse sides. Make sure that there is good contact between the defibrillator pads and the patient’s skin.

  • Page 60: Cardiopulmonary Resuscitation (Cpr)

    CU-ER1 Operator’s Manual _ver 3.00 6.4 Cardiopulmonary Resuscitation (CPR) After delivery of a shock, the Paramedic CU-ER1 pauses for you to administer CPR to the patient. Check the patient for signs of circulation after delivering a shock. In the absence of circulation, administer 5 cycles of cardiopulmonary resuscitation (CPR).

  • Page 61: Ecg Monitoring Mode

    7. ECG Monitoring Mode You may activate the ECG Monitoring Mode by connecting the custom-made ECG Monitoring Cable and Connector Assembly provided by CU Medical Systems, Inc. In this mode, the Paramedic CU-ER1 does not do any arrhythmia analysis. Only the ECG and the calculated heart rate of the patient are shown on the screen display.
  • Page 62 Do not attempt to operate the Paramedic CU-ER1 in ECG MONITORING MODE using cable and connector assemblies other than the proper cable and connector assembly supplied by CU Medical Systems, Inc. During ECG MONITORING MODE, the Paramedic CU-ER1 does not do any analysis of the ECG waveform.

  • Page 63: Power Supply

    CU-ER1 Operator’s Manual _ver 3.00 8 Power Supply 8.1 Power Sources The Paramedic CU-ER1 may be powered by the following power sources Internal Battery Pack External Battery Pack AC/DC Adapter (mains powered) Car Cigar Lighter Jack 8.2 Internal Battery Pack The default power supply of the Paramedic CU-ER1 is its internal battery pack, which is made of rechargeable Nickel Metal Hydride cells.
  • Page 64 CU-ER1 Operator’s Manual _ver 3.00 After the low battery condition is detected, the Paramedic CU-ER1 turns the ERROR indicator light ON then OFF and emits a single beep every minute. When the Paramedic CU-ER1 is turned ON after a low battery condition is detected, it does the following: Display the text prompt “LOW BATTERY CODE:0001”.
  • Page 65 CU-ER1 Operator’s Manual _ver 3.00 Internal Battery Charging Indicator The Paramedic CU-ER1 indicates that charging is in progress through the Battery Indicator lamp. When charging is in progress, the Battery Indicator lamp is red and flashing. When charging is finished, the Battery Indicator lamp is green and non-flashing. Do not remove or change the internal battery pack.

  • Page 66: External Battery Pack

    8.3 External Battery Pack An optional disposable external LiMnO battery pack is available from CU Medical Systems, Inc. This battery pack has a capacity of 200 shocks (150J into 50Ω) when used before the recommended usage date. The battery pack is shown in the following figure:...
  • Page 67 CU-ER1 Operator’s Manual _ver 3.00 External Battery Pack Status The energy level of the external battery pack is monitored by the Paramedic CU-ER1. The status of the external battery pack is indicated by the battery status icon which is displayed on the LCD screen during operation. See section 4.3 for the explanation of the battery status icon.

  • Page 68: Ac/Dc Adapter

    CU-ER1 Operator’s Manual _ver 3.00 8.4 AC/DC Adapter The AC/DC Adapter is primarily used for recharging the internal battery pack. However, it may also be used to power the Paramedic CU-ER1 during rescue operations. It has medical device grade isolation properties (passes the requirements of EN 60601-1). The AC/DC Adapter and the power cord are shown in the following figures Output Jack Power Cord Receptacle...

  • Page 69: Car Cigar Lighter Jack

    CU-ER1 Operator’s Manual _ver 3.00 Connecting the AC/DC Adapter a. Connect the power cord to the adapter. b. Plug the power cord to the power mains. c. Connect the output jack of the adapter to the AC/DC port of the Paramedic CU-ER1. Do not connect or disconnect the AC adapter plug while the device is being used, the transients during power changeover in the middle of a rescue operation may cause some problems in the operation of the device.

  • Page 70: Testing, Maintenance, And Troubleshooting

    CU-ER1 Operator’s Manual _ver 3.00 9 TESTING, MAINTENANCE, AND TROUBLESHOOTING 9.1 Testing To ensure that the Paramedic CU-ER1 is always ready for any emergencies, self tests and interactive tests are performed by the device. If the ERROR LED is ON, consult the chapter on Troubleshooting.

  • Page 71: Periodic Self-Tests

    CU-ER1 Operator’s Manual _ver 3.00 9.1.3 Periodic Self-Tests When the Paramedic CU-ER1 is stored with a charged battery pack connected to it, it performs periodic self-tests to ensure that it is ready for use in emergencies. Three types of periodic self-tests are done. These are: a) Daily Periodic Self-Test –...

  • Page 72: Manual Self-Test

    CU-ER1 Operator’s Manual _ver 3.00 9.1.5 Manual Self-Test The Paramedic CU-ER1 can also run a manual self-test that requires your intervention. The manual mode test evaluates all functions tested in all the automated test modes (Power On Self-Test, Run Time Self-Test, Daily/Weekly/Monthly Periodic Self-Test,). To initiate a Manual Self-Test: Press the UP( ) and DOWN( ) keys in the MENU keypad simultaneously.
  • Page 73 CU-ER1 Operator’s Manual _ver 3.00 Maintenance Activities Frequency Activity Actions to be Taken Check the Paramedic CU-ER1 If a message that the battery is low for any error messages that is displayed, recharge the battery. Daily might have been generated other error messages,...
  • Page 74 CU-ER1 Operator’s Manual _ver 3.00 MAINTENANCE CHECKLIST Paramedic CU-ER1 Serial Number: _______________ Location/Vehicle ID: ___________ Date Scheduled Frequency Paramedic CU-ER1: Clean, no signs of damage, free of excessive wear Supplies Available -2 sets of defibrillator electrode pads, undamaged, sealed, within expiration date -supplementary supplies (razor, scissors, gloves, gauze)

  • Page 75: Cleaning The Paramedic Cu-Er3

    CU-ER1 Operator’s Manual _ver 3.00 9.3 Cleaning the Paramedic CU-ER1 After each use, clean the Paramedic CU-ER1 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-ER1 in fluids.

  • Page 76: Troubleshooting

    CU-ER1 Operator’s Manual _ver 3.00 10 Troubleshooting 10.1 Self-Tests The Paramedic CU-ER1 executes automated and manual self-tests to verify the functionality of its major subsystems. The Paramedic CU-ER1 raises alarms if it detects a fault during those self-tests. It raises more alarms when it is turned ON after a fault is detected.
  • Page 77 CU-ER1 Operator’s Manual _ver 3.00 Self-Test Errors, continued Error Name Code Fault Remedial Action Capacitor charge Return to an authorized SYSTEM ERROR 0032 comparator failure service center for repair Return to an authorized SYSTEM ERROR 0064 ECG relay failure service center for repair Impedance Measurement Return to an authorized SYSTEM ERROR...

  • Page 78: Prompts During Rescue Operation

    CU-ER1 Operator’s Manual _ver 3.00 10.2 Prompts During Rescue Operation If there are problems during a rescue operation that prevents the Paramedic CU-ER1 from successfully operating, the Paramedic CU-ER1 gives voice and text prompts to inform you of the problems. These prompts, together with the remedial actions are shown in the following table.

  • Page 79: Data Management And Review

    SmartMedia Flash Memory Card – this is the optional, removable, nonvolatile memory card available from CU Medical Systems, Inc. Audio signals may be stored here. This card is also erased during the start of a rescue operation if it is inserted in its port before the Paramedic CU-ER1 is turned ON.

  • Page 80: Data Review Using The Paramedic Cu-Er3

    Voice Recording option is ON. is displayed when the Voice Recording option is OFF Only SmartMedia Cards supplied by CU Medical Systems, Inc. are compatible with the Paramedic CU-ER1. Do not use any other kind of flash memory card.
  • Page 81 CU-ER1 Operator’s Manual _ver 3.00 Removal of a SmartMedia Card Turn the Paramedic CU-ER1 OFF Pull out the SmartMedia Card from the SmartMedia Card port. Make sure that the SmartMedia Card is loaded before turning ON the device. Do not pull out the SmartMedia Card before turning OFF the device. Loading or pulling out the SmartMedia Card while the power is ON will cause data error and may damage the SmartMedia card Reviewing Data Using a SmartMedia Card...

  • Page 82: Data Transfer To Personal Computer

    To keep data permanently, it must be transferred to a computer that is running the CU Expert ECG Data Management Software. The CU Expert is an optional data management software available from CU Medical Systems, Inc. Data transfer can be done through the IrDA port or the UART port of the Paramedic CU- ER1.
  • Page 83 CU-ER1 Operator’s Manual _ver 3.00 Transmit the data from the Paramedic CU-ER1 through the following steps: Open the CU Expert ECG Data Management Software in the host personal computer. Do not connect any cable connector to the ECG-DEFIB port (defibrillator electrode pads assembly or ECG Monitoring Cable Connector assembly.).

  • Page 84: Uart Port

    CU-ER1 Operator’s Manual _ver 3.00 The Connection icon shows the status of the connection of the Paramedic CU-ER1 with the PC during data transmission Meaning Icon Before the start of data transmission: A connection has not been made yet. At the end of data transmission: Data transfer has been finished.

  • Page 85: Printing Using A Stand-Alone Serial Printer

    CU-ER1 Operator’s Manual _ver 3.00 11.4 Printing Using a Stand-alone Serial Printer The UART port may also be used to transmit data to a stand-alone serial printer. Stand-alone Serial Thermal Printer The optional stand-alone printer is a serial printer configured to receive data using RS232 protocol.
  • Page 86 CU-ER1 Operator’s Manual _ver 3.00 Loading Paper into the Printer Open the paper compartment of the printer by pushing the locks inward simultaneously. When the locks are disengaged, pull the paper compartment lid upward. This is shown in the following figure. Place a roll of printer paper into the compartment.
  • Page 87 CU-ER1 Operator’s Manual _ver 3.00 Printing Data from the Paramedic CU-ER1 Connect the UART Port connector of the printer to the Paramedic CU-ER1’s UART port. Do not connect any connector (defibrillator electrode pads assembly or ECG monitoring electrodes assembly connector) to the ECG-DEFIB port of the Paramedic CU-ER1.
  • Page 88 CU-ER1 Operator’s Manual _ver 3.00 The Paramedic CU-ER1 displays the following figure during printing (PRINT ALL). PRINT ALL PRESS THE MENU KEY TO RETURN If it is desired to print only a segment of the stored ECG data, highlight PRINT SEGMENT, then press the MENU button.
  • Page 89 CU-ER1 Operator’s Manual _ver 3.00 PRINT SEGMENT POWER ON 00:00:00 PADS ON 00:00:00 00:00:05 ANALYZING 00:00:09 SHOCK ADVISED 00:00:18 ARMED PRESS THE MENU KEY TO RETURN Press the MENU button to print the chosen segment. While the segment is being printed, the Paramedic CU-ER1 displays the PRINT SEGMENT screen.
  • Page 90 CU-ER1 Operator’s Manual _ver 3.00 Notes...

  • Page 91: E~Cube Biphasic Technology

    CU-ER1 Operator’s Manual _ver 3.00 APPENDIX A cube Biphasic Technology 1. What is Defibrillation? Sudden cardiac arrest (SCA) associated with ventricular fibrillation (VF) remains a leading cause of unexpected death in the Western world. It has been estimated that chances for survival from SCA decrease approximately 7% to 10% with each passing minute and that survival rates after 12 minutes are only 2% to 5%.
  • Page 92 CU-ER1 Operator’s Manual _ver 3.00 When the Defibrillation shock is delivered, current flow is affected by transthoracic impedance, the body’s resistance from electrode to heart. Impedance is dependent on the anatomy of the chest, skin surface, air in the chest, hair, fat and bone, as well as the size and location of the defibrillation electrodes.
  • Page 93 CU-ER1 Operator’s Manual _ver 3.00 cube ◈ Biphasic technology: 1. makes it asy to compensate the shock waveform to match the patient’s impedance. 2. is more fficient than monophasic technology 3. delivers nough energy for restoring heart rhythm. ase in compensation of patient impedance variance. Through e-cube Biphasic technology, defibrillation shock delivery is controlled while taking into consideration...
  • Page 94 CU-ER1 Operator’s Manual _ver 3.00 2. more fficient than monophasic waveform The electrical therapy delivered by transthoracic cardiac defibrillators has changed little since the introduction of direct-current defibrillation more than 30 years ago. Throughout this time, the industry-standard shock waveform external defibrillators been...
  • Page 95 CU-ER1 Operator’s Manual _ver 3.00 Extensive animal and human data with implanted devices demonstrate that biphasic waveforms offer substantial reductions in defibrillation thresholds and produce less myocardial dysfunction than monophasic waveforms. [1], [2], [3], [4] The defibrillation efficacy of the 150-J biphasic waveform was superior to that of the 200-J to 360-J conventional escalating-energy monophasic waveforms for 115 patients who presented with VF.
  • Page 96 CU-ER1 Operator’s Manual _ver 3.00 nough energy for restoring heart rhythm The Biphasic Truncated Exponential waveform uses lower energy than the Monophasic waveform. But the lower energy of biphasic shock is more efficient than high energy of the monophasic shock for defibrillation to restore heart rhythm. In a multicenter, randomized, controlled trial of 150J biphasic waveform compared with 200J and 360J monophasic waveforms done in humans, Schneider et al [5] showed that “the 150-J biphasic waveform defibrillated at higher rates, resulting in more patients who...
  • Page 97 CU-ER1 Operator’s Manual _ver 3.00 REFERENCES Chapman PD, Vetter JW, Souza JJ, Wetherbee JN, Troup PJ. Comparison of monophasic with single and dual capacitor biphasic waveforms for nonthoracotomy canine internal defibrillation. J Am Coll Cardiol. 1989;14:242.5. Kavanagh KM, Tang ASL, Rollins DL, Smith WM, Ideker RE. Comparison of the internal defibrillation thresholds for monophasic and double and single capacitor biphasic waveforms.

  • Page 98: Rescue Protocol

    CU-ER1 Operator’s Manual _ver 1.00 APPENDIX B Rescue Protocol Start You pressed the ON/OFF button to turn ON the Paramedic CU-ER1 Paramedic CU-ER1 detects/decides: Voice and text prompts: ATTACH PADS AED electrode pads attached? Voice and text prompts: DO NOT TOUCH THE PATIENT Voice and text prompts: ANALYZING HEART RHYTHM Paramedic...

  • Page 99: Parts And Accessories Number

    CU-ER1 Operator’s Manual _ver 1.00 APPENDIX C Parts and Accessories Number To order replacement parts and accessories, please cite the part numbers given in the table below. Standard Parts Name Part Number Paramedic CU-ER1 2 sets of Multifunction Defibrillator Electrode Pads CUA0508O Power Cord ER1-NSP1...

  • Page 100: Technical Specifications

    CU-ER1 Operator’s Manual _ver 3.00 APPENDIX D TECHNICAL SPECIFICATIONS Physical Category Nominal Specifications Size 305 mm X 250 mm X 95 mm (L X W X H) Weight Approximately 2.7 kg Environmental Category Nominal Specifications 32 °F to 104 °F (0 °C to 40 °C) Temperature Operating Conditions...
  • Page 101 CU-ER1 Operator’s Manual _ver 3.00 Arrhythmia Detector Performance ECG Analysis System - ECG Database Test 90% One Test Minimum test Performance Shock No Shock Observed Sided Lower Rhythm Rhythms sample sample size goal Decision Decision Performance Confidence size Class Limit 97.26% Coarse >90%...
  • Page 102 CU-ER1 Operator’s Manual _ver 3.00 Defibrillator Category Nominal Specifications Operating Modes Semi automatic Waveform (Manual and e-cube biphasic (Truncated exponential type); impedance AED Modes) compensated Shock Delivery Via multi-function defibrillator electrode pads Patient Impedance 25Ω to 175Ω Range Delivered Energy (Joules) VS Load Impedance (Ω) Nominal Load Impedance (Ohms) Energy...
  • Page 103 CU-ER1 Operator’s Manual _ver 3.00 Charging Time Less than 9 Using new, fully charged NiMH internal battery pack seconds Time from Less than 9 Using new, disposable, external LiMnO2 battery pack activation of seconds RHYTHM RECOGNITION Less than 9 Using AC power at 100% of rated mains voltage seconds DETECTOR to Less than 9...
  • Page 104 CU-ER1 Operator’s Manual _ver 3.00 AED Energy Fixed energy at 150 Joules Profile Text and Voice Provided to user in every step of a rescue operation Prompts AED Controls Power On/Off, SHOCK button, Volume control Electroluminescent back lit Liquid Crystal Display for ECG waveform and text prompts.
  • Page 105 • May also be printed using a personal computer by ECG Record Printing downloading the data to the PC using the data management software from CU Medical Systems, Inc. (CU Expert) External Links UART Port / IrDA Port...
  • Page 106 CU-ER1 Operator’s Manual _ver 3.00 Display Type Liquid Crystal Display with electroluminescent backlight Size 4 inches (10.16 cm) diagonal Resolution 320X240 pixels Sweep speed 25 mm/s nominal, stationary trace, sweeping erase bar Viewing Time 3.2 seconds Battery Internal Battery Pack Type 4500mAh, 12V, rechargeable, Nickel Metal Hydride Dimensions...
  • Page 107 CU-ER1 Operator’s Manual _ver 3.00 Thermal Array Printer Printing method Direct thermal line printing Resolution 230dpi, 8 dots/mm Printing Speed 50mm/s Dimensions 75mmX95mmX35mm Weight 169g (including roll paper) Input power 12V DC, Standby current 60mA, maximum current 3A Operating Temperature -10 °C to 40 °C Storage Temperature -10 °C to 70 °C...

  • Page 108: Electromagnetic Compatibility

    CU-ER1 Operator’s Manual _ver 3.00 Electromagnetic Compatibility Guidance and manufacturer’s declaration – electromagnetic emissions The Paramedic CU-ER1 is intended for use in the electromagnetic environment specified below. The customer or the user of the Paramedic CU-ER1 should assure that it is used in such an environment.
  • Page 109 CU-ER1 Operator’s Manual _ver 3.00 Guidance and manufacturer’s declaration – electromagnetic immunity The Paramedic CU-ER1 is intended for use in the electromagnetic environment specified below. The customer or the user of the Paramedic CU-ER1 should assure that it is used in such an environment.
  • Page 110 CU-ER1 Operator’s Manual _ver 3.00 Guidance and manufacturer’s declaration – electromagnetic immunity- for LIFE SUPPORTING EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic immunity The Paramedic CU-ER1 is intended for use in the electromagnetic environment specified below. The customer or the user of the Paramedic CU-ER1 should assure that it is used in such an environment.
  • Page 111 CU-ER1 Operator’s Manual _ver 3.00 Recommended separation distances between portable and mobile RF communications equipment and the Paramedic CU-ER1 – LIFE SUPPORTING FUNCTIONS Recommended separation distances between portable and mobile RF communications equipment and the Paramedic CU-ER1 The Paramedic CU-ER1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 112: Paramedic Cu-Er1 Shock Waveform Plots

    CU-ER1 Operator’s Manual _ver 1.00 Paramedic CU-ER1 Shock Waveform Plots 25Ω Impedance Load 150 Joules output 50Ω Impedance Load 150 Joules output...
  • Page 113 CU-ER1 Operator’s Manual _ver 3.00 75Ω Impedance Load 150 Joules output 100Ω Impedance Load 150 Joules output...
  • Page 114 CU-ER1 Operator’s Manual _ver 3.00 125Ω Impedance Load 150 Joules output 150Ω Impedance Load 150 Joules output...
  • Page 115 CU-ER1 Operator’s Manual _ver 3.00 175Ω Impedance Load 150 Joules output...

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