CU-PH1 Operators Manual Ver 2.10

Operator’s Manual

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OPERATOR’S MANUAL Version 2.10

Notice: This Operator’s Manual applies to CardioMeter CU-PH1, the portable ECG monitoring equipment from CU Medical Systems, Inc. The information contained in this manual is subject to change without prior notice. Copyright Copyright © 2003 CU Medical Systems, Inc. Medical Instrument Industry Park 1720-26 Taejang-Dong, Wonju-Si, Kangwon-Do Korea This document may not be reproduced without prior written consent of CU Medical Systems, Inc.

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Table of Contents

Table of Contents ... 4 General... 5 Warranty ... 6 Service Request ... 7 Contact Us... 8 1. How to Use This Manual ... 9 1.1 Contents of This Manual... 9 1. 2 Safety Messages... 10 2. Device Operation Guidelines... 11 2.1 Storage and Operating Environment Guidelines... 11 2.2 Notes On Electrical Safety ... 13 2.3 Cleaning and Maintenance ... 14 3. INTRODUCTION... 15 3.1 PRODUCT DESCRIPTION ... 15 3.2 INTENDED USE AND USERS ... 20 4. OPERATING CONTROLS, INDICATORS, PORTS, AND ACCESSORIES ... 20 4.1 OPERATING CONTROLS... 20 4.2 INDICATOR LAMPS... 21 4.3 PORTS... 21 4.4 Equipment Symbols ... 22 5. OPERATION ... 23 5.1 UNPACKING... 23 5.1.1 Battery Installation... 23 5.2 SCREEN DISPLAY... 24 5.3 USER INTERFACE... 26 5.3.1 DEVICE SUBMENU... 26 5.3.2 ECG SUBMENU ... 30 5.3.3 REVIEW SUBMENU ... 31 5.3.4 EXIT SUBMENU... 35 5.4 USING THE CU-PH1... 36 5.4.1 ECG Acquisition Using the 3 Electrode ECG Cable Assembly .. 36 Step 1: Preparation... 36 Device Preparation... 36 User/Patient Preparation... 36 Step 2: ECG SIGNAL ACQUISITION ... 38 5.4.2 ECG Acquisition Using the Hand Electrodes... 39 6. MAINTENANCE AND TROUBLESHOOTING... 40 6.1 MAINTENANCE ... 40 6.2 CLEANING THE CU-PH1... 42 6.3 TROUBLESHOOTING GUIDE ... 42 6.4 Device Life ... 43 7. INDICATIONS AND SAFETY CONSIDERATIONS... 44 7.1 INDICATIONS ... 44 7.2 CONTRAINDICATIONS ... 44 7.3 INTENDED USERS... 44 7.4 SAFETY CONSIDERATIONS ... 44 8. DATA MANAGEMENT AND REVIEW ... 47 9. SPECIFICATIONS ... 48

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General Thank you for choosing the CU-PH1. Please read this Operator’s Manual carefully and thoroughly before using the CU-PH1. This Manual contains instructions on how to operate and maintain the CU-PH1. The features of the CU-PH1 are all discussed in this Manual. It is very important for the user to fully understand all the instructions and guidelines discussed in this Manual in order to fully utilize the features of this device and to ensure safe operation. CU Medical Systems, Inc. designs and manufactures all 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: ? Only persons authorized by CU Medical Systems, Inc. should do all servicing of the device. ? You should ensure that the correct batteries are properly installed before using this device. ? You should operate this device in accordance with the instructions specified in this manual. To ensure safety and reliability, use only parts and accessories recommended by CU Medical Systems, Inc.

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Warranty

? 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 of the particular country where this device is sold. ? The warranty period of this device is within two years after the date of purchase. ? When the device malfunctions during the warranty period, it will be repaired free of charge at our service centers. ? When you submit the device for maintenance, please specify the details as listed below : The device model, serial number, date of purchase, name of sales representative, customer information and a brief description of the problems. Name of Product Model

CardioMeter CU-PH1

Date of Purchase

Serial No. Sales Representative

Name Customer Information

Address Contact No.

Brief Description of Problems

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Service Request

Only CU Medical Systems, Inc. or its authorized representatives should service the device. If the device is serviced by unauthorized personnel 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. Damage to the device incurred beyond normal use is not covered by the warranty. When the device is not functioning properly, it has to be submitted for maintenance immediately.

When any problems are found in the device or when a danger to bodily harm exists, the device has to be repaired immediately by authorized personnel.

When the need for maintenance arises: ? Please contact CU Medical Systems, Inc. or its authorized representatives immediately. Prepare a summary of the problems.

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? 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. Medical Instrument Industry Park 1720-26 Taejang-Dong, Wonju-Si, Kangwon-Do Korea Tel : +82 33 747 7657 Fax : +82 33 747 7659 email address: [email protected] Service Request and Technical Support Customer Service Team CU Medical Systems, Inc. Medical Instrument Industry Park 1720-26 Taejang-Dong, Wonju-Si, Kangwon-Do Korea Tel : +82 33 747 7657 Fax : +82 33 747 7659 email address: [email protected] Our website: http://www.cu911.com

Authorized European Representative of CU Medical Systems, Inc. A.M.I Italia s.r.l Via Cupa Reginella N 17A 80010 Quarto (Napoli) Italy Tel No 0039 (0) 81 806 34 75 0039 (0) 81 806 34 75 Fax No 0039 (0) 81 876 47 69 Email: [email protected] Website: www.amitaliasrl.it

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1 How to Use This Manual 1.1

Contents of This Manual

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This Operator’s Manual contains all the information a user needs to operate the CU-PH1 properly. The CU-PH1 is designed to acquire, display, and extract the heart rate of the ECG of a patient/user.

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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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Specifications and information in this manual are subject to change without prior notice.

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1. 2 Safety Messages Safety messages are used throughout this manual to emphasize important things that must be followed during the operation of the CU-PH1. You must follow the instructions in all the Warnings, Cautions, and Notice messages 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 its authorized representatives shall not be responsible for the said damage or loss to the product.

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

Conditions, hazards, or unsafe practices that can result in minor personal injury, damage to the CU-PH1, or loss of data stored in the device.

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

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2 Device Operation Guidelines 2.1

Storage and Operating Environment 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-STD810E)

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.

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The following are the general guidelines in storage and operating environment conditions. ? Do not expose the device to direct sunlight during storage. ? Do not store the device in locations with temperature and humidity conditions that are beyond the specified safe range Temperature: -20°C to 70°C Relative Humidity: 5% to 95% (non-condensing) ? Do not store the device close to heating equipment and appliances. ? Do not store the device near sources of vibration. ? Do not store and operate the device in locations that are exposed to chemicals, explosive gas and solvents. ? Keep the device away from dusty environments. ? There are no user serviceable parts inside the CU-PH1. Only authorized service personnel should open the device for repairs. The Standard Operating Conditions are as Follows: ? Temperature: 0 °C to 50 °C ? Relative Humidity: 5 % to 95 % (non-condensing) The standard storage and shipping conditions are as follows: ? Temperature: -20 °C to 70 °C ? Relative Humidity : 5 % to 95 % (non-condensing)

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2.2 Notes On Electrical Safety

During operation, the device should be placed away from sources of electromagnetic interference such as motors, generators, X-Ray equipment, radio transmitters, cellular mobile telephones and others, as these might interfere with the signals being acquired.

The CU-PH1 is classified as follows: - It is a Class I, Type BF equipment in terms of electrical shock prevention (EN 60601-1). It is not proper to operate this device around combustible anesthetic or solvents. - The noise level is “B” Class according to EN 60601-1 (Safety of Electric Medical Equipment), and the noise redemption is “B” level according to the EN 60601-1-2 (Electromagnetic Compatibility Requirements).

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2.3 Cleaning and Maintenance When the case is contaminated with dirt, clean the CU-PH1 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 CU-PH1 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 the LCD display and the infrared filter on the IrDA port. Do not sterilize the CU-PH1.

Although there are no user serviceable parts inside the CU-PH1, you can do some maintenance check that will help ensure that the device stays in mint condition. ? Check the case of the device for any apparent damage. ? Check the ports (ECG connector port) to see that it is tightly in place. ? Check the accessories, especially the ECG electrodes, to see that they are in good condition and that they have not yet reached their expiration dates.

A more comprehensive maintenance routine is discussed in the chapter on Maintenance of this User’s Manual.

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3. INTRODUCTION

3.1 PRODUCT DESCRIPTION The CU-PH1 is a lightweight, portable, battery operated, 3-lead Electrocardiogram (ECG) monitoring device. It has a bandwidth of 0.3 Hz to 40 Hz. The CU-PH1 has a high resolution (320x240 pixels) liquid crystal display (LCD). One of the three bipolar limb leads (Lead I, Lead II, Lead III) can displayed at a given time. The CU-PH1 runs on two AAA size 1.5V batteries. This makes the device very lightweight and very safe as it is not connected to any power mains. ECG signal acquisition is achieved through a three-electrode ECG acquisition assembly with disposable electrodes. User interaction is through three function buttons (LEFT, RIGHT, and MENU). Through these buttons, the settings of the device can be changed. ECG signals can be recorded in the internal nonvolatile memory of the device. The stored signals can later be reviewed. These recorded signals can also be transferred to a personal computer that is running the CU Expert ECG Data Management Software. The CU-PH1 analyzes the signal it acquires from the user and determines the heart rate of the user. The device prompts the user through the beeper and the LED alarm indicator if it detects an abnormal heart rate. Abnormal heart rate is any heart rate beyond the normal limits defined by the user.

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CU-PH1 top view

?1 ?2

Power indicator Power switch

?3

Alarm LED

?4

LCD display

?5

LEFT arrow button

?6

MENU button

?7

RIGHT arrow button

Green LED, lit when the device is ON. Used to turn the device ON or OFF Red LED, flashes when the device detects an ECG signal with beat rate that is beyond the normal range defined by the user. Displays the following: a. ECG signal acquired from the patient b. ECG signal recorded in the memory of the device c. Menu d. Device settings Used to scroll the menu highlight to the left or upward. This button is also used to change the Lead of the ECG signal being acquired. Used to activate the menu. When the menu is activated, it is used to select the highlighted menu item Used to scroll the menu highlight to the right or downward. This button is also used to turn the QRS beeper ON or OFF

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22mm

32mm

CU-PH1 right side view ?1 IrDA port ?2 RA Hand Electrode

used to transmit data from the CU-PH1 to a personal computer electrode for the right forefinger when the hand electrode system is used instead of the ECG pad and cable system

?3

CU-PH1 left side view ?3 LA Hand Electrode

electrode for the left forefinger when the hand electrode system is used instead of the ECG pads and cable system

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CU-PH1 back view

?1 ECG/UART Cable Connector Port

Used to connect the ECG pads and cable assembly to the CU-PH1. This port is also used to connect the CU-PH1 to the COM Port of a personal computer during data transmission.

CU-PH1 Bottom View ?1 Battery Cover ?2 LL Electrode

covers the battery compartment. The battery compartment contains the two AAA batteries that are used to power the device. electrode for the right hand middle finger. This is used when the ECG signal is acquired through the hand electrodes.

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ACCESSORIES

Cable and Connector Assembly ?1 ECG Port Connector ?2 Snap Electrode Connector

used to connect the assembly to the CU-PH1 used to connect the assembly to the disposable ECG electrodes.

Disposable ECG Electrodes ?1 Snap Connector

used to connect the electrode to the cable assembly

Optional Accessories Leather Case Cradle CU Expert Patient Management Software IrDA Cable UART Cable

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3.2 INTENDED USE AND USERS

The CU-PH1 is intended for ECG signal monitoring. It can indicate whether an ECG signal is normal or abnormal based on a normal range defined by the user. The ECG signal acquired from the user is recorded in the internal flash memory of the device. The signal can be retrieved later for proper diagnosis by a medical professional.

4. OPERATING CONTROLS, INDICATORS, PORTS, AND ACCESSORIES 4.1 OPERATING CONTROLS

Turns the power of the CU-PH1 ON or OFF. ON/OFF Switch

LEFT BUTTON

RIGHT BUTTON

a. Scrolls the Menu highlight UP or to the LEFT b. Scrolls the ECG record to the left (displaying the earlier parts of a recorded ECG) during RECORD REVIEW c. Changes the ECG Lead acquired by the device when pressed during ECG acquisition. a. Scrolls the Menu highlight DOWN or to the RIGHT b. scrolls the ECG record to the right (displaying the later parts of a recorded ECG) during RECORD REVIEW c. Turns the QRS beep ON or OFF

Used to select an item in a menu MENU BUTTON

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