CU-PH2 Operators Manual Ver 1.00

OPERATOR’S MANUAL Version 1.00

Notice: This Operator’s Manual applies to i-VIEWER CU-PH2, the portable ECG and SPO2 monitoring equipment from CU Medical Systems, Inc. The information contained in this manual is subject to change without prior notice. Copyright Copyright © 2006 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.

3

Table of Contents Table of Contents ... 4 General... 6 Warranty ... 7 Service Request... 8 Contact Us ... 9 1. How to Use This Manual ... 10 1.1 Contents of This Manual... 10 1. 2 Safety Messages... 11 2. Device Operation Guidelines... 12 2.1 Storage and Operating Environment Guidelines... 12 2.2 Notes On Electrical Safety ... 14 2.3 Cleaning and Maintenance ... 15 3. Introduction... 16 3.1 Product Description... 16 3.1.1 Controls and Ports... 17 3.1.2 ACCESSORIES... 20 3.1.3 Optional Accessories... 22 3.2 Intended Use ... 23 4. Operating Controls, Indicators, Ports, And Accessories... 23 4.1 Operating Controls... 23 4.2 Indicator Lamps ... 24 4.3 Ports... 24 4.4 Equipment Symbols ... 25 5. OPERATION... 26 5.1 Unpacking ... 26 5.1.1 Battery Installation... 26 5.2 Screen Display... 27 5.3 User Interface... 29 5.3.1 Device Setting Submenu ... 29 5.3.2 Monitoring Setting... 33 5.3.3 Record Review... 35 5.3.4 Save And Exit... 38 5.4 Using The i-Viewer CU-PH2... 39 5.4.1 ECG Acquisition Using the 3 Electrode ECG Cable Assembly .. 39 Step 1: Preparation... 39 Device Preparation... 39 User/Patient Preparation... 39 Step 2: Ecg Signal Acquisition ... 41 5.4.2 ECG Acquisition Using the 5 Electrode ECG Cable Assembly .. 42 5.4.3 SPO2 Monitoring... 43 Pulse Oximetry Sensors ... 44 Application and Connection of the Sensor ... 45 SPO2 Monitoring... 45 SPO2 Monitoring Notes and Warnings ... 46

4

6. Maintenance And Troubleshooting ... 48 6.1 Maintenance ... 48 6.2 Cleaning The i-Viewer CU-PH2... 50 6.3 Troubleshooting Guide ... 50 6.4 Device Life ... 51 7. Safety Considerations ... 52 8. Data Management And Review... 55 9. Specifications... 56

5

General Thank you for choosing the i-Viewer CU-PH2. Please read this Operator’s Manual carefully and thoroughly before using the i-Viewer CU-PH2. This Manual contains instructions on how to operate and maintain the i-Viewer CU-PH2. The features of the i-Viewer CU-PH2 are all discussed in this Manual. It is very important for you 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. must do all servicing of the device. ? You must ensure that the correct batteries are properly installed before using this device. ? You must 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.

6

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

i-Viewer CU-PH2

Date of Purchase

Serial No. Sales Representative

Name Customer Information

Address Contact No.

Brief Description of Problems

7

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.

8

? 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

9

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 i-Viewer CU-PH2 properly. The i-Viewer CU-PH2 is designed to acquire, display, and extract the heart rate of the ECG of a patient/user. The i-Viewer CU-PH2 is also equipped with the capability to monitor the SPO2 of a patient.

?

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

?

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

10

1. 2 Safety Messages Safety messages are used throughout this manual to emphasize important things that must be followed during the operation of the i-Viewer CU-PH2. 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-PH2, 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.

11

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.

12

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 i-Viewer CU-PH2. 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)

13

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 i-Viewer CU-PH2 is classified as follows: - It is a Class I, Type CF 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).

14

2.3 Cleaning and Maintenance When the case is contaminated with dirt, clean the i-Viewer CU-PH2 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 i-Viewer CU-PH2 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 i-Viewer CU-PH2.

Although there are no user serviceable parts inside the i-Viewer CU-PH2, 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.

15

3. INTRODUCTION 3.1 PRODUCT DESCRIPTION The i-Viewer CU-PH2 is a lightweight, portable, battery operated, 5-lead Electrocardiogram (ECG) and SPO2 monitoring device. It has a high resolution (320x240 pixels) liquid crystal display (LCD). One of the leads and the plethysmographic wave is displayed simultaneously. The i-Viewer CU-PH2 runs on four AAA size 1.5V batteries. It may also run using a supplied AC/DC adapter. ECG signal acquisition is achieved through a five-electrode ECG acquisition assembly with disposable electrodes while SPO2 signal acquisition is done using the recommended Nellcor SPO2 Sensors. 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 Expert is available as an option. The i-Viewer CU-PH2 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.

16

3.1.1 Controls and Ports

i-Viewer CU-PH2 top view

Power indicator

Green LED, lit when the device is ON.

Power switch

Used to turn the device ON or OFF

Alarm LED

Red LED, flashes when the device detects an ECG signal with beat rate that is beyond the normal range defined by the user.

LCD display

Displays the following: a. ECG signal acquired from the patient b. ECG signal recorded in the memory of the device c. Plethysmographic wave of the patient. d. Menu e. Device settings

LEFT arrow button

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.

MENU button

Used to activate the menu. When the menu is activated, it is used to select the highlighted menu item

RIGHT arrow button

Used to scroll the menu highlight to the right or downward. This button is also used to turn the QRS beeper ON or OFF

17

i-Viewer CU-PH2 right side view IrDA port

used to transmit data from the i-Viewer CU-PH2 to a personal computer using an IrDA transmission.

UART port

used to transmit data from the i-Viewer CU-PH2 to a personal computer using serial wired connection.

i-Viewer CU-PH2 back side view SpO2 Sensor Port

used to connect the SpO2 sensor to the i-VIEWER CU-PH2

ECG Sensor Port

used to connect the ECG electrode assembly to the iVIEWER CU-PH2

AC/DC Power Port

used to connect the AC/DC adapter to the i-VIEWER CUPH2

18

i-Viewer CU-PH2 Bottom View

Battery Cover

covers the battery compartment. The battery compartment contains the four AA batteries that are used to power the device.

19

3.1.2 ACCESSORIES

5-electrode Cable and Connector Assembly

3-electrode Cable and Connector Assembly

ECG Sensor Port Connector

used to connect the cable and connector assembly to the i-Viewer CU-PH2

Snap Electrode Connector

used to connect the cable and connector assembly to the disposable ECG electrodes.

20

Disposable ECG Electrodes Snap Connector

used to connect the electrode to the cable assembly

SPO2 Sensor Assembly SPO2 Sensor

used to acquire the SPO2 signal from the patient

SPO2 Sensor Port Connector

used to connect the sensor assembly to the SPO2 sensor port on the i-Viewer CU-PH2

21