CIC Pro Clinical Information Center Operators Manual Sw Ver 4.1 Rev A April 2004

NOTE: The information in this manual only applies to CIC Pro Clinical Information Center software version 4.1. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.

Listed below are GE Medical Systems Information Technologies trademarks used in this document. All other trademarks contained herein are the property of their respective owners. APEX and CD TELEMETRY are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office. APEXPRO, CD TELEMETRY®-LAN, CENTRALSCOPE, CIC PRO, and OCTACOMM are a trademarks of GE Medical Systems Information Technologies. © GE Medical Systems Information Technologies, 2004. All rights reserved.

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CE Marking Information

CE Marking Information Compliance The CIC Pro Clinical Information Center bears CE mark CE-0459 indicating its conformity with the provisions of the Council Directive 93/ 42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive. The product is in radiointerference protection class A in accordance with EN 55011. The country of manufacture can be found on the equipment labeling. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility - Medical Electrical Equipment”. The CE marking prescribed above is only found on the equipment labeling of the 230V European equipment. Only applicable equipment will bear the CE marking. The safety and effectiveness of this device has been verified against previously distributed devices. Although all standards applicable to presently marketed devices may not be appropriate for prior devices (i.e. electromagnetic compatibility standards), this device will not impair the safe and effective use of those previously distributed devices. See user’s information.

CE Marking Information Exceptions EMC: Immunity Performance Users should be aware of known RF sources, such as radio or TV stations and hand-held or mobile two-way radios, and consider them when installing a medical device or system. Be aware that adding accessories or components, or modifying the medical device or system may degrade the EMI performance. Consult with qualified personnel regarding changes to the system configuration.

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Specified Electromagnetic Environment. The CIC Pro and ApexPro server is suitable for use in the specified electromagnetic environment. The customer and/or the user of the CIC Pro and ApexPro server should assure that it is used in an electromagnetic environment as described below: CE Exception Table EN60601-1-2 Clause 36 36.202.1 Immunity: ESD

Exception

Electromagnetic Environment Guidance

Direct - Discharges of 6 KV or greater to the rear I/O connector area may cause the system to lock up, thus experiencing loss of data and loss of functionality. Operator intervention may be required.

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Likelihood of occurrence: Remote During testing there were 2 occurrences out of 1,920 discharges. The rear I/O connector area is not considered to be user accessible during normal operation. 36.202.3.1 Immunity: Fast Transient

Transients on the AC power line of +/- 1 KV or higher may cause momentary network packet loss (i.e. waveform and/or numeric data), thus experiencing momentary loss of data at the time of the surge.

Mains power quality should be that of a typical commercial and/or hospital environment.

36.202.3.2 Immunity: Fast Surges

Surges on the AC power line of +/- 1 KV or higher may cause momentary network packet loss (i.e. waveform and/or numeric data), thus experiencing momentary loss of data at the time of the surge.

Mains power quality should be that of a typical commercial and/or hospital environment.

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General Information

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This manual is an integral part of the product and describes its intended use. It should always be kept close to the equipment. Observance of the manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.

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The symbol documents.

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Information which refers only to certain versions of the product is accompanied by the model number(s) of the product(s) concerned. The model number is given on the nameplate of the product.

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The warranty does not cover damages resulting from the use of accessories and consumables from other manufacturers.

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GE Medical Systems Information Technologies is responsible for the effects on safety, reliability, and performance of the product, only if:

means ATTENTION: Consult accompanying

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assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE Medical Systems Information Technologies;

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the electrical installation of the relevant room complies with the requirements of the appropriate regulations; and,

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the Clinical Information Center is used in accordance with the instructions for use.

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All publications conform with the product specifications and applicable IEC publications on safety and essential performance of electromedical equipment as well as with applicable UL and CSA requirements and AHA recommendations valid at the time of printing.

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The quality management system complies with the international standards EN ISO 9001, ISO 13485 and EN 46001, and the Council Directive on Medical Devices 93/42/EEC.

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CE Marking Information For your notes

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Contents

1

The Basics... 1-1 About This Manual... 1-3 Manual Purpose... 1-3 Intended Audience... 1-3 Definitions... 1-4 Illustrations and Names... 1-4 Revision History... 1-5 About the Clinical Information Center... 1-6 Power... 1-8 Turning Power On... 1-8 ... 1-8 Controls... 1-9 Mouse... 1-9 Optional Touchscreen Display... 1-11 Keyboard... 1-12 Display Formats... 1-13 Terminology... 1-14 Bedside Monitoring... 1-14 Telemetry Monitoring... 1-14 Locked or Unlocked Beds... 1-15 Multiple Patient Viewer... 1-16 Telemetry and Network Bed Names... 1-18 Locked/Unlocked Beds... 1-18 Waveform Window... 1-19 ECG Parameter Window... 1-21 Initiating a Manual Graph... 1-22 User Help Message Area... 1-22 Alarm Condition Indicators... 1-23 Main Menu Buttons... 1-23 Single Patient Viewer... 1-24 Data Source... 1-25

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Time Focus... 1-26 Viewing Alarm Histories... 1-26 Viewing Graphic Trends... 1-26 Viewing Vital Signs... 1-27 Viewing Full Disclosure... 1-27 Web Browser... 1-28 Browser Configuration... 1-28 Menu Formats... 1-29 Main Menu... 1-29 Popup Menus... 1-29 Text Entry Fields... 1-30 Controls... 1-31 Radio Buttons... 1-31 Check Boxes... 1-31 Scroll Bars... 1-32 System Environment Monitor Notification... 1-33

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Safety... 2-1 For Your Safety... 2-3 Intended Use... 2-3 Terminology... 2-3 Monitor Safety... 2-4 Reference Literature... 2-11 Equipment Symbols... 2-12 Classification... 2-14 Underwriters Laboratories, Inc... 2-14

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Maintenance... 3-1 Biocompatibility... 3-3 Inspection... 3-4 Cleaning... 3-5 General Cleaning... 3-5 Cleaning the Touchscreen... 3-6 Technical Maintenance... 3-7

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CIC Setup... 4-1 Introduction... 4-3 CIC Defaults... 4-4 CIC Defaults Controls... 4-5 Telemetry Unit Defaults... 4-9 Telemetry Unit Defaults Controls... 4-10 Telemetry Alarm Control Defaults... 4-12 Telemetry Alarm Control Defaults Controls... 4-13 Current Telemetry Listings... 4-14 Current Telemetry Listings Controls... 4-15 Alpha-Numeric TTX ID Numbering... 4-15 Display Format... 4-16 Display Format Controls... 4-17 Changing the Display Format... 4-18 Assigning Patients to Patient Slots... 4-20 Screen Calibration... 4-21 Service Password... 4-22 Full Disclosure Defaults... 4-23 Full Disclosure Controls... 4-24 Full Disclosure Off-line Storage (Minute Rule)... 4-26 Bedside Status Messages... 4-27

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Printing... 5-1 Initiating and Stopping a Graph... 5-3 Initiating a Graph... 5-3 Stopping a Graph... 5-3 Graph All Patients... 5-4 Initiating a Graph All Patients Request... 5-5 Graph Paper Out Indicator... 5-6 Graph Location Settings... 5-7 Graph Setup Tab Sheet... 5-8 Graph Waveforms Controls... 5-9 Graph Location Controls... 5-11 Graph Speed Controls... 5-14 Laser Printer... 5-15

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Alarm Control... 6-1 Alarm Structure... 6-3 Patient Status Alarms... 6-3 System Status Alarms... 6-5 Alarm Control Tab Sheet... 6-6 Printing Alarm Settings... 6-12 Silencing Alarms... 6-13

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Admit/View a Patient... 7-1 Admitting a Patient... 7-3 Ways to Monitor... 7-3 Admit Instructions... 7-5 Special Considerations for Rover Monitoring... 7-8 Discharging a Patient... 7-9 Discharge Procedure... 7-9 New Patient... 7-12 Move Telemetry Patients... 7-13 Moving Locked/Unlocked Beds... 7-13 Viewing a Patient... 7-14 View Patient Tab Sheet... 7-15 Viewing Other Patients... 7-16 View Other Button... 7-16 Viewing Patients Through Alarm Condition Indicators... 7-17 Viewing PDS Data For a Discharged Patient... 7-17

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Alarm Histories... 8-1 Alarm Histories... 8-3 Alarm Histories Controls... 8-5 Printing Alarm Histories... 8-9

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Graphic Trends... 9-1 Graphic Trends... 9-3 Graphic Trends Tab Sheet... 9-4 Graphic Trends Controls... 9-5 Printing Graphic Trends... 9-9

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Vital Signs... 10-1 Vital Signs... 10-3 Vital Signs Controls... 10-4 Printing Vital Signs... 10-6

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Full Disclosure... 11-1 Full Disclosure... 11-3 Full Disclosure Tab Sheet... 11-4 Full Disclosure Window... 11-5 Full Disclosure Controls... 11-7 Printing Full Disclosure Information... 11-10 Print Report... 11-10 Printing from the Main Menu... 11-13 Calipers... 11-14 Measurement Table... 11-15 Calipers Measurement Window... 11-16 Performing a Calipers Measurement... 11-18

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Parameter Monitoring... 12-1 Introduction... 12-3 Data Synchronization... 12-3 ECG Monitoring... 12-4 ECG Controls... 12-4 SpO2/Respiration Monitoring... 12-8 SpO2 Controls... 12-8 Respiration Controls... 12-9 Pressure Monitoring... 12-11 NBP Controls... 12-12 Invasive Pressure Controls... 12-13

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Abbreviations and Symbols...A-1 Abbreviations... A-3 Symbols... A-8

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Supplies...B-1 Contact Information... B-3

Index... Index-1

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The Basics

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For your notes

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The Basics: About This Manual

About This Manual Manual Purpose This operator manual has been prepared by the Technical Writing staff of GE Medical Systems Information Technologies. It provides operating instructions for the CIC Pro with GE Medical Systems Information Technologies patient monitors and interface devices. The CIC Pro can be used as a central station for viewing bedside monitored patients, telemetry patients, or both. All of the basic operating instructions for the CIC Pro itself are in this manual. Information presented in this manual applies when the type of monitoring (using either a bedside patient monitor or telemetry) is not a factor in CIC Pro operation. For information about monitoring functions that are specific to the patient monitor or telemetry system, refer to the operator’s manual for that product.

Intended Audience This manual is geared for clinical professionals. Clinical professionals are expected to have working knowledge of medical procedures, practices, and terminology as required for monitoring of critically ill patients.

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The Basics: About This Manual

Definitions The following formats are used in this manual to highlight various web viewer features and functions. Black text

Indicates keys on the keyboard, text to be entered, or hardware items such as buttons or switches on the equipment.

Italicized text

Indicates software terms that identify menu items, buttons, or options in various windows.

Ctrl+Esc

Indicates a keyboard operation. A (+) sign between the names of two keys indicates that you must press and hold the first key while pressing the second key once. For example, “Press Ctrl+Esc” means to press and hold down the Ctrl key while pressing the Esc key.

<Space>

Indicates you must press the spacebar. When instructions are given for typing a precise text string with one or more spaces, the point where the spacebar must be pressed is indicated as: <Space>. The purpose of the < > brackets is to ensure you press the spacebar when required.

Enter

Indicates you must press the “Enter” or “Return” key on the keyboard. Do not type “enter”.

Illustrations and Names All illustrations in this manual are provided as examples only. They may not necessarily reflect your monitoring setup or data displayed on your monitor. In this manual, all names appearing in examples and illustrations are fictitious. The use of any real person’s name is purely coincidental.

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The Basics: About This Manual

Revision History This manual has a revision letter, located at the bottom of each page. This revision letter changes whenever the manual is updated. Revision A is the initial release of the document.

Revision A

Revision

Date

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22 April 04

Comments Manual released with this document number to correspond with CIC Pro software version 4.1

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The Basics: About the Clinical Information Center

About the Clinical Information Center This manual addresses the operation of the Clinical Information Center. The Clinical Information Center is referred to as the CIC Pro throughout the rest of this document. The CIC Pro displays data from up to 16 bedside devices (patient monitors, Unity Network ID connectivity devices, telemetry transmitters, etc.) at one time. This data is collected for each individual monitor and sent to the CIC Pro via the Unity Network. Included are the bed number, the primary ECG waveform, heart rate, alarm messages, etc. The vital sign numerics displayed are determined at the GE Medical Systems Information Technologies bedside monitor or the telemetry receiver cabinet. GE bedside monitors send numerics for all actively monitored parameters as well. Control is provided through the mouse or optional touchscreen display and keyboard. The following page shows an illustration of the CIC Pro with the various components, indicators, and controls labeled. Refer to the service manual for installation instructions, including mounting and support requirements.

Telemetry Compatibility The following issues apply with regard to compatibility with CIC Pro software version 4.1

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Due to changes in Telemetry Unit Defaults and Telemetry Alarm Control defaults, CentralscopeTM central stations and previous software versions of CIC are not in-unit compatible with CIC Pro software version 4.1.

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The CD Telemetry-LAN software is compatible with all versions of CIC Pro software.

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The ApexPro telemetry system software 3.x is only compatible with CIC Pro software version 4.x.

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The ApexPro telemetry system software 1.7 and 2.x is compatible with CIC software version 3.x.

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The ApexPro telemetry system software 1.x is compatible with CIC software version 2.x.

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The ApexPro telemetry system is not compatible with versions of CIC software earlier than 2.x.

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The Basics: About the Clinical Information Center

Front View

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Clinical Information Center The components shown in the photograph above are representative of a typical CIC Pro. They may not appear identical to the components of your system. The CIC Pro processing unit is not shown.

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The Basics: Power

Power Turning Power On WARNING Check the service manual for AC power requirements before installation.

When you properly connect all cables, press the power switches on the back of the processing unit and the monitor. (Refer to the service manual for information on system connections.) A green indicator light means the power is on. (Refer to the figure on the previous page.) CAUTION Do NOT load any software other than that specified by GE Medical Systems Information Technologies onto the CIC Pro. Installation of software not specified by GE Medical Systems Information Technologies may cause damage to the server or loss or corruption of data.

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