CIC Pro Clinical Information Center Operators Manual Sw Ver 5.0 Oct 2006

NOTE Due to continuing product innovation, specifications in this manual are subject to change without notice. The information in this manual supports software versions 5.0 or later. NOTE For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems Information Technologies. 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, Aware, CD TELEMETRY, Quantitative Sentinel, SOLAR, and MUSE are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office. APEXPRO, CD TELEMETRY® -LAN, CENTRALSCOPE, CIC PRO, OCTACOMM, and UNITY NETWORK are trademarks of GE Medical Systems Information Technologies.

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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 radio-interference 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 (for example, electromagnetic compatibility standards), this device will not impair the safe and effective use of those previously distributed devices. See user’s information.

Exceptions Users should be aware of known RF sources, such as radio or TV stations and handheld 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.

General information „

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

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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 is responsible for the effects on safety, reliability, and performance of the product, only if: ‹

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means ATTENTION: Consult accompanying documents.

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

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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 device 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 ISO 9001 and EN ISO 13485, and the Council Directive on Medical Devices 93/42/ EEC.

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Contents 1

Introduction... 1-1 Equipment information... 1-2 Intended use of the equipment... 1-2 Safety statements... 1-2 Equipment symbols... 1-10 Equipment compliance... 1-12 Manual information... 1-13 Purpose... 1-13 Intended audience... 1-13 Conventions used... 1-13 Ordering manuals... 1-14 Revision history... 1-14

2

Equipment overview... 2-1 Standard components... 2-2 Display... 2-3 Processor box... 2-3 Controls... 2-4 Indicator... 2-6 Optional components... 2-6 Second display... 2-6 Touchscreen display... 2-6 Remote display with speakers... 2-6 Laser printer... 2-6 PRN 50-M digital writer... 2-7 Networking... 2-8 Patient monitoring network... 2-8 Web access server network... 2-8 Preparation for use... 2-9 Turning on the power... 2-9 Configuring the CIC Pro center... 2-10 Verifying proper operation... 2-10 Patient data viewers... 2-10 Multi-patient viewer... 2-10 Single patient viewer... 2-12 Patient data... 2-12 Real-time patient data... 2-12 Stored patient data... 2-14

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3

Customizing your CIC Pro center... 3-1 Identifying your configuration... 3-2 Licenses (instituted)... 3-2 Defaults (persistent)... 3-3 Control settings (temporary)... 3-4 Configuring user-level defaults (persistent)... 3-4 Configuring the alarm volume... 3-4 The Display Configuration window... 3-5 Configuring full disclosure defaults... 3-11 Adjusting control settings (temporary)... 3-13 Adjusting the displayed waveforms and colors... 3-13

4

Alarms... 4-1 Alarm notification... 4-2 Alarm categories... 4-3 Patient status alarms... 4-3 System status alarms... 4-4 Managing patient alarms... 4-4 Silencing alarms... 4-4 Adjusting alarm control settings... 4-6 Printing patient alarm graphs... 4-9 Configure the automatic printing of alarm graphs... 4-9 Stop printing an alarm graph... 4-9

5

Managing patients... 5-1 Admit... 5-2 Factors guiding the admit process... 5-2 Admitting a patient... 5-4 Changing patient demographic information... 5-10 Moving a patient to a different bed... 5-10 Move a telemetry or non-telemetry patient to a different bed... 5-10 Move a patient from Combo monitoring to telemetry monitoring... 5-11 Move a telemetry patient to a different transmitter... 5-11 Discharging an admitted patient... 5-12

6

Viewing real-time patient data... 6-1 Real-time patient views... 6-2 Multi-patient viewer... 6-2 Single patient viewer... 6-3

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In-unit patient beds... 6-5 Viewing in-unit patients experiencing an alarm condition... 6-5 Viewing patient beds from another in-unit CIC Pro center... 6-6 Out-of-unit patient beds... 6-6 Viewing an out-of-unit patient bed... 6-7 Removing viewed out-of-unit patient beds... 6-7 Configuring the real-time trend window... 6-7 Printing real-time data... 6-9 Printing a continuous ECG strip... 6-9 Printing parameter limits or waveforms for all in-unit patient beds... 6-9 Stopping a print job... 6-10 Monitored parameters... 6-11 Adjusting parameter control settings... 6-11

7

Viewing stored patient data... 7-1 Stored data... 7-2 Time focus data... 7-2 Events directory... 7-3 Viewing the Events directory... 7-3 Printing the Events directory... 7-4 Counting how many events occurred... 7-5 Identifying the most recent occurring event... 7-5 Deleting a stored event or data sample... 7-5 Viewing or printing an Event strip... 7-6 Full disclosure data... 7-7 Full disclosure strip... 7-7 Full disclosure page... 7-10 Graphic trends data... 7-16 Viewing graphic trends... 7-16 Printing graphic trends data... 7-18 Vital signs data... 7-19 Viewing vital signs data... 7-20 Printing vital signs data... 7-21 Measuring ECG waveform intervals and amplitude... 7-21 View a waveform from the Calipers window... 7-21 Adjusting the waveform display... 7-23 Compare the rate of multiple waveform complexes... 7-23 Calculating a measurement value... 7-24 Printing a caliper measurement report... 7-25

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Printing... 8-1 Print devices... 8-2 Print output... 8-2 Hardwired or Combo bed parameter data... 8-2 Telemetry bed parameter data... 8-3 Graph location... 8-3 Printing real-time data... 8-4 Printing stored patient data... 8-4 Stopping a print job... 8-5 Stop printing to a laser printer... 8-5 Stop printing to a local digital writer... 8-5 Adjusting print control settings... 8-5

A

Abbreviations and symbols... A-1 Abbreviations... A-2 Symbols... A-7

B

Maintenance... B-1 Biocompatibility... B-2 Supplies... B-2 Inspection... B-2 Disposal... B-3 Cleaning... B-3 Procedure... B-3 Cautions... B-4 Impact or results of improper cleaning products and processes... B-4 Cleaning products to avoid... B-5 Digital writer... B-5 Changing thermal writer paper... B-5 Storing thermal writer paper... B-6 Maintaining the processor battery... B-7 Technical maintenance... B-7 Safety tests... B-7 Verifying alarm function... B-8

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C

Troubleshooting... C-1 Messages... C-2 Other symptoms of trouble... C-4

D

Supported parameters... D-1 Interfacing with non-GE devices... D-2 Arterial blood gas (ABG)... D-2 Arterial pressure (ART)... D-3 BIS data... D-3 BIS module data... D-3 Cardiac calculations... D-4 Cardiac output (CO)... D-4 Central venous pressure (CVP)... D-4 Cerebral perfusion pressure (CPP)... D-5 Continuous cardiac output (CCO)... D-5 CO2 parameter... D-5 ECG... D-6 EEG... D-7 Episodic temperature... D-8 Estimated pulmonary calculations... D-9 Femoral pressure (FEM)... D-9 Impedance cardiograpy (ICG)... D-9 Intracranial pressure (ICP)... D-10 Left-arterial pressure (LA)... D-10 Mass spectrometry... D-10 Non-invasive blood pressure (NBP)... D-11 Non-invasive cardiac output (Novametrix - NICO)... D-11

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Pulmonary artery pressure (PA)... D-12 Pulmonary calculations... D-12 Right-arterial pressure (RA)... D-13 Respiration data... D-13 Respiratory mechanics (RM)... D-13 SpO2... D-14 Special pressure (SP)... D-14 SvO2... D-15 Transcutaneous CO2 (TCO2)... D-15 Transcutaneous CO2 (TCO2) with a Tram module... D-15 Temperature (Temp)... D-15 Umbilical artery pressure (UAC)... D-16 Umbilical venous pressure (UV or UVC)... D-16 Ventilator data (Vent)... D-16

E

Customized defaults worksheet... E-1 Graphic Trends data views... E-2 Vital Signs data views... E-4 Single display screen layout... E-9 Dual display screen layout... E-9 Telemetry defaults... E-11 Alarms Off Selection... E-11 Telemetry Unit Defaults... E-11 Telemetry parameter limits and alarm levels... E-12

F

Technical specifications... F-1 General performance specifications... F-2 Alarms... F-4 Display requirements... F-4 Computer specifications... F-4

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Software platform... F-5 Power requirements... F-5 Environmental specifications... F-6 Physical specifications... F-6

Index 1

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1

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Introduction

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Introduction

Equipment information Intended use of the equipment The CIC Pro™ Clinical Information Center (CIC Pro center) is intended for use under the direct supervision of a licensed health care practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. The CIC Pro center is intended to collect information from a network and display this data. This data includes medical data (physiological and demographic) or nonmedical information or both. Physiological parameters and waveforms from GE monitors and telemetry systems can be displayed and printed from the CIC Pro center. Beat-to-beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed. The CIC Pro center supports the ability to access information from GE products in a web browser format. Additionally, the CIC Pro center supports the ability to access patient information collected from the Unity Network™ and stored on a network server.

Safety statements The safety statements presented in this chapter refer to the equipment in general and, in most cases, apply to all aspects of the device. There are additional safety statements in other chapters which are specific to that chapter content. The order in which safety statements are presented in no way implies the order of importance.

Dangers Danger statements identify an imminent hazard which, if not avoided, will result in death or serious injury. No danger statements apply to this monitoring system.

Warnings Warning statements identify a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury. The following warning statements apply to this monitoring system: WARNING ACCIDENTAL SPILLS - To avoid electric shock or device malfunction, liquids must not be allowed to enter the device. If liquids have entered a device, take it out of service and have it checked by a service technician before it is used again.

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Introduction

WARNING ACCURACY - If the accuracy of any value displayed on the screen or printed on a graph strip is questionable, first determine the patient's vital signs by alternative means. Then, verify the CIC Pro center and printer are working correctly.

WARNING ALARMS - Do NOT rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in a hazard to the patient. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. After connecting the monitor to the central station and/or nurse-alert system, verify the function of the alarm system. Repeat this verification periodically, including a check of all connected speakers. CIC Pro center audible alarms will not sound for patients with bedside monitoring devices configured to “Operating Room” mode.

WARNING BEFORE INSTALLATION - Compatibility is critical to safe and effective use of this device. Please contact your local sales or service representative prior to installation to verify equipment compatibility.

WARNING BEFORE USE - Before putting the system into operation visually inspect all connecting cables for signs of damage. Damaged cables and connectors must be replaced immediately. Before using the system, the operator must verify that it is in correct working order and operating condition. Periodically, and whenever the integrity of the product is in doubt, test all functions.

WARNING DISCHARGE TO CLEAR PATIENT DATA - When admitting a new patient, you must clear all previous patient data from the system. To accomplish this, disconnect patient cables then do a discharge.

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WARNING DISCONNECTION FROM MAINS - When disconnecting the system from the power line, remove the plug from the wall outlet first. Then you may disconnect the power cord from the device. If you do not observe this sequence, there is a risk of coming into contact with line voltage by inserting metal objects, such as the pins of leadwires, into the sockets of the power cord by mistake.

WARNING DISPOSAL - Dispose of the packaging material, observing the applicable waste control regulations and keeping it out of children’s reach.

WARNING EXPLOSION HAZARD - Do NOT use this equipment in the presence of flammable anesthetics, vapors or liquids.

WARNING INTERFACING OTHER EQUIPMENT - Devices may only be interconnected with each other or to parts of the system when it has been determined by qualified biomedical engineering personnel that there is no danger to the patient, the operator, or the environment as a result. In those instances where there is any element of doubt concerning the safety of connected devices, the user must contact the manufacturers concerned (or other informed experts) for proper use. In all cases, safe and proper operation should be verified with the applicable manufacturer's instructions for use, and system standards IEC 60601-1-1/EN 60601-1-1 must be complied with.

WARNING LEAKAGE CURRENT TEST - When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients.

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WARNING LOSS OF MONITORING - If the monitoring at the CIC Pro center is temporarily interrupted, alternate monitoring devices or close observation of the patients must be used until the monitoring function at the CIC Pro center is restored. Indications of a loss of the monitoring function at the CIC Pro center are as follows: „

RED SCREEN indicates the CIC Pro center application is restarting itself and patient monitoring at the CIC Pro center is not occurring. The monitoring function at the CIC Pro center will automatically resume in less than 30 seconds. No user action is required.

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BLUE SCREEN indicates the Windows® operating system has a functional error and patient monitoring at the CIC Pro center is not occurring. If the CIC Pro center does not automatically restart after 90 seconds, the monitoring function at the CIC Pro center will not resume until you turn off the power to the CIC Pro center and then turn the power back on. The monitoring function should resume in less than three minutes.

Once the monitoring function at the CIC Pro center has been restored, you should verify the correct monitoring state and alarm function.

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Introduction

WARNING LOSS OF MONITORING - If the browser function is inappropriately used, loss of monitoring function may result. Use alternate monitoring devices or close patient observation until the monitoring function at the CIC Pro center is restored. When using the browser function, follow these restrictions: „

Do not attempt to access the file systems of the CIC Pro center through the use of the browser.

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Do not attempt to download files of any type. This includes, but is not limited to, audio or video files.

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Do not play user-defined audio (e.g. Media Player, streaming radio stations).

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Do not attempt to access web applications or web sites outside of the protected and isolated hospital intranet environment.

Inappropriate use of the CIC Pro center browser function may result in a loss of monitoring function at the CIC Pro center. If a loss of monitoring should occur, use alternate monitoring devices or close patient observation until the CIC Pro center monitoring function is restored. If the CIC Pro center does not automatically resume operation within 90 seconds, power cycle the CIC Pro center by turning the power switch off, then on again. The monitoring function should resume in less than three minutes. Once monitoring is restored, you should verify correct monitoring state and alarm function. If the monitoring function is not restored, have a qualified service person verify proper operation.

WARNING NETWORK INTEGRITY - The CIC Pro center resides on the hospital’s computer network, and it is possible that inadvertent or malicious network activity could adversely affect patient monitoring. The integrity of the computer network is the responsibility of the hospital.

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WARNING POWER SUPPLY - The device must be connected to a properly installed power outlet with protective earth contacts only. If the installation does not provide for a protective earth conductor, disconnect the monitor from the power line and operate it on battery power, if possible. GE recommends the use of an Uninterrupted Power Supply (UPS) with the CIC Pro center. If a UPS is not used, improper shutdowns of the system could result in the event of a power outage and cause a lengthy disk scan procedure when the unit reboots. You could also lose data in the event of a power outage if you do not use a UPS. All devices of a system must be connected to the same power supply circuit. Devices which are not connected to the same circuit must be electrically isolated when operated.

WARNING RATE METERS - Keep pacemaker patients under close observation. Rate meters may continue to count the pacemaker rate during cardiac arrest and some arrhythmias. Therefore, do not rely entirely on rate meter alarms.

WARNING SITE REQUIREMENTS - Do not route cables in a way that they may present a stumbling hazard. For devices installed above the user, adequate precautions must be taken to prevent them from dropping on the user.

WARNING MISMATCHED PATIENT DATA - Always verify the displayed patient data corresponds to the medical record number of the patient on the monitor.

WARNING INADEQUATE DATA RESOLUTION - Images displayed on this device are not to be used for diagnostic purposes. Always review the original images.

Cautions Caution statements identify a potential hazard or unsafe practice which, if not avoided, could result in minor personal injury or product or property damage. The following caution statements apply to this monitoring system:

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Introduction

CAUTION DISPOSAL - At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have questions concerning disposal of the product, please contact GE or its representatives.

CAUTION EMC - Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.

CAUTION INSTRUCTIONS FOR USE - For continued safe use of this equipment, it is necessary that the listed instructions are followed. However, instructions listed in this manual in no way supersede established medical practices concerning patient care.

CAUTION LOSS OF DATA - Should the monitor at any time temporarily lose patient data, the potential exists that active monitoring is not being done. Close patient observation or alternate monitoring devices should be used until monitor function is restored. If the monitor does not automatically resume operation within 60 seconds, power cycle the monitor using the power on/off switch. Once monitoring is restored, you should verify correct monitoring state and alarm function.

CAUTION MAINTENANCE - Regular preventative maintenance should be carried out annually. You are responsible for any requirements specific to your country.

CAUTION MPSO - Do not use a multiple portable socket outlet (MPSO) for a system because it could result in unacceptable enclosure leakage currents.

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