Natus Olympic CFM 6000 User manual

Operator’s Manual

OLYMPIC CFM 6000

Version 2

	Read and be familiar with this manual before operating this device.
	To ensure operator, technician, and patient safety, use only as
CAUTION	specified in this manual.

0086

602053A DCN: 08-0175

Product Manufacturer:

Natus Medical Incorporated

5900 First Avenue South

Seattle, WA 98108 USA

Toll-free:	1-800-308-8684 (US/Canada)
Phone:	[phone] (international)
Customer Service Fax:	[phone]
Technical Service Fax:	[phone]

Any product vigilance related communications per 93/42/EEC Article 10 should be referred to:

European Union Authorized Representative

Natus Europe GmbH

Bärmannstrasse 38

D-81245 München, Germany

The information in this manual is subject to change without notice.

No part of this manual may be photocopied, reproduced, translated, or reduced to any electronic medium without the express written permission of Natus Medical Incorporated.

All tradenames and trademarks mentioned herein are property of their respective owners.

The CFM 6000 software described in this manual is ©2003–2008 Natus Medical Incorporated.

© 2008 Natus Medical Incorporated. All rights reserved.

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

CFM 6000 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

CFM 6000 Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

CFM Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

CFM Cart Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Using the CFM Cart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Olympic CFM 6000 Data Displays. . . . . . . . . . . . . . . . . . . . . 8

CFM Tracings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 EEG Tracings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Impedance Tracings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Starting and Stopping the CFM 6000 . . . . . . . . . . . . . . . . . 10 Preparing the Patient — Applying Electrodes . . . . . . . . . . 10

Operating the CFM 6000 . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Understanding the CFM 6000 Screen . . . . . . . . . . . . . . . . 13 Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Customizing Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Changing Predefined (Standard) Markers . . . . . . . . . . 15 Changing the CFM Tracing Display Style . . . . . . . . . 16 Adjusting the System Date/Time . . . . . . . . . . . . . . . . 16 Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Changing the Operation Mode . . . . . . . . . . . . . . . . . . 16 Changing Data Entry Capitalization . . . . . . . . . . . . . . 17 Changing Patient Information to Display . . . . . . . . . . 17 Recording a Session. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Viewing an EEG Tracing. . . . . . . . . . . . . . . . . . . . . . . . . . 18 Navigating an EEG Tracing . . . . . . . . . . . . . . . . . . . . 19 Changing EEG Speed and Amplitude . . . . . . . . . . . . . 20 Entering Patient Information . . . . . . . . . . . . . . . . . . . . . . . 20 Using Markers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Placing Markers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Editing a Placed Marker . . . . . . . . . . . . . . . . . . . . . . . 22 Finding Placed Markers . . . . . . . . . . . . . . . . . . . . . . . 22 Viewing Marker Details . . . . . . . . . . . . . . . . . . . . . . . 23 Opening a Session for Viewing . . . . . . . . . . . . . . . . . . . . . 23 Using the CFM 6000 Printer . . . . . . . . . . . . . . . . . . . . . . . 23 Printing a Tracing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Replacing Printer Paper . . . . . . . . . . . . . . . . . . . . . . . 25 Managing Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Archiving a Session to CD . . . . . . . . . . . . . . . . . . . . . 26 Restoring Sessions from CD . . . . . . . . . . . . . . . . . . . . 27 Deleting Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Checking Hard Disk Space . . . . . . . . . . . . . . . . . . . . . 28

OLYMPIC CFM 6000 Operator’s Manual

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Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 28

Cleaning the CFM 6000 and the CFM Cart . . . . . . . . . . . 28

Tightening the Tilt Adjustment Hinge . . . . . . . . . . . . . . . 29

Updating Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Disposing of Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Assembling the CFM Cart . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

CFM 6000 Catalog Items . . . . . . . . . . . . . . . . . . . . . . . . . 35

Standards and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . 35

Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

ii	OLYMPIC CFM 6000 Operator’s Manual

Introduction

This manual provides the necessary information for installing, maintaining, and operating the Olympic CFM 6000 and the Olympic CFM cart. Olympic CFM 6000 is a cerebral function monitor (CFM) that monitors the state of the brain by acquiring an EEG signal and passing it through a special algorithm to display a continuous view of global electrocortical activity. It is suited for use in the NICU, ICU, PICU, emergency room, operating room, and clinical research laboratory.

The CFM 6000 should be used only under the direct supervision of a licensed medical practitioner who is trained in its operation and safe use.

Indications for Use

The Olympic CFM 6000 is intended to be used by a variety of clinicians for the acquisition of electroencephalography (EEG) signals that can be used in conjunction with other clinical data to:

Monitor the state of the brain.

Determine and monitor long-term the neurological status of patients who may have suffered an hypoxic-ischemic event.

Assist in the clinical management and treatment of a patient by monitoring neurological status to indicate how the treatment affects the neurological status.

Assist in the prediction of neurological outcome.

Monitor and record frequency and intensity of seizures to assist in the management of anticonvulsive therapy.

Assist in the prediction of the severity of hypoxic-ischemic encephalopathy (HIE) and the long-term outcome in infants who have suffered an hypoxic-ischemic event.

OLYMPIC CFM 6000 Operator’s Manual

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Warnings and Precautions

Electrical Grounding:

Always connect the system power cord directly to a hospital-grade

WARNING	grounded power receptacle with a functional ground.
	To avoid electrical shock hazard, never touch the open rear-panel
	connectors and the patient at the same time. Always place connector
	covers over their receptacles when not in use.

Internal Voltage:

To avoid electrical shock hazard, always turn off the CFM 6000 and unplug its power cord before cleaning the outer surfaces of the device or disassembling the device. For cleaning instructions, see Cleaning and Maintenance on page 28.

Liquids & Gases:

Never use liquids on or near the CFM 6000. Fluid seepage into internal components creates a potential shock hazard. Never operate the system if internal components have been exposed to fluid.

Cables:

Use of cables that exceed the lengths or are of different types than noted in the Specifications on page 36, may result in increased radio emissions or decreased RF immunity.

Operation:

Only properly trained medical and service personnel should operate and CAUTION maintain the CFM 6000 and the CFM cart. As appropriate, maintain any records

that indicate training attendance and completion.

This device should only be used under the direct supervision of a licensed medical practitioner.

Explosion hazard. Do not use in the presence of flammable anesthetics.

Service:

Only technically qualified personnel should perform service procedures. On request, Natus Medical Incorporated will provide circuit diagrams, parts lists, and instructions to assist qualified technical personnel to repair the CFM 6000 to the printed circuit board (PCB) level. To obtain service, see Service on page 34.

Detachable Components:

Never autoclave the CFM 6000 or its components as doing so will cause damage and void the warranty.

Electromagnetic Interference:

Operation of this device may affect or be affected by other nearby equipment due to electromagnetic interference (EMI). If this occurs, place the devices further apart, re-orient the device cabling, or plug the devices into separate outlet circuit branches.

Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents.

Portable and mobile RF communications equipment can affect medical electrical equipment.

2	OLYMPIC CFM 6000 Operator’s Manual

CONT’D

CAUTION

USB Devices:

To meet electrical safety requirements, USB devices used with the CFM 6000 must meet the requirements of IEC 60601-1. Alternately, if line connected and approved to an appropriate national standard other than 60601-1, a separation device must be used (refer to IEC 60601-1-1).

To avoid electrical shock hazard, ensure that the cover is securely placed over the USB port connector when not in use, and never touch the connector and patient simultaneously.

Product Disposal:

The fluorescent lamp in the LCD display contains a small amount of Mercury. Follow your local ordinances and regulations for disposal.

Conventions

The following conventions are used in this manual:

Table 1 Conventions

Convention	Description

#Provides additional information to clarify a point.

NOTE

NOTICE!	Indicates situations that could result in damage to the equipment.
	Indicates situations that, if not avoided, could result in minor to moderate injury
	to the patient or operator.
CAUTION
	Indicates situations that, if not avoided, could result in serious injury or death
	to the patient or operator.
WARNING

Symbols

The following symbols are used on the CFM 6000, its accessories, or packaging.

Table 2	Symbols
Symbol		Definition
		Alternating current (AC)
		Atmospheric pressure
		Attention, consult accompanying
		documents
		Authorized representative
		Defibrillation proof type-BF and
		complies with IEC Publication 601

Symbol	Definition

Equipotential ground

Latex free

Lot—the manufacturer’s production identification number

Manufacturer

Mouse—this port is intended only for use in Service mode

Catalog number

Network/Ethernet port

OLYMPIC CFM 6000 Operator’s Manual

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Table 2	Symbols, Continued
Symbol		Definition
		Cart tilt
		Cart raise/lower
		CE mark
		Electrical shock hazard
		Package of three electrodes,
		Silver/Silver Chloride (Ag/AgCl)
		Bag of 20 electrode sets:
		20 packages per bag
		Box of 100 electrode sets: five
		bags of electrodes per box
		Foot activated
		Fuse
		Ground
		Input/output—RS-232 in/out serial
		port
		Keyboard—this port is intended
		only for use in Service mode

Symbol	Definition
	Percent humidity
	Mains power ON
	Mains power OFF
	Serial number
	Shipping specification
	Single use only—discard after use,
	do not sterilize
	Storage specification
	Temperature
	USB port—see the USB port
	precautions on page 3
	Use by the expiration date
	Use indoors at normal room
	temperature and keep out of direct
	sunlight

4	OLYMPIC CFM 6000 Operator’s Manual

CFM 6000 System

The CFM 6000 comes fully assembled with all the accessories (electrodes, NuPrepTM skin prep gel, printer paper, clips, and power cord) required to get started. Just plug in the power cord and the amplifier module, and the device is ready to operate.

CFM 6000 Components

	1 Touch screen: see Understanding the CFM 6000 Screen
1	on page 13

2Printer: see Replacing Printer Paper on page 25

3CD-RW drive: for archiving patient files to compact disc and for updating software

4Amplifier module: connects electrodes to the CFM 6000

2	5 Handle: use to carry the CFM 6000

3

6Power cord receptacle: connects the CFM 6000 to a hospital-grade electrical outlet via power cord

	4	7 Power on/off switch: use to turn the CFM 6000 power ON
		or OFF (see Starting and Stopping the CFM 6000 on
		page 10)

8Fuses

9Serial I/O port: for future use

5

10Keyboard port: for service use only

11Mouse port: for future use only

12USB port: for future use; shown with cover in place (see the USB port precautions on page 3)

13Network/Ethernet port: for future use

					14	Equipotential ground
6	10 11	12	13	14	15	Electrodes with touch-proof
						connectors: connect to the
7	8					amplifier module (hydrogel
	9
						electrodes shown)

4

15

OLYMPIC CFM 6000 Operator’s Manual

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CFM Cart

The optional Olympic CFM cart is intended for use with the Olympic CFM 6000. The cart makes it easy to use, move, and store the CFM 6000 and provides storage space for related accessories. For ordering information, see CFM 6000 Catalog Items on page 35.

For information about assembling the CFM cart, see Assembling the CFM Cart on page 30.

CFM Cart Components

1

2

6

3

7

	4		8
	5
1	Storage drawer	5	Footprint base with five caster wheels,
			two locking
2	Handle	6 Power cord clamp and cleats
3	Post	7	Thumbscrews with spacers
4	Foot pedal – for height adjustment	8	Drawer slides

The storage drawer provides space for the following CFM 6000 accessories:

Amplifier module

Several packages of electrodes

A tube of electrode cream or NuPrep™ Skin Prep Gel

Several blank CD-R discs

A roll of thermal imaging paper

6	OLYMPIC CFM 6000 Operator’s Manual

Using the CFM Cart

Keep the CFM cart caster wheels locked during use to prevent the CFM 6000 from pulling on the electrode connections.

CAUTION Periodically inspect the caster wheels to ensure that the locking mechanism works correctly.

To lock/unlock the two locking caster wheels:

Press the wheel lock down to lock the wheel.

Pull the wheel lock up to unlock the wheel.

Figure 1 Locking/unlocking the caster wheels

press down	press up
to lock	to unlock

To adjust the height:

Press the foot pedal while pulling the handle up to raise the device.

Press the foot pedal while pushing the handle down to lower the device.

To tilt the drawer assembly and the CFM 6000:

With one hand on top of the CFM 6000 and the other on the bottom of the drawer, firmly tilt the drawer forward or backward.

The drawer tilts up to 15º in either direction (up/down), allowing you to easily change the viewing angle and optimize touch-screen access from a seated or standing position.

Figure 2 Adjusting the height and tilt

To maneuver the CFM cart:

Use the handle to move or maneuver the cart.

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