Natus Olympic CFM 6000 User manual
CAUTION
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
specified in this manual.
602053A
DCN: 08-0175
0086
Product Manufacturer:
Natus Medical Incorporated
5900 First Avenue South
Seattle, WA 98108 USA
Toll-free: 1-800-308-8684 (US/Canada)
Phone: +1-650-802-0400 (international)
Customer Service Fax: +1-650-802-6620
Technical Service Fax: +1-650-802-8680
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 i
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
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
6000 and the Olympic CFM cart. Olympic CFM 6000 is a cerebral
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 1
WARNING
CAUTION
Warnings and Precautions
Electrical Grounding:
Always connect the system power cord directly to a hospital-grade
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
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 CF M 6000 Operator’s Manual
CAUTION
NOTE
#
NOTICE!
CAUTION
WARNING
CONT’D
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
Convention Description
Conventions
Provides additional information to clarify a point.
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.
Indicates situations that, if not avoided, could result in serious injury or death
to the patient or operator.
Symbols
The following symbols are used on the CFM 6000, its accessories, or packaging.
Table 2
Symbols
Symbol Definition Symbol Definition
Alternating current (AC) Equipotential ground
Atmospheric pressure Latex free
Attention, consult accompanying
documents
Authorized representative Manufacturer
Defibrillation proof type-BF and
complies with IEC Publication 601
Catalog number Network/Ethernet port
Lot — the manufacture r’s production
identification number
Mouse — this port is intended only
for use in Service mode
OLYMPIC CFM 6000 Operator’s Manual 3
Table 2
Symbols, Continued
Symbol Definition Symbol Definition
Cart tilt Percent humidity
Cart raise/lower Mains power ON
CE mark Mains power OFF
Electrical shock hazard Serial number
Package of three electrodes,
Shipping specification
Silver/Silver Chloride (Ag/AgCl)
Bag of 20 electrode sets:
20 packages per bag
Box of 100 electrode sets: five
Single use only — discard after use,
do not sterilize
Storage specification
bags of electrodes per box
Foot activated Temperature
Fuse USB port — see the USB port
precautions on page 3
Ground Use by the expiration date
Input/output — RS-232 in/out serial
port
Use indoors at normal room
temperature and keep out of direct
sunlight
Keyboard — this port is intended
only for use in Service mode
4 OLYMPIC CF M 6000 Operator’s Manual
Touch screen: see Understanding the CFM 6000 Screen
on page 13
Printer: see Replacing Printer Paper on page 25
CD-RW drive: for archiving patient files to compact disc
and for updating software
Amplifier module: connects electrodes to the CFM 6000
Handle: use to carry the CFM 6000
Power cord receptacle: connects the CFM 6000 to a
hospital-grade electrical outlet via power cord
Power on/off switch: use to turn the CFM 6000 power ON
or OFF (see Starting and Stopping the CFM 6000 on
page 10)
Fuses
Serial I/O port: for future use
Keyboard port: for service use only
Mouse port: for future use only
USB port: for future use; shown with cover in place (see
the USB port precautions on page 3)
Network/Ethernet port: for future use
Equipotential ground
Electrodes with touch-proof
connectors: connect to the
amplifier module (hydrogel
electrodes shown)
1
2
34567891011
12
13
14
15
5
2
3
4
1
6
7 8
9
10 11
12 13 14
4
15
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
OLYMPIC CFM 6000 Operator’s Manual 5
CFM Cart
Storage drawer
Handle
Post
Foot pedal – for height adjustment
1
2
3
4
2
5
4
1
Footprint base with five caster wheels,
two locking
Power cord clamp and cleats
Thumbscrews with spacers
Drawer slides
5
6
7
8
6
7
8
3
CFM Cart Components
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
related accessories. For ordering information, see
6000 and provides storage space for
CFM 6000 Catalog Items on page 35.
For information about assembling the CFM cart, see Assembling the CFM Cart
on page 30.
6 OLYMPIC CF M 6000 Operator’s Manual
The storage drawer provides space for the following CFM 6000 accessories:
Amplifier module
Several packages of electrodes
A tube of electrode cream or NuPrep
Several blank CD-R discs
Skin Prep Gel
™
A roll of thermal imaging paper
CAUTION
press up
to unlock
press down
to lock
Using the CFM Cart
Keep the CFM cart caster wheels locked during use to prevent the CFM 6000 from pulling
on the electrode connections.
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
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.
OLYMPIC CFM 6000 Operator’s Manual 7
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