Service Manual
58 Pages
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Page 1
Service Manual OLYMPIC CFM™ 6000 with Version 2 software
CAUTION
Read and be familiar with this manual before installing, maintaining, or servicing this device.
To ensure operator, technician, and patient safety, perform procedures only as specified in this manual.
600008-OL Rev. B DCN: 08-0103
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 Fax: Web:
+44.161.903.9787 www.mdqaconsultancy.co.uk
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 ©2003–2009 Natus Medical Incorporated. Copyright © 2009 Natus Medical Incorporated. All rights reserved. Olympic CFM™ 6000 Service Manual, 600008-OL Rev. B
0086
Natus Medical Incorporated has declared that this product conforms with the European Council Directive 93/ 42/EEC Medical Device Directive (MDD) when it is used in accordance with the instructions provided in the Olympic CFM 6000 Operator’s Manual.
Contents Section 1
Overview... 1-1 Conventions and Symbols... 1-1 Warnings and Cautions... 1-2 System Overview... 1-3
Section 2
Before First Use... 2-1 Testing the Device... 2-2
Section 3
Maintenance... 3-1 Cleaning the Device and Its Accessories... 3-1 Cleaning the Vents and Fan... 3-2 Replacing the Paper Roll... 3-2 Replacing the Fuses... 3-3 Maintaining the Hard Drive... 3-4 Updating and Installing Software... 3-4 Removing Data... 3-5 Changing System Settings... 3-7 Changing the Standard Markers... 3-7 Changing the Display Settings... 3-7 Changing the System Date/Time... 3-8 Adjusting the Alarm Volume... 3-8 Calibration... 3-9 Calibrating the Touch Screen... 3-9 Performing Safety Inspections... 3-9 Visual Inspection... 3-10 Electrical Safety Testing and Measurements... 3-10
Section 4
Troubleshooting... 4-1 Technical Support... 4-3
Section 5
Service... 5-1 Service and Repair Policy... 5-1 Repairing the Device... 5-2 Removing the Back Cover... 5-2 Replacing the Back Cover... 5-4 Replacing the Fan Assembly... 5-5 Replacing the CD-RW Drive and/or Hard Drive... 5-6 Replacing the Power Supply Assembly... 5-8 OLYMPIC CFM 6000 Service Manual
i
Replacing the Speaker... 5-10 Replacing the Ferrite Filter... 5-11 Replacing the Internal Printer... 5-15 Replacing the Printer Door... 5-17 Compressing and Saving Large Files to CD (for version 1.x before upgrading to version 2.0)... 5-19 Repairing the Amplifier Module... 5-21 Repairing the CFM Cart... 5-21 Returning the Device for Service... 5-21
Section 6
Replacement Parts... 6-1 Ordering Information... 6-1 Parts List... 6-1
Section 7
Specifications... 7-1 Electromagnetic Specifications – Manufacturer’s Declaration... 7-3 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the CFM 6000... 7-5
OLYMPIC CFM 6000 Service Manual
ii
Section
1 Overview This manual provides the necessary information to install, maintain, and service the Olympic CFM™ 6000. It is intended for use by qualified service technicians such as biomedical technicians and Natus Medical–approved technicians.
#
For instructions on using the CFM 6000, refer to the Olympic CFM 6000 Operator’s Manual.
For guidance on interpreting recordings, refer to the Olympic CFM 6000 Clinical Guide.
For instructions on using and maintaining the CFM Cart, refer to the Olympic CFM 6000 Operator’s Manual.
NOTE
Conventions and Symbols Table 1.1 describes the conventions used in this manual. Table 1.1
Conventions
Convention
#
Description Notes provide additional information to clarify a point in the text.
NOTE
Cautions indicate situations that, if not avoided, could result in minor to moderate injury to the patient or operator or damage to the equipment. CAUTION
Warnings indicate situations that, if not avoided, could result in serious injury or death to the patient or operator. WARNING
#
BUTTON
This character style represents buttons and controls that the user can touch or press.
text
This character style represents user-entered text. Text entry at the command line is case sensitive (i.e., the system is Linux-based).
For a list of symbols used on the CFM 6000 and its accessories, refer to the Olympic CFM 6000 Operator’s Manual.
For a list of symbols used on the CFM Cart, refer to the Olympic CFM Cart Instruction Manual.
NOTE
OLYMPIC CFM 6000 Service Manual
1-1
Warnings and Cautions
Warnings and Cautions The following are general warnings and cautions that apply to the CFM 6000. Additional warnings and cautions, as they apply to specific content, are provided throughout this manual.
WARNING
Electrical Grounding: Always connect the system power cord directly to a hospital-grade grounded power receptacle with a functional ground. Never use a non-ground plug adapter to connect primary power to the system. Use of a non-ground adapter disconnects the utility ground, creating a severe shock hazard. Never alter or cut the instrument plug as this causes instrument damage and a shock hazard. Internal Voltage: To avoid electrical shock hazard, always turn off the CFM 6000 and unplug its power cord before cleaning or disassembling the device.
Liquids and 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.
CAUTION
Explosion hazard. Do not use in the presence of flammable anesthetics.
Operation: Only properly trained medical and service personnel should install, operate, maintain, and service this device. 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.
Service: Only technically qualified personnel should perform service procedures.
To assure ground integrity, secure all washers and ground wires when reassembling this device.
Printed circuit boards (PCBs) contain static-sensitive parts. Always use appropriate electrostatic discharge protection, such as an electrical-grounding wrist strap, when working with interior components.
USB Devices: To meet electrical safety requirements, USB devices used with the CFM 6000 must meet the requirements of IEC 60601-1. Alternately, if the line connected device is approved to an appropriate national standard other than 60601-1, a separation device must be used (refer to IEC 60601-1-1).
1-2
OLYMPIC CFM 6000 Service Manual
System Overview
System Overview The Olympic CFM 6000 is easy to operate. To set-up and start collecting patient data, the user simply: 1
Plugs in and turns on the device (see Figure 1.1),
2
Connects the amplifier module to the device (see Figure 1.2),
3
Connects the electrode leads to the amplifier module (see Figure 1.3) and the patient’s head, and
4
Starts the recording.
The clinician then monitors, reviews, and interprets the recording to determine the state of the patient’s brain activity. The CFM 6000 records a single channel of EEG. First, the signal is filtered, compressed, and rectified. Then, the range of amplitude of the signal, in microvolts (µV), displays in the CFM area of the screen (see Figure 1.2). Frequencies of less than 2 Hz and greater than 20 Hz are selectively filtered to reduce artifacts caused by patient movement, electrocardiogram (ECG), and other electronic equipment. The signal is recorded from two electrodes that are placed on the patient’s head; a third electrode acts as a ground. Figure 1.1
CFM 6000 back
a
a Handle: use to carry the CFM 6000 b Power cord receptacle: connects the CFM 6000 to a hospital-grade electrical outlet via power cord c Power on/off switch: turns the CFM 6000 mains power ON (|) or OFF (O) d Fuses e Serial in/out (I/O) port: for future use f
Keyboard port
g Mouse port: for service use only h USB port: for future use; shown with cover in place (see the USB port precautions on page 1-2) b
c
d
f
g
h
i
j
e
OLYMPIC CFM 6000 Service Manual
i
Network/Ethernet port: for future use
j
Equipotential ground
1-3
System Overview
Figure 1.2
CFM 6000 front
PLAYBACK
RECORDING
LEADS OFF
CFM
CFM area
IMPEDANCE
Touch screen Impedance / EEG area Record
Marker
EEG
Patient
Tools
Amplifier module receptacle
Printer door (shown with paper)
Feet (x4) CD door Amplifier module Plug electrode lead connectors into these receptacles (refer to the label and the Olympic CFM 6000 Operator’s Manual)
Figure 1.3
Amplifier module with electrodes
Amplifier module
Electrodes with touch-proof connectors (hydrogel electrodes shown) Plugs into the amplifier module port on the CFM 6000
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OLYMPIC CFM 6000 Service Manual
Section
2 Before First Use The CFM 6000 requires minimal handling during unpacking and installation.
#
NOTE
For information on unpacking the cart, refer to the Olympic CFM Cart Instruction Manual.
When unpacking the CFM 6000 verify that:
Seals cover the two bottom screws on the back cover. If the seals are missing the device may have been tampered with during shipping, such as during customs inspection; contact Natus Medical Incorporated.
The following items are included:
CFM 6000
Roll of printer paper
Power cord
Hydrogel electrodes
Amplifier module
Skin prep gel
Figure 2.1
Seals cover two bottom screws
Seals cover the bottom screws (x2)
To setup the CFM 6000:
#
NOTE
For information on mounting the CFM 6000 to the Olympic CFM Cart, refer to the Olympic CFM Cart Instruction Manual.
1
Place the CFM 6000 on a stable surface.
2
Remove the protective plastic sheet from the touch screen. OLYMPIC CFM 6000 Service Manual
2-1
Testing the Device
3
Connect the power cord to the device, then plug it into an appropriate hospitalgrade electrical outlet.
4
Perform the test procedure (see Testing the Device on page 2-2).
Testing the Device Perform the following test before using the device after installation or service. After servicing the device, a qualified biomedical engineer or technician should perform electrical safety tests. To verify that the CFM 6000 is ready for use: 1
2
#
NOTE
2-2
Plug in the power cord, then press the power switch to the ON (|) position. Verify the following:
The Olympic Medical splash screen briefly appears, followed by the main user-interface screen.
An audible beep sounds, indicating that the speaker is operational.
Verify that the controls and indicators function as stated in the Olympic CFM 6000 Operator’s Manual.
If the device does not operate as expected, consult Table 4.1, Troubleshooting Chart, on page 4-1.
3
Verify that the correct date and time are shown in the upper-right corner of the screen. Correct the time if applicable (see Changing the System Date/Time on page 3-8).
4
Turn off the device.
OLYMPIC CFM 6000 Service Manual
Section
3 Maintenance #
NOTE
CAUTION
WARNING
To prevent contamination, perform cleanup procedures after each use.
For instructions on cleaning the cart, refer to the Olympic CFM Cart Instruction Manual.
Only qualified technicians should maintain the CFM 6000.
Use only mild cleaning detergents; other cleaning agents may damage the exterior of the CFM 6000. Dilute cleaning agents according to their instructions.
Never autoclave the CFM 6000, its amplifier module, or other components as doing so will cause damage and void the warranty.
To avoid damage to internal electronics and wiring, do not allow liquids to enter the CFM 6000 enclosure or its vents.
To avoid electrical shock hazard, always turn off the power and unplug the device prior to cleaning the device.
Cleaning the Device and Its Accessories Required Items:
Soft cloth
Mild cleaning detergent (e.g., Virex™ Tb, Virustat®, Coverage®)
Disinfectant (e.g., Sporicidin®)
To clean the CFM 6000: 1
Press the power switch to the OFF (O) position, then unplug the power cord.
2
Using a soft cloth dampened with mild detergent, wipe the exterior of the CFM 6000, including the touch screen and power cable.
3
Using a soft cloth dampened with Sporicidin or similar disinfectant, wipe the exterior of the amplifier module and its cord, as well as the touch screen, to disinfect.
OLYMPIC CFM 6000 Service Manual
3-1
Cleaning the Vents and Fan
Cleaning the Vents and Fan Periodically check the fan inside the CFM cover and the vents on either side of the device for accumulation of debris, such as dust and lint. Required Items:
Can of compressed air or vacuum cleaner
To prevent air blockage that may cause overheating: 1
Remove the back cover (see page 5-2).
2
Blow the debris from the device using a can of compressed air, or vacuum the debris from the device.
3
Reattach the back cover (see page 5-4).
Replacing the Paper Roll Required Items:
Roll of thermal paper, 50-mm wide (part no. 62066)
To replace the printer paper: 1
Open the service access door on the front of the device (see Figure 3.1).
2
Press the bottom of the black switch to open the printer door.
3
Place the paper in the printer enclosure. With the paper feeding from the bottom, ensure that it is over the roller and slides down through the slot in the service access door.
4
Close the printer door, then close the service access door.
Figure 3.1
Replacing the printer paper
2 2
Printer door Service access door
3
1 Roller Slot
3-2
OLYMPIC CFM 6000 Service Manual
4
Replacing the Fuses
Replacing the Fuses If the device does not function when the power cord is plugged in and the power is turned on, an internal fuse may be blown. Required Items:
Flat-head screwdriver
Replacement fuses (part no. 200021)
To remove the fuses: 1
Press the power switch to the OFF (O) position, then unplug the power cord.
2
Place the tip of the flat-head screwdriver under the tab next to the power switch, then gently pry the fuse door open.
3
Remove the fuse block from the device.
4
To remove either fuse, place the screwdriver tip between the end of the fuse holder and the power switch and carefully pull out the holder.
Figure 3.2
Replacing the fuse
Using a flat-head screwdriver, gently pry the fuse door open
To install the new fuse:
CAUTION
For protection against fire hazard, replace only with the correct type and rating of fuse (part no. 200021).
1
Place the replacement fuses into the fuse block.
2
Slide the fuse block back into the device, then close the fuse door.
3
Perform the test procedure (see Testing the Device on page 2-2).
OLYMPIC CFM 6000 Service Manual
3-3
Maintaining the Hard Drive
Maintaining the Hard Drive Updating and Installing Software Natus Medical Incorporated periodically releases software updates for the CFM 6000.
CAUTION
Archive patient data to CD-R before installing software. Installation will overwrite the device’s operating system, including patient files that reside on the hard drive. When updating software, archiving patient files is not necessary but is recommended.
To identify the software version on your CFM 6000: Version 1.8 1
Touch TOOLS, then touch ABOUT CFM. The About CFM window displays, stating the version and build of software that is currently installed on your device.
2
Touch OK to close the message box.
Version 2.0 1
Touch
, then touch ABOUT CFM.
2
Touch
.
To update software:
#
NOTE
Stop recording before updating software.
Back up all data before installing version 2.0.
When 2.0 installs, a touch screen calibration will appear. Users should use a stylus and carefully touch the center of the circles.
Version 1.8 to Version 2.0 1
Touch TOOLS, and then touch UPDATE. The Update message appears and the CD tray opens.
3-4
2
Insert the installation CD in the tray, and manually close the tray. With the CD in the tray, cycle the power off and on.
3
Touch INSTALL, and follow the on-screen instructions. The system installs the software and restarts.
4
A touch screen calibration screen appears. Use a stylus to carefully touch the center of the circles.
5
Cycle the power off and on once again.
OLYMPIC CFM 6000 Service Manual
Maintaining the Hard Drive
Version 2.0 to Version 2.X
CAUTION
1
Touch TOOLS, then SYSTEM, and then S/W UPDATES.
2
Touch OPEN TRAY. Place the installation CD in the tray, and touch CLOSE TRAY.
3
Touch START UPDATE.
4
Touch either INSTALL or UPGRADE, and follow the on-screen instructions.
Remove the CD when done. Rebooting with the Install/Update CD in place will restart upgrade/install operation.
5
A touch screen calibration screen appears. Use a stylus to carefully touch the center of the circles.
6
Cycle the power off and on once again.
To install the operating system and software on a new hard drive: 1
Manually open the CD tray.
2
Insert the CD, then manually close the tray.
3
Turn the power on, then select INSTALL. The system installs the software and restarts. The software install takes several minutes to finalize after restarting.
4
A touch screen calibration screen appears. Use a stylus to carefully touch the center of the circles.
5
Cycle the power off and on once again.
Removing Data You can archive and delete files (remove data), as needed, to assure adequate disk space is available. To delete patient files: 1
Touch TOOLS, FILES.
2
Touch file(s) to delete, then touch DELETE. The display will confirm the number of session to delete.
3
Touch OK to delete the listed files.
OLYMPIC CFM 6000 Service Manual
3-5
Maintaining the Hard Drive
Figure 3.3
Confirming the files to be deleted, version 2.0 Tools Files
Delete 1 session?
Restore
1. <Filename>
Settings
OK Cancel
4
3-6
When done, touch
to close the window.
OLYMPIC CFM 6000 Service Manual
Changing System Settings
Changing System Settings Changing the Standard Markers Standard markers can be customized to better meet the needs of your clinical staff. To change the standard markers:
#
1
Touch TOOLS, then SETTINGS, then MARKERS.
2
Touch the MARKER field to change, then type the new event name up to 11 characters.
3
Touch ACCEPT.
4
Touch
The changes made become the standard default markers, which are selectable when in Marker mode. For information on Marker mode and placing markers, refer to the Olympic CFM 6000 Operator’s Manual.
Changing the standard marker settings does not change the previously applied markers on any patient files.
Markers are limited to 11 characters.
5
Repeat steps 2 through 4 for each marker to be modified.
6
Touch
NOTE
.
.
Changing the Display Settings A CFM tracing is created by the continuous up and down movement of a digital pen responding to subtle variations in a brain's electrocortical activity. A tracing rises in response to increased activity and drops in response to lowered activity according to a fixed algorithm. With the pen moving at a very slow rate accross the screen, 1 pixel width of CFM tracing reflects about 15 seconds of data. Previous versions of the Olympic CFM 6000 offered only one view, using the CFM Basic algorithm. Here, the CFM creates a series of vertical lines of different lengths, each of uniform density. This view shows no variation in the color of the 'ink.' Version 2.0 introduces a new and more senstitive algorithm, CFM Insight. Each vertical line is now of variable density reflecting the relative amount of time the brain spends at different levels of electrical activity. Sometimes these two views are nearly identical; in other cases, Insight provides a clear "grayscale" effect where we see a dark central band of activity surrounded by lighter bands of activity above or below. This can be a valuable aid in identifying artefacts and can help more clearly identify certain conditions. The CFM 6000 now offers both views and the capabilty to toggle back and forth. To change the display settings: 1
Touch TOOLS, then SETTINGS, then DISPLAY.
2
Touch selection:
3
Dark on light: Insight or basic
Light on dark :Insight or basic
Touch
. OLYMPIC CFM 6000 Service Manual
3-7
Changing System Settings
Changing the System Date/Time When you first receive your CFM 6000, you may need to change the system date and time. The system date and time displays in the upper-right corner of the screen (see Figure 1.2 on page 1-4) and is used to date/time stamp recordings and markers. To change the system date and/or time: 1
Touch TOOLS, then SETTINGS, then DATE/TIME.
2
Touch the DATE button, touch to change the year and month, then touch the day on the calendar. Touch ACCEPT.
3
Touch the TIME button, touch the scrollbars and Touch ACCEPT.
4
Touch the TIME ZONE button, and adjust with the zone.
5
Touch to select/deselect daylight savings time as needed. Touch ACCEPT.
6
Touch date format-US/Canada MM/DD/YY or European DD.MM.YY.
7
Touch
to change the time. buttons to select your
.
Adjusting the Alarm Volume Adjust the alarm if it is too loud or too soft. Required Items:
Phillips-head screwdriver, #1
Electrical-grounding wrist strap
To adjust the alarm volume: 1
Remove the back cover from the CFM 6000 (see Removing the Back Cover on page 5-2).
Electrical shock hazard. Ensure that the power cord is unplugged before continuing. WARNING
2
3-8
Using the screwdriver, turn the blue screw on the power distribution PCB (see Figure 3.4) fully counterclockwise, then adjust the volume:
For a quiet alarm, turn the blue screw one-quarter turn clockwise.
For a medium alarm, turn the blue screw one-half turn clockwise.
For a loud alarm, turn the blue screw three-quarters to fully clockwise.
OLYMPIC CFM 6000 Service Manual
Calibration
Figure 3.4
Adjusting the alarm volume
Using a screwdriver, adjust the alarm on the power distribution PCB
3
Reattach the back cover to the CFM 6000 (see page 5-4).
4
Test the device for proper operation (see Testing the Device on page 2-2). Verify that the audible level is appropriate; readjust as appropriate.
Calibration The CFM 6000 performs a self-calibration check each time a recording is started.
Calibrating the Touch Screen Screen calibration is only required if the configuration file has been deleted or the hard drive has been changed. Should your touch-screen require calibration, contact Natus Medical Incorporated (see Technical Support on page 4-3).
Performing Safety Inspections Qualified technicians should perform safety inspections on an annual basis or as recommended by your facility’s policies or after any servicing. Devices used frequently should be inspected several times a year. Safety inspections include:
Visual inspection - cord integrity, device exterior and display, accessibility of instruction manual, type of fuses, and dust/lint build up
Electrical safety testing and measurements
OLYMPIC CFM 6000 Service Manual
3-9
Performing Safety Inspections
Visual Inspection
#
Record all safety inspections in the Safety Inspections section of the Medical Device History.
The CFM 6000 has an internal self-check that tests the amplifier module.
NOTE
To visually inspect the CFM 6000:
#
NOTE
1
Examine the amplifier module cord for damage.
2
Examine the power cord for damage.
3
Check the type and value of fuse located in the device (see Replacing the Fuses on page 3-3). Ensure that two internal 3AG 2.5A Slo-Blo 250V~ fuses are in use.
Damage to the amplifier module cord or power cord could be a result of improper storage or use. Replace damaged items before continuing.
4
5
Visually examine the CFM 6000:
Check the device for visual damage (e.g., safety symbols and labels are legible, parts are not broken).
Ensure that the vents are free from obstruction and dust/lint when placed in its operating environment. Remove the cover to ensure that the device is free from dust and lint (see Removing the Back Cover on page 5-2).
If the CFM 6000 is mounted to a movable platform, such as the Olympic CFM Cart, ensure that it is secure.
Plug in the power cord, then press the power switch to the ON (|) position. Verify the following:
An audible beep sounds, indicating that the speaker is operational.
The Olympic Medical splash screens briefly appear, followed by the main user-interface screen.
6
Verify that the instruction manual is near the device.
7
Verify that the controls and indicators function as stated in the Olympic CFM 6000 Operator’s Manual.
Electrical Safety Testing and Measurements The following safety tests meet the standards of, and are performed in accordance with, IEC 60601-1 Amendment 1 and Amendment 2; CAN/CSA C22.2 No. 601.1-M90, Supplement 1, and Amendment 2; and UL 60601-1 for Class 1 and TYPE BF instruments. Applicable tests for these standards are listed below. Technicians must be familiar with the standards that apply to their institution and country. Test equipment and it use must comply with the appropriate standard. Ground Integrity 100 milliohms or less
3-10
OLYMPIC CFM 6000 Service Manual