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OLYMPIC CFM 6000

Operator’s Manual

In Asia and the European Union

Contact your Olympic CFM 6000 distributor.

CFM 6000 Catalog Items

When ordering, provide the item number to the customer service representative.

Table 3

Accessories

Item Description

Catalog Number

Amplifier module clips, bag of 5

62065

Olympic CFM cart

62080

Electrode cream, 3.5-oz. tube

60119

Electrodes, disk (available only in the United States)

60126

Electrodes, low-impedance (needle type): box of 10

62056

Electrodes, low-impedance (needle type): box of 50

62057

Electrodes, hydrogel: bag of 20

62050

Electrodes, hydrogel: box of 100

62051

NuPrep

™

Skin Prep Paste, 4-oz. tube

62060

Paper: thermal, 50-mm wide roll

62066

Publication:

An Atlas of Amplitude-Integrated EEGs in the Newborn

62070

Publication:

Atlas of Neonatal Electroencephalography

62071

Standards and Compliance

Electrical Safety Standards and Classification

European Union Notice (EN) 60601-1-1 / International Electrotechnical Commission
(IEC) 60601-1, Amendments I and II

Canadian Standards Association (CSA) C22.2 No. 60601-1-M90

Underwriters Laboratory (UL) 2601-1

EMI/EMC

IEC 60601-1-2

Regulatory Classification

Food and Drug Administration (FDA), Class II

Health Canada, Therapeutic Products Directorate, Class III

European Union (EU) Medical Device Directive (MDD), Class IIb

Содержание OLYMPIC CFM 6000

Страница 1: ...0175 Operator s Manual OLYMPIC CFM 6000 Version 2 CAUTION Read and be familiar with this manual before operating this device To ensure operator technician and patient safety use only as specified in t...

Страница 2: ......

Страница 3: ...hen 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 w...

Страница 4: ......

Страница 5: ...ned 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 In...

Страница 6: ...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 Info...

Страница 7: ...d 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 oth...

Страница 8: ...perate 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...

Страница 9: ...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 se...

Страница 10: ...bag Single use only discard after use do not sterilize Box of 100 electrode sets five bags of electrodes per box Storage specification Foot activated Temperature Fuse USB port see the USB port precaut...

Страница 11: ...fier 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 us...

Страница 12: ...sembling the CFM cart see Assembling the CFM Cart on page 30 CFM Cart Components The storage drawer provides space for the following CFM 6000 accessories Amplifier module Several packages of electrode...

Страница 13: ...e 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 15 in either direction up down allowing you to easily change t...

Страница 14: ...generally best to observe the record for a longer continuous period The exact length of this period depends on the frequency of the seizures or the condition or treatment being monitored The CFM may r...

Страница 15: ...mplitude on page 20 The following illustration shows a CFM tracing with underlying EEG data Figure 4 CFM tracing with EEG detail Impedance Tracings The impedance tracing indicates the connection quali...

Страница 16: ...ccording to the instructions in Cleaning and Maintenance on page 28 Preparing the Patient Applying Electrodes Required items Electrodes hydrogel or low impedance needle Skin prep gel such as NuPrep br...

Страница 17: ...ient s left of this point right if facing the patient c The YELLOW electrode 3 is to be placed approximately 75 mm to the patient s right of the red electrode left if facing the patient CAUTION Medica...

Страница 18: ...s prepare the areas of contact prior to placement as follows a Apply a small dot of skin prep gel such as NuPrep to each area of contact You can use a 2x2 or 4x4 gauze pad to apply the NuPrep b Vigoro...

Страница 19: ...g Operating the CFM 6000 Understanding the CFM 6000 Screen The following illustration shows the location of major types of information on the CFM 6000 screen Figure 8 Main screen NOTE Read the warning...

Страница 20: ...is reached or drag the scrollbar all the way to the right EEG cursor or marker position Touch to scroll the EEG cursor or a marker cursor backward or forward in 15 second increments Close Touch to cl...

Страница 21: ...rd buttons to edit it 3 Touch ACCEPT to save the change and close the TOOLS window CONNECTION The connection to the CFM 6000 is lost The amplifier module might have come loose Check the connections to...

Страница 22: ...TIME and select the format for the date 3 Touch TIME ZONE to set the time zone relative to Greenwich Mean Time and then touch ACCEPT 4 Touch DAYLIGHT SAVINGS TIME to activate or deactivate Daylight S...

Страница 23: ...ard disk and the tracing is displayed on the screen The default name for the file on the hard disk is cfm followed by the system date and time in the format cfm_mm_dd_yy_hh_mm You can enter a patient...

Страница 24: ...to playback mode To return to the real time display scroll forward to the end of the tracing See Understanding the CFM 6000 Screen on page 13 Place markers on areas of interest See Using Markers on pa...

Страница 25: ...re 9 EEG window The following table describes the buttons and controls you can use to navigate the EEG tracing Button Function EEG cursor position Touch to scroll the EEG cursor backward or forward in...

Страница 26: ...displayed in the EEG tracing To change the EEG speed or amplitude 1 With the EEG tracing displayed touch to enlarge the EEG window and display the available options 2 Select the desired speed in mm s...

Страница 27: ...he session is long it might take several minutes to open To avoid opening multiple files in sequence take care to select a single session from the list Once the session is open and the tracing is disp...

Страница 28: ...eted You can change the marker information directly from the tracing or from a list Tip Since markers cannot be deleted once placed you can use one of the following procedures to notate any markers th...

Страница 29: ...ATIENT and then touch OPEN If OPEN is not available a patient session is already open In this case touch END and then YES to close the current session and then touch PATIENT again to select the sessio...

Страница 30: ...nd time of birth print date and time CFM software version and amplifier module serial number CFM GRAPH EEG GRAPH IMPEDANCE GRAPH MARKER TEXT Includes only the markers and marker text that are displaye...

Страница 31: ...r 4 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 Close the printer door...

Страница 32: ...network Shared with colleagues for diagnosis and other purposes You can remove confidential patient identification on archived files Restored and viewed on a Microsoft Windows computer by using the C...

Страница 33: ...ording the current patient session before deleting files Permanently removing files from the hard disk to free up space is a 2 step process deleting the files and then removing them from the trash To...

Страница 34: ...a soft cloth dampened with mild detergent or disinfectant wipe the CFM cart including the handle foot pedal and both interior and exterior regions of the drawer WARNING To avoid electrical shock hazar...

Страница 35: ...sion 2 0 or later is already installed 1 Touch TOOLS touch SYSTEM and then touch S W UPDATES 2 Touch OPEN TRAY to open the CD tray 3 Place the software disk in the CD tray touch CLOSE TRAY and then to...

Страница 36: ...screws and Allen wrenches 5 32 in and 3 16 in Cart post with handle and drawer assembly To assemble the CFM cart 1 Remove the cart components from the shipping boxes 2 Place the cart post upside down...

Страница 37: ...ng the thumbscrews and ensure that the thumbscrew spacers are not resting on the threads The spacers should spin freely 3 Place the CFM 6000 on the top of the drawer enclosure visually aligning the de...

Страница 38: ...the back of the CFM 6000 b Unscrew the thumbscrew on the back of the drawer on the CFM cart see Figure 17 Select a cord clamp small diameter for a European power cord or larger diameter for a North Am...

Страница 39: ...ition 4 Confirm that the two locking caster wheels lock and unlock see Figure 1 on page 7 Troubleshooting If you have problems when operating the CFM 6000 look in the following table for a solution If...

Страница 40: ...to obtain service contact In the United States and Canada Natus Medical Incorporated Toll free 1 800 308 8684 U S and Canada Phone 1 650 802 0400 international Customer Service Fax 1 650 802 6620 Tec...

Страница 41: ...ogel bag of 20 62050 Electrodes hydrogel box of 100 62051 NuPrep Skin Prep Paste 4 oz tube 62060 Paper thermal 50 mm wide roll 62066 Publication An Atlas of Amplitude Integrated EEGs in the Newborn 62...

Страница 42: ...llowing lengths USB two meters shielded Serial four meters shielded Ethernet five meters Category 5 Note Mouse and keyboard ports are for service use only Printer Paper Thermal paper roll 50 mm wide F...

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