Manual by Cortech V6 EEG
Manual by Cortech V6 EEG
System
Operating Guidelines
Edited by: Lloyd Smith
Cortech Solutions, LLC
[email protected]
A. Consumable supplies
1. Electrolytes for use with active
electrodes
c) Electrolytes to avoid
(1) Abralyt (Easy-Cap GmbH)
Contains unnecessary pumice.
b) 10 cc Luer-Lok syringe
Use with 15 or 16 gauge blunt-tipped needle
c) 12 x 4 (pkg. of 100)
d) 19 x 4 (pkg. of 100)
4. Other consumable items you might
find useful
a) Distilled water
Used with table salt for balancing electrodes and for testing /
troubleshooting. Tap water will suffice for washing and occasional
testing, but distilled water is best for routine electrode balancing.
c) Medical tape
Use 3M M icropore paper tap to hold electrodes or
leads in place or to bundle leads together. Avoid
cloth (Durapore) or transparent (Transpore) tape, as
these tapes leave residues.
d) Disinfectant solution
Below is a list of disinfectant solutions in ascending order of effectiveness
AND ascending order of deleterious effects on electrode materials.
Standard cap layouts for 16, 32 and 64 channels are based on the International
10/20 System. Layouts for 128, 160 and 256 channels have electrode positions
that are radially equidistant from CZ. The electrode position coordinates of
standard ActiveTwo head caps are available from the
www.cortechsolutions.com/Downloads.htm web page.
The images below provide a top view of the 32, 64, 128, 160 and 256 channel
standard head cap layouts.
b) 64 channel layout
C. Active electrodes
1. Pin-type electrodes on ribbon
cable
a) Typical application:
EEG
These electrodes are designed to
be used with the ActiveTwo
electrode holders, especially with a head cap, for measuring EEG.
Standard electrode sets contain 32 active electrodes, and are labeled
according to either 10-20/10-5 positions or arbitrary A1-32, …H1-32
nomenclature.
D. A/D box
1. ActiveTwo User
Manual
See the latest version of the
ActiveTwo User M anual for
detailed specifications and
operating instructions for the
A/D box.
3. Front panel
a) Aux connectors
(1) Left-most
(Aux1) now
carries CMS/DRL
(common)
(ii) Respiration
(iii) Temperature
(a) Microphone
(b) Photocell
(c) Accelerometer
(e) Custom
b) LED indicators
(1) Power (green)
On indicates power is reaching the A/D box from the battery.
c) Speed-mode dial
This dial sets the overall sample-rate and bandwidth of system. The final
sample-rate to file is a function of both the speed-mode and the
Before setting the speed mode, first identify if your A/D box is model
M k1 or Mk2. To do so, see the ‘About ActiView’ tab-page in the
ActiView software, where the model will be identified after the software
has communicated with the system at least once since boot. The rotary
switch can be used to select 8 different speedmodes for the A/D box
(speed-mode 9 is reserved for use as Analog Input Box). Use a small
screwdriver to rotate the switch to the preferred number according to the
table below. After changing the speed-mode, switch the A/D box off and
on again to reset the ADCs. Changing the speed-mode having the power
connected is not harmful to the electronic circuitry, but the
synchronization between channels may be lost.
Note: When an auxiliary analog input box (AIB) is connected, the A/D
box should always be on SpeedM ode 4.
e) Optical output
Fiber optic signal cable from A/D box to optical receiver
4. Top panel
b) Key-shaped two-contact
connectors labeled EX1-
EX8
(1) Each connector
carries one monopolar channel of data
b) Fuse
Replaceable 5 AM P fuse
3. Connections
2. Description
1. Advantages
a) Portability
M akes ActiveTwo completely portable when used with a notebook
computer
b) Flexibility
Programmable logic allows easy changing of number of channels and
sample rate
c) Electrical isolation
Trigger inputs remain galvanically isolated from A/D box, electrodes and
patient
e) Simplifies troubleshooting
LED indicators for data input and output
2. Front-panel
d) Ground on pin 37
Pin 37 carries the system ground. Connect to ground of trigger port of
stimulus computer or ground of other devices connected to trigger port.
Use caution when considering connecting this ground to a device that the
subject will come in contact with (e.g. a button box), as this can
compromise system safety and reduce signal-to-noise ratio of
physiological measurements.
1. Respiration
A Nihon Kohden TR-753T respiration belt is
provided with a cable wired for use with one of
the three available circular DIN connectors on the
ActiveTwo front panel. Strong reliable signals
are produced, because the respiration belt uses the
ActiveTwo system's power supply. An additional
LabVIEW module is delivered with the system
when a respiration belt is ordered.
The version of coupler installed can also be checked by identifying the "physical
dimension" of the “GSR” channel in the header of the BDF file (field 13 of the
header, see http://www.biosemi.com/faq/file_format.htm).
The GSR signal itself is the result of processing in ActiView, and only reflects
(slow) impedance/conductance variations. The original excitation frequency is
not present in the signal. In other words: FTT or any other analysis of the GSR
signal stored in the BDF file will not reveal the underlying 16 or 512 Hz
excitation signals.
The GSR signals to file are not filtered (bandwidth is the anti-aliasing filter
frequency as displayed in the right sidebar). However, the frequency of the
excitation frequency imposes a limit in the maximal frequency of the variations in
impedance/conductance that can be measured. With the 16 Hz GSR, a full wave
of the excitation signal is necessary to calculate a conductance value. This means
that a new GSR value can only appear every half-wave, or every 31.25 ms. At a
2048 Hz sample rate, the BDF file will contain 64 identical samples for each
single GSR value). In other words, the effective sample rate of the GSR is 32 Hz,
and consequently GSR variations faster than 16 Hz are ignored (Nyquist
See the appropriate heading below for further information about the type of unit
you are using.
The LSB value (resolution) is 1 . With the 24-bit ADC, the GSR signal
has an input range of 0 to +262 k. Because ActiveTwo uses a higher
excitation frequency than most stand-alone devices, it measures smaller
absolute skin resistance values. Also, the response on subject's arousal is
an INCREASE in skin resistance, instead of the DECREASE of skin
resistance seen with DC and low frequency (up to approx. 10 Hz)
excitation. However, the response is very reliable: we measure a typical
resting skin resistance of approx. 5 k, with responses of (+) 50-100 ,
and a quick return to the baseline value after when the subject relaxes
again.
Note that the GSR sensor only works in speed modes that allow recording
of sensor channels (i.e. 4, 5, 6, 7 and 8). Remember that if you change the
speed mode, you will need to turn off the power at the battery unit and
turn it on again to let the internal firmware adjust itself to the new speed
mode.
Also, your ActiView CFG file must enable the use of sensors. Since most
systems are sold without GSR measurement capability, the default
configuration files that come with new versions of software contain a code
that disables the sensors. To edit the CFG file, open it in Windows
Notepad, and go to the section entitled [FreeChoice]. Look for the code:
AuxFree=0%
AuxFree=1%
Note that the CM S and DRL electrodes must be attached to the subject
and connected to the system, and the blue “CM in range” light must be on
for GSR measurement to work properly. Also, the green "GSR in range"
lights should be on when GSR electrodes make adequately low impedance
contacts with the subject. Note that the green GSR lights always remain
off if the blue CM light is off. GSR can only be measured with the blue
CM light and the green G SR lights glowing.
Finally, if the GSR signal looks flat after you have made all of the other
settings, it may be that you need to increase the scale of the GSR signal on
the display. There is a scale tool at the left side of the Sensors display
page.
b) 16 Hz SC coupler
The 16 Hz SC circuit in ActiveTwo uses 1 A constant current, 16 Hz
square wave signal that is synchronized with the ActiveTwo system’s
sample rate. The 16 Hz design is intended to make the SC coupler
consistent with traditional SC methodology. Although the 16 Hz
Note that the SC sensor only works in speed modes that allow recording of
sensor channels (i.e. 4, 5, 6, 7 and 8). Remember that if you change the
speed mode, you will need to turn off the power at the battery unit and
turn it on again to let the internal firmware adjust itself to the new speed
mode.
Also, your ActiView CFG file must enable the use of sensors. Since most
systems are sold without SC measurement capability, the default
configuration files that come with new versions of software contain a code
that disables the sensors. To edit the CFG file, open it in Windows
Notepad, and go to the section entitled [FreeChoice]. Look for the code:
AuxFree=0%
AuxFree=1%
Note that the CM S and DRL electrodes must be attached to the subject
and connected to the system, and the blue “CM in range” light must be on
for GSR measurement to work properly. Also, the green "GSR in range"
lights should be on when GSR electrodes make adequately low impedance
contacts with the subject. Note that the green GSR lights always remain
off if the blue CM light is off. GSR can only be measured with the blue
CM light and the green G SR lights glowing.
Finally, if the GSR signal looks flat after you have made all of the other
settings, it may be that you need to increase the scale of the GSR signal on
the display. There is a scale tool at the left side of the Sensors display
page.
3. Temperature
With this high precision temperature sensor from
HP (Agilent 21078A), skin temperatures can be
measured. The temperature sensor directly plugs
into one of the three available circular DIN
connectors on the front panel of the ActiveTwo
A/D Interface Box. An additional LabVIEW
module is delivered with the system when a
temperature sensor is ordered.
4. Pulse / plethysmograph
This Plethysmograph sensor from ADI instruments
(M LT1020) uses an infrared photoelectric sensor
to detect changes in tissue blood volume. The
Plethysmograph sensor directly plugs into the front
of the ActiveTwo. An additional LabVIEW
module is delivered with the system when a
J. ActiView software
ActiveTwo is provided with a free, open-source data
acquisition software program called ActiView.
ActiView is optimized for use with ActiveTwo, and it
provides mechanisms for visualizing and storing
signals from all of the system’s available sensors,
including specialized sensors like the Jazz Synchronic
Vigilance M onitor. The source code is provided so
that 1) users have access at the most basic level to
understand how their data are being treated, and 2)
developers can easily modify the standard application to add specific functionality they
need. ActiView has been developed using National Instruments LabVIEW, so the source
code is provided in the form of LabVIEW llb files, and developers must have access to
LabVIEW to view and modify the source code. See the sections on ActiView Software
Installation and Operating the ActiView Software for detailed instructions on using the
software.
E. Turn on power
Depress the power switch on the battery unit connected to the A/D box.
(c) Sele ct “Include this location in the se arch”, and type the
path to the folde r whe re you place d the drive r or use the
Browse option to locate the folde r.
1. Locate “LVRunTimeEng.exe”
Open Windows Explorer. If you are installing from the CD, then browse to the
BioSemi CD, and find the folder containing the LVRTE self-installer called
“LVRunTimeEng.exe”. If you downloaded ActiView and LVRTE from the
BioSemi web site, then browse to the folder in which you placed the
“LVRunTimeEng.exe.”.
2. Double-click LVRunTimeEng.exe
The LVRTE installation will begin.
“<DriveLetter>:\Program Files\ActiView\<VersionNumber_Resolution>\”
where “<DriveLetter>” is the letter of the drive that contains your existing
Program Files folder and <VersionNumber_Resolution> is the version number of
the ActiView software and resolution (e.g. LoRes). Assuming multiple versions
of ActiView that you want to use rely upon the same version of the LVRTE
(http://www.biosemi.com/download_actiview.htm), you can have multiple
versions of ActiView installed on the PC at once.
Exact names for the .EXE, .INI and .LLB files will differ depending upon which
version of ActiView you chose in the step above.
Note that the .CFG files will be recognized as M icrosoft Office Outlook
configuration files if you have M icrosoft Outlook installed.
Note also that, beginning with version 6.00, CFG files with channel label schemes
matching the 1020 head caps are located in the folder named “Configuring”.
a) Nasion
b) Inion
c) Left preauricular
point (LPA) and right
preauricular point
(RPA)
d) Vertex
(intersection of lines
between nasion/inion
and left/right
preauricular points),
also know as Cz
2. Fit the head cap
1 2 3
e) Measure nasion-to-inion
distance and adjust cap position
from front-to-back
After putting on the cap, measure to be sure
that the vertex electrode is where it should
be. With caps labeled according to the
10/20 or 10/5 system, the vertex electrode
site will be labeled Cz, but in the standard
ActiveTwo 128, 160 and 256 channel head
a) If using SignaGel…
If using SignaGel, remove the plunger from a clean syringe, and inject
approximately 10 ml of gel into the syringe. This is a suitable amount for
about 64 channels. Use less gel if you have fewer channels. Replace the
plunger.
d) Ask the participant whether they feel the gel at the scalp
If the participant does not feel the cold sensation of the gel at the scalp, the
use the tip of the syringe to part the hair (touch the scalp with the tip and
rock gently back-and-forth once or twice) and then inject a small amount
of gel. Ask the participant again if they feel the gel. If so, then proceed to
the next step. If not, then try another location where the hair is less full.
Repeat this until the participant reports feeling the cold sensation of the
gel on the scalp. Use this self-report technique any time you doubt
whether the gel is making contact with the scalp.
4. Then, remove the paper backing from the adhesive ring and
attach to participant
Remove the paper backing and place the electrode where you want it. Note that
when you position the electrode, you will be looking at the label side. Remember
that the electrode contact is at about the junction of the lead wire with the plastic
housing, rather than directly under the label. Following the procedure outlined
here should help remove any excess gel that might otherwise prevent the adhesive
from sticking to the skin.
a) Preparation
(1) Start with clean electrodes
Tarnish on the electrodes may affect the baseline resistance
reading, but it will not affect the ability of the system to measure
changes in skin conductance.
b) SC electrode application
(1) Select an electrolyte to use as a conductive medium.
Skin conductance is best measured using an electrolyte formulated
specifically for skin conductance measurements rather than the
strongly hypertonic solutions generally used for EEG or ECG
measurements. Keep the electrolyte container closed between
uses. Do not use SignaGel or other electrolyte solutions with high
salt concentrations for GSR. One option is to have a local
compounding pharmacist make a batch of electrolyte paste
according to one of the recipes found in:
2. Respiration
The ActiveTwo respiration sensor is a Nihon Kohden TR-
753T respiration belt. Two channels on the ActiveTwo are
modified in order to provide a bipolar signal. Strong
reliable signals are available because the respiration belt
uses the power supply from the ActiveTwo system. The
respiration belt directly plugs into the front of the
3. Temperature
With this high precision temperature sensor from HP
(Agilent 21078A), skin temperatures can be measured. The
temperature sensor directly plugs into the front of the
ActiveTwo.
4. Plethysmograph
This Plethysmograph sensor from ADI instruments
(M LT1020) uses an infrared photoelectric sensor to
detect changes in tissue blood volume. The
Plethysmograph sensor directly plugs into the front of the
ActiveTwo. This sensor can be ordered with a finger clip
(BS-AT-PSF option), with a Velcro strap (BS-AT-PSP
option) or with an ear clip (BS-AT-PSE).
5. Other sensors
Sensors other than those above are generally provided with a connector designed
to plug into a circular DIN jack labeled Ergo1 or Ergo 2 on the front panel of the
A/D box. Regardless of whether these are physiological sensors, it is still
necessary for the CM S and DRL electrodes to be connected to the participant and
for the CM in Range light to be on (indicating the system has a stable common
against which to measure electrical potential) for meaningful signals to be
measured.
D. Turn on the A/D box power and verify the contacts at CMS
and DRL
Once the equipment is connected, depress the power switch on the battery unit connected
to the A/D box and follow the instructions under Electrode Offset below to verify that the
CM S/DRL electrodes are properly connected to the subject and that there are no other
problems that would prevent you from recording meaningful data.
I. Record data
1. Click Start File
Start File is at the lower right side of the M onopolar Display page, and it is
available only while viewing data (see above).
3. Shielded room
An electrically-shielded room often does not produce a noticeable improvement in
the quality of EEG measured with ActiveTwo. Whether it will be helpful depends
on the environment and what type of devices you decide to bring inside of the
shielded room with the participant.
4. Lighting
Lighting in the participant room can be a source of electrical interference and
heat, both of which can be problematic for EEG recording. Special attention
should be paid to selecting light fixtures that provide adequate illumination while
emitting minimum heat. In general, fluorescent lighting produces the greatest
amount of electrical interference. AC incandescent lighting is better, but still
somewhat electrically noisy. The best option for minimizing electrical
interference in a lab environment is low-voltage DC lighting. DC lights normally
use halogen bulbs, which generate more heat than incandescent bulbs, so be
careful to select DC lighting that does not generate excessive heat or compensate
for the extra heat by providing extra AC / ventilation.
5. Ventilation
Ventilation and temperature control are important variables in preparing the
participant room. Be sure that you have adequate temperature control and plenty
of ventilation in the participant room to make the environment comfortable for the
participant. You will get better data from a comfortable participant.
6. Furniture
(2) If the signal starts out noisy but becomes quiet over the
course of 3-5 minutes
This is most likely a sign that the electrodes started out dry and it
took a few minutes for the moisture to penetrate the hard electrode
material. 3-5 minutes of slightly noisy signals when starting out
with dry electrodes is within the expected range of normal
operation. To avoid this initial noisy period, try soaking your
active electrodes in salt water for 5 minutes once a week or for 5
minutes before each recording session. IM PORTANT: Soaking
active electrodes in any liquid for longer than 10 minutes at a time
is inadvisable as moisture will penetrate the electrode pellets and
accelerate corrosion (loss of electrode material), resulting in poor
electrode performance.
i) Observe/record signal
Observe the signal on the connected channels over the course of 1-2
minutes. To determine whether the system is measuring the same voltage
across channels, save the data to a file and review it in your preferred
analysis software tool.
c) Dry flat.
Dry your head caps flat on a towel to avoid stretching.
d) Avoid heat.
Do not use heat to accelerate drying. A cool fan will accelerate drying
considerably.
d) Unstable offsets
Have the participant move her head back and forth a few times to ensure
that the contacts are stable even during rapid movements.
a) High 60 Hz interference
ActiveTwo Operating Guidelines Page - 62
Rev. 6, Printed: January 31, 2007
60 Hz is identifiable by the periodic envelope that results from the fact
that the display does not have adequate horizontal resolution to display the
high-frequency signal.
b) Low-frequency instability
Low-frequency instability can result from poor electrode contacts
(inadequate contact between gel/skin/electrode), but it can also be caused
by aged electrodes from which too much Chloride has been lost. Use the
one-bucket test above to distinguish between the two.
6. Select Edit->Channels
Scroll to the bottom of the list.
C. EDF vs BDF
In fact, the only substantive difference between BDF and EDF files is the fact that the
EDF data files have 16 bits per data sample and the BDF data files have 24 bits per data
sample.
1. EMSE Suite
2. BESA
3. g.BSanalyze
4. EEGLAB
5. BIOSIG
a) EOG (electrooculogram)
There are a few different reasons why one would want to measure EOG in
combination with EEG:
b) ECG (electrocardiogram)
(1) Monitoring heart-rate as a dependent variable or for
trial selection/rejection
M ost often, ECG would be combined with EEG to permit
monitoring of heart-rate on a moment-by-moment basis for
purposes of trial selection/rejection or categorization. For this
purpose, one may be better-off using a version of ActiView (i.e.
BETA release of ActiView 5.35B) that calculates heart-rate on-line
from EXG7-EXG8 and saves it in the Sensor channel named
Ergo1. Strangely enough, even with all of the fancy algorithms
they incorporate, EEG signal analysis tools generally do not
incorporate mechanisms that can easily derive heart rate from an
ECG signal.
c) EMG (electromyogram)
EM G signals are typically recorded from a bipolar pair of electrodes
placed over the muscle group of interest.
c) Temperature
Only a few customers are using our temperature sensor, but generally they
seem to be interested in sleep and circadian rhythms. In combination with
EEG, temperature would most-likely be used for segment
selection/rejection or categorization. This could be accomplished in
EM SE Suite, BESA, g.BSanalyze and EEGLAB.
d) Plethysmograph
Although the signal looks entirely different, the Pleth signal would be used
for the same primary purpose as ECG: derivation of heart-rate for
selection/rejection/categorization of data segments or trials.
3. Reference
EEGLAB knows that ActiveTwo data are stored unreferenced, so it wants the
operator to say which channel should be used to rereference the data. Enter a
channel number and click OK.
B. Handling
1. Remove electrodes from cap and connector from A/D box
gently
Do not use force on the cable or pull the electrodes at the ribbon cable when
removing the electrode out of the head cap or the connector out of the A/D box.
3. Connector ejectors
The A/D box has ejectors on the top for easy removal of the connector. Always
make sure to use them.
C. Cleaning
The silver/silver-chloride (AgA gCl) sintered electrodes behave like sponges, they absorb
water and electrode gel. The deeper the water/gel has penetrated the electrode, the longer
it will take afterwards for the water to vaporize. As long as your electrodes are ‘wet’,
corrosion processes will take place. This corrosion process will in the long run make your
electrodes noisier. That is why it is important to clean the electrodes immediately after
use and dry them immediately to eliminate the opportunity for corrosion to develop.
4. No soap
Only use soap if water does not seem to clean the electrodes properly, never use
solvents (e.g. acetone), acids or alkaline.
E. Malfunctions
1. If an electrode is not operating as specified, please do the
following:
(1) If this causes the blue led to turn off, then the electrode
set is in need of repair (return to dealer/manufacturer)
2. Battery type
Standard battery is high-capacity, rechargeable, lead-acid type with no memory
effect.
5. Useful life
Useful life defined as over 1000 charge/recharge cycles.
6. Charge time
Fully-depleted standard battery with full capacity will take approximately 3.5
hours to charge.
7. Reduced capacity
Reduced charge time reflects diminished capacity.
2. Overcharging
It is not possible to overcharge using the standard charger.
3. Diminished capacity
If capacity is significantly diminished (charge time less than 3 hours), cycle
battery fully 3-5 times by charging/discharging/charging until capacity (charge
time) increases to normal.
4. Storage
Never store a fully-depleted battery; store only fully charged.
7. When to recharge
Connect battery to charger after using approximately 75% of capacity.
8. Battery meter
See meter in ActiView for current battery state or place on charger when Low
Battery LED comes on.
If the bottom of the screen is cut-off, or you see only a blue-gray screen without any
controls at left, right, top or bottom, try changing the video display mode to
accommodate the number of lines (900, 1024 or 1200) required by the chosen version of
ActiView.
a) Go to Control Panel
Go to Start->Control Panel (or Start->Settings->Control Panel when
operating in Classic Start M enu mode).
b) Select Display
In the Control Panel, select Appearance->Themes->Display (or select
Display when operating in Classic Control Panel mode).
(2) If the signal starts out noisy but becomes quiet over the
course of 3-5 minutes
This is most likely a sign that the electrodes started out dry and it
took a few minutes for the moisture to penetrate the hard electrode
material. 3-5 minutes of slightly noisy signals when starting out
with dry electrodes is within the expected range of normal
operation. To avoid this initial noisy period, try soaking your
active electrodes in salt water for 5 minutes before each recording
session. IM PORTANT: Soaking active electrodes in any liquid for
1. Possible causes
1. Options that are set in ActiView and saved in the text .CFG
file
The entries in the sections listed below are best set within ActiView by using the
interactive menus. The purposes of these entries are mostly apparent from their
names.
a) [Selectors]
b) [FreeChoice]
c) [TCP]
2. Options that you may want to adjust in the text .CFG file
(underlined below)
Note that any entry not underlined below is inadvisable to change by editing the
text .CFG file.
a) [System]
Warning=0
M otherboard=12
ElecGain="0....................................//0: 31.25nV/bit, 1: 125nV/bit."
AIBGain="1....................................//0: 31.25nV/bit, 1: 125nV/bit."
RespSwitch="0...........//0: standard ergo, 1: ergo 1 and 2 coupled to
trigger 9 and 10 (for response switches)."
LineWidth="1 .................................................//1 to 5, thin to thick"
Cursor="0..........................................................................................
....................................... //0: LabVIEW cursor, 1: Windows cursor"
b) [Labels]
(For the entries below, be careful to change only the text to the right of the
equal sign! Keep labels to four characters or less for convenience of data
display.)
Chan1=Fp1
Chan2=AF7
Chan3=AF3
…
c) [Save]
Subset=6
Touchproofs=1
Sensors=0
Jazz=1
Anas=1
SaveBox=15
PauseOff="-1................................//-1 is disabled, 0-255 is enabled"
PauseOn="-1................................//-1 is disabled, 0-255 is enabled"
SavePath=c:\BDFdata\Testdata.bdf
http://0-www.cdc.gov.mill1.sjlibrary.org/ncidod/dhqp/bp_sterilization_medDevices.html
The following principles are applicable to most questions CDC receives about sterilization or
disinfection of patient-care equipment. However, these statements are not comprehensive.
General Principles
1. In general, reusable medical devices or patient-care equipment that enters normally sterile
tissue or the vascular system or through which blood flows should be sterilized before
each use. Sterilization means the use of a physical or chemical procedure to destroy all
microbial life, including highly resistant bacterial endospores. The major sterilizing
agents used in hospitals are a) moist heat by steam autoclaving, b) ethylene oxide gas,
and c) dry heat. However, there are a variety of chemical germicides (sterilants) that have
been used for purposes of reprocessing reusable heat-sensitive medical devices and
appear to be effective when used appropriately, i.e., according to manufacturer's
instructions. These chemicals are rarely used for sterilization, but appear to be effective
for high-level disinfection of medical devices that come into contact with mucous
membranes during use (e.g., flexible fiberoptic endoscopes).
2. Disinfection means the use of a chemical procedure that eliminates virtually all
recognized pathogenic microorganisms but not necessarily all microbial forms (e.g.,
bacterial endospores) on inanimate objects. There are three levels of disinfection: high,
intermediate, and low. High-level disinfection kills all organisms, except high levels of
bacterial spores, and is effected with a chemical germicide cleared for marketing as a
sterilant by the Food and Drug Administration. Intermediate-level disinfection kills
mycobacteria, most viruses, and bacteria with a chemical germicide registered as a
"tuberculocide" by the Environmental Protection Agency (EPA). Low-level disinfection
kills some viruses and bacteria with a chemical germicide registered as a hospital
disinfectant by the EPA.
3. Heat stable reusable medical devices that enter the blood stream or enter normally sterile
tissue should always be reprocessed using heat-based methods of sterilization (e.g., steam
autoclave or dry heat oven).
4. Laparoscopic or arthroscopic telescopes (optic portions of the endoscopic set) should be
subjected to a sterilization procedure before each use; if this is not feasible, they should
receive high-level disinfection. Heat stable accessories to the endoscopic set (e.g., trocars,
operative instruments) should be sterilized by heat-based methods (e.g., steam autoclave
or dry heat oven).
Exceptional circumstances that require noncritical items to be either dedicated to one patient or
patient cohort, or subjected to low-level disinfection between patient uses are those involving:
If you have questions about a low- or intermediate-level disinfectant and certain sterilants,
contact the manufacturer, or the Antimicrobial Program Branch, Environmental Protection
Agency (EPA) hotline (703) 308-0127 or email: [email protected]. The EPA is the
federal regulatory agency for low- or intermediate-level disinfectants and some sterilants.
If you have questions about high-level disinfectants (sterilants), or how to clean, disinfect or
sterilize a particular medical device, first contact the manufacturer of the product. If you are
unable to obtain sufficient information in this manner, contact the Food and Drug Administration
(FDA) regional office or the FDA Center for Devices and Radiological Health at (301) 443-
4690. FDA is the federal regulatory agency for safe and effective use of medical devices and is
now also responsible for regulation of chemical sterilants.