Stryker SERFAS User manual

5900 Optical Court, San Jose, CA 95138
APPROVALS DATE TITLE
DRAWN
A. Infanger 7/21/03
ORIGINATOR
A. Infanger 7/18/03
DOC. CONTROL
W. Hu 7/22/03 SIZE DOCUMENT NO. SHEET OF
A
1000
-
400
-
433
1
35
REVISIONS REVISIONS
LTR ECN NO. DATE APPROVED LTR ECN NO. DATE APPROVED
F 22464 9/10/02 A. Infanger
G 24214 12/19/02 A. Infanger
H 25909 07/21/03 A. Infanger
SERFAS User Manual

(Stryker Endoscopy Radio Frequency Ablation System)
USER MANUAL

I. INDICATIONS/CONTRAINDICATIONS ........................................................................................ 1
II. WARNINGS AND CAUTIONS ....................................................................................................... 2
User and Patient Safety............................................................................................................. 2
Operator Qualification ............................................................................................................... 3
General Warnings and Cautions ................................................................................................ 3
III. PRODUCT DESCRIPTION AND USE .......................................................................................... 4
RF Generator ............................................................................................................................ 4
Disposable Probes .................................................................................................................... 7
Footswitch ................................................................................................................................. 7
Handpiece Cable ....................................................................................................................... 7
IV. SETUP AND INTERCONNECT SECTION ................................................................................... 8
Initial Set-up of RF Generator .................................................................................................... 8
Connecting System Accessories .............................................................................................. 8
V. INSTRUCTIONS FOR USE ......................................................................................................... 10
Modes of Operation ................................................................................................................. 10
Volume Adjustment .................................................................................................................. 11
Tone/Voice Selection ............................................................................................................... 11
Changing Probes During Surgery ........................................................................................... 12
Recommendations During Surgery ......................................................................................... 12
After Surgery ........................................................................................................................... 13
VI. CLEANING AND STERILIZATION ............................................................................................. 14
RF Generator .......................................................................................................................... 14
Footswitch ............................................................................................................................... 14
Probes ..................................................................................................................................... 14
Handpiece Cable ..................................................................................................................... 14
Equipment Disposal Guidelines .............................................................................................. 16
VII. ERROR CODES AND TROUBLESHOOTING GUIDE .............................................................. 17
VIII. TECHNICAL SPECIFICATIONS ................................................................................................. 19
IX. PRODUCT CLASSIFICATIONS .................................................................................................. 21
X. MAINTENANCE ........................................................................................................................... 22
XI. SERVICE AND CLAIMS .............................................................................................................. 23
Service .................................................................................................................................... 23
Other Service .......................................................................................................................... 24
XII. WARRANTY ................................................................................................................................. 26
APPENDIX A......................................................................................................................................... 27
APPENDIX B......................................................................................................................................... 28
APPENDIX C......................................................................................................................................... 29
TABLE OF CONTENTS

INDICAINDICA
INDICAINDICA
INDICATIONS:TIONS:
TIONS:TIONS:
TIONS:
SERFAS is designed and intended to be used in the resection, ablation and excision of soft tissue, and hemostasis of
blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, elbow, hip, and wrist. This
system is intended to be used with conductive irrigants such as, saline or Ringer’s lactate.
CONTRAINDICACONTRAINDICA
CONTRAINDICACONTRAINDICA
CONTRAINDICATIONS:TIONS:
TIONS:TIONS:
TIONS:
SERFAS is contraindicated in any surgical procedure where saline, Ringer’s lactate or other conductive solution is not
used as an irrigant. The system is not appropriate for use in patients for whom an arthroscopic procedure is contraindi-
cated for any reason. SERFAS is contraindicated in patients with heart pacemakers and other electronic device
implants.
INDICATIONS/CONTRAINDICATIONS
1

Please read this entire manual as well as all user inserts for associated components and follow their instructions
carefully. The words WARNING, CAUTION, and NOTE are followed by important information and should be carefully
reviewed.
WARNING: The personal safety of the patient may be involved. Disregarding this information could result in
injury to the patient.
CAUTION: Special service procedures or precautions must be followed to avoid damaging the instrument.
NOTE: Special information to make maintenance easier or important information clearer.
A lightning bolt within a triangle is intended to warn of the presence of hazardous voltage. Refer all
service to authorized personnel.
USERUSER
USERUSER
USER AND PAND P
AND PAND P
AND PAA
AA
ATIENT SAFETYTIENT SAFETY
TIENT SAFETYTIENT SAFETY
TIENT SAFETY
WARNINGS:
●Do not use this device in the presence of flammable anesthetics; other flammable gases; near flammable fluids
such as skin prepping agents and tinctures; flammable objects; or with oxidizing agents. Observe appropriate fire
precautions at all times.
●Do not use this device in oxygen enriched atmospheres, nitrous oxide (N2O) atmospheres, or in the presence of
other oxidizing agents to prevent risk of explosion. Ensure that oxygen connections are not leaking.
●Electrosurgical components, such as the probe, may remain hot after activation. Keep all electrosurgical
equipment away from flammable materials to avoid combustion.
●Use only conductive irrigants such as, saline or Ringer’s lactate in order for system to function.
●Do not allow the patient to come into direct contact with grounded metal objects, such as a surgical table frame,
an instrument table, etc. to avoid risk of shock.
●Do not use SERFAS on patients with heart pacemakers or other electronic device implants. Doing so could lead
to electromagnetic interference and possible death.
●Do not activate SERFAS for prolonged or unnecessary lengths of time when not in contact with tissue. Doing so
may lead to unintentional damage to surrounding tissue.
●When SERFAS is activated, the conducted and radiated electrical fields may interfere with other electrical medical
equipment. Provide as much distance as possible between the RF Generator and other electronic equipment.
●Temporarily unused electrodes should be stored in an electrically insulated container. The unused active electrode
should never be placed on the patient to prevent risk of electric shock.
●The output power selected should be as low as possible for the intended purpose to prevent injury to patient.
CAUTIONS:
●Do not activate SERFAS until the probe is properly positioned in the patient.
●Do not touch probe tip at any time during application of power. After electrosurgical current is deactivated, tip
may still remain hot enough to cause burns.
●Do not obstruct the activation light. The activation tone and light are important safety features.
●SERFAS components are designed to be used together as a system. Use only the appropriate SERFAS
Footswitch, Probe and Handpiece Cable with the RF Generator.
●The main power cord of SERFAS must be connected to a properly grounded receptacle. Extension cords and/or
adapter plugs must not be used to prevent risk of electric shock.
WARNINGS AND CAUTIONS
2

WARNINGS AND CAUTIONS
●Be sure that no liquid is present between connections to the RF Generator or Probe. Connection of wet
accessories may lead to electric shock.
●Do not wrap the SERFAS Handpiece Cable around metal objects. Wrapping cables around metal objects may
induce hazardous currents.
●Do not attempt to reuse or resterilize any product labeled “SINGLE USE” as this may lead to malfunctioning
of the equipment, injury to the patient/user, and/or cross contamination.
●Smoke generated during electrosurgical procedures may be harmful to surgical personnel. Take appropriate
precautions by wearing surgical masks or other means of protection.
●The generator should be positioned such that the fan directs the flow of air away from the patient.
OPERAOPERA
OPERAOPERA
OPERATT
TT
TOR QOR Q
OR QOR Q
OR QUU
UU
UALIFICAALIFICA
ALIFICAALIFICA
ALIFICATIONTION
TIONTION
TION
The surgeon using SERFAS should:
●Be a qualified physician, having complete knowledge of the use of this equipment.
●Have current knowledge of technological advances in surgical products and techniques.
●Read this operating manual thoroughly and be familiar with its contents prior to operating the equipment.
●Be sure that the system functions as outlined in this User Manual prior to a surgical procedure. SERFAS was
fully tested at the factory before shipment.
GENERALGENERAL
GENERALGENERAL
GENERAL WW
WW
WARNINGSARNINGS
ARNINGSARNINGS
ARNINGS AND CAAND CA
AND CAAND CA
AND CAUTIONS:UTIONS:
UTIONS:UTIONS:
UTIONS:
TO AVOID POTENTIAL SERIOUS INJURY TO THE USER AND THE PATIENT AND/OR DAMAGE TO THIS DE-
VICE, THE USER MUST:
1. Carefully unpack the unit and check to ensure that all pertinent equipment is accounted for and that no
damage has occurred during shipment. If damage is detected, please see the Service and Claims section in
this manual.
2. Do not remove cover on SERFAS Generator to avoid electric shock and damage to the unit.
3. Attempt no internal repairs or adjustments, unless specified otherwise in this manual. Units requiring repair
should be returned to Stryker Endoscopy for repair.
4. Pay close attention to the care, cleaning, sterilization, and disinfection instructions in this manual. A
deviation may cause damage to the equipment.
5. Disconnect the SERFAS Generator from the electrical outlet when inspecting fuses.
NOTE: The SERFAS warranty is void if any of these warnings are disregarded.
Stryker Endoscopy accepts full responsibility for the effects on safety, reliability, and performance of the equip-
ment ONLY if:
●Re-adjustments, modifications, and/or repairs are carried out exclusively by Stryker Endoscopy.
●The electrical installation of the relevant operating room complies with the applicable IEC, CEC, and NEC
requirements.
WARNING: Federal law (U.S.A.) restricts this device to use by, or on order of a physician.
3
CAUTIONS:

SERFAS consists of the RF Generator, Footswitch, Handpiece Cable and Probe. The RF Generator is a radio-frequency
energy-generating unit, designed to deliver a high frequency output to perform electrosurgical procedures. Components
of SERFAS, the Footswitch, Probe and Handpiece Cable are specifically designed to connect with the RF Generator
and are intended to be used together as a single unit. This system should only be used as indicated in this manual.
RF GENERARF GENERA
RF GENERARF GENERA
RF GENERATT
TT
TOROR
OROR
OR (REF - 278-100-000)::
::
:
FRONT PANEL:
NOTE: Refer to Appendix B for front panel labeling definitions.
1. Mains Power Switch – The mains connection to the generator can be turned ON/OFF using this switch. The
switch will illuminate when mains power to the unit is turned on.
2. RF CUT output level change – Cut level UP and DOWN buttons will change the setting for energy delivered to the
tip during CUT mode. Output level selected should be as low as possible for the intended purpose and cannot be
changed while RF energy is being delivered. To scroll through levels, hold down either the UP or DOWN button until
desired level is reached.
3. CUT RF Output Level / Error Code Display – This display shows the set-point CUT level (1 through 10 depending
on probe used or ‘0’ during start-up display). In case of an error, the CUT RF Output Level display will show the
corresponding error code.
4. RF CUT Activation Indicator – A yellow indicator will illuminate when RF energy is delivered due to the CUT pedal/
button being pressed.
5. RF COAG output level set/change – COAG level setting will be controlled by three separate buttons (HIGH, MED,
and LOW) for high, medium and low settings, respectively. Pressing one of these options will set the corresponding
COAG level. Output level selected should be as low as possible for the intended purpose and cannot be changed
while RF energy is being delivered. The output level of HIGH, MED, and LOW settings depend on Probe type used.
Refer to the SERFAS Probe User Insert and Appendix A of this manual for COAG Level definitions.
6. RF COAG Activation Indicator – A blue indicator will illuminate when RF energy is delivered due to the COAG
pedal/button being pressed.
PRODUCT DESCRIPTION AND USE
1
6
3
410
8
9
11 275
12
4
Pull-out Tray (see page 6)

7. RF COAG Output Level Indicators – The blue indicators corresponding to the relevant COAG buttons (HIGH,
MED, and LOW) will illuminate to indicate the level set.
8. Footswitch Connector – Connection for the footswitch. The Footswitch indicator above the connector will
illuminate upon proper connection to the RF Generator. The footswitch has four pedals that control CUT
Activation, COAG Activation, CUT Level Up, and CUT Level Down.
9. Footswitch Indicator – Indicator will illuminate upon proper connection of Footswitch to Generator.
10. Handpiece Cable Connector – Connection for the Handpiece Cable that connects to the Probe. The Handpiece
Cable facilitates radio-frequency energy delivery to the electrode tip, CUT activation, COAG activation and probe
family identification. The Probe indicator above the connector will illuminate upon proper connection of the
Handpiece Cable to the RF Generator and the Handpiece Cable to the Probe.
11. Probe Indicator – Indicator will illuminate upon proper connection of Handpiece Cable to Generator.
12. Error Indicator – A red indicator will flash to indicate an error.
REAR PANEL:
NOTE: Refer to Appendix B for rear panel labeling definitions.
1. Equipotential Ground Stud – Provides a means of securely linking the earth grounds of SERFAS to other
grounded equipment.
2. RS-232 Port – For manufacturing and test purposes only.
3. Power Entry Module – This module has a fuse drawer that contains two fuses.
4. Flash Memory Screw – For manufacturing and repair access only.
5. Speaker Volume Control – Controls the volume of the tones, beeps and voice feedback.
6. Voice/Tone Selector – A two-position switch, which enables or disables the digitized audio messages.
PRODUCT DESCRIPTION AND USE
1
2 5
6
3
4
5

Synthesized Voice Feature:
When the Synthesized Voice feature of SERFAS is enabled, the user has the option for receiving voice feedback for
actions.
The following commands will be issued in the selected language:
ACTION MESSAGE
Probe Connection “Level 1 … 10” (default cut level for probe.)
Footswitch Pedal Pressed and Probe not detected “Probe Not Detected”
COAG High Button Pressed “COAG High”
COAG Medium Button Pressed “COAG Medium”
COAG Low Button Pressed “COAG Low”
CUT Up Button pressed (on generator or footswitch) “Maximum Level for Probe”
when generator is set at probe maximum
CUT Up or CUT Level Down Button “Level 1 … 10” (present cut level for probe.)
Pressed (on generator or footswitch)
Pull-Out Tray:
A pull-out tray with System Set-up Instructions and Error Code descriptions (as shown below) can be found
mounted underneath the RF Generator for quick reference. (Also provides Stryker Endoscopy contact information.)
PRODUCT DESCRIPTION AND USE
6

DISPOSABLE PROBESDISPOSABLE PROBES
DISPOSABLE PROBESDISPOSABLE PROBES
DISPOSABLE PROBES (REF - 278-5xx-xxx)::
::
:
1. Probe Tip – point of delivery of RF energy used to cut and coagulate.
2. Probe Shaft – Insulated.
3. Probe Handle – depending on probe used, handle may house two buttons. The yellow button is used to
activate the CUT function. The blue button is used to activate the COAG function.
4. Probe Connector – connects to Handpiece Cable.
FOOFOO
FOOFOO
FOOTSWITTSWIT
TSWITTSWIT
TSWITCHCH
CHCH
CH (REF - 278-200-000)::
::
:
NOTE: Use of the Footswitch is optional when a Hand-fire Probe is used.
1. Yellow CUT Pedal – used for activation of CUT function.
2. Blue COAG Pedal – used for activation of COAG function.
3. Yellow Minus (-) Pedal – used to adjust CUT level down.
4. Yellow Plus (+) Pedal – used to adjust CUT level up.
5. Footswitch Connector – Connects to front panel of RF Generator.
1. Handpiece Cable Connectors – used to connect to Probe and RF Generator. Either end of the Handpiece
Cable may be used to connect to the Probe or the Generator.
PRODUCT DESCRIPTION AND USE
HANDPIECE CABLEHANDPIECE CABLE
HANDPIECE CABLEHANDPIECE CABLE
HANDPIECE CABLE (REF - 278-300-000)::
::
:
NOTE: Handpiece Cable is shipped non-sterile. Sterilize and clean Handpiece Cable prior to first use and before each
subsequent use (refer to Section VI, Cleaning and Sterilization).
1
25
43
4
12
7
NOTE: Probe appearance and functions will vary depending on the probe used. Refer to Probe User Insert for Probe
Type Definitions. 3
11

INITIAL SETINITIAL SET
INITIAL SETINITIAL SET
INITIAL SET-UP OF RF GENERA-UP OF RF GENERA
-UP OF RF GENERA-UP OF RF GENERA
-UP OF RF GENERATT
TT
TOR:OR:
OR:OR:
OR:
1. The RF Generator should be placed on a Stryker cart or on any sturdy table or platform. Refer to hospital
procedures or local codes for detailed information.
2. Provide at least four to six inches of space around the sides and top of the RF Generator for convection cooling.
It is normal for the top and rear panel to be warm when system is used continuously for extended periods of
time.
3. The RF Generator is shipped with an approved hospital grade mains power cord. Plug the RF Generator into a
grounded receptacle. DO NOT use extension cords or three-prong to two-prong adapters. The mains power cord
assembly should be checked periodically for damaged insulation or connectors.
CONNECTING SYCONNECTING SY
CONNECTING SYCONNECTING SY
CONNECTING SYSTEMSTEM
STEMSTEM
STEM AA
AA
ACCESSORIES:CCESSORIES:
CCESSORIES:CCESSORIES:
CCESSORIES:
NOTE: Refer to System Set-up Instructions located on pull-out tray.
GENERATOR
1. Plug power cord into back of Generator.
2. Plug power cord into AC mains.
FOOTSWITCH
1. Connect Footswitch cable to the Footswitch connector located on the front panel of the Generator.
2. When proper connection is achieved, the Footswitch indicator above the connector will illuminate.
SET UP AND INTERCONNECT SECTION
8
NOTE: Use only the the appropriate SERFAS accessories with the RF Generator. Refer to the Product Description
and Use section for product reference numbers.

HANDPIECE CABLE/PROBE
Align connection features
SET UP AND INTERCONNECT SECTION
Connect
9
1. Connect either end of the Handpiece Cable to the probe connector on the front panel of Generator.
2. Connect the other end of the Handpiece Cable to the Probe as shown.
3. When proper connection is achieved on both ends of the Handpiece Cable, the probe indicator above the
connector will illuminate, the CUT Level will default to a level appropriate for the probe used, and the COAG level
will default to MED. Refer to the SERFAS Probe User Insert and Appendix B of this manual for definition of CUT/
COAG Levels.

NOTE: Be sure that the RF Generator and all components are properly connected before use (refer to Section IV, Set
Up and Interconnect Section). Be sure that all components are functioning properly, that all indicators are lit as
appropriate, and that tone sounds during system self-test.
CAUTION: Improper connection may lead to arcing, sparking or malfunction of the unit, which can result in injury to
the patient, user, and/or damage to the system.
NOTE: SERFAS Handpiece Cable is supplied non-sterile (refer to Section VI, Cleaning and Sterilization).
NOTE: A sterile probe should be used for each new procedure. Discard after one use. DO NOT attempt to
resterilize.
1. Press the green RF Generator power switch to the ON position. A long tone will sound during the system self-
test. If probe is connected and synthesized voice feature is enabled, the voice will announce the default CUT
level following the tone. If probe is connected and synthesized voice feature is disabled a beep will sound
following the tone.
2. Be sure that the RF Generator and all components are properly connected. All components are properly
connected when the following are present on the front panel of the RF Generator:
●Footswitch Indicator is lit (if Footswitch is used)
●Probe Indicator is lit
●CUT Level Window displays default cut level
●COAG default setting at MED
NOTE: If probe is not properly attached, a ‘0’ will be displayed in the CUT Level window and the probe indicator will
not be lit.
MODES OF OPERAMODES OF OPERA
MODES OF OPERAMODES OF OPERA
MODES OF OPERATION:TION:
TION:TION:
TION:
CUT MODE:
1. CUT Level can be adjusted by using either the Up/Down arrow buttons on the front panel of the Generator or by
using the yellow plus/minus pedals on the Footswitch. The maximum and default cut levels for the probe are
determined by probe type used. The generator will automatically recognize probe type upon connection and
set defaults appropriately. The maximum and default CUT Level can range from 1 to 10 depending on the type
of probe being used. Refer to the Probe Family Definition table located in the SERFAS Probe User Insert.
2. Activation of the CUT Mode can be achieved by pressing the yellow pedal of the Footswitch, or by pressing the
yellow button on the Probe, if available (NOTE: Some models of the Probe do not have hand-control
capabilities).
3. When CUT Mode is activated, the yellow cut indicator will appear and a continuous high-pitched tone will
sound for the duration of the activation.
INSTRUCTIONS FOR USE
10

COAG MODE:
1. There are three levels available in the COAG Mode: HIGH, MED, and LOW. COAG Level will default to MED
following proper connection of the Probe. Power settings for the COAG Mode are dependent on probe type used
(refer to the Probe Family Definition table located in the SERFAS Probe User Insert).
2. COAG Level can be adjusted by pressing either the HIGH, MED, or LOW button on the front panel of the
Generator. A beep will sound when a different COAG Level is selected or the synthesized voice will announce
COAG Level.
3. Activation of the COAG Mode can be achieved by pressing the blue pedal on the Footswitch, or by pressing the
blue button on the Probe, if available (NOTE: some models of the Probe do not have hand-control capabilities).
4. When COAG Mode is activated, the blue COAG Indicator will illuminate and a pitched tone (lower than the CUT
tone) will sound continuously for the duration of the activation.
NOTE: Avoid pressing two buttons or pedals simultaneously. If this occurs, an error alarm will sound, the red
triangle indicator on the front panel will illuminate, and an error code will be displayed in the CUT Level
window. To return to normal mode of operation, press a single pedal or button. A list of error definitions can
be found on the Pull-out Tray underneath the Generator or in the Error Codes and Troubleshooting section of this
manual.
VV
VV
VOLOL
OLOL
OLUMEUME
UMEUME
UME ADJUSTMENTADJUSTMENT
ADJUSTMENTADJUSTMENT
ADJUSTMENT::
::
:
Volume of tones and voice feedback can be adjusted by using the Speaker Volume Control knob located on the back
panel of the Generator.
TT
TT
TONE/VONE/V
ONE/VONE/V
ONE/VOICE SELECTION:OICE SELECTION:
OICE SELECTION:OICE SELECTION:
OICE SELECTION:
The user has the option to select the type of audio feedback preferred. Either tone or voice feedback is available
with SERFAS. To select between the two, use the Tone/Voice Selector located on the back panel of the Generator.
INSTRUCTIONS FOR USE
11

CHANGING PRCHANGING PR
CHANGING PRCHANGING PR
CHANGING PROBES DURING SUROBES DURING SUR
OBES DURING SUROBES DURING SUR
OBES DURING SURGERGER
GERGER
GERYY
YY
Y::
::
:
NOTE: Be sure that system is not delivering RF energy while changing probes.
1. Twist and pull connector on Handpiece Cable to detach from Probe. When Probe is fully detached, the CUT
Level window will display a ‘0’.
2. Properly dispose of the used probe. Probes are for single use only. DO NOT attempt to reuse.
3. Attach new Probe to the Handpiece Cable. When new Probe is attached, the default setting for that particular Probe
will be displayed in the CUT Level window and a beep will sound. If using the Synthesized Voice feature, the default
CUT Level will be announced following proper connection.
WARNING: Do not insert or withdraw Probe while activated. Injury to patient and/or damage to the equipment may
result.
NOTE: If Generator is turned off while Probe is still attached or there is a loss of power to the unit, the Generator will
automatically return to the default output level when power is restored. Power can be increased/decreased
using the arrow buttons on Generator or the plus/minus pedals on the Footswitch.
RECOMMENDRECOMMEND
RECOMMENDRECOMMEND
RECOMMENDAA
AA
ATIONS DURING SURTIONS DURING SUR
TIONS DURING SURTIONS DURING SUR
TIONS DURING SURGERGER
GERGER
GERYY
YY
Y::
::
:
●The output power selected should be as low as possible for the intended purpose to prevent injury to patient.
●Avoid prolonged activation of the Probe. The system allows for a maximum of 160 seconds. If activation exceeds
160 seconds, an error alarm will sound and an error code will be displayed in the CUT Level window.
INSTRUCTIONS FOR USE
Twist Connector
12
Detach

INSTRUCTIONS FOR USE
AFTER SURAFTER SUR
AFTER SURAFTER SUR
AFTER SURGERGER
GERGER
GERYY
YY
Y::
::
:
1. Detach Probe from Handpiece Cable.
2. Withdraw Probe from the patient. Be sure that the Probe is NOT activated during withdrawal.
3. Detach the Handpiece Cable from the Generator.
4. Properly dispose of single-use Probes.
5. Prepare Handpiece Cable for sterilization. Refer to Section VI, Cleaning and Sterilization.
NOTE: When Probe is disconnected, a ‘0’ will be displayed in the CUT Level window and none of the COAG
indicators will be lit. The Generator will not produce RF energy in this state. The Generator can be left in
this state between surgical cases, but should be turned off at the end of an operating session.
13

RF GENERARF GENERA
RF GENERARF GENERA
RF GENERATT
TT
TOROR
OROR
OR
The RF Generator cannot be sterilized. If the Generator needs to be cleaned, wipe it down with a damp cloth or sponge.
Use only non-abrasive cleaning agents and DO NOT allow liquid to enter connectors on Generator.
FOOFOO
FOOFOO
FOOTSWITTSWIT
TSWITTSWIT
TSWITCHCH
CHCH
CH
Wipe the outside of the SERFAS Footswitch with a mild detergent and water according to standard hospital practices.
Do not disassemble the SERFAS Footswitch. Do not sterilize the SERFAS Footswitch. Do not immerse the SERFAS
Footswitch in liquid. Use only non-abrasive cleaning agents and DO NOT allow liquid to enter connectors.
PROBESPROBES
PROBESPROBES
PROBES
Probes are shipped sterile and are intended to be used ONE TIME ONLY. Do not attempt to resterilize or reuse Probes.
Dispose of Probes after single use.
HANDPIECE CABLEHANDPIECE CABLE
HANDPIECE CABLEHANDPIECE CABLE
HANDPIECE CABLE
CLEANING:
The Handpiece Cable is shipped NON-STERILE and must be cleaned and sterilized before its first use and before each
subsequent use. Use the following cleaning and sterilization instructions.
1. Remove any gross matter (blood, mucous, tissue) by wiping with a soft cloth or gauze pad and by using a non-
abrasive, mild cleanser according to hospital standards.
2. The cable can be rinsed under running water to remove any cleaning residue, but should not be immersed in water
or any other liquid.
3. After cleaning, inspect handpiece cable for any signs of damage, such as nicks or cuts. DO NOT reuse a damaged
cable.
4. Inspect the inside of the connectors at both ends of the cable to ensure that the O-rings are still in place or for any
signs of damage.
CLEANING AND STERILIZATION
14

CLEANING AND STERILIZATION
STERILIZATION:
The recommended sterilization parameters are only valid with sterilization equipment that is properly maintained and
calibrated. The Handpiece Cable can be sterilized using one of the following methods:
1. EtO Sterilization
2. Steam Sterilization
NOTE: Handpiece Cables can be sterilized and should be replaced if inspection indicates any damage.
1. Clean and prepare the Handpiece Cable as described in the Handpiece Cable Cleaning Section (pg 14).
2. Sterility has been validated using the following sterilization methods and parameters only. Do not use any other
sterilization method.
EtO Sterilization (100% EtO, wrapped)
Temperature: .............................................55ºC (131ºF)
Exposure Time: ............................................... 60 minutes
Aeration Time: .................................8 hours, 55ºC (131ºF)
Steam Sterilization
1. Pre-Vacuum, Wrapped:
Temperature: ........................... 132 – 135ºC (270 – 275ºF)
Exposure Time: ................................................. 4 minutes
Drying Time: .................................... 5 minutes (minimum)
2. Pre-Vacuum, Unwrapped:
Temperature: ........................... 132 – 135ºC (270 – 275ºF)
Exposure Time: ................................................. 4 minutes
Drying Time: .................................... 5 minutes (minimum)
3. Gravity, Wrapped:
Temperature: ........................ 121 – 123ºC (250 – 254ºF)
Exposure Time: ............................................... 30 minutes
Drying Time: ...................................................... 8 minutes
4. Gravity, Unwrapped:
Temperature: ........................... 132 – 135ºC (270 – 275°F)
Exposure Time: ............................................... 10 minutes
Drying Time: ...................................................... 8 minutes
CAUTION:
●Make sure the Handpiece Cable is thoroughly dry prior to use. Wet cables may damage the cable and other
system components.
●After sterilization, inspect the Handpiece Cable for any signs of damage, such as nicks or cuts. DO NOT reuse
any damaged cables.
●Ensure that cable connectors are properly attached to Probe and Generator prior to use.
15

EQUIPMENT DISPOSAL GUIDELINESEQUIPMENT DISPOSAL GUIDELINES
EQUIPMENT DISPOSAL GUIDELINESEQUIPMENT DISPOSAL GUIDELINES
EQUIPMENT DISPOSAL GUIDELINES
●The SERFAS Generator contains electronic printed circuit assemblies. Equipment should be disposed of at the end
of its useful life in accordance with applicable national or institutional related policies relating to obsolete electronic
equipment.
●Dispose of any system accessories according to normal institution practice relating to potentially contaminated
items.
CLEANING AND STERILIZATION
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