(Stryker Endoscopy Radio Frequency Ablation System)

USER MANUAL
 TABLE OF CONTENTS

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
 INDICATIONS/CONTRADICTIONS

INDICATIONS:

The Stryker Endoscopy SERFAS System 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.

CONTRAINDICATIONS:

The SERFAS System 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 contraindicated for any reason. The SERFAS system is contraindicated in patients with heart pacemak-
ers and other electronic device implants.

1
 WARNINGS AND CAUTIONS

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.

USER AND PATIENT 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 the SERFAS System on patients with heart pacemakers or other electronic device implants. Doing so
could lead to electromagnetic interference and possible death.
● Do not activate the SERFAS system 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.
2
 WARNINGS AND CAUTIONS

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.

OPERATOR QUALIFICATION

The surgeon using the SERFAS System 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. The SERFAS
System was fully tested at the factory before shipment.

GENERAL WARNINGS AND CAUTIONS:

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 System 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
 PRODUCT DESCRIPTION AND USE

The SERFAS System 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 proce-
dures. Components of the SERFAS System, 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 GENERATOR (REF - 278-100-220):

FRONT PANEL:
NOTE: Refer to Appendix B for front panel labeling definitions.

11 2 7 5 12

10 4 3 6
Pull-out Tray (see page 6)

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.

4
 PRODUCT DESCRIPTION AND USE

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.

2 5
6

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.

5
 PRODUCT DESCRIPTION AND USE

Synthesized Voice Feature:

When the Synthesized Voice feature of the SERFAS System 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.)

6
 PRODUCT DESCRIPTION AND USE

DISPOSABLE PROBES (REF - 278-5xx-xxx):

NOTE: Probe appearance and functions will vary depending on the probe used. Refer to Probe User Insert for Probe
Type Definitions.
3
1 2
4

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.

FOOTSWITCH (REF - 278-200-000):

3 4
NOTE: Use of the Footswitch is optional when a Hand-fire Probe is used.

1
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. 2 5

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 1

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.

7
 SET UP AND INTERCONNECT SECTION

INITIAL SET-UP OF RF GENERATOR:

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 SYSTEM ACCESSORIES:

NOTE: Use only the the appropriate SERFAS accessories with the RF Generator. Refer to the Product Description
and Use section for product reference numbers.

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.

8
 SET UP AND INTERCONNECT SECTION

HANDPIECE CABLE/PROBE

Align connection features

Connect

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.

9
 INSTRUCTIONS FOR USE

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 OPERATION:

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.

10
 INSTRUCTIONS FOR USE

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.

VOLUME 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.

TONE/VOICE SELECTION:

The user has the option to select the type of audio feedback preferred. Either tone or voice feedback is available
with the SERFAS System. To select between the two, use the Tone/Voice Selector located on the back panel of the
Generator.

11
 INSTRUCTIONS FOR USE

CHANGING PROBES DURING SURGERY:

Twist Connector

Detach

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.

RECOMMENDATIONS DURING SURGERY:

● 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.

12
 INSTRUCTIONS FOR USE

AFTER SURGERY:

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
 CLEANING AND STERILIZATION

RF GENERATOR

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.

FOOTSWITCH
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.

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 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.

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
 CLEANING AND STERILIZATION

EQUIPMENT DISPOSAL GUIDELINES

● The SERFAS System RF 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.

16
 ERROR CODES & TROUBLESHOOTING GUIDE

If a fault condition should occur, one of the displays on the front panel will display an error code and an error beep
will sound. The interpretation of the error code, as well as possible causes and solutions are listed in Table 1.
NOTE: To recover system from Errors E1 – E9, press any button or attach the Handpiece Cable to the Generator. If
errors persist, refer to Solution section in Table1. If solutions do not prevent error occurrence, refer to the
Service and Claims section of this manual to obtain repair service.

Table 1. Error code interpretation.

RECOVERABLE ERRORS & CORRESPONDING CODES

Error Code Reason for error Solutions
● Reconnect Probe
● Reconnect Handpiece Cable
E1 Unable to identify probe tip
● Replace Probe

● Replace Handpiece Cable

● Reconnect Probe
Probe/Handpiece Cable not detected (when footswitch ● Reconnect Handpiece Cable
E2
pedal is activated) ● Replace Probe

● Replace Handpiece Cable

E3 Multiple switches pressed simultaneously ● Press one switch at a time

● Check Probe for inadvertent

contact with metal
E4 Low impedance measured (Short-circuit)
● Replace Probe

● Replace Handpiece Cable

● Probe activated outside saline if

E5 High impedance measured (Open-circuit)
error persists, replace probe

● Check Probe for damage

E6 RF Power too high ● Replace Probe

● Replace Handpiece Cable

E7 RF Voltage too high Same as above

E8 RF Current too high Same as above

● Reactive (uninterrupted activation

E9 RF delivery activated for more than 160 seconds limited to 160 seconds)

17
 ERROR CODES & TROUBLESHOOTING GUIDE

NON-RECOVERABLE ERRORS & CORRESPONDING CODES

Error Code Reason for error Solutions

Cycle power to the unit (turn unit off

F1 RF Current measurement error
and then on)

Hardware shutdown (current, voltage, or power limits Same as above

F2
exceeded)

RF generation/measurement error during

F3 Same as above
power-on test

F4 CPU Configuration error Same as above

F5 COP Timeout error Same as above

F6 ROM CRC error Same as above

F7 RAM error Same as above

F8 Illegal CPU Instruction Same as above

F9 Software error Same as above

NOTE: If errors (F1-F9) persist, refer to the Service and Claims section of this manual to obtain repair service.

NOTE: If disturbance occurs on the video monitor or any other electronic instrument, the user should:
● Ensure that Handpiece Cable is not near any other instrument cables.
● Ensure that Endoscope has a non-metallic coupling ring (i.e. Stryker CE Mark Endoscopes).

18
 TECHNICAL SPECIFICATIONS

SERFAS Probe
Overall Length .......................................................................................... 8.7-13.2in (22 – 33.5cm)
Working Length ......................................................................................... 3.93- 6.9in (10 – 17.5cm)
Shaft Diameter ...................................................................................... 0.06 – 0.18in (1.5 – 4.5mm)
Shaft Bend Angle .................................................................................................................. 0 – 45º
Active Tip Orientation ............................................................................................................ 0 – 90º
Supplied Sterile and For Single-use ONLY
Sterilization Method .......................................................................................................... Irradiation
SERFAS Handpiece Cable
Overall Length ........................................................................................................... 9ft. 9in (2.97m)
Sterilization Method .................................................................................................... EtO or Steam
Supplied Non-sterile
Reusable
RF Generator
Dimensions ......................................................................... 12.2” x 15” x 4.1” (31cmx38cmx10.5cm)
Weight ........................................................................................................................ 13.0 lb. (5.9kg)
Operating Temperature Range ...................................................................................... 10ºC to 40ºC
Operating Relative Humidity ............................................................... 15% to 80% (non-condensing)
Transport & Storage Temperature Range ............................................. -34ºC (-29ºF) to 65ºC (149ºF)
Transport & Storage Relative Humidity ............................................... 10% to 85% (non-condensing)
Shipped Non-sterile

Nominal Voltage .......................................... 115 Volts RMS (UL certified) or 230Volts RMS 50/60Hz
Operating Range ............................ 90-130 VAC @ 50/60Hz (UL certified) or 200–240 VAC @ 50 Hz
Inlet Fuse .............................................................................. 4A, 250V, normal, 5x20mm,UL/CSA or
2.5A, 250V, T-lag, 5x20mm, IEC127

Leakage Currents .......................................Within limits of Class CF equipment as per IEC 60601-1

Alarm Volume ........................ Adjustable between 45dB (minimum) and 65dB (maximum) at 1meter.
Intermittent Operation.............................. Under maximum power setting and rated load conditions,
the Generator is suitable for 15 seconds on, 45 seconds
off duty cycle for 1 hour.
RF Output
Waveform.............................................460kHz±1%, square wave, Crest factor <1.3 @ 140 ohms
Maximum Power (CUT Mode)....................................................................225 Watts @ 140 ohms
Maximum Power (COAG Mode)...................................................................40 Watts @ 140 ohms

19
 TECHNICAL SPECIFICATIONS

Maximum Open Circuit Voltage

Cut Level vs. Peak Voltage Coag Level vs. Peak Voltage

600 300

Peak Voltage (V)

500 250
Voltage (V)

400 200
150
300
100
200
50
100
0
0
1 2 3 4 5
1 2 3 4 5 6 7 8 9 10
Coag Level
Cut Level

Resistance vs. Power (Cut) Resistance vs. Power (Coag)

250 40
200
Power (W)

30
Power (W)

Cut Level 10 Coag Level C3

150
100 20
Coag Level C5

50 Cut Level 5
10
0
0 250 500 750 1000 0
0 250 500 750 1000
Resistance (ohms)
Resistance (ohms)

Cut Level vs. Power @ 140ohms Coag Level vs. Power @ 140ohms

250 50

200 40
Power (W)
Power (W)

150 30

100 20
10
50
0
0
1 2 3 4 5
1 2 3 4 5 6 7 8 9 10
Coag Level
Cut Level

20
 PRODUCT CLASSIFICATIONS

CONFORMANCE TO STANDARDS
● 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety
● 60601-1-2, Medical Electrical Equipment: Electromagnetic Compatibility Requirements and Tests
● 60601-1-4, Medical Electrical Equipment: General Requirements for Programmable Electrical Medical
Systems
● 60601-2-2, Medical Electrical Equipment: Particular Requirements for the Safety of High Frequency Surgical
Equipment

(115 V units only)

0197 Denotes compliance to European Community Directive: 93/42/EEC

Stryker European Representative

RA/QA Manager - Stryker Europe
BP50040 - 95946 Roissy CDG France

CLASSIFICATION
● Type of protection against electrical shock
• Class I Equipment
● Degree of protection against electrical shock
• Type CF Defibrillation-Proof Applied Part
● Degree of protection against harmful ingress of water
Generator:
• IEC 60601-1: Ordinary Equipment
• IEC 60601-2-2: Requirement per clause 44.3
Footswitch:
• IPX7 Water-tight Equipment
• IEC60601-2-2: Requirement per clause 44.6
● Equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous
oxide.

21
 MAINTENANCE

FUSE REPLACEMENT INSTRUCTIONS:

1. Unplug RF Generator from electrical outlet and unplug power cord from Generator.
2. Locate Fuse Box on rear panel of the Generator.
3. Unlatch fuse holder below the AC Inlet and remove. You may need to press the tab on the fuse holder with a
slender screwdriver to release the latch.
4. Replace the fuse with a new fuse of the same value rating as indicated on the back panel label.
WARNING: To avoid risk of fire, replace only with a fuse of the value specified on the fuse label on back of the RF
Generator.
5. Reinstall the fuse holder until the tab snaps in place.

HANDPIECE CABLE O-RINGS:

Silicone O-rings are inserted into the connectors on both ends of the Handpiece Cable to help prevent fluids from
reaching electrical contacts during use. The Cable O-rings may break or damage after repeated use. Inspect O-
rings periodically to ensure that the are still in place and are not damaged.

NOTE: Refer calibration and operating difficulties not detailed in this manual to your Stryker Endoscopy sales
representative, or Stryker Endoscopy Customer Service (in the United states: 1-800-624-4422 / 408-567-
9100). For service outside of the United States, contact your local Stryker Endoscopy Distributor (listed on
pages 24-25).

22
 SERVICE AND CLAIMS

SERVICE

If service is needed either during or after the warranty period:

1. Contact Stryker Endoscopy at 1-800-624-4422 / 408-567-9100 or call your local Stryker Endoscopy sales
representative.
2. Package all the components carefully in the original shipping container if possible.
3. Ship the SERFAS System, pre-paid and insured to:

Stryker Endoscopy Customer Service

Attention: Repair Department
2590 Walsh Avenue
Santa Clara, CA 95051
USA

NOTE: Stryker Endoscopy reserves the right to make improvements in the product(s) described herein. Product(s)
therefore may not agree in detail to the published design or specifications. All specifications are subject to
change without notice. Please contact your local Stryker Endoscopy Distributor (listed on pages 24-25) or
call your local Stryker Endoscopy sales representative or agent for information on changes and new products.

23
 SERVICE AND CLAIMS

OTHER SERVICE

For service in the U.S.A., call your Stryker Endoscopy representative or Stryker Endoscopy Customer Service at 1-
800-624-4422. Outside of the U.S.A., please contact your Stryker Endoscopy distributor at one of the following
locations:

Stryker Corporation Stryker France

2725 Fairfield Road Z.A.C. Paris-Nord 11
Kalamazoo, MI 49002 13, Rue de la Perdrix
USA 93290 Tremblay les Gonesse
Phone: 1-616-385-2600 FRANCE
Telex: 224464 STRYKER KMZ Phone: 33-1-48175038
Fax: 1-616-385-1996 Fax: 33-1-48632175

Stryker Canada Styker Korea

3375 North Service Road 11F Dong Sung Bldg. 154-24
Unit C-9 Samsung-dong, Kangnam-ku
Burlington, Ontario Seoul
L7N 3G2 KOREA 135-090
CANADA Phone: 82-2-565-7303
Phone: 905-332-3235 Fax: 82-2-552-4156
Fax: 905-332-7674
Styker Australia
Stryker Osteo GmbH 50 Broughton Road
Gewerbeallee 18 Artarmon NSW 2064
D-45478 Mulheim an der Ruhr AUSTRALIA
GERMANY Phone: 61-29-439-5100
Phone: 49-208-999060 Fax: 61-29-439-6400
Fax: 49-208-9990666
Stryker Pacific Headquarters
Stryker Taiwan Suite 2501, Citibank Tower
5F-1, 23 Pa Te Road Citibank Plaza
Section 1, Taipai, TAIWAN, R.O.C. 3 Garden Road
Phone: 886-22-322-2895 HONG KONG
Fax: 886-22-357-8543 Phone: 852-2840-4400
Fax: 852-2804-6303
Stryker U.K.
Medway House Styker Singapore (ASEAN)
4200 Newbury Business Park 70 Bendemeer Road
London Rd., Newbury #03-32 Hiap Huat House
Berkshire RG14 2st SINGAPORE 339940
ENGLAND Phone: 65-293-0119
Phone: 44-1635-262400 Fax: 65-293-7028
Fax: 44-1635-580300

Stryker B.V. Stryker Osteonics, SA

Marinus van Meelweg 17 Via della Posta, PO Box 254
P.O. Box 8747 6934 Bioggio
5657 EN Eindhoven SWITZERLAND
THE NETHERLANDS Phone: 41-91-610-4410
Phone: 31-40-2922522 Fax: 41-91-610-4421
Fax: 31-40-2922555

24
 SERVICE AND CLAIMS

Stryker India
Matsumoto Medical Instruments India Liaison Office
3-13-3 Hongo First Floor, 94 Uday Park
Bunkyo-Ku, Tokyo 113 New Delhi 110049
JAPAN INDIA
Phone: 81-3-3814-7901 Phone: 91-11-686-2567
Fax: 81-3-3814-8073 Fax: 91-11-651-5496

Stryker China Stryker Mexico, S.A. de C.V.

Room 1710, Kodak House Montecito No. 38
39 Healthy Street East Piso 12, Oficina 31
North Point Colonia Napoles
HONG KONG MEXICO 03810
Phone: 852-2814-7463 Phone: 525-488-0890
Fax: 852-2873-0210 Fax: 525-488-0891

Stryker Europe Headquarters NV Stryker SA (Belgium)

Cite-Centre, Grand-Rue 92 Ikaros Business Park
CH-1820 Montreux Fase III, Ikaroslaan 12
SWITZERLAND 1930 Zaventen
Phone: 41-21-966-5201 BELGIUM
Fax: 41-21-966-5200 Phone: 32-2-717-9210
Fax: 32-2-725-1178
Stryker Latin America
Plaza Royale Suite 304 Stryker Chile
15600 NW 67th Ave. Avenida Nueva Tajamer 481
Miami Lakes, Florida 33014 Oficina 805 Piso 8
USA Torre Norte, Santiago
Phone: 1-305-821-1888 CHILE
Fax: 1-305-826-0067 Phone: 562-244-3600
Fax: 562-244-3696

Stryker Middle East / Africa

1404 Al Masoud Bldg, Suite 604 Stryker Spain
Hamdan Street Puentecesures, 1 bajo
Abu Dhabi 28029 Madrid
U.A.E SPAIN
Phone: 9712-312145 Phone: 34-91-323-1731
Fax: 9712-313698 Fax: 34-91-315-2782

Stryker AB Scandinavia Stryker AB Finland

Krossverksgatan 3 PL80 (Makelankatu 2)
2-216 16 Malmö FIN 00501 Helsinki
SWEDEN FINLAND
Phone: 46 40 69 18 136 Phone: 358 9 773 2277
Fax: 46 40 69 18 190 Fax: 358 9 773 2233

Stryker A/S MANUFACTURER

Stamholmen 193D Stryker Endoscopy Inc.
DK 2650 Hvidovre 2590 Walsh Avenue
DENMARK Santa Clara, CA 95051
Phone: 45-33-936-099 USA
Fax: 45-33-932-069 Phone: 1-408-567-9100
Fax: 1-408-567-2505

25
 WARRANTY

This warranty applies to customers in the United States only. Outside of the U.S.A, contact your Stryker sales
representative or your local Stryker subsidiary (listed on pages 24-25).

Stryker Endoscopy warrants the products listed below against defects in both materials and workmanship to the regis-
tered owner at the time of purchase. All components on the SERFAS System are covered by the warranty as described
below.
This warranty does not apply to any unit which has been subject to misuse, neglect, improper installation or that which
has been altered, adjusted, or tampered with by any person other than Stryker Endoscopy authorized personnel.
If, upon examination by authorized service personnel, it is determined that the malfunction is due to misuse or abuse,
warranty provisions will not apply. An estimate of the cost of repair work will be given to the customer prior to servic-
ing and repairing the unit.
The customer is responsible for returning the defective equipment to the factory at his or her own expense. Stryker
Endoscopy or its representative will service the unit, repair or replace any defective parts thereof, and return the unit.
If, upon examination, it is determined that the fault has been caused by misuse or abnormal conditions of operation,
the repairs will be billed to the customer as out-of-warranty repairs.
Instruments repaired under Stryker Endoscopy’s standard repair program will be issued a thirty day warranty against
defects in both materials and workmanship, provided the original warranty period has passed. Instruments submitted
due to defects in materials and workmanship during the warranty period will be repaired at no charge to the customer.
The warranty set forth herein is exclusive and in lieu of all other warranties, remedies, obligations and liabilities of
Stryker Endoscopy Inc., expressed or implied, including the implied warranties of merchantability and fitness for use
and of consequential damages. These products are being sold only for the purpose described herein, and such
warranty only runs to the purchaser. In no event shall Stryker Endoscopy be liable for any breach of warranty in any
amount exceeding the purchase price of the product.
No agent, employee or representative of Stryker Endoscopy has the authority to bind the Company to any other
warranty, affirmation, or representation concerning this instrument.
This warranty is valid only to the original purchaser of Stryker Endoscopy products directly from a Stryker Endoscopy
authorized agent. The warranty cannot be transferred or assigned by the original purchaser.
The warranty periods for components of the SERFAS System are as follows:

RF Generator ..........................................................................................1 year from shipment date

Footswitch ........................................................................................... 90 days from shipment date
Handpiece Cable ................................................................................... 90 days from shipment date
Probes .................................................................................................................... Single Use Only

26
 APPENDIX A

RATED-POWER TABLES FOR CUT and COAG MODES

*CUT Settings Power Output (watts) **COAG Settings Power Output (watts)

1 15 C1 5
2 25 C2 10
3 40 C3 20
4 55 C4 30
5 70 C5 40
6 90
7 110
8 140
9 180
10 225

*Maximum CUT and default CUT levels for individual probes are chosen from CUT Power Table. Refer to the Probe
Family Definition table located in the SERFAS Probe User Insert.
**COAG HIGH, MEDIUM, and LOW settings are selected from C1 – C5, depending on probe type used. Refer to the
Probe Family Definition table located in the SERFAS Probe User Insert.

27
 APPENDIX B

DESCRIPTION OF LABELING (RF Generator: Front and Rear Panels)

Alternating Current

Attention: consult accompanying documents

Dangerous Voltage

Defibrillator-proof, Type CF Applied Part

Equipotential Ground

Fuses

Non-Ionizing Radiation

Power OFF

Power ON

Relative Humidity Range

Temperature Range

28
 APPENDIX C

LANGUAGE SELECTION INSTRUCTIONS FOR SYNTHESIZED VOICE FEATURE

The user may select an alternative language for voice feedback from the selection available. The language selec-
tion process should occur during the system self-test (when system is turned ON using the Mains Power Switch).

To select a language:
1. Press any two of the three “COAG” buttons located on the front panel simultaneously during the system
self-test.
2. Use the Up/Down Cut Level arrows located on the front panel to cycle through languages.
3. Press any one of the three “COAG” buttons to select a language. Language chosen will be announced.

29
 2590 Walsh Avenue, Santa Clara, CA 95051 USA. 1-408-567-9100 1-800-624-4422

1000-400-444 Rev. B