BMDV Project

BMDV 5131
TERM PROJECT
Submitted for: Sandra Kudla
Nick Shiels & Soroush Yagini, BMDV 5131, Term Project, Sunday, December 6,
2015.
Table of Contents
Abstract....................................................................................... 3
Device Information.......................................................................3
Operation Instructions..................................................................3
Preventative Maintenance Instructions..........................................4
PM Procedure.............................................................................................................. 5
Operating Errors........................................................................... 9
Block Diagram & Description.........................................................9
Bovie IDS 200 Safety...................................................................11
Device Specific Safety Features................................................................................11
General Safety Information for ESUs........................................................................11
Bovie ESU Recalls.......................................................................12

Reusable Active Chord for Bovie ESUs.....................................................................12
Reason.................................................................................................................. 13
Affected Product Manufacturers............................................................................13
NOTICE TO HOSPITALS Important Safety Information on Bovie Electosurgery Units
................................................................................................................................. 13
Reason.................................................................................................................. 13
Recommended Actions......................................................................................... 14
Device Training...........................................................................14
Interview with Professional.........................................................14
Point of Contact Information..................................................................................... 14
Interview Questions.................................................................................................. 14
Conclusion.................................................................................. 15
References.................................................................................15
2015.
Abstract
The following is a report providing information on the Bovie IDS 200 series
electrical surgical generator. The report includes information such as
operation instruction, preventative maintenance instructions, block
diagrams, safety, and recall information.
Device Information
Manufacturer: Bovie
Medical License Number: 62662 (Health Canada, 2015)
Cost: Approx. $15,164.97 USD (Health Products Express Inc., 2015)
Weight: < 19lbs (Bovie Medical Corporation, 2015)
Footprint: Width: 31.1cm / Height: 15.3cm / Depth: 41.3cm (Bovie Medical
Corporation, 2015)
Competition: Many competitors from Fluke to Enertech. Bovie remains one
of the largest manufacturers of ESU generators however. (Medical Expo,
2015)
Operation Instructions (Bovie Medical Corporation, 2013)

1. Inspect for any damage, wear and tear on connectors and cords, that
all accessories that are needed are present and in good condition and
that no errors pop up when you first turn the generator on.
2. Check to see if the patient has an implantable cardioverter defibrillator
and, if they do, contact the manufacturer of that ICD to see if there are
workarounds when electrosurgery will be performed.
3. First check to make sure the power switch on the unit is in the Off
position then plug in the generator.
4. The self-test will run and, if it is successful, a tone will sound. If it is not
successful, then an alarm will sound and an error code will display in
the Bipolar section of the unit.
5. The following applies for monopolar surgery:
a. Connect a return electrode to the appropriate port on front of the
unit. The unit will automatically sense if it is a split or solid
electrode and adjust its monitoring of the resistance between the
electrode and patient
b. Connect the appropriate 3-pin monopolar accessory to the
monopolar port on the front of the unit.
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c. Operate the unit by depressing either coag or cut buttons on the

monopolar handpiece attachment itself.
6. The following applies for bipolar surgery:
a. Connect a bipolar cable to the bipolar port on front of the unit.
b. Connect the appropriate forceps instrument to the bipolar cable.
c. Connect the appropriate bipolar footswitch to the footswitch port
on the back of the unit.
d. To activate, you must step on the footswitch pedal for bipolar
operation.
Preventative Maintenance Instructions (Bovie Medical

Corporation, 2013)
7. The following applies to qualified biomedical technicians:
a. Inspect and calibrate every six months
b. When cleaning the unit, use a mild disinfectant and a damp cloth
to wipe all the surfaces down. However, never sterilize the
generator itself nor allow any fluids to penetrate into the chassis.
c. Check the fuse in the event that the unit does not power on
whatsoever and does not display any error codes.
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PM Procedure (Franks Hospital Workshop, 2015)

The following is a preventative maintenance test data sheet for an IDS series
ESU:
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Operating Errors
1. Any errors with the Bovie IDS-200 will display in the Bipolar display on
the front of the unit. This can then be looked up in the correct service
manual and troubleshooting can proceed from there.
2. If the unit does not power on whatsoever and no error messages
display, then there is a heavy possibility the issue is a blown fuse or
power supply issue.
3. The unit always undergoes a self-test procedure on start up and plays a
tone if that test is correct. If the self-test fails at any point it will signal
an alarm and an error code will display.
Block Diagram & Description
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Controls and Indicators Circuit

The front panel consists of 10 function switches that are used to toggle
between modes, presets, and power settings.
Activation Sense Circuits
The activation sense circuits are used to detect both hand and foot operation
by the user and is in communication with the control circuits to act on the
activation requests.
Temperature Sensing Circuits
The temperature sensing circuits monitor the internal temperature of the
device and act as thermal protection. When the internal temperature is to
high an error code is displayed.
Neural Electrode Monitoring Circuit
The NEM circuit is a monitoring system that detects the type of electrode
being used (solid or split) and monitors the contact quality between the
patient and the return electrode to eliminate the chance od patient burns.
Footswitch Sensor Circuit
The footswitch sensor circuit is used to determine if there is a bipolar and a
monopolar footswitch attached to the ESU.
Display Control Circuit
The display controls circuit is used to control all of the parameters of the
displays and LEDs on the front panel.
Control Circuit
Every operation is controlled by this system. The control circuit uses a field
programmable gate array to interpret inputs. It also consists of a system
clock to provide an operating frequency of 10MHz and a reset circuit that
provides a pulse when the system is powered on to reset the field
programmable gate array.
Power Factor Control Circuit
This circuit allows the ESU to use the lowest voltage required for proper
operation. It is used to decrease the power consumption of the unit.
Switch Mode Power Supply Circuit
This circuit generates a high current voltage used to pass through the patient
for operation.
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Speaker Circuit
The audio circuit is used to produce alarm sounds to alert for errors and
activation tones.
RF Drive
The RF drive circuit regulates the output of the operational power.
HV Relay
The high voltage relay circuits are used to direct the output power to the
proper output depending on the operating mode being used.
Bovie IDS 200 Safety

Device Specific Safety Features
Activation tone a tone which signals whenever an accessory is active

and ready to use (i.e. the different kinds of surgical handles)
Alarm indicators for example, alarms will trigger and will display on
front of the unit in the event of any issues with the return electrode.
Return Electrode indicator the unit uses an active check for a return
electrode for all modes and will not function without one.
Keyed receptacles all receptacles are keyed to function with only that
specific designed accessory for the unit for safety purposes.
Electrode Contact Quality Monitor Some ESUs, in this case in
particular, have a monitor for checking on the contact quality of the
return electrode on the patient. In the case of Bovie, they have their
own proprietary Bovie NEM system.
General Safety Information for ESUs

When using such an invasive device like an electro-surgery unit one
must be extremely cautious about every aspect. One must always work to
ensure the highest rate of both patient and user safety. First, when buying an
electro-surgery unit keep in mind that all parts and accessories are
considered high-risk medical devices, and all parts must meet standards set
by The Association for the Advancement of Medical Equipment (AAMI) and
are approved. That being said, when purchasing an ESU the buyer should
choose a unit and accessories based on there safety features that minimize
patient and personnel injury ie; pad site burns, component failure,
unintentional activation.
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Secondly, when using an ESU the operator should always operate the
device in a manor to prevent injury. First, before using the unit one should
always review a user manual that is for the specific model of ESU they are
going to be operating. If a manual is not available, they can often be easily
obtained from online sources. Also, regular maintenance and calibration
should be done on the device to ensure proper functionality thus increasing
patient/user safety. Always wear appropriate clothing when using an ESU,
this includes tying long hair back, no jewelry, and do not wear conductive
materials such as metals. The devices safety alarms should be operational
and audible at all times. The device should also be placed in a position so
that the front panel and alarms are visual at all times. Always remember to
visually inspect the ESU before use, a basic inspection should include
checking return electrodes for damage, placement, and contact quality,
check electrode contact monitoring system, check alarms, check that when
features are change ie. Power or mode, that it has an effect on the operation.
Always check that the electrode tip and make sure it is clean and not
damaged or in need of replacement. When placing electrodes on the patient
always be careful to make sure that they are being placed in a way that will
minimize patient injury. This includes always remembering to prep the
patients skin before placing the electrodes. One must clean the electrode
contact site and also may have to shave the area to increase contact. When
placing the electrode place it on a part of the body where it can get a lot of
skin contact, a good place if the thigh. Once the electrode is in place check
to make sure that the return electrode contact monitoring system is running
correctly and is saying the connection is of good quality. The return electrode
contact monitoring system should always be running during operation, this is
to prevent patient burns at the return electrode site.
Lastly, one good thing to remember when using an ESU is to use the
least amount of power for the desired effect. This means to use the lowest
power settings you can to get a good effect from the device. If the user feels
they need to continue to increase the power settings to get a good effect a
full inspection of the device should be done before increasing the power
further as this is most commonly a dirty tip or poor contact quality between
the patient and the return electrode. Another good thing to keep in mind is to
keep away from flammable materials, liquids, or gases. When using the ESU
for surgery around the gastrointestinal area be sure to flush the body of the
natural methane gas and substitute for an inert gas to prevent fires or even
explosion.
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Bovie ESU Recalls

There have been a few recalls and warnings about the Bovie ESUs in Canada
but not many. The following are warnings from Health Canada on Bovie
ESUs.
Reusable Active Chord for Bovie ESUs

Posting date: November 29, 2013
Type of communication: Medical Device Recall
Subcategory: Medical Device
Hazard classification: Type II
Source of recall: Health Canada
Issue: Medical Devices
Audience: General Public, Healthcare Professionals, Hospitals
Identification number: RA-36915
Reason
This warning was issued on behalf of Health Canada as an updated
statement for safety practices under the instructions of use for this device. It
is stated that the reusable active chords have a service life and must be
replaced after a period of one year of use. They also warn users that any
damage to the chord may increase the risk of injury and also runs the risk of
starting a fire.
Affected Product Manufacturers

Gyrus ACMI, Inc.
136 Turnpike Road
Southborough
01772
Massachusetts
UNITED STATES
NOTICE TO HOSPITALS Important Safety Information on Bovie

Electosurgery Units
Posting date: February 7, 2014
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Type of communication: Notice to Hospitals

Subcategory: Medical Device
Source of recall: Health Canada
Issue: Fire Hazard
Audience: Healthcare Professionals
Identification number: RA-37973
Reason
Health Canada is issuing this warning to inform users that there have been
some problems with the Bovie ESUs reusable active chords. There have
been reports of these chords smoking and catching fire. Health Canada says
that they are not certain if it is the generators themselves that are causing
the problem but they suggest users to test their equipment for potential
safety hazards.
Recommended Actions
Health Canada suggests that users of Bovie ESUs perform yearly safety and
calibration tests to ensure that their machines are up to quality standards or
replacement of active chord. Suggested test include; ensuring that the
output voltage meet quality standards.
Device Training
If one desires to seek training on the Bovie IDS 200 they can always refer to
the products service and users manuals which are always are great place to
start and provide all the information you could need about the device. If
manuals are not redily available they can often be easily obtained from
online sources, a good source to start with is a website called
www.frankshospitalworkshop.com which offers online PDFs of medical
device manuals for free. While searching online, you may want to also watch
online videos that can also be very informative. Bovie also has many helpful
links for literature on their devices as well as video tutorials on their website
at www.boviemedical.com
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Interview with Professional

Point of Contact Information
Name: Jason Maahs
Position: Dialysis Technician
Contact #: 416-427-2161
E-Mail: Jason_maahs@baxter.com
Interview Questions
-
What are some changes that have been made in this model from the
previous versions of the device?
- How often is this device known to have functionality issues?
- What parameters of the device tend to act up the most?
- Are there any safety precautions that should be taken when attempting
to repair this device?
- Are there any improvements you would personally suggest for the
device?
- Can this device typically be repaired on site rather than being sent
offsite to a third party?
- What steps would be taken when performing a performance test?
- What are some of the most common signs of an issue with this device?
- Does the manufacturer offer a service contract with purchase?
- How many of these devices are typically in a hospital?
- Are there any other accessories that can be used with this device that
are not included in a typical purchase order? If so what are they?
- In your experience, is there a high demand for this device in a
hospital?
- What kind of safety features to both the patient and the user does this
device offer?
- If there was an issue that was difficult to solve what would be the best
source to consult for information on fixing the issue?
- Are there any rumours for advancement on the device?
- How compatible is this device with third-party accessories in the event
of an emergency where we cannot utilize the appropriate Bovie
sourced accessory?
Is there any proprietary technology within the device which Bovie would
prefer to service themselves rather than any biomedical technicians on-site?
Conclusion
The Bovie IDS 200 series electrical surgical generator is a reliable well
rounded device. With many different operating modes, it is a versatile and
powerful machine capable of completing many different tasks with great
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precision. The Bovie IDS series ESU is an essential part of any operating
room and could make a great part of any medical team who performs
surgeries.
References
Bovie Medical Corporation. (2013). Bovie IDS-200 User Guide. Clearwater, Florida:
Bovie Medical.
Bovie Medical Corporation. (2015, 11 22). Bovie Electrosurgery Generators.
Retrieved from Bovie IDS-200:
http://www.boviemedical.com/products_bovieids200.asp
Health Canada. (2015, 11 22). Health Canada. Retrieved from Medical Devices
Active License Listing: http://webprod5.hc-sc.gc.ca/mdll-limh/dispatchrepartition.do?type=active&lang=eng
Health Products Express Inc. (2015, 11 22). Bovie IDS Generators. Retrieved from
Health Products Express:
http://www.healthproductsexpress.com:8080/Electrosurgical/Units/13116BOVIE-AARON-MEDICAL-ESUIDS200-GENERATOR-ELECTROSURGICAL-IDS200.html;jsessionid=B110FD752CA8EB5B8D12C19FC0E6FA7B
Medical Expo. (2015, 11 22). Medical Expo. Retrieved from Medical Expo Products:
http://www.medicalexpo.com/cat/operating-theatresterilization/electrosurgery-units-d-166.html
Bovie ESU Service Manual (n.d.). In http://www.frankshospitalworkshop.com.
Retrieved November 22, 2015.
Health Canada, . (2014, February 7). Gyrus Bovie Electrosurgical Generators Possible Fire Hazard - Notice to Hospitals . In http://www.healthycanadians.gc.ca.
Retrieved from http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hcsc/2014/37973a-eng.php
Health Canada, . (2013, November 29). Reusable Active Cord for Bovie Style
Electosurgical Generator (2013-11-05). In http://www.healthycanadians.gc.ca.
Retrieved from http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hcsc/2013/36915r-eng.php
2012 Perioperative Standards and Recommended Practices Equipment and P roduct
Safety Last revised: July 2009. Copyright AORN, Inc. All rights reserved.
Recommended Practices for Electrosurgery. (2012, July). In www.medline.com.
Retrieved from https://www.medline.com/media/mkt/pdf/research/or-safetylean/AORN-electrosurgery-guidelines.pdf
Bovie (2013). Bovie IDS 200 User Manual
http://www.boviemedical.com/products_boviemed_lit/pdfs/ids200_userguide550560
01_sc.pdf
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2015.
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BMDV 5131

Submitted for: Sandra Kudla

Bovie ESU Recalls.......................................................................12

Operation Instructions (Bovie Medical Corporation, 2013)

c. Operate the unit by depressing either coag or cut buttons on the

Preventative Maintenance Instructions (Bovie Medical

PM Procedure (Franks Hospital Workshop, 2015)

Block Diagram & Description

Controls and Indicators Circuit

Bovie IDS 200 Safety

Activation tone a tone which signals whenever an accessory is active

General Safety Information for ESUs

Bovie ESU Recalls

Reusable Active Chord for Bovie ESUs

Affected Product Manufacturers

NOTICE TO HOSPITALS Important Safety Information on Bovie

Type of communication: Notice to Hospitals

Interview with Professional

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