diego & PK diego System Owners Manual Rev AC

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diego ® &

PK diego ® System

OWNER’S MANUAL

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Diego® & PK diego®

System Owner’s Manual

Manufactured by/Customer Service USA:

Gyrus ACMI, Inc.

136 Turnpike Road

Southborough, MA 01772

USA

Tel:

901 373 0200

800-773-4301

Fax: 901 373 0220

800-757-2942

Authorized European Representative:

Gyrus Medical Ltd.

Fortran Road

St. Mellons

Cardiff

CF3 OLT

United Kingdom

Tel: +44 (0) 29 2077 6300

Fax: +44 (0) 29 2077 6301

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a Physician.

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PK DIEGO® SYSTEM

TABLE OF CONTENTS

Page

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

PK Diego® Blade Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

System Layout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Using PK Diego® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Error and Fault Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Yearly Checklist for Technical Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Warnings and Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

ii

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Warnings and Cautions

• Federal law restricts this device to sale by or on the order of a physician.

• When unplugging the unit, do not pull on the power cord itself. This may damage wiring inside the

cord. Pull the connector housing only.

• When disconnecting the handpiece, do not pull the cord itself. This may cause damage to the internal

wiring. Pull on the connector housing only.

• Do not clean by ultrasonic means! Use of ultrasonic cleaning equipment may damage the

handpiece and will void the product warranty.

• Always remove blade/burr before sterilization of the handpiece.

• To provide adequate cooling, where appropriate, for the blade/burr, to prevent accumulation of

unwanted materials in the surgical site, and to prevent abnormal wear of the cutting surfaces, be

certain to periodically irrigate the surgical site and the tip of the blade/burr and ensure that suction

(at least 127mm hg vacuum) is flowing whenever the instrument is running.

• Set pump flow so that irrigation is seen at the surgical site. (The flow of irrigating solution must exceed

the level of suction.)

• Avoid the use of chemical cleaning agents that might damage the silicone used in this instrument.

Use a non-residue type cleaner, preferably isopropyl alcohol, or a solution of 10% mild detergent

and 90% water.

• Do not autoclave the handpiece unless it is thoroughly clean.

• Follow cleaning instructions and use recommended brushes.

• Visually inspect to ensure that no tissue, fluid, or blood has contacted the inner surfaces.

• Mains disconnect device is unplugging cord. Position system so unplugging power cord is easily

accessible.

• The handpieces listed in this manual are for use with Gyrus ACMI, Inc. - ENT Division blade and burr

attachments only.

• Do not use sterile packaged items (blades, burrs, suction/irrigation tubing, trigger switch) if package

seal is torn or broken.

• Do not attempt to disassemble the handpiece. Failure to observe this caution will void the product

warranty.

• To mount the Diego controller to an IV pole, use the following height parameters. When the top of

the IV pole is set to 72 inches, the top of the controller should not exceed 40 inches. When the top

of the IV pole is set to 68-1/2 inches, the top of the controller should not exceed 58-1/2 inches.

• Diego passed IEC 601-1-2 testing; however, do not place the Diego controller in direct contact with

electrosurgery equipment or near any equipment that may emit electromagnetic fields or radio

frequency. If interference is encountered, move/locate devices farther apart from each other.

• To avoid risk of electrical shock, the equipment must be connected to a supply mains with protected

earth.

• Grounding reliability can only be achieved when this equipment is connected to an

equivalent receptacle marked “HOSPITAL ONLY” or “HOSPITAL GRADE”

• Neuromuscular stimulation of tissue may occur

• No modification of this equipment is allowed.

Diego® System Manual

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System Description

The Diego Powered Dissector & Drill System from Gyrus ACMI, Inc. - ENT Division is

comprised of a console, optional powered handpieces, footswitch, tubing set and

hospital grade power cord.

Console –Provides power and functionality to the specified Diego and Otologic

handpieces. In addition, a peristaltic irrigation pump is integrated into the controller

unit to facilitate local irrigation.

Footswitch – The footpedal’s loop style base allows for easy “no-look” identification, orientation and movement under the table. Lights are incorporated on the

pedal for easy orientation in a darkened operating room. Footswitch allows the

user to operate the Diego handpiece in the traditional way. Diego also provides

the option of handpiece actuation.

Handpiece – The handpiece accepts a range of one-time use cutting blades, and

tissue removal and drilling burrs. The handpiece's shape takes into account the

comfortable neutral hand position and is designed to reduce "cord drag" to

optimize balance and reduce fatigue.

The handpiece includes a proprietary fluid control design that retards contact of

bodily fluids from soiling the inner surfaces of Diego. The handpiece also allows

the user to aim the cutting window of the blade circumferentially with minimal

arm motion. Diego uses Diego blades and burrs from Gyrus ACMI, Inc. - ENT

Division.

Otologic handpiece styles are available in addition to Diego, including the Stapes

drill, and Viper Straight or Angled handpieces. All are lightweight and designed to

provide balanced power.

One-Time-Use Tubing Set – The disposable tubing set combines suction and

irrigation tubing into one component. The tubing set snaps into place, and works

in tandem with the fluid control design to speed set-up and cleaning. The tubing

set is discarded at the end of the procedure. The Viper high-speed drill uses a

separate tubing set that does not include suction.

Under normal conditions, blades and burrs may come in contact with the patient.

PK blades are type BF applied parts.

Diego® System Manual

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Indicated Use

The Diego Powered Dissector System

The Diego Powered Dissector System’s intended use is the cutting and removal of bone and

tissue in general ENT, Head & Neck, and Otoneurologic procedures. Sinus applications would

embody Ethmoidectomy, Sphenoethmoidectomy, Polypectomy, Septoplasty, and procedures

such as the removal of septal spurs, Antrostomy, Frontal Sinus Trephination and irrigation, Frontal

Sinus Drill-out, Endoscopic DCR and Trans-sphenoidal procedures. Nasopharyngeal/Laryngeal

procedures would comprise Adenoidectomy, Laryngeal lesion de-bulking, laryngeal

polypectomy, tracheal procedures and tonsillectomy. Head & Neck procedures would

encompass soft tissue shaving, Rhinoplasty (narrowing of the bony vault and revision of the

bony pyramid), removal of fatty (adipose) tissue (Lipodebridement) in the maxillary and

mandibular regions of the face, and acoustic neuroma removal. Otology procedures would

include Mastoidectomy and Mastoidotomy. Additionally, an irrigation pump is integrated into

the controller unit to provide irrigant to the surgical site in conjunction with the procedures.

Diego Handpiece

The Diego handpiece is intended for general nose, throat, and head & neck procedures. All

Powered Dissector handpieces are intended to be used with the Gyrus ACMI, Inc. - ENT

Division disposable sinus Powered Dissector blades and burrs. The equipment can be used in

endoscopic or traditional methods of surgery. This equipment is not intended for use in

Arthroscopy.

Stapes/Viper Handpiece

The Stapes and Viper Handpieces are for use in otologic and otoneurologic procedures only.

All Stapes and Viper handpieces are intended for use with Gyrus ACMI, Inc. - ENT Division burrs

only.

Transport and Storage Conditions

Parameter

Ambient Temperature Range

Relative Humidity Range (Non-condensing)

Atmospheric Pressure Range

From

0º C

30%

500 hPa

Power Ratings

100 - 120/220 - 240 V AC, 50/60 Hz, 2 A.

Diego® System Manual

3

To

50º C

90%

1060 hPa

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System Layout

Diego Powered Dissector Console

70339000

Front Panel

1

2

3

4

5

6

8

9

7

10

11

12

13

1. Power On/Standby Switch

2. Maximum Handpiece RPM Display

3. Handpiece Speed Adjustment

Control Switches

5. Actual Handpiece RPM Display

4. Active Handpiece Selection Switches

7. Footswitch Operating Mode

Switches (constant & variable)

9. Irrigating Pump Flow Rate Control

Switches / Display

11. Footswitch Input Connector

13. Irrigation Tubing

Diego® System Manual

6. Handpiece Operating Mode Switches

(forward, reverse, oscillate)

8. Irrigating Pump On/Off Switch

10. Irrigating Pump Prime Switch

12. Handpiece Input Connectors

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System Layout (cont.)

Diego Powered Dissector Console

70339000

Rear Panel

1

2

3

1. IV Attachment Clamp

2. Grounding Post

3. Power Input Connector

Diego® System Manual

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System Layout (cont.)

Diego Powered Dissector Handpiece

70338010

70339001

6

3

2

1

4

5

1. Blade/Burr Engagement Collet

2. Nose Cone (revolving action)

3. Housing

4. Strain relief boot

5. Power Cord

6. Dual Lumen Suction & Irrigation Tubing

Set, disposable (with snap-on connector)

Diego® System Manual

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System Layout (cont.)

Diego Powered Dissector Footswitch

70338011

1

2

3

1. Mode Change Button

2. Lighted Footpedal

3. Toe Loop

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System Description

Maximum Handpiece RPM Display

This is a 5 segment, LED display to indicate the maximum attainable RPM of the active handpiece.

Actual Handpiece RPM Display

This is a 5 segment, LED display to indicate the actual RPM of the active handpiece.

Handpiece Speed Limit Adjustment Control Switches

The plus and minus button controls—located on the front of the console on either side of the

maximum speed display—allow the user to set the upper speed limit in either constant or variable

mode.

Handpiece Operating Mode Switches

The Diego Powered Dissector & Drill System operates the Diego Powered Dissector handpiece, Gyrus

ACMI, Inc. - ENT Division Viper straight and angled drills, and the Gyrus ACMI, Inc. - ENT Division Stapes

drill. Switches are provided on the front panel to control the mode of the active handpiece. If the

handpiece does not support a mode, the switch shall not allow selection of that mode. The following

modes are available:

Powered Dissector

Drill(s)

Oscillate, Forward & Reverse

Forward & Reverse

Active Handpiece Selection Switches

An LED display indicates which handpiece is active, as determined by the selector switches.

Footswitch Operating Mode Switches

Changes the footswitch function from constant to variable.

Irrigating Pump

The irrigation pump is a rotary type, peristaltic pump designed to drive irrigating solution to the surgical

site via the Powered Dissector blade/burr or Viper mastoid drill handpiece. The irrigating pump is located

on the side of the unit.

Irrigating Pump On/Off Switch

The irrigation pump can be turned on/off by the power switch located on the front of the console as

indicated by the LED light.

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Irrigating Pump Prime Switch

To facilitate easy setup of the irrigation pump, a prime switch is provided that allows

continuous pump operation to fill all tubing and/or handpiece with irrigant.

Irrigating Pump Flow Rate Control Switches/Display

The flow rate of the pump is displayed on the front panel of the controller using a vertical

bar-graph type display. The flow rate of the pump can be adjusted by pressing the (+)

increase or (-) decrease switches located on the front panel. The pump is on the side

of the unit.

Diego® System Manual

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System Set-Up Instructions

System Components

Description

Console & Power Cord

Diego Handpiece

Cat. No.

70339000

70338010

70339001

Otology Drill Handpieces

Synergy Viper Straight

Synergy Viper Angled

Synergy Stapes

Footswitch

Accessories

Diego System Bifurcated Suction/Irrigation Tubing

Irrigation Bag Spike Assembly for Mastoid Drill

Handpiece Cleaning Kit

Powered Dissector

Mastoid and Stapes Drill

70338009

70325512

Power Cord for use in the U.K.

Power Cord for use in Continental Europe

Power Cord for use in Australia

70231054

70231055

70231056

70338030

70338031

70338032

70338011

70338003

70338007

A visual inspection should be completed prior to each use of the system. Examine the

handpiece power cord for damage, such as nicks and cuts. DO NOT USE THE

HANDPIECE IF THE POWER CORD IS DAMAGED.

Verify the blade or burr is in good condition. DO NOT USE A BLADE OR BURR IF IT IS

NOT IN PROPER WORKING ORDER. Test the chucking mechanism by engaging and

removing a blade/burr several times.

Verify that the system is operating properly by connecting the handpiece and footswitch

and then running the system in the appropriate modes.

Diego® System Manual

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Console

Step 1

a) Connect the power cord into the port on the back of the console and into the appropriate

power outlet.

b) Press the Power On/Standby switch. All displays will turn on, then go off. The Power light

will remain illuminated.

Step 2

Connect the desired handpiece. The handpiece default mode illuminates, and the button for

the selected handpiece (1 or 2) illuminates. NOTE: Maximum RPM shows the default

handpiece setting. Actual RPM shows 0.

Step 3

Connect the footpedal into the plug labeled as follows. The footpedal lights on both the

console and footswitch illuminate. NOTE: If the handpiece is not first connected, only

footswitch lights illuminate.

Step 4

a) The irrigating pump flow rate control display illuminates flow display defaults. NOTE:

When using the Stapes drill handpiece, the pump is not available.

b) You may now adjust the flow by pressing the + or - buttons. (See icons below.)

(To ensure irrigation of the surgical site, the flow of irrigating solution must exceed the

level of suction.)

c) Prime the pump by pressing the PRIME button. The flow display will show this.

Footswitch

The Diego single-pedal footswitch (Catalog No. 70338011) allows for operation in both

variable and constant modes, depending on the console setting. Footswitch lights will illuminate

when the footswitch is connected.

Handpiece(s)

Active Handpiece

Handpieces can be connected to the controller by aligning the indicator mark on the plug with

the corresponding indicator mark on the console input port and pushing until it clicks. Switches

provided on the front panel select the active handpiece. Pressing the switches changes the

active handpiece to the other connected handpiece.

Diego® System Manual

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Handpiece(s) (Cont.)

IT IS VERY IMPORTANT THAT THE INDICATOR MARKINGS ARE PROPERLY ALIGNED. If

the alignment is incorrect, you will not be able to connect the handpiece with the console and

the handpiece will not operate.

70339001

SPEED (Maximum RPM)

Forward & Reverse Mode

Oscillate Mode

Diego® System Manual

Stapes

Viper

70338032

70338030

70338031

15,000

12,000

5,000

Table 1–Supported Handpieces

12

44,000

-

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Blade and

Burr Set-up

(Powered Dissector)

The Diego Handpiece (Sold separately from console)

The Diego Powered Dissector handpiece (Catalog No. 70338010, 70339001) is a lightweight

and powerful handpiece specifically designed for use with the Diego console, and performs to

the parameters listed in Table 1. In order to operate the handpiece, chuck a single use

disposable blade/burr into the chucking mechanism (one of 8 available positions). Diego

includes a revolving blade chucking feature, allowing the user to orient the blade window

manually. Once securely chucked, the user can manually orient the blade window orientation

by rotating the nose cone left or right.

Powered Dissector Blades and Burrs

Diego Powered Dissector blades/burrs are provided sterile and are single-use disposable instruments. Their hubs are designed to fit only the Gyrus ACMI, Inc. - ENT Division Diego Powered

Dissector handpieces. There are various patterns, including straight, curved, smooth blades,

serrated blades, and burrs.

Powered Dissector Blade and Burr Engagement

A Powered Dissector blade or burr may be positioned in each of 24 different positions on

Diego. The window position may be changed intraoperatively by rotating the nose cone.

To engage the Powered Dissector blades/burrs:

1. Pull the sliding collet back.

2. Rotate the hub until the key aligns on the chucking mechanism.

3. Insert the plastic driver hub of the blade/burr into the handpiece until it stops completely.

4. Release the collet and firmly push the blade/burr into the handpiece until the collet springs

back into its original position.

5. Pull slightly on the shaft of the blade/burr to verify engagement.

6. If the blade/burr pulls out, repeat steps 1-5.

To disengage the Powered Dissector blade/burr:

1. Pull the sliding collet back.

2. Pull the blade/burr out of the handpiece.

NOTE: Since the Powered Dissector blade/burr is a two-piece configuration, it is possible that

the inner component may remain in the handpiece when the outer component is removed.

If this happens, simply pull the inner component out. The chucking mechanism will not engage

the inner component alone.

The blades, burrs and tubing sets are one-time use disposable items. These items should be

replaced after each surgery. Disposal of these items should comply with local hospital regulations for disposable items.

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Burr

Set-up

(Otologic Drills)

Viper Handpieces: (Sold separately from console)

There are 2 Viper handpieces: Angled (70338030) and Straight (70338031). The handpiece

power cord attaches through a custom strain relief for anti-rotation and anti-pullout, and attaches

to the console with a quick release connecor. Hybrid ceramic bearings are used for decreased

friction and corrosion resistance. The burr chucking mechanism features a locking ring with no

external button to eliminate accidental release of the burr. Each handpiece has replaceable

irrigation tubing that is secured to the power cord with quick release connectors. This tubing has

a male luer connector.

Stapes Handpiece: (Sold separately from console)

There is one stapes handpiece: (70338032) The handpiece power cord attaches through a

custom strain relief for anti-rotation and anti-pullout, and attaches to the console with a quick

release connector. The burr chucking mechanism incorporates a sliding collet. Hybrid ceramic

bearings are used for decreased friction and corrosion resistance. The shaft is bent at a 15º angle

to maximize visualization of the operative site.

Viper / Drill Burr Engagement:

THE VIPER HANDPIECES WILL WORK ONLY WITH THE VIPER/MASTOID BURRS. THE

STAPES HANDPIECE WILL WORK ONLY WITH THE STAPES BURRS.

NOTE: ALL VIPER/MASTOID BURRS COME STERILE AND ARE INTENDED FOR ONE USE

ONLY. STAPES BURRS ARE NON-STERILE AND CAN BE RE-USED, AFTER STERILIZATION.

The Viper drill has a burr locking ring for engaging and disengaging burrs. When this locking

mechanism is open the burrs will not engage. The locking ring must be closed in order to

engage the burrs.

Viper / Mastoid burrs are engaged as follows:

1.

2.

3.

4.

Lock the locking ring by rotating it forward until it stops turning.

Insert the notched end of the burr into the nosecone of the handpiece.

Rotate the burr back and forth, and pull in and out slightly until you hear and feel a click.

Tug slightly on the burr. If it does not pull out, it has engaged. If it pulls out, repeate the above

procedure. Another indicator of burr engagement is a ring around the shank of the burr. If

this ring is visible after burr insertion, the burr is not properly engaged.

5. If the burr still does not engage, pull it out of the nosecone, rotate the bur one-quarter turn,

and repeat the initial procedure again.

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The stapes handpiece has a sliding collet burr engagement mechanism. This grooved collet is

located just behind the angled shaft of the nosecone. Engage the Stapes Burrs as follows:

1.

2.

3.

4.

Pull back on the sliding collet.

Hold the collet in place and insert the burr into the nosecone.

Release the sliding collet.

Gently tug outward on the burr. If it does not pull out, the burr has engaged. If it does pull

out, repeat the burr engagement procedure.

DO NOT OPERATE THE HANDPIECE IF THE BURR IS NOT PROPERLY ENGAGED. If the

burr is not properly engaged, the drill will not cut and the drive components may be damaged.

THE DRILL HANDPIECES ARE DESIGNED FOR USE ONLY WITH GYRUS ACMI BURRS.

No other burrs will engage or function with these handpieces.

ALL GYRUS ACMI CUTTING BURRS ARE DESIGNED TO CUT IN THE FORWARD

DIRECTION. The diamond burr functions equally well in forward or reverse.

Viper / Mastoid burrs are changed as follows:

1. Loosen the locking ring one-half to one full turn. IT IS RECOMMENDED THAT THE

CONSOLE BE TURNED OFF PRIOR TO BURR REMOVAL.

2. Remove the burr. BURRS, PARTICULARLY CUTTING BURRS, MAY BECOME VERY

HOT DURING USE. Exercise caution when removing burrs.

3. Lock the ring by rotating it forward until it stops turning.

4. Repeat the burr engagement procedure.

Stapes burrs are changed as follows:

1.

2.

3.

4.

Pull back on the sliding collet.

Remove the burr and hold the collet open.

Insert the new burr

Release the collet.

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Suction/Irrigation Set-up

Suction/Irrigation Tubing Assembly Installation (Powered Dissector)

1. Inspect sterile package to assure that sterility has been maintained.

2. Remove tubing from package using appropriate sterile technique.

3. Center the tubing into the pump assembly located on the side of the console as

shown on page 4, then turn the knob. When the knob handle is at the 3 o’clock/9

o’clock position, the pump is closed and ready for use. THE TUBING SHOULD

NOT BE STRETCHED, NOR SHOULD THERE BE ANY SLACK.

4. Connect the spike end to a standard I.V. bag. Connect the integrated suction tube

to the suction canister. Push the tubing connector into the connection port on the

rear (proximal) end of the Diego handpiece until a palpable “click” is felt. Suction

and irrigation is now ready to use. No additional attachment to the blade is

necessary (To ensure irrigation of the surgical site, the flow of irrigating solution

must exceed the level of suction.)

Suction/Irrigation Tubing Assembly Installation (Otologic Drills)

Repeat steps 1 - 3

4. Connect the spike end to a standard I.V. bag. The Viper drill is provided with an

attached irrigation tube with male Luer lock. Connect the two irrigation lines by

inserting the male Luer lock into the female Luer lock and secure by twisting. (To

ensure irrigation of the surgical site, the flow of irrigating solution must exceed the

level of suction.)

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Cleaning and Sterilization

Important Guidelines for Cleaning

Thorough cleaning and rinsing is vital to reprocessing reusable medical devices. Effective cleaning

must be carried out to achieve proper decontamination. All cleaning should be performed in a

manner designed to minimize exposure to bloodborne pathogens. Reusable medical devices

should be kept moist immediately after use until cleaning. Devices capable of disassembly must be

disassembled prior to cleaning. Thorough cleaning and rinsing should be carried out as soon as

possible. Manual cleaning with appropriate brushes should be done while the instrument is

being rinsed (if applicable). The purpose of cleaning and rinsing is to remove all adherent visible soil

and to reduce particulate matter, microorganisms and pyrogens. Furthermore, thorough rinsing is

necessary to remove any residual cleaning agents from the medical devices that could protect microorganisms from destruction and reduce the lethality of the sterilization process. Medical devices that will

be stored between cleaning and decontamination should be dried with low linting, non-abrasive soft

cloth to prevent microbial contamination that could result from wet instruments.

Console and Footswitch

Wipe the outside of the console and footswitch using a soft wipe and isopropyl alcohol.

Cleaning Agents and Equipment

Detergents

Proteolytic enzymatic detergents with a pH range between 6.0 and 8.0

should be used. These detergents have nonionic surfactants. Detergents

should be used at the concentration level recommended by the manufacturer. Note: Undiluted detergents and ones with pHs greater than 8.0

can strip the coloration from metal instruments.

Water

The quality of water should be carefully considered for use in preparing

enzymatic detergents and for rinsing in the cleaning procedure. Water

hardness is a concern because deposits left on medical devices may result

in ineffective cleaning and decontamination. Deionized water can help

prevent discoloration and staining associated with mineral residues found

in tap water.

Sterile isopropyl

alcohol prep pads

Soft Cloths

Cleaning Brushes

Used for cleaning console and footswitch.

For drying handpiece.

Diego Powered Dissector Cleaning Kit (70338009) and the Synergy

Drill Cleaning Kit (70325512) are both available from Gyrus ACMI, Inc. ENT Division at 1-800-773-4301.

Diego® System Manual

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OBSERVE THE FOLLOWING CAUTIONS WHEN CLEANING THE

HANDPIECE:

• HANDPIECE SHOULD BE STERILIZED PRIOR TO FIRST USE.

• CLEAN THE HANDPIECE THOROUGHLY AFTER EVERY PROCEDURE. The

Powered Dissector and Drill handpiece are motorized equipment. The reliability

and performance of this equipment is highly dependent on proper care and

cleaning. Without proper cleaning, suction strength may be reduced resulting in

diminished cutting performance.

• DO NOT AUTOCLAVE THE HANDPIECE UNLESS IT HAS BEEN THOROUGHLY

CLEANED ACCORDING TO THE PROCEDURES OUTLINED BELOW. Debris left

in the handpiece will be much more difficult to clean and remove after heating in

an autoclave.

• USE WARM SOAPY WATER FOR CLEANING. Warm water is much more effective

at removing blood and tissue.

• DO NOT ALLOW FLUID, BLOOD, AND TISSUE TO DRY IN THE HANDPIECE

PRIOR TO CLEANING OR AUTOCLAVING.

• AVOID THE USE OF CHEMICAL CLEANING AGENTS, WHICH MIGHT DAMAGE

THE INSTRUMENT. USE A NON-RESIDUE CLEANER, PREFERABLY

ISOPROPYL ALCOHOL, OR A SOLUTION OF 10% MILD DETERGENT AND

90% WATER.

• DO NOT CLEAN USING CIDEX® OR ULTRASONIC WASHERS! ANY OF THESE

CLEANING METHODS MAY DAMAGE THE HANDPIECE AND WILL VOID THE

PRODUCT WARRANTY.

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Diego Handpiece

Required Cleaning

Equipment:

Lukewarm water, a clean, soft towel, and sterile isopropyl alcohol

prep pads

Cleaning Procedure:

1. Wipe down the external surface of the hand piece with warm soapy

(enzymatic, biocidal, detergent) water.

2. Using a round, small diameter, soft bristle brush, moistened with the

soapy water, gently scrub the interior of the chucking mechanism, and

the through channel to loosen any soil. Take care not to scratch the

interior of the handpiece.

3. Holding the hand piece with the chuck end up, flush the interior of the

hand piece with running water, to remove loosened soil.

4. Flush the exterior of the hand piece with running water to remove

detergent and other soil.

5. Visibly inspect the exterior of the hand piece for any adherent soil.

6. Visibly inspect the interior, as far as possible, for adherent soil, paying

particular attention to the chucking mechanism and crevices in and

around the interior of the device.

7. Repeat if needed.

Sterilization

The Diego Powered Dissector handpiece is designed for sterilization by steam

autoclave.

ALWAYS REMOVE BLADES BEFORE STERILIZATION OF THE HANDPIECE.

IT IS CRITICAL TO PROPERLY CLEAN ALL REUSABLE DEVICES PRIOR TO

STERILIZATION.

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Yes1

Yes2

Yes

Handpieces

Stapes Burrs

Yes

Yes2

Gravity

Wrapped

Yes

Yes1

Gravity

Unwrapped

Yes

No

EO

Yes

No

Chemical

Disinfectant

Yes

No

Chemical

Sterilant

No

No

Gas

Plasma3

Diego® System Manual

NOTES:

1. The flash cycle is not recommended as optimum sterilization method for the handpieces due to the lack of a vacuum drying cycle.

2. A 30-minute vacuum drying cycle must follow the steam autoclave cycle to remove moisture remaining inside the handpiece.

3. Gas plasma cycle refers to the STERRAD® Sterilization System.

Cycle Parameters

The following cycle parameters relate to the table above.

Handpieces

A 30-MINUTE VACUUM DRYING CYCLE MUST FOLLOW THE STEAM AUTOCLAVE CYCLE TO REMOVE MOISTURE

REMAINING INSIDE THE HANDPIECE.

Gravity Cycle: Full Cycle–15 minutes @ 270 -275ºF (132ºC)

Pre-vacuum Cycle, Flash: Full Cycle–3 minutes @ 270-275ºF (132ºC)

Pre-vacuum Cycle, Wrapped: Full Cycle–3 minutes @ 270-275ºF (132ºC)

*NOTE: May be processed at temperatures up to 278.6 °F (137 °C)

CAUTION: Do not quench the handpiece following sterilization as damage to the handpiece may occur.

Additional information on cleaning and sterilizing ENT devices may be obtained by contacting the Quality Assurance Department at

Gyrus ACMI, Inc. - ENT Division by telephone at 800-262-3540 or 901-373-0200 (USA).

A “No” indicates Gyrus ACMI, Inc. - ENT Division does not currently have the data to support the recommendation of the specified method of sterilization for the given category. It does not necessarily indicate the inability of the cycle to effectively sterilize this category of device.

Yes

Prevacuum

Unwrapped

Prevacuum

Wrapped

Device Type

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Sterilization

Recommendations

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Otologic Handpieces and Burrs

Cleaning and Sterilization

Cleaning

CLEAN THE HANDPIECES THOROUGHLY PRIOR TO EVERY STERILIZATION CYCLE.

Blood and tissue not removed prior to sterilization may become dried and affixed to the interior

of the Handpiece. These deposits will detract from the Handpiece performance and life span.

The following is the recommended cleaning procedure for the Handpieces:

Disconnect the Irrigation Spike Assembly from the Handpiece Irrigation Tubing. Damaged or

discolored irrigation tubing should be replaced with part number 70921605. Flush the Irrigation

Tubing with a syringe filled with distilled water. Remove the remaining fluid from the Irrigation

Tubing. This can be done by placing the Irrigation Tubing in the Pump. Turn the pump on by

pressing the pump on/off switch, then flush the remaining fluid by using the primer button. The

remaining fluid can be forced out by inserting an empty syringe into the Handpiece Irrigation

Tubing and forcing 2-3 syringes of air through the tubing.

If you choose not to use the pump to flush out the extra irrigation fluid you may flush out the

fluid solely with the syringe.

ALWAYS DISCONNECT THE HANDPIECE(S) FROM THE CONSOLE AFTER FLUSHING,

BUT PRIOR TO CLEANING.

Remove the bur from the Handpiece and close the Locking Ring to the locked position. Using

a soft wipe and a mild, low-sudsing detergent or isopropyl alcohol, remove any blood and tissue

from the exterior of the Handpiece and tubing. Wipe debris from the Console at this time

following the same procedure.

DO NOT IMMERSE THE HANDPIECES IN LIQUID OR CLEAN BY ULTRASONIC MEANS!

DO NOT USE AUTOMATED WASHING-DISINFECTION SYSTEMS ON THE HANDPIECES.

The Handpieces contain electrical components that are not designed for immersion. Failure to

observe this caution can result in damage to the Handpieces and the warranty will be voided.

Fill a syringe from the Cleaning Kit (70325512) with isopropyl alcohol. Hold the handpiece

upside down (nosecone down) and insert the tip of the syringe into the Nosecone of the

inverted Handpiece. DO NOT FLUSH THE HANDPIECE UNLESS THE NOSECONE IS

POINTED DOWN.

Diego® System Manual

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